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.     

ASVCP guidelines: allowable total error guidelines for biochemistry

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 (TE_a) is a simple comparative quality concept used to define acceptable analytical performance. These guidelines are recommendations for determination and interpretation of TE_a for commonly measured biochemical analytes in cats, dogs, and horses for equipment commonly used in veterinary diagnostic medicine. TE_a 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. TE_a 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.     

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

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.     

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.     

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.     

Survey of the prevalence and methodology of quality assurance for B‐mode ultrasound image quality among veterinary sonographers

Image quality in B‐mode ultrasound is important as it reflects the diagnostic accuracy and diagnostic information provided during clinical scanning. Quality assurance programs for B‐mode ultrasound systems/components are comprised of initial quality acceptance testing and subsequent regularly scheduled quality control testing. The importance of quality assurance programs for B‐mode ultrasound image quality using ultrasound phantoms is well documented in the human medical and medical physics literature. The purpose of this prospective, cross‐sectional, survey study was to determine the prevalence and methodology of quality acceptance testing and quality control testing of image quality for ultrasound system/components among veterinary sonographers. An online electronic survey was sent to 1497 members of veterinary imaging organizations: the American College of Veterinary Radiology, the Veterinary Ultrasound Society, and the European Association of Veterinary Diagnostic Imaging, and a total of 167 responses were received. The results showed that the percentages of veterinary sonographers performing quality acceptance testing and quality control testing are 42% (64/151; 95% confidence interval 34–52%) and 26% (40/156: 95% confidence interval 19–33%) respectively. Of the respondents who claimed to have quality acceptance testing or quality control testing of image quality in place for their ultrasound system/components, 0% have performed quality acceptance testing or quality control testing correctly (quality acceptance testing 95% confidence interval: 0–6%, quality control testing 95% confidence interval: 0–11%). Further education and guidelines are recommended for veterinary sonographers in the area of quality acceptance testing and quality control testing for B‐mode ultrasound equipment/components.     

Genomic Tandem Repeat Analysis Proves Laboratory‐Acquired Brucellosis in Veterinary (Camel) Diagnostic Laboratory in the United Arab Emirates

We report a case of a 64‐year‐old veterinarian working in a state camel veterinary laboratory who was diagnosed with and treated for acute brucellosis with complicating epididymo‐orchitis. Genomic tandem repeat analysis (MLVA‐16) revealed identical Brucella strains in patient cultures and from different dromedary milk samples positive for Brucella melitensis, thereby confirming the diagnosis of a laboratory acquired infection. The case illustrates the high (airborne) infectivity of brucellosis in laboratory settings and the need to implement vigorous bio‐safety measures in veterinary laboratories handling camel specimen diagnostic veterinary laboratory.     

Differentiating between analytical and diagnostic performance evaluation with a focus on the method comparison study and identification of bias

Prior to introduction of a new method to the diagnostic laboratory, analytical performance must be validated to ensure operation within the manufacturer's specifications and/or within predetermined quality requirements. In addition, the new method may require diagnostic performance assessment to ensure it differentiates between diseased and nondiseased individuals as intended. These 2 phases of assessment, while complementary, are not equivalent and require a different set of experiments, statistical analyses, and interpretation. Studies of analytical performance typically include a method comparison experiment, the purpose of which is to identify bias (inaccuracy) of the “test” (or “index”) method (new method) relative to a “comparative method” (established method). Analysis of method comparison data is facilitated by commercial software programs that present the statistical significance of identified bias; however, the clinical relevance of any bias also should be considered. Studies of diagnostic performance should not be pursued until analytical performance is fully characterized and may not be required for well‐established tests or for those for which results are nonspecific (ie, not referable to a specific disease or condition). Diagnostic performance assessment may include assessment of sensitivity, specificity, predictive values, odds ratios, and/or likelihood ratios. The purpose of this review is to clarify differences between the assessment of analytical and diagnostic performance, and to explore the method comparison study and bias assessment from a perspective not addressed in prior veterinary articles.     

Appraisal of the Australian Veterinary Prescribing Guidelines for antimicrobial prophylaxis for surgery in dogs and cats

The Australian Veterinary Prescribing Guidelines for antimicrobial prophylaxis for surgery on dogs and cats are evidence‐based guidelines for veterinary practitioners. Validation of these guidelines is necessary to ensure quality and implementability. Two validated tools, used for medical guideline appraisal, were chosen to assess the guidelines. The terminology from the GuideLine Implementability Appraisal (GLIA) and the Appraisal of Guidelines for Research and Evaluation version 2 (AGREE II) were adapted for use by veterinarians. A two‐phase evaluation approach was conducted. In the first phase of the evaluation, the GLIA tool was used by two specialist veterinary surgeons in clinical practice. The results of this phase were then used to modify the guidelines. In the second phase, the AGREE II tool was used by 6 general practitioners and 6 specialists to appraise the guidelines. In phase 1, the specialist surgeons either agreed or strongly agreed that the guidelines were executable, decidable, valid and novel, and that the guidelines would fit within the process of care. The surgeons were neutral on flexibility and measurability. Additional clarity around one common surgical procedure was added to the guidelines, after which the surgeons agreed that the guidelines were sufficiently flexible. In phase 2, 12 veterinarians completed the assessment using the AGREE II tool. In all sections the scaled domain score was greater than 70%. The overall quality of the guidelines was given a global scaled score of 76%. This assessment has demonstrated that the guidelines for antimicrobial prophylaxis for companion animal surgery are valid and appear implementable.     

Current and emerging concepts in biological and analytical variation applied in clinical practice

A single laboratory result actually represents a range of possible values, and a given laboratory result is impacted not just by the presence or absence of disease, but also by biological variation of the measurand in question and analytical variation of the equipment used to make the measurement. Biological variation refers to variability in measurand concentration or activity around a homeostatic set point. Knowledge of biological and analytical variation can be used to facilitate interpretation of patient clinicopathologic data and is particularly useful for interpreting serial patient data and data at or near reference limits or clinical decision thresholds. Understanding how biological and analytical variation impact laboratory results is of increasing importance, because veterinarians evaluate serial data from individual patients, interpret data from multiple testing sites, and use expert consensus guidelines that include decision thresholds for clinicopathologic data interpretation. The purpose of our report is to review current and emerging concepts in biological and analytical variation and discuss how biological and analytical variation data can be used to facilitate clinicopathologic data interpretation. Inclusion of veterinary clinical pathologists having expertise in laboratory quality management and biological variation on research teams and veterinary practice guideline development teams is recommended, to ensure that various considerations for clinicopathologic data interpretation are addressed.     

检测实验室仪器设备管理工作

根据兽药检验机构在实验室认可工作中实验室仪器设备的管理现状,结合检测和校准实验室能力认可准则,对检测实验室仪器设备的规范化管理进行了探讨.     

ASVCP reference interval guidelines: determination of de novo reference intervals in veterinary species and other related topics

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.     

OIE抗菌药耐药性国际标准

兽用抗菌药耐药性已经成为一个全球普遍关注的公共健康问题,各国际组织都积极采取相应的措施控制耐药性的产生和蔓延。介绍了国际组织世界动物卫生组织OIE制定的五个国际标准,包括协调抗菌药耐药性监督和检测程序指南、畜牧业抗菌药消耗量监测指南、兽用抗菌药慎用指南、抗菌药敏感性检测的实验室方法指南、动物源抗菌药耐药性对公共健康潜在影响的风险分析方法指南,以期为我国政策制定者和决策者参照国际标准制定出符合我国国情的耐药性相关指南。     

Inductively coupled plasma mass‐spectrometric determination of platinum in excretion products of client‐owned pet dogs

Residues of antineoplastic drugs in canine excretion products may represent exposure risks to veterinary personnel, owners of pet dogs and other animal care‐takers. The aim of this study was to measure the extent and duration of platinum (Pt) excretion in pet dogs treated with carboplatin. Samples were collected before and up to 21 days after administration of carboplatin. We used validated, ultra‐sensitive, inductively coupled plasma‐mass spectrometry assays to measure Pt in canine urine, faeces, saliva, sebum and cerumen. Results showed that urine is the major route of elimination of Pt in dogs. In addition, excretion occurs via faeces and saliva, with the highest amounts eliminated during the first 5 days. The amount of excreted Pt decreased over time but was still quantifiable at 21 days after administration of carboplatin. In conclusion, increased Pt levels were found in all measured excretion products up to 21 days after administration of carboplatin to pet dogs, with urine as the main route of excretion. These findings may be used to further adapt current veterinary guidelines on safe handling of antineoplastic drugs and treated animals.     

ASVCP guidelines: Allowable total error hematology

The purpose of this document is to provide total allowable error (TE_a) recommendations for commonly analyzed hematology measurands for veterinary personnel. These guidelines define relevant terminology and highlight considerations specific to hematology measurands. They also provide reasons and guidelines for using TE_a in instrument performance evaluation, including recommendations for when the total observed error exceeds the recommended TE_a. Biological variation‐based quality specifications are briefly discussed. The appendix describes the derivation of the hematology TE_a recommendations and provides resources for external quality assurance/proficiency testing programs and a worksheet for implementation of the guidelines.     

INVITED REVIEW—NEUROIMAGING RESPONSE ASSESSMENT CRITERIA FOR BRAIN TUMORS IN VETERINARY PATIENTS

The evaluation of therapeutic response using cross‐sectional imaging techniques, particularly gadolinium‐enhanced MRI, is an integral part of the clinical management of brain tumors in veterinary patients. Spontaneous canine brain tumors are increasingly recognized and utilized as a translational model for the study of human brain tumors. However, no standardized neuroimaging response assessment criteria have been formulated for use in veterinary clinical trials. Previous studies have found that the pathophysiologic features inherent to brain tumors and the surrounding brain complicate the use of the response evaluation criteria in solid tumors (RECIST) assessment system. Objectives of this review are to describe strengths and limitations of published imaging‐based brain tumor response criteria and propose a system for use in veterinary patients. The widely used human Macdonald and response assessment in neuro‐oncology (RANO) criteria are reviewed and described as to how they can be applied to veterinary brain tumors. Discussion points will include current challenges associated with the interpretation of brain tumor therapeutic responses such as imaging pseudophenomena and treatment‐induced necrosis, and how advancements in perfusion imaging, positron emission tomography, and magnetic resonance spectroscopy have shown promise in differentiating tumor progression from therapy‐induced changes. Finally, although objective endpoints such as MR imaging and survival estimates will likely continue to comprise the foundations for outcome measures in veterinary brain tumor clinical trials, we propose that in order to provide a more relevant therapeutic response metric for veterinary patients, composite response systems should be formulated and validated that combine imaging and clinical assessment criteria.     

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.     

An internationally recognized quality assurance system for diagnostic parasitology in animal health and food safety, with example data on trichinellosis.

A quality assurance (QA) system was developed for diagnostic parasitology and implemented for several diagnostic assays including fecal flotation and sedimentation assays, trichomonad culture assay, and the testing of pork and horse meat for Trichinella to facilitate consistently reliable results. The system consisted of a validated test method, procedures to confirm laboratory capability, and protocols for documentation, reporting, and monitoring. Specific system components included a quality assurance manual, training program, proficiency panels, inter-laboratory check-sample exchange program, assay critical control points, controls, and audits. The quality assurance system of the diagnostic laboratory was audited according to ISO/IEC Standard 17025 by an international third party accrediting body and accredited as a testing laboratory for the specific parasitology tests. Test results generated from the laboratory were reliable and scientifically defensible according to the defined parameters of the tests and were therefore valid for a variety of purposes, including food safety, international trade, and declaration of disease status in an animal, herd, farm, or region. The system was applicable to various test methods for the detection of parasites in feces or other samples, and a digestion test system developed for Trichinella was used as an example. A modified tissue digestion assay was developed, validated, and implemented by the Canadian Food Inspection Agency's Centre for Animal Parasitology for efficiency and quality assurance. The details of the method were properly documented for routine testing and consisted of a homogenization process, an incubation at 45+/-2 degrees C, and two sequential sedimentations in separatory funnels to concentrate and clarify final aliquots for microscopic examination. To facilitate consistently reliable test results, 14 critical control points were identified and monitored, analysts were certified, and the test system verified through the use of validation data, proficiency samples, and training modules.     

The use of low‐dose metronomic chemotherapy in dogs—insight into a modern cancer field

The era of chemotherapy, which started in the middle of the last century, has been ruled by the routine use of dose‐intense protocols, based on the “maximum‐tolerated dose” concept. By promoting a balance between patient's quality of life and the goal of rapidly killing as many tumour cells as possible, these protocols still play a prominent role in veterinary oncology. However, with the opening of a new millennium, metronomic chemotherapy (MC) started to be considered a possible alternative to traditional dose‐intense chemotherapy. Characterized by a long‐term daily administration of lower doses of cytotoxic drugs, this new modality stands out for its unique combination of effects, namely on neovascularization, immune response and tumour dormancy. This article reviews the rationale for treatment with MC, its mechanism of action and the main studies conducted in veterinary medicine, and discusses the key challenges yet to be solved.