Advances for proficiency testing for genetic laboratory science

Nucleic acid based clinical genetic testing has undergone explosive growth in recent years due in large part to the human genome project. Characterization of the human genome has led to a molecular understanding of the pathogenesis of many human diseases, and ultimately to clinical molecular tests becoming routinely used to diagnose a wide diversity of diseases. This rapid growth in clinical molecular genetic testing coupled with the complexity of the analytical procedures underscores the necessity for proficiency testing (i.e. external quality assessment) to allow laboratories offering such services the ability to evaluate their analytical procedures via inter-laboratory comparisons. The American College of Medical Genetics (ACMG) in partnership with the College of American Pathologists (CAP) have been offering proficiency testing for clinical molecular genetics laboratories since 1995, and presently have more than 230 laboratories from 11 countries enrolled in this program. This paper describes the evolution of this program and several challenges encountered in the delivery of a proficiency testing program for laboratories offering clinical molecular genetic services. Received: 13 April 2002 Accepted: 18 July 2002     

The correlation of laboratory performance in proficiency testing with other QA characteristics

Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise.     

Performance indication improvement for a proficiency testing

The paper discusses peculiarities of Z scores and E _n numbers, which are most often used for the treatment of proficiency test data. The important conditions of proper usage of these performance indicators and their improvement are suggested on the basis of systematic approach, on the idea of accuracy classification, and on some principles of optimality borrowed from information theory. The author believes that this paper may be of interest and practical value for all those engaged in applied metrology, specifically in the field of developing of and participating in proficiency testing programs, and in the activity connected with accrediting testing and calibration laboratories.Presented at 15th International Conference on Quality in Israel, November 2004     

Reliability of food measurements: the application of proficiency testing to GMO analysis

This paper reviews the experience of the Food Analysis Performance Assessment Scheme (FAPAS^®) in operating a proficiency testing scheme for the analysis of genetically modified (GM) food. Initial rounds of proficiency testing have shown a tendency for laboratories to over-estimate GM levels, results obtained by polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay (ELISA) detection methods to be significantly different and that data are skewed and not normally distributed until log-transformed. During the initial rounds, it was found that for analysis and quantification of GM material, it was not possible to assign a target value for standard deviation external to the round data, from which performance could be assessed. However, when working in a log scale, the internally derived, robust standard deviation (^σ) was found to be constant and could be used directly to predict a target value (σ) for performance assessment. Results from the first four rounds have provided valuable information and a general overview of laboratory ability. Choosing a target value for standard deviation which reflects current best practice has enabled laboratory performance to be assessed. Issues surrounding the assessment of performance are discussed which highlight some of the implications raised as a result of this initial assessment, regarding the enforcement of European labelling legislation.     

Measurement of organochlorine pesticides in drinking water: laboratory technical proficiency testing in Mexico

Accreditation and Quality Assurance - An interlaboratory comparison exercise was performed to assess the technical proficiency of laboratories in measuring the organochlorine pesticides in drinking...     

The application of data from proficiency testing to laboratory accreditation according to ISO 17025

Current methods of testing laboratories for their proficiency in reporting correct measurement results are liable to substantial errors of the second kind. This means that laboratories with deflated uncertainties are accepted as proficient, even though their reported measurement results pave the way for erroneous conclusions. Only by using E _n numbers based on an accepted reference value with the lowest possible uncertainty can the risk of recognising incorrect measurement results be kept at an acceptable level. Based on an actual set of proficiency test (PT)-data for the concentration of Pb in water, this paper compares PT results obtained by methods using E _n numbers with methods based on z-scores. Kaj Heydorn is a technical assessor at The Danish Accreditation and Metrology Fund (DANAK).     

Application of a new AMIQAS computer program for integrated quality control, method evaluation and proficiency testing

Summary The computer program AMI - Quality Assessment Scheme (AMIQAS) was designed to give easy statistical management of analytical data in relation to method evaluation, internal quality control and proficiency testing. The program is designed in accordance with the recommendation of the ISO 5725 guideline and other official recommendations. The program consists of a database, test for outliers, statistics and graphs for evaluation of an analytical method for chemical, biological and environmental analysis, different control charts to be used in day-to-day internal quality control (Shewhart charts and z-charts). Finally the program has facilities to perform proficiency testing (also called external quality control) and produce the relevant evaluation reports for the documentation of method performance and quality control of results of measurements. The present paper demonstrates the applicability of the AMIQAS program for integrated method evaluation, internal quality control and proficiency testing using the determination of the concentration of lead in human whole blood as the numerical example.     

Validation studies and proficiency testing

Genetically modified organisms (GMOs) entered the European food market in 1996. Current legislation demands the labeling of food products if they contain <1% GMO, as assessed for each ingredient of the product. To create confidence in the testing methods and to complement enforcement requirements, there is an urgent need for internationally validated methods, which could serve as reference methods. To date, several methods have been submitted to validation trials at an international level; approaches now exist that can be used in different circumstances and for different food matrixes. Moreover, the requirement for the formal validation of methods is clearly accepted; several national and international bodies are active in organizing studies. Further validation studies, especially on the quantitative polymerase chain reaction methods, need to be performed to cover the rising demand for new extraction methods and other background matrixes, as well as for novel GMO constructs.     

Quality issues in proficiency testing

 Proficiency testing is a means of assessing the ability of laboratories to competently perform specific tests and/or measurements. It supplements a laboratory's own internal quality control procedure by providing an additional external audit of their testing capability and provides laboratories with a sound basis for continuous improvement. It is also a means towards achieving comparability of measurement between laboratories. Participation is one of the few ways in which a laboratory can compare its performance with that of other laboratories. Good performance in proficiency testing schemes provides independent evidence and hence reassurance to the laboratory and its clients that its procedures, test methods and other laboratory operations are under control. For test results to have any credibility, they must be traceable to a standard of measurement, preferably in terms of SI units, and must be accompanied by a statement of uncertainty. Analytical chemists are coming to realise that this is just as true in their field as it is for physical measurements, and applies equally to proficiency testing results and laboratory test reports. Recent approaches toward ensuring the quality and comparability of proficiency testing schemes and the means of evaluating proficiency test results are described. These have led to the drafting of guidelines and subsequently to the development of international requirements for the competence of scheme providers. Received: 2 January 1999 · Accepted: 7 April 1999     

Harmonisation of proficiency testing schemes

The harmonisation of proficiency testing (PT) schemes has been under debate for a long time. There are obvious reasons why harmonisation of the practices in PT would be beneficial. In many areas, there is still a belief that further harmonisation of practices in PT would improve the comparability of measurement data. In particular when two laboratories are to be compared that have not participated in a single PT, problems arise which allegedly can be overcome by further harmonisation of PT schemes. In practice, however, parties involved in PT are not always embracing the idea of harmonisation. With the results of two European projects in mind, a discussion is given on harmonisation aspects, and some considerations are given that may help to decide in practice whether harmonisation is likely to solve particular problems. The first project, the European Proficiency Testing Network (EPTN), is concerned with further harmonisation. The second European project (COEPT) aims at providing a basis to assess equivalence across proficiency tests, and explores the conditions under which such an assessment is feasible.

     

Harmonisation of proficiency testing schemes

The harmonisation of proficiency testing (PT) schemes has been under debate for a long time. There are obvious reasons why harmonisation of the practices in PT would be beneficial. In many areas, there is still a belief that further harmonisation of practices in PT would improve the comparability of measurement data. In particular when two laboratories are to be compared that have not participated in a single PT, problems arise which allegedly can be overcome by further harmonisation of PT schemes. In practice, however, parties involved in PT are not always embracing the idea of harmonisation. With the results of two European projects in mind, a discussion is given on harmonisation aspects, and some considerations are given that may help to decide in practice whether harmonisation is likely to solve particular problems. The first project, the European Proficiency Testing Network (EPTN), is concerned with further harmonisation. The second European project (COEPT) aims at providing a basis to assess equivalence across proficiency tests, and explores the conditions under which such an assessment is feasible.     

A comparison of performance statistics for proficiency testing programmes

Recently, ISO issued a new document on statistical methods for use in proficiency-testing schemes. The document presented a number of new performance statistics that involve the use of measurement uncertainties of the participants’ results and/or the assigned values for the performance evaluation. Making use of the Monte Carlo simulation technique, this paper attempts to compare selected performance statistics of different approaches. In addition, the simulation programme was extended to study the effect of multi-modality in participants’ results on the performance evaluation when different performance statistics were applied.     

Microbiology proficiency testing schemes in wine

Accreditation and Quality Assurance - The number of laboratories performing microbiological analyses of wines has gradually increased in recent years over the world. However, the lack of regular...