No third-party funding or support was received in connection with this study or the writing or publication of the manuscript. The authors declare that there were no conflicts of interest.
Key quality indicator
Standard operating procedure
Total quality management system
- 1. ↑
US FDA. Clinical Laboratory Improvement Amendments (CLIA). Available at: www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia. Accessed Jul 29, 2020.
- 2. ↑
American Association of Veterinary Laboratory Diagnosticians. AAVLD accreditation program. Available at: aavld.memberclicks.net/accreditation-explained. Accessed Aug 29, 2020.
- 3. ↑
International Organization for Standardization. ISO 15189:2012. Medical laboratories—requirements for quality and competence. Available at: www.iso.org/standard/56115.html. Accessed Aug 29, 2020.
- 4. ↑
International Organization for Standardization. ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories. Available at: www.iso.org/standard/66912.html. Accessed Aug 29, 2020.
- 5. ↑
Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011;136:829–833.
- 6. ↑
Lundberg GD. Adding outcome as the 10th step in the brain-to-brain laboratory test loop. Am J Clin Pathol 2014;141:767–769.
- 7. ↑
Plebani M, Sciacovelli L, Aita A, et al. Performance criterial and quality indicators for the pre-analytical phase. Clin Chem Lab Med 2015;53:943–948.
- 8. ↑
Deming WE. Out of the crisis. Cambridge, Mass: Massachusetts Institute of Technology, Center for Advanced Engineering Study, 1986;1–17, 465–474.
- 11. ↑
Nabity MB, Harr KE, Camus MS, et al. ASVCP guidelines: allowable total error hematology. Vet Clin Pathol 2018;47:9–21.
- 12. ↑
Harr KE, Flatland B, Nabity M, et al. ASVCP guidelines: allowable total error guidelines for biochemistry. Vet Clin Pathol 2013;42:424–436.
- 13. ↑
- 14. ↑
Camus MS, Flatland B, Freeman KP, et al. ASVCP guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories. Vet Clin Pathol 2015;44:477–492.
- 15. ↑
Veterinary Laboratory Association. Quality assurance program. Available at: www.vetlabassoc.com/quality-assurance-program. Accessed Sep 11, 2020.
- 16. ↑
Synlab. Veterinary quality assurance scheme. Available at: vet.synlab.co.uk/the-veterinary-pathology-group-launches-their-external-quality-assurance-scheme. Accessed Sep 11, 2020.
- 17. ↑
Idexx. EQA programme for Idexx VetLab analysers. Available at: www.idexx.co.uk/en-gb/veterinary/reference-laboratories/eqa-programme. Accessed Sep 11, 2020.
- 18. ↑
Arnold JE, Camus MS, Freeman KP, et al. ASVCP guidelines: principles of quality assurance and standards for veterinary clinical pathology (version 3.0): developed by the American Society for Veterinary Clinical Pathology's (ASVCP) Quality Assurance and Laboratory Standards (QALS) Committee. Vet Clin Pathol 2019;48:542–618.
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Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments. Available at: www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index. Accessed Jul 29, 2020.
- 21. ↑
Royal College of Veterinary Surgeons. Apply for accreditation. Available at: www.rcvs.org.uk/setting-standards/practice-standards-scheme/apply-for-accreditation. Accessed Jul 29, 2020.
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American Animal Hospital Association. AAHA standards of accreditation. Available at: www.aaha.org/accreditation-membership/aaha-standards. Accessed Jul 29, 2020.
Hypothetical example of a quality plan for an in-clinic laboratory.
|Quality Plan for Laboratory Services|
Checklist for development of a TQMS for in-clinic laboratories.
|Recommendation||Compliant?||Additional comments by auditor|
|At least 1 quality manager or team leader is identified who has a special interest in laboratory testing and who can educate and motivate the entire staff to participate in a culture of laboratory quality and continuous improvement.||□ Yes □ No|
|A quality plan is drafted that includes descriptions of the laboratory environment, personnel, equipment, and working practices.||□ Yes □ No|
|Quality goals are drafted for preanalytic, analytic, and postanalytic phases of testing.||□ Yes □ No|
|SOPs are developed for all laboratory functions.||□ Yes □ No|
|QC data are assessed for automated instruments per manufacturer instructions or more frequently. If QC failure occurs, the protocol is to cease patient sample analysis and troubleshoot until laboratory instruments are operating within QC specifications.||□ Yes □ No|
|Laboratory spaces and equipment are clean and well maintained, with logs for recording cleaning and maintenance activities.||□ Yes □ No|
|Reagents and other supplies are stored and disposed of properly. An inventory list is maintained with preferred and backup suppliers.||□ Yes □ No|
|Key quality indicators for the preanalytic, analytic, and postanalytic testing phases have been identified and are tracked, with number and percentage of errors and nonconformities evaluated at routine intervals against predefined goals. Smaller laboratories may choose to keep an incident log.||□ Yes □ No|
|Preventive and corrective actions are taken as appropriate to decrease errors, with scheduled periodic review to assess the effectiveness of these actions.||□ Yes □ No|
|SOPs and the TQMS are reviewed for potential updates or improvements at predetermined intervals. Such reviews will include staff and client feedback and evaluation of any changes implemented since the previous review.||□ Yes □ No|