Quality in pathology laboratory practice.

Science.gov (United States)

Weinstein, S

1995-06-01

Quality refers not only to analytical quality control, a traditional area of laboratory excellence, but to the entire science of quality management. As measures of quality, structural indicators refer to staffing and physical facilities, process indicators to the institutions operations and, perhaps most importantly, outcome indicators address the ultimate patient care uses that pathology information is put to. Comparison of performance to peer laboratories, external quality control, is a practical, if limited, yardstick of performance. Customer satisfaction and turn-around-time of tests are receiving more recent attention as quality measures. Blood banking, because of its inherently complex cycle from donor phlebotomy to product infusion, requires special considerations with regard to quality management. Reporting of anatomical pathology, where the only gold standard is a consensus of experts, also does not lend itself to classical numerical quality assessment.

Laboratory quality assurance and its role in the safeguards analytical laboratory evaluation (SALE) program

International Nuclear Information System (INIS)

Delvin, W.L.; Pietri, C.E.

1981-07-01

Since the late 1960's, strong emphasis has been given to quality assurance in the nuclear industry, particularly to that part involved in nuclear reactors. This emphasis has had impact on the analytical chemistry laboratory because of the importance of analytical measurements in the certification and acceptance of materials used in the fabrication and construction of reactor components. Laboratory quality assurance, in which the principles of quality assurance are applied to laboratory operations, has a significant role to play in processing, fabrication, and construction programs of the nuclear industry. That role impacts not only process control and material certification, but also safeguards and nuclear materials accountability. The implementation of laboratory quality assurance is done through a program plan that specifies how the principles of quality assurance are to be applied. Laboratory quality assurance identifies weaknesses and deficiencies in laboratory operations and provides confidence in the reliability of laboratory results. Such confidence in laboratory measurements is essential to the proper evaluation of laboratories participating in the Safeguards Analytical Laboratory Evaluation (SALE) Program

Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory.

Science.gov (United States)

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti

2014-09-01

To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

Public health laboratory quality management in a developing country.

Science.gov (United States)

Wangkahat, Khwanjai; Nookhai, Somboon; Pobkeeree, Vallerut

2012-01-01

The article aims to give an overview of the system of public health laboratory quality management in Thailand and to produce a strengths, weaknesses, opportunities and threats (SWOT) analysis that is relevant to public health laboratories in the country. The systems for managing laboratory quality that are currently employed were described in the first component. The second component was a SWOT analysis, which used the opinions of laboratory professionals to identify any areas that could be improved to meet quality management systems. Various quality management systems were identified and the number of laboratories that met both international and national quality management requirements was different. The SWOT analysis found the opportunities and strengths factors offered the best chance to improve laboratory quality management in the country. The results are based on observations and brainstorming with medical laboratory professionals who can assist laboratories in accomplishing quality management. The factors derived from the analysis can help improve laboratory quality management in the country. This paper provides viewpoints and evidence-based approaches for the development of best possible practice of services in public health laboratories.

First Worldwide Proficiency Study on Variable-Number Tandem-Repeat Typing of Mycobacterium tuberculosis Complex Strains

Science.gov (United States)

de Beer, Jessica L.; Kremer, Kristin; Ködmön, Csaba; Supply, Philip

2012-01-01

Although variable-number tandem-repeat (VNTR) typing has gained recognition as the new standard for the DNA fingerprinting of Mycobacterium tuberculosis complex (MTBC) isolates, external quality control programs have not yet been developed. Therefore, we organized the first multicenter proficiency study on 24-locus VNTR typing. Sets of 30 DNAs of MTBC strains, including 10 duplicate DNA samples, were distributed among 37 participating laboratories in 30 different countries worldwide. Twenty-four laboratories used an in-house-adapted method with fragment sizing by gel electrophoresis or an automated DNA analyzer, nine laboratories used a commercially available kit, and four laboratories used other methods. The intra- and interlaboratory reproducibilities of VNTR typing varied from 0% to 100%, with averages of 72% and 60%, respectively. Twenty of the 37 laboratories failed to amplify particular VNTR loci; if these missing results were ignored, the number of laboratories with 100% interlaboratory reproducibility increased from 1 to 5. The average interlaboratory reproducibility of VNTR typing using a commercial kit was better (88%) than that of in-house-adapted methods using a DNA analyzer (70%) or gel electrophoresis (50%). Eleven laboratories using in-house-adapted manual typing or automated typing scored inter- and intralaboratory reproducibilities of 80% or higher, which suggests that these approaches can be used in a reliable way. In conclusion, this first multicenter study has documented the worldwide quality of VNTR typing of MTBC strains and highlights the importance of international quality control to improve genotyping in the future. PMID:22170917

The impact of laboratory quality assurance standards on laboratory operational performance

Directory of Open Access Journals (Sweden)

E Ratseou

2014-01-01

Full Text Available It has become a trend for companies to implement and be certified to various quality management systems so as to improve consistency, reliability, and quality of product delivery to customers. The most common quality management systems adopted are the ISO 9000 series of standards for manufacturing and services related organisations, with ISO 17025 and Good Laboratory Practices (GLP standards adopted specifically by laboratories as quality assurance initiatives. There are various reports on the impact of the ISO 9000 series on organisational performance but no studies or reports have been done on the performance of laboratory standards. Therefore this article reports on a study conducted to investigate the impact of ISO 17025 and GLP on the operational performance of both commercial and non-commercial laboratories. A qualitative research study was conducted to examine the impact standards on the aspects of health and safety, supplier selection and performance, human resources, customer satisfaction and profitability of the laboratory. The data collected suggest that there is no difference in laboratory operational performance with or without the standards. In other words it appears that the basic fundamental requirements inherent with laboratories are sufficient to perform both operationally and optimally. This leads to the view that standards are implemented as a customer requirement and not as an operational requirement.

AUTOMATION OF THE SYSTEM OF INTERNAL LABORATORY QUALITY CONTROL

Directory of Open Access Journals (Sweden)

V. Z. Stetsyuk

2015-05-01

Full Text Available Quality control system base d on the principles of standardi zation of all phases of laboratory testing and analysis of internal laboratory quality control and external quality assessment. For the detection accuracy of the results of laboratory tests, carried out internally between the laboratory and laboratory quality control. Under internal laboratory quality control we understand measurement results of each analysis in each anal ytical series rendered directly in the lab every day. The purpose of internal laboratory control - identifying and eliminating unacceptable deviations from standard perfor mance test in the laboratory, i.e. identifying and eliminating harmful analytical errors. The solutions to these problems by implementing automated systems - software that allows you to optimize analytical laboratory research stage of the procedure by automatically creating process control charts was shown.

BYU Food Quality Assurance Laboratory

Data.gov (United States)

Federal Laboratory Consortium — The Quality Assurance Lab is located in the Eyring Science Center in the department of Nutrition, Dietetics, and Food Science. The Quality Assurance Lab has about 10...

Selecting clinical quality indicators for laboratory medicine.

Science.gov (United States)

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

Analytical quality, performance indices and laboratory service

DEFF Research Database (Denmark)

Hilden, Jørgen; Magid, Erik

1999-01-01

analytical error, bias, cost effectiveness, decision-making, laboratory techniques and procedures, mass screening, models, statistical, quality control......analytical error, bias, cost effectiveness, decision-making, laboratory techniques and procedures, mass screening, models, statistical, quality control...

Troubles for the sustainability of the quality assurance in the laboratories of radiological control in Peru

International Nuclear Information System (INIS)

Gonzales, Susana; Lopez, Edith

2008-01-01

Full text: The Nuclear Energy Peruvian Institute (IPEN) has laboratories which offer services of radiological control. Radiometric analysis in raw and processed foodstuff is requested by several enterprises of both public and private sectors which uses the results for trading purposes like exportation, importation and licitations. The service of assays and calibration with reliable results has become a need due to the external audits performed by accredited laboratories to fulfil the requirements of the Peruvian standard organism. With the support of the International Atomic Energy Agency (IAEA), the IPEN laboratory of radiometric analysis implemented its quality system in 2001 under the ISO IEC 17025 Standard 'General Requirements for the Competence of the Calibration and Testing Laboratories' with the purpose to organize the activities and offer an enhanced service to the clients. The implementation of the quality system has allowed giving a better service with enhanced efficiency to the clients, assuring the reliability of the final output, the analytical results. It had been possible since the laboratories have participated in worldwide proficiency tests sponsored by the IAEA and currently work with reference material. The quality system allows identifying potential faults in any stage of the process in order to prevent any problem in the final output, assuring the appropriate quality of the issued analytical results and to take the necessary corrective actions to avoid those events to happen again. This study has identified and assessed several difficulties and troubles which prevent to fulfil the requirements of the Quality Standard and as a consequence, disable the sustainability of the quality systems and prevent the accreditation. Several proposals and solution alternatives which involve the Executive Staff and the proactive participation of the personnel are presented. (author)

Quality systems in veterinary diagnostics laboratories.

Science.gov (United States)

de Branco, Freitas Maia L M

2007-01-01

Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

Measurement quality assurance for radioassay laboratories

Energy Technology Data Exchange (ETDEWEB)

McCurdy, D.E. [Yankee Atomic Environmental Laboratory, Boston, MA (United States)

1993-12-31

Until recently, the quality of U.S. radioassay laboratory services has been evaluated by a limited number of governmental measurement assurance programs (MAPs). The major programs have been limited to the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA) and the U.S. Nuclear Regulatory Commission (NRC). In 1988, an industry MAP was established for the nuclear power utility industry through the U.S. Council for Energy Awareness/National Institute of Standards and Technology (USCEA/NIST). This program functions as both a MAP for utility laboratories and/or their commercial contractor laboratories, and as a traceability program for the U.S. radioactive source manufacturers and the utility laboratories. Each of these generic MAPs has been initiated and is maintained to serve the specific needs of the sponsoring agency or organization. As a result, there is diversification in their approach, scope, requirements, and degree of traceability to NIST. In 1987, a writing committee was formed under the American National Standards Institute (ANSI) N42.2 committee to develop a standard to serve as the basis document for the creation of a national measurement quality assurance (MQA) program for radioassay laboratories in the U.S. The standard is entitled, {open_quotes}Measurement Quality Assurance For Radioassay Laboratories.{open_quotes} The document was developed to serve as a guide for MQA programs maintained for the specialized sectors of the radioassay community, such as bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear facilities. It was the intent of the writing committee to develop a guidance document that could be utilized to establish a laboratory`s specific data quality objectives (DQOs) that govern the operational requirements of the radioassay process, including mandated protocols and recommendations.

Quality assurance and quality control in mammography: a review of available guidance worldwide.

Science.gov (United States)

Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

2013-10-01

Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

Extra-analytical quality indicators and laboratory performances.

Science.gov (United States)

Sciacovelli, Laura; Aita, Ada; Plebani, Mario

2017-07-01

In the last few years much progress has been made in raising the awareness of laboratory medicine professionals about the effectiveness of quality indicators (QIs) in monitoring, and improving upon, performances in the extra-analytical phases of the Total Testing Process (TTP). An effective system for management of QIs includes the implementation of an internal assessment system and participation in inter-laboratory comparison. A well-designed internal assessment system allows the identification of critical activities and their systematic monitoring. Active participation in inter-laboratory comparison provides information on the performance level of one laboratory with respect to that of other participating laboratories. In order to guarantee the use of appropriate QIs and facilitate their implementation, many laboratories have adopted the Model of Quality Indicators (MQI) proposed by Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of IFCC, since 2008, which is the result of international consensus and continuous experimentation, and updating to meet new, constantly emerging needs. Data from participating laboratories are collected monthly and reports describing the statistical results and evaluating laboratory data, utilizing the Six Sigma metric, issued regularly. Although the results demonstrate that the processes need to be improved upon, overall the comparison with data collected in 2014 shows a general stability of quality levels and that an improvement has been achieved over time for some activities. The continuous monitoring of QI data allows identification all possible improvements, thus highlighting the value of participation in the inter-laboratory program proposed by WG-LEPS. The active participation of numerous laboratories will guarantee an ever more significant State-of-the-Art, promote the reduction of errors and improve quality of the TTP, thus guaranteeing patient safety. Copyright © 2017. Published by Elsevier Inc.

Measurement quality assurance for radioassay laboratories

International Nuclear Information System (INIS)

McCurdy, D.E.

1993-01-01

Until recently, the quality of U.S. radioassay laboratory services has been evaluated by a limited number of governmental measurement assurance programs (MAPs). The major programs have been limited to the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA) and the U.S. Nuclear Regulatory Commission (NRC). In 1988, an industry MAP was established for the nuclear power utility industry through the U.S. Council for Energy Awareness/National Institute of Standards and Technology (USCEA/NIST). This program functions as both a MAP for utility laboratories and/or their commercial contractor laboratories, and as a traceability program for the U.S. radioactive source manufacturers and the utility laboratories. Each of these generic MAPs has been initiated and is maintained to serve the specific needs of the sponsoring agency or organization. As a result, there is diversification in their approach, scope, requirements, and degree of traceability to NIST. In 1987, a writing committee was formed under the American National Standards Institute (ANSI) N42.2 committee to develop a standard to serve as the basis document for the creation of a national measurement quality assurance (MQA) program for radioassay laboratories in the U.S. The standard is entitled, open-quotes Measurement Quality Assurance For Radioassay Laboratories.open-quotes The document was developed to serve as a guide for MQA programs maintained for the specialized sectors of the radioassay community, such as bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear facilities. It was the intent of the writing committee to develop a guidance document that could be utilized to establish a laboratory's specific data quality objectives (DQOs) that govern the operational requirements of the radioassay process, including mandated protocols and recommendations

222-S Laboratory Quality Assurance Plan. Revision 1

International Nuclear Information System (INIS)

Meznarich, H.K.

1995-01-01

This Quality Assurance Plan provides,quality assurance (QA) guidance, regulatory QA requirements (e.g., 10 CFR 830.120), and quality control (QC) specifications for analytical service. This document follows the U.S Department of Energy (DOE) issued Hanford Analytical Services Quality Assurance Plan (HASQAP). In addition, this document meets the objectives of the Quality Assurance Program provided in the WHC-CM-4-2, Section 2.1. Quality assurance elements required in the Guidelines and Specifications for Preparing Quality Assurance Program Plans (QAMS-004) and Interim Guidelines and Specifications for Preparing Quality Assurance Project Plans (QAMS-005) from the US Environmental Protection Agency (EPA) are covered throughout this document. A quality assurance index is provided in the Appendix A. This document also provides and/or identifies the procedural information that governs laboratory operations. The personnel of the 222-S Laboratory and the Standards Laboratory including managers, analysts, QA/QC staff, auditors, and support staff shall use this document as guidance and instructions for their operational and quality assurance activities. Other organizations that conduct activities described in this document for the 222-S Laboratory shall follow this QA/QC document

Laboratory quality stepwise implementation tool: National reference TB laboratory of Iran

OpenAIRE

Ali Naghi Kebriaee; Donya Malekshahian; Mojtaba Ahmadi; Parissa Farnia

2015-01-01

Background and objective: During recent years, the World Health Organization (WHO) proposed new software for improving the tuberculosis (TB) laboratory services. The protocol is known as “quality stepwise implementation tool” and is based on enforcement of quality assurance services through accreditation by the International Organization for Standardization (ISO) 15189. As a national reference TB laboratory (NRL) of Iran, the benefit and challenges of implementing this standard were analyzed....

Review and comparison of quality standards, guidelines and regulations for laboratories

Directory of Open Access Journals (Sweden)

Tjeerd A.M. Datema

2011-12-01

Full Text Available Background: The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. Objectives: There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. Method: We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services. Results: Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Conclusion: Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory

Quality assurance programme for isotope diagnostic laboratories

International Nuclear Information System (INIS)

Krasznai, Istvan

1987-01-01

Quality assurance systems are suggested to be introduced in laboratories, in accordance with the recommendations of IAEA and WHO, taking local circumstances into consideration. It is emphasized that a quantitative enhancement of work must not endanger its quality; diagnostic information must be undistorted, reproducible, and gathered with the minimum of radiation burden. National authorities are requested to strengthen their supervision. Recommendations for quality assurance methods are given for medical isotope diagnostic laboratories. (author)

Quality control activities in the environmental radiology laboratory

International Nuclear Information System (INIS)

Llaurado, M.; Quesada, D.; Rauret, G.; Tent, J.; Zapata, D.

2006-01-01

During the last twenty years many analytical laboratories have implemented quality assurance systems. A quality system implementation requires documentation of all activities (technical and management), evaluation of these activities and its continual improvement. Implementation and adequate management of all the elements a quality system includes are not enough to guarantee quality of the analytical results generated at a time. That is the aim of a group of specific activities labelled as quality control activities. The Laboratori de Radiologia Ambiental (Environmental Radiology Laboratory; LRA) at the University of Barcelona was created in 1984 to carry out part of the quality control assays of the Environmental Radiology Monitoring Programs around some of the Spanish nuclear power plants, which are developed by the Servei Catala d'Activitats Energetiques (SCAR) and the Consejo de Seguridad Nuclear (CSN), organisations responsible for nuclear security and radiological protection. In these kind of laboratories, given the importance of the results they give, quality control activities become an essential aspect. In order to guarantee the quality of its analytical results, the LRA Direction decided to adopt the international standard UNE-EN ISO/IEC 17025 for its internal quality system and to accreditate some of the assays it carries out. In such as system, it is established, the laboratory shall monitor the validity of tests undertaken and data shall be recorded in such a way that trends are detectable. The present work shows the activities carried out in this way by the LRA, which are: Equipment control activities which in the special case of radiochemical techniques include measurement of backgrounds and blanks as well as periodical control of efficiency and resolution. Activities to assure the specifications settled by method validation, which are testing of reference materials and periodical analysis of control samples. Evaluation of the laboratory work quality

Quality assurance for analitical dairy laboratories

Directory of Open Access Journals (Sweden)

Šimun Zamberlin

2005-04-01

Full Text Available Quality evaluation of analytical laboratories must be estimated through accuracy, precision and traceability of measurement results. In European countries, acceptable analytical results are those which come from accredited laboratories (EN ISO/IEC 17025:2000. This paper presents examples of traceability, measurement uncertainty, inner quality control and control through the interlaboratory proficiency testing of results for milk fat. Also it demonstrates proficiency testing organization of results for fat, protein, lactose and somatic cells in milk.

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I.

Science.gov (United States)

Guzel, Omer; Guner, Ebru Ilhan

2009-03-01

Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has

Research report 1987-1989: Environmental Quality Laboratory and Environmental Engineering Science, W. M. Keck Laboratories

OpenAIRE

Brooks, Norman H.

1990-01-01

This research biennial report for 1987-89 covers the activities of both the Environmental Engineering Science program and the Environmental Quality Laboratory for the period October 1987-November 1989. Environmental Engineering Science is the degree-granting academic program housed in the Keck Laboratories, with associated research projects. The Environmental Quality Laboratory is a research center focusing on large scale problems of environmental quality and natural resources. All the facult...

Quality assurance system in gamma spectrometry laboratory

International Nuclear Information System (INIS)

Mielnikow, A.; Michalik, B.; Chalupnik, S.; Lebecka, J.

1996-01-01

On basis of guidelines for development of QUALITY SYSTEM for a testing laboratory (European Standard Series EN 45000) a quality assurance system was implemented in gamma spectroscopy laboratory, where routine measurements of natural (mainly Ra-226, Ra-228, Ra-224, K-40) and artificial (mainly Cs-137 and Cs-134) isotopes are performed. We measure a variety of samples, but mainly coal, vaste rock, ashe, deposits, vegetation and air filters. Laboratory of gamma spectroscopy in Central Mining Institute has three HPGe detectors. There is one coaxial detector with 45% relative efficiency, one detector for low energy region and one detector with extended range). We have also two Ge(Li) detectors from former Czechoslovakia. Shielding is made mainly of steel (40 cm) with the interior covered with lead and copper. The electronics and software (Genie-PC) was bought at 'Canberra' and 'Silena'. The paper describes not only the system of quality assurance but also main problems met by its implementation and results of intercomparison measurements. The QAS has been introduced in 1992. In 1993 the Accreditation Certificate of Testing Laboratory for our Laboratory has been obtained from the Polish Bureau of Research and Certification as a fifth laboratory in Poland. (author)

Implementing a Quality Management System in the Medical Microbiology Laboratory.

Science.gov (United States)

Carey, Roberta B; Bhattacharyya, Sanjib; Kehl, Sue C; Matukas, Larissa M; Pentella, Michael A; Salfinger, Max; Schuetz, Audrey N

2018-07-01

This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum. Copyright © 2018 American Society for Microbiology.

[Quality assessment of microscopic examination in tuberculosis diagnostic laboratories: a preliminary study].

Science.gov (United States)

Simşek, Hülya; Ceyhan, Ismail; Tarhan, Gülnur; Güner, Uğur

2010-10-01

Recently, the diagnosis of pulmonary tuberculosis (TB) has based on smear microscopy in the Direct Observed Treatment Strategy (DOTS) programme which provides the basis of treatment worldwide. Microscopic detection of AFB (Acid-Fast Bacilli) is one of the main components in the National TB Control Programmes (NTCP). Precision level in microscopy procedures and evaluations are the most important steps for accurate diagnosis of the disease and to initiate proper treatment. Therefore, the external quality assessment (EQA) is the most important implement to provide the reliability and validity of tests. In countries where NTCP are performed, this task is fulfilled by the National Reference Laboratories (NRL) according to the guidelines of the World Health Organization (WHO). For this purpose a pilot study was initiated by the central NRL of Turkey for EQA of AFB smear microscopy as part of the NTCP on January 1, 2005. A total of 5 laboratories of which 2 were district TB laboratories (A, B), 2 were tuberculosis control dispensaries (C, D), 1 was a national reference laboratory (E), participated in this study. Blind re-checking method (re-examination of randomly selected slides) was used for the evaluation, and the slides were sent to the central NRL with 3 months interval, four times a year, selected according to LQAS (Lot Quality Assurance Sampling) guides. In the re-evaluation of the slides, false positivity (FP), false negativity (FN) and quantification errors (QE) were noted. Laboratory A, sent totally 525 slides between January 1, 2005 and April 1, 2008. In the result of re-checking, 514 (97.9%) slides were found concordant, and 11 (2.1%) were discordant (10 FP, 1 FN). Laboratory B, participated in the study between October 1, 2005 and July 1, 2006 and of the 67 re-examined slides, 60 (89.5%) were concordant and 7 (10.5%) were discordant (2 FP, 0 FN, 5 QE). Laboratory C, sent 235 slides between January 1, 2005 and April 1, 2006; of them 218 (92.8%) were detected

Laboratory diagnostic methods, system of quality and validation

Directory of Open Access Journals (Sweden)

Ašanin Ružica

2005-01-01

Full Text Available It is known that laboratory investigations secure safe and reliable results that provide a final confirmation of the quality of work. Ideas, planning, knowledge, skills, experience, and environment, along with good laboratory practice, quality control and reliability of quality, make the area of biological investigations very complex. In recent years, quality control, including the control of work in the laboratory, is based on international standards and is used at that level. The implementation of widely recognized international standards, such as the International Standard ISO/IEC 17025 (1 and the implementing of the quality system series ISO/IEC 9000 (2 have become the imperative on the grounds of which laboratories have a formal, visible and corresponding system of quality. The diagnostic methods that are used must constantly yield results which identify the animal as positive or negative, and the precise status of the animal is determined with a predefined degree of statistical significance. Methods applied on a selected population reduce the risk of obtaining falsely positive or falsely negative results. A condition for this are well conceived and documented methods, with the application of the corresponding reagents, and work with professional and skilled staff. This process requires also a consistent implementation of the most rigorous experimental plans, epidemiological and statistical data and estimations, with constant monitoring of the validity of the applied methods. Such an approach is necessary in order to cut down the number of misconceptions and accidental mistakes, for a referent population of animals on which the validity of a method is tested. Once a valid method is included in daily routine investigations, it is necessary to apply constant monitoring for the purpose of internal quality control, in order adequately to evaluate its reproducibility and reliability. Consequently, it is necessary at least twice yearly to conduct

7 CFR 58.523 - Laboratory and quality control tests.

Science.gov (United States)

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

The quality of veterinary in-clinic and reference laboratory biochemical testing.

Science.gov (United States)

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

Quality control of parasitology stool examination in Tabriz clinical laboratories

Directory of Open Access Journals (Sweden)

shahram Khademvatan

2011-06-01

Full Text Available The purpose of quality control program was to make doctors and laboratory personnel trust in laboratory results and consequently increasing confidence in laboratory achievements. The quality assurance means raising the level of quality in all tests that lead to raising the level of work efficiency and laboratories including minimum expense for society and minimum time for lab personnel. This study aimed to assess and determine the accuracy and precision of results in Tabriz medical diagnostic laboratories. Materials and Methods: In this retrospective study, 790 stool samples were selected randomly and tested by standard methods.Student t- test, SPSS software and sensitivity and accuracy formulas were used for data analysis. Results: The sensitivity was 62%, 22% and 8% with 95% confidence intervals for worm's eggs, protozoan cysts and trophozoite detection respectively. Conclusion: To elevate quality assurance in clinical diagnostic laboratory, monitoring and check of the laboratories by standard methods continually should be done.

Worldwide Open Proficiency Test: Determination of Natural and Artificial Radionuclides in Moss-Soil and Water IAEA-CU-2009-03

International Nuclear Information System (INIS)

2012-01-01

Reliable determination of natural and artificial radionuclides in environmental samples is necessary to comply with radiation protection and environmental regulations. The IAEA assists Member State laboratories in maintaining and improving their readiness by producing reference materials, by developing standardized analytical methods, and by conducting interlaboratory comparisons and proficiency tests as tools for quality control. To fulfil this obligation and ensure a reliable, worldwide, rapid and consistent response, the IAEA Terrestrial Environment Laboratory in Seibersdorf, Austria, organizes interlaboratory comparisons and proficiency tests. This summary report presents the results of the worldwide proficiency test IAEA-CU-2009- 03 on the determination of natural and artificial radionuclides in moss-soil and spiked water. The methodologies, data evaluation approach, summary evaluation of each nuclide and individual evaluation reports for each laboratory are also described. This proficiency test was designed to identify analytical problems, to support Member State laboratories to improve the quality of their analytical results and maintain their accreditation, and to provide a regular forum for discussion and technology transfer in this area. The number of samples, their matrix interferences and the concentration levels of the analytes were designed in a way that enables identification of potential analytical problems.

Radioanalytical laboratory quality control: Current status at Tennessee Valley Authority's western area radiological laboratory

International Nuclear Information System (INIS)

Rogers, W.J.

1986-01-01

The Tennessee Valley Authority operates a laboratory for radiological analysis of nuclear plant environmental monitoring samples and also for analysis of environmental samples from uranium mining and milling decommissioning activities. The laboratory analyzes some 9,000 samples per year and employs approximately 20 people as analysts, sample collectors, and supervisory staff members. The laboratory is supported by a quality control section of four people involved in computer support, production of radioactive standards, quality control data assessment and reporting, and internal reviews of compliance. The entire laboratory effort is controlled by 60 written procedures or standards. An HP-1000 computer and data base software are used to schedule samples for collection, assign and schedule samples within the laboratory for preparation and analysis, calculate sample activity, review data, and report data outside the laboratory. Gamma spectroscopy systems with nine germanium detectors, an alpha spectroscopy system, five alpha/beta counters, two liquid scintillation counters, four beta-gamma coincidence systems, two sodium iodide single-channel systems, and four photomultipliers for counting Lucas cells are all employed. Each device has various calibration and quality control checks performed on it routinely. Logbooks and control charts are in use for each instrument

Medical laboratories in sub-Saharan Africa that meet international quality standards.

Science.gov (United States)

Schroeder, Lee F; Amukele, Timothy

2014-06-01

A recent survey of laboratories in Kampala, Uganda, demonstrated that only 0.3% of laboratories (3/954) met international quality standards. To benchmark laboratory quality throughout the rest of sub-Saharan Africa (SSA), we compiled a list of SSA laboratories meeting international quality standards. Accrediting bodies were queried via online registries or direct communication in May 2013. There were 380 laboratories accredited to international standards in SSA. Ninety-one percent were in South Africa. Thirty-seven of 49 countries had no laboratories accredited to international quality standards. Accredited laboratory density (per million people) in South Africa, Namibia, and Botswana were similar to those in many European countries. Single variable linear regression showed a correlation between accredited laboratory density and health expenditures per person (adjusted R(2) = 0.81, P clinical laboratory. For those that do, there is a strong correlation between country-specific accredited laboratory density and per-capita health expenditures. Copyright© by the American Society for Clinical Pathology.

Laboratory quality management system: Road to accreditation and beyond

Directory of Open Access Journals (Sweden)

V Wadhwa

2012-01-01

Full Text Available This review attempts to clarify the concepts of Laboratory Quality Management System (Lab QMS for a medical testing and diagnostic laboratory in a holistic way and hopes to expand the horizon beyond quality control (QC and quality assurance. It provides an insight on accreditation bodies and highlights a glimpse of existing laboratory practices but essentially it takes the reader through the journey of accreditation and during the course of reading and understanding this document, prepares the laboratory for the same. Some of the areas which have not been highlighted previously include: requirement for accreditation consultants, laboratory infrastructure and scope, applying for accreditation, document preparation. This section is well supported with practical illustrations and necessary tables and exhaustive details like preparation of a standard operating procedure and a quality manual. Concept of training and privileging of staff has been clarified and a few of the QC exercises have been dealt with in a novel way. Finally, a practical advice for facing an actual third party assessment and caution needed to prevent post-assessment pitfalls has been dealt with.

Phlebotomy and quality in the African laboratory

Directory of Open Access Journals (Sweden)

Henry A. Mbah

2014-08-01

Full Text Available Phlebotomy, the act of drawing blood through venepuncture, is one of the most common medical procedures in healthcare, as well as being a basis for diagnosis and treatment. A review of the available research has highlighted the dearth of information on the phlebotomy practice in Africa. Several studies elsewhere have shown that the pre-analytical phase (patient preparation, specimen collection and identification, transportation, preparation for analysis and storage is the most error-prone process in laboratory medicine. The validity of any laboratory test result hinges on specimen quality; thus, as the push for laboratory quality improvement in Africa gathers momentum, the practice of phlebotomy should be subjected to critical appraisal. This article offers several suggestions for the improvement of phlebotomy in Africa.

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

Science.gov (United States)

Ehrmeyer, Sharon S; Laessig, Ronald H

2004-08-02

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

Worldwide proficiency test for X ray fluorescence laboratories PTXRFIAEA/05 determination of minor and trace elements in marine sediment

International Nuclear Information System (INIS)

2009-01-01

The proficiency test (code PTXRFIAEA05) was the fifth worldwide exercise organized by the IAEA Seibersdorf Laboratories in order to assist X ray fluorescence laboratories in assessment and improvement of their analytical performance. The test was carried out within the IAEA Project 1.4.3.4 (D.3.03) on Nuclear Spectrometry for Analytical Applications, under the Nuclear Science Programme. The main objective of the project was to enhance capability of interested Member States in effective utilization of nuclear spectrometries and analytical services in industry, human health, agriculture, and in monitoring and evaluation of environmental pollution. Marine sediment test samples with established homogeneity and well characterized known target values of the mass fractions of analytes were distributed to participating laboratories. The laboratories were requested to analyze the sample using established techniques following their analytical procedures. Based on the results of the proficiency test presented in the report each participating laboratory should assess its analytical performance results by using the specified criteria and, if appropriate, to identify discrepancies, and to correct relevant analytical procedures. The next proficiency test exercise will be executed in 2009

Environmental Quality Laboratory Research Report, 1985-1987

OpenAIRE

Brooks, Norman H.

1988-01-01

The Environmental Quality Laboratory at Caltech is a center for research on large-scale systems problems of natural resources and environmental quality. The principal areas of investigation at EQL are: 1. Air quality management. 2. Water resources and water quality management. 3. Control of hazardous substances in the environment. 4. Energy policy, including regulation, conservation and energy-environment tradeoffs. 5. Resources policy (other than energy); residuals m...

7 CFR 58.442 - Laboratory and quality control tests.

Science.gov (United States)

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.442 Section... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a) Chemical... Methods or by other methods giving equivalent results. (b) Weight or volume control. Representative...

Quality system implementation in the Radiotoxicology Laboratory of IPEN, Brazil

International Nuclear Information System (INIS)

Gaburo, J.C.; Caldeira Filho, J.S.; Todo, A.S.; Sanches, M.; Campos, L.L.

2002-01-01

The perception of assured quality is getting more transparence in the research and development areas. The Radiotoxicology Laboratory, LRT, of IPEN, operating since 1978, has as main attribution the development and implantation of analytical techniques for the measurements of different radionuclides in biological samples. Thus, the LRT considers being of extreme importance to have a management of the quality system to guarantee the reliability of the results and to obtain Accreditation Certificate of the National Institute of Metrology, INMETRO. With this objective the LRT has participated of projects of quality assurance for analytical laboratories since 1997, promoted by International Atomic Energy Agency, IAEA. Currently the quality system of the LRT is in implementation phase, operating in compliance with the quality system of IPEN (consistent pair ISO 9001-9004:2000) and with NBR ISO/IEC 17025. The quality system implemented in the LRT is described in its Quality Manual, MQ-LRT and in complementary procedures that are in their first revision. The participation of the laboratory in intercomparison programs among national as international laboratories and the analysis of the results of internal as well as external audits has demonstrated that the LRT laboratory presents good performance and with suitable methodology and accurate and precise results. With the implementation of the quality system it was possible to verify the effectiveness and efficiency of the tests carried out in the Radiotoxicology Laboratory. The project ARCAL XXVI was concluded in November 2001 and the LRT earned the Certificate of Recognition by IAEA. (author)

Worldwide Report, Environmental Quality

National Research Council Canada - National Science Library

1983-01-01

..., Environmental Impact, Forest Policy, Endangers, Water Level, Air Quality, Water Shortage, Protecting Environment,Wood Resource, Drough, Crop Failure, Water Crisis, Dams, Government Aid, Water Quality...

Iowa Central Quality Fuel Testing Laboratory

Energy Technology Data Exchange (ETDEWEB)

Heach, Don; Bidieman, Julaine

2013-09-30

The objective of this project is to finalize the creation of an independent quality fuel testing laboratory on the campus of Iowa Central Community College in Fort Dodge, Iowa that shall provide the exploding biofuels industry a timely and cost-effective centrally located laboratory to complete all state and federal fuel and related tests that are required. The recipient shall work with various state regulatory agencies, biofuel companies and state and national industry associations to ensure that training and testing needs of their members and American consumers are met. The recipient shall work with the Iowa Department of Ag and Land Stewardship on the development of an Iowa Biofuel Quality Standard along with the Development of a standard that can be used throughout industry.

Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety.

Science.gov (United States)

Plebani, Mario; Sciacovelli, Laura; Marinova, Mariela; Marcuccitti, Jessica; Chiozza, Maria Laura

2013-09-01

The identification of reliable quality indicators (QIs) is a crucial step in enabling users to quantify the quality of laboratory services. The current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence pointing to the multitude of errors that continue to occur in the pre- and post-analytical phases. Different QIs and terminologies are currently used and, therefore, there is the need to harmonize proposed QIs. A model of quality indicators (MQI) has been consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The model includes 57 QIs related to key processes (35 pre-, 7 intra- and 15 post-analytical phases) and 3 to support processes. The developed MQI and the data collected provide evidence of the feasibility of the project to harmonize currently available QIs, but further efforts should be done to involve more clinical laboratories and to collect a more consistent amount of data. Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Quality assurance in radionuclide laboratories

International Nuclear Information System (INIS)

Otto, R.; Voelkle, H.; Wershofen, H.; Wilhelm, C.

2003-01-01

The authors are members of an ad-hoc working group preparing a contribution to the procedures manual (''Loseblattsammlung'') dealing with quality assurance and quality control in radionuclide laboratories. The Loseblattsammlung is edited by the working group ''Environmental Monitoring'' of the German-Swiss Radiological Protection Association. The intention of the manual under preparation is not to give a procedure on how to establish a quality management system allowing for an accreditation in accordance with the international standard DIN EN ISO/IEC 17025:2000 04 (''ISO 17025'') [1] but to compile routine quality control procedures necessary for reliable measurements and to give tips to the practitioner on how to keep both the extent and the frequency of procedures on a reasonable level. A short version of the Loseblatt is presented here. (orig.)

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

Science.gov (United States)

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency

Quality assurance in medical laboratories

International Nuclear Information System (INIS)

Boroviczeny, K.G. von; Merten, R.; Merten, U.P.

1987-01-01

The book presents a comprehensive and specified survey of the quality assurance measures and methods applied in medical laboratories in the pre-analytical phase and in the analytical and post-analytical phases. It also gives information on computer-aided procedures, cost-benefit analyses in this field, and on official requirements and standards in the fields of clinical chemistry, hematology, immunology and microbiology, and equipment testing and inspection. One chapter of the book particularly deals with quality assurance for radioimmunological in-vitro analyses. With 112 figs., 337 tabs [de

Approaches to quality management and accreditation in a genetic testing laboratory

Science.gov (United States)

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

Directory of Open Access Journals (Sweden)

Vinko Peric

2014-06-01

Full Text Available In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.

Analytical quality control concept in the Euratom on-site laboratories

International Nuclear Information System (INIS)

Mayer, K.; Duinslaeger, L.; Cromboom, O.; Ottmar, H.; Wojnowski, D.; Vegt, H. van der

2001-01-01

Full text: Two on-site laboratories have been developed, installed, commissioned and put into routine operation by the Euratom safeguards office (ESO), jointly with the Institute for Transuranium Elements (ITU). These laboratories are operated by ITU staff and provide verification measurement results on samples taken by Euratom inspectors. The analysts work in weekly changing shift teams, manage the laboratories and operate the various analytical techniques. Operating such a laboratory at a remote location, without a senior scientist immediately available in case of problems, The existing boundary conditions challenge the robustness of the entire laboratory, i.e. comprising staff and instrumentation. In order to continuously ensure a high degree of reliability of the measurement results, a stringent quality control system was implemented. The quality control concept for the two on-site laboratories was developed at a very early stage and implemented in the pre-OSL training facility at ITU. This enabled to thoroughly test and develop further the concept. At the same time the analysts get acquainted with the quality control procedures in place and they are instilled with the principles. The quality control concept makes use of a fully computerized data management and data acquisition system. All measurement devices, including balances, density meters, mass spectrometers, passive neutron counter, hybrid K-edge instrument, gamma spectrometers and alpha spectrometers are networked and data exchange is performed on electronic basis. A specifically developed laboratory information management system collects individual measurement data, calculates intermediate and final result and shares the information with a quality control module. In order to ensure the reliability of the results, which are reported to the ESO inspectorate, five levels of quality control were implemented. The present paper describes in detail the different levels of quality control, which check the

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

Science.gov (United States)

Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

2010-09-01

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

Information systems as a quality management tool in clinical laboratories

Science.gov (United States)

Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

2007-11-01

This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

Information systems as a quality management tool in clinical laboratories

International Nuclear Information System (INIS)

Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el

2007-01-01

This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system

External Quality Assurance: Annual Proficiency Test on 15N and 13C isotopic abundance in plant materials [Activities of the Soil and Water Management and Crop Nutrition Laboratory, Seibersdorf

International Nuclear Information System (INIS)

Aigner, Martina

2014-01-01

Eight out of twelve laboratories (67%) participating in the nitrogen analysis reported 15 N-data within the control limits for the enriched plant sample and eight out of nine (89%) participating laboratories for carbon analysis reported 13 C isotopic abundance results within the control limits for this test sample. The reported analytical data and WEPAL evaluation of the 15 N enriched plant material produced by SWMCNL is shown. All participants received a certificate of participation. Worldwide comparison of stable 15 N and 13 C isotope measurements will provide confidence in the laboratory's analytical performance and is hence an invaluable tool for external quality control. It is hoped that in the future more stable isotope laboratories will make use of this unique opportunity to assess their analytical performance and provide evidence of the high quality of their analytical data

Quality assurance in the HIV/AIDS laboratory network of China.

Science.gov (United States)

Jiang, Yan; Qiu, Maofeng; Zhang, Guiyun; Xing, Wenge; Xiao, Yao; Pan, Pinliang; Yao, Jun; Ou, Chin-Yih; Su, Xueli

2010-12-01

In 2009, there were 8273 local screening laboratories, 254 confirmatory laboratories, 35 provincial confirmatory central laboratories and 1 National AIDS Reference Laboratory (NARL) in China. These laboratories were located in Center for Disease Control and Prevention (CDC) facilities, hospitals, blood donation clinics, maternal and child health (MCH) hospitals and border health quarantine health-care facilities. The NARL and provincial laboratories provide quality assurance through technical, bio-safety and managerial training; periodic proficiency testing; on-site supervisory inspections; and commercial serologic kit evaluations. From 2002 to 2009, more than 220 million HIV antibody tests were performed at screening laboratories, and all reactive and indeterminate samples were confirmed at confirmatory laboratories. The use of highly technically complex tests, including CD4 cell enumeration, viral load, dried blood spot (DBS)-based early infant diagnosis (EID), drug resistance (DR) genotyping, HIV-1 subtyping and incidence assays, have increased in recent years and their performance quality is closely monitored. China has made significant progress in establishing a well-coordinated HIV laboratory network and QA systems. However, the coverage and intensity of HIV testing and quality assurance programmes need to be strengthened so as to ensure that more infected persons are diagnosed and that they receive timely prevention and treatment services.

Quality assurance of laboratory work and clinical use of laboratory tests in general practice in norway: a survey.

Science.gov (United States)

Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre

2011-09-01

Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices. In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests. Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests. Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.

Performance Indicators For Quality In Surgical And Laboratory ...

African Journals Online (AJOL)

Methodology: Hospital records were reviewed and information recorded for planned and postponed operations, laboratory equipment, reagents, laboratory tests and quality assurance programmes. Results: In the year 2001 a total of 4332 non-emergency operations were planned, 3313 operations were performed and 1019 ...

Evaluating laboratory key performance using quality indicators in Alexandria University Hospital Clinical Chemistry Laboratories.

Science.gov (United States)

Rizk, Mostafa M; Zaki, Adel; Hossam, Nermine; Aboul-Ela, Yasmin

2014-12-01

The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare. To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards. The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement (March-May 2012); an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement (June 2012); and phase II, which included data collection for evaluation of the process after improvement (July 2012-September 2012). In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items (Plaboratories.

[Standardization in laboratory hematology by participating in external quality assurance programs].

Science.gov (United States)

Nazor, Aida; Siftar, Zoran; Flegar-Mestrić, Zlata

2011-09-01

Since 1985, Department of Clinical Chemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, has been participating in the International External Quality Assessment Scheme for Hematology (IEQAS-H) organized by the World Health Organization (WHO). Owing to very good results, in 1987 the Department received a certificate of participation in this control scheme. Department has been cooperating in the external quality assessment program in laboratory hematology which has been continuously performed in Croatia since 1986 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists and School of Pharmacy and Biochemistry, University of Zagreb. Nowadays, 186 medical biochemical laboratories are included in the National External Quality Assessment program, which is performed three times per year. Our Department has participated in the international projects of the European Committee for External Quality Assurance Programs in Laboratory Medicine (EQALM).

[External quality assessment in clinical biochemistry laboratories: pilot study in 11 laboratories of Lomé (Togo)].

Science.gov (United States)

Kouassi, Kafui; Fétéké, Lochina; Assignon, Selom; Dorkenoo, Ameyo; Napo-Koura, Gado

2015-01-01

This study aims to evaluate the performance of a few biochemistry analysis and make recommendations to the place of the stakeholders. It is a cross-sectional study conducted between the October 1(st), 2012 and the July 31, 2013 bearing on the results of 5 common examinations of clinical biochemistry, provided by 11 laboratories volunteers opening in the public and private sectors. These laboratories have analysed during the 3 cycles, 2 levels (medium and high) of serum concentration of urea, glucose, creatinine and serum aminotransferases. The performance of laboratories have been determined from the acceptable limits corresponding to the limits of total errors, defined by the French Society of Clinical Biology (SFBC). A system of internal quality control is implemented by all laboratories and 45% of them participated in international programs of external quality assessment (EQA). The rate of acceptable results for the entire study was of 69%. There was a significant difference (plaboratories engaged in a quality approach and the group with default implementation of the quality approach. Also a significant difference was observed between the laboratories of the central level and those of the peripheral level of our health system (plaboratories remains relatively unsatisfactory. It is important that the Ministry of Health put in place a national program of EQA with mandatory participation.

Laboratory diagnosis of the rare anaemias: external quality assessment benefits patient care

OpenAIRE

Barbara De La Salle; Andrea Mosca; Renata Paleari; Vasileios Rapanakis; Keith Hyde

2013-01-01

Since its introduction in the 1960s, external quality assessment has developed to become an essential component of the quality management system of the diagnostic laboratory. External quality assessment provides a long term, retrospective view of laboratory performance, demonstrating the competence of the laboratory to others. The ENERCA project (the European Network for Rare and Congenital Anaemias) has established a list of core laboratory tests that are used in the diagnosis of rare and co...

Air quality inside subway metro indoor environment worldwide: A review.

Science.gov (United States)

Xu, Bin; Hao, Jinliang

2017-10-01

The air quality in the subway metro indoor microenvironment has been of particular public concern. With specific reference to the growing demand of green transportation and sustainable development, subway metro systems have been rapidly developed worldwide in last decades. The number of metro commuters has continuously increased over recent years in metropolitan cities. In some cities, metro system has become the primary public transportation mode. Although commuters typically spend only 30-40min in metros, the air pollutants emitted from various interior components of metro system as well as air pollutants carried by ventilation supply air are significant sources of harmful air pollutants that could lead to unhealthy human exposure. Commuters' exposure to various air pollutants in metro carriages may cause perceivable health risk as reported by many environmental health studies. This review summarizes significant findings in the literature on air quality inside metro indoor environment, including pollutant concentration levels, chemical species, related sources and health risk assessment. More than 160 relevant studies performed across over 20 countries were carefully reviewed. These comprised more than 2000 individual measurement trips. Particulate matters, aromatic hydrocarbons, carbonyls and airborne bacteria have been identified as the primary air pollutants inside metro system. On this basis, future work could focus on investigating the chronic health risks of exposure to various air pollutants other than PM, and/or further developing advanced air purification unit to improve metro in-station air quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

222-S laboratory quality assurance plan

International Nuclear Information System (INIS)

Meznarich, H.K.

1995-01-01

This document provides quality assurance guidelines and quality control requirements for analytical services. This document is designed on the basis of Hanford Analytical Services Quality Assurance Plan (HASQAP) technical guidelines and is used for governing 222-S and 222-SA analytical and quality control activities. The 222-S Laboratory provides analytical services to various clients including, but not limited to, waste characterization for the Tank Waste Remediation Systems (TWRS), waste characterization for regulatory waste treatment, storage, and disposal (TSD), regulatory compliance samples, radiation screening, process samples, and TPA samples. A graded approach is applied on the level of sample custody, QC, data verification, and data reporting to meet the specific needs of the client

Quality of HIV laboratory testing in Tanzania: a situation analysis ...

African Journals Online (AJOL)

December 2004 to February 2005 in 12 laboratories which were conveniently selected to represent all the zones of Tanzania. The questionnaires comprised of questions on laboratory particulars, internal and external quality control for HIV testing and quality control of reagents. Source and level of customer satisfaction of ...

Improving laboratory data entry quality using Six Sigma.

Science.gov (United States)

Elbireer, Ali; Le Chasseur, Julie; Jackson, Brooks

2013-01-01

The Uganda Makerere University provides clinical laboratory support to over 70 clients in Uganda. With increased volume, manual data entry errors have steadily increased, prompting laboratory managers to employ the Six Sigma method to evaluate and reduce their problems. The purpose of this paper is to describe how laboratory data entry quality was improved by using Six Sigma. The Six Sigma Quality Improvement (QI) project team followed a sequence of steps, starting with defining project goals, measuring data entry errors to assess current performance, analyzing data and determining data-entry error root causes. Finally the team implemented changes and control measures to address the root causes and to maintain improvements. Establishing the Six Sigma project required considerable resources and maintaining the gains requires additional personnel time and dedicated resources. After initiating the Six Sigma project, there was a 60.5 percent reduction in data entry errors from 423 errors a month (i.e. 4.34 Six Sigma) in the first month, down to an average 166 errors/month (i.e. 4.65 Six Sigma) over 12 months. The team estimated the average cost of identifying and fixing a data entry error to be $16.25 per error. Thus, reducing errors by an average of 257 errors per month over one year has saved the laboratory an estimated $50,115 a year. The Six Sigma QI project provides a replicable framework for Ugandan laboratory staff and other resource-limited organizations to promote quality environment. Laboratory staff can deliver excellent care at a lower cost, by applying QI principles. This innovative QI method of reducing data entry errors in medical laboratories may improve the clinical workflow processes and make cost savings across the health care continuum.

Quality assurance practices in Europe: a survey of molecular genetic testing laboratories

Science.gov (United States)

Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth

2012-01-01

In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (Pquality assurance (Pquality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, Pquality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339

[CAP quality management system in clinical laboratory and its issue].

Science.gov (United States)

Tazawa, Hiromitsu

2004-03-01

The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

Laboratory system strengthening and quality improvement in Ethiopia

Directory of Open Access Journals (Sweden)

Tilahun M. Hiwotu

2014-11-01

Full Text Available Background: In 2010, a National Laboratory Strategic Plan was set forth in Ethiopia to strengthen laboratory quality systems and set the stage for laboratory accreditation. As a result, the Strengthening Laboratory Management Toward Accreditation (SLMTA programme was initiated in 45 Ethiopian laboratories. Objectives: This article discusses the implementation of the programme, the findings from the evaluation process and key challenges. Methods: The 45 laboratories were divided into two consecutive cohorts and staff from each laboratory participated in SLMTA training and improvement projects. The average amount of supportive supervision conducted in the laboratories was 68 hours for cohort I and two hoursfor cohort II. Baseline and exit audits were conducted in 44 of the laboratories and percent compliance was determined using a checklist with scores divided into zero- to five-star ratinglevels. Results: Improvements, ranging from < 1 to 51 percentage points, were noted in 42 laboratories, whilst decreases were recorded in two. The average scores at the baseline and exit audits were 40% and 58% for cohort I (p < 0.01; and 42% and 53% for cohort II (p < 0.01,respectively. The p-value for difference between cohorts was 0.07. At the exit audit, 61% ofthe first and 48% of the second cohort laboratories achieved an increase in star rating. Poor awareness, lack of harmonisation with other facility activities and the absence of a quality manual were challenges identified. Conclusion: Improvements resulting from SLMTA implementation are encouraging. Continuous advocacy at all levels of the health system is needed to ensure involvement of stakeholders and integration with other improvement initiatives and routine activities.

External quality assurance performance of clinical research laboratories in sub-saharan Africa.

Science.gov (United States)

Amukele, Timothy K; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J Brooks

2012-11-01

Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.

Implementing self sustained quality control procedures in a clinical laboratory.

Science.gov (United States)

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

Science.gov (United States)

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

External Quality Assurance: Annual Proficiency Test on {sup 15}N and {sup 13}C isotopic abundance in plant materials [Activities of the Soil and Water Management and Crop Nutrition Laboratory, Seibersdorf

Energy Technology Data Exchange (ETDEWEB)

Aigner, Martina [Soil and Water Management and Crop Nutrition Laboratory, Joint FAO/IAEA Division for Nuclear Techniques in Food and Agriculture, Seibersdorf (Austria)

2014-07-15

Eight out of twelve laboratories (67%) participating in the nitrogen analysis reported {sup 15}N-data within the control limits for the enriched plant sample and eight out of nine (89%) participating laboratories for carbon analysis reported {sup 13}C isotopic abundance results within the control limits for this test sample. The reported analytical data and WEPAL evaluation of the {sup 15}N enriched plant material produced by SWMCNL is shown. All participants received a certificate of participation. Worldwide comparison of stable {sup 15}N and {sup 13}C isotope measurements will provide confidence in the laboratory's analytical performance and is hence an invaluable tool for external quality control. It is hoped that in the future more stable isotope laboratories will make use of this unique opportunity to assess their analytical performance and provide evidence of the high quality of their analytical data.

Role of a quality management system in improving patient safety - laboratory aspects.

Science.gov (United States)

Allen, Lynn C

2013-09-01

The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety. A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program - Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined. Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety. Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

GESCAL: Quality management automated system for a calibration and test laboratory

International Nuclear Information System (INIS)

Manzano de Armas, J.; Valdes Ramos, M.; Morales Monzon, J.A.

1998-01-01

GESCAL is a software created to automate all elements composing the quality system in a calibration and test laboratory. It also evaluates quality according to its objectives and policies. This integrated data system decreases considerably the amount of time devoted to manage quality. It is speedier in searching and evaluating information registers thus notably in reducing the workload for laboratory staff

Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

Science.gov (United States)

Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

2014-01-01

Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

Preanalytical quality in clinical chemistry laboratory.

Science.gov (United States)

Ahmad, M Imteyaz; Ramesh, K L; Kumar, Ravi

2014-01-01

Haemolysis is usually caused by inadequate specimen collection or preanalytical handling and is suggested to be a suitable indicator of preanalytical quality. We investigated the prevalence of detectable haemolysis in all routine venous blood samples in OPDs and IPDs to identify differences in preanalytical quality. Haemolysis index (HI) values were obtained from a Vitros 5,1 in the routine clinical chemistry laboratory for samples collected in the outpatient department (OPD) collection centres, a hospital, and inpatient departments (IPD). Haemolysis was defined as a HI > or = 15 (detection limit). Samples from the OPD with the highest prevalence of haemolysis were 6.1 times (95% confidence interval (CI) 4.0 - 9.2) more often haemolysed compared to the center with the lowest prevalence. Of the samples collected in primary health care, 10.4% were haemolysed compared to 31.1% in the IPDs (p = 0.001). A notable difference in haemolysed samples was found between the IPDs section staffed by emergency medicine physicians and the section staffed by primary health care physicians (34.8% vs. 11.3%, p = 0.001). The significant variation in haemolysis indices among the investigated units is likely to reflect varying preanalytical conditions. The HI is a valuable tool for estimation and follow-up of preanalytical quality in the health care laboratory.

Recommended procedures for performance testing of radiobioassay laboratories: Volume 1, Quality assurance

International Nuclear Information System (INIS)

Fenrick, H.W.; MacLellan, J.A.

1988-11-01

Draft American National Standards Institute (ANSI) Standard N13.30 (Performance Criteria for Radiobioassay) was developed in response to a concern expressed by the US Department of Energy and US Nuclear Regulatory Commission to help ensure that bioassay laboratories provide accurate and consistent results. The draft standard specifies the criteria for defining the procedures necessary to establish a bioassay performance-testing laboratory and program. The testing laboratory will conduct tests to evaluate the performance of service laboratories. Pacific Northwest Laboratory helped define responsibilities and develop procedures as part of an effort to evaluate the draft ANSI N13.30 performance criteria for quality assurance at bioassay laboratories. This report recommends elements of quality assurance and quality control responsibilities for the bioassay performance-testing laboratory program, including the qualification and performance of personnel and the calibration, certification, and performance of equipment. The data base and recommended records system for documenting radiobioassay performance at the service laboratories are also presented. 15 refs

Quality manual for Laboratories of the Nuclear Materials Characterization Division

International Nuclear Information System (INIS)

Sabato, S.F.

1991-05-01

This publication presents the first Quality Manual for the Laboratories at the Nuclear Materials Characterization Division. The Manual describes the laboratories, its organization structure, fields of activities, personnel records, equipments, maintenance and calibration. The main aspects concerning quality assurance in the analysis were discussed. The whole system of receiving, identifying and processing analysis of the samples is shown. Since there are many information to be contained in several subjects of the Quality Manual, there were produced separate documents that are cross referenced in the manual. (author)

Development of a quality assurance program for ionizing radiation secondary calibration laboratories

Energy Technology Data Exchange (ETDEWEB)

Heaton, H.T. II; Taylor, A.R. Jr. [Center for Devices and Radiological Health, Rockville, MD (United States)

1993-12-31

For calibration laboratories, routine calibrations of instruments meeting stated accuracy goals are important. One method of achieving the accuracy goals is to establish and follow a quality assurance program designed to monitor all aspects of the calibration program and to provide the appropriate feedback mechanism if adjustments are needed. In the United States there are a number of organizations with laboratory accreditation programs. All existing accreditation programs require that the laboratory implement a quality assurance program with essentially the same elements in all of these programs. Collectively, these elements have been designated as a Measurement Quality Assurance (MQA) program. This paper will briefly discuss the interrelationship of the elements of an MQA program. Using the Center for Devices and Radiological Health (CDRH) X-ray Calibration Laboratory (XCL) as an example, it will focus on setting up a quality control program for the equipment in a Secondary Calibration Laboratory.

The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

Science.gov (United States)

Anderson, Nancy

2015-11-15

As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

Development of a quality assurance program for ionizing radiation secondary calibration laboratories

International Nuclear Information System (INIS)

Heaton, H.T. II; Taylor, A.R. Jr.

1993-01-01

For calibration laboratories, routine calibrations of instruments meeting stated accuracy goals are important. One method of achieving the accuracy goals is to establish and follow a quality assurance program designed to monitor all aspects of the calibration program and to provide the appropriate feedback mechanism if adjustments are needed. In the United States there are a number of organizations with laboratory accreditation programs. All existing accreditation programs require that the laboratory implement a quality assurance program with essentially the same elements in all of these programs. Collectively, these elements have been designated as a Measurement Quality Assurance (MQA) program. This paper will briefly discuss the interrelationship of the elements of an MQA program. Using the Center for Devices and Radiological Health (CDRH) X-ray Calibration Laboratory (XCL) as an example, it will focus on setting up a quality control program for the equipment in a Secondary Calibration Laboratory

Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation

Directory of Open Access Journals (Sweden)

Heidi Albert

2017-03-01

Full Text Available Background: Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA programme. Development: The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool. Implementation: Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility based approach in five tuberculosis laboratories in five countries. Conclusion: Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories

Worldwide Laboratory Comparison on the Determination of Radionuclides in IAEA-446 Baltic Sea Seaweed (Fucus vesiculosus)

International Nuclear Information System (INIS)

2013-01-01

The Radiometrics Laboratory of the IAEA Environment Laboratories in Monaco has been providing quality products and services for the past forty years, including the organization of interlaboratory comparisons, the production of reference and certified reference materials and the provision of training. More than 45 reference materials have been produced, including a wide range of marine sample matrices and radionuclide concentrations. As part of these activities, a new interlaboratory comparison was organized to provide participating laboratories with the opportunity to test the performance of their analytical methods on a seaweed sample with elevated radionuclide levels due to the effects of the Chernobyl accident on the Baltic Sea region. The material used in the analysis of anthropogenic and natural radionuclides in seaweed was the bladder wrack (Fucus vesiculosus). It is expected that the sample, after successful certification, will be issued as a certified reference material for analysing radionuclides in seaweed. The participating laboratories were informed that the IAEA publication would contain a list of the laboratories and the results and descriptions of the interlaboratory comparisons, but that the results would not be attributed to individual laboratories

Worldwide Laboratory Comparison on the Determination of Radionuclides in IAEA-446 Baltic Sea Seaweed (Fucus vesiculosus)

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-07-15

The Radiometrics Laboratory of the IAEA Environment Laboratories in Monaco has been providing quality products and services for the past forty years, including the organization of interlaboratory comparisons, the production of reference and certified reference materials and the provision of training. More than 45 reference materials have been produced, including a wide range of marine sample matrices and radionuclide concentrations. As part of these activities, a new interlaboratory comparison was organized to provide participating laboratories with the opportunity to test the performance of their analytical methods on a seaweed sample with elevated radionuclide levels due to the effects of the Chernobyl accident on the Baltic Sea region. The material used in the analysis of anthropogenic and natural radionuclides in seaweed was the bladder wrack (Fucus vesiculosus). It is expected that the sample, after successful certification, will be issued as a certified reference material for analysing radionuclides in seaweed. The participating laboratories were informed that the IAEA publication would contain a list of the laboratories and the results and descriptions of the interlaboratory comparisons, but that the results would not be attributed to individual laboratories.

[Accreditation of clinical laboratories based on ISO standards].

Science.gov (United States)

Kawai, Tadashi

2004-11-01

International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

Improving of Quality Control and Quality Assurance in 14C and 3H Laboratory; Participation in the IAEA Model Project

International Nuclear Information System (INIS)

Obelic, B.

2001-01-01

Full text: Users of laboratory's analytical results are increasingly requiring demonstrable proofs of the reliability and credibility of the results using internationally accepted standards, because the economic, ecological, medical and legal decisions based on laboratory results need to be accepted nationally and internationally. Credibility, respect and opportunities of the laboratories are improved when objective evidence on the reliability and quality of the results can be given. This is achieved through inculcation of a quality culture through definition of well-defined procedures and controls and operational checks characteristic of quality assurance and quality control (Q A/QC). IAEA launched in 1999 a two-and-a-half year model project entitled Quality Control and Quality Assurance of Nuclear Analytical Techniques with participation of laboratories using alpha, beta and/or gamma spectrometry from CEE and NIS countries. The project started to introduce and implement QA principles in accordance with the ISO-17025 guide, leading eventually to a level at which the QA system is self-sustainable and might be appropriate for formal accreditation or certification by respective national authorities. Activities within the project consist of semi-annual reports, two training workshops, two inspection visits of the laboratories by IAEA experts and proficiency tests. The following topics were considered: organisation requirements, acceptance criteria and non-conformance management of QC, internal and external method validation, statistical analyses and uncertainty evaluation, standard operation procedures and quality manual documentation. 14 C and 3 H Laboratory of the Rudjer Boskovic Institute has been one of ten laboratories participating in the Project. In the Laboratory all the procedures required in the quality control were included implicitly, while during the Model Project much effort has been devoted to elaboration of explicit documentation. Since the beginning

Piloting laboratory quality system management in six health facilities in Nigeria.

Directory of Open Access Journals (Sweden)

Henry Mbah

Full Text Available Achieving accreditation in laboratories is a challenge in Nigeria like in most African countries. Nigeria adopted the World Health Organization Regional Office for Africa Stepwise Laboratory (Quality Improvement Process Towards Accreditation (WHO/AFRO- SLIPTA in 2010. We report on FHI360 effort and progress in piloting WHO-AFRO recognition and accreditation preparedness in six health facility laboratories in five different states of Nigeria.Laboratory assessments were conducted at baseline, follow up and exit using the WHO/AFRO- SLIPTA checklist. From the total percentage score obtained, the quality status of laboratories were classified using a zero to five star rating, based on the WHO/AFRO quality improvement stepwise approach. Major interventions include advocacy, capacity building, mentorship and quality improvement projects.At baseline audit, two of the laboratories attained 1- star while the remaining four were at 0- star. At follow up audit one lab was at 1- star, two at 3-star and three at 4-star. At exit audit, four labs were at 4- star, one at 3-star and one at 2-star rating. One laboratory dropped a 'star' at exit audit, while others consistently improved. The two weakest elements at baseline; internal audit (4% and occurrence/incidence management (15% improved significantly, with an exit score of 76% and 81% respectively. The elements facility and safety was the major strength across board throughout the audit exercise.This effort resulted in measurable and positive impact on the laboratories. We recommend further improvement towards a formal international accreditation status and scale up of WHO/AFRO- SLIPTA implementation in Nigeria.

WHO global salm-surv external quality assurance system (EQAS): an important step toward improving the quality of Salmonella serotyping and antimicrobial susceptibility testing worldwide

DEFF Research Database (Denmark)

Petersen, A.; Aarestrup, Frank Møller; Angulo, F. J.

2002-01-01

% of the results were correct. For susceptibility testing, 92% of the results were in agreement with the expected results. However, only 78% of the performed tests with the E. coli ATCC 25922 reference strain were within the quality control range specified by National Committee for Clinical Laboratory Standards...... susceptibility testing through international training courses and an External Quality Assurance System (EQAS). In 2000, 44 WHO Global Salm-Surv member laboratories from 35 countries determined the serotype and antimicrobial susceptibility pattern for eight "blinded" Salmonella isolates. For serotyping, 73...... (NCCLS) guidelines. These EQAS results demonstrate the need for further training to improve the performance of some of the laboratories. WHO Global Salm-Surv activities, including international training courses and EQAS, represent an important step toward improving the quality of Salmonella serotyping...

Quality management system in hospital radiopharmacy laboratory

International Nuclear Information System (INIS)

Poch, Carolina; Rabiller, Graciela; Basualdo, Daniel A.; El Tamer, Elias A.

2009-01-01

Objective: 1) To determine the necessary conditions for increasing the complexity of the Radiopharmacy Laboratory and reach an operational level defined by the IAEA as 3a (Operational Guidance on Hospital Radiopharmacy). Our aim is that, within a framework of quality, last generation radiopharmaceuticals can be used, by sophisticated techniques such as labeling with bifunctional chelating agents, like HYNIC; 2) Consequently, we decided to implement a Quality Management System (QMS) in the field of Hospital Radiopharmacy in order to guarantee the safe and effective preparation and handling of radiopharmaceuticals for the diagnosis of patients, based on recommendations of the IAEA. Procedure For the implementation of the QMS, the sector of Radiopharmacy was capacitated in the application of ISO 9001. In a first stage it had begun with the formulation of the main documents and their enumeration. According to the recommendations of the IAEA Operational Guide, this year we proceeded to the optimization of the documents produced in the first stage and formulation of new documents essential to the improvement of work in the Radiopharmacy Laboratory. Results: Corrections were made to the performed procedures, and new ones were composed such as: Reception of raw materials, Control dose calibrator (Activity meter), General procedure of dosage, Procedure for decontamination, for Using the bio safety cabinet, for Cleaning the hot laboratory, etc. The Quality Controls were added to each of the Work Instructions of radiopharmaceuticals to be undertaken and how and when to carry out, with their respective references. Records were modified and new ones incorporated, in order to ensure traceability of the results before and after injection. Finally, the require documentation has been completed with the addition of the Staff Training Plan, and other records such as Nonconformance and Corrective and Preventive Actions. Conclusion: With the application of a QMS correctly implemented

Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China.

Science.gov (United States)

Fei, Yang; Kang, Fengfeng; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Wang, Zhiguo; Chen, Wenxiang

2016-08-01

The aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs. Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively. Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ). Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.

Quality Indicators in Laboratory Medicine: from theory to practice. Preliminary data from the IFCC Working Group Project "Laboratory Errors and Patient Safety".

Science.gov (United States)

Sciacovelli, Laura; O'Kane, Maurice; Skaik, Younis Abdelwahab; Caciagli, Patrizio; Pellegrini, Cristina; Da Rin, Giorgio; Ivanov, Agnes; Ghys, Timothy; Plebani, Mario

2011-05-01

The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required. In order to reduce errors in laboratory testing, the IFCC Working Group on "Laboratory Errors and Patient Safety" (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs. The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.

WorldWide Web: Hypertext from CERN.

Science.gov (United States)

Nickerson, Gord

1992-01-01

Discussion of software tools for accessing information on the Internet focuses on the WorldWideWeb (WWW) system, which was developed at the European Particle Physics Laboratory (CERN) in Switzerland to build a worldwide network of hypertext links using available networking technology. Its potential for use with multimedia documents is also…

Importance of implementing an analytical quality control system in a core laboratory.

Science.gov (United States)

Marques-Garcia, F; Garcia-Codesal, M F; Caro-Narros, M R; Contreras-SanFeliciano, T

2015-01-01

The aim of the clinical laboratory is to provide useful information for screening, diagnosis and monitoring of disease. The laboratory should ensure the quality of extra-analytical and analytical process, based on set criteria. To do this, it develops and implements a system of internal quality control, designed to detect errors, and compare its data with other laboratories, through external quality control. In this way it has a tool to detect the fulfillment of the objectives set, and in case of errors, allowing corrective actions to be made, and ensure the reliability of the results. This article sets out to describe the design and implementation of an internal quality control protocol, as well as its periodical assessment intervals (6 months) to determine compliance with pre-determined specifications (Stockholm Consensus(1)). A total of 40 biochemical and 15 immunochemical methods were evaluated using three different control materials. Next, a standard operation procedure was planned to develop a system of internal quality control that included calculating the error of the analytical process, setting quality specifications, and verifying compliance. The quality control data were then statistically depicted as means, standard deviations, and coefficients of variation, as well as systematic, random, and total errors. The quality specifications were then fixed and the operational rules to apply in the analytical process were calculated. Finally, our data were compared with those of other laboratories through an external quality assurance program. The development of an analytical quality control system is a highly structured process. This should be designed to detect errors that compromise the stability of the analytical process. The laboratory should review its quality indicators, systematic, random and total error at regular intervals, in order to ensure that they are meeting pre-determined specifications, and if not, apply the appropriate corrective actions

Accreditation of Medical Laboratories – System, Process, Benefits for Labs

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Zima Tomáš

2017-09-01

Full Text Available One and key of the priorities in laboratory medicine is improvement of quality management system for patient safety. Quality in the health care is tightly connected to the level of excellence of the health care provided in relation to the current level of knowledge and technical development. Accreditation is an effective way to demonstrate competence of the laboratory, a tool to recognize laboratories world-wide, is linked to periodical audits, to stimulate the maintenance and improvement of the quality, which leads to high standard of services for clients (patients, health care providers, etc.. The strategic plans of IFCC and EFLM include focusing on accreditation of labs based on ISO standards and cooperation with European Accreditation and national accreditation bodies. IFCC and EFLM recognised that ISO 15189:2012 Medical laboratories – Requirements for quality and competence, encompasses all the assessment criteria specified in the policy of quality. The last version is oriented to process approach with detailed division and clearly defined requirements. The accreditation of labs improves facilitation of accurate and rapid diagnostics, efficiency of treatment and reduction of errors in the laboratory process. Accreditation is not about who the best is, but who has a system of standard procedures with aim to improve the quality and patient safety. Quality system is about people, with people and for people.

Quality assurance programs at the PNL calibrations laboratory

International Nuclear Information System (INIS)

Piper, R.K.; McDonald, J.C.; Fox, R.A.; Eichner, F.N.

1993-03-01

The calibrations laboratory at Pacific Northwest Laboratory (PNL) serves as a radiological standardization facility for personnel and environmental dosimetry and radiological survey instruments. As part of this function, the calibrations laboratory must maintain radiological reference fields with calibrations traceable to the National Institute of Standards and Technology (NIST). This task is accomplished by a combination of (1) sources or reference instruments calibrated at or by NIST, (2) measurement quality assurance (MQA) interactions with NIST, and (3) rigorous internal annual and quarterly calibration verifications. This paper describes a representative sample of the facilities, sources, and actions used to maintain accurate and traceable fields

Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group "Laboratory Errors and Patient Safety" project.

Science.gov (United States)

Sciacovelli, Laura; Lippi, Giuseppe; Sumarac, Zorica; West, Jamie; Garcia Del Pino Castro, Isabel; Furtado Vieira, Keila; Ivanov, Agnes; Plebani, Mario

2017-03-01

The knowledge of error rates is essential in all clinical laboratories as it enables them to accurately identify their risk level, and compare it with those of other laboratories in order to evaluate their performance in relation to the State-of-the-Art (i.e. benchmarking) and define priorities for improvement actions. Although no activity is risk free, it is widely accepted that the risk of error is minimized by the use of Quality Indicators (QIs) managed as a part of laboratory improvement strategy and proven to be suitable monitoring and improvement tools. The purpose of QIs is to keep the error risk at a level that minimizes the likelihood of patients. However, identifying a suitable State-of-the-Art is challenging, because it calls for the knowledge of error rates measured in a variety of laboratories throughout world that differ in their organization and management, context, and the population they serve. Moreover, it also depends on the choice of the events to keep under control and the individual procedure for measurement. Although many laboratory professionals believe that the systemic use of QIs in Laboratory Medicine may be effective in decreasing errors occurring throughout the total testing process (TTP), to improve patient safety as well as to satisfy the requirements of International Standard ISO 15189, they find it difficult to maintain standardized and systematic data collection, and to promote continued high level of interest, commitment and dedication in the entire staff. Although many laboratories worldwide express a willingness to participate to the Model of QIs (MQI) project of IFCC Working Group "Laboratory Errors and Patient Safety", few systematically enter/record their own results and/or use a number of QIs designed to cover all phases of the TTP. Many laboratories justify their inadequate participation in data collection of QIs by claiming that the number of QIs included in the MQI is excessive. However, an analysis of results suggests

LEAN LABORATORY APPROACHES FOR QUALITY ASSURANCE IN FOOD

Directory of Open Access Journals (Sweden)

Laxmana Naik

2011-09-01

Full Text Available A lean laboratory is one which is focused on testing products and materials to deliver results in the most efficient way in terms of cost or speed or both; primarily focused on improving measurable performance and reducing costs. The goal of a lean laboratory is to use less effort, less resources and less time to test incoming samples. Laboratories have a critical role to play in establishing and improving process capability and key performance indicator (KPI of the organization. There are inevitably many opinions as to what a lean lab actually is; here is one version fr om. Quality assurance laboratories are crucial to the success of organization and this effectiveness needs to be measurable and demonstrable. To facilitate this, a method of measuring a laboratory's progress towards complete deployment has been created by lean tools. These tools allow laboratories to conduct gap analysis and identify opportunities for improvement.

The role of the EPA radiation quality assurance program in the measurement quality assurance accreditation program for radioassay laboratories

Energy Technology Data Exchange (ETDEWEB)

Grady, T.M. [Environmental Monitoring Systems Laboratory, Las Vegas, NV (United States)

1993-12-31

As the nature and extent of radiological contamination becomes better documented and more public, radioanalytical laboratories are faced with a constantly expanding variety of new and difficult analytical requirements. Concurrent with those requirements is the responsibility to provide customers, regulatory officials, or the public with defensible data produced in an environment of verifiable, controlled quality. To meet that need, a quality assurance accreditation program for radioassay laboratories has been proposed by the American National Standards Institute (ANSI). The standard will provide the organizational framework and functional requirements needed to assure the quality of laboratory outputs. Under the proposed program, the U.S. Environmental Protection Agency`s (EPA`s) Laboratory Intercomparison Program plays a key role as a reference laboratory. The current and proposed roles of the EPA Intercomparison Program are discussed, as are the functional relationships between EPA, the accreditating organization, and the service and monitoring laboratories.

SLIPTA e-Tool improves laboratory audit process in Vietnam and Cambodia.

Science.gov (United States)

Nguyen, Thuong T; McKinney, Barbara; Pierson, Antoine; Luong, Khue N; Hoang, Quynh T; Meharwal, Sandeep; Carvalho, Humberto M; Nguyen, Cuong Q; Nguyen, Kim T; Bond, Kyle B

2014-01-01

The Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist is used worldwide to drive quality improvement in laboratories in developing countries and to assess the effectiveness of interventions such as the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. However, the paper-based format of the checklist makes administration cumbersome and limits timely analysis and communication of results. In early 2012, the SLMTA team in Vietnam developed an electronic SLIPTA checklist tool. The e-Tool was pilot tested in Vietnam in mid-2012 and revised. It was used during SLMTA implementation in Vietnam and Cambodia in 2012 and 2013 and further revised based on auditors' feedback about usability. The SLIPTA e-Tool enabled rapid turn-around of audit results, reduced workload and language barriers and facilitated analysis of national results. Benefits of the e-Tool will be magnified with in-country scale-up of laboratory quality improvement efforts and potential expansion to other countries.

SLIPTA e-Tool improves laboratory audit process in Vietnam and Cambodia

Directory of Open Access Journals (Sweden)

Thuong T. Nguyen

2014-11-01

Full Text Available Background: The Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA checklist is used worldwide to drive quality improvement in laboratories in developing countries and to assess the effectiveness of interventions such as the Strengthening Laboratory Management Toward Accreditation (SLMTA programme. However, the paperbased format of the checklist makes administration cumbersome and limits timely analysis and communication of results. Development of e-Tool: In early 2012, the SLMTA team in Vietnam developed an electronic SLIPTA checklist tool. The e-Tool was pilot tested in Vietnam in mid-2012 and revised. It was used during SLMTA implementation in Vietnam and Cambodia in 2012 and 2013 and further revised based on auditors’ feedback about usability. Outcomes: The SLIPTA e-Tool enabled rapid turn-around of audit results, reduced workload and language barriers and facilitated analysis of national results. Benefits of the e-Tool will be magnified with in-country scale-up of laboratory quality improvement efforts and potential expansion to other countries.

System Quality Management in Software Testing Laboratory that Chooses Accreditation

Directory of Open Access Journals (Sweden)

Yanet Brito R.

2013-12-01

Full Text Available The evaluation of software products will reach full maturity when executed by the scheme and provides third party certification. For the validity of the certification, the independent laboratory must be accredited for that function, using internationally recognized standards. This brings with it a challenge for the Industrial Laboratory Testing Software (LIPS, responsible for testing the products developed in Cuban Software Industry, define strategies that will permit it to offer services with a high level of quality. Therefore it is necessary to establish a system of quality management according to NC-ISO/IEC 17025: 2006 to continuously improve the operational capacity and technical competence of the laboratory, with a view to future accreditation of tests performed. This article discusses the process defined in the LIPS for the implementation of a Management System of Quality, from the current standards and trends, as a necessary step to opt for the accreditation of the tests performed.

Quality control for diagnostic oral microbiology laboratories in European countries

Directory of Open Access Journals (Sweden)

Andrew J. Smith

2011-11-01

Full Text Available Participation in diagnostic microbiology internal and external quality control (QC processes is good laboratory practice and an essential component of a quality management system. However, no QC scheme for diagnostic oral microbiology existed until 2009 when the Clinical Oral Microbiology (COMB Network was created. At the European Oral Microbiology Workshop in 2008, 12 laboratories processing clinical oral microbiological samples were identified. All these were recruited to participate into the study and six laboratories from six European countries completed both the online survey and the first QC round. Three additional laboratories participated in the second round. Based on the survey, European oral microbiology laboratories process a significant (mean per laboratory 4,135 number of diagnostic samples from the oral cavity annually. A majority of the laboratories did not participate in any internal or external QC programme and nearly half of the laboratories did not have standard operating procedures for the tests they performed. In both QC rounds, there was a large variation in the results, interpretation and reporting of antibiotic susceptibility testing among the laboratories. In conclusion, the results of this study demonstrate the need for harmonisation of laboratory processing methods and interpretation of results for oral microbiology specimens. The QC rounds highlighted the value of external QC in evaluating the efficacy and safety of processes, materials and methods used in the laboratory. The use of standardised methods is also a prerequisite for multi-centre epidemiological studies that can provide important information on emerging microbes and trends in anti-microbial susceptibility for empirical prescribing in oro-facial infections.

SSCL magnet systems quality program implementation for laboratory and industry

International Nuclear Information System (INIS)

Warner, D.G.; Bever, D.L.

1992-01-01

The development and delivery of reliable and producible magnets for the Superconducting Super Collider Laboratory (SSCL) require the teamwork of a large and diverse workforce composed of personnel with backgrounds in laboratory research, defense, and energy. The SSCL Magnet Quality Program is being implemented with focus on three definitive objectives: (1) communication of requirements, (2) teamwork, and (3) verification. Examination of the SSCL Magnet Systems Division's (MSD) current and planned approach to implementation of the SSCL Magnet Quality Program utilizing these objectives is discussed

[Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

Science.gov (United States)

Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

2010-09-01

We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?

Science.gov (United States)

Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter

2013-01-01

Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.

Implementation of quality assurance and quality control in the Nuclear Analytical Laboratory of the Estonian Radiation Protection Centre

International Nuclear Information System (INIS)

Koeoep, T.; Jakobson, E.

2002-01-01

The Analytical Laboratory of the Estonian Radiation Protection Centre is in the process of implementing the system of Quality Assurance (QA) and Quality Control (QC) in the framework of the IAEA TC Project RER/2/004/ 'QA/QC of Nuclear Analytical Techniques'. The draft Quality Manual with annexes has been prepared accordingly to the ISO 17025 Guide, documents and other printed material delivered on the seminars of the project. The laboratory supply has been supplemented with necessary equipment for guaranteeing of quality. Proficiency testing included in the project has been performed successfully. (author)

Working toward a sustainable laboratory quality improvement programme through country ownership: Mozambique's SLMTA story.

Science.gov (United States)

Masamha, Jessina; Skaggs, Beth; Pinto, Isabel; Mandlaze, Ana Paula; Simbine, Carolina; Chongo, Patrina; de Sousa, Leonardo; Kidane, Solon; Yao, Katy; Luman, Elizabeth T; Samogudo, Eduardo

2014-01-01

Launched in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has emerged as an innovative approach for the improvement of laboratory quality. In order to ensure sustainability, Mozambique embedded the SLMTA programme within the existing Ministry of Health (MOH) laboratory structure. This article outlines the steps followed to establish a national framework for quality improvement and embedding the SLMTA programme within existing MOH laboratory systems. The MOH adopted SLMTA as the national laboratory quality improvement strategy, hired a dedicated coordinator and established a national laboratory quality technical working group comprising mostly personnel from key MOH departments. The working group developed an implementation framework for advocacy, training, mentorship, supervision and audits. Emphasis was placed on building local capacity for programme activities. After receiving training, a team of 25 implementers (18 from the MOH and seven from partner organisations) conducted baseline audits (using the Stepwise Laboratory Quality Improvement Process Towards Accreditation [SLIPTA] checklist), workshops and site visits in six reference and two central hospital laboratories. Exit audits were conducted in six of the eight laboratories and their results are presented. The six laboratories demonstrated substantial improvement in audit scores; median scores increased from 35% at baseline to 57% at exit. It has been recommended that the National Tuberculosis Reference Laboratory apply for international accreditation. Successful implementation of SLMTA requires partnership between programme implementers, whilst effectiveness and long-term viability depend on country leadership, ownership and commitment. Integration of SLMTA into the existing MOH laboratory system will ensure durability beyond initial investments. The Mozambican model holds great promise that country leadership, ownership and institutionalisation can set the stage for

Acoustic Technology Laboratory

Data.gov (United States)

Federal Laboratory Consortium — This laboratory contains an electro-magnetic worldwide data collection and field measurement capability in the area of acoustic technology. Outfitted by NASA Langley...

Quality control for diagnostic oral microbiology laboratories in European countries

NARCIS (Netherlands)

Rautemaa-Richardson, R.; van der Reijden, W.A.; Dahlen, G.; Smith, A.J.

2011-01-01

Participation in diagnostic microbiology internal and external quality control (QC) processes is good laboratory practice and an essential component of a quality management system. However, no QC scheme for diagnostic oral microbiology existed until 2009 when the Clinical Oral Microbiology (COMB)

The impact of SLMTA in improving laboratory quality systems in the Caribbean Region.

Science.gov (United States)

Guevara, Giselle; Gordon, Floris; Irving, Yvette; Whyms, Ismae; Parris, Keith; Beckles, Songee; Maruta, Talkmore; Ndlovu, Nqobile; Albalak, Rachel; Alemnji, George

Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow. To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA) training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS). Audits were conducted at baseline, six months, exit (at 12 months) and post-SLMTA (at 18 months) using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation.

Quality assurance in a large research and development laboratory

International Nuclear Information System (INIS)

Neill, F.H.

1980-01-01

Developing a quality assurance program for a large research and development laboratory provided a unique opportunity for innovative planning. The quality assurance program that emerged has been tailored to meet the requirements of several sponsoring organizations and contains the flexibility for experimental programs ranging from large engineering-scale development projects to bench-scale basic research programs

Laboratory diagnosis of the rare anaemias: external quality assessment benefits patient care

Directory of Open Access Journals (Sweden)

Barbara De La Salle

2013-03-01

Full Text Available Since its introduction in the 1960s, external quality assessment has developed to become an essential component of the quality management system of the diagnostic laboratory. External quality assessment provides a long term, retrospective view of laboratory performance, demonstrating the competence of the laboratory to others. The ENERCA project (the European Network for Rare and Congenital Anaemias has established a list of core laboratory tests that are used in the diagnosis of rare and congenital anaemias, which has been used as the basis for questionnaires to laboratories, to establish the use and quality assurance of diagnostic testing in the congenital and rare anaemias, and to European EQA providers for services in this key area. In general, the provision of EQA for rare and congenital anaemias is widely variable with little provision for the very rare disorders. For the more common congenital anaemias, such as the haemoglobinopathies and thalassaemias, provision is better but there is variation in aspects of the scheme design, especially the frequency of distribution. Where laboratories did not take part in EQA for individual tests, or there was no EQA available, a desire to participate was expressed in 66% (102/154 of cases. The provision of external quality assessment (EQA services for rare disorders is a challenge. For many of these conditions, the number of patients in any one member state is very small with only a few laboratories providing diagnostic testing. In these cases, the development of pan-European or cross-border EQA may be the only means by which standardisation of methods and results can be achieved. An EQA survey of 243 laboratories for performance in Hb A2 quantification showed encouraging results in that there was a clear differentiation in the results from a beta Thalassaemia carrier and an individual with no evidence of Thalassaemia; however, a bias was observed between different methods of measurement.

Tracking progress toward global polio eradication--worldwide, 2009-2010.

Science.gov (United States)

2011-04-15

Since the Global Polio Eradication Initiative (GPEI) began in 1988, progress has been tracked by 1) surveillance comprised of detection and investigation of cases of acute flaccid paralysis (AFP), coupled with environmental surveillance (sewage testing) in selected areas, and 2) timely testing of fecal specimens in accredited laboratories to identify polioviruses. The sensitivity of AFP case detection and the timeliness of AFP investigations are monitored with performance indicators. Polioviruses are isolated and characterized by the Global Polio Laboratory Network (GPLN). This report assesses the quality of polio surveillance and the timeliness of poliovirus isolation reporting and characterization worldwide during 2009--2010. During that period, 77% of countries affected by wild poliovirus (WPV) met national performance standards for AFP surveillance; underperforming subnational areas were identified in two of four countries with reestablished WPV transmission and in 13 of 22 countries with WPV outbreaks. Targets for timely GPLN reporting of poliovirus isolation results were met in five World Health Organization (WHO) regions in 2009 and in four of six regions in 2010; targets for timely poliovirus characterization were met in four WHO regions in 2009 and in five regions in 2010. Monitoring of surveillance performance indicators at subnational levels continues to be critical to identifying surveillance gaps that might allow WPV circulation to be missed in certain areas or subpopulations. To achieve polio eradication, efforts are needed to further strengthen AFP surveillance, implement targeted environmental surveillance, and ensure that GPLN quality is maintained.

Improving quality in national reference laboratories: The role of SLMTA and mentorship

Directory of Open Access Journals (Sweden)

Rosemary A. Audu

2014-09-01

Full Text Available Background: The Nigerian Institute of Medical Research houses two reference laboratories: the virology and tuberculosis laboratories. Both were enrolled in the Strengthening Laboratory Management Toward Accreditation (SLMTA programme. Objective: To describe the impact of SLMTA and discuss factors affecting the results, with an emphasis on mentorship. Methods: The SLMTA programme was implemented from April 2010 through November 2012. Participants attended three workshops and executed quality improvement projects; laboratory auditors evaluated performance using a standard checklist. The virology laboratory did not receive mentorship; however, the tuberculosis laboratory had an international mentor who visited the laboratory four times during the programme, spending two to four weeks embedded within the laboratory during each visit. Results: There was an overall improvement in the performance of both laboratories, with the virology laboratory increasing 13% (from 80% at baseline to 93% at exit audit and the tuberculosis laboratory increasing 29% (from 66% to 95%. These scores were maintained nine months later at the surveillance audit. Conclusion: The SLMTA programme resulted in improved and sustained quality management performance for both laboratories. Mentoring was a possible factor in the substantial improvement made by the tuberculosis laboratory and should be considered in order to augment the training received from the SLMTA workshops.

[The external evaluation of study quality: the role in maintaining the reliability of laboratory information].

Science.gov (United States)

Men'shikov, V V

2013-08-01

The external evaluation of quality of clinical laboratory examinations was gradually introduced in USSR medical laboratories since 1970s. In Russia, in the middle of 1990 a unified all-national system of external evaluation quality was organized known as the Federal center of external evaluation of quality at the basis of laboratory of the state research center of preventive medicine. The main positions of policy in this area were neatly formulated in the guidance documents of ministry of Health. Nowadays, the center of external evaluation of quality proposes 100 and more types of control studies and permanently extends their specter starting from interests of different disciplines of clinical medicine. The consistent participation of laboratories in the cycles of external evaluation of quality intrinsically promotes improvement of indicators of properness and precision of analysis results and increases reliability of laboratory information. However, a significant percentage of laboratories does not participate at all in external evaluation of quality or takes part in control process irregularly and in limited number of tests. The managers of a number of medical organizations disregard the application of the proposed possibilities to increase reliability of laboratory information and limit financing of studies in the field of quality control. The article proposes to adopt the national standard on the basis of ISO 17043 "Evaluation of compliance. The common requirements of professional competence testing".

Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.

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Pereira, Paulo; Westgard, James O; Encarnação, Pedro; Seghatchian, Jerard; de Sousa, Gracinda

2015-04-01

The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.

An overview of Quality Management System implementation in a research laboratory

Science.gov (United States)

Molinéro-Demilly, Valérie; Charki, Abdérafi; Jeoffrion, Christine; Lyonnet, Barbara; O'Brien, Steve; Martin, Luc

2018-02-01

The aim of this paper is to show the advantages of implementing a Quality Management System (QMS) in a research laboratory in order to improve the management of risks specific to research programmes and to increase the reliability of results. This paper also presents experience gained from feedback following the implementation of the Quality process in a research laboratory at INRA, the French National Institute for Agronomic Research and details the various challenges encountered and solutions proposed to help achieve smoother adoption of a QMS process. The 7Ms (Management, Measurement, Manpower, Methods, Materials, Machinery, Mother-nature) methodology based on the Ishikawa `Fishbone' diagram is used to show the effectiveness of the actions considered by a QMS, which involve both the organization and the activities of the laboratory. Practical examples illustrate the benefits and improvements observed in the laboratory.

The economic impact of poor sample quality in clinical chemistry laboratories: results from a global survey.

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Erdal, Erik P; Mitra, Debanjali; Khangulov, Victor S; Church, Stephen; Plokhoy, Elizabeth

2017-03-01

Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.

[Evaluation of clinical laboratories--assurance of their quality and competence].

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Kawai, Tadashi

2007-01-01

Since ISO 15189:2003 was published, the accreditation program of clinical laboratories based on ISO 15189 has been introduced in many countries, except for those in USA where all clinical laboratories must be required to follow the federal law, CLIA'88. It will certainly help the accredited clinical laboratories improve their quality and competence. In relation to the activity of JCTLM, reference measurement laboratories will be accredited, based on ISO 15195 which is now under its review and amendment by ISO/TC212/WG2. In Japan, JCCLS (Japanese Committee for Clinical Laboratory Standards) and JAB (Japan Accreditation Board for Conformity Assessment) cojointly started the accreditation program for clinical laboratories, based on ISO 15189:2003, and a total of 15 laboratories including university hospitals, community hospitals and independent clinical laboratories have been accredited up until the end of 2006.

Factors Affecting Quality of Laboratory Services in Public and Private Health Facilities in Addis Ababa, Ethiopia.

Science.gov (United States)

Mesfin, Eyob Abera; Taye, Binyam; Belay, Getachew; Ashenafi, Aytenew; Girma, Veronica

2017-10-01

Quality laboratory service is an essential component of health care system but in Sub-Saharan Africa such as Ethiopia, laboratories quality system remains weak due to several factors and it needs more attention to strengthen its capacity and quality system. A cross sectional study was conducted using a questionnaire to assess factors affecting the quality of laboratory service at private and public health institutions in Addis Ababa. A total of 213 laboratory professionals participated in the study and 131 (61.5%) participants had bachelor degree. Majority, 133 (62.4%), of the professionals did not attend any work related training. Seventy five (35.2%) respondents believed that their laboratories did not provide quality laboratory services and the major reported factors affecting provision of quality services were shortage of resources (64.3%), poor management support (57.3%), poor equipment quality (53.4%), high workload (41.1%), lack of equipment calibration (38.3%) and lack of knowledge (23.3%). Moreover logistic regression analysis showed that provision of quality laboratory service was significantly associated with result verification (AOR=9.21, 95% CI=2.26, 37.48), internal quality control (AOR= 6.11, 95% CI=2.11, 17.70), turnaround time (AOR=5.11, 95% CI=1.94, 13.46), shortage of equipment (AOR=7.76, 95% CI=2.55, 23.66), communication with clinicians (AOR=3.24, 95% CI=1.25, 8.41) and lack of job description (AOR=3.67, 95% CI=1.319, 10.22). In conclusion, the major factors that affecting the quality of laboratory service were associated with poor human resource management, poor resources provision, poor management commitment, ineffective communication system and lack of well-established quality management system.

Methodological and reporting quality in laboratory studies of human eating behavior

NARCIS (Netherlands)

Robinson, E.; Bevelander, K.E.; Field, M.; Jones, A.

2018-01-01

The methodological quality and reporting practices of laboratory studies of human eating behavior determine the validity and replicability of nutrition science. The aim of this research was to examine basic methodology and reporting practices in recent representative laboratory studies of human

Correction of stream quality trends for the effects of laboratory measurement bias

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Alexander, Richard B.; Smith, Richard A.; Schwarz, Gregory E.

1993-01-01

We present a statistical model relating measurements of water quality to associated errors in laboratory methods. Estimation of the model allows us to correct trends in water quality for long-term and short-term variations in laboratory measurement errors. An illustration of the bias correction method for a large national set of stream water quality and quality assurance data shows that reductions in the bias of estimates of water quality trend slopes are achieved at the expense of increases in the variance of these estimates. Slight improvements occur in the precision of estimates of trend in bias by using correlative information on bias and water quality to estimate random variations in measurement bias. The results of this investigation stress the need for reliable, long-term quality assurance data and efficient statistical methods to assess the effects of measurement errors on the detection of water quality trends.

Radiation safety and quality control in the cyclotron laboratory

International Nuclear Information System (INIS)

Sharma, S.; Krause, G.; Ebadi, M.

2006-01-01

Radiation safety was determined to maintain quality control in the cyclotron laboratory. Based on the results of 438 runs in the Faraday cup (20 μA for 10 min), 20 runs on 18 O-water target (40 μA for 2 h) and 10 runs on 18 O-gas targets (30 μA for 45 min), we have established that occupationally exposed workers remain 10 ± 5 times below federal regulatory limits (FRLs) in the cyclotron vault, 30 ± 8 times below FRL in the radiochemistry laboratory and 200 ± 10 times below the FRL outside the cyclotron laboratory during beam operation. (The FRL for unrestricted area are <20 μSv in 1 h.) The non-occupationally exposed workers serving in offices in the vicinity of the cyclotron vault within 100 m distance remained 200 times below the FRL irrespective of beam being on or off, suggesting that routine beam operation of 40 μA for 2 h once a day during office hours is safe provided quality control and system performance measures as discussed in this report are strictly maintained. (authors)

Quality management systems for your in vitro fertilization clinic′s laboratory: Why bother?

Directory of Open Access Journals (Sweden)

Jan I Olofsson

2013-01-01

Full Text Available Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.

Working toward a sustainable laboratory quality improvement programme through country ownership: Mozambique’s SLMTA story

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Jessina Masamha

2014-11-01

Full Text Available Background: Launched in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA programme has emerged as an innovative approach for the improvement of laboratory quality. In order to ensure sustainability, Mozambique embedded the SLMTA programme within the existing Ministry of Health (MOH laboratory structure. Objective: This article outlines the steps followed to establish a national framework for quality improvement and embed the SLMTA programme within existing MOH laboratory systems. Methods: The MOH adopted SLMTA as the national laboratory quality improvement strategy, hired a dedicated coordinator and established a national laboratory quality technical working group comprising mostly personnel from key MOH departments. The working group developed an implementation framework for advocacy, training, mentorship, supervision and audits. Emphasis was placed on building local capacity for programme activities. After receiving training, a team of 25 implementers (18 from the MOH and sevenfrom partner organisations conducted baseline audits (using the Stepwise Laboratory Quality Improvement Process Towards Accreditation [SLIPTA] checklist, workshops and site visits in six reference and two central hospital laboratories. Exit audits were conducted in six of the eight laboratories and their results are presented. Results: The six laboratories demonstrated substantial improvement in SLIPTA checklistscores; median scores increased from 35% at baseline to 57% at exit. It has been recommended that the National Tuberculosis Reference Laboratory apply for international accreditation. Conclusion: Successful implementation of SLMTA requires partnership between programme implementers, whilst effectiveness and long-term viability depend on country leadership, ownership and commitment. Integration of SLMTA into the existing MOH laboratory system will ensure durability beyond initial investments. The Mozambican model holds great promise that

The impact of SLMTA in improving laboratory quality systems in the Caribbean Region

Directory of Open Access Journals (Sweden)

Giselle Guevara

2014-11-01

Objective: To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. Method: Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS. Audits were conducted at baseline, six months, exit (at 12 months and post-SLMTA (at 18 months using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. Results: Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. Conclusion: The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation.

[Study of continuous quality improvement for clinical laboratory processes via the platform of Hospital Group].

Science.gov (United States)

Song, Wenqi; Shen, Ying; Peng, Xiaoxia; Tian, Jian; Wang, Hui; Xu, Lili; Nie, Xiaolu; Ni, Xin

2015-05-26

The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for

Internal quality control of neutron activation analysis laboratory

Energy Technology Data Exchange (ETDEWEB)

Kim, S. H.; Mun, J. H.; BaeK, S. Y.; Jung, Y. S.; Kim, Y. J. [KAERI, Taejon (Korea, Republic of)

2004-07-01

The importance for quality assurance and control in analytical laboratories has been emphasized, day by day. Internal quality control using certified reference materials(CRMs) can be one of effective methods for this purpose. In this study, 10 kinds of CRMs consisting of soil, sediment and biological matrix were analyzed. To evaluate the confidence of analytical results and the validation of testing method and procedure, the accuracy and the precision of the measured elements were treated statistically and the reproducibility was compared with those values produced before 2003.

Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.

Science.gov (United States)

Shiferaw, Melashu Balew; Hailu, Hiwot Amare; Fola, Abebe Alemu; Derebe, Mulatu Melese; Kebede, Aimro Tadese; Kebede, Abayneh Admas; Emiru, Manamnot Agegne; Gelaw, Zelalem Dessie

2015-01-01

Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS) strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48%) in Amhara region compared to the World Health Organization (WHO) estimate (70%). This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia. A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS) method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20. Among 201 laboratories enrolled in this study, 47 (23.4%) laboratories had major errors. Forty one (20.4%) laboratories had a total of 67 false negative and 29 (14.4%) laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%), 133 (66.2%) and 126 (62.7%) laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013) and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024) were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007) was associated with false positive results. The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.

Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.

Directory of Open Access Journals (Sweden)

Melashu Balew Shiferaw

Full Text Available Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48% in Amhara region compared to the World Health Organization (WHO estimate (70%. This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia.A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20.Among 201 laboratories enrolled in this study, 47 (23.4% laboratories had major errors. Forty one (20.4% laboratories had a total of 67 false negative and 29 (14.4% laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%, 133 (66.2% and 126 (62.7% laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013 and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024 were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007 was associated with false positive results.The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.

Water Quality & Pollutant Source Monitoring: Field and Laboratory Procedures. Training Manual.

Science.gov (United States)

Office of Water Program Operations (EPA), Cincinnati, OH. National Training and Operational Technology Center.

This training manual presents material on techniques and instrumentation used to develop data in field monitoring programs and related laboratory operations concerned with water quality and pollution monitoring. Topics include: collection and handling of samples; bacteriological, biological, and chemical field and laboratory methods; field…

QUALITY ASSURANCE GUIDELINES FOR LABORATORIES PERFORMING FORENSIC ANALYSIS OF CHEMICAL TERRORISM

Science.gov (United States)

The Scientific Working Group on Forensic Analysis of Chemical Terrorism (SWGFACT) has developed the following quality assurance guidelines to provide laboratories engaged in forensic analysis of chemical evidence associated with terrorism a framework to implement a quality assura...

The external quality assessment scheme: Five years experience as a participating laboratory

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Chaudhary Rajendra

2010-01-01

Full Text Available Background and Aim : Quality assurance in blood banking includes active participation in the external quality program. Such a program offers valuable benefits to patient care, their safety, and an overall quality of laboratory practices. In the year 2002, we participated in the External Quality Assessment Scheme (EQAS under the World Health Organization (WHO, Bureau of Laboratory Quality Standards, Thailand. Materials and Methods: In the current study we evaluated our EQAS test result of the past five years, from 2003 to 2007. Test results of all blood samples such as ABO grouping, D typing, antibody screening, antibody identification, and transfusion transmitted infection (TTI testing were analyzed and documented. Results: Discordant results in one or more instances were observed with antibody identification, weak D testing, and tests for anti-HIV1/2 and HBsAg. Twice we failed to detect the ′anti-Mia′ antibody in the issued sample and that could be attributed to the absence of the corresponding antigen in the used cell panel. HBsAg was missed due to its critically low titer in the serum and the comparatively low sensitivity of our Enzyme-Linked Immunosorbent Assay (ELISA test kit. Conclusion: All these failures in the last five years have helped us to significantly improve our transfusion service in terms of performance evaluation, patient care and safety issues, and the overall quality of laboratory practices. We therefore recommend all laboratories and hospitals to participate in the EQAS program, which will definitely help them to improve from what they learn.

Cost effectiveness of adopted quality requirements in hospital laboratories.

Science.gov (United States)

Hamza, Alneil; Ahmed-Abakur, Eltayib; Abugroun, Elsir; Bakhit, Siham; Holi, Mohamed

2013-01-01

The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase. In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.

Current worldwide nuclear cardiology practices and radiation exposure: results from the 65 country IAEA Nuclear Cardiology Protocols Cross-Sectional Study (INCAPS)

Science.gov (United States)

Einstein, Andrew J.; Pascual, Thomas N. B.; Mercuri, Mathew; Karthikeyan, Ganesan; Vitola, João V.; Mahmarian, John J.; Better, Nathan; Bouyoucef, Salah E.; Hee-Seung Bom, Henry; Lele, Vikram; Magboo, V. Peter C.; Alexánderson, Erick; Allam, Adel H.; Al-Mallah, Mouaz H.; Flotats, Albert; Jerome, Scott; Kaufmann, Philipp A.; Luxenburg, Osnat; Shaw, Leslee J.; Underwood, S. Richard; Rehani, Madan M.; Kashyap, Ravi; Paez, Diana; Dondi, Maurizio

2015-01-01

Aims To characterize patient radiation doses from nuclear myocardial perfusion imaging (MPI) and the use of radiation-optimizing ‘best practices’ worldwide, and to evaluate the relationship between laboratory use of best practices and patient radiation dose. Methods and results We conducted an observational cross-sectional study of protocols used for all 7911 MPI studies performed in 308 nuclear cardiology laboratories in 65 countries for a single week in March–April 2013. Eight ‘best practices’ relating to radiation exposure were identified a priori by an expert committee, and a radiation-related quality index (QI) devised indicating the number of best practices used by a laboratory. Patient radiation effective dose (ED) ranged between 0.8 and 35.6 mSv (median 10.0 mSv). Average laboratory ED ranged from 2.2 to 24.4 mSv (median 10.4 mSv); only 91 (30%) laboratories achieved the median ED ≤ 9 mSv recommended by guidelines. Laboratory QIs ranged from 2 to 8 (median 5). Both ED and QI differed significantly between laboratories, countries, and world regions. The lowest median ED (8.0 mSv), in Europe, coincided with high best-practice adherence (mean laboratory QI 6.2). The highest doses (median 12.1 mSv) and low QI (4.9) occurred in Latin America. In hierarchical regression modelling, patients undergoing MPI at laboratories following more ‘best practices’ had lower EDs. Conclusion Marked worldwide variation exists in radiation safety practices pertaining to MPI, with targeted EDs currently achieved in a minority of laboratories. The significant relationship between best-practice implementation and lower doses indicates numerous opportunities to reduce radiation exposure from MPI globally. PMID:25898845

Worldwide open proficiency test IAEA-CU-2007-09/A: Determination of Po-210 in water

International Nuclear Information System (INIS)

2009-01-01

The IAEA helps the Member States' laboratories to maintain their readiness by coordination activities, by development of standardized methods for sample collection and analysis, and by conducting interlaboratory comparisons and proficiency tests as a tool for external quality control. The Chemistry Unit of the Physics, Chemistry and Instrumentation Laboratory in the International Atomic Energy Agency's Seibersdorf Laboratories in Austria, has the programmatic responsibility to support global radionuclide measurement systems. To fulfil this obligation and ensure a reliable worldwide, rapid and consistent response, the Chemistry Unit organises interlaboratory studies and proficiency tests. The Po-210 poisoning event which occurred in November 2006 brought into focus a number of issues, including the capacity of laboratories to rapidly and accurately determine this radionuclide in environmental samples. A number of requests were received from Member States to address this issue. Responding to these requests, the Chemistry Unit of the Physics, Chemistry and Instrumentation Laboratory in the Agency's Laboratories, conducted a world wide proficiency test on the determination of Po-210 in water. The aim was to gather information on the current state of practice for Po-210 measurements at various levels in aqueous samples. This report describes the methodology employed and the results obtained in this proficiency test

Quality assurance plan for the Close Support Laboratory for the remedial investigation at Oak Ridge National Laboratory, Oak Ridge, Tennessee

International Nuclear Information System (INIS)

1993-08-01

The primary purpose of the Close Support Laboratory (CSL) is to provide rapid radiological screening of investigation-derived samples before they are shipped to off-site laboratories for more detailed analyses. Analyses for volatile organic compounds and miscellaneous water quality parameters are also performed at the CSL. CSL data are also used to select samples for off-site laboratory analysis, for rapid qualitative and quantitative determinations, and for other processes when off-site analysis is not needed and/or is impractical. This plan specifies methods of implementing analytical and radiological protocols and procedures for the documentation, handling, control, and analysis of samples and describes the levels of authority and responsibility for laboratory operation. Specific quality control methods used by the CSL for individual analyses are described in project procedures

National survey on internal quality control for tumour markers in clinical laboratories in China.

Science.gov (United States)

Wang, Wei; Zhong, Kun; Yuan, Shuai; He, Falin; Du, Yuxuan; Hu, Zhehui; Wang, Zhiguo

2018-06-15

This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications. This survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa. A total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5 th percentile) to 13% (95 th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs. The performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.

Worldwide and Regional Laboratory Comparison on the Determination of Organochlorine Compounds, Polybrominated Diphenyl Ethers and Petroleum Hydrocarbons in IAEA-457 Clam (Gafrarium tumidum) Sample

International Nuclear Information System (INIS)

2013-01-01

For nearly thirty years, the Marine Environmental Studies Laboratory (MESL) of the IAEA Environment Laboratories has conducted worldwide laboratory performance studies, also known as interlaboratory comparisons (ILCs). The results have been used to evaluate the participating laboratories' performance with respect to a wide range of organic and inorganic pollutants. This work has been conducted in collaboration with the Regional Seas Programme of the United Nations Environment Programme. The goal of the performance studies is to demonstrate the measurement capabilities of laboratories participating in ILCs and proficiency tests (PTs). The results of ILCs or PTs are of crucial interest to laboratories, as they provide clear information about the laboratories' measurement capabilities. Participation is voluntary or is undertaken to fulfil external requirements (e.g. legal, accreditation, control bodies). The ILC and PT schemes involve the comparison of participant results with an assigned value, usually delivered as a consensus value from the overall population of test results. These exercises are designed to monitor and demonstrate the performance and analytical capabilities of the participating laboratories, and to identify gaps and problem areas where further development is needed. Regular participation has benefits with regard to training and educational opportunities, enhanced mutual trust in results and methodology, and objective evidence for accreditation purposes. The present interlaboratory study was designed to evaluate the measurement performance of the participating laboratories on the analysis of organic contaminants in biota samples. The data reported by the laboratories, together with the technical and statistical evaluations of the results for each element, are included in this report

Quality-assurance results for routine water analysis in US Geological Survey laboratories, water year 1991

Science.gov (United States)

Maloney, T.J.; Ludtke, A.S.; Krizman, T.L.

1994-01-01

The US. Geological Survey operates a quality- assurance program based on the analyses of reference samples for the National Water Quality Laboratory in Arvada, Colorado, and the Quality of Water Service Unit in Ocala, Florida. Reference samples containing selected inorganic, nutrient, and low ionic-strength constituents are prepared and disguised as routine samples. The program goal is to determine precision and bias for as many analytical methods offered by the participating laboratories as possible. The samples typically are submitted at a rate of approximately 5 percent of the annual environmental sample load for each constituent. The samples are distributed to the laboratories throughout the year. Analytical data for these reference samples reflect the quality of environmental sample data produced by the laboratories because the samples are processed in the same manner for all steps from sample login through data release. The results are stored permanently in the National Water Data Storage and Retrieval System. During water year 1991, 86 analytical procedures were evaluated at the National Water Quality Laboratory and 37 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic (major ion and trace metal) constituent data for water year 1991 indicated analytical imprecision in the National Water Quality Laboratory for 5 of 67 analytical procedures: aluminum (whole-water recoverable, atomic emission spectrometric, direct-current plasma); calcium (atomic emission spectrometric, direct); fluoride (ion-exchange chromatographic); iron (whole-water recoverable, atomic absorption spectrometric, direct); and sulfate (ion-exchange chromatographic). The results for 11 of 67 analytical procedures had positive or negative bias during water year 1991. Analytical imprecision was indicated in the determination of two of the five National Water Quality Laboratory nutrient constituents: orthophosphate as phosphorus and

A summary of deliberations on strategic planning for continuous quality improvement in laboratory medicine.

Science.gov (United States)

Grzybicki, Dana Marie; Shahangian, Shahram; Pollock, Anne M; Raab, Stephen S

2009-03-01

On September 24-26, 2007, the Centers for Disease Control and Prevention convened the 2007 Institute on Critical Issues in Health Laboratory Practice: Managing for Better Health to develop an action plan for change for the immediate and long-term future. A wide variety of stakeholders, including pathologists, pathologist extenders, clinicians, and researchers, examined means to improve laboratory service communication, quality parameters, and potential future laboratory contributions to health care. In this summary document, we present the identified gaps, barriers, and proposed action plans for improvement for laboratory medicine in the 6 quality domains identified by the Institute of Medicine: safety, effectiveness, patient centeredness, timeliness, efficiency, and equity. Five major recommendations emerged from concluding discussions and included focusing on preanalytic and postanalytic processes as areas of potential quality improvement and recruiting a multidisciplinary group of nonlaboratory stakeholders to work with laboratory personnel to achieve improvement goals.

Association Between Echocardiography Laboratory Accreditation and the Quality of Imaging and Reporting for Valvular Heart Disease.

Science.gov (United States)

Thaden, Jeremy J; Tsang, Michael Y; Ayoub, Chadi; Padang, Ratnasari; Nkomo, Vuyisile T; Tucker, Stephen F; Cassidy, Cynthia S; Bremer, Merri; Kane, Garvan C; Pellikka, Patricia A

2017-08-01

It is presumed that echocardiographic laboratory accreditation leads to improved quality, but there are few data. We sought to compare the quality of echocardiographic examinations performed at accredited versus nonaccredited laboratories for the evaluation of valvular heart disease. We enrolled 335 consecutive valvular heart disease subjects who underwent echocardiography at our institution and an external accredited or nonaccredited institution within 6 months. Completeness and quality of echocardiographic reports and images were assessed by investigators blinded to the external laboratory accreditation status and echocardiographic results. Compared with nonaccredited laboratories, accredited sites more frequently reported patient sex (94% versus 78%; P heart disease. Future quality improvement initiatives should highlight the importance of high-quality color Doppler imaging and echocardiographic quantification to improve the accuracy, reproducibility, and quality of echocardiographic studies for valvular heart disease. © 2017 American Heart Association, Inc.

Development and Implementation of a Quality Improvement Process for Echocardiographic Laboratory Accreditation.

Science.gov (United States)

Gilliland, Yvonne E; Lavie, Carl J; Ahmad, Homaa; Bernal, Jose A; Cash, Michael E; Dinshaw, Homeyar; Milani, Richard V; Shah, Sangeeta; Bienvenu, Lisa; White, Christopher J

2016-03-01

We describe our process for quality improvement (QI) for a 3-year accreditation cycle in echocardiography by the Intersocietal Accreditation Commission (IAC) for a large group practice. Echocardiographic laboratory accreditation by the IAC was introduced in 1996, which is not required but could impact reimbursement. To ensure high-quality patient care and community recognition as a facility committed to providing high-quality echocardiographic services, we applied for IAC accreditation in 2010. Currently, there is little published data regarding the IAC process to meet echocardiography standards. We describe our approach for developing a multicampus QI process for echocardiographic laboratory accreditation during the 3-year cycle of accreditation by the IAC. We developed a quarterly review assessing (1) the variability of the interpretations, (2) the quality of the examinations, (3) a correlation of echocardiographic studies with other imaging modalities, (4) the timely completion of reports, (5) procedure volume, (6) maintenance of Continuing Medical Education credits by faculty, and (7) meeting Appropriate Use Criteria. We developed and implemented a multicampus process for QI during the 3-year accreditation cycle by the IAC for Echocardiography. We documented both the process and the achievement of those metrics by the Echocardiography Laboratories at the Ochsner Medical Institutions. We found the QI process using IAC standards to be a continuous educational experience for our Echocardiography Laboratory physicians and staff. We offer our process as an example and guide for other echocardiography laboratories who wish to apply for such accreditation or reaccreditation. © 2016, Wiley Periodicals, Inc.

AUDILAB: a knowledge-based quality audit simulator for testing laboratories.

Science.gov (United States)

Brai, A; Garnerin, P

1997-05-01

In order to obtain an accreditation, a laboratory must be prepared to provide a point-by-point check of various activities against the chosen reference standard, both from a general point of view and in relation to details of application. This paper describes AUDILAB, a computerized simulator accessible by network, able to provide testing laboratories with realistic quality audits performed in a customized way. AUDILAB establishes a detailed list of strengths (compliance with corresponding requirements of established standards) and weaknesses (improvements needed for laboratory's accreditation). The standard used by AUDILAB is the EN 45001 "General criteria for the operation of testing laboratories". A preliminary validation has already been completed. AUDILAB became operational in September 1993.

Student laboratory reports: an approach to improving feedback and quality

Science.gov (United States)

Ellingsen, Pål Gunnar; Støvneng, Jon Andreas

2018-05-01

We present an ongoing effort in improving the quality of laboratory reports written by first and second year physics students. The effort involves a new approach where students are given the opportunity to submit reports at intermediate deadlines, receive feedback, and then resubmit for the final deadline. In combination with a differential grading system, instead of pass/fail, the improved feedback results in higher quality reports. Improvement in the quality of the reports is visible through the grade statistics.

Managing quality in laboratory analysis

International Nuclear Information System (INIS)

Piciorea, Iuliana

2007-01-01

For the results of analyses to be reliable, the laboratories has to be authorized or to prove that they follows ISO/CEI standard no. 17025:2005 'General requirements for the competence of testing and calibration laboratories'. Analytic measurements are the results of analytic methods and procedures. It is considered that the chosen analytic method or procedure is appropriated for the desired purpose. From the legal point of view 'matching for a purpose' means that all methods and procedures are valid and this validation is made using qualified and verified equipment. Using state of art equipment in a laboratory, it is not enough to obtain correct results. The type, the extension and management of a validation action permit to obtain conclusions regarding the existence of adequate equipment, showing at the same time that the lab has an adequate management and competent personnel. To give results of required quality ensuring the conformity with national and international regulations, hence to prove its qualifications and competence some of measures are required as follows: - the usage of validated testing methods; - the usage of their quality control procedures; - participating to capability testing of the lab; -accreditation according to the requirements of an international standard as ISO/CEI 17025:2005. This accreditation is a set of technical and organization requirements about equipment checking, the way of choosing test methods, personal competence, determination of measurement uncertainty, etc. According to ISO, the validation represents the confirmation throughout examination and supplying of realistic proofs showing that the necessary requirements needed for utilization are fulfilled. The object of validation is checking the fact that the measurement conditions and the equation used to get the final result include all influences that could affect it. For validation studies, a series of checks is made: - linearity check - it is checked if the method is

Soil sampling intercomparison exercise by selected laboratories of the ALMERA Network

International Nuclear Information System (INIS)

2009-01-01

The IAEA's Seibersdorf Laboratories in Austria have the programmatic responsibility to provide assistance to Member State laboratories in maintaining and improving the reliability of analytical measurement results, both in radionuclide and trace element determinations. This is accomplished through the provision of reference materials of terrestrial origin, validated analytical procedures, training in the implementation of internal quality control, and through the evaluation of measurement performance by the organization of worldwide and regional interlaboratory comparison exercises. The IAEA is mandated to support global radionuclide measurement systems related to accidental or intentional releases of radioactivity in the environment. To fulfil this obligation and ensure a reliable, worldwide, rapid and consistent response, the IAEA coordinates an international network of analytical laboratories for the measurement of environmental radioactivity (ALMERA). The network was established by the IAEA in 1995 and makes available to Member States a world-wide network of analytical laboratories capable of providing reliable and timely analysis of environmental samples in the event of an accidental or intentional release of radioactivity. A primary requirement for the ALMERA members is participation in the IAEA interlaboratory comparison exercises, which are specifically organized for ALMERA on a regular basis. These exercises are designed to monitor and demonstrate the performance and analytical capabilities of the network members, and to identify gaps and problem areas where further development is needed. In this framework, the IAEA organized a soil sampling intercomparison exercise (IAEA/SIE/01) for selected laboratories of the ALMERA network. The main objective of this exercise was to compare soil sampling procedures used by different participating laboratories. The performance evaluation results of the interlaboratory comparison exercises performed in the framework of

Quality assurance consideration for cement-based grout technology programs at Oak Ridge National Laboratory

International Nuclear Information System (INIS)

McDaniel, E.W.; Tallent, O.K.; Sams, T.L.; Delzer, D.B.

1987-01-01

Oak Ridge National Laboratory has developed and is continuing to refine a method of immobilizing low-level radioactive liquid wastes by mixing them with cementitious dry-solid blends. A quality assurance program is vital to the project because Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA) and state environmental regulations must be demonstrably met (the work must be defensible in a court of law). The end result of quality assurance (QA) is, by definition, a product of demonstrable quality. In the laboratory, this entails traceability, repeatability, and credibility. This paper describes the application of QA in grout technology development at Oak Ridge National Laboratory

Quality management at Argonne National Laboratory: Status, accomplishments, and lessons learned

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-06-01

In April 1992, Argonne National Laboratory (ANL) launched the implementation of quality management (QM) as an initiative of the Laboratory Director. The goal of the program is to seek ways of improving Laboratory performance and effectiveness by drawing from the realm of experiences in the global total quality management movement. The Argonne QM initiative began with fact finding and formulating a strategy for implementation; the emphasis is that the underlying principles of QM should be an integral part of how the Laboratory is managed and operated. A primary theme that has guided the Argonne QM initiative is to consider only those practices that offer the potential for real improvement, make sense, fit the culture, and would be credible to the broad population. In October 1993, the Laboratory began to pilot a targeted set of QM activities selected to produce outcomes important to the Laboratory--strengthening the customer focus, improving work processes, enhancing employee involvement and satisfaction, and institutionalizing QM. This report describes the results of the just-concluded QM development and demonstration phase in terms of detailed strategies, accomplishments, and lessons learned. These results are offered as evidence to support the conclusion that the Argonne QM initiative has achieved value-added results and credibility and is well positioned to support future deployment across the entire Laboratory as an integrated management initiative. Recommendations for follow-on actions to implement future deployment are provided separately.

Worldwide Open Proficiency Test for X Ray Fluorescence Laboratories PTXRFIAEA09: Determination of Major, Minor and Trace Elements in a River Clay

International Nuclear Information System (INIS)

2014-01-01

This publication presents the results of the worldwide proficiency test PTXRFIAEA09 on the determination of major, minor and trace elements in river clay. Methodologies, a data evaluation approach, a summary evaluation of each element and individual evaluation reports for each laboratory are also described. The test was carried out within the IAEA project Nuclear Spectrometry for Analytical Applications, under the Nuclear Science Programme. The main objective of the project was to enhance the capability of interest Member States in effective utilization of nuclear spectrometries and analytical services in industry, human health and agriculture, and in monitoring and evaluating environmental pollution

Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development.

Science.gov (United States)

Wang, Jin; Patel, Vimal; Burns, Daniel; Laycock, John; Pandya, Kinnari; Tsoi, Jennifer; DeSilva, Binodh; Ma, Mark; Lee, Jean

2013-07-01

Regulated bioanalytical laboratories that run ligand-binding assays in support of biotherapeutics development face ever-increasing demand to support more projects with increased efficiency. Laboratory automation is a tool that has the potential to improve both quality and efficiency in a bioanalytical laboratory. The success of laboratory automation requires thoughtful evaluation of program needs and fit-for-purpose strategies, followed by pragmatic implementation plans and continuous user support. In this article, we present the development of fit-for-purpose automation of total walk-away and flexible modular modes. We shared the sustaining experience of vendor collaboration and team work to educate, promote and track the use of automation. The implementation of laboratory automation improves assay performance, data quality, process efficiency and method transfer to CRO in a regulated bioanalytical laboratory environment.

Worldwide end-of-life practice for patients in ICUs.

Science.gov (United States)

Wong, Wai-Tat; Phua, Jason; Joynt, Gavin M

2018-04-01

Published data and practice recommendations on end-of-life (EOL) generally reflect Western practice frameworks. Understanding worldwide practices is important because improving economic conditions are promoting rapid expansion of intensive care services in many previously disadvantaged regions, and increasing migration has promoted a new cultural diversity previously predominantly unicultural societies. This review explores current knowledge of similarities and differences in EOL practice between regions and possible causes and implications of these differences. Recent observational and survey data shows a marked variability in the practice of withholding and withdrawing life sustaining therapy worldwide. Some evidence supports the view that culture, religion, and socioeconomic factors influence EOL practice, and individually or together account for differences observed. There are also likely to be commonly desired values and expectations for EOL practice, and recent attempts at establishing where worldwide consensus may lie have improved our understanding of shared values and practices. Awareness of differences, understanding their likely complex causes, and using this knowledge to inform individualized care at EOL is likely to improve the quality of care for patients. Further research should clarify the causes of EOL practice variability, monitor trends, and objectively evaluate the quality of EOL practice worldwide.

ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

Science.gov (United States)

Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

2015-12-01

The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

Quality Indicators for the Total Testing Process.

Science.gov (United States)

Plebani, Mario; Sciacovelli, Laura; Aita, Ada

2017-03-01

ISO 15189:2012 requires the use of quality indicators (QIs) to monitor and evaluate all steps of the total testing process, but several difficulties dissuade laboratories from effective and continuous use of QIs in routine practice. An International Federation of Clinical Chemistry and Laboratory Medicine working group addressed this problem and implemented a project to develop a model of QIs to be used in clinical laboratories worldwide to monitor and evaluate all steps of the total testing process, and decrease error rates and improve patient services in laboratory testing. All laboratories are invited, at no cost, to enroll in the project and contribute to harmonized management at the international level. Copyright © 2016 Elsevier Inc. All rights reserved.

Standard guide for establishing a quality assurance program for analytical chemistry laboratories within the nuclear industry

CERN Document Server

American Society for Testing and Materials. Philadelphia

2006-01-01

1.1 This guide covers the establishment of a quality assurance (QA) program for analytical chemistry laboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001, Quality Systems, provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program. 1.2 The essential, basic elements of a laboratory QA program appear in the following order: Section Organization 5 Quality Assurance Program 6 Training and Qualification 7 Procedures 8 Laboratory Records 9 Control of Records 10 Control of Procurement 11 Control of Measuring Equipment and Materials 12 Control of Measurements 13 Deficiencies and Corrective Actions 14

Sunway Medical Laboratory Quality Control Plans Based on Six Sigma, Risk Management and Uncertainty.

Science.gov (United States)

Jairaman, Jamuna; Sakiman, Zarinah; Li, Lee Suan

2017-03-01

Sunway Medical Centre (SunMed) implemented Six Sigma, measurement uncertainty, and risk management after the CLSI EP23 Individualized Quality Control Plan approach. Despite the differences in all three approaches, each implementation was beneficial to the laboratory, and none was in conflict with another approach. A synthesis of these approaches, built on a solid foundation of quality control planning, can help build a strong quality management system for the entire laboratory. Copyright © 2016 Elsevier Inc. All rights reserved.

Worldwide Protein Data Bank biocuration supporting open access to high-quality 3D structural biology data

Science.gov (United States)

Westbrook, John D; Feng, Zukang; Persikova, Irina; Sala, Raul; Sen, Sanchayita; Berrisford, John M; Swaminathan, G Jawahar; Oldfield, Thomas J; Gutmanas, Aleksandras; Igarashi, Reiko; Armstrong, David R; Baskaran, Kumaran; Chen, Li; Chen, Minyu; Clark, Alice R; Di Costanzo, Luigi; Dimitropoulos, Dimitris; Gao, Guanghua; Ghosh, Sutapa; Gore, Swanand; Guranovic, Vladimir; Hendrickx, Pieter M S; Hudson, Brian P; Ikegawa, Yasuyo; Kengaku, Yumiko; Lawson, Catherine L; Liang, Yuhe; Mak, Lora; Mukhopadhyay, Abhik; Narayanan, Buvaneswari; Nishiyama, Kayoko; Patwardhan, Ardan; Sahni, Gaurav; Sanz-García, Eduardo; Sato, Junko; Sekharan, Monica R; Shao, Chenghua; Smart, Oliver S; Tan, Lihua; van Ginkel, Glen; Yang, Huanwang; Zhuravleva, Marina A; Markley, John L; Nakamura, Haruki; Kurisu, Genji; Kleywegt, Gerard J; Velankar, Sameer; Berman, Helen M; Burley, Stephen K

2018-01-01

Abstract The Protein Data Bank (PDB) is the single global repository for experimentally determined 3D structures of biological macromolecules and their complexes with ligands. The worldwide PDB (wwPDB) is the international collaboration that manages the PDB archive according to the FAIR principles: Findability, Accessibility, Interoperability and Reusability. The wwPDB recently developed OneDep, a unified tool for deposition, validation and biocuration of structures of biological macromolecules. All data deposited to the PDB undergo critical review by wwPDB Biocurators. This article outlines the importance of biocuration for structural biology data deposited to the PDB and describes wwPDB biocuration processes and the role of expert Biocurators in sustaining a high-quality archive. Structural data submitted to the PDB are examined for self-consistency, standardized using controlled vocabularies, cross-referenced with other biological data resources and validated for scientific/technical accuracy. We illustrate how biocuration is integral to PDB data archiving, as it facilitates accurate, consistent and comprehensive representation of biological structure data, allowing efficient and effective usage by research scientists, educators, students and the curious public worldwide. Database URL: https://www.wwpdb.org/ PMID:29688351

Los Alamos National Laboratory transuranic waste quality assurance project plan. Revision 1

International Nuclear Information System (INIS)

1997-01-01

This Transuranic (TRU) Waste Quality Assurance Project Plan (QAPjP) serves as the quality management plan for the characterization of transuranic waste in preparation for certification and transportation. The Transuranic Waste Characterization/Certification Program (TWCP) consists of personnel who sample and analyze waste, validate and report data; and provide project management, quality assurance, audit and assessment, and records management support, all in accordance with established requirements for disposal of TRU waste at the Waste Isolation Pilot Plant (WIPP) facility. This QAPjP addresses how the TWCP meets the quality requirements of the Carlsbad Area Office (CAO) Quality Assurance Program Description (QAPD) and the technical requirements of the Transuranic Waste Characterization Quality Assurance Program Plan (QAPP). The TWCP characterizes and certifies retrievably stored and newly generated TRU waste using the waste selection, testing, sampling, and analytical techniques and data quality objectives (DQOs) described in the QAPP, the Los Alamos National Laboratory Transuranic Waste Certification Plan (Certification Plan), and the CST Waste Management Facilities Waste Acceptance Criteria and Certification [Los Alamos National Laboratory (LANL) Waste Acceptance Criteria (WAC)]. At the present, the TWCP does not address remote-handled (RH) waste

Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

Science.gov (United States)

Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming

2014-04-30

The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation.

Science.gov (United States)

Alemnji, George; Edghill, Lisa; Guevara, Giselle; Wallace-Sankarsingh, Sacha; Albalak, Rachel; Cognat, Sebastien; Nkengasong, John; Gabastou, Jean-Marc

2017-01-01

Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. We report the development of a stepwise process for quality systems improvement in the Caribbean Region. The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.

International standards for tuberculosis care: Relevance and implications for laboratory professionals

Directory of Open Access Journals (Sweden)

Pai M

2007-01-01

Full Text Available On World Tuberculosis (TB Day 2006, the International Standards for Tuberculosis Care (ISTC was officially released and widely endorsed by several agencies and organizations. The ISTC release was the culmination of a year long global effort to develop and set internationally acceptable, evidence-based standards for tuberculosis care. The ISTC describes a widely endorsed level of care that all practitioners, public and private, should seek to achieve in managing individuals who have or are suspected of having, TB and is intended to facilitate the effective engagement of all healthcare providers in delivering high quality care for patients of all ages, including those with smear-positive, smear-negative and extra-pulmonary TB, TB caused by drug-resistant Mycobacterium tuberculosis and TB/HIV coinfection. In this article, we present the ISTC, with a special focus on the diagnostic standards and describe their implications and relevance for laboratory professionals in India and worldwide. Laboratory professionals play a critical role in ensuring that all the standards are actually met by providing high quality laboratory services for smear microscopy, culture and drug susceptibility testing and other services such as testing for HIV infection. In fact, if the ISTC is widely followed, it can be expected that there will be a greater need and demand for quality assured laboratory services and this will have obvious implications for all laboratories in terms of work load, requirement for resources and trained personnel and organization of quality assurance systems.

Quality assurance program plan for low-level waste at the WSCF Laboratory

International Nuclear Information System (INIS)

Morrison, J.A.

1994-01-01

The purpose of this document is to provide guidance for the implementation of the Quality Assurance Program Plan (QAPP) for the management of low-level waste at the Waste Sampling and Characterization Facility (WSCF) Laboratory Complex as required by WHC-CM-4-2, Quality Assurance Manual, which is based on Quality Assurance Program Requirements for Nuclear Facilities, NQA-1 (ASME)

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

Science.gov (United States)

Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

2016-12-01

Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

ABACC laboratories quality assurance through Secondary Standards Exchange Program

International Nuclear Information System (INIS)

Guidicini, Olga Mafra; Thompson, Jay; Soriano, Michael

2003-01-01

In September 1999, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC), with assistance from the New Brunswick Laboratory (NBL) of the U.S. Department of Energy, started a new cooperative activity with, among other objectives, the production and characterization of a traceable uranium secondary standard and the performance of the Third Round Robin for ABACC's laboratory network. Brazil and Argentina have fabricated UO 2 pellets for use as a secondary standard. Samples from the two batches were sent to NBL for the determination of the reference values for both uranium concentration (%U) and isotopic composition for each batch. ABACC and NBL then organized the Third ABACC Round Robin for Brazilian and Argentine laboratories that are part of the ABACC network. The laboratories comprising the network can be used to analyze real samples collected during the ABACC inspections. The Brazilian and Argentine pellets were distributed to all the laboratories together with the protocol to be followed for the uranium concentration analysis, the forms for reporting the measurement results, and natural UO 2 pellets (CETAMA OU1) to be used as reference material. For the laboratories with capability of measuring isotopics, NBL reference material CRM 125-A was provided. Several laboratories from each country provided results. As soon as the measurement results were sent to the organizers, they were statistically evaluated by NBL. During a meeting held at ABACC headquarters with the participation of NBL representatives, the ABACC technical support officer, and representatives of all the participant laboratories, the results were discussed and compared with the reference values. All the laboratories had the occasion, in an open discussion, to explain and show the difficulties and problems they faced during the exercise. ABACC had the opportunity not only to judge the quality of the measurements these laboratories performed, but also to determine

[The practice of development and implementation of quality management systems in medical laboratories. The GOST R ISO 15189-2009 "medical laboratories. The detailed requirements to quality and competence". Particular difficulties of global nature].

Science.gov (United States)

Emanuel', A V; Ivanov, G A; Fleganova, I N; Emanuel', V L

2012-12-01

The article discusses the methodological issues related to the implementation of international principles of standardization in the format of GOST R ISO 9001-2008 "Quality management systems. Requirements", GOST R ISO 15189-2009 "Medical laboratories. The detailed requirements to quality and competence" and GOST R ISO 18113.1-5 "Medical items for diagnostics in vitro. Information provided by manufacturer (marking)". This approach legibly assigns the responsibility concerning the support of metrological correctness of laboratory measurements. The lacking of both full-value public and sectorial normative documentation and coordinated positions of Rosstandard and Minzdrav of Russia on functioning of medical laboratories is noted.

Comparison of Laboratory and Field Remote Sensing Methods to Measure Forage Quality

OpenAIRE

Guo, Xulin; Wilmshurst, John F.; Li, Zhaoqin

2010-01-01

Recent research in range ecology has emphasized the importance of forage quality as a key indicator of rangeland condition. However, we lack tools to evaluate forage quality at scales appropriate for management. Using canopy reflectance data to measure forage quality has been conducted at both laboratory and field levels separately, but little work has been conducted to evaluate these methods simultaneously. The objective of this study is to find a reliable way of assessing grassland quality ...

QUALITY MANAGEMENT SYSTEM IN CLINICAL LABORATORIES ACCORDING TO THE ISO 15189:2007 STANDARD - EVALUATION OF THE BENEFITS OF IMPLEMENTATION IN AN ASSISTED REPRODUCTION LABORATORY

Directory of Open Access Journals (Sweden)

A.D. Sialakouma

2011-03-01

Full Text Available Biomedical science is a sensitive discipline and presents unique challenges due to its social character, continuous development and competitiveness. The issue of quality management systems and accreditation is gaining increasing interest in this sector. All over Europe, Health Services Units have started to introduce quality management systems and harmonization of criteria for accreditation is of increasing importance. Moreover, clinical laboratories, like the Assisted Reproduction laboratories and biochemical laboratories are required to apply a Quality Management System in order to ensure their correct, scientific and effective operation. Ultimately, it is a moral obligation for every health care organisation to supply the best possible care for the patient. The specific features and the diversity of clinical laboratories led to the introduction (2003 and, recently to the revision (2007 of the international standard ISO 15189, which is the first international standard developed specifically to address the requirements for accreditation of this type of laboratory. The basic principles for the quality assurance in the clinical laboratories are: x Complete and unambiguous standardized operating procedures. x Complete and unambiguous directives of operation. x Obligatory detailed written documentation, i.e., how each action is done, who will do it, where will this action take place and when. x Suitable scheduling of calibration/control/preventive maintenance of laboratory equipment and recording of each activity. x Distribution of responsibilities among the staff and continuous education and briefing according to current scientific data. x Complete and informed record file keeping. x Continuous improvement which is monitored with the adoption of quantified indicators. x Internal and external audit of all activities. x Troubleshooting. All these principles should be supported by the Management in order that the necessary adaptations should be made

External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China.

Science.gov (United States)

Wang, Lu-nan; Zhang, Rui; Shen, Zi-yu; Chen, Wen-xiang; Li, Jin-ming

2008-06-05

As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China (NCCL). The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus (HCV) RNA. Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value (TG) designated as +/- 0.5 log. The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens (10(3) IU/ml). The percentage of results within the range of GM +/- 0.5 log(10) varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest (3.00 log IU/ml) as well as of the highest viral levels (6.37 log IU/ml) values, very near to the limits of the dynamic range of the assays. The comparison of these results with the previous study confirms that a regular participation in external quality assessment (EQA) assures the achievement of a high

Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

Directory of Open Access Journals (Sweden)

Heidi Albert

2017-03-01

Full Text Available Background: Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS and laboratory accreditation are key to improving patient care. Objectives: The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs in the African Region. Method: An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. Results: A total of 21 laboratories (43.0% had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%, although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing. Barriers to accreditation included lack of training and accreditation programmes. Only 28.6%of NTRLs had developed strategic plans and budgets which included accreditation. Conclusion: Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient

Service Quality and Patient Satisfaction: An Exploratory Study of Pathology Laboratories in Jaipur.

Science.gov (United States)

Agarwal, Anuradha; Singh, Maithili R P

2016-01-01

One of the most important parts of healthcare system is diagnostics. Nowadays, Indians have become more aware of their health, due to improved and better availability of health related information, increase in medical tourism, and expanding health insurance. The demand for better diagnostic facilities have increased with the increase in lifestyle related diseases, excesses use of chemicals in agriculture practices and change in food habits. It is expected that the Indian diagnostic market will grow from USD $5 billion in the year 2012 to USD $32 billion by the year 2020 with 20% CAGR (India Brand Equity Foundation 2015 ). Today patients have easy access of information regarding the health services and they have become more concerned about it as they look forward to receiving the maximum value for their money. To win the confidence of the patients and to maintain that trust, it is required to deliver the right services to the right person at the right time. The purpose of this study was to develop a scale to measure the service quality at pathology laboratory. A thorough review of literature revealed that there are studies related to healthcare service quality but there is no such established scale to measure service quality of pathology laboratory. Thus, the authors strived to develop a reliable and valid instrument to measure the patients' perception toward pathology laboratory service quality. For this exploratory study was conducted on the sample of 80 patients of the laboratories in Jaipur city. The reliability and factor structures were tested to purify the scale. The findings revealed 13 items, comprising of three dimensions of service quality: responsiveness, tangibility, and reliability.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

Science.gov (United States)

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Impact of Nuclear Laboratory Personnel Credentials & Continuing Education on Nuclear Cardiology Laboratory Quality Operations.

Science.gov (United States)

Malhotra, Saurabh; Sobieraj, Diana M; Mann, April; Parker, Matthew W

2017-12-22

Background/Objectives: The specific credentials and continuing education (CME/CE) of nuclear cardiology laboratory medical and technical staff are important factors in the delivery of quality imaging services that have not been systematically evaluated. Methods: Nuclear cardiology accreditation application data from the Intersocietal Accreditation Commission (IAC) was used to characterize facilities performing myocardial perfusion imaging by setting, size, previous accreditation and credentials of the medical and technical staff. Credentials and CME/CE were compared against initial accreditation decisions (grant or delay) using multivariable logistic regression. Results: Complete data were available for 1913 nuclear cardiology laboratories from 2011-2014. Laboratories with initial positive accreditation decisions had a greater prevalence of Certification Board in Nuclear Cardiology (CBNC) certified medical directors and specialty credentialed technical directors. Certification and credentials of the medical and technical directors, respectively, staff CME/CE compliance, and assistance of a consultant with the application were positively associated with accreditation decisions. Conclusion: Nuclear cardiology laboratories directed by CBNC-certified physicians and NCT- or PET-credentialed technologists were less likely to receive delay decisions for MPI. CME/CE compliance of both the medical and technical directors was associated with accreditation decision. Medical and technical directors' years of experience were not associated with accreditation decision. Copyright © 2017 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for laboratory operations associated with the production and process control system? 111.110 Section 111.110 Food... § 111.110 What quality control operations are required for laboratory operations associated with the...

International External Quality Assurance for Laboratory Diagnosis of Diphtheria ▿

Science.gov (United States)

Neal, S. E.; Efstratiou, A.

2009-01-01

The diphtheria surveillance network (DIPNET) encompassing National Diphtheria Reference Centers from 25 European countries is a Dedicated Surveillance Network recognized by the European Commission. A key DIPNET objective is the quality assessment of microbiological procedures for diphtheria across the European Union and beyond. A detailed questionnaire on the level of reference laboratory services and an external quality assessment (EQA) panel comprising six simulated throat specimens were sent to 34 centers. Twenty-three centers are designated National Diphtheria Reference Centers, with the laboratory in the United Kingdom being the only WHO Collaborating Centre. A variety of screening and identification tests were used, including the cysteinase test (20/34 centers), pyrazinamidase test (17/34 centers), and commercial kits (25/34 centers). The classic Elek test for toxigenicity testing is mostly used (28/34 centers), with variations in serum sources and antitoxin concentrations. Many laboratories reported problems obtaining Elek reagents or media. Only six centers produced acceptable results for all six specimens. Overall, 21% of identification and 13% of toxigenicity reports were unacceptable. Many centers could not isolate the target organism, and most found difficulties with the specimens that contained Corynebacterium striatum as a commensal contaminant. Nineteen centers generated either false-positive or negative toxigenic results, which may have caused inappropriate medical management. The discrepancies in this diphtheria diagnostics EQA alarmingly reflect the urgent need to improve laboratory performance in diphtheria diagnostics in Europe, standardize feasible and robust microbiological methods, and build awareness among public health authorities. Therefore, DIPNET recommends that regular workshops and EQA distributions for diphtheria diagnostics should be supported and maintained. PMID:19828749

Worldwide prevalence and incidence of osteoporotic vertebral fractures.

Science.gov (United States)

Ballane, G; Cauley, J A; Luckey, M M; El-Hajj Fuleihan, G

2017-05-01

We investigated the prevalence and incidence of vertebral fractures worldwide. We used a systematic Medline search current to 2015 and updated as per authors' libraries. A total of 62 articles of fair to good quality and comparable methods for vertebral fracture identification were considered. The prevalence of morphometric vertebral fractures in European women is highest in Scandinavia (26%) and lowest in Eastern Europe (18%). Prevalence rates in North America (NA) for White women ≥50 are 20-24%, with a White/Black ratio of 1.6. Rates in women ≥50 years in Latin America are overall lower than Europe and NA (11-19%). In Asia, rates in women above ≥65 are highest in Japan (24%), lowest in Indonesia (9%), and in the Middle East, Lebanon, rates are 20%. The highest-lowest ratio between countries, within and across continents, varied from 1.4-2.6. Incidence data is less abundant and more heterogeneous. Age-standardized rates in studies combining hospitalized and ambulatory vertebral fractures are highest in South Korea, USA, and Hong Kong and lowest in the UK. Neither a North-South gradient nor a relation to urbanization is evident. Conversely, the incidence of hospitalized vertebral fractures in European patients ≥50 shows a North-South gradient with 3-3.7-fold variability. In the USA, rates in Whites are approximately 4-fold higher than in Blacks. Vertebral fractures variation worldwide is lower than observed with hip fractures, and some of highest rates are unexpectedly from Asia. Better quality representative studies are needed. We investigate the occurrence of vertebral fractures, worldwide, using published data current until the present. Worldwide, the variation in vertebral fractures is lower than observed for hip fractures. Some of the highest rates are from North America and unexpectedly Asia. The highest-lowest ratio between countries, within and across continents, varied from 1.4-2.6. Better quality representative data is needed.

Assessing the outcome of Strengthening Laboratory Management Towards Accreditation (SLMTA) on laboratory quality management system in city government of Addis Ababa, Ethiopia.

Science.gov (United States)

Sisay, Abay; Mindaye, Tedla; Tesfaye, Abrham; Abera, Eyob; Desale, Adino

2015-01-01

Strengthening Laboratory Management Toward Accreditation (SLMTA) is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The aim of this study is to assess the outcome of SLMTA on laboratory quality management system in Addis Ababa, Ethiopia. The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA. The study was conducted in Addis Ababa city government and the data was collected from February 'April 2014 and data was entered in to EPI-data version 3.1 and was analyzed by SPSS version 20. The assessment finding indicate that there was a significant improvement in average scores (141.4; range of 65-196, 95%CI=86.275-115.5, p=0.000) at final with 3 laboratories become 3 star, 6 laboratories were at 2 star, 11 were 1 star. Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2.5 times more likely to get good success in the final score(AOR=2.501, 95% CI=1.109-4.602) than which did not get it. At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance. Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories.

A Decade of Experience in Implementing Quality Management System at Radiochemistry and Environmental Laboratory (RAS)

International Nuclear Information System (INIS)

Norfaizal Mohamed; Nita Salina Abu Bakar; Zal U'yun Wan Mahmood; Wo, Y.M.; Abdul Kadir Ishak; Nurrul Assyikeen Md Jaffary; Noor Fadzilah Yusof

2016-01-01

Quality management system has been introduced to a few laboratories in the Malaysian Nuclear Agency (Nuclear Malaysia) for the purpose to enhance the delivery of quality services to customers. Radiochemistry and Environmental Laboratory (RAS) is a service center in Nuclear Malaysia has implemented a quality management system in procedures carried out and has obtained accreditation for MS ISO/ IEC 17025 since 8 December 2005. This paper is intended to share experiences RAS in implementing a quality management system in accordance with standard MS ISO/ IEC 17025 accreditation and managed to keep it to this day. In addition, the RAS achievements including issues and challenges in implementing the quality management system in the past 10 years will also be discussed. (author)

Data analysis considerations for pesticides determined by National Water Quality Laboratory schedule 2437

Science.gov (United States)

Shoda, Megan E.; Nowell, Lisa H.; Stone, Wesley W.; Sandstrom, Mark W.; Bexfield, Laura M.

2018-04-02

In 2013, the U.S. Geological Survey National Water Quality Laboratory (NWQL) made a new method available for the analysis of pesticides in filtered water samples: laboratory schedule 2437. Schedule 2437 is an improvement on previous analytical methods because it determines the concentrations of 225 fungicides, herbicides, insecticides, and associated degradates in one method at similar or lower concentrations than previously available methods. Additionally, the pesticides included in schedule 2437 were strategically identified in a prioritization analysis that assessed likelihood of occurrence, prevalence of use, and potential toxicity. When the NWQL reports pesticide concentrations for analytes in schedule 2437, the laboratory also provides supplemental information useful to data users for assessing method performance and understanding data quality. That supplemental information is discussed in this report, along with an initial analysis of analytical recovery of pesticides in water-quality samples analyzed by schedule 2437 during 2013–2015. A total of 523 field matrix spike samples and their paired environmental samples and 277 laboratory reagent spike samples were analyzed for this report (1,323 samples total). These samples were collected in the field as part of the U.S. Geological Survey National Water-Quality Assessment groundwater and surface-water studies and as part of the NWQL quality-control program. This report reviews how pesticide samples are processed by the NWQL, addresses how to obtain all the data necessary to interpret pesticide concentrations, explains the circumstances that result in a reporting level change or the occurrence of a raised reporting level, and describes the calculation and assessment of recovery. This report also discusses reasons why a data user might choose to exclude data in an interpretive analysis and outlines the approach used to identify the potential for decreased data quality in the assessment of method recovery. The

Worldwide deposition of 90Sr through 1984

International Nuclear Information System (INIS)

Larsen, R.J.; Juzdan, Z.R.

1986-10-01

The deposition of 90 Sr in the Northern Hemisphere during 1984 was 0.3 PBq (0.008 MCi), while that of the Southern Hemisphere was 0.1 PBq (0.003 MCi). This resulted in a total deposition on the surface of the earth during 1984 of 0.4 PBq (0.011 MCi). This is the lowest total yearly deposit since the initiation of the Environmental Measurements Laboratory's global fallout program in the mid-1950's. The worldwide cumulative deposit decreased to 357 PBq (9.6 MCi)

a worldwide assessment of medical journal editors' practices and ...

African Journals Online (AJOL)

responding editors reported having access to the Internet, making participation in ... of improving the quality of medical science and practice.! A critical activity of ... undertook a worldwide survey of medical editors to determine their interest in a ...

Worldwide associations between air quality and health end-points: Are they meaningful?

Directory of Open Access Journals (Sweden)

Peter Wallner

2014-10-01

Full Text Available Objectives: The World Health Organization (WHO provides data on national indices of health, environment and economy. When we were asked, why air pollution is negatively correlated with cancer mortality, our first response (presumably the mortality data are not age-adjusted was not sufficient to explain the paradox. Material and Methods: A table including all-cause, cancer and childhood mortality, life expectancy, gross national product per person, smoking prevalence, physician density and particulate matter (PM10 per country (N = 193 was developed. For explorative purposes weighted cross-sectional multiple linear regressions models were built. Results: Air pollution is positively correlated with infant and overall mortality and negatively with life expectancy. This might not only depict a true causal effect of PM10 because air quality is also an indicator of a country’s prosperity and general state of environment. Cancer mortality is negatively correlated with PM10. However, this association turns positive when economic or health system indicators are controlled. Conclusions: The World Health Organization’s world-wide data sets demonstrate the large disparity of our world. A careful and professional approach is needed as interpretation is difficult, especially for lay persons. Therefore, with publicly available data WHO should also provide interpretation and guidance.

Laboratory quality assurance and its role in nuclear fuel reprocessing and refabrication

International Nuclear Information System (INIS)

Delvin, W.L.

1977-09-01

For the overall quality assurance (QA) program to be fully effective, the principles of QA must be applied to the operation of the analytical chemistry laboratory itself. This paper shows how QA is used at HEDL to produce confidence in each analytical result. Use of QA has resulted in the following benefits: poor laboratory practices have been found and eliminated, and an already adequate record system was improved even further

Impact of quality improvement in tuberculosis laboratories in low- and lower-middle-income countries: a systematic review.

Science.gov (United States)

Olaru, I D; Albert, H; Zallet, J; Werner, U-E; Ahmed, N; Rieder, H L; Salfinger, M; Kranzer, K

2018-03-01

The effect of quality improvement measures on the performance of diagnostic tuberculosis (TB) laboratories in low- and lower-middle-income countries is not known, and is the subject of this review. Three databases were searched for quality improvement studies presenting data on performance parameters before and after the implementation of quality improvement interventions. Twenty-one studies were included in this review. Quality improvement measures were most frequently implemented by an external organization; settings targeted ranged from microscopy centers, hospitals, districts, regional and national reference laboratories. Quality improvement interventions and outcome measurements were highly heterogeneous. Most studies investigated interventions aimed at improving smear microscopy (n = 17). Two studies evaluated comprehensive quality improvement measures (n = 2) and another three studies focused on mycobacterial culture and drug susceptibility testing. Most studies showed an improvement in outcomes measured on before-after or time trend analysis. Quality improvement measures implemented in TB laboratories showed a positive impact on various outcomes. Due to the high heterogeneity of outcome reporting and interventions and the low quality of the studies, the effect size was not clear. Identification of standardized quality indicators and their link to the quality of patient care would improve knowledge in this field.

Quality-assurance plan and field methods for quality-of-water activities, U.S. Geological Survey, Idaho National Engineering Laboratory, Idaho

International Nuclear Information System (INIS)

Mann, L.J.

1996-10-01

Water-quality activities at the Idaho National Engineering Laboratory (INEL) Project Office are part of the US Geological Survey's (USGS) Water Resources Division (WRD) mission of appraising the quantity and quality of the Nation's water resources. The purpose of the Quality Assurance Plan (QAP) for water-quality activities performed by the INEL Project Office is to maintain and improve the quality of technical products, and to provide a formal standardization, documentation, and review of the activities that lead to these products. The principles of this plan are as follows: (1) water-quality programs will be planned in a competent manner and activities will be monitored for compliance with stated objectives and approaches; (2) field, laboratory, and office activities will be performed in a conscientious and professional manner in accordance with specified WRD practices and procedures by qualified and experienced employees who are well trained and supervised, if or when, WRD practices and procedures are inadequate, data will be collected in a manner that its quality will be documented; (3) all water-quality activities will be reviewed for completeness, reliability, credibility, and conformance to specified standards and guidelines; (4) a record of actions will be kept to document the activity and the assigned responsibility; (5) remedial action will be taken to correct activities that are deficient

Laboratory-based surveillance in the molecular era: The typened model, a joint data-sharing platform for clinical and public health laboratories

NARCIS (Netherlands)

H.G.M. Niesters (Bert); J.W. Rossen (John); H.G.A.M. van der Avoort (Harrie); D. Baas; K. Benschop (Kimberley); E.C.J. Claas (Eric); A. Kroneman; N.M. van Maarseveen (Noortje); S.D. Pas (Suzan); W. van Pelt (Wilfred); J. Rahamat-Langendoen (Janette); R. Schuurman (Rob); H. Vennema (Harry); L. Verhoef; K.C. Wolthers (Katja); M.P.G. Koopmans D.V.M. (Marion)

2013-01-01

textabstractLaboratory-based surveillance, one of the pillars of monitoring infectious disease trends, relies on data produced in clinical and/or public health laboratories. Currently, diagnostic laboratories worldwide submit strains or samples to a relatively small number of reference laboratories

Laboratory-based surveillance in the molecular era : the TYPENED model, a joint data-sharing platform for clinical and public health laboratories

NARCIS (Netherlands)

Niesters, H G; Rossen, J W; van der Avoort, H; Baas, D; Benschop, K; Claas, E C; Kroneman, A; van Maarseveen, N; Pas, S; van Pelt, W; Rahamat-Langendoen, J C; Schuurman, R; Vennema, H; Verhoef, L; Wolthers, K; Koopmans, Marion

2013-01-01

Laboratory-based surveillance, one of the pillars of monitoring infectious disease trends, relies on data produced in clinical and/or public health laboratories. Currently, diagnostic laboratories worldwide submit strains or samples to a relatively small number of reference laboratories for

Laboratory-based surveillance in the molecular era: the TYPENED model, a joint data-sharing platform for clinical and public health laboratories

NARCIS (Netherlands)

Niesters, H. G.; Rossen, J. W.; van der Avoort, H.; Baas, D.; Benschop, K.; Claas, E. C.; Kroneman, A.; van Maarseveen, N.; Pas, S.; van Pelt, W.; Rahamat-Langendoen, J. C.; Schuurman, R.; Vennema, H.; Verhoef, L.; Wolthers, K.; Koopmans, M.

2013-01-01

Laboratory-based surveillance, one of the pillars of monitoring infectious disease trends, relies on data produced in clinical and/or public health laboratories. Currently, diagnostic laboratories worldwide submit strains or samples to a relatively small number of reference laboratories for

Fuel quality control: Five years of activity in laboratories

International Nuclear Information System (INIS)

Bettinelli, M.; Cimini, G.; Durello, G.; Lucchesi, P.L.

1991-01-01

A description of how ENEL (Italian National Electricity Board) carries out the activity of fuel quality control is given, and the results of the Round Robin circuit which has been operating for five years in laboratories regulary performing the control analyses of these products are reported. The laboratories taking part in the Round Robin circuit are 41 (out of which 35 are ENEL laboratories and 6 are owned by external companies) and they are situated throughout Italy; the controlled parameters are the following: heat of combustion (PCS), sulphur (S), vanadium (V) and asphaltenes (ASF); the adopted methods are the official ASTM or IP ones. The statistical analysis of the results has permitted, for every parameter, the calculation of the repeatability and the reproducibility which, in most cases, have turned out to be in keeping with the values provided for in the regulations. Among the collateral initiatives promoted in the framework of this Round Robin, the following are reported: preparation of standards of fuel oil with a known content of a sulphur and vanadium; expediting visits to all the ENEL laboratories participating in the RRT; publication of a handbook of the adopted analysis methods (in Italian); definition of guide-lines on the right selection of new automatic equipment

Comparison of laboratory and field remote sensing methods to measure forage quality.

Science.gov (United States)

Guo, Xulin; Wilmshurst, John F; Li, Zhaoqin

2010-09-01

Recent research in range ecology has emphasized the importance of forage quality as a key indicator of rangeland condition. However, we lack tools to evaluate forage quality at scales appropriate for management. Using canopy reflectance data to measure forage quality has been conducted at both laboratory and field levels separately, but little work has been conducted to evaluate these methods simultaneously. The objective of this study is to find a reliable way of assessing grassland quality through measuring forage chemistry with reflectance. We studied a mixed grass ecosystem in Grasslands National Park of Canada and surrounding pastures, located in southern Saskatchewan. Spectral reflectance was collected at both in-situ field level and in the laboratory. Vegetation samples were collected at each site, sorted into the green grass portion, and then sent to a chemical company for measuring forage quality variables, including protein, lignin, ash, moisture at 135 °C, Neutral Detergent Fiber (NDF), Acid Detergent Fiber (ADF), Total Digestible, Digestible Energy, Net Energy for Lactation, Net Energy for Maintenance, and Net Energy for Gain. Reflectance data were processed with the first derivative transformation and continuum removal method. Correlation analysis was conducted on spectral and forage quality variables. A regression model was further built to investigate the possibility of using canopy spectral measurements to predict the grassland quality. Results indicated that field level prediction of protein of mixed grass species was possible (r² = 0.63). However, the relationship between canopy reflectance and the other forage quality variables was not strong.

Comparison of Laboratory and Field Remote Sensing Methods to Measure Forage Quality

Directory of Open Access Journals (Sweden)

Zhaoqin Li

2010-09-01

Full Text Available Recent research in range ecology has emphasized the importance of forage quality as a key indicator of rangeland condition. However, we lack tools to evaluate forage quality at scales appropriate for management. Using canopy reflectance data to measure forage quality has been conducted at both laboratory and field levels separately, but little work has been conducted to evaluate these methods simultaneously. The objective of this study is to find a reliable way of assessing grassland quality through measuring forage chemistry with reflectance. We studied a mixed grass ecosystem in Grasslands National Park of Canada and surrounding pastures, located in southern Saskatchewan. Spectral reflectance was collected at both in-situ field level and in the laboratory. Vegetation samples were collected at each site, sorted into the green grass portion, and then sent to a chemical company for measuring forage quality variables, including protein, lignin, ash, moisture at 135 ºC, Neutral Detergent Fiber (NDF, Acid Detergent Fiber (ADF, Total Digestible, Digestible Energy, Net Energy for Lactation, Net Energy for Maintenance, and Net Energy for Gain. Reflectance data were processed with the first derivative transformation and continuum removal method. Correlation analysis was conducted on spectral and forage quality variables. A regression model was further built to investigate the possibility of using canopy spectral measurements to predict the grassland quality. Results indicated that field level prediction of protein of mixed grass species was possible (r2 = 0.63. However, the relationship between canopy reflectance and the other forage quality variables was not strong.

Quality assurance on the Idaho National Engineering Laboratory Buried Waste Program

International Nuclear Information System (INIS)

Rasmussen, T.L.

1989-01-01

This paper discusses the clean-up of an Idaho National Engineering Laboratory (INEL) site utilized for disposal of transuranic contaminated waste from 1954 until 1970. The author presents requirements of the environmental protection statutes that have generated quality assurance requirements in addition to those historically implemented as a part of facility design, construction and operation. A hierarchy of program guidance quality documentation and procedures is discussed. Data qualification and computer database management are identified as requirements

[Why medical consultation is needed in the clinical laboratory].

Science.gov (United States)

Kawai, T

1998-10-01

During the 20th century, at least until the 1980s, clinical laboratory practice had been rapidly expanded, mainly because of a significant advancement in medicine as a whole and also in laboratory technology. However, recent economic changes in health care environment worldwide have been influencing greatly future trends in clinical laboratory practice. Four major macroeconomic forces drive change in clinical laboratory practice as follows; (1) Increasing cost of health care, (2) Implications of an aging population, (3) Social change in the patient population, and (4) Explosion of new technologies. Obviously, the increasing cost of health care is the primary driver. Considering a rapid change in the health care environment, clearly there are two separate pathways to be considered with regard to future modes of delivering patient care services through the clinical laboratory: commercial independent laboratories and hospital laboratories. In most hospital laboratories, in addition to high-quality, accurate and precise laboratory data being delivered through automated informatics in a timely fashion, laboratory physicians and other laboratorians should be available 24 hours a day and 7 days a week. The primary purpose of this approach is to develop a system in which the physician can order the most efficient number of tests, which will provide the maximum amount of clinically relevant informations most rapidly and most accurately at the least cost to the patient. Laboratory physicians must play a key role particularly in hospital laboratories. Their most important roles include those of a professional supplier of laboratory results being useful for health care and clinically relevant, and that of a consultative role for primary care physicians and other co-medical staffs to make important medical decision, based on laboratory results obtained. Therefore, the Japan Society of Clinical Pathology started in 1990 in publishing a series of proposed guidelines for adequate

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

Science.gov (United States)

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Measurement control is one component of laboratory quality assurance: What are the others

International Nuclear Information System (INIS)

Delvin, W.L.

1986-01-01

The value of a quality assurance program is that the overlooking, ignoring, or downgrading of useful functions and practices will be minimized. The principles of quality assurance make a great tool for minimizing problems and for helping to find and correct deficiencies and problems when they occur. Finding and correcting deficiencies and problems while they are still small - before they become monsters - will certainly make life easier in the operation of a laboratory. This takes diligence in being aware of what is going on in the laboratory and firm resolve by management to take effective corrective actions when necessary. It takes more than applying band aids to problems. 4 refs

Exploring the links between quality assurance and laboratory resources. An audit-based study.

Science.gov (United States)

Singh, Navjeevan; Panwar, Aru; Masih, Vipin Fazal; Arora, Vinod K; Bhatia, Arati

2003-01-01

To investigate and rectify the problems related to Ziehl-Neelsen (Z-N) staining in a cytology laboratory in the context of quality assurance. An audit based quality assurance study of 1,421 patients with clinical diagnoses of tubercular lymphadenopathy who underwent fine needle aspiration cytology. Data from 8 months were audited (group 1). Laboratory practices related to selection of smears for Z-N staining were studied. A 2-step corrective measure based on results of the audit was introduced for 2 months (group 2). Results were subjected to statistical analysis using the chi 2 test. Of 1,172 patients in group 1,368 had diagnoses other than tuberculosis. Overall acid-fast bacillus (AFB) positivity was 42%. AFB positivity in 249 patients in group 2 was 89% (P assurance. Solving everyday problems can have far-reaching benefits for the performance of laboratory personnel, resources and work flow.

The WHO AFRO external quality assessment programme (EQAP): Linking laboratory networks through EQA programmes.

Science.gov (United States)

Boeras, Debrah I; Peeling, Rosanna W; Onyebujoh, Philip; Yahaya, Ali A; Gumede-Moeletsi, Hieronyma N; Ndihokubwayo, Jean B

2016-01-01

External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of public health microbiology laboratories, particularly for testing of epidemic-prone diseases in the African Region. These surveys revealed common issues such as supply chain management, skilled personnel, logistical support and overall lack of quality standards. For sustainable improvements to health systems as well as global health security, deficiencies identified need to be actively corrected through robust quality assurance programmes and implementation of laboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programme with a focus on vaccine-preventable diseases and emerging and re-emerging dangerous pathogens is important, and should not be stand-alone, but integrated within laboratory networks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Prevention, the London School of Hygiene & Tropical Medicine and partners in a series of consultations with countries and national and regional EQA providers for the development of quality assurance models to support HIV point-of-care testing and monitoring. These consultations revealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forth its experience in implementing quality standards for health programmes, and also opened discussions on how lessons learned through such established programmes can be utilised to supporting and strengthening the introduction of early infant diagnosis of HIV and viral load point-of-care testing. An optimised external quality assessment programme will impact the ability of countries to meet core capacities, providing improved quality management systems, improving the confidence of diagnostic network services in Africa, and including capacities to detect events

National Survey on Internal Quality Control Practice for Lipid Parameters in Laboratories of China from 2014 to 2016.

Science.gov (United States)

Ye, Yuanyuan; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-01

To investigate the situation of Internal Quality Control (IQC) practice for total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from 2014 to 2016 in laboratories in China and provide improvement measurements. A web-based External Quality Assessment (EQA) system was used to collect IQC data of lipid parameters in laboratories which continuously participated in the national EQA programs in China from 2014 to 2016. Pass rate of the coefficients of variation (CVs) of two level quality controls in four lipid parameters were calculated according to six quality specifications for precision to evaluate the current status of precision level of the four lipid parameters and their change over time in China. 533, 512, 504, and 466 laboratories continuously reported the data of level one for total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol, and 212, 210, 208 and 198 laboratories reported the level two, respectively. The percentage of laboratories meeting the quality specification varied based on different criteria. Non-significant change can be found in the pass rate of CVs over time. The number of laboratories using a closed system increased over time, but still only accounted for a small proportion. There is no significant difference in the pass rate of CVs between closed and open systems. Triglycerides currently have a fairly good performance in China. While the performance of laboratories on total cholesterol, HDL-cholesterol and LDL-cholesterol has yet to be improved.

Closing the brain-to-brain loop in laboratory testing.

Science.gov (United States)

Plebani, Mario; Lippi, Giuseppe

2011-07-01

Abstract The delivery of laboratory services has been described 40 years ago and defined with the foremost concept of "brain-to-brain turnaround time loop". This concept consists of several processes, including the final step which is the action undertaken on the patient based on laboratory information. Unfortunately, the need for systematic feedback to improve the value of laboratory services has been poorly understood and, even more risky, poorly applied in daily laboratory practice. Currently, major problems arise from the unavailability of consensually accepted quality specifications for the extra-analytical phase of laboratory testing. This, in turn, does not allow clinical laboratories to calculate a budget for the "patient-related total error". The definition and use of the term "total error" refers only to the analytical phase, and should be better defined as "total analytical error" to avoid any confusion and misinterpretation. According to the hierarchical approach to classify strategies to set analytical quality specifications, the "assessment of the effect of analytical performance on specific clinical decision-making" is comprehensively at the top and therefore should be applied as much as possible to address analytical efforts towards effective goals. In addition, an increasing number of laboratories worldwide are adopting risk management strategies such as FMEA, FRACAS, LEAN and Six Sigma since these techniques allow the identification of the most critical steps in the total testing process, and to reduce the patient-related risk of error. As a matter of fact, an increasing number of laboratory professionals recognize the importance of understanding and monitoring any step in the total testing process, including the appropriateness of the test request as well as the appropriate interpretation and utilization of test results.

Pace studying worldwide coke production

International Nuclear Information System (INIS)

Anon.

1993-01-01

Pace Consultants Inc., Houston, has started a multiclient study of world-wide petroleum coke production, examining environmental initiatives and eventually forecasting prices of fuel grade coke. Pace expects coker expansions, increased operating severity, and reduced cycle times to boost coke supply to more than 50 million metric tons/year in 2000, compared with 39.7 million metric tons in 1992. Increased supply and tightened environmental rules in countries consuming large amounts of petroleum coke will be the main factors affecting coke markets. The paper discusses coke quality and the Japanese market

A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory.

Science.gov (United States)

Banks, Peter; Brown, Richard; Laslowski, Alex; Daniels, Yvonne; Branton, Phil; Carpenter, John; Zarbo, Richard; Forsyth, Ramses; Liu, Yan-Hui; Kohl, Shane; Diebold, Joachim; Masuda, Shinobu; Plummer, Tim; Dennis, Eslie

2017-05-01

Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. : Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs. © American Society for Clinical Pathology 2017.

The spectra of the standard x-ray qualities used in STUK's Radiation Metrology Laboratory

International Nuclear Information System (INIS)

Tapiovaara, T.; Tapiovaara, M.; Siiskonen, T.; Hakanen, A.

2008-02-01

This report presents the fluence spectra of the standard x-radiation qualities used in the Radiation Dosimetry Laboratory of Radiation and Nuclear Safety Authority (STUK). The spectra were measured in August 2007. The radiation qualities characterised in the report are the ISO Narrow spectrum series (ISO N10-N200, ISO 4037-1:1996) and both of the RQR-spectrum series specified by the IEC (IEC 1267:1994 and IEC 61267:2005). The measurements were made using a high purity Ge-detector and the measured pulse height spectra were corrected to fluence spectra. Spectral characteristics were computed from the spectral data and compared to the requirements in the standards and to the values given in the quality manual of the laboratory. (orig.)

Launching a Laboratory Testing Process Quality Improvement Toolkit: From the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP).

Science.gov (United States)

Fernald, Douglas; Hamer, Mika; James, Kathy; Tutt, Brandon; West, David

2015-01-01

Family medicine and internal medicine physicians order diagnostic laboratory tests for nearly one-third of patient encounters in an average week, yet among medical errors in primary care, an estimated 15% to 54% are attributed to laboratory testing processes. From a practice improvement perspective, we (1) describe the need for laboratory testing process quality improvements from the perspective of primary care practices, and (2) describe the approaches and resources needed to implement laboratory testing process quality improvements in practice. We applied practice observations, process mapping, and interviews with primary care practices in the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP)-affiliated practice-based research networks that field-tested in 2013 a laboratory testing process improvement toolkit. From the data collected in each of the 22 participating practices, common testing quality issues included, but were not limited to, 3 main testing process steps: laboratory test preparation, test tracking, and patient notification. Three overarching qualitative themes emerged: practices readily acknowledge multiple laboratory testing process problems; practices know that they need help addressing the issues; and practices face challenges with finding patient-centered solutions compatible with practice priorities and available resources. While practices were able to get started with guidance and a toolkit to improve laboratory testing processes, most did not seem able to achieve their quality improvement aims unassisted. Providing specific guidance tools with practice facilitation or other rapid-cycle quality improvement support may be an effective approach to improve common laboratory testing issues in primary care. © Copyright 2015 by the American Board of Family Medicine.

Evaluation of the implementation of a quality system in a basic research laboratory: viability and impacts.

Science.gov (United States)

Fraga, Hilda Carolina de Jesus Rios; Fukutani, Kiyoshi Ferreira; Celes, Fabiana Santana; Barral, Aldina Maria Prado; Oliveira, Camila Indiani de

2012-01-01

To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement. This was a prospective and qualitative study. We employed the norm "NIT DICLA 035--Princípios das Boas Práticas de Laboratório (BPL)" and auxiliary documents of Organisation for Economic Co-operation and Development to complement the planning and implementation of a Quality System, in a basic research laboratory. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. This study enabled the laboratory to comply with the NIT DICLA 035 norm and to implement this norm during execution of a research study. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. The implementation of a quality system, the setting of a laboratory focused on basic research is feasible once certain structural changes are made. Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine.

Comparison of semen quality between university-based and private assisted reproductive technology laboratories

DEFF Research Database (Denmark)

Jensen, Christian Fuglesang S; Khan, Omar; Sønksen, Jens

2018-01-01

laboratory, the first at each laboratory was selected for analysis. Comparison of major semen parameters was performed using descriptive statistics and Bland-Altman plots, with differences tested using Wilcoxon-signed rank test. RESULTS: Twenty-eight men aged 33 ± 5 (mean ± SD) years were included......OBJECTIVE: Obtaining a semen analysis (SA) is an essential step in evaluating infertile men. Despite using standardized procedures for analysis semen quality in the same individual often varies on repeated tests. The objective of this study was to investigate inter-laboratory variation in semen...

Country-wide quality control of equipment in Norwegian laboratories performing in vivo nuclear medicine examinations

International Nuclear Information System (INIS)

Skretting, A.; Rootwelt, K.; Berthelsen, T.

1984-01-01

The report presents the methods used and the results obtained in quality control tests performd in all Norwegian hospital laboratories performing in vivo nuclear medicine examinations. The tests included activity meters and scintillation cameras. The activity meters were tested by means of calibrated, long-lived radioactive sources. The quality of these instruments were judged to be satisfactory for moderate and high activities, non of them showing a deviation of more than 10% from the calibration value. Deviations were larger at low activities and were for some laboratories unacceptable. The scintillation cameras test included studies of flood field (homogeneity), geometrical resolution and energy resolution, as well as measurements of count rate characteristics and sensitivity. 40% of the cameras were judged to have flood field responses with satisfactory homogeneity, whereas 32% of the cameras had a satisfactory resolution ability. A liver/abdomen phantom test was carried out by the staff of the actual laboratory. This test proved that only 20% of the laboratories had a satisfactory total performance, managing to detect and describe satisfactorily 4 out of 5 simulated defects in the liver phantom. Lack of information density and insufficient number of projections was the main reason for unsatisfactory results with good cameras. It is recommended that quality control equipment as used in the described tests should be made available to Norwegian hospitals for self assessment. Regular quality assurance tests as recommended by the Norwegian Association for Radiation Physics and Norwegian Society of Nuclear Medicine should be implemented in all hospitals. Moreover, a practical training course in quality assurance should be arranged. (RF)

DNA decontamination methods for internal quality management in clinical PCR laboratories.

Science.gov (United States)

Wu, Yingping; Wu, Jianyong; Zhang, Zhihui; Cheng, Chen

2018-03-01

The polymerase chain reaction (PCR) technique, one of the most commonly applied methods in diagnostic and molecular biology, has a frustrating downside: the occurrence of false-positive signals due to contamination. In previous research, various DNA decontamination methods have been developed to overcome this limitation. Unfortunately, the use of random or poorly focused sampling methods for monitoring air and/or object surfaces leads to the incomplete elimination during decontamination procedures. We herein attempted to develop a novel DNA decontamination method (environmental surveillance, including surface and air sampling) and quality management program for clinical molecular diagnostic laboratories (or clinical PCR laboratories). Here, we performed a step-by-step evaluation of current DNA decontamination methods and developed an effective procedure for assessing the presence of decontaminating DNA via PCR analysis. Performing targeted environmental surveillance by sampling, which reached optimal performance over 2 weeks, and the decontamination process had been verified as reliable. Additionally, the process was validated to not affect PCR amplification efficiency based on a comparative study. In this study, effective guidelines for DNA decontamination were developed. The method employed ensured that surface DNA contamination could be effectively identified and eliminated. Furthermore, our study highlighted the importance of overall quality assurance and good clinical laboratory practices for preventing contamination, which are key factors for compliance with regulatory or accreditation requirements. Taken together, we provided the evidence that the presented scheme ranged from troubleshooting to the elimination of surface contamination, could serve as critical foundation for developing regular environmental surveillance guidelines for PCR laboratories. © 2017 Wiley Periodicals, Inc.

College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

Science.gov (United States)

Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

2013-02-01

Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.

Implementation of quality control systems in laboratories in Paraguay by the participants of ARCAL LXXVI project

International Nuclear Information System (INIS)

Villanueva, Z.

2004-12-01

In the Project ARCAL LXXVII, was realized the National Course of Control of Quality of Analytic Laboratories, from 12 to 16 of April in the CNEA, Paraguay, as a result of the one mentioned course was elaborated this project whose purpose is to elaborate the necessary documentation to fulfill the requirements of administration in the Analytic Laboratories to be adapted to the system of quality according to the ISO 17025 [es

European specialist porphyria laboratories: diagnostic strategies, analytical quality, clinical interpretation, and reporting as assessed by an external quality assurance program.

Science.gov (United States)

Aarsand, Aasne K; Villanger, Jørild H; Støle, Egil; Deybach, Jean-Charles; Marsden, Joanne; To-Figueras, Jordi; Badminton, Mike; Elder, George H; Sandberg, Sverre

2011-11-01

The porphyrias are a group of rare metabolic disorders whose diagnosis depends on identification of specific patterns of porphyrin precursor and porphyrin accumulation in urine, blood, and feces. Diagnostic tests for porphyria are performed by specialized laboratories in many countries. Data regarding the analytical and diagnostic performance of these laboratories are scarce. We distributed 5 sets of multispecimen samples from different porphyria patients accompanied by clinical case histories to 18-21 European specialist porphyria laboratories/centers as part of a European Porphyria Network organized external analytical and postanalytical quality assessment (EQA) program. The laboratories stated which analyses they would normally have performed given the case histories and reported results of all porphyria-related analyses available, interpretative comments, and diagnoses. Reported diagnostic strategies initially showed considerable diversity, but the number of laboratories applying adequate diagnostic strategies increased during the study period. We found an average interlaboratory CV of 50% (range 12%-152%) for analytes in absolute concentrations. Result normalization by forming ratios to the upper reference limits did not reduce this variation. Sixty-five percent of reported results were within biological variation-based analytical quality specifications. Clinical interpretation of the obtained analytical results was accurate, and most laboratories established the correct diagnosis in all distributions. Based on a case-based EQA scheme, variations were apparent in analytical and diagnostic performance between European specialist porphyria laboratories. Our findings reinforce the use of EQA schemes as an essential tool to assess both analytical and diagnostic processes and thereby to improve patient care in rare diseases.

HPV testing for primary cervical screening: Laboratory issues and evolving requirements for robust quality assurance.

Science.gov (United States)

Carozzi, Francesca Maria; Del Mistro, Annarosa; Cuschieri, Kate; Frayle, Helena; Sani, Cristina; Burroni, Elena

2016-03-01

This review aims to highlight the importance of Quality Assurance for Laboratories performing HPV test for Cervical Cancer Screening. An HPV test, to be used as primary screening test, must be validated according to international criteria, based on comparison of its clinical accuracy to HC2 or GP5+/6+ PCR-EIA tests. The number of validated platforms is increasing and appropriate Quality Assurance Programs (QAPs) which can interrogate longitudinal robustness and quality are paramount. This document describes the following topics: (1) the characteristics of an HPV laboratory and the personnel training needs, to ensure an elevated quality of the entire process and the optimal use of the resources; (2) the Quality Assurance, as both internal (IQA) and external quality assessment (EQA) systems, to be implemented and performed, and the description of the existing EQAs, including limitations; (3) general considerations for an optimal EQA program for hrHPV primary screening Due to the importance of Quality Assurance for this field, international efforts are necessary to improve QA International Collaboration. Copyright © 2015 Elsevier B.V. All rights reserved.

Performance indicators for quality in surgical and laboratory services at Muhimbili National Hospital (MNH) in Tanzania.

Science.gov (United States)

Mbembati, Naboth A; Mwangu, Mugwira; Muhondwa, Eustace P Y; Leshabari, Melkizedek M

2008-04-01

Muhimbili National Hospital (MNH), a teaching and national referral hospital, is undergoing major reforms to improve the quality of health care. We performed a retrospective descriptive study using a set of performance indicators for the surgical and laboratory services of MNH in years 2001 and 2002, to help monitor and evaluate the impact of reforms on the quality of health care during and after the reform process. Hospital records were reviewed and information recorded for planned and postponed operations, laboratory equipment, reagents, laboratory tests and quality assurance programmes. In the year 2001 a total of 4332 non-emergency operations were planned, 3313 operations were performed and 1019 (23.5%) operations were postponed. In the year 2002, 4301 non-emergency operations were planned, 3046 were performed and 1255 (29%) were postponed. The most common reasons for operation postponement were "time-barred", interference by emergency operations, no show of patients and inoperable anaesthetic machines. Equipment problems and supply and staff shortages together accounted for one quarter of postponements. In the laboratory, a lack of equipment prevented some tests, but quality assurance was performed for most tests. Current surgical services at MNH are inadequate; operating theatres require modern, functioning equipment and adequate supplies of consumables to provide satisfactory care.

Implementation of the first worldwide quality assurance program for cystic fibrosis multiple mutation detection in population-based screening.

Science.gov (United States)

Earley, Marie C; Laxova, Anita; Farrell, Philip M; Driscoll-Dunn, Rena; Cordovado, Suzanne; Mogayzel, Peter J; Konstan, Michael W; Hannon, W Harry

2011-07-15

CDC's Newborn Screening Quality Assurance Program collaborated with several U.S. Cystic Fibrosis Care Centers to collect specimens for development of a molecular CFTR proficiency testing program using dried-blood spots for newborn screening laboratories. Adult and adolescent patients or carriers donated whole blood that was aliquoted onto filter paper cards. Five blind-coded specimens were sent to participating newborn screening laboratories quarterly. Proficiency testing results were evaluated based on presumptive clinical assessment. Individual evaluations and summary reports were sent to each participating laboratory and technical consultations were offered if incorrect assessments were reported. The current CDC repository contains specimens with 39 different CFTR mutations. Up to 45 laboratories have participated in the program. Three years of data showed that correct assessments were reported 97.7% of the time overall when both mutations could be determined. Incorrect assessments that could have lead to a missed case occurred 0.9% of the time, and no information was reported 1.1% of the time due to sample failure. Results show that laboratories using molecular assays to detect CFTR mutations are performing satisfactorily. The programmatic results presented demonstrate the importance and complexity of providing proficiency testing for DNA-based assays. Published by Elsevier B.V.

Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation.

Science.gov (United States)

Ndihokubwayo, Jean-Bosco; Maruta, Talkmore; Ndlovu, Nqobile; Moyo, Sikhulile; Yahaya, Ali Ahmed; Coulibaly, Sheick Oumar; Kasolo, Francis; Turgeon, David; Abrol, Angelii P

2016-01-01

The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. By March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%. The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.

The Albuquerque Seismological Laboratory Data Quality Analyzer

Science.gov (United States)

Ringler, A. T.; Hagerty, M.; Holland, J.; Gee, L. S.; Wilson, D.

2013-12-01

The U.S. Geological Survey's Albuquerque Seismological Laboratory (ASL) has several efforts underway to improve data quality at its stations. The Data Quality Analyzer (DQA) is one such development. The DQA is designed to characterize station data quality in a quantitative and automated manner. Station quality is based on the evaluation of various metrics, such as timing quality, noise levels, sensor coherence, and so on. These metrics are aggregated into a measurable grade for each station. The DQA consists of a website, a metric calculator (Seedscan), and a PostgreSQL database. The website allows the user to make requests for various time periods, review specific networks and stations, adjust weighting of the station's grade, and plot metrics as a function of time. The website dynamically loads all station data from a PostgreSQL database. The database is central to the application; it acts as a hub where metric values and limited station descriptions are stored. Data is stored at the level of one sensor's channel per day. The database is populated by Seedscan. Seedscan reads and processes miniSEED data, to generate metric values. Seedscan, written in Java, compares hashes of metadata and data to detect changes and perform subsequent recalculations. This ensures that the metric values are up to date and accurate. Seedscan can be run in a scheduled task or on demand by way of a config file. It will compute metrics specified in its configuration file. While many metrics are currently in development, some are completed and being actively used. These include: availability, timing quality, gap count, deviation from the New Low Noise Model, deviation from a station's noise baseline, inter-sensor coherence, and data-synthetic fits. In all, 20 metrics are planned, but any number could be added. ASL is actively using the DQA on a daily basis for station diagnostics and evaluation. As Seedscan is scheduled to run every night, data quality analysts are able to then use the

Using performance tasks employing IOM patient safety competencies to introduce quality improvement processes in medical laboratory science education.

Science.gov (United States)

Golemboski, Karen; Otto, Catherine N; Morris, Susan

2013-01-01

In order to contribute to improved healthcare quality through patient-centered care, laboratory professionals at all levels of practice must be able to recognize the connection between non-analytical factors and laboratory analysis, in the context of patient outcomes and quality improvement. These practices require qualities such as critical thinking (CT), teamwork skills, and familiarity with the quality improvement process, which will be essential for the development of evidence-based laboratory science practice. Performance tasks (PT) are an educational strategy which can be used to teach and assess CT and teamwork, while introducing Medical Laboratory Science (MLS) students at both baccalaureate and advanced-practice levels to the concepts of quality improvement processes and patient outcomes research. PT presents students with complex, realistic scenarios which require the incorporation of subject-specific knowledge with competencies such as effective team communication, patient-centered care, and successful use of information technology. A PT with assessment rubric was designed for use in a baccalaureate-level MLS program to teach and assess CT and teamwork competency. The results indicated that, even when students were able to integrate subject-specific knowledge in creative ways, their understanding of teamwork and quality improvement was limited. This indicates the need to intentionally teach skills such as collaboration and quality system design. PT represent one of many strategies that may be used in MLS education to develop essential professional competencies, encourage expert practice, and facilitate quality improvement.

Quality control for radionuclide determinations in the Saxon state laboratories for environmental radioactivity by intercomparison and comparative measurements

International Nuclear Information System (INIS)

Knobus, B.

2001-01-01

Quality control for radionuclide analysis is necessary and essential for the quality assurance of the measuring results executing the measuring programmes of surveillance of the radioactivity in the environment and from installations. Acts, ordinances and guidelines require the participation in intercomparisons for authorized institutions detecting the demanded quality of measurements (e.g. trueness, reproducibility) for Federal Authorities. These are mainly those intercomparisons which are prepared, practised and evaluated by the federal laboratories. Comparative measurements are generally organized and executed by the state laboratory itself with a few participants for special measuring tasks. In this paper are described and discussed extend and special results of those intercomparisons and comparative measurements of the Saxon state laboratories for environmental radioactivity from 1992 until 2000. If necessary, there are following improvements for quality assurance. (orig.) [de

Quality assurance and quality control at the joint IAEA NMCC On-Site Laboratory at RRP as a contribution to the inspectorate's review of near real time accountancy of nuclear material

International Nuclear Information System (INIS)

Ludwig, R.; Duhamel, G.; Raptis, K.; Mayorov, V.; Sato, Y.; Hara, S.; Itoh, Y.; Hayakawa, T.

2011-01-01

This paper provides updates on the elements of the quality management system (QMS) of the On-Site Laboratory for nuclear safeguards at the Rokkasho Reprocessing Plant. Representative examples of the OSL's quality control levels are discussed, such as analytical method performance review, method inter-comparison and participation in Laboratory inter-comparison exercises. It also highlights quality assurance measures to continuously improve the data quality within the boundary conditions of a high throughput industrial laboratory operating according to the guidelines of ISO 17025 and to meet the requirements of the ITV's on method uncertainties. (author)

Proficiency testing schemes as a quality rating in industrial hygiene laboratories

Directory of Open Access Journals (Sweden)

Marek Dobecki

2016-04-01

Full Text Available This publication presents the principles of organization, implementation, assessment and exploitation of proficiency testing results in the work environmental laboratory based on basic requirements included in standard PN-EN ISO/IEC 17043 and ISO 13528. The basis for the proper functioning of the laboratory is to use and observe the basic requirements for the competence to carry out the tests and the guidelines on ensuring reliable and accurate results, specified e.g., according to the guidelines described in the standard PN-EN ISO/IEC 17043. The confirmation of the laboratory competence is the obtained accreditation. To obtain this certificate several conditions, including proficiency testing (PT should be met. The main aspects of this paper is to show the role of proficiency testing in the process of assuring a properly functioning quality system in the laboratory. The accreditation requirements, the types of proficiency testing schemes, methods of statistical analysis and interpretation of results are also discussed by the authors. Med Pr 2016;67(2:267–283

Quality of the clinical laboratory department in a specialized hospital in Alexandria, Egypt.

Science.gov (United States)

Elhoseeny, T A; Mohammad, E K

2013-01-01

Assessment and improvement of turnaround times (TAT) as well as customer satisfaction is essential for laboratory quality management. This study in a specialized hospital in Alexandria, Egypt measured the current TAT for outpatient department bilirubin samples and evaluated the satisfaction of physicians with aspects of clinical laboratory services. While the mean TAT for 110 bilirubin tests [58.1 (SD 31.8) min] was within the College of American Pathologists' benchmark, the 90th percentile was long (96.7 min); 62.7% of tests were reported within 60 min. The mean overall satisfaction score of physicians (range 1-5) was 3.46 (SD 0.49). The highest satisfaction rating was for staff courtesy while the lowest ratings were for laboratory management responsiveness, outpatient stat TAT and critical value notification. Quality or reliability of results was judged by physicians as the most important factor (32.3%), followed by routine test TAT (18.5%). Further analysis of the different steps of the TAT would be helpful and follow-up through examining outliers is recommended

Automation of the National Water Quality Laboratories, U. S. Geological Survey. I. Description of laboratory functions and definition of the automation project

Energy Technology Data Exchange (ETDEWEB)

Morris, W.F.; Ames, H.S.

1977-07-01

In January 1976, the Water Resources Division of the U.S. Geological Survey asked Lawrence Livermore Laboratory to conduct a feasibility study for automation of the National Water Quality (NWQ) Laboratory in Denver, Colorado (formerly Denver Central Laboratory). Results of the study were published in the Feasibility Study for Automation of the Central Laboratories, Lawrence Livermore Laboratory, Rept. UCRL-52001 (1976). Because the present system for processing water samples was found inadequate to meet the demands of a steadily increasing workload, new automation was recommended. In this document we present details necessary for future implementation of the new system, as well as descriptions of current laboratory automatic data processing and analytical facilities to better define the scope of the project and illustrate what the new system will accomplish. All pertinent inputs, outputs, and other operations that define the project are shown in functional designs.

Automation of the National Water Quality Laboratories, U.S. Geological Survey. I. Description of laboratory functions and definition of the automation project

International Nuclear Information System (INIS)

Morris, W.F.; Ames, H.S.

1977-01-01

In January 1976, the Water Resources Division of the U.S. Geological Survey asked Lawrence Livermore Laboratory to conduct a feasibility study for automation of the National Water Quality (NWQ) Laboratory in Denver, Colorado (formerly Denver Central Laboratory). Results of the study were published in the Feasibility Study for Automation of the Central Laboratories, Lawrence Livermore Laboratory, Rept. UCRL-52001 (1976). Because the present system for processing water samples was found inadequate to meet the demands of a steadily increasing workload, new automation was recommended. In this document we present details necessary for future implementation of the new system, as well as descriptions of current laboratory automatic data processing and analytical facilities to better define the scope of the project and illustrate what the new system will accomplish. All pertinent inputs, outputs, and other operations that define the project are shown in functional designs

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan. Part 1: ASC software quality engineering practices, Version 2.0.

Energy Technology Data Exchange (ETDEWEB)

Sturtevant, Judith E.; Heaphy, Robert; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Minana, Molly A.; Hackney, Patricia; Forsythe, Christi A.; Schofield, Joseph Richard, Jr. (,; .); Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

2006-09-01

The purpose of the Sandia National Laboratories Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. The plan defines the ASC program software quality practices and provides mappings of these practices to Sandia Corporate Requirements CPR 1.3.2 and 1.3.6 and to a Department of Energy document, ASCI Software Quality Engineering: Goals, Principles, and Guidelines. This document also identifies ASC management and software project teams responsibilities in implementing the software quality practices and in assessing progress towards achieving their software quality goals.

The need for a quality standard for assurance in medical research laboratories

Directory of Open Access Journals (Sweden)

S Cohen

2014-01-01

Full Text Available The objective of this article is to show the results of a research study conducted to evaluate the need for a quality standard specific for medical research laboratories based on the shortfalls of ISO 15189 when used for this purpose. A qualitative research methodology was used, which comprised of collecting data from 20 well-qualified and experienced medical laboratory personnel by means of interviews based on a framework developed from a literature review. The data were analysed by means of a thematic technique and the results were verified by a team of medical researchers. The seven themes arising from the analyses were inflexibility; ambiguity; unfair requirements; inappropriate focus; inadequacy for research; renewal; and acceptance for accreditation. The results indicated that the ISO 15189 standard in its present content does not totally suit medical research laboratories and shows support for the development of a standard specific for research laboratories.

Quality assurance program in the External dosimetry laboratory of the CPHR

International Nuclear Information System (INIS)

Molina P, D.; Pernas S, R.; Martinez H, E.; Cardenas H, J.

2006-01-01

From 1999 the Laboratory of External Dosimetry of the Radiation Protection and Hygiene Center comes applying in its service of personal dosimetry a Program of Quality Assurance. This program was designed according to the recommendations of national and international organizations as the National Assuring Office of the Republic of Cuba (ONARC), the International Standards Organization (ISO), the International Electro technique Commission (IEC) and the International Atomic Energy Agency (IAEA). In this work it is presented in a summarized way the operation of this Program of Quality Assurance which includes the administration and conservation of the results and the documentation of the service, the controls that are carried out to the equipment, the acceptance tests that are applied to the equipment and new dosemeters, the shipment and prosecution of the dosemeters, the evaluation, storage and conservation of the doses, the report of the results, the traceability and reproducibility of the measurements, the attention to the reclamations and the clients complaints and the internal and external audits to those that it undergoes periodically the laboratory. (Author)

Quality control and assurance of Tc-99m generators and kits applied in SAEC laboratories

International Nuclear Information System (INIS)

Yassine, T.

1998-01-01

A brief description of quality assurance and quality control system applied in SAEC laboratories for production of 99m Tc-radiopharmaceuticals, is provided. The system includes documentation, procedures, releasing of the products and responsibilities. The system described here undergoes a continues development. (author)

[Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory].

Science.gov (United States)

Wang, Qin; Zhang, Yong; Nie, Kai; Wang, Huanyu; Du, Haijun; Song, Jingdong; Xiao, Kang; Lei, Wenwen; Guo, Jianqiang; Wei, Hejiang; Cai, Kun; Wang, Yanhai; Wu, Jiang; Gerald, Bangura; Kamara, Idrissa Laybohr; Liang, Mifang; Wu, Guizhen; Dong, Xiaoping

2016-03-01

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

The Quality Assurance_Quality Control of the Monitored Drift Tubes at the HEP Laboratory of the National Technical University of Athens

CERN Document Server

Alexopoulos, T; Dris, M; Filippas, A V; Fokitis, E; Gazis, E N; Katsoufis, E C; Maltezos, A; Maltezos, S; Papadopoulos, E; Papadopoulou, T D; Savva, Panagiota S; Stavropoulos, G D; Tsipolitis, G; Tzamariudaki, E

2001-01-01

The description of the Quality Assurance and Quality Control (QA_QC) procedures for the Monitored Drift Tubes (MDT's) followed at the HEP Laboratory of NTUA are presented and results of the tested tubes are given. The MDT's are the elements from which muon chambers for the ATLAS/LHC Muon Spectrometer are built..

Analytical laboratory quality assurance guidance in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-05-01

This document introduces QA guidance pertaining to design and implementation of laboratory procedures and processes for collecting DOE Environmental Restoration and Waste Management (EM) ESAA (environmental sampling and analysis activities) data. It addresses several goals: identifying key laboratory issues and program elements to EM HQ and field office managers; providing non-prescriptive guidance; and introducing environmental data collection program elements for EM-263 assessment documents and programs. The guidance describes the implementation of laboratory QA elements within a functional QA program (development of the QA program and data quality objectives are not covered here)

Implementation of ISO 28218 quality system in the laboratory of body radioactivity counter CIEMAT

International Nuclear Information System (INIS)

Navarro Amaro, J. F.; Perez Lopez, B.; Lopez Ponte, M. A.; Perez Jimenez, C.

2011-01-01

The laboratory of body radioactivity counter has implemented IS0 28218 standard Performance Criteria for Radio bioassay in all measured in vivo techniques of internal contamination in the human organism in monitoring programs defined by the Personal Dosimetry Service Internal CIEMAT. The application of this rule in the laboratory's quality system is essential to meet the technical requirements of the standard IS0/IEC 17025 with the purpose of obtaining ENAC accreditation as a testing laboratory and calibration within the framework of the accreditation of Service CIEMAT Radiation Dosimetry. (Author)

[Importance of quality control of baciloscopy in laboratories that perform diagnosis of tuberculosis].

Science.gov (United States)

Sardiñas, Misleidis; García, Grechen; Rosarys Martínez, María; Díaz, Raúl; Mederos, Lilian M

2016-06-01

Baciloscopy is the primary tool for pulmonary tuberculosis diagnosis, being this technique the most used internationally in the search for infectious cases. Quality control is the process of the rechecking smears by a highly qualified observer. To evaluate and highlight the importance of quality control of smear microscopy in the Provincial Laboratories diagnosticians of Tuberculosis in Cuba. This study was conducted at the National Reference Laboratory and Research in Tuberculosis, Leprosy and Mycobacteria in the Institute of Tropical Medicine "Pedro Kouri", Havana, Cuba, Were evaluated 2676 smears received from January 2013 to December 2014, from Provincial Centers of Hygiene, Epidemiology and Microbiology of Cuba, including the special municipality Isla de la Juventud. 2,664 (99.5%) were concordant smears, the correlation obtained for the positive smears were 96.5% and 99.8% for negative. Were identified12 reading errors: 7 (3.5%) false positive and 5 (0.2%) false negatives. Slides were classified with adequate quality of smears in 2039 (76.2%), showed difficulties in realizing the extension in 1464 (54.7%) and staining were adequate in 2343 (87.6%). The kappa index was 0.9674. Although there was good agreement between observations it is recommended to improve the quality of extended, maintain staff training program that performs this activity, like regular supervision by specialists, to further improve the quality of diagnosis.

Quality Control of Boar Sperm Processing : Implications from European AI Centres and Two Spermatology Reference Laboratories

NARCIS (Netherlands)

Riesenbeck, A; Schulze, M; Rüdiger, K; Henning, H; Waberski, D

In recent years, increased automatization has resulted in a higher efficiency of boar semen processing in AI laboratories. Sophisticated laboratory management and efficient quality control programmes are needed for current tendencies in major pork-producing countries to reduce the sperm number per

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

Science.gov (United States)

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Beacons of discovery the worldwide science of particle physics

CERN Document Server

International Committee for Future Accelerators (ICFA)

2011-01-01

To discover what our world is made of and how it works at the most fundamental level is the challenge of particle physics. The tools of particle physics—experiments at particle accelerators and underground laboratories, together with observations of space—bring opportunities for discovery never before within reach. Thousands of scientists from universities and laboratories around the world collaborate to design, build and use unique detectors and accelerators to explore the fundamental physics of matter, energy, space and time. Together, in a common world-wide program of discovery, they provide a deep understanding of the world around us and countless benefits to society. Beacons of Discovery presents a vision of the global science of particle physics at the dawn of a new light on the mystery and beauty of the universe.

Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers.

Science.gov (United States)

Ricós, Carmen; Ramón, Francisco; Salas, Angel; Buño, Antonio; Calafell, Rafael; Morancho, Jorge; Gutiérrez-Bassini, Gabriella; Jou, Josep M

2011-11-18

Four Spanish scientific societies organizing external quality assessment programs (EQAP) formed a working group to promote the use of common minimum quality specifications for clinical tests. Laboratories that do not meet the minimum specifications are encouraged to make immediate review of the analytical procedure affected and to implement corrective actions if necessary. The philosophy was to use the 95th percentile of results sent to EQAP (expressed in terms of percentage deviation from the target value) obtained for all results (except the outliers) during a cycle of 1 year. The target value for a number of analytes of the basic biochemistry program was established as the overall mean. However, because of the substantial discrepancies between routine methods for basic hematology, hormones, proteins, therapeutic drugs and tumor markers, the target in these cases was the peer group mean. The resulting specifications were quite similar to those established in the US (CLIA), and Germany (Richtlinie). The proposed specifications stand for the minimum level of quality to be attained for laboratories, to assure harmonized service performance. They have nothing to do with satisfying clinical requirements, which are the final level of quality to be reached, and that is strongly recommended in our organizations by means of documents, courses, symposiums and all types of educational activities.

Sandia National Laboratories ASCI Applications Software Quality Engineering Practices; TOPICAL

International Nuclear Information System (INIS)

ZEPPER, JOHN D.; ARAGON, KATHRYN MARY; ELLIS, MOLLY A.; BYLE, KATHLEEN A.; EATON, DONNA SUE

2002-01-01

This document provides a guide to the deployment of the software verification activities, software engineering practices, and project management principles that guide the development of Accelerated Strategic Computing Initiative (ASCI) applications software at Sandia National Laboratories (Sandia). The goal of this document is to identify practices and activities that will foster the development of reliable and trusted products produced by the ASCI Applications program. Document contents include an explanation of the structure and purpose of the ASCI Quality Management Council, an overview of the software development lifecycle, an outline of the practices and activities that should be followed, and an assessment tool. These sections map practices and activities at Sandia to the ASCI Software Quality Engineering: Goals, Principles, and Guidelines, a Department of Energy document

Reproducibility of cervical cytopathology following an intervention by an external quality control laboratory.

Science.gov (United States)

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Claudio; Tavares, Suelene Brito do Nascimento; Alves de Souza, Nadja Lindany; Magalhães, Juliana Cristina; Amaral, Rita Goreti

2016-04-01

This study assessed the effects of a continued education program on the agreement between cervical cytopathology exams interpreted by local laboratories and interpretation made by an external quality control laboratory (LabMEQ). Overall, 9,798 exams were analyzed between 2007 and 2008, prior to implementation of a continued education program, and 10,028 between 2010 and 2011, following implementation. Continued education consisted of theoretical and practical classes held every two months. The chi-square test and the kappa coefficient were used in the statistical analysis. Following implementation of continued education, the rate of false-negative results, and those leading to delays in clinical management fell in eight laboratories and the rate of false-positive results in five. Agreement between the results reported by the laboratories and the findings of LabMEQ, evaluated according to clinical management, remained excellent in three laboratories (kappa >0.80 and 0.60 and clinical management. © 2016 Wiley Periodicals, Inc.

Quality of Liver and Kidney Function Tests among Public Medical Laboratories in Western Region of Amhara National Regional State of Ethiopia.

Science.gov (United States)

Teka, Abaynesh; Kibatu, Girma

2012-03-01

Medical laboratories play essential roles in measurements of substances in body fluids for the purpose of diagnosis, treatment, prevention, and for greater understanding of the disease process. Thus, data generated from have to be reliable for which strict quality control, management and assurance are maintained. The aim of this study is to assess the accuracy and precision of clinical chemistry laboratories in western region of Amhara national regional state of Ethiopia in testing liver and kidney functions. Eight laboratories in hospitals and a Regional Health Research Laboratory Center participated in this study from February to March, 2011. Each participant was requested to measure six specimens for six chemistry tests from two control samples. Three hundred twenty four test results to be reported from all participant laboratories, if all measurements can be made, were designed to be collected and statistically evaluated. None of the study subject laboratories could deliver all the six tests for estimation of both liver and renal functions simultaneously during the study period. Only 213 values from the expected 324 values were reported and about 65 % of the 213 values reported fell outside of the allowable limits of errors for the chemistry tests of the control specimen used. This study finding showed that there were lack of accuracy and precision in chemistry measurements. A regular survey on medical laboratories should be conducted questioning the accuracy and precision of their analyses in order to sustain improvements in the quality of services provided by participating laboratories for the benefit of patients. Laboratory Quality Management Systems appreciate the need for regular quality control and quality assessment schemes in medical laboratories.

State-of-the-Art in Open Courseware Initiatives Worldwide

Science.gov (United States)

Vladoiu, Monica

2011-01-01

We survey here the state-of-the-art in open courseware initiatives worldwide. First, the MIT OpenCourseWare project is overviewed, as it has been the real starting point of the OCW movement. Usually, open courseware refers to a free and open digital publication of high quality university level educational materials that are organized as courses,…

Arsenic in drinking water: a worldwide water quality concern for water supply companies

Directory of Open Access Journals (Sweden)

J. C. van Dijk

2009-06-01

Full Text Available For more than a decade it has been known that shallow tube wells in Bangladesh are frequently contaminated with arsenic concentrations at a level that is harmful to human health. By now it is clear that a disaster of an unheard magnitude is going on: the World Health Organization has estimated that long-term exposure to arsenic in groundwater, at concentrations over 500 μg L⁻¹, causes death in 1 in 10 adults. Other studies show that problems with arsenic in groundwater/drinking water occur in many more countries worldwide, such as in the USA and China. In Europe the focus on arsenic problems is currently confined to countries with high arsenic levels in their groundwater, such as Serbia, Hungary and Italy. In most other European countries, the naturally occurring arsenic concentrations are mostly lower than the European drinking water standard of 10 μg L⁻¹. However, from the literature review presented in this paper, it is concluded that at this level health risks cannot be excluded. As consumers in European countries expect the drinking water to be of impeccable quality, it is recommended that water supply companies optimize arsenic removal to a level of <1 μg L⁻¹, which is technically feasible.

The SCALE Web site: Resources for the worldwide nuclear criticality safety community

International Nuclear Information System (INIS)

Bowman, S.M.

2000-01-01

The Standardized Computer Analyses for Licensing Evaluations (SCALE) computer software system developed at Oak Ridge National Laboratory (ORNL) is widely used and accepted around the world for criticality safety analyses. SCALE includes the well-known KENO V.a and KENO VI three-dimensional Monte Carlo criticality computer codes. For several years, the SCALE staff at ORNL has maintained a Web site to provide information and support to sponsors and users in the worldwide criticality safety community. The SCALE WEB site is located at www.cped.ornl.gov/scale and provides information in the following areas: 1. important notices to users; 2. SCALE Users Electronic Notebook; 3. current and past issues of the SCALE Newsletter; 4. verification and validation (V and V) and benchmark reports; 5. download updates, utilities, and V and V input files; 6. SCALE training course information; 7. SCALE Manual on-line; 8. overview of SCALE system; 9. how to install and run SCALE; 10. SCALE quality assurance documents; and 11. nuclear resources on the Internet

Emergency Response Proficiency Test for Japanese Laboratories: Determination of Selected Radionuclides in Water, Soil, Vegetation and Aerosol Filters

International Nuclear Information System (INIS)

2013-01-01

Reliable determination of natural and artificial radionuclides in environmental samples is necessary for compliance with radiation protection and environmental regulations. The IAEA assists Member State laboratories in maintaining and improving their readiness in this regard by producing reference materials, by developing standardized analytical methods, and by conducting interlaboratory comparisons and proficiency tests as tools for quality control. To fulfil this obligation and ensure a reliable, rapid and consistent worldwide response, the IAEA Terrestrial Environment Laboratory in Seibersdorf, Austria, organizes interlaboratory comparisons and proficiency tests. In addition, the IAEA coordinates the worldwide network of Analytical Laboratories for the Measurement of Environmental Radioactivity (ALMERA). After the accident at the Fukushima Daiichi nuclear power plant in March 2011, Japan requested the IAEA to organize an emergency response proficiency test for Japanese laboratories with the aim of assessing their capacity to rapidly and accurately measure radionuclides in environmental samples. The IAEA responded to the request by assembling a special sample set covering the main environmental samples and radionuclides of interest in the case of a nuclear emergency situation. Water, soil, vegetation and aerosol filter samples were made available to Japanese laboratories for analysis by gamma ray spectrometry. This report presents the results of the IAEA-TEL-2011-08 emergency response proficiency test for Japanese laboratories on the determination of selected radionuclides in water, soil, vegetation and aerosol filters. The report includes descriptions of the methodologies and data evaluation approach used, as well as summary evaluations of each radionuclide and individual evaluation reports of each laboratory. This proficiency test was designed to identify analytical problems and to support Member State laboratories in their efforts to improve the quality of

The quality management system at the European tritium handling experimental laboratory

International Nuclear Information System (INIS)

Dizadji, F.; Ferrario, L.

1992-01-01

The main limitations of conventional Quality Assurance (QA) are discussed with reference to the operational phase of a radio-chemical research laboratory. The paper suggests a broader approach utilizing a Quality Management System (QMS) which focuses on the operational efficiency of a R ampersand D organization in terms of reliability, reproducibility, cost effectiveness and safety. The management's role is presented with particular reference to the best fit of managerial style to the organization's mission, culture, personnel and surrounding environment. Qt. QMS policies and QA criteria are suggested for ETHEL to replace conventional QA requirements. Finally, guidelines for designing the ETHEL organizational structure are discussed

An approach to quality and performance control in a computer-assisted clinical chemistry laboratory.

Science.gov (United States)

Undrill, P E; Frazer, S C

1979-01-01

A locally developed, computer-based clinical chemistry laboratory system has been in operation since 1970. This utilises a Digital Equipment Co Ltd PDP 12 and an interconnected PDP 8/F computer. Details are presented of the performance and quality control techniques incorporated into the system. Laboratory performance is assessed through analysis of results from fixed-level control sera as well as from cumulative sum methods. At a simple level the presentation may be considered purely indicative, while at a more sophisticated level statistical concepts have been introduced to aid the laboratory controller in decision-making processes. PMID:438340

Quality management in environmental programs: Los Alamos National Laboratory's approach

International Nuclear Information System (INIS)

Maassen, L.; Day, J.L.

1998-03-01

Since its inception in 1943, Los Alamos National Laboratory's (LANL's) primary mission has been nuclear weapons research and development, which involved the use of hazardous and radioactive materials, some of which were disposed of onsite. LANL has established an extensive Environmental Restoration Project (Project) to investigate and remediate those hazardous and radioactive waste disposal sites. This paper describes LANL's identification and resolution of critical issues associated with the integration and management of quality in the Project

Quality assurance manual for the Department of Energy laboratory accreditation program for personnel dosimetry systems

International Nuclear Information System (INIS)

1987-02-01

The overall purpose of this document is to establish a uniform approach to quality assurance. This will ensure that uniform, high-quality personnel dosimetry practices are followed by the participating testing laboratories. The document presents guidelines for calibrating and maintaining measurement and test equipment (M and TE), calibrating radiation fields, and subsequently irradiating and handling personnel dosimeters in laboratories involved in the DOE dosimetry systems testing program. Radiation energies for which the test procedures apply are photons with approximately 15 keV to 2 MeV, beta particles above 0.3 MeV, neutrons with approximately 1 keV to 2 MeV. 12 refs., 4 tabs

Errors in clinical laboratories or errors in laboratory medicine?

Science.gov (United States)

Plebani, Mario

2006-01-01

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes

Electronic laboratory quality assurance program: A method of enhancing the prosthodontic curriculum and addressing accreditation standards.

Science.gov (United States)

Moghadam, Marjan; Jahangiri, Leila

2015-08-01

An electronic quality assurance (eQA) program was developed to replace a paper-based system and to address standards introduced by the Commission on Dental Accreditation (CODA) and to improve educational outcomes. This eQA program provides feedback to predoctoral dental students on prosthodontic laboratory steps at New York University College of Dentistry. The purpose of this study was to compare the eQA program of performing laboratory quality assurance with the former paper-based format. Fourth-year predoctoral dental students (n=334) who experienced both the paper-based and the electronic version of the quality assurance program were surveyed about their experiences. Additionally, data extracted from the eQA program were analyzed to identify areas of weakness in the curriculum. The study findings revealed that 73.8% of the students preferred the eQA program to the paper-based version. The average number of treatments that did not pass quality assurance standards was 119.5 per month. This indicated a 6.34% laboratory failure rate. Further analysis of these data revealed that 62.1% of the errors were related to fixed prosthodontic treatment, 27.9% to partial removable dental prostheses, and 10% to complete removable dental prostheses in the first 18 months of program implementation. The eQA program was favored by dental students who have experienced both electronic and paper-based versions of the system. Error type analysis can yield the ability to create customized faculty standardization sessions and refine the didactic and clinical teaching of the predoctoral students. This program was also able to link patient care activity with the student's laboratory activities, thus addressing the latest requirements of the CODA regarding the competence of graduates in evaluating laboratory work related to their patient care. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Harmonization activities of Noklus - a quality improvement organization for point-of-care laboratory examinations.

Science.gov (United States)

Stavelin, Anne; Sandberg, Sverre

2018-05-16

Noklus is a non-profit quality improvement organization that focuses to improve all elements in the total testing process. The aim is to ensure that all medical laboratory examinations are ordered, performed and interpreted correctly and in accordance with the patients' needs for investigation, treatment and follow-up. For 25 years, Noklus has focused on point-of-care (POC) testing in primary healthcare laboratories and has more than 3100 voluntary participants. The Noklus quality system uses different tools to obtain harmonization and improvement: (1) external quality assessment for the pre-examination, examination and postexamination phase to monitor the harmonization process and to identify areas that need improvement and harmonization, (2) manufacturer-independent evaluations of the analytical quality and user-friendliness of POC instruments and (3) close interactions and follow-up of the participants through site visits, courses, training and guidance. Noklus also recommends which tests that should be performed in the different facilities like general practitioner offices, nursing homes, home care, etc. About 400 courses with more than 6000 delegates are organized annually. In 2017, more than 21,000 e-learning programs were completed.

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan : ASC software quality engineering practices Version 3.0.

Energy Technology Data Exchange (ETDEWEB)

Turgeon, Jennifer L.; Minana, Molly A.; Hackney, Patricia; Pilch, Martin M.

2009-01-01

The purpose of the Sandia National Laboratories (SNL) Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. Quality is defined in the US Department of Energy/National Nuclear Security Agency (DOE/NNSA) Quality Criteria, Revision 10 (QC-1) as 'conformance to customer requirements and expectations'. This quality plan defines the SNL ASC Program software quality engineering (SQE) practices and provides a mapping of these practices to the SNL Corporate Process Requirement (CPR) 001.3.6; 'Corporate Software Engineering Excellence'. This plan also identifies ASC management's and the software project teams responsibilities in implementing the software quality practices and in assessing progress towards achieving their software quality goals. This SNL ASC Software Quality Plan establishes the signatories commitments to improving software products by applying cost-effective SQE practices. This plan enumerates the SQE practices that comprise the development of SNL ASC's software products and explains the project teams opportunities for tailoring and implementing the practices.

Field Methods and Quality-Assurance Plan for Quality-of-Water Activities, U.S. Geological Survey, Idaho National Laboratory, Idaho

Science.gov (United States)

Knobel, LeRoy L.; Tucker, Betty J.; Rousseau, Joseph P.

2008-01-01

Water-quality activities conducted by the staff of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation's water resources. The activities are conducted in cooperation with the U.S. Department of Energy's (DOE) Idaho Operations Office. Results of the water-quality investigations are presented in various USGS publications or in refereed scientific journals. The results of the studies are highly regarded, and they are used with confidence by researchers, regulatory and managerial agencies, and interested civic groups. In its broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the 'state-of-the-art' technology, and quality assurance ensures that quality control is maintained within specified limits.

OpenMeetings as a browser-based teleconferencing tool for EFDA laboratories

Energy Technology Data Exchange (ETDEWEB)

Santos, B., E-mail: bsantos@ipfn.ist.utl.pt [Associacao EURATOM/IST, Instituto de Plasmas e Fusao Nuclear - Laboratorio Associado, Instituto Superior Tecnico, P-1049-001 Lisboa (Portugal); Castro, R. [Asociacion EURATOM/CIEMAT Para Fusion, 28040 Madrid (Spain); Santos, J.H.; Gomes, D.; Fernandes, H.; Sousa, J.; Varandas, C.A.F. [Associacao EURATOM/IST, Instituto de Plasmas e Fusao Nuclear - Laboratorio Associado, Instituto Superior Tecnico, P-1049-001 Lisboa (Portugal)

2011-10-15

Remote participation is a key success factor for worldwide organizations and video-conference is an important aspect when laboratory collaborators are geographically dispersed. Several tools for video-conference are available worldwide. However, there is a need for a default integrated set of tools which provide all the needed features for remote participation between cooperating laboratories. Moreover, laboratories currently use different video-conference tools to communicate leading to a non-compatible method among them. OpenMeetings is open source software which provides video-conferences through web-browsing. It is operating system independent, requires no computer installation providing easy integration with already existing tools and customization of requirements. This paper intends to give an OpenMeetings overview as a video-conference application between worldwide laboratories and to demonstrate its integration with the European Fusion Development Agreement (EFDA) Federation authentication and authorization features. EFDA Federation is a multi-organization security infrastructure, whose purpose is to provide sharing and provision of a wide set of resources so that authenticated users may access them in a transparent and secure mode. This infrastructure is based on a distributed security technology called PAPI (Point of Access to Providers of Information). OpenMeetings can be a valuable EFDA Federation resource and a good approach as a method to provide a worldwide laboratory video-conferencing application, based on standard browsers.

OpenMeetings as a browser-based teleconferencing tool for EFDA laboratories

International Nuclear Information System (INIS)

Santos, B.; Castro, R.; Santos, J.H.; Gomes, D.; Fernandes, H.; Sousa, J.; Varandas, C.A.F.

2011-01-01

Remote participation is a key success factor for worldwide organizations and video-conference is an important aspect when laboratory collaborators are geographically dispersed. Several tools for video-conference are available worldwide. However, there is a need for a default integrated set of tools which provide all the needed features for remote participation between cooperating laboratories. Moreover, laboratories currently use different video-conference tools to communicate leading to a non-compatible method among them. OpenMeetings is open source software which provides video-conferences through web-browsing. It is operating system independent, requires no computer installation providing easy integration with already existing tools and customization of requirements. This paper intends to give an OpenMeetings overview as a video-conference application between worldwide laboratories and to demonstrate its integration with the European Fusion Development Agreement (EFDA) Federation authentication and authorization features. EFDA Federation is a multi-organization security infrastructure, whose purpose is to provide sharing and provision of a wide set of resources so that authenticated users may access them in a transparent and secure mode. This infrastructure is based on a distributed security technology called PAPI (Point of Access to Providers of Information). OpenMeetings can be a valuable EFDA Federation resource and a good approach as a method to provide a worldwide laboratory video-conferencing application, based on standard browsers.

The IAEA worldwide intercomparison exercises (1990-1997). Determination of trace elements in marine sediments and biological samples

International Nuclear Information System (INIS)

Coquery, M.; Carvalho, F.P.; Azemard, S.; Horvat, M.

1999-01-01

Four major worldwide intercomparison exercises for the determination of trace elements in various environmental matrices were completed by the IAEA Marine Environment Laboratory since 1990: SD-M-2/TM, deep sea marine sediment; IAEA-350, tuna fish homogenate; IAEA-356, contaminated coastal sediment and IAEA-140, sea plant (Fucus sp.). These intercomparison exercises aim at enabling individual laboratories to monitor their performance. The results of these exercises allowed us to make an overall evaluation of the quality of data provided for environmental assessment and to identify the trends of analytical performance in the determination of trace elements over the years. The number of participants in each exercise varied between 68 and 130, and permits statistical evaluation of the performance for a number of elements. For each intercomparison exercise, the performance of the participant laboratories was assessed by comparing reported results with established reference values calculating 'Z-scores'. The results show that for each sample matrix, the values reported by some laboratories were far from satisfactory in the earlier exercises, in particular for Cd, Cr and Pb. Nevertheless, over time, a general improvement of performance can clearly be seen for all elements. Moreover, there was a noticeable increase in the number of laboratories with good performance in the two most recent exercises, observed both for biological and for sediment matrices. However, the determination of trace elements such as Cd, Cr, Pb and Hg in low level environmental samples still remains a major challenge to the analysts. For this reason and in order to assess the current performance of laboratories for low environmental levels of contaminants, the future intercomparison exercises will concentrate on low level sediment and fish samples

Results of Use of WHO Global Salm-Surv External Quality Assurance System for Antimicrobial Susceptibility Testing of Salmonella Isolates from 2000 to 2007

DEFF Research Database (Denmark)

Hendriksen, Rene S.; Seyfarth, Anne Mette; Jensen, Arne Bent

2009-01-01

laboratories in 102 countries participated in at least one EQAS iteration. A large number of laboratories reported results for the E. coli ATCC 25922 reference strain which were outside the quality control ranges. Critical deviations for susceptibility testing of the Salmonella isolates varied from 4% in 2000......An international External Quality Assurance System (EQAS) for antimicrobial susceptibility testing of Salmonella was initiated in 2000 by the World Health Organization (WHO) Global Salm-Surv in order to enhance the capacities of national reference laboratories to obtain reliable data....... In particular, further training and dissemination of information on quality control, appropriate interpretive criteria (breakpoints), and harmonization of the methodology worldwide through WHO Global Salm-Surv and other programs will contribute to the generation of comparable and reliable antimicrobial...

Worldwide molecular epidemiology of HIV

Directory of Open Access Journals (Sweden)

Henry I Z Requejo

2006-04-01

Full Text Available Human immunodeficiency virus (HIV is the worldwide disseminated causative agent of acquired immunodeficiency syndrome (AIDS. HIV is a member of the Lentivirus genus of Retroviridae family and is grouped in two types named HIV-1 and HIV-2. These viruses have a notable ability to mutate and adapt to the new conditions of human environment. A large incidence of errors at the transcriptional level results in changes on the genetic bases during the reproductive cycle. The elevated genomic variability of HIV has carried important implications for the diagnosis, treatment and prevention as well as epidemiologic investigations. The present review describes important definitions and geographical distribution of subtypes, circulating recombinant forms and other genomic variations of HIV. The present study aimed at leading students of Biomedical Sciences and public health laboratory staff guidance to general and specific knowledge about the genomic variability of the HIV.

Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation

Directory of Open Access Journals (Sweden)

Jean-Bosco Ndihokubwayo

2016-05-01

SLIPTA implementation process: WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1–5 stars were issued. Preliminary results: By March 2015, 27 of the 47 (57% WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3, French (12 and English (83 languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62–77. Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars and 1% scored at least 95% (5 stars. The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit and 10 (Corrective Action, which both had mean scores below 50%. Conclusion: The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.

Prospects for high-power radioactive beam facilities worldwide

CERN Document Server

Nolen, Jerry A

2003-01-01

Advances in accelerators, targets, ion sources, and experimental instrumentation are making possible ever more powerful facilities for basic and applied research with short-lived radioactive isotopes. There are several current generation facilities, based on a variety of technologies, operating worldwide. These include, for example, those based on the in-flight method such as the recently upgraded National Superconducting Cyclotron Laboratory at Michigan State University, the facility at RIKEN in Japan, GANIL in Caen, France, and GSI in Darmstadt, Germany. Present facilities based on the Isotope-Separator On-Line method include, for example, the ISOLDE laboratory at CERN, HRIBF at Oak Ridge, and the new high-power facility ISAC at TRIUMF in Vancouver. Next-generation facilities include the Radioactive-Ion Factory upgrade of RIKEN to higher energy and intensity and the upgrade of ISAC to a higher energy secondary beam; both of these projects are in progress. A new project, LINAG, to upgrade the capabilities at...

National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

Science.gov (United States)

Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

2015-01-01

The narrow gap of HbA1 value of mass fraction between "normal" (control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

Science.gov (United States)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-04-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented.

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

International Nuclear Information System (INIS)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-01-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented

Quality control in the histopathology laboratory: An overview with stress on the need for a structured national external quality assessment scheme

Directory of Open Access Journals (Sweden)

Iyengar Jayaram

2009-01-01

Full Text Available The concept of quality control in histopathology is relatively young and less well understood. Like in other disciplines of laboratory medicine, the concept of quality and its control is applicable to pre analytical, analytical and post analytical activities. Assessment of both precision and accuracy performances is possible by appropriate internal and external quality control and assessment schemes. This article is a review of all processes that achieve quality reporting in histopathology. There is a special focus on external quality assessment - a scheme that lacks organization on a national level in our country. Statistical data derived from a small scale external quality assurance program is also analyzed along with recommendations to organize an effective national scheme with the participation of authorized zonal centers.

Improvement in the performance of external quality assessment in Korean HIV clinical laboratories using unrecalcified human plasma.

Science.gov (United States)

Wang, Jin-Sook; Kee, Mee-Kyung; Choi, Byeong-Sun; Kim, Chan-Wha; Kim, Hyon-Suk; Kim, Sung Soon

2012-01-01

The external quality assessment schemes (EQAS) organizer provides a suitable program to monitor and improve the quality of human immunodeficiency virus (HIV) testing laboratories with EQAS panels prepared under various conditions. The aim of the current study was to investigate the effects of human plasma samples on the EQAS results of HIV obtained from hospital-based clinical laboratories. From 2007 to 2009, HIV EQAS panels consisted of four to six samples that consisted of undiluted positive and negative samples and were provided to laboratories twice per year. Up until the first half EQAS in 2008, EQAS panel materials were obtained by converting acid citrate dextrose treated plasma to serum via chemical treatment with CaCl2. Beginning with the second EQAS in 2008, all materials were prepared without the defibrination process. Approximately 300 HIV clinical laboratories participated in this program. The overall performance of clinical laboratories was shown to be improved when using unrecalcified plasma panels compared with recalcified panels. Significant differences were observed in EIA analyses of plasma for both positive (plaboratories.

The experience of 3 years of external quality assessment of preimplantation genetic diagnosis for cystic fibrosis

Science.gov (United States)

Deans, Zandra; Fiorentino, Francesco; Biricik, Anil; Traeger-Synodinos, Joanne; Moutou, Céline; De Rycke, Martine; Renwick, Pamela; SenGupta, Sioban; Goossens, Veerle; Harton, Gary

2013-01-01

Preimplantation genetic diagnosis (PGD) was first performed over 20 years ago and has become an accepted part of genetic testing and assisted reproduction worldwide. The techniques and protocols necessary to carry out genetic testing at the single-cell level can be difficult to master and have been developed independently by the laboratories worldwide offering preimplantation testing. These factors indicated the need for an external quality assessment (EQA) scheme for monogenic disease PGD. Toward this end, the European Society for Human Reproduction and Embryology came together with United Kingdom National External Quality Assessment Services for Molecular Genetics, to create a pilot EQA scheme followed by practical EQA schemes for all interested parties. Here, we detail the development of the pilot scheme as well as development and findings from the practical (clinical) schemes that have followed. Results were generally acceptable and there was marked improvement in results and laboratory scores for those labs that participated in multiple schemes. Data from the first three schemes indicate that the EQA scheme is working as planned and has helped laboratories improve their techniques and result reporting. The EQA scheme for monogenic PGD will continue to be developed to offer assessment for other monogenic disorders. PMID:23150080

Quality assurance in the measurement of internal radioactive contamination and dose assessment and the United States Department of Energy Laboratory Accreditation Program

International Nuclear Information System (INIS)

Bhatt, Anita

2016-01-01

The Quality Assurance for analytical measurement of internal radioactive contamination and dose assessment in the United States (US) is achieved through the US Department of Energy (DOE) Laboratory Accreditation Program (DOELAP) for both Dosimetry and Radio bioassay laboratories for approximately 150,000 radiation workers. This presentation will explain the link between Quality Assurance and the DOELAP Accreditation process. DOELAP is a DOE complex-wide safety program that ensures the quality of worker radiation protection programs. DOELAP tests the ability of laboratories to accurately measure and quantify radiation dose to workers and assures the laboratories quality systems are capable of defending and sustaining their measurement results. The United States Law in Title 10 of the Code of Federal Regulations 835 requires that personnel Dosimetry and Radio bioassay programs be tested and accredited

Factoring quality laboratory diagnosis into the malaria control agenda for sub-Saharan Africa.

Science.gov (United States)

Aidoo, Michael

2013-09-01

Recent progress in malaria control in sub-Saharan Africa has been achieved primarily through provision of insecticide-treated nets, indoor residual spraying, and antimalarial drugs. Although these interventions are important, proper case identification and accurate measurement of their impact depend on quality diagnostic testing. Current availability of diagnostic testing for malaria in sub-Saharan Africa is inadequate to support disease management, prevention programs, and surveillance needs. Challenges faced include a dearth of skilled workforce, inadequate health systems infrastructure, and lack of political will. A coordinated approach to providing pre-service clinical and laboratory training together with systems that support a scale-up of laboratory services could provide means not only for effective malaria case management but also, management of non-malaria febrile illnesses, disease surveillance, and accurate control program evaluation. A synthesis of the challenges faced in ensuring quality malaria testing and how to include this information in the malaria control and elimination agenda are presented.

Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.

Science.gov (United States)

Jassam, Nuthar; Yundt-Pacheco, John; Jansen, Rob; Thomas, Annette; Barth, Julian H

2013-08-01

The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications. Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation. Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ. Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.

Maternal Colonization With Group B Streptococcus and Serotype Distribution Worldwide: Systematic Review and Meta-analyses.

Science.gov (United States)

Russell, Neal J; Seale, Anna C; O'Driscoll, Megan; O'Sullivan, Catherine; Bianchi-Jassir, Fiorella; Gonzalez-Guarin, Juan; Lawn, Joy E; Baker, Carol J; Bartlett, Linda; Cutland, Clare; Gravett, Michael G; Heath, Paul T; Le Doare, Kirsty; Madhi, Shabir A; Rubens, Craig E; Schrag, Stephanie; Sobanjo-Ter Meulen, Ajoke; Vekemans, Johan; Saha, Samir K; Ip, Margaret

2017-11-06

Maternal rectovaginal colonization with group B Streptococcus (GBS) is the most common pathway for GBS disease in mother, fetus, and newborn. This article, the second in a series estimating the burden of GBS, aims to determine the prevalence and serotype distribution of GBS colonizing pregnant women worldwide. We conducted systematic literature reviews (PubMed/Medline, Embase, Latin American and Caribbean Health Sciences Literature [LILACS], World Health Organization Library Information System [WHOLIS], and Scopus), organized Chinese language searches, and sought unpublished data from investigator groups. We applied broad inclusion criteria to maximize data inputs, particularly from low- and middle-income contexts, and then applied new meta-analyses to adjust for studies with less-sensitive sampling and laboratory techniques. We undertook meta-analyses to derive pooled estimates of maternal GBS colonization prevalence at national and regional levels. The dataset regarding colonization included 390 articles, 85 countries, and a total of 299924 pregnant women. Our adjusted estimate for maternal GBS colonization worldwide was 18% (95% confidence interval [CI], 17%-19%), with regional variation (11%-35%), and lower prevalence in Southern Asia (12.5% [95% CI, 10%-15%]) and Eastern Asia (11% [95% CI, 10%-12%]). Bacterial serotypes I-V account for 98% of identified colonizing GBS isolates worldwide. Serotype III, associated with invasive disease, accounts for 25% (95% CI, 23%-28%), but is less frequent in some South American and Asian countries. Serotypes VI-IX are more common in Asia. GBS colonizes pregnant women worldwide, but prevalence and serotype distribution vary, even after adjusting for laboratory methods. Lower GBS maternal colonization prevalence, with less serotype III, may help to explain lower GBS disease incidence in regions such as Asia. High prevalence worldwide, and more serotype data, are relevant to prevention efforts. © The Author 2017. Published by

Guidelines for establishing quality systems in veterinary diagnostic testing laboratories. Report of a Joint FAO/IAEA consultants meeting/workshop. Draft

International Nuclear Information System (INIS)

2002-01-01

The purpose of this report is to assist veterinary testing laboratories to develop and implement a quality system based on the OIE Standard 'Management and Technical Requirements for Laboratories Conducting Tests for Infectious Animal Diseases'. The introduction to the OIE Standard states: This document describes the OIE Standard for management and technical competence that serves as the basis for accreditation of laboratories that conduct tests for infectious animal diseases, especially those laboratories involved in testing for international trade. It contains the specific requirements unique to laboratories conducting tests for infectious animal diseases. These specific requirements represent an interpretation of the generally stated requirements of ISO/IEC 17025:1999, General requirements for the competence of testing and calibration laboratories (as outlined in Annex B of ISO/IEC 17025). Accreditation bodies that recognize the competence of such testing laboratories may use this Standard as the basis for their accreditation. This report gives an example-oriented overview of the structure and contents of critical documents and procedures such as Quality Manual (QM), Standard Operating Procedures (SOPs), etc. inherent to a quality system and describes the different stages in the implementation of the OIE Standard. For that reason it can be used as a practical guide for the production of necessary documents but also as a help to determine the status of a laboratory during its journey towards establishing a QS

Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1994 quality program status report

International Nuclear Information System (INIS)

Bolivar, S.L.

1996-03-01

This status report is for calendar year 1994. It summarizes the annual activities and accomplishments of the Los Alamos National Laboratory Yucca Mountain Site Characterization Project (YMP or Project) quality assurance program. By identifying the accomplishments of the quality program, a baseline is established that will assist in decision making, improve administrative controls and predictability, and allow us to annually identify adverse trends and to evaluate improvements. This is the fourth annual status report

Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1994 quality program status report

Energy Technology Data Exchange (ETDEWEB)

Bolivar, S.L.

1996-03-01

This status report is for calendar year 1994. It summarizes the annual activities and accomplishments of the Los Alamos National Laboratory Yucca Mountain Site Characterization Project (YMP or Project) quality assurance program. By identifying the accomplishments of the quality program, a baseline is established that will assist in decision making, improve administrative controls and predictability, and allow us to annually identify adverse trends and to evaluate improvements. This is the fourth annual status report.

Expert Assessment of Conditions for Accredited Quality Management System Functioning in Testing Laboratories

Science.gov (United States)

Mytych, Joanna; Ligarski, Mariusz J.

2018-03-01

The quality management systems compliant with the ISO 9001:2009 have been thoroughly researched and described in detail in the world literature. The accredited management systems used in the testing laboratories and compliant with the ISO/IEC 17025:2005 have been mainly described in terms of the system design and implementation. They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland. On 8 October 2015, 1,213 accredited testing laboratories were present in Poland. They investigated various scientific areas and substances/objects. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment (survey) carried out to examine the conditions for the functioning of a management system in an accredited laboratory. It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented.

Quality improvement project in cervical cancer screening: practical measures for monitoring laboratory performance.

Science.gov (United States)

Tarkkanen, Jussi; Geagea, Antoine; Nieminen, Pekka; Anttila, Ahti

2003-01-01

We conducted a quality improvement project in a cervical cancer screening programme in Helsinki in order to see if detection of precancerous lesions could be influenced by external (participation rate) and internal (laboratory praxis) quality measures. In order to increase the participation rate, a second personal invitation to Pap-test was mailed to nonparticipants of the first call. In order to improve the quality of screening, the cytotechnicians monitored their performance longitudinally by recording the number of slides reviewed per day, the pick-up rate of abnormal smears, the report of the consulting cytopathologist, and the number of histologically verified lesions detected from the cases that they had screened. Regular sessions were held to compare the histological findings with the cytological findings of all cases referred for colposcopy. No pressure was applied on the cytotechnicians to ensure that they felt comfortable with their daily workload. A total of 110 000 smears were screened for cervical cancer at the Helsinki City Hospital during 1996-99. Initially, the overall participation rate increased from 62% to 71%. The number of histologically confirmed precancerous lesions (CIN 1-3) more than doubled and their detection rate increased from 0.32% to 0.72%. Continuous education and feedback from daily work performance were important, yet rather inexpensive means in increasing laboratory performance. Additional measures are needed to further increase the participation rate. Impact of the quality measures on cancer incidence needs to be assessed later on.

Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1995 quality program status report

International Nuclear Information System (INIS)

Bolivar, S.L.

1996-07-01

This status report summarizes the activities and accomplishments of the Los Alamos National Laboratory Yucca Mountain Site Characterization Project's (YMP's) quality assurance program for January 1 to September 30, 1995. The report includes major sections on program activities and trend analysis

Quality and future of clinical laboratories: the Vico's whole cyclical theory of the recurring cycles.

Science.gov (United States)

Plebani, Mario

2018-05-24

In the last few decades, laboratory medicine has undergone monumental changes, and laboratory technology, which has made enormous advances, now has new clinical applications thanks to the identification of a growing number of biomarkers and risk factors conducive to the promotion of predictive and preventive interventions that have enhanced the role of laboratory medicine in health care delivering. However, the paradigm shift in the past 50 years has led to a gap between laboratory and clinic, with an increased risk of inappropriateness in test request and interpretation, as well as the consolidation of analytical work in focused factories and megastructurers oriented only toward achieving greater volumes, decreasing cost per test and generating a vision of laboratory services as simple commodities. A careful historical revision of the changing models for delivering laboratory services in the United States leads to the prediction that there are several reasons for counteracting the vision of clinical laboratory as a commodity, and restoring the true nature of laboratory services as an integral part of the diagnosis and therapy process. The present study, which reports on internal and external drivers for change, proposes an integrated vision of quality in laboratory medicine.

Quality Evaluation of Zirconium Dioxide Frameworks Produced in Five Dental Laboratories from Different Countries.

Science.gov (United States)

Schneebeli, Esther; Brägger, Urs; Scherrer, Susanne S; Keller, Andrea; Wittneben, Julia G; Hicklin, Stefan P

2017-07-01

The aim of this study was to assess and compare quality as well as economic aspects of CAD/CAM high strength ceramic three-unit FDP frameworks ordered from dental laboratories located in emerging countries and Switzerland. The master casts of six cases were sent to five dental laboratories located in Thailand (Bangkok), China (Peking and Shenzhen), Turkey (Izmir), and Switzerland (Bern). Each laboratory was using a different CAD/CAM system. The clinical fit of the frameworks was qualitatively assessed, and the thickness of the framework material, the connector height, the width, and the diameter were evaluated using a measuring sensor. The analysis of the internal fit of the frameworks was performed by means of a replica technique, whereas the inner and outer surfaces of the frameworks were evaluated for traces of postprocessing and damage to the intaglio surface with light and electronic microscopes. Groups (dental laboratories and cases) were compared for statistically significant differences using Mann-Whitney U-tests after Bonferroni correction. An acceptable clinical fit was found at 97.9% of the margins produced in laboratory E, 87.5% in B, 93.7% in C, 79.2% in A, and 62.5% in D. The mean framework thicknesses were not statistically significantly different for the premolar regions; however, for the molar area 4/8 of the evaluated sites were statistically significantly different. Circumference, surface, and width of the connectors produced in the different laboratories were statistically significantly different but not the height. There were great differences in the designs for the pontic and connector regions, and some of the frameworks would not be recommended for clinical use. Traces of heavy postprocessing were found in frameworks from some of the laboratories. The prices per framework ranged from US$177 to US$896. By ordering laboratory work in developing countries, a considerable price reduction was obtained compared to the price level in Switzerland

Historical return on investment and improved quality resulting from development and mining of a hospital laboratory relational database.

Science.gov (United States)

Brimhall, Bradley B; Hall, Timothy E; Walczak, Steven

2006-01-01

A hospital laboratory relational database, developed over eight years, has demonstrated significant cost savings and a substantial financial return on investment (ROI). In addition, the database has been used to measurably improve laboratory operations and the quality of patient care.

Quality control of calibration system for area monitors at National Laboratory of Metrology from Ionizing Radiations (LNMRI)

International Nuclear Information System (INIS)

Ramos, M.M.O.; Freitas, L.C. de

1992-01-01

The quality control of equipment used in calibration from the National Laboratory of Metrology on Ionizing Radiations is presented, with results of standard measure systems and irradiation system. Tables and graphics with the quality of systems are also shown. (C.G.C.)

[THE VIRTUAL CYTOLOGIC SLIDES FOR EXTERNAL EVALUATION OF QUALITY OF IMPLEMENTATION OF CYTOLOGIC ANALYSES IN CLINICAL DIAGNOSTIC LABORATORIES: POSSIBILITIES AND PERSPECTIVES].

Science.gov (United States)

Djangirova, T V; Shabalova, I P; Pronichev, A N; Polyakov, E V

2015-08-01

The article considers application of technology of analysis of cytological slides in external quality control of clinical diagnostic laboratories. The advantages of virtual slides are demonstrated against other applied technologies of external evaluation of quality i.e. slide plate and digital micro-photography. The conditions of formation of virtual slides for external evaluation of quality of clinical diagnostic laboratories. The technology of their application is described. The success of practical application of considered technology in the Federal system of external evaluation of quality is emphasized.

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.

Science.gov (United States)

Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome

2015-01-15

Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P 80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.

Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1995 quality program status report

Energy Technology Data Exchange (ETDEWEB)

Bolivar, S.L.

1996-07-01

This status report summarizes the activities and accomplishments of the Los Alamos National Laboratory Yucca Mountain Site Characterization Project`s (YMP`s) quality assurance program for January 1 to September 30, 1995. The report includes major sections on program activities and trend analysis.

Los Alamos National Laboratory Yucca Mountain Site Characterization Project: 1991 quality program status report

International Nuclear Information System (INIS)

1992-07-01

This status report summarizes the activities and accomplishments of the Los Alamos National Laboratory (Los Alamos) Yucca Mountain Site Characterization Project's (YMP) quality assurance program for calendar year 1991. The report is divided into three Sections: Program Activities, Verification Activities, and Trend Analysis

Using Focused Laboratory Management and Quality Improvement Projects to Enhance Resident Training and Foster Scholarship

Science.gov (United States)

Ford, Bradley A.; Klutts, J. Stacey; Jensen, Chris S.; Briggs, Angela S.; Robinson, Robert A.; Bruch, Leslie A.; Karandikar, Nitin J.

2017-01-01

Training in patient safety, quality, and management is widely recognized as an important element of graduate medical education. These concepts have been intertwined in pathology graduate medical education for many years, although training programs face challenges in creating explicit learning opportunities in these fields. Tangibly involving pathology residents in management and quality improvement projects has the potential to teach and reinforce key concepts and further fulfill Accreditation Council for Graduate Medical Education goals for pursuing projects related to patient safety and quality improvement. In this report, we present our experience at a pathology residency program (University of Iowa) in engaging pathology residents in projects related to practical issues of laboratory management, process improvement, and informatics. In this program, at least 1 management/quality improvement project, typically performed during a clinical chemistry/management rotation, was required and ideally resulted in a journal publication. The residency program also initiated a monthly management/informatics series for pathology externs, residents, and fellows that covers a wide range of topics. Since 2010, all pathology residents at the University of Iowa have completed at least 1 management/quality improvement project. Many of the projects involved aspects of laboratory test utilization, with some projects focused on other areas such as human resources, informatics, or process improvement. Since 2012, 31 peer-reviewed journal articles involving effort from 26 residents have been published. Multiple projects resulted in changes in ongoing practice, particularly within the hospital electronic health record. Focused management/quality improvement projects involving pathology residents can result in both meaningful quality improvement and scholarly output. PMID:28913416

Using Focused Laboratory Management and Quality Improvement Projects to Enhance Resident Training and Foster Scholarship.

Science.gov (United States)

Krasowski, Matthew D; Ford, Bradley A; Klutts, J Stacey; Jensen, Chris S; Briggs, Angela S; Robinson, Robert A; Bruch, Leslie A; Karandikar, Nitin J

2017-01-01

Training in patient safety, quality, and management is widely recognized as an important element of graduate medical education. These concepts have been intertwined in pathology graduate medical education for many years, although training programs face challenges in creating explicit learning opportunities in these fields. Tangibly involving pathology residents in management and quality improvement projects has the potential to teach and reinforce key concepts and further fulfill Accreditation Council for Graduate Medical Education goals for pursuing projects related to patient safety and quality improvement. In this report, we present our experience at a pathology residency program (University of Iowa) in engaging pathology residents in projects related to practical issues of laboratory management, process improvement, and informatics. In this program, at least 1 management/quality improvement project, typically performed during a clinical chemistry/management rotation, was required and ideally resulted in a journal publication. The residency program also initiated a monthly management/informatics series for pathology externs, residents, and fellows that covers a wide range of topics. Since 2010, all pathology residents at the University of Iowa have completed at least 1 management/quality improvement project. Many of the projects involved aspects of laboratory test utilization, with some projects focused on other areas such as human resources, informatics, or process improvement. Since 2012, 31 peer-reviewed journal articles involving effort from 26 residents have been published. Multiple projects resulted in changes in ongoing practice, particularly within the hospital electronic health record. Focused management/quality improvement projects involving pathology residents can result in both meaningful quality improvement and scholarly output.

Power supplies for space systems quality assurance by Sandia Laboratories

International Nuclear Information System (INIS)

Hannigan, R.L.; Harnar, R.R.

1976-07-01

The Sandia Laboratories' participation in Quality Assurance programs for Radioisotopic Thermoelectric Generators which have been used in space systems over the past 10 years is summarized. Basic elements of this QA program are briefly described and recognition of assistance from other Sandia organizations is included. Descriptions of the various systems for which Sandia has had the QA responsibility are presented, including SNAP 19 (Nimbus, Pioneer, Viking), SNAP 27 (Apollo), Transit, Multi-Hundred Watt (LES 8/9 and MJS), and a new program, High-Performance Generator Mod 3. The outlook for Sandia participation in RTG programs for the next several years is noted

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan part 2 mappings for the ASC software quality engineering practices, version 2.0.

Energy Technology Data Exchange (ETDEWEB)

Heaphy, Robert; Sturtevant, Judith E.; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Minana, Molly A.; Hackney, Patricia; Forsythe, Christi A.; Schofield, Joseph Richard, Jr. (,; .); Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

2006-09-01

The purpose of the Sandia National Laboratories Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. The plan defines the ASC program software quality practices and provides mappings of these practices to Sandia Corporate Requirements CPR001.3.2 and CPR001.3.6 and to a Department of Energy document, ''ASCI Software Quality Engineering: Goals, Principles, and Guidelines''. This document also identifies ASC management and software project teams' responsibilities in implementing the software quality practices and in assessing progress towards achieving their software quality goals.

The Hazardous-Drums Project: A Multiweek Laboratory Exercise for General Chemistry Involving Environmental, Quality Control, and Cost Evaluation

Science.gov (United States)

Hayes, David; Widanski, Bozena

2013-01-01

A laboratory experiment is described that introduces students to "real-world" hazardous waste management issues chemists face. The students are required to define an analytical problem, choose a laboratory analysis method, investigate cost factors, consider quality-control issues, interpret the meaning of results, and provide management…

IAEA reference materials for quality assurance of marine radioactivity measurements

International Nuclear Information System (INIS)

Povinec, P.P.; Pham, M.K.

2001-01-01

The IAEA's Marine Environment Laboratory has been assisting laboratories in Analytical Quality Control Services (AQCS) for the analysis of radionuclides in the marine environment since the early seventies. AQCS through world-wide and regional intercomparison exercises and the provision of reference methods and reference materials (RM) have been recognized as an important component of quality assurance/quality control. A total of 43 intercomparison exercises were organized and 37 RM were produced for marine radioactivity studies. All important marine matrices were covered, e.g., seawater, marine sediments of different chemical compositions, fish, shellfish and seaplants. RM were prepared from samples collected at contaminated sites (e.g., the Irish Sea, the Baltic Sea, the Arabian Sea, Mururoa and Bikini Atolls, etc.) as well as from sites affected only by global fallout (e.g., the Pacific Ocean). Available RM are listed in the IAEA biennial catalogue and can be purchased at a minimal price. An overview of prepared RM for radionuclides in marine matrices is presented and discussed in more detail. (author)

[RESAOLAB: West African network of laboratories to enhance the quality of clinical biology].

Science.gov (United States)

Delorme, L; Machuron, J L; Sow, I; Diagne, R; Sakandé, J; Nikiéma, A; Bougoudogo, F; Keita, A; Longuet, C

2015-02-01

The Fondation Mérieux, in partnership with the Ministries of Health of Burkina Faso, Mali and Senegal, implemented for four years a project to reinforce the laboratory sector in the three participating countries: the RESAOLAB project (West African Network of Biomedical Analysis Laboratories).The objective of RESAOLAB project, in partnership with the WHO Office for West Africa and the West African Health Organization, was to strengthen the systems of biomedical laboratories to improve diagnostic services, access, monitoring and management of infectious diseases. Following the successful results achieved under the RESAOLAB project and due to the demand of the neighbour countries ministries, the RESAOLAB project is now extended to four other countries of the West African region: Benin, Guinea-Conakry, Niger and Togo. The RESAOLAB project has become the RESAOLAB programme, its purpose is to strengthen the quality of the medical biology services thanks to a regional and transversal approach.

Clinical laboratory accreditation in India.

Science.gov (United States)

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

Report on the IAEA-CU-2006-03 world-wide open proficiency test on the determination of gamma emitting radionuclides

International Nuclear Information System (INIS)

Shakhashiro, A.; Sansone, U.; Trinkl, A.; Makarewicz, M.; Yonezawa, C.; Kim, C.K.; Kis-Benedek, G.; Benesch, T.; Schorn, R.

2007-05-01

The results of analytical measurements play a vital role in our daily lives. Analytical data may be the basis upon which economic, legal or environmental management decisions are made, and they are essential in international trade, environmental protection, safe transportation, law enforcement, consumer safety and the preservation of human health. As an incorrect decision can be extremely costly and detrimental, it is essential that such measurements are accurate, reliable, cost effective and defensible. In addition, measurements performed by laboratories located worldwide should yield traceable and comparable results. Proficiency testing is a method for regularly assessing the accuracy of the analytical data produced by the laboratories of particular measurements. The IAEA-CU-2006-03 world-wide proficiency test (PT) on the determination of gamma emitting radionuclides in water grass and soil is conducted by the Chemistry Unit of the IAEA's Laboratories located in Seibersdorf (Austria), which is actively involved in the production and characterization of matrix reference materials of terrestrial origin, widely used for method validation and organization of proficiency tests and intercomparison studies. The Chemistry Unit is a part of the Physics, Chemistry and Instrumentation Laboratory. This report describes the sample preparation methodology, data evaluation approach, summary evaluation of each nuclide and individual evaluation report for each laboratory

Quality control at the Regional Centre of Nuclear Sciences chemical dosimetry laboratory

Energy Technology Data Exchange (ETDEWEB)

Souza, Vivianne L.B. de; Melo, Roberto T. de; Silva, Danubia B. da; Pedroza, Eryka H.; Rodrigues, Kelia R.G.; Cunha, Manuela S. da; Figueiredo, Marcela D.C. de [Centro Regional de Ciencias Nucleares (CRCN-NE/CNEN-PE), Recife, PE (Brazil); Oliveira, Aristides, E-mail: vlsouza@cnen.gov.b, E-mail: rtmelo@cnen.gov.b [Hospital de Cancer de Pernambuco, Recife, PE (Brazil)

2011-07-01

Standards for accreditation of laboratories as in ISO 9001 in section: 4.11 require inspection, measuring and equipment testing; likewise, IEC 17025: 2005 in section: 5.5.2 requires the equipment to be calibrated or verified before being put into use. In our laboratory, quality control is often accomplished by standards set done by the laboratory scientists themselves; however, at present, Hellma secondary calibration standards (4026 - Holmium oxide - Filters: F0, F2, F3, F4 and filter didymium - F7) have been used in order to verify if errors in the laboratory have been close to the 1-2% margin. Control graphs were made by using the results of synthetically prepared standards and standardized spectral calibration certificates. The set of secondary calibration standards permits to check the accuracy of the spectrophotometers used in research for both the absorbance in the visible spectrum (at 440, 465, 546, 590 and 635 nm wavelengths) and for the wavelengths (270, 280, 300, 320 nm) of the ultraviolet light. Filters (F0, F2, F3, F4 and F7) are stable and do not suffer the influence of temperature (the influence is negligible), the F0 filter was being used as a blank. The purpose is to verify whether the spectrometer needs adjustments, an important procedure to check absorbance stability, baseline flatness, slit width accuracy and stray radiation. The calibration tests are performed annually in our laboratory and recalibration of Hellma secondary standards is recommended every two years. The results show that the Chemical Dosimetry Laboratory in CRCN has a calibrated spectrophotometer and their synthetic standards for Fricke dosimetry could be used as an alternative method for testing the proficiency and competence of calibration laboratories in accordance with the regulations and standards. (author)

Improved Specimen-Referral System and Increased Access to Quality Laboratory Services in Ethiopia: The Role of the Public-Private Partnership.

Science.gov (United States)

Kebede, Yenew; Fonjungo, Peter N; Tibesso, Gudeta; Shrivastava, Ritu; Nkengasong, John N; Kenyon, Thomas; Kebede, Amha; Gadde, Renuka; Ayana, Gonfa

2016-04-15

Nonstandardized specimen-transport logistics, lack of laboratory personnel to transport specimens, lack of standard specimen containers, and long turnaround time (TAT) hindered access to quality laboratory services. The objective of the Becton, Dickinson, and Company (BD)-US President's Emergency Plan for AIDS Relief (PEPFAR) Public-Private Partnership (PPP) was to support country-specific programs to develop integrated laboratory systems, services, and quality improvement strategies, with an emphasis on strengthening the specimen-referral system (SRS). In 2007, through the Centers for Disease Control and Prevention (CDC), the Ethiopian Public Health Institute (EPHI) joined with the BD-PEPFAR PPP to strengthen laboratory systems. A joint planning and assessment committee identified gaps in the SRS for prioritization and intervention and piloted the system in Addis Ababa and Amhara Region. The PPP established standardized, streamlined specimen logistics, using the Ethiopian Postal Service Enterprise to support a laboratory network in which 554 facilities referred specimens to 160 laboratories. The PPP supported procuring 400 standard specimen containers and the training of 586 laboratory personnel and 81 postal workers. The average TAT was reduced from 7 days (range, 2-14 days) to 2 days (range, 1-3 days) in Addis Ababa and from 10 days (range, 6-21 days) to 5 days (range, 2-6 days) in Amhara Region. This study highlights the feasibility and untapped potential of PPPs to strengthen laboratory systems. This planned and structured approach to improving specimen referral enhanced access to quality laboratory services. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

[The system of quality management in medical laboratory: the problematic issues of implementation of GOST RKS 9001-2008, GOST R ISO 15189-2009 and GOST R ISO 53079-2008].

Science.gov (United States)

Dolgikh, T I

2013-04-01

The article presents the approaches to development and implementation of system of quality management in laboratory as an integral part of the given system in whole medical institution. The costs of works execution concerning quality support are to be weighted with economic profitability and timeliness of medical care provision to ill people considering pre-analytic stage (out-laboratory and in-laboratory) laboratory analysis. Factually it is a matter of development of system of balanced indicators concerning quality management of institution and laboratory functioning. The problematic issues are presented concerning maintenance of particular requirements of GOSTR ISO 15189 about quality of production. The emphasis is made on the necessity of training of administrations of laboratories in the field of quality management and economics of laboratory business.

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan. Part 1 : ASC software quality engineering practices version 1.0.

Energy Technology Data Exchange (ETDEWEB)

Minana, Molly A.; Sturtevant, Judith E.; Heaphy, Robert; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Forsythe, Christi A.; Schofield, Joseph Richard, Jr.; Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

2005-01-01

The purpose of the Sandia National Laboratories (SNL) Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. Quality is defined in DOE/AL Quality Criteria (QC-1) as conformance to customer requirements and expectations. This quality plan defines the ASC program software quality practices and provides mappings of these practices to the SNL Corporate Process Requirements (CPR 1.3.2 and CPR 1.3.6) and the Department of Energy (DOE) document, ASCI Software Quality Engineering: Goals, Principles, and Guidelines (GP&G). This quality plan identifies ASC management and software project teams' responsibilities for cost-effective software engineering quality practices. The SNL ASC Software Quality Plan establishes the signatories commitment to improving software products by applying cost-effective software engineering quality practices. This document explains the project teams opportunities for tailoring and implementing the practices; enumerates the practices that compose the development of SNL ASC's software products; and includes a sample assessment checklist that was developed based upon the practices in this document.

The impact of laboratory characteristics on molecular detection of respiratory syncytial virus in a European multicentre quality control study

NARCIS (Netherlands)

Meerhoff, T. J.; MacKay, W. G.; Meijer, A.; Paget, W. J.; Niesters, H. G. M.; Kimpen, J. L. L.; Schellevis, F.

2008-01-01

The performance of nucleic acid amplification techniques for detecting respiratory syncytial virus (RSV) was evaluated in 25 laboratories across Europe by an external quality assessment study. In addition, factors related to the diagnostic performance of laboratories were explored. The results of

[The quality management in clinical diagnostic laboratory in conditions of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary)].

Science.gov (United States)

Nikolaev, N S; Nazarova, V V; Dobrovol'skaia, N Iu; Orlova, A V; Pchelova, N N

2014-10-01

The article presents experience of clinical diagnostic laboratory of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary) in the area of quality management of medical laboratory services on the basis of evaluation of efficacy and effectiveness of processes. The factors effecting quality of functioning of clinical diagnostic laboratory are indicated. The criteria and indicators of efficacy of work of employees of clinical diagnostic laboratory are presented.

Effect of clinical and laboratory parameters on quality of life in celiac patients using celiac disease-specific quality of life scores.

Science.gov (United States)

Lee, Jungmin; Clarke, Kofi

2017-11-01

Health-related quality of life (HR-QOL) in patients with celiac disease is reduced compared to the general population. We investigated the association between HR-QOL and clinical, laboratory findings using the previously validated CD-QOL (celiac disease-specific quality of life) instrument in patients with celiac disease. To our knowledge, no study has previously explored the relationship between HR-QOL and clinical, laboratory parameters in celiac patients. Patients who received care at the Allegheny Health Network Celiac Center, Pittsburgh, PA were asked to complete the CD-QOL questionnaire. A cross sectional study with predetermined clinical and laboratory parameters was performed. Data collected included IgA anti-tissue transglutaminase (tTG) antibody titers, iron studies, calcium, vitamin A, B12, 25 OH vitamin D, and E levels. Correlation between clinical findings and CD-QOL was also assessed. Seventy-eight out of 124 patients who completed the questionnaire was included in the analysis. Patients with concomitant irritable bowel syndrome (IBS) had significantly reduced HR-QOL with CD-QOL score of 52.4 ± 11.3 vs. 44.6 ± 12.9 in those without IBS (p = .009). There was no difference in HR-QOL in relation to IgA tTG titers or vitamin D levels. Of note, there was a trend towards correlation between higher level of vitamin E and better QOL (r = -0.236, p = .074). Celiac patients with concomitant IBS have reduced HR-QOL. There was no statistically significant association between HR-QOL and laboratory parameters or levels of micronutrients.

Proficiency Test Program Involvement as a Tool for External Quality Control for Radiochemistry and Environmental Laboratory, Malaysian Nuclear Agency

International Nuclear Information System (INIS)

Nurrul Assyikeen Mohd Jaffary; Wo, Y.M.; Zal U'yun Wan Mahmood; Norfaizal Mohamed; Abdul Kadir Ishak; Noor Fadzilah Yusof; Jalal Sharib

2016-01-01

As the only Laboratory in Malaysia under the IAEA Analytical Laboratories for the Measurement of Environmental Radioactivity (ALMERA) Network, the Radiochemistry and Environmental Laboratory (RAS), Malaysian Nuclear Agency participates in the proficiency test programmes organised by ALMERA to achieve mutual acceptance of analytical data. The ALMERA has been providing quality support of proficiency tests using sets of different samples matrices and radionuclide levels typically encountered in environmental and food monitoring laboratories. The involvement of RAS laboratory in the IAEA proficiency tests gives opportunity to improve the laboratory capability and personnel skills in the field of radioactivity testing. (author)

The quality of impressions for crowns and bridges: an assessment of the work received at three commercial dental laboratories. assessing the quality of the impressions of prepared teeth.

Science.gov (United States)

Storey, D; Coward, T J

2013-06-01

The literature is limited in studies directly assessing the quality of impressions for crowns and bridges in the UK. The aim of the study was to assess the quality of impressions for conventional crown and bridgework received by commercial dental laboratories. Three dental laboratories were visited over a 3-month period. All impressions for conventional crowns and bridges that arrived on the days of the visits were examined prior to any laboratory processing. A total of 206 impression cases were examined and assessed against criteria laid out in a custom-designed assessment form. Defects were commonly found in the recording of prepared teeth. Overall, 44.2% of impression cases were unsatisfactory. NHS impressions were more than twice as likely to be unsatisfactory compared to private impressions. If the results of this survey are typical then the general quality of impressions for fixed crown and bridgework is unacceptable. This is particularly true for work completed under the NHS contract.

[Application of laboratory information system in the management of the key indicators of quality inspection].

Science.gov (United States)

Guo, Ye; Chen, Qian; Wu, Wei; Cui, Wei

2015-03-31

To establish a system of monitoring the key indicator of quality for inspection (KIQI) on a laboratory information system (LIS), and to have a better management of KIQI. Clinical sample made in PUMCH were collected during the whole of 2014. Next, interactive input program were designed to accomplish data collecting of the disqualification rate of samples, the mistake rate of samples and the occasions of losing samples, etc. Then, a series moment of sample collection, laboratory sample arrived, sample test, sample check, response to critical value, namely, trajectory information left on LIS were recorded and the qualification rate of TAT, the notification rate of endangering result were calculated. Finally, the information about quality control were collected to build an internal quality control database and the KIQI, such as the out-of-control rate of quality control and the total error of test items were monitored. The inspection of the sample management shows the disqualification rates in 2014 were all below the target, but the rates in January and February were a little high and the rates of four wards were above 2%. The mistake rates of samples was 0.47 cases/10 000 cases, attaining the target (laboratory reports shows the qualification rates of TAT was within the acceptable range (> 95%), however the rates of blood routine in November (94.75%) was out of range. We have solved the problem by optimizing the processes. The notification rate of endangering result attained the target (≥ 98%), while the rate of timely notification is needed to improve. Quality inspection shows the CV of APTT in August (5.02%) was rising significantly, beyond the accepted CV (5.0%). We have solved the problem by changing the reagent. The CV of TT in 2014 were all below the allowable CV, thus the allowable CV of the next year lower to 10%. It is an objective and effective method to manage KIQI with the powerful management mode of database and information process capability on LIS.

[Laboratory accreditation and proficiency testing].

Science.gov (United States)

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories.

Science.gov (United States)

Vap, Linda M; Harr, Kendal E; Arnold, Jill E; Freeman, Kathleen P; Getzy, Karen; Lester, Sally; Friedrichs, Kristen R

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

The current status of radiopharmacy laboratories in Turkey, conveniences to good radiopharmacy practice (GRP) and quality management systems (ISO)

International Nuclear Information System (INIS)

Atak, I.E.

2004-01-01

This study ha been conducted in the Radiopharmacy Laboratories of Nuclear Medicine departments of various hospitals and private nuclear medicine laboratories. A total of 35 laboratories from 7 regions of Turkey have been selected by layered sampling method from 131 Radiopharmacy Laboratories located in 30 different cities. During the study, a GRP investigation list with 67 questions and direct communication technique have been used. The aim was determine the current status of the Radiopharmacy Laboratories in general and the administration of radiopharmaceuticals on patients, and good practices in radiopharmacy and conformance with quality assurance systems. In this respect, questions have been asked to determine a) General status, b) Information level of lab workers regarding to the GRP and ISO concepts (i-Status of lab managers, ii- Responsibilities and knowledge of lab workers and iii- regarding to GRP and ISO-9000), c) Conditions of infrastructure, and lab services and its quality, d) Status of organizations. Results showed that only two of the 35 managers of laboratories were radiopharmacists, the rest were Nuclear Medicine specialists. There were less knowledge on GRP than ISO, the labs holding ISO certificate were in minority even though ISO is known concept, radiopharmacist were more knowledgeable in GRP while nuclear medicine specialists were in ISO, the labs with better GRP knowledge have better infrastructure, the GRP knowledge were better in the university and armed forces hospitals while ISO knowledge and certificates were more in private labs and hospitals, the armed forces hospitals better paraphernalia, practically almost all radiopharmaceutical kits were imported goods and there were important problems in quality control

Improvement of the quality control program of the clinical dosimeters calibration laboratory of the IPEN/CNEN-SP

Energy Technology Data Exchange (ETDEWEB)

Damatto, Willian B.; Potiens, Maria da Penha A.; Vivolo, Vitor, E-mail: wbdamatto@ipen.br, E-mail: mppotiens@ipen.br, E-mail: vivolo@ipen.br [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

2013-07-01

A set of clinical dosimeters (thimble ionization chamber coupled to an electrometer) commonly used in radiotherapy in Brazil and sent to the Calibration Laboratory of IPEN were under several tests and analysis parameters for the dosimeters behaviour were established, specifying their sensitivities and operating characteristics. Applied tests were: repeatability, reproducibility and current leakage. Thus it was possible to determine the most common defects found in these equipment and the actions that could be taken to prevent it (clinical dosimeters quality control programs). The behaviour of 167 dosimeters was analyzed and in this study, 62 of them have been tested. The main problem detected during calibration tests was current leakage, i.e. electronic noise. The tests were applied to the routine measurements at the Calibration Laboratory implementing an ideal calibration procedure. New calibration criteria were established following international recommendations. Therefore, it was made the improvement of the quality control programme of the clinical dosimeters calibration laboratory, benefiting the users of such equipment with better consistent calibration measurements. (author)

Improvement of the quality control program of the clinical dosimeters calibration laboratory of the IPEN/CNEN-SP

International Nuclear Information System (INIS)

Damatto, Willian B.; Potiens, Maria da Penha A.; Vivolo, Vitor

2013-01-01

A set of clinical dosimeters (thimble ionization chamber coupled to an electrometer) commonly used in radiotherapy in Brazil and sent to the Calibration Laboratory of IPEN were under several tests and analysis parameters for the dosimeters behaviour were established, specifying their sensitivities and operating characteristics. Applied tests were: repeatability, reproducibility and current leakage. Thus it was possible to determine the most common defects found in these equipment and the actions that could be taken to prevent it (clinical dosimeters quality control programs). The behaviour of 167 dosimeters was analyzed and in this study, 62 of them have been tested. The main problem detected during calibration tests was current leakage, i.e. electronic noise. The tests were applied to the routine measurements at the Calibration Laboratory implementing an ideal calibration procedure. New calibration criteria were established following international recommendations. Therefore, it was made the improvement of the quality control programme of the clinical dosimeters calibration laboratory, benefiting the users of such equipment with better consistent calibration measurements. (author)

Evaluation of controls for the assurance of quality data in a radiochemistry laboratory

International Nuclear Information System (INIS)

Morton, J.S.

1993-01-01

The paper describes the controls implemented by the U.S. Department of Energy (DOE) at the Radiological and Environmental Sciences Laboratory (RESL) to secure data quality. A description of the analytical instrumentation and methodology employed by RESL is provided. The results of the intercomparison program with the National Institute of Standards and Technology (NIST) are provided to demonstrate traceability to a primary source. A description of the methods and techniques used to ensure quality control on a daily basis is given. The techniques used to evaluate the sources of uncertainty are reviewed and specific examples cited. The intercomparison programs operated by RESL are discussed

Evaluation of controls for the assurance of quality data in a radiochemistry laboratory

Energy Technology Data Exchange (ETDEWEB)

Morton, J.S. [Radiological and Environmental Sciences Lab., Idaho Falls, ID (United States)

1993-12-31

The paper describes the controls implemented by the U.S. Department of Energy (DOE) at the Radiological and Environmental Sciences Laboratory (RESL) to secure data quality. A description of the analytical instrumentation and methodology employed by RESL is provided. The results of the intercomparison program with the National Institute of Standards and Technology (NIST) are provided to demonstrate traceability to a primary source. A description of the methods and techniques used to ensure quality control on a daily basis is given. The techniques used to evaluate the sources of uncertainty are reviewed and specific examples cited. The intercomparison programs operated by RESL are discussed.

First worldwide UNEP interlaboratory study on persistent organic pollutants (POPs) with data on polychlorinated biphenyls and organochlorine pesticides

NARCIS (Netherlands)

Leeuwen, van S.P.J.; Bavel, van B.; Boer, de J.

2013-01-01

The first worldwide interlaboratory study on persistent organic pollutants (POPs) under the Stockholm Convention was organized, with a participation of 103 laboratories from Asia, Europe, the Americas, Africa and Australia, of which the majority submitted data on polychlorinated biphenyls (PCBs) and

Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital.

Science.gov (United States)

Iqbal, Sahar; Mustansar, Tazeen

2017-03-01

Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (≥3) for glucose (L2), cholesterol, triglyceride, HDL, direct bilirubin and creatinine at both levels of control. For rest of the analytes sigma metric was found control levels (8.8 and 8.0 at L2 and L3, respectively). We conclude that analytes with the sigma value quality control procedure. In this study application of sigma rules provided us the practical solution for improved and focused design of QC procedure.

[Quality use of commercial laboratory for clinical testing services - considering laboratory's role].

Science.gov (United States)

Ogawa, Shinji

2014-12-01

The number of commercial laboratories for clinical testing in Japan run privately has decreased to about 30 companies, and their business is getting tougher. Branch Lab. and FMS businesses have not expanded recently due to the new reimbursement system which adds an additional sample management fee, becoming effective in 2010. This presentation gives an outline of each role for hospital and commercial laboratories, and their pros & cons considering the current medical situation. Commercial laboratories have investigated how to utilize ICT systems for sharing test information between hospitals and our facilities. It would be very helpful to clarify issues for each hospital. We will develop and create new values for clinical laboratory testing services and forge mutually beneficial relationships with medical institutions. (Review).

Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.

Science.gov (United States)

Feller, Etty

2008-01-01

Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Economic Co-operation and Development (OECD). Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. The similarities and differences between the ISO/IEC 17025 standard and the OECD principles of GLP are compared and discussed.

A utilidade dos indicadores da qualidade no gerenciamento de laboratórios clínicos Usefulness of quality indicators in the management of clinical laboratories

Directory of Open Access Journals (Sweden)

Keila Furtado Vieira

2011-06-01

Full Text Available O uso dos indicadores da qualidade vem sendo valorizado na gestão dos laboratórios clínicos para otimizar a qualificação e a quantificação das falhas nos diferentes processos laboratoriais, bem como para auxiliar a implantação de medidas corretivas e preventivas e apontar a eficácia das ações tomadas. O objetivo deste trabalho é discorrer sobre a evolução da qualidade na área da saúde, com ênfase na área laboratorial. Alguns indicadores laboratoriais citados na literatura nas fases pré-analítica, analítica e pós-analítica também são apresentados e discutidos neste artigo. Por fim, destaca-se a experiência brasileira do Programa de Indicadores Laboratoriais desenvolvido pela Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial (SBPC/ML em parceria com a Control-Lab e o projeto Model of Quality Indicator, em fase de desenvolvimento pela International Federation of Clinical Chemistry and Laboratory Medicine (IFCC.The use of quality indicators has been appreciated in laboratory management so as to optimize quality and error quantification in several laboratory processes. Furthermore, it assists in the implementation of preventive and corrective measures and it shows their corresponding efficiency. The objective of the present study is to discuss the evolution of quality, mainly in the laboratory area, focusing on the importance of quality indicators in laboratory management. Some pre-analytical, analytical and post-analytical laboratory indicators are also presented and discussed in this work. Finally, we highlight the Brazilian initiative in the Laboratory Indicator Program developed by the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML in partnership with Control-Lab and the Model of Quality Indicator project, which has been developed by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC.

Los Alamos National Laboratory Meteorology Monitoring Program: 2016 Data Completeness/ Quality Report

Energy Technology Data Exchange (ETDEWEB)

Bruggeman, David Alan [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2017-06-15

This report summarizes data completeness by tower and by instrument for 2016 and compares that data with the Los Alamos National Laboratory (LANL) and American National Standards Institute (ANSI) 2015 standards. This report is designed to make data users aware of data completeness and any data quality issues. LANL meteorology monitoring goals include 95% completeness for all measurements. The ANSI 2015 standard requires 90% completeness for all measurements. This report documents instrument/tower issues as they impact data completeness.

Quality in cytopathology: an analysis of the internal quality monitoring indicators of the Instituto Nacional de Câncer

Directory of Open Access Journals (Sweden)

Mario Lucio C. Araujo Jr

2015-04-01

Full Text Available Introduction: Quality control programs are required to ensure the effectiveness of Pap smear, which still remain a key strategy for control of cervical cancer worldwide. Objective: This study was based on the retrospective and quantitative analysis of the post-analytical phase indicators from the internal quality monitoring (IQM program for cytopathology laboratories, such as: positivity rate, atypical squamous cell (ASC/satisfactory exams ratio, ASC/abnormal test results ratio, ASC/squamous intraepithelial lesions (SIL ratio, percentage of tests compatible with high-grade squamous intraepithelial lesion (HSIL, and total of false negative. Materials and methods: The information was extracted from the computerized system of the Section for Integrated Technology in Cytopathology (Seção Integrada de Tecnologia em Citopatologia [SITEC], a reference institution for cancer cytopathology, from July 2013 to June 2014. From a total of 156,888 Pap smears, 157,454 were considered satisfactory for indicator analysis and 566 were excluded because they were considered unsatisfactory and/or rejected for analysis. The data was organized in tables using Microsoft Excel 2010 software, and categorized as indicators. Results: The averages for the indicators were: 7.2% for positivity rate, 56.9 for ASC/abnormal test ratio, 4.1 for ASC/satisfactory tests ratio, 1.4 for ASC/SIL ratio, 0.6% percentage for tests compatible with HSIL, and 2.1% for false-negative rate. Conclusion: The results show that an Internal Quality Monitoring Program is essencial to ensure quality for cytopathology laboratories, and a randomized review of at least 10% of the negative exams, as recommended by the Brazilian Ministry of Health/Instituto Nacional de Câncer (INCA, since is an effective method, especially for large laboratories.

Worldwide outdoor round robin study of organic photovoltaic devices and modules

DEFF Research Database (Denmark)

Madsen, Morten Vesterager; Gevorgyan, Suren; Pacios, R.

2014-01-01

Accurate characterization and reporting of organic photovoltaic (OPV) device performance remains one of the important challenges in the field. The large spread among the efficiencies of devices with the same structure reported by different groups is significantly caused by different procedures......-to-roll coated OPV cells and modules conducted among 46 laboratories worldwide is presented, where the samples and the testing equipment were integrated in a compact suitcase that served both as a sample transportation tool and as a holder and test equipment during testing. In addition, an internet based...

Assembly and evaluation of an inventory of guidelines that are available to support clinical hematology laboratory practice.

Science.gov (United States)

Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M

2015-05-01

Practice guidelines provide helpful support for clinical laboratories. Our goal was to assemble an inventory of publically listed guidelines on hematology laboratory topics, to create a resource for laboratories and for assessing gaps in practice-focused guidelines. PubMed and website searches were conducted to assemble an inventory of hematology laboratory-focused guidelines. Exclusions included annual, technical, or collaborative study reports, clinically focused guidelines, position papers, nomenclature, and calibration documents. Sixty-eight guidelines were identified on hematology laboratory practice topics from 12 organizations, some as joint guidelines. The median year of publication was 2010 and 15% were >10 years old. Coagulation topics had the largest numbers of guidelines, whereas some areas of practice had few guidelines. A minority of guidelines showed evidence of periodic updates, as some organizations did not remove or identify outdated guidelines. This inventory of current practice guidelines will encourage awareness and uptake of guideline recommendations by the worldwide hematology laboratory community, with the International Society for Laboratory Hematology facilitating ongoing updates. There is a need to encourage best guideline development practices, to ensure that hematology laboratory community has current, high-quality, and evidence-based practice guidelines that cover the full scope of hematology laboratory practice. © 2015 John Wiley & Sons Ltd.

[Future roles of clinical laboratories and clinical laboratory technologists in university hospitals].

Science.gov (United States)

Yokota, Hiromitsu; Yatomi, Yutaka

2013-08-01

Clinical laboratories in university hospitals should be operated with a good balance of medical practice, education, research, and management. The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians involved in medical practice and health maintenance of patients. Improvement and maintenance of the quality of the laboratory staff and environment are essential to achieve this goal. In order to implement these requirements efficiently, an appropriate quality management system should be introduced and established, and evaluated objectively by a third party (e.g. by obtaining ISO 15189 certification). ISO 15189 is an international standard regarding the quality and competence of clinical laboratories, and specifies a review of the efficient operational system and technical requirements such as competence in implementing practical tests and calibration. This means the results of laboratory tests reported by accredited laboratories withstand any international evaluation, which is very important to assure the future importance of the existence and management of clinical laboratories as well as internationalization of medical practice. "Education" and "research" have important implications in addition to "medical practice" and "management", as the roles that clinical laboratories should play in university hospitals. University hospital laboratories should be operated by keeping these four factors in good balance. Why are "education" and "research" required in addition to "medical practice" services? If individual clinical laboratory technologists can provide an appropriate response to this question, the importance of the existence of clinical laboratories would be reinforced, without being compromised.

Organization of a radioisotope based molecular biology laboratory

International Nuclear Information System (INIS)

2006-12-01

-isotopes: they often have concerns related to safety. Member States have repeatedly requested help for training when first establishing radioactive-based molecular biology laboratories in particular in radiosafety and quality assurance. The current TECDOC has been prepared in response to these requests and requirements. It represents one of the IAEA's many efforts to contribute with the worldwide implementation of these techniques, and to be a relevant source of information to be used by molecular scientists, major national research institutions, laboratory workers and national health institutions authorities

A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

Science.gov (United States)

Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

2014-12-01

A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

Health laboratories in the Tanga region of Tanzania: the quality of diagnostic services for malaria and other communicable diseases

DEFF Research Database (Denmark)

Ishengoma, D R S; Rwegoshora, R T; Mdira, K Y

2009-01-01

Although critical for good case management and the monitoring of health interventions, the health-laboratory services in sub-Saharan Africa are grossly compromised by poor infrastructures and a lack of trained personnel, essential reagents and other supplies. The availability and quality of diagn......Although critical for good case management and the monitoring of health interventions, the health-laboratory services in sub-Saharan Africa are grossly compromised by poor infrastructures and a lack of trained personnel, essential reagents and other supplies. The availability and quality...... of diagnostic services in 37 health laboratories in three districts of the Tanga region of Tanzania have recently been assessed. The results of the survey, which involved interviews with health workers, observations and a documentary review, revealed that malaria accounted for >50% of admissions and out...

Does laboratory automation for the preanalytical phase improve data quality?

Science.gov (United States)

Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Danese, Elisa; Montagnana, Martina; Brocco, Giorgio; Voi, Monica; Picheth, Geraldo; Guidi, Gian Cesare

2013-10-01

Our aim was to evaluate whether automation for the preanalytical phase improves data quality. Blood from 100 volunteers was collected into two vacuum tubes. One sample from each volunteer was respectively assigned to (G1) traditional processing, starting with centrifugation at 1200 g for 10 min, and (G2) the MODULAR PRE-ANALYTICALS EVO-MPA system. The routine clinical chemistry tests were performed in duplicate on the same instrument Cobas 6000 module. G1 samples were uncapped manually and immediately placed into the instrument. G2 samples were directly fed from the MPA system to the instrument without further staff intervention. At the end, (1) the G1 samples were stored for 6 h at 4 °C as prescribed in our accredited laboratory and (2) the G2 samples were stored for 6 h in the MPA output buffer. Results from G1 and G2, before and after storage, were compared. Significant increases were observed in G1 compared with G2 samples as follows: (1) before storage for alkaline phosphatase (ALP), lactate dehydrogenase (LDH), phosphate (P), magnesium (MG), iron (FE), and hemolysis index and (2) after storage for total cholesterol (COL), triglycerides (TG), total protein (TP), albumin (ALB), blood urea nitrogen (BUN), creatinine (CRE), uric acid (UA), ALP, pancreatic amylase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyltransferase (GGT), LDH, creatine kinase (CK), calcium (CA), FE, sodium (NA), potassium (K), and hemolysis index. Moreover, significant increases were observed in (3) G1-after versus G1-before storage samples for COL, high-density lipoprotein cholesterol, TG, TP, ALB, BUN, CRE, UA, AST, ALT, GGT, LDH, P, CA, MG, FE, NA, K, and hemolysis index and (4) G2-after versus G2-before storage only for BUN, AST, LDH, P, and CA. In conclusion, our results show that the MPA system improves the quality of laboratory testing.

Clear progress in nuclear safety worldwide: Convention on nuclear safety concludes

International Nuclear Information System (INIS)

2002-01-01

It has been concluded that a significant progress has been observed in a number of key areas, such as strengthened legislation, regulatory independence, the availability of financial resources, enhanced emergency preparedness and safety improvements at nuclear power plants built to earlier standards. The objective of the Convention is to achieve and maintain a high level of nuclear safety worldwide. During the two week Review Meeting, parties engaged in a 'peer review' process in which the National Reports from individual States were collectively examined and discussed, with written replies provided to all the questions raised. Clear improvement was noted in the quality of the National Reports, the number of questions and the openness and quality of discussion and answers. The Contracting Parties praised the IAEA's various safety review missions and services, which they use widely to help enhance the effectiveness of their national safety arrangements. Forty-six contracting parties participated at the Review Meeting with over 400 delegates attending, including many heads and senior officers from regulatory bodies and experts from industry. To date, the Convention has been signed by sixty-five States and ratified by fifty-four, representing 428 of the 448 nuclear power reactors worldwide

Diagnosis and improvement proposals for the Ezeiza Atomic Center quality management system by carrying out the third laboratories workshop

International Nuclear Information System (INIS)

Eliosoff, Nilda M.

2003-01-01

By the end of 2001 the management of the Ezeiza Atomic Center (EAC) under the National Atomic Energy Commission of Argentina, stated the necessity of carrying out a survey of its laboratories. The purpose of this survey was to get information that would allow to assess the quality of the laboratories and the services they perform, including the degree of implementation of the management systems. In order to comply with this purpose fourteen EAC's laboratories were studied. The information obtained was related to the staff, their training, the kind of tasks they perform as services or as research and development, the customers, the amount of invoicing, the premises, the equipment and the adapting and implementation of the quality management system. With the results obtained from the survey a report was issued. Economic, Financial, Commercial and Human Resources workshops as well as Technical Aspects and Quality Management workshops were organized. These workshops were to go deep into the analysis of the information obtained and to generate improvement proposals of the different subjects. (author)

Creating a sustainable culture of quality through the SLMTA programme in a district hospital laboratory in Kenya

Directory of Open Access Journals (Sweden)

Phidelis M. Maruti

2014-09-01

Objectives: To describe how the SLMTA programme and enhanced quality interventions changed the culture and management style at BDHL and instilled a quality system designed to sustain progress for years to come. Methods: SLMTA implementation followed the standard three-workshop series, mentorship site visits and audits. In order to build sustainability of progress, BDHL integrated quality improvement processes into its daily operations. The lab undertook a process of changing its internal culture to align all hospital stakeholders – including upper management, clinicians, laboratory staff and maintenance staff – to the mission of sustainable quality practices at BDHL. Results: After 16 months in the SLMTA programme, BDHL improved from zero stars (38% to four stars (89%. Over a period of two to three years, external quality assessment results improved from 47% to 87%; staff punctuality increased from 49% to 82%; clinician complaints decreased from 83% to 16; rejection rates decreased from 12% to 3%; and annual equipment repairs decreased from 40 to 15. Twelve months later the laboratory scored three stars (81% in an external surveillance audit conducted by Kenya Accreditation Service (KENAS. Conclusion: Management buy-in, staff participation, use of progress-monitoring tools and feedback systems, as well as incorporation of improvement processes into routine daily activities, were vital in developing and sustaining a culture of quality improvement.

Evaluation of quality assurance/quality control data collected by the U.S. Geological Survey for water-quality activities at the Idaho National Engineering and Environmental Laboratory, Idaho, 1994 through 1995

International Nuclear Information System (INIS)

Williams, L.M.

1997-03-01

More than 4,000 water samples were collected by the US Geological Survey (USGS) from 179 monitoring sites for the water-quality monitoring program at the Idaho National Engineering Laboratory from 1994 through 1995. Approximately 500 of the water samples were replicate or blank samples collected for the quality assurance/quality control program. Analyses were performed to determine the concentrations of major ions, nutrients, trace elements, gross radioactivity and radionuclides, total organic carbon, and volatile organic compounds in the samples. To evaluate the precision of field and laboratory methods, analytical results of the replicate pairs of samples were compared statistically for equivalence on the basis of the precision associated with each result. In all, the statistical comparison of the data indicated that 95% of the replicate pairs were equivalent. Within the major ion analyses, 97% were equivalent; nutrients, 88%; trace elements, 95%; gross radioactivity and radionuclides, 93%; and organic constituents, 98%. Ninety percent or more of the analytical results for each constituent were equivalent, except for nitrite, orthophosphate, phosphorus, aluminum, iron, strontium-90, and total organic carbon

Laboratory biorisk management biosafety and biosecurity

CERN Document Server

Salerno, Reynolds M

2015-01-01

Over the past two decades bioscience facilities worldwide have experienced multiple safety and security incidents, including many notable incidents at so-called ""sophisticated facilities"" in North America and Western Europe. This demonstrates that a system based solely on biosafety levels and security regulations may not be sufficient.Setting the stage for a substantively different approach for managing the risks of working with biological agents in laboratories, Laboratory Biorisk Management: Biosafety and Biosecurity introduces the concept of biorisk management-a new paradigm that encompas

Evaluation of quality indicators in a laboratory supporting tertiary cancer care facilities in India.

Science.gov (United States)

Kumar, Savitha Anil; Jayanna, Prashanth; Prabhudesai, Shilpa; Kumar, Ajai

2014-01-01

To collect and tabulate errors and nonconformities in the preanalytical, analytical, and postanalytical process phases in a diagnostic clinical laboratory that supports a super-specialty cancer center in India, and identify areas of potential improvement in patient services. We collected data from our laboratory during a period of 24 months. Departments in the study included clinical biochemistry, hematology, clinical pathology, microbiology and serology, surgical pathology, and molecular pathology. We had initiated quality assessment based on international standards in our laboratory in 2010, with the aim of obtaining accreditation by national and international governing bodies. We followed the guidelines specified by International Organization for Standardization (ISO) 15189:2007 to identify noncompliant elements of our processes. Among a total of 144,030 specimens that our referral laboratory received during the 2-year period of our study, we uncovered an overall error rate for all 3 process phases of 1.23%; all of our error rates closely approximated the results from our peer institutions. Errors were most common in the preanalytical phase in both years of study; preanalytical- and postanalytical-phase errors constituted more than 90% of all errors. Further improvements are warranted in laboratory services and are contingent on adequate training and interdepartmental communication and cooperation. Copyright© by the American Society for Clinical Pathology (ASCP).

Quality assurance for radon exposure chambers at the National Air and Radiation Environmental Laboratory, Montgomery, Alabama

Energy Technology Data Exchange (ETDEWEB)

Semler, M.O.; Sensintaffar, E.L. [National Air and Radiation Environmental Laboratory, Montgomery, AL (United States)

1993-12-31

The Office of Radiation and Indoor Air, U.S. Environmental Protection Agency (EPA), operates six radon exposure chambers in its two laboratories, the National Air and Radiation Environmental Laboratory (NAREL) in Montgomery, Alabama, and the Las Vegas Facility, Las Vegas, Nevada. These radon exposure chambers are used to calibrate and test portable radon measuring instruments, test commercial suppliers of radon measurement services through the Radon Measurement Proficiency Program, and expose passive measurement devices to known radon concentrations as part of a quality assurance plan for federal and state studies measuring indoor radon concentrations. Both laboratories participate in national and international intercomparisons for the measurement of radon and are presently working with the National Institute of Standards and Technology (NIST) to receive a certificate of traceability for radon measurements. NAREL has developed an estimate of the total error in its calibration of each chamber`s continuous monitors as part of an internal quality assurance program. This paper discusses the continuous monitors and their calibration for the three chambers located in Montgomery, Alabama, as well as the results of the authors intercomparisons and total error analysis.

Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness.

Science.gov (United States)

Ialongo, Cristiano; Bernardini, Sergio

2018-03-28

The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness. A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity. Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing. The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.

Evaluating dissection in the gross anatomy course: Correlation between quality of laboratory dissection and students outcomes.

Science.gov (United States)

Nwachukwu, Chika; Lachman, Nirusha; Pawlina, Wojciech

2015-01-01

Anatomy learned by active exploration through dissection has many proven benefits including improvement of anatomic knowledge. Decreased laboratory time may affect the quality of dissection and ultimately lower student performance in anatomy translating to lower knowledge acquisition. The aim of this study was to determine whether the quality of students' dissection in teams correlates with their performance in the gross anatomy course. Quality of dissections for each team enrolled in a gross anatomy course at Mayo Medical School was evaluated biweekly using a five-point rubric based on course learning objectives. Assessment of anatomic knowledge was based on sequential laboratory practice practical examination scores, achievements on daily audience response system (ARS) quizzes, and final practical, written, and National Board of Medical Examiners(®) (NBME(®) ) Gross Anatomy and Embryology Subject Examinations. Twelve teams comprising 48 students were included in the study. There was a positive correlation between dissection quality and practice practical examination score (R = 0.83) and a negative correlation between dissection quality and ARS quizzes (R = -0.985). Dissection teams with a passing score on their dissection evaluations (>70%) performed better on their final examinations. Based on an end of course survey, students agreed that dissection evaluations should continue to be a part of the course. This study showed that better quality of dissection was associated with higher scores on practice practical examinations, final practical, written, and NBME examinations. The study demonstrated a positive correlation between dissection evaluations, accompanied by formative feedback during the course, and higher scores on final course assessments. © 2014 American Association of Anatomists.

Proposal of a methodology for quality control in thermoluminescent dosimetry laboratory

International Nuclear Information System (INIS)

Feital, Joao Carlos da S.; Almeida, Claudio Domingues de; Bezerra, Marcos A.

2005-01-01

Taken into account that in thermoluminescence dosimetry adequate selection procedures as well as accurate TLD readings are necessary, this paper presents results of methodology that can be applied as part of quality control programs in thermoluminescence dosimetry laboratories. For the experiment, a set of 200 TLDs ( LiF 100 ) were used and 9 from which were selected, a standard source of Cs -137 , a PTW kiln, a TL 'Harshaw' reader - model 5500 operating under the 'Win Rem' software and a Sr 90 / Y 90 'Bicron' irradiator. In the proceeding the selected dosimeters were irradiated and read 28 times during 18 months, then by one of the standard deviation properties, values up to 14 % were found, for a confidence level of 95 %. The results found and the bibliographic data related to the responses (arbitrary reading) in the crystals used in TLDs, have shown that this methodology can be applied in quality control programs. (author)

Field methods and quality-assurance plan for water-quality activities and water-level measurements, U.S. Geological Survey, Idaho National Laboratory, Idaho

Science.gov (United States)

Bartholomay, Roy C.; Maimer, Neil V.; Wehnke, Amy J.

2014-01-01

Water-quality activities and water-level measurements by the personnel of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation’s water resources. The activities are carried out in cooperation with the U.S. Department of Energy (DOE) Idaho Operations Office. Results of the water-quality and hydraulic head investigations are presented in various USGS publications or in refereed scientific journals and the data are stored in the National Water Information System (NWIS) database. The results of the studies are used by researchers, regulatory and managerial agencies, and interested civic groups. In the broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the “state-of-the-art” technology, and quality assurance ensures that quality control is maintained within specified limits.

Parents of children referred to a sleep laboratory for disordered breathing reported anxiety, daytime sleepiness and poor sleep quality.

Science.gov (United States)

Cadart, Marion; De Sanctis, Livio; Khirani, Sonia; Amaddeo, Alessandro; Ouss, Lisa; Fauroux, Brigitte

2018-07-01

We evaluated the impact that having a child with sleep-disordered breathing had on their parents, including their own sleep quality. Questionnaires were completed by 96 parents of 86 children referred for a sleep study or control of continuous positive airway pressure (CPAP) or noninvasive ventilation (NIV) at the sleep laboratory of the Necker Hospital, Paris, France, between October 2015 and January 2016. The questionnaires evaluated anxiety and depression, family functioning, the parents' quality of life, daytime sleepiness and sleep quality. The children had a mean age of seven ±five years and most of the responses (79%) came from their mothers. These showed that 26% of parents showed moderate-to-severe anxiety, 8% moderate-to-severe depression, 6% complex family cohesion, 59% moderate-to-severe daytime sleepiness and 54% poor sleep quality. Anxiety was higher in mothers than in fathers (p parents of children referred to a sleep laboratory reported frequent anxiety, daytime sleepiness and poor sleep quality. ©2018 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

World-wide environmental problems

International Nuclear Information System (INIS)

Wohlers, H.C.

1975-01-01

Man and the physical and natural resources necessary to support him in a civilized society are on a collision course. It is simple to say that man cannot continue to grow in number at an ever-increasing rate without a destructive effect upon the environment. Positive scientific proof for this impending calamity is not now available, yet many indications--sometimes physical and sometimes natural--point toward major world-wide environmental troubles in the near future. A number of environmental problems are described, particularly as they relate to the total world system. A computer model simulating future world-wide environmental trends from 1900 to 2100 A.D. is evaluated and suggested as a major tool for data-gathering purposes to determine the extent of world-wide environmental problems. It is suggested that scientists take an active role in the study of the environment, particularly in relation to man's future on earth

National continuous surveys on internal quality control for HbA1c in 306 clinical laboratories of China from 2012 to 2016: Continual improvement.

Science.gov (United States)

Li, Tingting; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-01

This study aimed to evaluate whether the quality performance of clinical laboratories in China has been greatly improved and whether Internal Quality Control (IQC) practice of HbA1c has also been changed since National Center for Clinical Laboratories (NCCL) of China organized laboratories to report IQC data for HbA1c in 2012. Internal Quality Control information of 306 External Quality Assessment (EQA) participant laboratories which kept reporting IQC data in February from 2012 to 2016 were collected by Web-based EQA system. Then percentages of laboratories meeting four different imprecision specifications for current coefficient of variations (CVs) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements. The current CVs of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CVs all showed the increasing tendency year by year. As for analytical system, 52.1% (159/306) laboratories changed their systems with the change in principle of assay. And many laboratories began to use cation exchange high-performance liquid chromatography (CE-HPLC) instead of Immunoturbidimetry, because CE-HPLC owed a lower intra-laboratory CVs. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements. The imprecision performance of HbA1c tests has been improved in these 5 years with the change in IQC practice, but it is still disappointing in China. Therefore, laboratories should actively find existing problems and take action to promote performance of HbA1c measurements. © 2016 Wiley Periodicals, Inc.

Calibrations and evaluation of the quality assurance during 1999 at the National Laboratory for ionising radiation

International Nuclear Information System (INIS)

Grindborg, Jan-Erik; Israelsson, Karl-Erik; Kylloenen, Jan-Erik; Samuelson, Goeran

2000-06-01

The Swedish Radiation Protection Institute is the National Laboratory for the dosimetric quantities kerma, absorbed dose and dose equivalent. The activity is based on established calibration procedures and a quality assurance program for the used standards. This report gives a brief summary of the calibrations performed during 1999 and a more detailed description and analysis of the quality assurance during this year. The report makes it easier to draw conclusions about the long-term stability and possible malfunctions

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

Science.gov (United States)

Akyar, Işin

2009-10-01

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory.

Science.gov (United States)

Kumar, B Vinodh; Mohan, Thuthi

2018-01-01

Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. This is a retrospective study, and data required for the study were extracted between July 2015 and June 2016 from a Secondary Care Government Hospital, Chennai. The data obtained for the study are IQC - coefficient of variation percentage and External Quality Assurance Scheme (EQAS) - Bias% for 16 biochemical parameters. For the level 1 IQC, four analytes (alkaline phosphatase, magnesium, triglyceride, and high-density lipoprotein-cholesterol) showed an ideal performance of ≥6 sigma level, five analytes (urea, total bilirubin, albumin, cholesterol, and potassium) showed an average performance of sigma level and for level 2 IQCs, same four analytes of level 1 showed a performance of ≥6 sigma level, and four analytes (urea, albumin, cholesterol, and potassium) showed an average performance of sigma level. For all analytes sigma level, the quality goal index (QGI) was 1.2 indicated inaccuracy. This study shows that sigma metrics is a good quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides a benchmark for the laboratory to design a protocol for IQC, address poor assay performance, and assess the efficiency of existing laboratory processes.

External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

Directory of Open Access Journals (Sweden)

Sean C Murphy

Full Text Available Nucleic acid testing (NAT for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

Interlaboratory test comparison among Environmental Radioactivity Laboratories using the ISO/IUPAC/AOAC Protocol

International Nuclear Information System (INIS)

Romero, L.; Ramos, L.; Salas, R.

1998-01-01

World-wide acceptance of results from radiochemical analyses requires reliable, traceable and comparable measurements to SI units, particularly when data sets generated by laboratories are to contribute to evaluation of data from environmental pollution research and monitoring programmes. The Spanish Nuclear Safety Council (CSN) organizes in collaboration with CIEMAT periodical interlaboratory test comparisons for environmental radioactivity laboratories aiming to provide them with the necessary means to asses the quality of their results. This paper presents data from the most recent exercise which, for the first time, was evaluated following the procedure recommended in the ISO/IUPAC/AOAC Harmonized Protocol for the proficiency testing of analytical laboratories (1). The test sample was a Reference Material provided by the IAEA-AQCS, a lake sediment containing the following radionuclides: k-40, Ra-226, Ac-228, Cs-137, Sr-90, Pu-(239+240). The results of the proficiency test were computed for the 28 participating laboratories using the z-score approach, the evaluation of the exercises is presented in the paper. The use of a z-score classification has demonstrated to provide laboratories with a more objective means of assessing and demonstrating the reliability of the data they are producing. Analytical proficiency of the participating laboratories has been found to be satisfactory in 57 to 100 percent of cases. (1)- The International harmonized protocol for the proficiency testing of (chemical) analytical laboratories. Pure and Appl. Chem. Vol. 65, n 9, pp. 2123-2144, 1993 IUPAC. GB (Author) 3 refs

Quantification of histochemical stains using whole slide imaging: development of a method and demonstration of its usefulness in laboratory quality control.

Science.gov (United States)

Gray, Allan; Wright, Alex; Jackson, Pete; Hale, Mike; Treanor, Darren

2015-03-01

Histochemical staining of tissue is a fundamental technique in tissue diagnosis and research, but it suffers from significant variability. Efforts to address this include laboratory quality controls and quality assurance schemes, but these rely on subjective interpretation of stain quality, are laborious and have low reproducibility. We aimed (1) to develop a method for histochemical stain quantification using whole slide imaging and image analysis and (2) to demonstrate its usefulness in measuring staining variation. A method to quantify the individual stain components of histochemical stains on virtual slides was developed. It was evaluated for repeatability and reproducibility, then applied to control sections of an appendix to quantify H&E staining (H/E intensities and H:E ratio) between automated staining machines and to measure differences between six regional diagnostic laboratories. The method was validated with laboratories from 0.57 to 0.89. A simple method using whole slide imaging can be used to quantify and compare histochemical staining. This method could be deployed in routine quality assurance and quality control. Work is needed on whole slide imaging devices to improve reproducibility. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Quality system of the Chemical Analysis Laboratory to fulfill the requirements with Certification Organizations

International Nuclear Information System (INIS)

Merlo S, L.; Rodriguez L, R.; Cota S, G.

1996-01-01

In the present work was described the Quality System established in the Chemical Analysis Department to fulfill with the Organization requirements, personnel, measurement equipment, calibration, working procedures, etc. to get official acknowledgment by the National Assurance System for Testing laboratories, dependent of the General Standards Direction. There are described the available resources, the performance and control of each of one principal points of the system. (Author)

Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

Science.gov (United States)

Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

2012-01-01

Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

Quality of diabetes care worldwide and feasibility of implementation of the Alphabet Strategy: GAIA project (Global Alphabet Strategy Implementation Audit).

Science.gov (United States)

Lee, James D; Saravanan, Ponnusamy; Varadhan, Lakshminarayanan; Morrissey, John R; Patel, Vinod

2014-10-11

The Alphabet Strategy (AS) is a diabetes care checklist ensuring "important, simple things are done right all the time." Current audits of diabetes care in developed countries reveal wide variations in quality with performance of care processes frequently sub-optimal. This study had three components:• an audit to assess diabetes care quality worldwide,• a questionnaire study seeking opinions on the merits of the AS,• a pilot study to assess the practicality of implementation of the AS in a low socioeconomic setting. Audit data was collected from 52 centres across 32 countries. Data from 4537 patients were converted to Quality and Outcome Framework (QOF) scores to enable inter-centre comparison. These were compared to each country's Gross Domestic Product (GDP), and Total Health Expenditure percentage per capita (THE%). The opinions of diabetes patients and healthcare professionals from the diabetes care team at each of these centres were sought through a structured questionnaire. A retrospective audit on 100 randomly selected case notes was conducted prior to AS implementation in a diabetes outpatient clinic in India, followed by a prospective audit after four months to assess its impact on care quality. QOF scores showed wide variation across the centres (mean 49.0, range 10.2-90.1). Although there was a positive relationship between GDP and THE% to QOF scores, there were exceptions. 91% of healthcare professionals felt the AS approach was practical. Patients found the checklist to be a useful education tool. Significant improvements in several aspects of care as well as 36% improvement in QOF score were seen following implementation. International centres observed large variations in care quality, with standards frequently sub-optimal. 71% of health care professionals would consider adopting the AS in their daily practice. Implementation in a low resource country resulted in significant improvements in some aspects of diabetes care. The AS checklist for

Study on the internal quality control of thyroid hormones assays in a hospital laboratory

International Nuclear Information System (INIS)

Hu Haiqiang; Chu Shaolin; Ye Peihong; Lei Qiufang; Chai Luhua; Xia Wei

2004-01-01

Objective: With the aim of providing more reliable information for clinical diagnosis, this study investigated the possible causes of the occasional instability of thyroid hormones (T 3 , T 4 , FT 3 , FT 4 TSH) assays in this laboratory and tried to seek plausible explanation for some seemingly contradictory (mismatching) readings of the laboratory reports. Methods: Regular monitoring and checks were enforced on laboratory equipment from sampling pipet to gamma-counters. Results of separation with PR reagent and solid - phase coated tube were compared for superiority (FT 3 ). Collected specimens were tested in monthly sets; this study consisted of 10 sets with total 964 specimens. Serum T 3 , T 4 , FT 3 , FT 4 levels were measured with RIA. For every hormone tested, values of parameters of the standard cure (B 0 , NSB, a, b, r, ED 20 , ED 50 , ED 80 , ABCV) were recorded in detail, from which the QC (quality control) table was derived. For complementary sake , mean level in patients' sera was noted along with the quality control sera. Shewart control chart was drawn for quick reference. Serum TSH levels were measured with IRMA; the parameters involved were: B 0 NSB, ED 80 , ED 50 , ED 20 , standard point deviation. Results: Among the 964 specimens tested, there were 154 specimens with seemingly contradictory (mismatching) results, of which, the majority (n=145) were not erroneous and were compatible with the clinical manifestations of thyroid dysfunction other than plain simple hyper-or hypothyroidism. Only 9 (5.8% of the 154) were due to technical errors (defective technic in removing the supernatant n=7, lipid blood separated with PR reagent n=2). Conclusion: Faulty technic in separation is the main source of random error. From the data of this laboratory, authors believe that solid-phase separation method is better than the conventional homogenous-phase separation method and is the preferred one. With meticulous adherence to standard laboratory procedures and

Report of investigation into allegations of retaliation for raising safety and quality of work issues regarding Argonne National Laboratory's Integral Fast Reactor project

International Nuclear Information System (INIS)

1991-12-01

In August 1990 James A. Smith resigned his position as an experimenter at Argonne National Laboratory-West (ANL-W), located near Idaho Falls, Idaho. Smith who holds a Ph.D. in metallurgy, had worked at the Laboratory since 1988, primarily on its Integral Fast Reactor (IFR) project. He alleged that the quality of the Laboratory's work on that project had been undermined by fundamental errors in metallurgy and related sciences, at least some of which had nuclear safety implications; that the Laboratory had published false and misleading accounts of its work; that prevailing attitudes at the Laboratory were antithetical to quality scientific work; and that because he had expressed concerns about these matters his job was threatened by his managers. Evidence gathered during an investigation by the Department of Energy's Office of Nuclear Safety (NS) is presented and conclusions and recommendations are provided

Evaluation of Performance of Laboratories and Manufacturers Within the Framework of the IFCC model for Quality Targets of HbA1c.

Science.gov (United States)

Weykamp, Cas; Siebelder, Carla

2017-11-01

HbA1c is a key parameter in diabetes management. For years the test has been used exclusively for monitoring of long-term diabetic control. However, due to improvement of the performance, HbA1c is considered more and more for diagnosis and screening. With this new application, quality demands further increase. A task force of the International Federation of Clinical Chemistry and Laboratory Medicine developed a model to set and evaluate quality targets for HbA1c. The model is based on the concept of total error and takes into account the major sources of analytical errors in the medical laboratory: bias and imprecision. Performance criteria are derived from sigma-metrics and biological variation. This review shows 2 examples of the application of the model: at the level of single laboratories, and at the level of a group of laboratories. In the first example data of 125 individual laboratories of a recent external quality assessment program in the Netherlands are evaluated. Differences between laboratories as well as their relation to method principles are shown. The second example uses recent and 3-year-old data of the proficiency test of the College of American Pathologists. The differences in performance between 26 manufacturer-related groups of laboratories are shown. Over time these differences are quite consistent although some manufacturers improved substantially either by better standardization or by replacing a test. The IFCC model serves all who are involved in HbA1c testing in the ongoing process of better performance and better patient care.

Pacific Northwest National Laboratory Apatite Investigation at the 100-NR-2 Quality Assurance Project Plan

Energy Technology Data Exchange (ETDEWEB)

Fix, N. J.

2008-03-28

This Quality Assurance Project Plan provides the quality assurance requirements and processes that will be followed by staff working on the 100-NR-2 Apatite Project. The U.S. Department of Energy, Fluor Hanford, Inc., Pacific Northwest National Laboratory, and the Washington Department of Ecology agreed that the long-term strategy for groundwater remediation at 100-N would include apatite sequestration as the primary treatment, followed by a secondary treatment. The scope of this project covers the technical support needed before, during, and after treatment of the targeted subsurface environment using a new high-concentration formulation.

Replicating the microbial community and water quality performance of full-scale slow sand filters in laboratory-scale filters.

Science.gov (United States)

Haig, Sarah-Jane; Quince, Christopher; Davies, Robert L; Dorea, Caetano C; Collins, Gavin

2014-09-15

Previous laboratory-scale studies to characterise the functional microbial ecology of slow sand filters have suffered from methodological limitations that could compromise their relevance to full-scale systems. Therefore, to ascertain if laboratory-scale slow sand filters (L-SSFs) can replicate the microbial community and water quality production of industrially operated full-scale slow sand filters (I-SSFs), eight cylindrical L-SSFs were constructed and were used to treat water from the same source as the I-SSFs. Half of the L-SSFs sand beds were composed of sterilized sand (sterile) from the industrial filters and the other half with sand taken directly from the same industrial filter (non-sterile). All filters were operated for 10 weeks, with the microbial community and water quality parameters sampled and analysed weekly. To characterize the microbial community phyla-specific qPCR assays and 454 pyrosequencing of the 16S rRNA gene were used in conjunction with an array of statistical techniques. The results demonstrate that it is possible to mimic both the water quality production and the structure of the microbial community of full-scale filters in the laboratory - at all levels of taxonomic classification except OTU - thus allowing comparison of LSSF experiments with full-scale units. Further, it was found that the sand type composing the filter bed (non-sterile or sterile), the water quality produced, the age of the filters and the depth of sand samples were all significant factors in explaining observed differences in the structure of the microbial consortia. This study is the first to the authors' knowledge that demonstrates that scaled-down slow sand filters can accurately reproduce the water quality and microbial consortia of full-scale slow sand filters. Copyright © 2014 Elsevier Ltd. All rights reserved.

Worldwide Airfield Summary

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — The Worldwide Airfield Summary contains a selection of climatological data produced by the U.S. Air Force, Air Weather Service. The reports were compiled from dozens...

Quality assurance programme at the National Calibration Laboratory in Tanzania

International Nuclear Information System (INIS)

Muhogora, W.E.; Yoloye, O.; Ngaile, J.; Lema, U.S.

2000-01-01

A quality assurance programme at the National Calibration Laboratory for ionizing radiation in Tanzania is described. The programme focuses mainly on regular stability check source and reference output measurements, performance testing of TLD systems as well as some external audit checks. It is found that the stability check source measurements are within ± 1%. Similarly, the air kerma rate measurements agree well with calibration uncertainties, that is ± 2% for protection level measurements and ± 1.5% for clinical dosimetry. The results of comparison of dose measurements done on site and those obtained from some external audit checks are also within requirements. This shows that the working standards have been kept with good care, and that the traceability to the international measurement system is adequately maintained. Some examples on calibration transfer activities are briefly discussed

Quality assurance guidance for laboratory assessment plates in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-05-01

This document is one of several guidance documents developed to support the EM (DOE Environmental Restoration and Waste Management) Analytical Services program. Its purpose is to introduce assessment plates that can be used to conduct performance assessments of an organization's or project's ability to meet quality goals for analytical laboratory activities. These assessment plates are provided as non-prescriptive guidance to EM-support organizations responsible for collection of environmental data for remediation and waste management programs at DOE facilities. The assessments evaluate objectively all components of the analytical laboratory process to determine their proper selection and use

National surveys on internal quality control for blood gas analysis and related electrolytes in clinical laboratories of China.

Science.gov (United States)

Duan, Min; Wang, Wei; Zhao, Haijian; Zhang, Chuanbao; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2018-05-01

Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl-) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl- got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl- were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.

The underground research laboratories

International Nuclear Information System (INIS)

1997-06-01

This educational booklet is a general presentation of the selected sites for the installation of underground research laboratories devoted to the feasibility studies of deep repositories for long-life radioactive wastes. It describes the different type of wastes and their management, the management of long life radioactive wastes, the site selection and the 4 sites retained, the preliminary research studies, and the other researches carried out in deep disposal facilities worldwide. (J.S.)

Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1993 Quality Program status report

International Nuclear Information System (INIS)

Boliver, S.L.

1995-05-01

This status report is for calendar year 1993. It summarizes the annual activities and accomplishments of the Los Alamos National Laboratory (Los Alamos) Yucca Mountain Site Characterization Project (YMP or Project) quality assurance program. By identifying the accomplishments of the quality program, we establish a baseline that will assist in decision making, improve administrative controls and predictability, and allow us to annually identify long term trends and to evaluate improvements. This is the third annual status report (Bolivar, 1992; Bolivar, 1994). This report is divided into two primary sections: Program Activities and Trend Analysis. Under Program Activities, programmatic issues occurring in 1993 are discussed. The goals for 1993 are also listed, followed by a discussion of their status. Lastly, goals for 1994 are identified. The Trend Analysis section is a summary of 1993 quarterly trend reports and provides a good overview of the quality assurance issues of the Los Alamos YMP

Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1993 Quality Program status report