Establishment of the European College of Veterinary Clinical Pathology (ECVCP) and the current status of veterinary clinical pathology in Europe

After 5 years of development, the European College of Veterinary Clinical Pathology (ECVCP) was formally recognized and approved on July 4, 2007 by the European Board of Veterinary Specialisation (EBVS), the European regulatory body that oversees specialization in veterinary medicine and which has approved 23 colleges. The objectives, committees, basis for membership, constitution, bylaws, information brochure and certifying examination of the ECVCP have remained unchanged during this time except as directed by EBVS. The ECVCP declared full functionality based on the following criteria: 1) a critical mass of 65 members: 15 original diplomates approved by the EBVS to establish the ECVCP, 37 de facto diplomates, 7 diplomates certified by examination, and 5 elected honorary members; 2) the development and certification of training programs, laboratories, and qualified supervisors for residents; currently there are 18 resident training programs in Europe; 3) administration of 3 annual board-certifying examinations thus far, with an overall pass rate of 70%; 4) European consensus criteria for assessing the continuing education of specialists every 5 years; 5) organization of 8 annual scientific congresses and a joint journal (with the American Society for Veterinary Clinical Pathology) for communication of scientific research and information; the College also maintains a website, a joint listserv, and a newsletter; 6) collaboration in training and continuing education with relevant colleges in medicine and pathology; 7) development and strict adherence to a constitution and bylaws compliant with the EBVS; and 8) demonstration of compelling rationale, supporting data, and the support of members and other colleges for independence as a specialty college. Formal EBVS recognition of ECVCP as the regulatory body for the science and practice of veterinary clinical pathology in Europe will facilitate growth and development of the discipline and compliance of academic, commercial diagnostic, and industry laboratories in veterinary clinical pathology. Future needs are in developing sponsorship for resident positions, increasing employment opportunities, increasing compliance with laboratory, training, and continuing education standards, and advancing relevant science and technology.     

The laboratory network in Australia and New Zealand – an evolving system

This paper discusses the network of government, private and university veterinary laboratories in Australia and New Zealand and how it is adapting and evolving to meet the challenges it faces. It includes the mechanisms for standardisation of procedures, quality assurance, and the role of national reference laboratories hosted by state government laboratories. It also highlights the crisis in supply of veterinary diagnosticians, especially the declining numbers of veterinary pathologists. Recent positive changes include the setting up of the National Animal Health Laboratory Strategy and an initiative to empower State and Territory government laboratories to test for exotic diseases. The ideal outcome for Australia and New Zealand is a laboratory service that remains the gold standard around the world.     

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

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.     

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

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.     

Postgraduate training programs in veterinary clinical pathology in the United States and Canada (1998 to 2002)

Background: Residency and graduate programs in veterinary clinical pathology provide specialized training for board certification and are important pathways to careers in clinical pathology diagnostics, teaching, and research. Information about training opportunities is useful for assessing disciplinary needs, outcomes, and changes, garnering program support, and providing objective data for program evaluation by faculty, trainees, and prospective applicants. Objectives: The goals of this study were to 1) compile detailed information on the number and types of postgraduate training programs in veterinary clinical pathology in the United States and Canada, 2) describe the goals, activities, strengths, and weaknesses of the programs, 3) assess the desirability of program accreditation and program standards, 4) identify supplemental training opportunities, and 5) evaluate changes in programs, trainees, and faculty 4 years later. Methods: In July 1998, the American Society for Veterinary Clinical Pathology Education Committee sent a survey to representatives at the 31 schools and colleges of veterinary medicine in the United States and Canada and 31 diagnostic laboratories, private hospitals, and pharmaceutical companies. Survey data were compared with updated information obtained from training program coordinators in November 2002. Results: Survey response rate was 94% for universities, 39% for nonuniversity institutions, and 66% overall. In 1998, there were 20 clinical pathology training programs, including residencies (n=10) and graduate programs combined with residency training (n=10), with 36 total training positions. In 2002, there were 25 training programs (14 residencies, 11 combined), with 52 total positions. The median faculty: trainee ratio was 2.0 in both years. Of 67 faculty members involved in training in 1998, 57 (85.1%) were board‐certified in clinical pathology and 53 (79.1%) had DVM/PhD degrees. Net faculty numbers increased by 17 (25.4%) but the median per institution remained at 3.0. Primary program goals were 1) eligibility for and successful achievement of board certification in clinical pathology by the American College of Veterinary Pathologists, 2) proficiency in laboratory diagnostics, and 3) contemporary basic or applied research training. Many programs cited research opportunities, caseloads, and training in hematology and cytology as strengths. Program weaknesses included insufficient funding, too few faculty, and limited training in clinical chemistry and laboratory operations/quality assurance. Trainees completing programs within the past 5 years (n=70) were employed in academia (28.6%), diagnostic laboratories (32.9%), and industry (18.6%). For trainees completing programs between 1999 and 2002 (n=38), these percentages were 52.6%, 21.1%, and 7.9%, respectively. Most (62.5%) respondents supported program standards and accreditation, and 76% supported board review sessions for trainees. Conclusions: Opportunities for postgraduate training in veterinary clinical pathology increased between 1998 and 2002, with 5 new programs and 16 new training positions. These additions and the increased emphasis on diagnostic proficiency, efforts to strengthen training in clinical chemistry and quality assurance, and continuation of combined PhD‐residency programs will help address the perceived need for increased numbers of qualified clinical pathologists in academia, diagnostic laboratories, and industry.     

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

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.     

Quality documentation challenges for veterinary clinical pathology laboratories

An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.     

Salmonella culture: sampling procedures and laboratory techniques.

In some respects, the multitude of options for isolation of Salmonella and the lack of interlaboratory consistency make Salmonella isolation one of the most variable procedures in veterinary laboratories. Even with the vast number of techniques available, it seems that at least one or two new media become available every year that promise to be more sensitive, more specific,and more rapid. With all the potential media and techniques available, the diagnostic laboratory must choose those that efficiently and accurately give the timely results required clinically and epidemiologically. Many veterinary diagnostic laboratories have invested the time and effort to explore these options and usually have developed standard methods to ensure that their laboratory tests have high sensitivity and specificity. Clients have greater assurance in the accuracy of laboratory results if these standards and the process of deriving them are made available to them. Many laboratories participate in external quality assurance programs to demonstrate their ability to culture microorganisms accurately. These quality control programs are designed to ensure that the client receives the correct answers to questions that are vital for the treatment and health care of their horses. This important information is available only if the initial steps of collecting and shipping the samples have been executed appropriately.     

The quality assurance of proficiency testing programs for animal disease diagnostic laboratories.

Laboratory data credibility has 3 major components: 1) valid methods, 2) proficiency testing (PT) to verify that the analyst can conduct the method and to compare results of other laboratories using the same method, and 3) third-party accreditation to verify that the laboratory is competent to conduct testing and that the method validation has been done within the environment and requirements of an effective quality-management system. Participation in external PT programs by a laboratory is strongly recommended in International Organization for Standardization/International Electrotechnical Commission International Standard 17025. Most laboratory accreditation bodies using this standard require that laboratories participate in such programs to be accredited. Internal PT is also recommended for each analyst. Benchmarking, or comparison between laboratories using PT or reference materials, is also recommended as part of the validation and evaluation of test methods. These requirements emphasize the need for proficiency test providers to demonstrate their competence. Requirements for competence are documented in national and international standards and guidelines, and accreditation is available for providers. This article discusses the activities and the components that are necessary and recommended for PT projects and programs for animal disease diagnostic testing. These are based on the requirements of the national and international standards, which address this subject, and on the experience of the author. The accreditation of external PT programs is also discussed. Organizations that accredit PT providers or that provide PT programs are listed. Existing references, guidelines, and standards that are relevant to PT in veterinary diagnostic laboratories are discussed.     

Veterinary pathology in the United Kingdom: past, present, and future

This article presents a historical perspective on veterinary anatomic pathology in the United Kingdom from the late nineteenth century to the present. Prior to World War II, the specialty was a rather general one that also included bacteriology and parasitology and was only slightly affected by strong Germanic developments in cell and tissue pathology. The few notable figures of this era include John McFadyean, Sidney Gaiger, and J.R.M Innes. The specialty developed strongly in the second half of the twentieth century, led by a small number of individuals, and was greatly aided by the development of specialist colleges and residency training. Key individuals of this era include W.F. Blakemore, Ernest Cotchin, R.J.M. Franklin, W.F.H. Jarrett, A.R. Jennings, and A.C. Palmer. A remarkable feature of this period has been the increased employment of veterinary pathologists in biomedical industry and in private diagnostic laboratories. While standards of pathology practice have benefited from the college initiatives, there are major financial constraints on the availability of funded training posts in the United Kingdom, and there remain considerable shortages in the supply of pathologists trained to contemporary standards. The acknowledged professional and scientific importance of veterinary pathology needs to be translated into effective financial support for the training that underpins competence in this specialty. Further developments seem likely to be dominated by advances in the technology of tissue handling, applications of molecular biology to pathology, and greater use of telepathology in teaching, in quality assurance, and in continuing professional development.     

Quality commitment and management in veterinary education

This article provides an overview of how quality assurance is developing as a major component of the evaluation of establishments of veterinary education in Europe and, hence, of the evaluation of the veterinary training provided. Also discussed are the ways in which education in veterinary medicine in Europe is currently regulated and assessed and how this assessment is evolving. Major attention is paid to quality indicators, quality-assurance implementation, the development of a culture of quality in veterinary education within Europe, quality assurance for certification or accreditation of such schools, and promoting the development of a global network of evaluation of veterinary education.     

Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.     

ASVCP guidelines: quality assurance for point‐of‐care testing in veterinary medicine

Point‐of‐care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in‐clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 1_3s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all‐inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting.     

ASVCP guidelines: quality assurance for portable blood glucose meter (glucometer) use in veterinary medicine

Portable blood glucose meters (PBGM, glucometers) are a convenient, cost effective, and quick means to assess patient blood glucose concentration. The number of commercially available PBGM is constantly increasing, making it challenging to determine whether certain glucometers may have benefits over others for veterinary testing. The challenge in selection of an appropriate glucometer from a quality perspective is compounded by the variety of analytic methods used to quantify glucose concentrations and disparate statistical analysis in many published studies. These guidelines were developed as part of the ASVCP QALS committee response to establish recommendations to improve the quality of testing using point‐of‐care testing (POCT) handheld and benchtop devices in veterinary medicine. They are intended for clinical pathologists and laboratory professionals to provide them with background knowledge and specific recommendations for quality assurance (QA) and quality control (QC), and to serve as a resource to assist the provision of advice to veterinarians and technicians to improve the quality of results obtained when using PBGM. These guidelines are not intended to be all‐inclusive; rather they provide a minimum standard for management of PBGM in the veterinary setting.     

Accreditation of veterinary schools in Australia and New Zealand

Veterinary schools in Australia and New Zealand are assessed for accreditation purposes every six years by the Veterinary Schools Accreditation Advisory Committee (VSAAC), which is a standing committee of the Australasian Veterinary Boards Council (AVBC).1 Prior to undertaking an assessment, VSAAC requests a Self Evaluation Report from the school and subsequently spends a week on site to collect additional information. The committee also takes into consideration other quality assurance procedures within the university and aims for a process that complements other evaluation activities. Internal evaluation procedures within VSAAC are designed to reflect the process and outcomes of each visit and lead to annual revisions of the publication Policies, Procedures and Guidelines publication. The committee has close links with the Royal College of Veterinary Surgeons (RCVS), and there is a routine exchange of observers on all visits in the United Kingdom and Australasia. In recent years VSAAC has become increasingly interested in looking at ways to place greater emphasis on the outcomes of veterinary education and, eventually, to reduce our reliance on input measures. There has been good progress in identifying desirable attributes for veterinary graduates, but further work is needed to establish the reliability of assessment procedures. The Australasian accreditation system is very supportive of recent moves to achieve greater compatibility of veterinary accreditation systems in different parts of the world because we believe it has the potential to assist globalization of animal disease control and veterinary education.     

Clinical hematology practices at veterinary teaching hospitals and private diagnostic laboratories

The clinical hematology practices utilized at veterinary teaching hospitals and private veterinary diagnostic laboratories were surveyed using a questionnaire. The hematology caseload at private diagnostic laboratories was larger, and comprised predominantly of canine and feline submissions. The Coulter S Plus IV and Serono Baker 9000 were the hematology analyzers used most frequently at veterinary medical laboratories. The Abbott Cell-Dyn 3500, a multispecies analyzer capable of leukocyte differential counting, was utilized more by private laboratories. Commercial hematology control reagents were used at all laboratories; teaching hospital laboratories more often used reagents supplied by the manufacturer of the analyzer. A greater percentage of private diagnostic laboratories participated in the external quality assurance programs offered by Veterinary Laboratory Association and College of American Pathologists. While private diagnostic laboratories retained the EDTA blood specimens longer after initial testing, the teaching hospital laboratories retained blood smears and complete blood count reports longer. The complete blood count reports at veterinary teaching laboratories more often included red blood cell volume distribution width, mean platelet volume, manual hematocrit, plasma protein, and leukocyte differentials as absolute concentrations. The laboratory practices utilized by these veterinary medical laboratories were generally similar, and differences were attributed to divergent emphasis on economic accountability and clinical investigation.     

Developments in international standardization

Trade in animals and animal products has reached global proportions and so too has the threat of infectious diseases of veterinary importance. The Manual of Standards for Diagnostic Tests and Vaccines, published by the Office International des Epizooties (OIE), contains chapters on infectious diseases that may cause various degrees of socio-economic, public health, and/or zoo-sanitary consequence. These chapters cover the major diseases of cattle, sheep, goats, horses, pigs, poultry, lagomorphs and bees. A number of factors are considered when qualifying animals and animal products for international trade including epidemiological, clinical and testing parameters. Of particular note and relevance is a strong international movement to standardize the test methods and reference reagents in order to promote harmonization of testing and facilitation of trade. There is message here that is directed to those of us involved in the development and application of test methods for infectious disease diagnosis. Serological test methods have been and still remain the mainstay of diagnostic methods prescribed for trade. More than ever, there is a need to observe and apply international guidelines for the development and validation of serological test methods. There is also a need to develop international standard reagents for use in the calibration of test methods and the production of national and working standards. In the future, veterinary diagnostic testing laboratories involved in trade may also require a form of international accreditation unique to their specialty. This presentation describes the current developments in international standardization of test methods and reference reagents.     

兽医实验室仪器设备标识管理的现状及建议

实验室资质认定认可均对仪器设备标识管理提出了具体要求,可见标识管理在实验室质量管理中具有重要作用。通过分析兽医实验室仪器设备标识管理存在的问题,提出了规范化管理的仪器设备标识建议,以期为提高兽医实验室仪器设备标识管理水平提供参考。