Accreditation and Quality Assurance (v.7, #8-9)

Addressing issues associated with the development and management of PT programs and with their optimum use by Jean Claude Libeer; Harold Richardson; David Bullock; Claus Heuck; D. Tholen; Robert Martin; Jane Carter; E. J. Boone; M. Noble (320-334).
Over 200 participants from 54 countries took part in working group (WG) discussions on proficiency testing (PT) held in conjunction with the Global Odyssey 2002 conference on 24–26 February, 2002 in Atlanta, Georgia, USA. Each WG addressed a series of questions focusing on the role of PT in laboratory quality management (WG1), alternatives to traditional PT (WG2), international aspects of PT programs (WG3), quality management of PT programs (WG4), how to assess laboratory performance (WG5), and developing and funding PT for resource-limited countries and regions (WG6). Each large WG was further subdivided into smaller groups to allow maximum participation, which was one objective of the WGs. Some subgroups addressed the same questions, but in most cases they drew very similar conclusions. Individual participants were surprised to discover the truly global nature of some problems with PT, while at the same time how specific differences among countries or regions can either enhance or hinder opportunities to implement PT programs.
Keywords: Keywords  Accreditation; External quality assessment; Proficiency testing; Specimen transport; Sustainability

Proficiency testing and external quality assurance of medical laboratories is now entering its sixth decade. These activities comprise a broad range of applications including: providing participants and public health authorities with estimates of measurement uncertainty and national infrastructure; providing education; provision of a practical basis for accreditation and regulatory compliance. All branches of medical laboratory science have employed external quality assurance as a basis for improvement and comparability. The opportunities and challenges reviewed here include: the proper establishment of multiple target values in comparison to a system of traceability to reference or definitive methods; the problems of matrix effects and commutability of patient and proficiency test samples; generating information on laboratory infrastructure and trends in analytical technique and performance; providing education and setting goals for laboratory improvement; problems of specimen distribution; application of Internet technology; the role of programs in legal mandates and accreditation.
Keywords: Keywords Medical laboratories; Proficiency testing; Interlaboratory comparisons; Review

Advances in microbiology EQA by Michael A. Noble (341-344).
External quality assessment for microbiology laboratories has seen many changes over the past ten years. EQA is much less focused on the pure analytic process of identifying single organisms submitted in an artificial medium. Samples are more realistic, and can be used to address clinical relevancy. Samples can be supplemented with a variety of non-traditional challenges to extend testing to include a wider range of the pre- and post-analytic aspects of the laboratory cycle. A look to the future sees a broad range of newer targets, with increasing interest in virology and point-of-care testing.
Keywords: Keywords Microbiology; proficiency testing; External quality assessment; Global odyssey; Laboratory quality management

Developing external quality assessment programmes for primary health: care level in resource limited countries by J. Y. Carter; Orgenes E. Lema; Christine G. Adhiambo; Sadiki F. Materu (345-350).
Laboratory services are an essential component of health care delivery in tropical countries and play a vital role in improving the accuracy of clinical diagnosis and the investigation of disease outbreaks. In developing countries, laboratories face numerous constraints to providing quality services, including poor selection of techniques, difficulties in equipment availability and maintenance, and shortages of supplies, staffing and supervision. Currently in the eastern African countries (Kenya, Tanzania and Uganda), internal quality control procedures are inconsistently carried out in most laboratories. National External Quality Assessment Schemes (EQAS) have been established in all countries addressing a limited number of tests, but are constrained by difficulties of sustainability and poor coverage. The Laboratory Programme of the African Medical and Research Foundation (AMREF) has been operating a simple EQAS for primary heath care laboratories since 1993. Tests addressed are those carried out in primary health care laboratories in eastern Africa. A total of 81 laboratories from 5 countries in the eastern African region have participated in the scheme since 1993 and 9 distributions were submitted since the start of the scheme. No laboratory participated in all distributions; 24 (30%) laboratories participated in 4 or more distributions. Of these, the hospital laboratories in Kenya and Tanzania showed improved average mean scores between the first two and subsequent distributions. The educational benefit of participation in the scheme is emphasised. There was an overall low rate of participation of laboratories (35%) once the scheme was expanded to include laboratories outside direct AMREF project activities. Contributing factors include shortages of staff and lack of time in busy rural laboratories, together with difficulties in communication; however, the voluntary nature and lack of appreciation of the benefits of participation may also play a role. To increase participation in the scheme and to address the quality of laboratory services throughout the region, AMREF is currently developing a Regional EQAS in collaboration with the Ministries of Health of Kenya, Tanzania and Uganda, in affiliation with the World Health Organisation (WHO). The approaches used to establish reference values for haemoglobin samples are discussed. The scheme has also been utilised to examine the performance of different techniques for haemoglobin estimation, demonstrating the inaccuracy of the visual comparator methods.
Keywords: Keywords Laboratory; Primary health care; Quality assurance; Developing countries

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.
Keywords: Keywords Proficiency testing; External quality assessment; Molecular genetic testing; DNA testing; American College of Medical Genetics (ACMG)/ College of American Pathologists (CAP) Biochemical and Molecular Genetics Resource Committee

Proficiency testing in cervical cytopathology by Timothy J. O’Leary (357-361).
Cervical cancer is a leading cause of cancer death in women and may be significantly reduced by the introduction of effective screening and treatment programs. Although proficiency testing programs should, in principle, contribute to the reduction of cervical cancer mortality, the data does not provide convincing evidence for such a result. In this paper we review some results from current and past cytology proficiency testing programs, outlining the challenges to be overcome if these programs are to have an effect on cervical cancer mortality.
Keywords: Keywords Cytopathology; Cytology; Proficiency testing; Cervical cancer; Cervix

Applications of the Internet to PT by D. W. Seccombe (363-364).
The Internet provides laboratory professionals with a unique opportunity to come together as a network and to develop an integrated system for monitoring the quality of testing in their laboratories on a real-time basis. Once established this network could provide a quality and standards promoting infrastructure for catalyzing the standardization process. Through a collaborative sharing of information on performance and through the use of a common database with harmonized test materials, proficiency testing providers can play a pivotal role in developing such a system. The challenge is now up to us.
Keywords: Keywords External quality assessment; Communication; Internet

Providing laboratory external quality assessment (EQA) programs for countries in need requires special considerations not ordinarily part of EQA for laboratories in industrialized countries. Cultural, professional, service and economic factors must be understood and accommodated in order to carry out successful programs. Coordination of worldwide efforts for countries in need requires more resources and planning than have thus far been devoted to the enterprise.
Keywords: Keywords Laboratory accreditation; External quality assessment programs; Countries in need; Proposals

EURACHEM News by M. F. Camões (371-371).

News from EOTC (373-373).