The Procedure for Accreditation of Medical Laboratories for Compliance with the Requirements of GOST R ISO 15189-2015 «Medical Laboratories. Particular Requirements for Quality and Competence» in the National Accreditation System

Introduction. The laboratory should have a quality management system for laboratory research.
The objective was to analyze the requirements of regulatory documentation related to the accreditation of medical laboratories in the National Accreditation System for compliance with GOST R ISO 15189-2015.
Methods and materials. A retrospective analysis of the requirements of national and industry standards related to medical laboratories was carried out.
Results. The policy management of the activities of the National Accreditation System is based on strict compliance with the requirements of international rules. The provisions of the regulations of the Ministry of Economic Development are a priority for the Federal Accreditation Service. Applicants must comply not only with GOST R ISO 15189-2015, but also with the accreditation criteria of the National Accreditation System. Failure to comply with the requirements related to the traceability of measurement results, measurement uncertainty during calibrations and rules for registration of protocols, entails refusal of accreditation or suspension of its validity.
It is mandatory to provide information on the results of activities, including information on issued reports (protocols) with the attachment of an electronic document «in the form of an electronic image (scanned copy) of the document» using the Federal State Information System, about changes in the composition of its employees and their competence, changes in technical equipment in the field of accreditation, about the temporary absence of an employee. Work experience in the field of employee accreditation needs to be documented. Participation in qualification verification programs in the field of accreditation is a criterion of laboratory competence and confirmation of the reliability of measurement results issued by laboratories. It is important to observe strictly defined deadlines for submitting documents to confirm competence. Submitting an application outside of school hours leads to refusal.
Conclusion. It is necessary to recommend participation in voluntary accreditation for laboratories conducting research at the interstate level. It is necessary to form a state policy in the field of quality of laboratory diagnostics based on GOST R ISO 15189-2015 and formulate it in the format of a federal law. The formed chain of metrological traceability should include reference, calibration and routine laboratories. It is necessary to introduce changes and clarifications into the regulatory framework of the National Accreditation System, taking into account the peculiarities of medical laboratories.

1. Order of the Ministry of Health of the Russian Federation No. 464n. May 18, 2021. «On Approval of the Rules for Laboratory Research» (as amended) (registered with the Russian Ministry of Justice on 01.06.2021, No. 6373737). Available at: http://publication.pravo.gov.ru/Document/View/0001202106010055 (accessed: 22.06.2023). (In Russ.).

2. GOST R ISO 15189-2015. «Medical laboratories. Particular requirements for quality and competence», approved and put into effect by the Order of the Federal Agency for Technical Regulation and Metrology datedApril 27, 2015 No. 297-st «On approval of the national standard». M., Standartinform, 2015. (In Russ.).

3. Korzhov V. Yu., Slepenkova O. A., Bevzyuk E. A., Hlistun Yu. V., Shishelova S. A., Yudina A. B., Ageshkina N. A. Commentary to the Federal Law No. 412-FZ of 28.12.2013 «On accreditation in the national accreditation system» (article-by-article) // SPS KonsultantPlyus. 2015. (In Russ.).

4. GOST 91500.13.0001-2003. «Industry standard. Rules for intralaboratory quality control of quantitative methods of clinical laboratory tests using control materials» (approved by Order of the Ministry of Health of Russia from 26.05.2003 No. 220.Available at: https://dokipedia.ru/document/1722519 (accessed: 22.06.2023). (In Russ.).

5. Order of Russian Ministry of Health of 07.02.2000 No. 45 «On the system of measures to improve the quality of clinical laboratory tests in Russian Federation healthcare institutions» (together with «Regulations on the organization of quality management of clinical laboratory tests in healthcare institutions», «Rulesforintralaboratory quality control of quantitative laboratory tests», «Temporary norms of accuracy of clinical laboratory tests»). Available at: https://docs.cntd.ru/document/901755005 (accessed: 22.05.23). (In Russ.).

6. Order of the Ministry of Health and Medical Industry of the Russian Federation of 03.05.1995 No. 117 (ed. from 19.02.1996). «On the participation of clinical diagnostic laboratories of medical and preventive institutions of Russia in the Federal system of external quality assessment of clinical laboratory tests».Available at: https://base.garant.ru/4120242 (accessed: 22.05.23). (In Russ.).

7. Order of the Ministry of Health of the Russian Federation of 26.01.1994 No. 9. «On improvement of work on external quality control of clinical laboratory tests». URL: https://docs.cntd.ru/document/9049825 (accessed: 22.05.23). (In Russ.).

8. GOST P 53022.1-2008. «Clinical laboratory technologies – Quality requirementsfor clinical laboratory tests». Part 1. Quality management rules for clinical laboratory tests. – Moscow: Standardinform, 2009. (In Russ.).

9. GOST R 53022.2-2008. «Clinical laboratory technologies – Quality requirementsfor clinical laboratory tests». Part 2. Evaluation of analytical reliability of methods of research. Moscow, Standartinform, 2009. (In Russ.).

10. GOSTR 53022.3-2008. «Clinical laboratory technologies –Requirementsforthe quality of clinical laboratory tests». Part 3. Rules for the assessment of clinical informativeness of laboratory tests. Moscow, Standartinform, 2009. (In Russ.).

11. GOST R 53022.4-2008. «Clinical laboratory technologies – Requirements for the quality of clinical laboratory tests». Part 4. Rules for the development of requirements for the timeliness of the provision of laboratory information. Moscow, Standartinform, 2009. (In Russ.).

12. GOST R 53079.1-2008. «Clinical laboratory technologies. Quality assurance of clinical laboratory tests». Part 1. Description of methods of investigation. Moscow, Standardinform, 2009. (In Russ.).

13. GOST R 53079.2-2008. «Clinical laboratory technologies. Quality assurance of clinical laboratory tests». Part 2. Guidance on quality of investigationsin clinical diagnostic laboratory.Typemodel.Moscow, Standartinform, 2009.(InRuss.).

14. GOST R 53079.3-2008. «Clinical laboratory technologies. Quality assurance of clinical laboratory tests». Part 3. Rules of interaction of personnel of clinical departments and clinical diagnostic laboratories of medical organizations in the performance of clinical laboratory tests. Moscow, Standartinform, 2009. (In Russ.).

15. GOST R 53079.4-2008. «Clinical laboratory technologies. Quality assurance of clinical laboratory tests». Part 4. Rules for maintenance of the preanalytical phase. Moscow, Standartinform, 2009. (In Russ.).

16. GOSTR 53133.1-2008. «Clinical laboratory technologies. Quality control of clinical laboratory tests». Part 1. Limits of tolerable errors of measurement results of analytes in clinical diagnostic laboratories. Moscow, Standartinform, 2009. (In Russ.).

17. GOSTR 53133.2-2008. «Clinical laboratory technologies. Quality control of clinical laboratory tests». Part 2. Rules for intralaboratory quality control of quantitative methods of clinical laboratory tests using control materials. Moscow, Standartinform, 2009. (In Russ.).

18. GOSTR 53133.3-2008. «Medical laboratory technologies. Quality control of clinical laboratory tests». Part 3. Description of materialsfor quality control of clinical laboratory tests. Moscow: Standardinform, 2009. (In Russ.).

19. GOSTR53133.4-2008. «Medical laboratory technologies. Quality control of clinical laboratory tests». Part 4. Rules for clinical audit of the effectiveness of laboratory support of medical organizations. Moscow: Standartinform, (In Russ.).

20. Menshikov V. V., Pimenova L. M., Lugovskaya S. A., Pochtar M. E., Soboleva T. N., Zubrikhina G. N., Antonov V. S., Sukhacheva E. A. Standardized technology «Examination of the cellular composition of blood using hematological analyzers». М,2014/ (In Russ.).

21. GOST R 59778-2021. «Procedures for taking venous and capillary blood samples for laboratory research». Moscow, Standartinform, 2021. (In Russ.).

22. Order of the Ministry of Health of the Russian Federation from 31.07.2020 No. 785n. «On approval of the Requirements for organizing and conducting internal control of the quality and safety of medical activities». Available at: https://www.garant.ru/products/ipo/prime/doc/74610282/ (accessed: 22.05.23). (In Russ.).

23. FederalLawof28.12.2013No.412-FZ(ed.of11.06.2021). «On accreditation in the national accreditation system» (with amendments and additions, in force from 01.03.2022). Available at: https://www.consultant.ru/document/cons_doc_LAW_156522/ (date of accession: 22.05.23). (In Russ.).

24. Federal Law of Russian Federation «On ensuring the unity of measurements» No. 102-FZ of 26.06.2008.Available at: https://www.consultant.ru/document/cons_doc_LAW_77904/ (accessed: 22.05.23). (In Russ.).

25. Federal Law of the Russian Federation “On technical regulation» No. 184-FZ of 27.12.2002 Available at: https://www.consultant.ru/document/cons_doc_LAW_40241/ (accessed: 22.05.23). (In Russ.).

26. Order ofthe Ministry of Economic Development ofthe Russian Federation of 30.05.2014 No. 326. «OnApproval of theAccreditation Criteria, the List of Documents Confirming Compliance of the Applicant, Accredited Person with Accreditation Criteria, and the List of Documents in the Field of Standardization, Compliance with whose Requirements by Applicants, Accredited Persons Ensures Their Compliance with Accreditation Criteria». Available at: https://docs.cntd.ru/document/420203443 (access date: 22.05.23). (In Russ.).

27. Order of the Ministry of Economic Development of Russia of 26.10.2020 No. 707 (ed. of 29.10.2021). «On Approval of Accreditation Criteria and List of Documents Confirming Compliance of Applicant, Accredited Person with Accreditation Criteria» (registered with the Russian Ministry ofJustice on 16.11.2020 No. 60907).Available at: https://docs.cntd.ru/document/566305944 (accessed: 22.05.23).(InRuss.).

28. Decree of the Government of the Russian Federation of 26.11.2021 No. 2050. 28. «On Approval of the Rules for accreditation in the national accreditation system, Rules for Certification Procedure of accredited person,RulesforAmendments in data on accredited person included in the register of accredited persons and stipulated by Subparagraphs 7 and 8 Paragraph 1 Article 21 of the Federal Law «On Accreditation in the National Accreditation System», Rules for review of a licensee application fortermination of accreditation andmaking by national accreditation body ofthe decision on termination of accreditation validity of a licensee's competence.Available at: https://www.consultant.ru/document/cons_doc_LAW_401725/ (accessed: 22.05.23). 29. (In Russ.).

29. Order of the Ministry of Economic Development of Russia of 28.01.2021, No. 34. «On Approval of the List of Non-Compliances of the Applicant with the Accreditation Criteria, which Result in Accreditation Denial and the List of Non-Compliances of the Accredited Person with the Requirements of the Russian Federation Law for the Activities of Accredited Persons, which Result in Suspension of Accreditation» (registered with the Russian Ministry of Justice on 31.03.2021, No. 62949). Available at: https://fsa.gov.ru/documents/15722/ (accessed 22.05.23). (In Russ.).

30. GOST ISO/IEC 17025-2019. «General requirements for the competence of testing and calibration laboratories» (approved and put into effect by Order of the FederalAgency for Technical Regulation and Metrology from 15.07.2019 No. 385-st «On enactment of the interstate standard»). Moscow, Standardinform, 2019. (In Russ.).

31. Р 50.1.108-2016. «ILAC policy on traceability of measurement results» (approved and put into effect by Order of the Federal Agency for Technical Regulation and Metrology from October 12, 2016 No. 1387-st «On approval of recommendations for standardization of the Russian Federation»). Moscow, Standardinform, 2016. (In Russ.).

32. Р 50.1.109-2016. «ILAC Policy on Uncertainty in Calibrations» (approved and put into effect by Order of the FederalAgency for Technical Regulation and Metrology dated October 12, 2016 No. 1388-st «On Approval of Recommendations for Standardization of the Russian Federation». Moscow, Standardinform, 2016. (In Russ.).

33. GOST P 58973-2020. «Rules to the execution of test reports» (approved and put into effect by Order of the Federal Agency forTechnicalRegulation and Metrology No. 593-st of August 27, 2020). Moscow, Standardinform, 2020. (In Russ.).

34. Draft Order of the Ministry of Economic Development of Russia «On Amendments to the Orders of the Ministry of Economic Development of Russia No. 707 dated October 26, 2020, No. 496 datedAugust 16, 2021 and on the Recognition of Some Orders of the Ministry of Economic Development of Russia on Accreditation in the National Accreditation System (as of February 11, 2022) (prepared by the Ministry of Economic Development of Russia, Project ID 02/08/02-22/00124915).Available at: https://www.garant.ru/products/ipo/prime/doc/56810396/ (accessed: 22.05.23). (In Russ.).

35. ILAC P9:06/2014. Recommendations on standardization. Conformity assessment. ILAC policy on participation in proficiency testing activities. Moscow, Standardinform, 2021. (In Russ.).

36. GOST ISO/IEC 17043-2013. «Conformity assessment. Basic requirements for proficiency testing» (approved and put into effect by the Order of the Federal Agency for Technical Regulation and Metrology No. 1941-st dated November 22, 2013 «On enactment of the interstate standard». Moscow, Standardinform, 2013. (In Russ.).

37. Order of Rosakkreditatsiya from January 25, 2019 No. 11. «On approval of methodological recommendations on the description of the accreditation scope of a testing laboratory (center)».Available at: https://fsa.gov.ru/documents/9082/ (accessed: 22.05.23). (In Russ.).

38. Proposals(practicalrecommendations) oninternal control of quality and safety ofmedical laboratory activities(developed by FGBU «National Institute of Quality» of Roszdravnadzor). Available at: https://legalacts.ru/doc/predlozhenija-prakticheskie-rekomendatsii-po-organizatsii-vnutrennego-kontrolja-kachestva-i/ (accessed: 22.05.23). (In Russ.).