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1.
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.  相似文献   

2.
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.  相似文献   

3.
Reference intervals (RI) are an integral component of laboratory diagnostic testing and clinical decision‐making and represent estimated distributions of reference values (RV) from healthy populations of comparable individuals. Because decisions to pursue diagnoses or initiate treatment are often based on values falling outside RI, the collection and analysis of RV should be approached with diligence. This report is a condensation of the ASVCP 2011 consensus guidelines for determination of de novo RI in veterinary species, which mirror the 2008 Clinical Laboratory and Standards Institute (CLSI) recommendations, but with language and examples specific to veterinary species. Newer topics include robust methods for calculating RI from small sample sizes and procedures for outlier detection adapted to data quality. Because collecting sufficient reference samples is challenging, this document also provides recommendations for determining multicenter RI and for transference and validation of RI from other sources (eg, manufacturers). Advice for use and interpretation of subject‐based RI is included, as these RI are an alternative to population‐based RI when sample size or inter‐individual variation is high. Finally, generation of decision limits, which distinguish between populations according to a predefined query (eg, diseased or non‐diseased), is described. Adoption of these guidelines by the entire veterinary community will improve communication and dissemination of expected clinical laboratory values in a variety of animal species and will provide a template for publications on RI. This and other reports from the Quality Assurance and Laboratory Standards (QALS) committee are intended to promote quality laboratory practices in laboratories serving both clinical and research veterinarians.  相似文献   

4.
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 13s 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.  相似文献   

5.
The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices.  相似文献   

6.
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.  相似文献   

7.
As all laboratory equipment ages and contains components that may degrade with time, initial and periodically scheduled performance assessment is required to verify accurate and precise results over the life of the instrument. As veterinary patients may present to general practitioners and then to referral hospitals (both of which may each perform in‐clinic laboratory analyses using different instruments), and given that general practitioners may send samples to reference laboratories, there is a need for comparability of results across instruments and methods. Allowable total error (TEa) is a simple comparative quality concept used to define acceptable analytical performance. These guidelines are recommendations for determination and interpretation of TEa for commonly measured biochemical analytes in cats, dogs, and horses for equipment commonly used in veterinary diagnostic medicine. TEa values recommended herein are aimed at all veterinary settings, both private in‐clinic laboratories using point‐of‐care analyzers and larger reference laboratories using more complex equipment. They represent the largest TEa possible without generating laboratory variation that would impact clinical decision making. TEa can be used for (1) assessment of an individual instrument's analytical performance, which is of benefit if one uses this information during instrument selection or assessment of in‐clinic instrument performance, (2) Quality Control validation, and (3) as a measure of agreement or comparability of results from different laboratories (eg, between the in‐clinic analyzer and the reference laboratory). These guidelines define a straightforward approach to assessment of instrument analytical performance.  相似文献   

8.
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9.
BACKGROUND: The Education Committee of the American Society for Veterinary Clinical Pathology (ASVCP) identified a need for improved structure and guidance in training residents in clinical pathology. To begin to meet this need, guidelines for training in clinical chemistry were published in 2003. OBJECTIVE: The goal of this report is to define learning objectives and competencies in hematology, including coagulation and immunohematology. METHODS: These guidelines were developed and written with the input of ASVCP Education Committee members and peer experts. RESULTS: The primary objectives of training in hematology are: 1) to accrue a thorough, extensive, and relevant knowledge base of the types, principles, and properties of hematology tests and concepts of pathophysiology in animals; 2) to develop abilities to reason, think critically, communicate effectively, and exercise judgment in hematologic data interpretation and investigative problem-solving; and 3) to acquire technical and statistical skills important in hematology and laboratory operations. We also provide options and ideas for training activities and identify hematology resources useful for clinical pathology faculty and staff, training program coordinators, and residents. CONCLUSIONS: The guidelines define expected competencies that will help ensure proficiency, leadership, and the advancement of knowledge in veterinary hematology and provide a useful framework for didactic and clinical activities in resident-training programs. The learning objectives can readily be adapted to institutional and individual needs, interests, goals, and resources.  相似文献   

10.
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.  相似文献   

11.
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12.
Falconry is a long-standing tradition in the United Arab Emirates (UAE), and in 2016, falconry was included by UNESCO in the list of intangible cultural heritage of humanity. The health and wellness of falconry raptors is a priority for the local culture; plasma chemistry analysis plays an important role in monitoring, assessing, and managing diseases in avian patients. Imbalances of Cu, Mg, and Zn have been linked to several diseases in avian species; therefore, determining the reference intervals (RIs) of these minerals has important implications in the clinical management of falcons. We determined the RIs in plasma for Cu, Mg, and Zn in captive (falconry-managed) falcons according to the Quality Assurance and Laboratory Standards Committee of the American Society for Veterinary Clinical Pathology, and the Clinical Laboratory Standards Institute guidelines. Blood chemistry analyses were carried out on 252 clinically healthy falcons examined at the Dubai Falcon Hospital in the UAE: 124 gyrfalcons (Falco rusticolus) and 128 falcons of other species. We observed no significant variation in RIs of Cu (1.5–7.0 µmol/L), Mg (0.49–0.78 mmol/L), or Zn (11.8–34.1 µmol/L) based on different species or sex.  相似文献   

13.

Background

There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval.

Methods

Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology.

Results

Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory.

Conclusions

In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods.  相似文献   

14.
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.  相似文献   

15.
This document is the consensus of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) Subcommittee on Standardization of Immunohistochemistry on a set of guidelines for immunohistochemistry (IHC) testing in veterinary laboratories. Immunohistochemistry is a powerful ancillary methodology frequently used in many veterinary laboratories for both diagnostic and research purposes. However, neither standardization nor validation of IHC tests has been completely achieved in veterinary medicine. This document addresses both issues. Topics covered include antibody selection, fixation, antigen retrieval, antibody incubation, antibody dilutions, tissue and reagent controls, buffers, and detection systems. The validation of an IHC test is addressed for both infectious diseases and neoplastic processes. In addition, storage and handling of IHC reagents, interpretation, quality control and assurance, and troubleshooting are also discussed. Proper standardization and validation of IHC will improve the quality of diagnostics in veterinary laboratories.  相似文献   

16.
Quality control (QC) validation is used to determine: 1) whether statistical QC procedures are appropriate for detecting medically important errors; and 2) the equality of performance required by different laboratory tests. QC validation is well documented in the medical literature, but we are unaware of studies addressing its application, problems or unique differences in veterinary laboratories. We applied QC validation to automated hematology and biochemistry analyses in our laboratories, with goals of >/= 90% probability of error detection and 相似文献   

17.
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.  相似文献   

18.
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.  相似文献   

19.
Technologic advances in information management have rapidly changed laboratory testing and the practice of veterinary medicine. Timely and strategic sampling, same-day assays, and 24-h access to laboratory results allow for rapid implementation of intervention and treatment protocols. Although agent detection and monitoring systems have progressed, and wider tracking of diseases across veterinary diagnostic laboratories exists, such as by the National Animal Health Laboratory Network (NAHLN), the distinction between detection of agent and manifestation of disease is critical to improved disease management. The implementation of a consistent, intuitive, and useful disease diagnosis coding system, specific for veterinary medicine and applicable to multiple animal species within and between veterinary diagnostic laboratories, is the first phase of disease data aggregation. Feedback loops for continuous improvement that could aggregate existing clinical and laboratory databases to improve the value and applications of diagnostic processes and clinical interventions, with interactive capabilities between clinicians and diagnosticians, and that differentiate disease causation from mere agent detection, remain incomplete. Creating an interface that allows aggregation of existing data from clinicians, including final diagnosis, interventions, or treatments applied, and measures of outcomes, is the second phase. Prototypes for stakeholder cooperation, collaboration, and beta testing of this vision are in development and becoming a reality. We focus here on how such a system is being developed and utilized at the Iowa State University Veterinary Diagnostic Laboratory to facilitate evidence-based medicine and utilize diagnostic coding for continuous improvement of animal health and welfare.  相似文献   

20.
OBJECTIVE: To determine the extent of use of cytology as a diagnostic method in veterinary practice and assess how veterinarians in practice communicate with veterinary clinical pathologists. DESIGN: Online survey. STUDY POPULATION: 870 veterinarians. PROCEDURES: An online survey was made available to members of the Veterinary Information Network from October 1, 2004, through December 1, 2004. RESULTS: Respondents reported obtaining a median of 7 cytology samples weekly (range, 0 to 100). On average, respondents reported that 48.1% of the samples they collected were evaluated in-house, 29.5% were submitted to a veterinary diagnostic laboratory, and 21.6% were evaluated in-house and then submitted to a diagnostic laboratory. Most respondents (89.2%) reported using cytologic assessments to guide additional testing, and most (80.3%) indicated that they found the comments section of the cytology report to be the most important section. When asked to indicate the importance of various factors in their decision to use cytology as a diagnostic method, respondents overwhelmingly indicated that accuracy was very important. The most common reasons for consulting with a clinical pathologist were to discuss a discrepancy between clinical and cytologic findings, to clarify a diagnosis, and to ascertain the pathologist's confidence in a diagnosis. Respondents expressed more confidence in results when board-certified clinical pathologists were examining cytology samples than when others were. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggested that improving communication between veterinary practitioners and veterinary clinical pathologists could enhance the diagnostic value of cytologic examinations and improve clinical decision-making.  相似文献   

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