ASVCP guidelines: Allowable total error hematology Nabity, Mary B.; Harr, Kendal E.; Camus, Melinda S. ...
Veterinary clinical pathology,
March 2018, 2018-Mar, 2018-03-00, 20180301, Volume:
47, Issue:
1
Journal Article
Peer reviewed
Open access
The purpose of this document is to provide total allowable error (TEa) 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 TEa in instrument performance evaluation, including recommendations for when the total observed error exceeds the recommended TEa. Biological variation‐based quality specifications are briefly discussed. The appendix describes the derivation of the hematology TEa recommendations and provides resources for external quality assurance/proficiency testing programs and a worksheet for implementation of the guidelines.
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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.
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Cytologic examination of the urine sediment in animals suspected of having urinary tract disease or lower urinary tract masses is one of the best means of distinguishing inflammation, infection, and ...neoplasia and can help determine if a positive dipstick result for hemoglobin/blood is due to hemorrhage or blood contamination. The quality of the specimen collection and handling plays an important role in the quality of results, the validity of interpretations, and selection of appropriate course of action. The method of sample collection aids localization of pathology. Air dry but do not heat fix, freeze, or expose films to formalin fumes, temperature extremes, or condensation.
Background
The Cobas u411 Analyzer (Roche Diagnostics) is an automated, reflectance photometry‐based urinalysis instrument designed for use with Roche's CHEMSTRIP 10UA technology and human urine ...samples.
Objective
We aimed to optimize and validate the Cobas u411 Analyzer for use in canine and feline urinalysis.
Methods
Patient urine samples presenting to the Clinical Pathology Laboratory at the Colorado State University Veterinary Teaching Hospital were analyzed with the Cobas u411 and by manual readings in parallel. Initially, 223 canine and 83 feline urine samples were run using the u411 factory settings. Following comparisons with manual results, and evaluation for directional bias, adjustments to the reflectance values were made in the instrument's programming. An additional 183 canine and 95 feline samples were run using the adjusted settings. Total urine protein concentrations were measured in 48 samples and used to generate receiver operating characteristic curves for the protein test pad.
Results
Following adjustments in reflectance programming, concordance between u411 and manual results was increased by 17.7% for protein, 11.7% for ketones, and 4.5% for bilirubin. Concordances for pH, glucose, and blood were not substantially changed. Discordance for all analytes was ≤3%. Canine and feline samples had similar levels of discordance, though marginal concordance was higher in dogs for ketones, bilirubin, and blood.
Conclusions
Adjustments to the reflectance programming of the Cobas u411 Analyzer improved concordance with manual results for canine and feline samples. This instrument has the potential to greatly increase both efficiency and consistency of urinalysis procedures in higher throughput veterinary diagnostic laboratories.
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: 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.
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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.
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In-house hematology testing has distinct advantages and requires an ongoing commitment to quality assurance. Hematology POCA should always be operated by qualified personnel who have received ...adequate instrument operational, safety, and biohazard training. Likewise, blood samples should be acquired and handled, and blood smears made, by adequately trained personnel. Nonstatistical QA procedures are vital to minimize all types of laboratory error (preanalytical, analytical, and postanalytical) and include many common sense procedures already performed in well-maintained veterinary practices. Blood smear review is a critical component of QA in hematology testing. Each veterinary practice using POCA must determine frequency of QC (ie, frequency of “running controls”) based on factors such as POCA analyzer type, clinic operating budget, and caseload; at least daily QC is encouraged if possible. QC should be performed frequently enough that QCM are used cost-effectively and that POCA analytical error can be reliably detected. Unacceptable QC data (however defined) should prompt investigation of the POCA, reagents, and operator. Veterinarians and veterinary technicians are encouraged to pursue continuing education about laboratory quality management and to utilize relevant guidelines, such as those available from the ASVCP.
A 20-year-old gelding was diagnosed with peritonitis and severe reactive mesothelial hyperplasia. Exploratory laparotomy findings were suggestive of a neoplastic etiology; however, additional ...diagnostics ruled this out and the horse made a full recovery. This report demonstrates the difficulty and value of differentiating between reactive and neoplastic mesothelial processes.
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