Methodological Approaches to Creating a Documented Scope of Accreditation for Parasitology Laboratories

Introduction: The experience of individual countries in developing quality management systems provides a valuable resource for borrowing the most successful projects and understanding the resulting effects.

Objective: To present methodological approaches to developing a law enforcement framework for the scope of accreditation of a parasitology laboratory given the resource availability.

Materials and Methods: We conducted a comparative legal analysis of enforcement of the approved Rosaccreditation guidelines for elaborating the parasitology section of the scope of accreditation based on 21 regulations, seven instructions and guidelines. A methodological approach was used to create the key elements of the scope of accreditation for parasitology laboratories, taking into account regulation of its facilities by two or more different-level documents with explanations.

Results: The article describes the approaches to documenting the scope of accreditation under different levels of current regulations. When documenting the scope for parasitology laboratories, the facilities of which are regulated by two or more legal documents, the following recommendations must be implemented:

1)       The scope of accreditation should include all documents based on a practical approach to the readiness of the testing laboratory to perform various target tasks; and

2)       Methodological support for testing should meet all resource availability parameters for assessing the quality of procedural, organizational, and managerial solutions during testing.

The article also describes the main principles of enforcement of the guidelines issued by the Russian Federal Accreditation Service in 2019 for describing the scope of accreditation of parasitology laboratories, the conformity assessment of which is regulated by two or more legal acts simultaneously, e.g. Technical Regulations of the Customs Union, state standards and/or sanitary rules, and can be chosen by the testing laboratory depending on the resources.

Conclusion: The proposed approach to creating structural elements of the scope of accreditation and explanations to it may contribute to improving training of specialists for accreditation tasks.

1.

2. Manukyan GA. Foreign experience in quality management. Teoriya i Praktika Sovremennoy Nauki. 2022;(4(82)):128-131. (In Russ.)

3. Okawa Y, Yamashita H, Masuyama S, Fukazawa Y, Wakayama I. Quality assessment of Japanese clinical practice guidelines including recommendations for acupuncture. Integr Med Res. 2022;11(3):100838. doi: 10.1016/j.imr.2022.100838

4. Parija SC. From the desk of editor-in-chief: Ensuring quality assurance in parasitology laboratories. Trop Parasitol. 2025;15(2):69-70. doi: 10.4103/tp.tp_81_25

5. Cools P, van Lieshout L, Koelewijn R, et al. First international external quality assessment scheme of nucleic acid amplification tests for the detection of Schistosoma and soil-transmitted helminths, including Strongyloides: A pilot study. PLoS Negl Trop Dis. 2020;14(6):e0008231. doi: 10.1371/journal.pntd.0008231

6. Xia J, Ning X, Jiang L, et al. Visual analysis of quality management in Chinese drug clinical trials based on CiteSpace and COOC. Front Med (Lausanne). 2025;12:1600915. doi: 10.3389/fmed.2025.1600915

7. Zhang J, Tang S, Sun P. From command-control to lifecycle regulation: Balancing innovation and safety in China’s pharmaceutical legislation. Healthcare (Basel). 2025;13(6):588. doi: 10.3390/healthcare13060588

8. Cao S, Liang W, Liang C, et al. Impact of China Guidelines for Pharmacoeconomic Evaluations on study quality: A systematic review of economic evaluations in China. Health Econ Rev. 2025;15(1):53. doi: 10.1186/s13561-025-00650-7

9. Yi K, Qian K, Du X, Zhang M. Application of Sigma metrics for the optimization of quality control program in the clinical chemistry laboratory. Clin Lab. 2025;71(8):241039. doi: 10.7754/Clin.Lab.2025.241039

10. von der Leyen H, Delgado J, Mazouz C, Schmitt M, Caplan V. Implementation of a quality management system for decentralized manufacturing of cell and gene therapy products – technical and regulatory considerations. Front Med (Lausanne). 2025;12:1591751. doi: 10.3389/fmed.2025.1591751

11. Kropp M, Harmening N, Bascuas T, et al. GMP-grade manufacturing and quality control of a non-virally engineered advanced therapy medicinal product for personalized treatment of age-related macular degeneration. Biomedicines. 2022;10(11):2777. doi: 10.3390/biomedicines10112777

12. Giannoli JM, Vassault A, Carobene A, et al.; International Federation of Clinical Chemistry; Laboratory Medicine Task Force on Global Lab Quality TF-GLQ. Ensuring internal quality control practices in medical laboratories: IFCC recommendations for practical applications based on ISO 15189:2022. Clin Chim Acta. 2025;571:120240. doi: 10.1016/j.cca.2025.120240

13. Ardysheva AA. Analysis of reforming accreditation and standardization in accordance with international requirements. Aktual’nye Problemy Aviatsii i Kosmonavtiki. 2016;2(12):134-135. (In Russ.)

14. Glebova EV, Dokuchaevа AV, Kuznecova OV, Torba AS, Yazykov RO. Scientific-practical bases of forming field accreditation of testing laboratories in the monitoring system quality and safety of fish products the Far East. Nauchnye Trudy Dal’rybvtuza. 2015;34:109-115. (In Russ.)

15. Glebova EV, Dokuchaevа AV, Panachina VS, Yazykov RO, Torba AS. Process preparation for the accreditation testing laboratory. Nauchnye Trudy Dal’rybvtuza. 2015;36:113-119. (In Russ.)

16. Tarasova EYu, Petrova EI. Accreditation as a major element in ensuring the quality of facilities and services. Elektronnyy Nauchno-Metodicheskiy Zhurnal Omskogo GAU. 2016;(3(6)):17. (In Russ.)

17. Ardysheva AA, Soldatova SV, Zhirnova EA. The procedure for the verification of compliance with legal requirements of technical regulation and accreditation of testing laboratories and legal certification. Aktual’nye Problemy Aviatsii i Kosmonavtiki. 2015;2(11):64-66. (In Russ.)

18. Zhiltzov EN, Egorov EV, Naumenko TV, et al. [Economics and Social Management: A Manual for Bachelors.] Moscow: Dashkov and Co.; 2015. (In Russ.)

19. Molchanov IN, Titova AI. [Informatization as a factor in improving the quality of public services delivery.] In: Russia: Development Trends and Prospects: Conference Proceedings, Moscow, December 20–21, 2016. Moscow: RAS Institute of Scientific Information on Social Sciences; 2017;(12-2):620-624. (In Russ.)

20. Molchanov IN, Titova AI. Improving the management of providing public services process by Federal Service for Accreditation. Strategii Biznesa. 2017;(11):25-29. (In Russ.) doi: 10.17747/2311-7184-2017-11-25-29

21. Alizade MQ. State services in Russia: Notion (concept) and types. Vestnik Universiteta Imeni O.E. Kutafin (MGYuA). 2019;(6(58)):173-178. (In Russ.) doi: 10.17803/2311-5998.2019.58.6.173-178

22. Kazakova NE. Problems of professional and public accreditation in Russia: Comprehensive analysis. Vek Kachestva. 2024;(2):270-278. (In Russ.)

23. Kolennikova OA, Toksanbaeva MS. Systemic problems of institutions for assessing the qualification of medical specialists. Problemy Sotsial’noy Gigieny, Zdravookhraneniya i Istorii Meditsiny. 2022;30(S):1027-1032. (In Russ.) doi: 10.32687/0869-866X-2022-30-s1-1027-1032

24. Slepchuk YV, Gorelova AV. Actual issues of reforming the accreditation system. Aktual’nye Problemy Aviatsii i Kosmonavtiki. 2017;2(13):831-833. (In Russ.)

25. Abramovsky PD. [German experience in quality management.] In: Information and Telecommunication Systems and Technologies: Proceedings of the Russian Scientific and Practical Conference, Kemerovo, October 8–10, 2020. Kemerovo: T.F. Gorbachev Kemerovo State Technical University; 2020:184-187. (In Russ.)

26. Demidenko GN, Medvedev IV, Sulman MG. Problems of accreditation of conformity assessment bodies. Byulleten’ Nauki i Praktiki. 2017;(2(15)):299-303. (In Russ.) doi: 10.5281/zenodo.291917

27. Kolennikova OA, Toksanbaeva MS. Factors of dysfunction of institutes for assessing the qualifications of medical specialists. Zdravookhranenie Rossiyskoy Federatsii. 2021;65(5):467-476. (In Russ.) doi: 10.47470/0044-197X-2021-65-5-467-476