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.     

Evaluation of a point‐of‐care blood glucose monitor in healthy goats

Objective

To assess agreement between a point‐of‐care glucometer (POCG) and a laboratory chemistry analyzer for blood glucose measurements in goats.

Design

Prospective study.

Setting

University teaching hospital.

Animals

Eighteen healthy adult goats.

Investigations

Whole blood samples were obtained via jugular venipuncture prior to premedication with xylazine and butorphanol (T0), following premedication (T20), and after 1 hour of inhalant anesthesia (T60). Each sample was tested with a POCG and a laboratory analyzer (HITA). Agreement was assessed using concordance correlation coefficients and calculation of bias and 95% limits of agreement.

Measurements and Main Results

Mean blood glucose concentration at T0 was 3.9 ± 0.6 mmol/L (70 ± 10 mg/dL; POCG) and 2.9 ± 0.4 mmol/dL (53 ± 8 mg/dL; HITA). Glucose concentrations at T20 were 6.7 ± 2.4 mmol/L (121 ± 43 mg/dL) and 5.4 ± 2.1 mmol/L (97 ± 37 mg/dL) and at T60 were 5.7 ± 1.7 mmol/L (102 ± 31 mg/dL) and 4.7 ± 1.3 mmol/L (85 ± 24 mg/dL) when measured with the POCG and HITA, respectively. The POCG overestimated blood glucose compared to the HITA. The bias ± SD was 1.08 ± 0.53 mmol/L (19.4 ± 9.5 mg/dL) (95% LOA 0.04 to 2.11 mmol/L [0.7 to 38.0 mg/dL]) and the concordance correlation coefficient was 0.82. After correcting the results of the POCG using a mixed‐effects linear model, the bias was 0.0 ± 0.38 mmol/L (0.0 ± 6.8 mg/dL) (95% LOA ± 0.74 mmol/L [± 13.4 mg/dL]) and the concordance correlation coefficient was 0.98.

Conclusions

The POCG overestimated blood glucose concentrations in goats, compared to the HITA, but when the POCG concentrations were corrected, the agreement was excellent.     

2010年全国兽药质量监督抽检分析

根据农业部下达的2010年兽药监督抽检计划,2010年共抽检兽药13080批,合格产品共11926批,合格率为91．2％,比2009年兽药监督抽检合格率提高了3．8个百分点,兽药监督抽检合格率有了明显的提高。从抽检类别分析,评价性抽检合格率（93．7％）最高;从抽检环节分析,生产环节抽检合格率（97．2％）最高;从抽检的产品类别分析,化药类产品抽检合格率（92．6％）最高。建议加强对企业不确认产品的监督与核查,加强对违法、违规行为的查处,从而进一步提高兽药监督抽检的效果。     

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.