Principles of laboratory service management in modern conditions

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Abstract

Introduction. Today, the medical laboratory is focused on operational efficiency and cost control. Our work presents the experience of transforming laboratory practice, its informatization and reorganization of the management model.

Purpose of the study. Creation of a management model for fast, economical and high-quality testing in laboratories of various levels to provide Muscovites with laboratory services in full.

Materials and methods. An assessment of the resource support of clinical diagnostic laboratories (CDL) of the Moscow City Health Department (MCHD) number of attached population and the need for tests, made it possible to develop and implement concepts for their centralization in the outpatient clinic link, unify the nomenclature of laboratory studies and tests, create a unified reference book of laboratory studies (IF) for the centralized laboratory service (CLS) of the unified medical information and analytical system (UMIAS), develop a plan for the development of a quality management system based on international standards and begin the activity on the standardization of laboratory services through accreditation of medical laboratories in the national accreditation system, manage centralized large-scale screening for SARS-CoV-2; implement sequencing technology (NGS) for genomic surveillance.

Results. The MCHD laboratory service is built according to a 3-level system. There is a complex IF EMIAS. Laboratory studies are computerized, test results are transferred to the personal account and the patient’s electronic medical record. A single information space has been created for all CDL MCHD. The tariffs for laboratory services of the registry of the Moscow City Compulsory Medical Insurance Fund (MCCMIF) have been changed, the list has been optimized. Under the control of spending, the productivity of laboratories has increased. Moscow’s needs for laboratory services have been met.

Research limitations. The scenario of managerial approaches was carried out in a strategic partnership with MCHD, proved to be viable only in the conditions of the city of Moscow.

Conclusion. The problems of precision medicine have been solved and the sustainable provision of laboratory services to the population by the clinical diagnostic laboratories of the MCHD has been ensured.

Compliance with ethical standards. The study was approved at a meeting of the Scientific and Methodological Council of the Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department, Moscow, 115088, Russian Federation in Moscow, protocol No. 5 dated May 17, 2022, the materials of the completed study meet the requirements of the Code of Ethics for conducting research in the field of healthcare institutions and public health, developed in the, on compliance with ethical standards in the process of preparing a study, respect for human rights in relation to respondents and researchers themselves, compliance with a social portrait and the necessary training of interviewers.

Contribution of the authors:
Tsibin A.N. — concept and design of the study;
Latypova M.F. — collection and processing of material, writing the text;
Komarov A.G. — writing text;
Slutsky E.A. — collection and processing of material;
Ivanushkina O.I. — compiling a list of references.
All co-authors — approval of the final version of the article, responsibility for the integrity of all parts of the article.

Acknowledgment. Organizational measures and logistical support of subordinate clinical diagnostic laboratories were carried out with the support of the Moscow Department of Health.

Conflict of interests. The authors declare no conflict of interest.

Received: July 18, 2022 
Accepted: September 07, 2022
Published: December 12, 2022

About the authors

Alexander N. Tsibin

Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department

Author for correspondence.
Email: noemail@neicon.ru
ORCID iD: 0000-0002-0169-4820
Russian Federation

Munira F. Latypova

Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department

Email: kdlorg-1@mail.ru
ORCID iD: 0000-0002-2643-7791

Candidate of Biological Sciences, Chief Specialist of the Organizational and Methodological Department for Clinical Laboratory Diagnostics of the Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department, Moscow, 115088, Russian Federation.

e-mail: kdlorg-1@mail.ru

Russian Federation

Andrew G. Komarov

Diagnostic Center (Laboratory Testing Center) of Moscow Healthcare Department

Email: noemail@neicon.ru
ORCID iD: 0000-0001-8200-0503
Russian Federation

Egor A. Slutsky

Diagnostic Center (Laboratory Testing Center) of Moscow Healthcare Department

Email: noemail@neicon.ru
ORCID iD: 0000-0001-6211-006X
Russian Federation

Olga I. Ivanushkina

Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department

Email: noemail@neicon.ru
ORCID iD: 0000-0003-3675-8166
Russian Federation

References

  1. Tsai E.R., Tintu A.N., Demirtas D., Boucherie R.J., de Jonge R., de Rijke Y.B. A critical review of laboratory performance indicators. Crit. Rev. Clin. Lab. Sci. 2019; 56(7): 458–71. https://doi.org/10.1080/10408363.2019.1641789
  2. Church D.L., Naugler C. Essential role of laboratory physicians in transformation of laboratory practice and management to a value-based patient-centric model. Crit. Rev. Clin. Lab. Sci. 2020; 57(5): 323–44. https://doi.org/10.1080/10408363.2020.1720591
  3. Beriault D.R., Gilmour J.A., Hicks L.K. Overutilization in laboratory medicine: tackling the problem with quality improvement science. Crit. Rev. Clin. Lab. Sci. 2021; 58(6): 430–46. https://doi.org/10.1080/10408363.2021.1893642
  4. Khatab Z., Yousef G.M. Disruptive innovations in the clinical laboratory: catching the wave of precision diagnostics. Crit. Rev. Clin. Lab. Sci. 2021; 58(8): 546–62. https://doi.org/10.1080/10408363.2021.1943302
  5. Naugler C., Church D.L. Automation and artificial intelligence in the clinical laboratory. Crit. Rev. Clin. Lab. Sci. 2019; 56(2): 98–110. https://doi.org/10.1080/10408363.2018.1561640
  6. Church D.L., Naugler C. Using a systematic approach to strategic innovation in laboratory medicine to bring about change. Crit. Rev. Clin. Lab. Sci. 2022; 59(3): 178–202. https://doi.org/10.1080/10408363.2021.1997899
  7. Ozarda Y., Sikaris K., Streichert T., Macri J. Distinguishing reference intervals and clinical decision limits – A review by the IFCC Committee on Reference Intervals and Decision Limits. Crit. Rev. Clin. Lab. Sci. 2018; 55(6): 420–31. https://doi.org/10.1080/10408363.2018.1482256
  8. Armes P. Using CLSI at university of Texas southwestern medical center library. Sci. Technol. Libr. 1988; 9(1): 35–41. https://doi.org/10.1300/J122v09n01_05
  9. Review on the topic «Accreditation of certification bodies for products and testing laboratories». Part 5. Experience of accreditation in foreign countries. Available at: https://www.academ-s.ru/articles/chast_5_opyt_akkreditatsii_v_zarubezhnykh_stranakh/ (in Russian)
  10. Lippi G., Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin. Chem. Lab. Med. 2020; 58(7): 1131–4. https://doi.org/10.1515/cclm-2020-0198
  11. Lippi G., Simundic A.M., Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin. Chem. Lab. Med. 2020; 58(7): 1070–6. https://doi.org/10.1515/cclm-2020-0285
  12. Zou L., Ruan F., Huang M., Liang L., Huang H., Hong Z., et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N. Engl. J. Med. 2020; 382(12): 1177–9. https://doi.org/10.1056/nejmc2001737
  13. van Zyl G., Maritz J., Newman H., Preiser W. Lessons in diagnostic virology: expected and unexpected sources of error. Rev. Med. Virol. 2019; 29(4): e2052. https://doi.org/10.1002/rmv.2052
  14. WHO. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance; 2020. Available at: https://apps.who.int/iris/handle/10665/331329
  15. Centers for Disease Control and Prevention. Interim guidelines for collecting, handling, and testing clinical specimens from persons under investigation (PUIs) for coronavirus disease 2019 (COVID-19), 2020. Available at: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
  16. Kuang J., Yan X., Genders A.J., Granata C., Bishop D.J. An overview of technical considerations when using quantitative real-time PCR analysis of gene expression in human exercise research. PLoS One. 2018; 13(5): e0196438. https://doi.org/10.1371/journal.pone.0196438
  17. Cuong H.Q., Hai N.D., Linh H.T., Anh N.H., Hieu N.T., Thang C.M., et al. Comparison of primer-probe sets among different master mixes for laboratory screening of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2). Biomed. Res. Int. 2020; 2020: 7610678. https://doi.org/10.1155/2020/7610678
  18. Gürtler C., Laible M., Schwabe W., Steinhäuser H., Li X., Liu S., et al. Transferring a quantitative molecular diagnostic test to multiple real-time quantitative PCR platforms. J. Mol. Diagn. 2018; 20(4): 398–414. https://doi.org/10.1016/j.jmoldx.2018.02.004
  19. Lippi G., Simundic A.M. The EFLM strategy for harmonization of the preanalytical phase. Clin. Chem. Lab Med. 2018; 56(10): 1660–6. https://doi.org/10.1515/cclm-2017-0277

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