The main scientific provisions formulated by the author on the basis of the research:
- The introduction of a quality management system in clinical diagnostic laboratories of blood service institutions makes it possible to ensure the transition from the performance of functional duties of QLD specialists aimed at the technical execution of laboratory tests to the policy of ensuring the quality system of clinical laboratory diagnostics processes with the introduction of the function of a quality management representative, chief and internal auditors, ensuring effective use human resources due to the rational arrangement of equipment, personnel, rationalization and intensification of labor.
- The introduction into the activities of blood service institutions of the developed algorithms for examining donors, culling of hemocomponents, withdrawal from donation based on the results of a study for blood-contact hemotransmissible infections can improve the safety of donation.
- Medical economic efficiency implementation of the developed algorithms for laboratory diagnosis of bloodborne infections is to reduce the residual risk of post-transfusion infection, reduce the incidence in this spectrum of pathology and reduce the cost of treatment.
- The developed calculation system, which is based on the study of the dependence of the cost of donor blood tests to ensure the infectious safety of various amounts of daily donations with various levels automation of the laboratory, allows you to evaluate the effectiveness of the centralization of laboratory research for all institutions of the blood service.
- The cost-effectiveness of organizing a laboratory for the study of at least 200 blood samples per day for the determination of markers of 4 blood-contact-transmissible diseases has been shown.
1. Tarasenko O.A., Polyakov S.V. To be clinical laboratory diagnostics in Moscow polyclinics // Clinical laboratory diagnostics. - 2003 - No. 9. - P. 4-5.
2. Tarasenko O.A., Zhukhovitsky V.G. Prospects for the development of microbiological diagnostics in medical institutions in Moscow // Clinical laboratory diagnostics. - 2003. - No. 9. - P. 5-6.
3. Tarasenko O.A., Gukasyan I.A., Goldyreva N.G., Bondarenko V.A., Vasil'eva O.L. Experience in using the INNO-LIA confirmatory test for hepatitis C // Bulletin of the blood service of Russia. - 2004. - No. 3. - S. 30-32.
4. Tarasenko O.A. The work of clinical diagnostic laboratories of health care institutions with pathogens of infectious diseases of III-IV pathogenicity groups // Clinical laboratory diagnostics. - 2007. - No. 9. -FROM. 25-26.
5. Tarasenko O.A., Shubina Yu.F. Risk assessment of transfusion-transmissive transmission of viral hepatitis C // Bulletin of the RSMU. - 2010. No. 2. -S. 51-53.
6. Tarasenko O.A., Gukasyan I.A., Sobolevskaya L.V., Shubina Yu.F., Popova I.Yu., Kulinich L.I., Chernenko T.V., Bondarenko V.A. The first effective experience of using multiplex screening systems for donor blood to detect HBV infection in HBsAg-negative donors // Blood Service Bulletin - 2009. - No. 3. - P. 18-20.
7. Tarasenko O. A., Zakharova L. R., Toguzov R. T. Laboratory information system in ensuring the efficient operation of the centralized blood service laboratory. Clinical laboratory diagnostics. - 2008 No. 9, S. 36.
8. Tarasenko O. A., Brodskaya A. P. Information systems in ensuring the safety of donation. // Clinical laboratory diagnostics. - 2008 No. 9, S. 39.
9. Tarasenko O. A., Zakharova L. R., Lukin Yu. information systems as a guarantee of quality assurance and continuity of research in the laboratory of the metropolis. // Clinical laboratory diagnostics. - 2008 No. 9, S. 39.
10. Tarasenko O. A., Tarasenko Yu. F. Molecular biological methods in the system of ensuring the safety of blood transfusions. // Clinical laboratory diagnostics. - 2008. - No. 9. - P. 46.
11. Tarasenko O.A., Tarasenko Yu.F. Ensuring the viral safety of blood products and components in blood service institutions of the Moscow City Health Department - Abstracts XIII International Conference"New information technologies in medicine, biology, pharmacology and ecology". - 2005. - P. 210-211.
12. Tarasenko O.A. Organizational aspects in the activities of CDL to ensure the prevention of nosocomial infections - Abstracts of the III Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2005. - S. 22.
13. Tarasenko O.A., Zakharov V.V. Laboratory support of viral safety of blood products and blood components in the prevention of bloodborne diseases - Abstracts of the III Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2005. - S. 23.
14. Tarasenko O.A., Zakharov V.V., Oprishchenko S.A., Larina MN. Effective quarantine in ensuring the prevention of nosocomial infections. – Abstracts of the IV Scientific-practical conference “Nosocomial infections in hospitals of various profiles, prevention, treatment of complications. - M., 2006. -S. 19.
15. Tarasenko O.A. Provision of microbiological benefits to medical and preventive institutions of the Department of Health of the city of Moscow. - Abstracts of the IV Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2006. - S.36-37.
16. Tarasenko O.A., Zakharov V.V., Oprishchenko S.A. The system of culling of harvested products in the blood service of the Department of Health in ensuring the prevention of nosocomial infections. - Abstracts of the IV Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2006. -S. 37-38.
17. Tarasenko O.A., Olshansky A.Ya., Tarasenko. Yu.F., Bondarenko V.A. Rationale for testing blood serum samples of donors that do not contain HBsAg for other serological markers of hepatitis B virus to reduce the risk of post-transfusion complications. - Abstracts of the XIV International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology". - Gurzuf, 2006. - S. 175-176.
18. Tarasenko O.A., Tarasenko Yu.F. The system of culling of prepared products in the blood service based on the results of testing donor blood for markers of infectious diseases. – Abstracts of the XIV International Conference “New Information Technologies in Medicine, Biology, Pharmacology and Ecology”. - M.. 2006. - S. 178.
19. Tarasenko O.A., Zakharov V.V. Quarantine of hemocomponents in reducing the risk of post-transfusion hemotransmissible diseases. - Materials of the V Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2007. -S. 25.
20. Tarasenko O.A., Zakharov V.V., Tarasenko Yu.F. The effectiveness of a new algorithm for laboratory examination of blood donors and its components and the use of prepared products in the prevention of nosocomial infections. - Abstracts of the V Scientific-practical conference “Nosocomial infections in hospitals of various profiles, prevention, treatment of complications. - M., 2007. - S. 46-47.
21. Tarasenko O.A., Kundelsky R.V. Economic aspects centralization of laboratory tests for blood service institutions – Materials scientific and practical conference « Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis. - 2008. -S. 23-25.
22. Tarasenko O.A., Torshin V.A. Modern solutions in laboratory express diagnostics of critical conditions. - Abstracts of the scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis." - 2008. - S. 25-26.
23. Tarasenko O.A. The view of a doctor of clinical laboratory diagnostics on the issues of licensing activities related to the use of pathogens of infectious diseases in ensuring the prevention of nosocomial infections. - Abstracts of the VI Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - 2008. -S. 55-56.
24. Tarasenko O.A., Olshansky A.Ya., Gukasyan I.A., Bondarenko V.A., Tarasenko Yu.F. The presence of total anti-HBcor antibodies in blood serum samples of donors that do not contain HBsAg. - Abstracts of the VI Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2008. - S. 56-57.
25. Tarasenko O.A., Osipova O.N. Biosecurity Fundamentals medical personnel at the preanalytical stage of laboratory research. - Abstracts of the VI Scientific-practical conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications" - M., 2008. - P. 57-58.
26. Tarasenko O.A., Troshin A.N., Kundelsky V.R. Economic aspects of the centralization of laboratory divisions of the blood service // Healthcare and medical equipment. - 2005. - No. 4. - S. 34.
27. Tarasenko O.A. Staffing of clinical diagnostic laboratories: legislative base // Health care and medical equipment. - 2005. - No. 7. - S. 32 - 34.
28. Tarasenko O.A. Problems of admission to work in clinical diagnostic (including microbiological) laboratories of medical and preventive institutions of specialists with higher education// Laboratory medicine. - 2005. - No. 7. - S. 15-16.
29. Tarasenko O.A. Prevention of hemotransmissible diseases in the blood service of the city of Moscow. - Materials of the city seminar "Actual issues of prevention of bloodborne infections in a multidisciplinary hospital." - M., 2006. -S.19-22.
30. Tarasenko O.A., Osipova O.N., Tarasenko Yu.F., Eremina M.V. Standard operating procedures for conducting the preanalytical stage of the activities of clinical diagnostic laboratories // Handbook of the head of the CDL. - 2007. - No. 4. - S. 13-19; No. 5. - S. 23-28; No. 6.- S. 11-14.
31. Tarasenko O.A., Tarasenko Yu.F., Zakharov V.V. Laboratory aspects of ensuring the infectious safety of blood transfusions // Sterilization and hospital infections. -2007. - No. 2 (4). - S. 18-23.
32. Tarasenko O.A. A look at the licensing of activities related to the use of pathogens of infectious diseases from the clinical diagnostic laboratory // Sterilization and hospital infections. - 2007. - No. 4 (6). - S. 17-19.
33. Oprishchenko S.A., Tarasenko O.A., Tarasenko Yu.F. The use of laboratory technologies in the blood service to ensure the infectious safety of hemocomponents.// Healthcare and medical technologies. - M. - 2008. - No. 5. - S. 24-26.
34. Tarasenko O.A., Novikov V.A., Osipova O.N., Emmanuel A.V. Implementation of international standards of the ISO system in Russia - problems and prospects // Clinical and laboratory consultation. - 2008. - No. 6 (25). -FROM. 4-7.
35. Tarasenko O.A. Preliminary determination of the blood group. Screening studies for HIV. Performance of the functions of the head of the CDL // Reference book of the head of the CDL. - 2008. - No. 9. - S. 24-26.
36. Tarasenko O.A. Modern laboratory technologies in ensuring the prevention of the development of post-transfusion infectious complications. Sterilization and hospital infections. - 2009. - No. 1. - S. 42-45.
37. Tarasenko O.A. Laboratory technologies in ensuring the infectious safety of blood transfusions // Handbook of the head of the CDL. - 2009. - No. 1. - S. 10-15.
38. Tarasenko O.A., Emanuel V.L., Emanuel A.V. Organization of work of a quality specialist // Medicine and quality. Quality management in healthcare and social development. - 2009. - No. 5. - S. 111-117.
39. Tarasenko O.A., Golovastova G.I. Medical and economic solution to the problems of ensuring the quality of laboratory diagnostics // Medical Alphabet. Laboratory - 2009. - No. 2. pp. 4-5.
40. Tarasenko O.A., Golovastova G.I., Emanuel V.L. Import-substituting products for high-tech clinical and diagnostic laboratories // Handbook of the head of the CDL. - 2009. - No. 7. С23-28.
41. Tarasenko O.A. Mayorova O.A., Shubina Yu.F. Effective laboratory methods in reducing the risk of transfusion-transmissible transmission of viral hepatitis C// Medical Alphabet. Epidemiology and sanitation. - 2009. - No. 1. pp. 8-10.
42. Tarasenko O.A. Responsibilities of a paramedic, laboratory assistant. License to work with microorganisms of the 3rd-4th pathogenicity groups. Disposal of waste from healthcare facilities. Working with immersion oil Issuance of milk // Directory of the head of the CDL. - 2009. - No. 6. pp. 26-28.
43. Tarasenko O.A., Shubina Yu.F. Effective laboratory diagnosis of viral hepatitis C in ensuring epidemic well-being - Proceedings of the scientific-practical conference "Laboratory medicine in the light of the Concept for the development of healthcare in Russia until 2020. - 2009. - P. 242.
44. Tarasenko O.A. Features of the organization of the work of laboratories for examining patients in hospitals in emergency conditions - Proceedings of the scientific-practical conference "Laboratory medicine in the light of the Concept for the development of health care in Russia until 2020. - 2009. - P. 247-248
45. Tarasenko O.A., Osipova O.N. Model staffing of centralized clinical diagnostic laboratories - Proceedings of the scientific-practical conference "Laboratory medicine in the light of the Concept for the development of health care in Russia until 2020. - 2009. - P. 258-259.
46. O. A. Tarasenko, A. I. Kryukov, N. V. Pavlov, Yu. V. Varshavskii, V. T. Palchun, N. L. Kunel’skaya, R. B. Khamzalieva, and G. N. Turovsky A.B., Kirasirova E.A., Romanenko S.G., Garov E.V. Therapeutic and diagnostic algorithm for the pathology of ENT organs: Guidelines No. 14. - M .: "Department of Health of the City of Moscow", 2007. - 62 p.
As a manuscript
Tarasenko Olga Anatolievna
QUALITY MANAGEMENT SYSTEM
CLINICAL DIAGNOSTIC LABORATORY
BLOOD SERVICES OF THE MEGAPOLIS
14.02.03 – Public health and healthcare
14.03.10 – Clinical laboratory diagnostics
dissertations for a degree
doctors of medical sciences
Moscow - 2010
The work was carried out at the State Educational Institution of Higher vocational education"Russian State Medical University of the Federal Agency for Health and social development»
Scientific consultants:
doctor of medical sciences, professor Uyba Vladimir Viktorovich
doctor of medical sciences, professor Toguzov Ruslan Timofeevich
Official opponents:
doctor of medical sciences, professor Bushmanov Andrey Yurievich
doctor of biological sciences, professor Malakhov Vladimir Nikolaevich
doctor of medical sciences, professor Alekseeva Vera Mikhailovna
Lead organization:
Research Institute of Emergency Medicine. N.V. Sklifosovsky Department of Health of the city of Moscow.
The defense of the dissertation will take place "" ________ 2010. in hour. at a meeting of the Dissertation Council D 462.001.03 at the Federal State Institution “Federal Medical Biophysical Center named after A.I. Burnazyan" at the address: 123192, Moscow, st. Picturesque, 46.
The dissertation can be found in the library of the Federal State Institution “Federal Medical Biophysical Center named after A.I. Burnazyan" at the address: 123192, Moscow, st. Picturesque, 46.
Scientific Secretary
dissertation council,
Doctor of Medical Sciences, Professor Korchazhkina Natalya Borisovna
GENERAL DESCRIPTION OF WORK
The relevance of research
Healthcare is a sphere where problems and results of activities of many other areas intersect and concentrate [Vyalkov A.I., 2001, Gafurov A.F., 2006, Grebennikova I.V., 2004, Roitman M.P., 1992]. To create a viable, modern, human-friendly health industry [Svitkin M.Z., 1999, Togunov I.A., 1996, Togunov I.A., 1998, Togunov I.A., 1999, Otdelnova K.A., 1991] requires the mobilization of the intellectual potential and efforts of not only medical professionals, but also all related industries [Reinhard Z., 1998, Enthoven, 1991]. One of the most important areas for ensuring the protection of public health is the improvement of the quality and safety system medical care based on the principles of standardization and certification. At the same time, the lack of a functioning system of standardization and certification in healthcare limits the possibilities strategic planning industry and its transparency.
Among the International Quality Standards, a group of standards in the field of the quality management system should be singled out, covering the issues of guaranteeing the manufacturer of products strict compliance with established regulations and procedures at all stages life cycle products/services. Modern, more stringent requirements of the quality management system for many medical industries, including the blood service, dictate the need to clearly navigate these standards.
The most important subdivision of blood service institutions, which ensures the quality of hemocomponents and blood preparations, and, consequently, the safety of recipients and medical personnel, is the clinical diagnostic laboratory. Decree of the Government of the Russian Federation of May 10, 2007 No. 280 on the Federal Target Program "Prevention and Control of Socially Significant Diseases (2007 - 2011)" set the task of reducing the incidence of acute viral hepatitis B to 2.7 cases per 100 thousand of the population, reducing the incidence of acute viral hepatitis C to 3.8 cases per 100 thousand of the population, using a set of measures, including improving the quality of diagnosis. The evolution of the methodology for laboratory diagnosis of blood-contact-transmissible infections reflects the general trends in the development of the system for diagnosing infectious diseases. It includes: the introduction of highly sensitive methods for the indication of antigens and antibodies; their quantitative determination; testing of viral RNA and DNA in a qualitative and quantitative way; determination of genetic variants and mutant forms of viruses. At the same time, the need to identify one or another serological marker to solve specific tasks facing the practitioner, determine the appropriateness of using the appropriate method of indication. A feature of the work of clinical diagnostic laboratories of the blood service is the need not only to determine the health status of the donor, but also to ensure the quality of prepared hemocomponents and blood products. For efficient operation blood service institutions require algorithms for laboratory diagnostics and, based on their results, algorithms for culling blood products and admitting donors to donations.
Purpose of the study
Develop and implement the functioning and continuous improvement of the quality management system of clinical diagnostic laboratories of blood service institutions of the metropolis to ensure biological safety, high quality, reliability, objectivity of research and provide guarantees to the donor/recipient of the most complete satisfaction of the needs that form his confidence in the activities of the laboratory.
Research objectives
1. Develop and implement a quality management system for a clinical diagnostic laboratory that allows:
To carry out the transition from the performance of the functional duties of QLD specialists to the policy of ensuring the quality management system;
Efficient use of specialists of various profiles;
Provide KDL with quality products medical purpose due to the developed management system for the acquisition of services and materials.
2. To increase the infectious safety of donation through the implementation in blood service institutions of the developed algorithms for examining donors, culling of blood components, rejection from donation based on the results of laboratory tests for the presence of markers of blood-contact - blood-borne infections.
3. Evaluate the medical and economic efficiency of the implementation of algorithms.
4. Evaluate the economic efficiency of the centralized and decentralized systems for the organization of clinical diagnostic laboratories of the blood service.
Scientific novelty
For the first time, a quality management system was developed for clinical diagnostic laboratories of blood service institutions.
Requirements for the training and management of personnel of clinical diagnostic laboratories of blood service institutions working in the quality management system have been developed.
Criteria for the selection of reagents have been developed, Supplies and equipment as part of the functioning of the quality management system.
For the first time, algorithms have been developed for examining donors, culling blood components, and rejecting donors based on the results of laboratory tests for the presence of markers of blood-contact-transmissible infections.
The medical and economic efficiency of the introduction of the developed algorithms for the laboratory diagnosis of blood-contact-transmissible infections in blood donors has been proven.
A system has been developed for calculating the effectiveness of creating clinical diagnostic laboratories, carrying out centralization and decentralization of laboratory research.
A system of effective centralization of laboratory research has been created for the blood service institutions of the metropolis.
Practical significance of the study
The implementation of the developed quality management system of the clinical diagnostic laboratory will ensure the transition from the performance of the functional duties of QLD specialists to the policy of ensuring the quality management system, including the introduction of the functions of a representative of the quality management and auditors, as well as the involvement of specialists of various profiles in the activities of the laboratory necessary to ensure the QMS.
On the basis of the developed management system for the purchase of services and materials, an adequate provision of CDL with high-quality medical products is justified.
The introduction of the first developed algorithms for examining donors, culling blood components, and rejecting donation based on the results of a study for blood-borne blood-borne infections made it possible to reduce the residual risk of infection in recipients during blood transfusions by more than 6 times.
The centralization of laboratory tests in blood service institutions will make it possible to save more than 700 million rubles a year.
Provisions for defense
1. The introduction of a quality management system in clinical diagnostic laboratories of blood service institutions makes it possible to ensure the transition from the performance of functional duties of QLD specialists aimed at the technical execution of laboratory tests to the policy of ensuring the quality system of clinical laboratory diagnostics processes with the introduction of the function of a quality management representative, chief and internal auditors, ensuring the efficient use of human resources through the rational placement of equipment, personnel, rationalization and intensification of labor.
2. The introduction into the activities of blood service institutions of the developed algorithms for examining donors, culling of hemocomponents, and rejection from donation based on the results of a study for blood-contact bloodborne infections can improve the safety of donation.
3. The medical and economic efficiency of the implementation of the developed algorithms for the laboratory diagnosis of bloodborne infections is to reduce the residual risk of post-transfusion infection, reduce the incidence in this spectrum of pathology and reduce the cost of treatment.
4. The developed calculation system, which is based on the study of the dependence of the cost of donor blood tests to ensure the infectious safety of various amounts of daily donations at various levels of laboratory automation, allows us to evaluate the effectiveness of the centralization of laboratory tests for all blood service institutions.
5. The cost-effectiveness of organizing a laboratory for the study of at least 200 blood samples per day for the determination of markers of 4 blood-contact-transmissible diseases is shown.
Implementation of research results
The developed algorithms for the laboratory diagnosis of blood-contact-transfusion-transmissible infections in blood donors formed the basis of the Order of the Moscow City Health Department No. 513 dated November 29, 2007 "On strengthening measures aimed at reducing the risk of developing post-transfusion complications" and introduced into the activities of the SEC of the Moscow Health Department, Federal State Institution "Rosplasma" of the FMBA of Russia, the Hematological Research Center of the Russian Academy of Medical Sciences and other institutions of the blood service of Russia.
The developed quality management system has been introduced into the activities of the centralized clinical diagnostic laboratory of the Blood Transfusion Station of the Moscow City Health Department. During the certification of the laboratory in the GOST R system, a certificate of conformity No. ROSS RU.IS65.K00054 dated 02.04.2009 was issued.
The economic model of centralization of laboratory research has been introduced into the activities of the blood service of the Moscow City Health Department, which resulted in the creation of a centralized clinical diagnostic laboratory of the SEC.
The materials of the dissertation research are used in the process of training physicians and biologists of KLD in the cycles of improvement and professional retraining at the departments of clinical laboratory diagnostics of the State Educational Institution of Higher Professional Education of the State Medical Institution of Higher Professional Education of the Russian State Medical University of Roszdrav and the Federal State Educational Institution of the IPK of the Federal Medical and Biological Agency of Russia.
The author analyzed the current documentation in the field of clinical laboratory diagnostics and blood service institutions, developed a quality management system for the clinical diagnostic laboratory of the blood service, algorithms for examining donors, culling of hemocomponents, rejection from donation based on the results of laboratory tests for the presence of markers of blood-contact-transmissible infections, criteria selection of equipment, diagnostic test systems, personnel requirements and aspects effective management staff, developed the architectural and planning solution of the laboratory, assessed the effectiveness of the centralization of laboratory research, which resulted in the creation of the Central Clinical Laboratory, organized the work of the laboratory staff to test donated blood for markers of infectious diseases, followed by analysis of the data obtained, their statistical processing and interpretation of the results .
She calculated the residual risk of transfusion-transmissible transmission of viral hepatitis C in the period before and after the introduction of blood testing of donors for the presence of HCV RNA.
The author independently carried out analytical review of domestic and foreign literature on the problem under study, a research program was drawn up, a collection of medical, social and clinical and statistical information was carried out. Planning, drawing up a program of mathematical and statistical processing of the material and the processing itself were carried out with the personal participation of the author. The interim results of the study were systematically reviewed by scientific advisors. Analysis, interpretation, presentation of the obtained data, formulation of conclusions and practical advice completely executed by the author personally. The share of the author's participation in the accumulation of information is up to 100%, mathematical and statistical processing - more than 80%, in the generalization and analysis of the material - 100%.
Approbation
Approbation took place on March 22, 2010. at a joint scientific and practical conference of a team of employees of the Department of Clinical Laboratory Diagnostics of the Faculty of Postgraduate Medical Education, the Department for the Development of Laboratory Technologies of the State Educational Establishment of Higher Professional Education of the Russian State Medical University of Roszdrav, the centralized clinical diagnostic laboratory of the blood transfusion station of the Moscow Health Department, the laboratory department of the NIISP named after. N.V. Sklifosovsky, laboratory department of the MHC AIDS of the Moscow City Health Department.
The results of the study were reported at: XIII International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology" (Moscow, 2005); XIV International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology" (Moscow, 2006); I Scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis" (Moscow, 2008); II Scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis" (Moscow, 2009); VI scientific-practical conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications" (Moscow, 2008); V Scientific-practical conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications" (Moscow, 2007); Scientific-practical symposium "Volume, organization and economics of laboratory support of medical care in the context of healthcare modernization" (Moscow, 2006); scientific and practical symposium "Key problems of improving the laboratory support of medical care" (Moscow, 2007); scientific and practical symposium "Laboratory medicine: innovative technologies in analytics, diagnostics, education, organization” (Moscow, 2008); scientific-practical conference "Laboratory medicine in the light of the Concept for the development of health care in Russia until 2020" (Moscow, 2009); collegiums of the Moscow Department of Health, meetings and seminars held by the organizational and methodological department for laboratory diagnostics of the Moscow Department of Health.
Publications
Scope and structure of the dissertation
Dissertation set out on 273 pages typewritten text and consists of an introduction, a review of the literature, the results of own research and their discussion, a conclusion, conclusions, a bibliographic list that includes 239 domestic and 60 foreign sources. The work contains 8 appendices, illustrated with 19 tables and 15 figures.
Materials and methods of research
The work was carried out at the Department of KLD FUV GOU VPO RSMU Roszdrav (Head of the Department, Doctor of Medical Sciences, Prof. R.T. Toguzov). Practical part The work was carried out on the basis of the centralized clinical diagnostic laboratory of the blood transfusion station of the Moscow Health Department ( chief physician PhD Zakharov V.V.).
Analyzed 987 legal documents in the field of organizing the activities of clinical diagnostic laboratories and blood service institutions.
The study included blood samples obtained during allogeneic donations of whole blood, platelet and plasmapheresis procedures performed at the blood transfusion station and in 15 blood transfusion departments of medical institutions of the Moscow Department of Health.
A total of 367,083 donor blood samples were examined.
341,952 donor cards were analyzed.
Hemolyzed and chylous serum samples were excluded from the study. A total of 184 samples were excluded.
Laboratory studies were performed in compliance with the current legislation on ensuring quality control of laboratory studies using test systems and control materials approved for use in the territory of the Russian Federation.
Identification of markers of blood-contact-transmissible infections was carried out using the following methods.
The determination of antibodies to the cardiolipin antigen was carried out by the precipitation method using the Lewis RPR test (Nearmedic-plus, Russia).
Antibodies to treponemal antigen were determined by ELISA using the RecombiBest antipallidum-total antibodies test systems (Vector-Best, Russia). ARCHITECT Syphilis test systems (Abbott, USA) were used to determine antibodies by CLLA.
As a confirmatory test in the study of positively reacting sera in the ELISA and / or RPR test, the method of indirect (passive) hemagglutination was used - the "Lewis RPHA test" (Nearmedic plus, Russia).
Determination of HBsAg in serum and blood plasma was carried out by ELISA using test systems "Monolisa HBsAg plus" (BioRad, USA). When determining the antigen by the CLLA method, the HBsAg test systems (Abbott, USA) were used.
A confirmatory test for the presence of HBsAg was performed by the neutralization method using the Monolisa HBsAg Ultra confirmatory test system (BioRad, USA).
The determination of the p24 antigen and antibodies to HIV 1,2 was carried out by ELISA using the test systems "Genscreen Ultra HIV Ag/Ab" (BioRad, USA). In the determination of antibodies/antigen by CLLA, test systems "HIV Ag/Ab Combo" were used. (Abbott, USA). To confirm the results obtained, blood serum samples were sent to the verification laboratory of the MHC AIDS.
Determination of antibodies to hepatitis C virus was carried out by ELISA using test systems manufactured by Murex anti-HCV (Abbott, USA), Monolisa HCV Ag Ab Ultra (BioRad, USA). In the determination of antibodies by CLLA, the Ab-HCV test systems (Abbott, USA) were used.
Confirmation of the presence of antibodies to HCV was carried out by immunoblotting based on the principles of ELISA, using the LIA HCV kit (Nearmedic plus, Russia)
Immunological studies were carried out using an automated system for CLLA "Architect-system", models 2000 and 4000 (Abbott, USA), an automatic enzyme immunoassay analyzer "Evolis" (BioRad, USA) and sets of semi-automatic equipment (BioRad, USA).
Testing of nucleic acids of the causative agents of HIV infection and viral hepatitis B and C was carried out by real-time polymerase chain reaction and transcripton-mediated amplification. For individual PCR testing, a Cobas Amplicor analyzer (Roche, Switzerland) with reagents for the determination of HIV RNA, HCV RNA, and HBV DNA was used. The Cobas Amplicor analyzer combines five different instruments: thermal cycler, thermostat, washer, photometer and automatic dispenser. For multiplex PCR analysis, the Cobas s 201 system with the Cobas TaqScreen test (Roche, Switzerland) was used, consisting of an automated system for pooling donor samples using a dispenser, automated sample preparation, and automated amplification and detection in the Cobas TaqMan analyzer. Cobas TaqScreen MPX (Roche, Switzerland) is a multiplex nucleic acid assay that can detect HIV-1, HIV-2 and HCV RNA and HBV DNA in human plasma samples.
Automated system "TIGRIS" (Chiron, Ireland, USA) was used for multiplex analysis of HBV, HCV, HIV nucleic acids in one sample in full automatic mode in modification of transcripton-mediated amplification
A retrospective analysis of the detection of viral hepatitis C in donors was carried out using the database of the single donor center of the SPC of the Moscow Health Department. 341,952 donor cards were analyzed for the period from 01/01/2000 to 12/31/2008.
Calculation of the residual risk of transfusion-transmissible transmission of viral hepatitis C was made using the mathematical model "detection/window period".
The original data for re-analysis can be obtained from the information base of the unified donor center and the archive of the Central Blood Transfusion Station of the Moscow Health Department.
Statistical processing of the results in evaluating the data obtained was carried out by generally accepted methods of mathematical statistics using the Statistica 6.0 program (Statsoft, USA) and the statistical package Excel programs 2003 (Microsoft, USA).
Research results and discussion
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003, establishing standards for the quality and safety of the collection, examination, storage and distribution of blood and human blood components, clearly defines blood service establishments (and therefore the blood service itself), which, in our opinion, should be applied in the territory Russian Federation. So from the definition of "blood service institutions - organizations or units responsible for any aspect of the collection, examination of blood and components, for whatever purposes they are used in the future, as well as their preparation, storage, distribution for transfusions. Does not include kroi hospital banks, which are branches medical institutions in which blood and components are stored and distributed, as well as transfusion compatibility tests are performed, all types of transfusion activities within the hospital are carried out” it follows that the blood service institutions are specialized organizations whose main task is to provide medical institutions with high-quality and safe blood components , and enterprises for the production of hemopharmaceuticals with high-quality raw materials. One of milestones ensuring the safety of blood transfusions in blood service institutions is clinical laboratory diagnostics. For the first time in the Russian Federation, for the clinical diagnostic laboratory of the blood service of the metropolis, we have developed and put into practice a quality management system in accordance with GOST R 9001-2000, harmonized with the requirements of the international standard ISO 9001:2000, which corresponds to the tasks defined by the reform of technical regulation in the Russian Federation, aimed at the entry of the Russian Federation into the World trade organization. The introduction of the QMS into the activities of the Central Committee of the Laboratory of Logistics made it possible to conduct a voluntary certification of the laboratory as a basis for confirming the compliance of the developed, including with our participation, federal law"Technical regulations on the safety of medical devices". The work within the framework of the draft of this law showed the possibility of moving from licensing activities in the field of clinical laboratory diagnostics to voluntary and / or mandatory certification laboratories.
As a result of the analysis of compliance with the current legislative framework and the QMS principle showed the need to improve the CDL personnel training system, which includes the introduction of a system of continuous education of personnel, the introduction of a scoring system for participation in meetings, seminars, conferences (including international ones), on-the-job training, etc. The current system, obliging to carry out advanced training at least once every 5 years in the amount of at least 144 hours, does not allow maintaining a high rate of development of laboratory diagnostics, the introduction of new methods, equipment, technologies. In fact, in large laboratories, at least once every three months, one or another improvement is made that requires staff training. As shown in the work, it is the proposed system of advanced training that allows not only to ensure a high professional level of personnel, but also contributes to the interest of people in work, to increase the prestige of the profession.
The system of postgraduate education should consist of 3 stages: basic education once every 5 years, ongoing education of staff in accordance with the needs of the unit, and self-education, including reading literature, attending exhibitions and conferences, participation in them. Basic education can be excluded provided that the current education is regular and self-education with passing an exam.
It follows from the analysis of the current legislation that persons with higher medical education, postgraduate education in the specialty "Clinical Laboratory Diagnostics" and as a biologist - persons with higher education in the specialty "Biology" have the right to work in the CDL as doctors of clinical laboratory diagnostics and having postgraduate education in the volume of primary specialty in "clinical laboratory diagnostics". The paper shows that up to 90% of the work in a modern laboratory is not related to medical activities, and to fulfill this particular volume, the heads of the CDL require chemists, programmers, biophysicists, nurses, housewives, economists, medical statisticians, medical registrars, etc. activities of CDL of persons with a special, but not medical education, it is possible to completely solve the personnel issues of providing CDL, increase the level of staff competence, which will also contribute to the efficiency of personnel use, improve the quality of laboratory research, and provide CDL with highly professional personnel.
In addition to the above, when forming personnel policy when implementing the QMS, there is a need for new functions of the CDL personnel, the implementation of which required the appointment of quality representatives, chief and internal auditors of the quality system. Creation and support of the movement system personnel information made it possible to inform employees about the appearance of vacancies, about the possibilities vocational training and advanced training, about personnel development programs.
The GOST R ISO 9001:2000 standard establishes a flexible system of staff incentives for ensuring the quality of work performed. The most important factors in stimulating staff include informing all departments about the results monthly work of all divisions on quality, as well as the results of internal audits conducted by internal auditors of the quality system. These data are posted on the stands. The results of audits are regularly discussed at quality meetings and taken into account by management in the annual review.
Implementation of the requirements of the standards GOST R ISO 9001:2000 and GOST R ISO 15189-2006 in the field of development labor resources, new approach for the selection and admission of personnel, the preparation of personnel certification, the preparation of test questionnaires, the preparation of " business game» allowed to improve the work with the staff. The introduction of a mandatory periodic audit (verification) of personnel knowledge in order to assess the level of competence of employees in relation to safety rules (safety, biological and chemical safety), their theoretical and practical knowledge was the basis for the selection and placement of personnel, adaptation, career development, formation of a reserve for promotion, evaluation of labor efficiency, rotation of personnel. The introduction of the QMS in the field of personnel management made it possible to take into account the goals of individual employees, natural working groups and the organization as a whole. The result of this activity was the adoption of an agreed policy option as guidance document quality systems. The interests of the individual, group and organization in the implementation of the QMS are considered during vocational training(ability, desire, need and opportunity to learn), certification, promotion. As part of the company's policy, it was possible to revise and update individual and group goals.
The most important guarantors of the quality of the performed studies include an adequate choice of equipment and reagents. At present, in accordance with the current legislation, the quality representative, the head of the CDL, does not have mechanisms for influencing purchases, however, this issue is spelled out in GOST R ISO 9001:2000. In accordance with the studies, criteria for selecting equipment were developed: an assessment of the possibility of using an automatic analyzer, taking into account the range of studies being carried out, the number of tests, the minimum and maximum interval for issuing analysis results. It has been shown that the necessary conditions for the purchased diagnostic test systems for the CDL of the blood service should be high specificity and sensitivity to minimize the risk of obtaining both false positive and false negative results. Reducing the requirements for purchased reagents and equipment will help reduce the safety of donation.
The most important component of the blood service QMS model, as can be seen from Figure 1, is the management of preventive corrective actions.
Figure 1. Quality management system model
Algorithms for laboratory diagnosis of blood-contact-transmissible infections have been developed to adequately carry out corrective and preventive actions, improve the safety of recipients and retain human donors.
The development of algorithms was based on several principles:
1. Ensuring high infectious safety of hemocomponents with a short shelf life (less than the duration of the "serological window"). At the slightest suspicion that a short-lived component may contain a pathogenic agent, it must be disposed of.
2. Determination of the possibility of quarantine of hemocomponents. If markers of infectious diseases are detected in a donor, hemocomponents subject to quarantine are disposed of; upon receipt of doubtful results that may be associated not only with the presence of pathogenic agents, hemocomponents are subject to quarantine until the donor is re-examined, which will allow to exclude or confirm the presence of infection and decide on the future fate hemocomponents.
3. Preservation of personnel donors. The source of raw materials for components and blood products are donors, and, first of all, personnel. An incorrectly made laboratory diagnosis entails not only the loss of a donor for the blood service, but can cause moral damage to him in the form of psychological trauma, complications in family relationships, and others. Therefore, in order to confirm the presence of a marker of an infectious disease in case of doubtful/non-confirmed results, the donor is sent for an additional laboratory examination after 1-3 months, and only after it and consultation of an infectious disease specialist, a laboratory diagnosis is made or removed and the issue of continuing donation is decided.
Algorithms have been developed for all blood contact-transmissible diseases studied in the blood service (HIV infection, viral hepatitis B and C, syphilis). As an example of evaluating the effectiveness of the implementation of algorithms, we consider the examination of donors for the presence of markers of viral hepatitis C.
The main task in the examination of donors for markers of viral infections is to reduce the likelihood of infection of potential recipients. The detection of antibodies to hepatitis C virus was introduced into the blood donation screening system in 1996. Over the past period, there has been a significant improvement in the methods and procedures of laboratory diagnostics, the improvement of methods and the transition to automatic methods analysis.
By the beginning of this study, the procedure for laboratory diagnosis of HCV in blood donors included two ELISA tests for the presence of anti-HCV. The first setting was carried out for all the studied samples without exception, the second setting was carried out on the same day when positive or questionable results were obtained to eliminate technical errors in the analysis and increase the reliability of the data obtained. To confirm the presence of infection, all two-ELISA-positive samples were additionally tested with a more sensitive method of linear immunochemical blotting to detect antibodies to specific HCV proteins.
Laboratory diagnosis of HCV in blood donors and its components is regulated by Russian legislation and includes the determination of ALT activity and the presence of antibodies to the hepatitis virus. C, however, they are not universal markers of the disease.
To develop an algorithm for diagnosing HCV, as well as other viral infections, it is necessary to know all the stages of the infectious process and the periods of appearance of certain markers of a viral infection at each stage of the disease. For HCV, nonspecific (ALT) and specific (antibodies to HCV, viral RNA) markers are isolated. The timing of the appearance and residence time of markers in the blood are shown in Figure 2.
Figure 2. Markers of viral hepatitis C at different periods of the infectious process
None of the HCV markers is elevated in the blood during the entire period of the disease. Viral hepatitis C is characterized by the presence of a "serological window", that is, a period of time during which antibodies to the hepatitis C virus are not detected. The period of the "serological window" depends on the type of viral infection. For HCV it is from one to three months. In accordance with the periodicity of the appearance of markers to improve the infectious safety of blood transfusion therapy, it is proposed to introduce two additional procedures:
1. Conducting repeated serological control of blood donors and its components.
2. Nucleic acid testing.
Repeat serological control procedure
The length of the period (average 66 days) of seroconversion, that is, the period from the moment of infection to the detection of anti-HCV in viral hepatitis C and analytical limitations modern methods laboratory diagnostics have led to the need to search for and implement new approaches to screening donor blood for HCV. In particular, a procedure for repeated serological control of donors was proposed.
Donors were sent for re-examination if in the test sample during the initial screening for anti-HCV by ELISA, the values of the optical density of the sample were within the “gray zone”, that is, they were considered as doubtful results, and the confirmatory test using immunological blotting was negative or indeterminate .
The appearance of doubtful results may be due to insufficient levels of antibodies in infected patients at this stage of the disease, or the presence of cross-reactions with other antigens in the absence of detectable pathology. The repeated examination of donors was carried out after a period of time within the "serological window", i.e. from 1 to 3 months. Delayed testing of donors greatly increases the likelihood of detectable anti-HCV levels in individuals with infection.
The study group included 99 donors. The repeated laboratory examination did not reveal antibodies to the hepatitis C virus in 70 (70.7%) donors, and the laboratory diagnosis of "Viral hepatitis C" was removed. At the same time, anti-HCV was detected in the blood serum of 5 (5.0%) donors from the study group and a laboratory diagnosis of "Viral hepatitis C" was made. These persons were excluded from donation and sent for clinical examination to the hepatological center of the infectious diseases clinical hospital No. 1 of the Moscow Health Department. In 24 (24.2%) donors, serological testing gave questionable results, which were regarded as a non-specific reaction to anti-HCV. These individuals were also suspended from donation and sent for clinical examination.
The effectiveness of the introduction of repeated laboratory examination of donors for the presence of markers of viral hepatitis C is shown in Figure 3.
Figure 3. Results of repeated serological control for HCV markers
After a clinical examination of 24 donors with a non-specific reaction, two of them were diagnosed with HCV in the laboratory, the diagnosis of the rest remained indeterminate.
Thus, during dynamic observation and additional clinical examination, seven donors (7.1%) out of 99 were diagnosed with "Viral hepatitis C" and the products prepared from them were rejected, which prevented infection of possible recipients. Healthy donors in the amount of 70 people (70.7%) were restored in donation
The results of a laboratory study determine the algorithm for the further use of prepared hemoproducts. Of all blood components, fresh frozen plasma has the longest shelf life. It is subjected to deep freezing and mandatory storage (quarantine) for 6 months. Based on the results of repeated serological control, the plasma of 70 donors with a negative serological test for HCV was quarantined and subsequently sold, the plasma of the remaining 29 donors was rejected and disposed of.
The introduction of the repeated serological control procedure made it possible in 2007 to return to the donor contingent 70 people who had a negative result during the examination for anti-HCV, which amounted to 0.19% of the total number (37250) of plasma and blood donors. The blood plasma of these donors was used for blood transfusions.
At the same time, anti-HCV positive donors (5 people, 0.013%) received an absolute rejection from donation, and all blood components were disposed of.
According to the laboratory examination procedure, which was used earlier and was regulated by the orders of the Ministry of Health of the Russian Federation and the Ministry of Health and Social Development of the Russian Federation, quarantined and non-quarantinable blood components of donors with questionable HCV test results could be used for recipients.
Thus, the introduction of repeated serological control after 1-3 months of the blood of donors, in which the sample was regarded as doubtful during the first ELISA, a negative result for anti-HCV was obtained during the second ELISA, and the confirmatory test was negative or indeterminate, allowed for 0.013% ( p<0,05, n=37250) снизить риск инфицирования реципиентов при применении компонентов крови, и на 0,19% (p<0,05, n=37250) уменьшить абсолютный отвод от донорства.
Nucleic acid testing
Since December 2007, the screening of blood of donors for the presence of HCV markers has been supplemented with the procedure of testing first all samples seronegative for anti-HCV, and subsequently all samples tested for the presence of hepatitis C virus RNA. RNA testing was carried out by real-time PCR analysis. time and transcripton-mediated amplification,
HCV RNA appears in the blood in detectable amounts on days 6-10 from the moment of infection (Figure 2). When the virus enters the target cells, its RNA may not be detected in the bloodstream until the onset of viremia. Therefore, HCV RNA is the earliest marker of the disease and is widely used abroad for screening of donated blood.
58,655 anti-HCV seronegative plasma samples were tested for the presence of HCV RNA. The results obtained are presented in table 1.
At the first PCR run, 14 (0.024%) samples were positive for the presence of hepatitis C virus RNA. All RNA-positive samples were re-examined by the same method to eliminate technical analysis errors within the laboratory's quality control system. On repeat PCR analysis of the samples, 10 out of 14 were confirmed as positive and 4 as negative.
Table 1. HCV RNA detection in anti-HCV seronegative blood donors
Thus, based on the results of testing samples for the presence of hepatitis C virus RNA, 10 (0.017%) donors were diagnosed with HCV RNA-positive in the laboratory, these individuals were removed from donation and sent for clinical examination. All blood components harvested from these donors were disposed of. In 4 cases (0.007%), a "doubtful reaction to HCV RNA" was obtained. These individuals were temporarily suspended from donation, the plasma was quarantined until the results of repeated serological control after 1 month were obtained, and the components not subject to quarantine were disposed of.
Prior to the introduction of the algorithm for laboratory diagnosis of viral hepatitis C in donors of nucleic acid testing, 10 “RNA-positive HCV” donors identified by us could be recognized as healthy.
From one dose of whole blood received from such a donor, on average, 4 hemocomponents can be prepared, which can be transfused to 4 potential recipients. Identification of 10 donors with a positive reaction to HCV RNA among those seronegative for anti-HCV made it possible, according to the expedition department, to prevent HCV infection in 38 potential recipients.
Thus, the introduction of testing donor blood samples for the presence of HCV RNA made it possible to reduce the risk of infection of recipients with viral hepatitis C when using blood components.
Detection of viral hepatitis C markers
To assess the detectability of viral hepatitis C markers, 341,952 donor cards were analyzed for the period from 01/01/2000 to 12/31/2008. The distribution of annual rates of detection of viral hepatitis C in donors of SEC DZM, which for the period from 2000 to 2008 was studied. is graphically reflected in Figure 4.
Figure 4. HCV detection in SEC DZM donors from 2000 to 2008
As can be seen from Figure 4, between 2000 and 2002 there was an increase in the detection of HCV in blood donors, which reached a level of 34.08±0.02 per 1000 donors.
The increase in HCV detection among donors in 2002, which differs from the incidence rate among the population of the Russian Federation, is associated with an artificial increase in the "gray zone" in the determination of anti-HCV to ensure the infectious safety of hemocomponents subject to quarantine.
Starting from 2003, the detection rate began to decrease and in 2008 it was 10.37±0.01 per 1000 donors. Thus, the HCV detection rate by 2008 decreased by 3.2 times compared to 2002.
The decrease in the detection rate is associated both with a general decrease in the incidence of HCV in the population of the Russian Federation, and with the improvement of methods for laboratory diagnosis of HCV, which is especially important when examining donors. The change in the trend of HCV detection in blood donors mainly corresponds to the trends in the incidence of HCV in the population of the Russian Federation as a whole during the observation period [Novoselov AV, Nizhechik Yu.S., et al., 1997; Onishchenko G.I., 2008].
For the period of time from 2000 to 2008. to detect HCV in donors, test systems for ELISA were changed, and new research methods were added (Table 2).
Table 2. Test systems for the detection of HCV markers in blood donors of the CCDL SEC DZM in the period from 2000 to 2008.
| Year | Type of test system | Serological window period | ||
| 2000 | 66 days | |||
| 2001 | ELISA test systems of the 2nd generation | 66 days | ||
| 2002 | 66 days | |||
| 2003 | 3rd generation ELISA test systems | Immunoblotting | 48 days | |
| 2004 | 3rd generation ELISA test systems | Immunoblotting | 48 days | |
| 2005 | 3rd generation ELISA test systems | Immunoblotting | 48 days | |
| 2006 | 3rd generation ELISA test systems | Immunoblotting | 48 days | |
| 2007 | 3rd generation ELISA test systems | Immunoblotting | 48 days | |
| 2008 | 3rd generation ELISA test systems | Immunoblotting | HCV RNA PCR analysis | 7 days |
As can be seen from Table 2, in 2000 and 2001. for the diagnosis of HCV, the SPK DZM laboratory used the ELISA test systems of the 2nd generation. Since 2002 ELISA test systems of the 3rd generation began to be used for the diagnosis of HCV, which differ from the test systems of the 2nd generation in higher sensitivity and a set of detectable antigens.
In order to improve screening based on the analysis of the work of the laboratory of previous years, the gray zone during the ELISA was increased from that specified in the methodology to 20%. An increase in the size of the "gray zone" led to a slight increase in false positive results, which were interpreted as a "positive reaction" for the rejection of hemoproducts, but were not used to make a laboratory diagnosis and reject a donor from donation. The introduction of more modern test systems and an increase in the size of the "gray zone" reduced the likelihood of donor infection, but did not affect the period of the serological window.
The introduction of immunoblotting in 2003 resulted in a slight decrease in the serological window.
In 2007, we introduced a second serological examination after 1-3 months of donors with doubtful results for the presence of anti-HCV, which allowed us to reduce the absolute withdrawal from donation and preserve the hemoproduction of healthy donors. The introduction in 2008 of additional RNA testing of all seronegative anti-HCV blood samples from donors made it possible to reduce the serological window period to 7 days.
Having monitored the detection of HCV in donors of the DZM blood transfusion station, having studied the methods and methods of laboratory analysis used for diagnosing HCV, the current regulatory and legal framework in the field of ensuring the infectious safety of blood transfusions, as well as instructions for laboratory testing of blood in the centralized clinical diagnostic laboratory that were in force in period from 2000 to 2005, a new algorithm for the laboratory diagnosis of viral hepatitis C in blood donors was proposed (Figure 5).
Figure 5. Algorithm for laboratory diagnosis of viral hepatitis C in blood donors
The algorithm includes several stages.
At the first stage of the study, each donor blood serum sample is examined in duplicate for the presence of anti-HCV by enzyme-linked immunosorbent assay (first ELISA). Based on the results obtained at the 1st stage, the further course of the analysis is selected.
At the second stage, all anti-HCV seronegative samples are sent for RNA testing, and all anti-HCV positive samples with optical density values within the 20% gray zone are re-examined for anti-HCV by ELISA.
Based on the results of RNA testing of samples seronegative for anti-HCV, the issue of the need for further clinical examination of the donor and the possibility of using the hemoproducts received from this donor is decided. Upon receipt of negative results for HCV RNA, the donor is considered healthy, the blood plasma is subject to quarantine, and the cellular components of the blood are sold. Upon receipt of a positive result for the presence of HCV RNA, the donor with a laboratory diagnosis of "RNA-positive" is sent for a clinical examination.
If questionable results are obtained for the presence of HCV RNA in the test sample, the donor with a laboratory diagnosis of "Doubtful reaction to HCV RNA" is sent for a second serological examination in 1-3 months, the plasma is quarantined until the results of serocontrol are obtained, and the cellular components of the blood are disposed of.
Depending on the results obtained during the analysis performed at the second stage of the ELISA study, the samples can be sent to the 3rd stage. In the event that a negative result for anti-HCV is obtained during the second ELISA, the donor is temporarily suspended from donation with a laboratory diagnosis of "Non-specific reaction to HCV" and sent for a second serological examination in 1-3 months, the plasma is quarantined until the results of serocontrol are obtained and blood components are utilized. All samples positive for anti-HCV at the second ELISA and with optical density values of the sample within the 20% gray zone are sent to the 3rd stage of the study for a confirmatory test for anti-HCV by immunological blotting. All donor blood components subject to and not subject to quarantine with questionable test values must be disposed of. Laboratory diagnosis of such donors occurs after receiving the results of a confirmatory test.
If a positive immunological blotting result is obtained, the donor with a laboratory diagnosis of "Viral hepatitis C" is sent for a clinical examination. Donors with a negative and indeterminate confirmatory test result with a laboratory diagnosis of "Non-specific HCV reaction" are referred for a second serological examination in 1-3 months.
The new algorithm allows not only to make a laboratory diagnosis, but also to determine the possibility of using prepared hemoproducts.
To obtain objective data, the effectiveness of the developed algorithm for the laboratory diagnosis of viral hepatitis C in blood donors was evaluated.
It is possible to tentatively assess the effectiveness of the implementation of each diagnostic stage of a laboratory test using the relative rejection rate, that is, the ratio of the number of positive samples identified by the diagnostic method to the total number of examined persons. The calculated relative indicators of marriage, reflecting the stages of this study, are presented in Table 3.
To assess the effectiveness of introducing RNA testing into the screening of donor blood, the residual risk of transfusion-transmissible transmission of HCV was calculated using the mathematical model "detection/window period" (Table 4).
Table 3. Relative indicators of marriage at the stages of implementation of the algorithm for laboratory diagnosis of viral hepatitis C in blood donors
| Number of donors examined | HCV detected before the implementation of the stage | Additionally, HCV was detected after the implementation of the stage | Increasing efficiency | |
| 35704 | - | - | - | |
| Serological control after 1-3 months (2007) | 37250 | 396 | 7 | 0,019%* |
| Determination of HCV RNA (2008) | 47146 | 479 | 10 | 0,0212%* |
Note: *p< 0,05
Table 4. Results of the assessment of the residual risk of transfusion-transmissible transmission of viral hepatitis C in Moscow
| years | Total number of donors | Number of repeat donors with HCV | Total man-years | "Window Period" | Detection per 100,000 person-years | Residual risk per 1 million donations |
| 2000 | 38320 | 43 | 37259,06 | 66 | 115,5155 | 5.7±1.6 |
| 2001 | 38512 | 47 | 37359,37 | 66 | 125,1627 | 5.3±1.6 |
| 2002 | 33510 | 46 | 32383,99 | 66 | 141,0574 | 4.6±1.5 |
| 2003 | 35704 | 31 | 34947,74 | 48 | 87,78823 | 5.5±1.6 |
| 2004 | 38860 | 25 | 38251,64 | 48 | 64,52011 | 7.4±1.5 |
| 2005 | 35580 | 23 | 35014,04 | 48 | 65,5737 | 7.3±1.6 |
| 2006 | 37070 | 19 | 36592,78 | 48 | 52,90662 | 9.0±1.5 |
| 2007 | 37250 | 20 | 36863,69 | 48 | 54,25393 | 8.8±1.5 |
| 2008 | 47146 | 28 | 46666,8 | 7 | 59,99983 | 1.1±1.7* |
Note: *p<0,05
In 2000, the residual risk was 5.7±1.6 per 1 million donations, and by 2002 it had decreased to 4.6±1.5 per 1 million donations (Table 4).
The decrease in residual risk in 2002 compared to 2000 can be explained by the following factors. The methodology for conducting a study on anti-HCV in 2000 and 2002 did not change, the same test systems were used with a serological window period of 66 days, however, in 2002, when making a laboratory diagnosis of "Viral hepatitis C", the "gray zone" was expanded to 20% . In 2003, a confirmatory test was introduced into the examination procedure, which reduced the number of false positive results during ELISA. This increased the residual risk to 5.5±1.6 per million donations.
Between 2003 and 2007 to determine anti-HCV, 3rd generation test systems were used with a "serological window" period of 48 days. The residual risk continued to decrease significantly until 2007, which is explained by an increase in the number of repeat donors with a laboratory-confirmed diagnosis of viral hepatitis C. The HCV detection rate among repeat donors does not correlate with the detection rate among all SEC donors and remains at a fairly high level despite the general trend towards a decrease in HCV detection in SEC DZM donors. This fact reflects the limitations in using the mathematical model "detectability/window period" to assess the effectiveness of the developed algorithm as a whole. In particular, this model does not take into account the positive impact on the increase in the infectious safety of blood transfusion of the measures taken to expand the "gray zone" to 20%, the introduction of a confirmatory test and the procedure for repeated serological control after 1-3 months.
The introduction of nucleic acid testing has reduced the serological window to 7 days.
Determination of HCV RNA in the blood of donors made it possible to significantly reduce the residual risk of developing post-transfusion HCV from 8.8±1.5 per 1 million donations in the period before the introduction of RNA testing to 1.1±1.7 per 1 million donations after the introduction ( p<0,05) (таблица 4). Полученные нами данные по остаточному риску в период до и после использования метода РНК-тестирования соответствуют мировым показателям.
The developed algorithm for laboratory diagnosis of viral hepatitis C in blood donors makes it possible to increase the infectious safety of blood transfusion therapy against viral hepatitis C for potential recipients.
Table 5. Prevention of HCV infection in recipients.
| Measures taken to increase infectious safety | Number of identified donors | Hemocomponents | Infection of recipients is prevented | |||
| FFP | ErM | OK | CT | |||
| Increase in the seronegative zone up to 20% (2003) | 8 | 10 | 8 | 8 | 6 | 32 |
| Serological control after 1-3 months (2007) | 7 | 7 | 7 | 7 | 6 | 27 |
| HCV RNA definition (2008) | 10 | 12 | 10 | 10 | 6 | 38 |
Note: ErM - erythrocyte mass, FFP - fresh frozen plasma, LC - leukoconcentrate, CT - platelet concentrate.
As can be seen from Table 5, each of the stages of implementation of the developed algorithm contributed to an increase in the infectious safety of hemocomponents in relation to viral hepatitis C: the expansion of the seronegative zone to 20% in 2003 made it possible to prevent infection of 32 recipients, repeated serological control of donors with uncertain results for anti-HCV in 2007 prevented 27 transfusions of infected blood, the introduction of HCV RNA detection into the practice of CCDL made it possible in 2008 to additionally prevent HCV infection in 38 recipients. During the study period, it was possible to prevent infection with viral hepatitis C in 57 potential recipients.
The paper shows that despite the above limitations of the mathematical model used, it is suitable for analyzing the effectiveness of new methods of laboratory diagnostics, in particular, nucleic acid testing, and is widely used by foreign researchers when calculating the residual risk of transfusion-transmissible transmission of viral infections to be provided in annual blood bank reports. The introduction of HCV RNA detection in the blood of anti-HCV seronegative donors into the practice of CCDL SPC allowed a 6.1-fold reduction in the residual risk of developing post-transfusion viral hepatitis C: from 6.7 ± 1.5 per 1 million donations in the period before the introduction of nucleic acid testing. acids to 1.1±1.7 per 1 million donations after the introduction in 2008 of HCV RNA detection, which corresponds to world indicators.
The introduction of modern methods of laboratory diagnostics, in particular, the detection of RNA when screening donor blood for the presence of markers of viral hepatitis C or nucleic acids of other pathogens, can significantly increase the infectious safety of blood transfusion therapy, and as a result, prevent the development of post-transfusion hepatitis C infection in recipients and in overall, to reduce the incidence of viral hepatitis C.
Often, a counterargument to the introduction of modern laboratory technologies is their high cost. As part of the work, a socio-economic study of the effectiveness of the introduction of modern highly sensitive, highly specific laboratory methods was carried out. As noted earlier, up to four different hemocomponents can be prepared from one dose of whole blood from one donor. Including erythrocyte mass, fresh frozen plasma, leukoconcentrate, platelet concentrate. Each harvested component, as a rule, is used for different recipients. Thus, a donor infected with HCV can become a source of infection for at least four recipients. It is worth noting the fact that in some cases the fractionation department prepares pediatric doses of hemocomponents. In this case, the number of potential recipients may increase by 1.5-2 times. The paper shows that during the study period it was possible to prevent infection with viral hepatitis C in 57 potential recipients. The news of the disease of viral hepatitis is almost always a strong stress for the patient and his environment. The severity of psychological shock is largely determined not only by the frightening, unstructured information about hepatitis, which is easy to obtain from the media, but also depends on the individual psychological characteristics of the individual. Anxiety, bad mood, shock prevent a person from adequately assessing the medical situation and become a serious problem. Medical psychologists note that most patients are convinced that life will fundamentally change and will never be the same as before. The disease, indeed, makes changes in life, but social restrictions for a patient with hepatitis are not so significant. A positive point is the fact that in most cases hepatitis C can be treated with medication, but the cost of 1 course of antiviral therapy ranges from 175,000 to 1,000,000 rubles. [Gerasimenko N.F., 1993]. For the complete or partial disappearance of the virus, 3-4 courses of therapy per year are necessary. The duration of such treatment is from 12 to 48 months. Thus, the cost of antiviral therapy alone for a patient with viral hepatitis C ranges from 525 thousand to 16 million rubles without taking into account the costs of other drugs, diagnostics and rehabilitation.
An analysis of the implementation of hepatitis B diagnostic algorithms using multiplex testing revealed 5 cases of hepatitis B among 15,682 HBsAg-negative donors. In one of them, a low level of viremia persisted despite the presence of anti-HBs. It is known that such a state can sometimes be observed for a long time after the clinical recovery of acute hepatitis B. It is assumed that the persistence of the virus in this case can be carried out in the form of an immune complex with anti-HBs. In other cases, the combination of a low level of viremia with the presence of only anti-HBc is more likely to fit into the picture of the "silent" form of chronic hepatitis B. It is believed that negative results in the detection of HBsAg in patients with HBV may be caused by a low level of HBsAg, the formation of immune complexes, as well as mutations virus in the S region. The mechanisms that maintain a low level of viral replication in the silent form of HBV need further study. Currently, the factors that can maintain the persistence of the virus in the blood during silent HBV infection include infection of blood monocytes with the virus, the formation of immune complexes with antibodies, weakened immunity, and coinfection.
Analyzing the results obtained in the light of literature data, it can be concluded that among donors whose blood does not detect HBsAg, there are cases of HBV infection. Blood components prepared from such donors can serve as a source of infection for recipients during blood transfusion. The PCR method using highly sensitive test systems makes it possible to detect HBV infection in HBsAg-negative donors and thereby reduce the number of cases of post-transfusion hepatitis B.
Thus, the work shows that the introduction of preventive corrective measures helped to reduce the residual risk of infection of recipients to the level of the blood service of the European Union, prevent psychological trauma of donors associated with incorrect laboratory diagnoses, prevent infection of 57 people with viral hepatitis C, 5 people with viral hepatitis B, ensure savings of more than 500,000 million rubles due to the lack of the need to treat possible patients with viral hepatitis, to prevent the spread of viral hepatitis.
When developing and implementing the QMS in the CDL of blood service institutions, in order to eliminate the risk of errors associated with the work of personnel, it is necessary to introduce automated equipment, involve people in the work of the QMS, etc. In a metropolis, the organization of taking blood and its components is carried out as close as possible to donors and recipients alike. Only in the structure of the Department of Health of the City of Moscow, blood collection is carried out in two territories of the SEC (Polikarpova St. and Bakinskaya St.), in field conditions, as well as 15 DICs.
To assess the possible effectiveness of laboratory research centralization for all blood service institutions on the basis of one laboratory, we have developed a laboratory calculator based on studying the dependence of the cost of blood tests to ensure the infectious safety of various amounts of daily donations at two levels of laboratory automation: using automatic ELISA- analyzer and using semi-automatic analyzers and plate washers. In the course of the work, we have shown that with the number of donations less than 50 per day, the creation and maintenance of an ELISA laboratory does not make economic sense; with the number of donations from 50 to 200 per day, the costs of infectious diagnostics are acceptable, but subject to optimization by increasing the load / centralization; with the number of donations more than 200 per day, the costs are close to the minimum.
Studies have shown that with an uneven distribution of donations between institutions, insufficient load on the laboratory, the cost of analysis increases significantly, so any centralization will lead to a noticeable economic effect. For example, the creation of one centralized laboratory per subject of the federation, which will carry out 80% of research in the region, will save the budget more than 780 million rubles. in year. This is most clearly manifested in the conditions of a metropolis, when a large number of blood service institutions are located on an insignificant area. The experience of the Central Clinical Laboratory of Blood Services, the only centralized blood service laboratory in the country, is a clear confirmation of the study.
As a result of the implementation of the QMS model in the CCD, the following advantages were obtained:
The transition from the performance of the functional duties of the head of the laboratory, the doctor of the KLD, the laboratory assistant, the medical technologist, aimed at the technical execution of the pre-analytical, analytical, post-analytical stages, regulated by the current regulatory documents, to the policy of ensuring the quality system of clinical laboratory diagnostics processes with the introduction of the function of the representative of the management for quality, chief and internal auditors;
A system has been introduced to ensure traceability and control by the laboratory staff of the entire chain of research and QMS support;
Improved understanding of the goals and objectives of the CDTC by the staff;
The level of motivation, executive discipline and responsibility of personnel for the final result has been increased due to the created working mechanism for the continuous improvement of diagnostic processes;
Reduced time for internal cycles and terms for issuing test results by increasing the pace of introduction of new methods and technologies for diagnosing blood-contact-transmissible infections in blood donors and its components;
The economic efficiency of the centralized clinical diagnostic laboratory of the metropolis blood service institution was ensured;
The efficiency of using laboratory equipment has been increased, the number of false positive and false negative results has been reduced by optimizing the processes for performing laboratory tests, which has increased efficiency
Increased detection of individuals with the presence of markers of infectious diseases that are in the "serological window" and in the presence of mutant strains of pathogens as a result of the introduction of corrective and preventive actions;
The number of unreasonable withdrawals from donation associated with false positive results was reduced, which made it possible to keep human donors in donation;
The number of psychological traumas for donors associated with the groundlessness of rejection and the need for additional examinations has been reduced, especially in the context of socially significant infections (HIV, viral hepatitis);
Efficient use of human resources was ensured through the rational placement of equipment, personnel and intensification of labor, subject to work within the framework of the QMS.
CONCLUSIONS
A model of the quality management system of a centralized clinical diagnostic laboratory for the blood service of a megalopolis has been developed, which makes it possible to ensure the transition from the performance of functional duties of QLD specialists to the policy of ensuring the quality system of clinical laboratory diagnostics processes.
The introduction of the developed model into practice has led to the effective use of various specialists in the laboratory, increasing the motivation and responsibility of staff, providing CDL with high-quality medical products through the developed management system for the purchase of services and materials, increasing the reliability of research and reducing the time for issuing results.
Algorithms for examination of donors, culling of hemocomponents, withdrawal from donation based on the results of a study for blood-contact-transmissible infections (HIV infections, viral hepatitis B and C, syphilis) have been developed, including, in addition to regulated methods, the detection of nucleic acids of viruses by gene testing and re-examination of donors using immunological tests to minimize the "serological window".
The introduction of laboratory diagnostic algorithms has improved the infectious safety of donation. Using viral hepatitis C as an example, it has been shown that:
Re-examination of donors and determination of hepatitis C virus RNA increased the safety of blood transfusions by 0.0212% (p<0,001) и минимизировали получение ложноположительных результатов;
The introduction of gene diagnostics of blood donors made it possible to reduce the residual risk of post-transfusion HCV infection in potential recipients by 6.1 times (p<0,05);
The introduction of the algorithm led to a reduction in the number of absolute withdrawals from donation and the preservation of hemoproducts;
A calculation system has been developed that makes it possible to assess the economic efficiency of centralization and decentralization of laboratory research for blood service institutions.
It is calculated that the creation of one centralized laboratory of a blood service institution per subject of the federation, which will carry out 80% of research in the region, will save the budget more than 780 million rubles. in year. The greatest efficiency is manifested in the conditions of a metropolis, when a large number of blood service institutions are located on a small territory.
For the effective use of specialists of various profiles in the activities of the laboratory, it is recommended to introduce the proposed quality management system.
In order to ensure the high quality of laboratory research, it is necessary to introduce mechanisms for influencing the quality management representative on the purchase of reagents, consumables, equipment in accordance with GOST R ISO 9001:2000 and using the developed criteria for selecting medical products.
Donors with inconclusive initial screening results for blood-contact-transmissible markers are recommended to re-serological control after 1-3 months.
In the regions, to calculate the effectiveness of centralization of laboratory tests in blood service institutions using a laboratory calculator.
- Tarasenko O.A., Polyakov S.V. To be clinical laboratory diagnostics in Moscow polyclinics // Clinical laboratory diagnostics. - 2003 - No. 9. - P. 4-5.
- Tarasenko O.A., Zhukhovitsky V.G. Prospects for the development of microbiological diagnostics in medical institutions in Moscow // Clinical laboratory diagnostics. - 2003. - No. 9. - P. 5-6.
- Tarasenko O.A., Gukasyan I.A., Goldyreva N.G., Bondarenko V.A., Vasilyeva O.L. Experience in using the INNO-LIA confirmatory test for hepatitis C // Bulletin of the blood service of Russia. - 2004. - No. 3. - S. 30-32.
- Tarasenko O.A. The work of clinical diagnostic laboratories of health care institutions with pathogens of infectious diseases of III-IV pathogenicity groups // Clinical laboratory diagnostics. - 2007. - No. 9. -FROM. 25-26.
- Tarasenko O.A., Shubina Yu.F. Risk assessment of transfusion-transmissive transmission of viral hepatitis C // Bulletin of the RSMU. - 2010. No. 2. -S. 51-53.
- Tarasenko O.A., Gukasyan I.A., Sobolevskaya L.V., Shubina Yu.F., Popova I.Yu., Kulinich L.I., Chernenko T.V., Bondarenko V.A. The first effective experience of using multiplex screening systems for donor blood to detect HBV infection in HBsAg-negative donors // Blood Service Bulletin - 2009. - No. 3. - P. 18-20.
- Tarasenko O. A., Zakharova L. R., Toguzov R. T. Laboratory information system in ensuring the efficient operation of the centralized blood service laboratory. Clinical laboratory diagnostics. - 2008 No. 9, S. 36.
- Tarasenko OA, Brodskaya AP Information systems in ensuring the safety of donation. // Clinical laboratory diagnostics. - 2008 No. 9, S. 39.
- Tarasenko OA, Zakharova LR, Lukin Yu. V. Standards of laboratory information systems as a guarantee of quality assurance and continuity of research in the laboratory of a metropolis. // Clinical laboratory diagnostics. - 2008 No. 9, S. 39.
- Tarasenko OA, Tarasenko Yu. F. Molecular biological methods in the system of ensuring the safety of blood transfusions. // Clinical laboratory diagnostics. - 2008. - No. 9. - P. 46.
- Tarasenko O.A., Tarasenko Yu.F. Ensuring the viral safety of blood products and blood components in blood service institutions of the Moscow City Health Department - Abstracts of the XIII International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology" - 2005. - P. 210-211.
- Tarasenko O.A. Organizational aspects in the activities of CDL to ensure the prevention of nosocomial infections - Abstracts of the III Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2005. - S. 22.
- Tarasenko O.A., Zakharov V.V. Laboratory support of viral safety of blood products and blood components in the prevention of bloodborne diseases - Abstracts of the III Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2005. - S. 23.
- Tarasenko O.A., Zakharov V.V., Oprishchenko S.A., Larina MN. Effective quarantine in ensuring the prevention of nosocomial infections. – Abstracts of the IV Scientific-practical conference “Nosocomial infections in hospitals of various profiles, prevention, treatment of complications. - M., 2006. -S. 19.
- Tarasenko O.A. Provision of microbiological benefits to medical and preventive institutions of the Department of Health of the city of Moscow. - Abstracts of the IV Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2006. - S.36-37.
- Tarasenko O.A., Zakharov V.V., Oprishchenko S.A. The system of culling of harvested products in the blood service of the Department of Health in ensuring the prevention of nosocomial infections. - Abstracts of the IV Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2006. -S. 37-38.
- Tarasenko O.A., Olshansky A.Ya., Tarasenko. Yu.F., Bondarenko V.A. Rationale for testing blood serum samples of donors that do not contain HBsAg for other serological markers of hepatitis B virus to reduce the risk of post-transfusion complications. - Abstracts of the XIV International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology". - Gurzuf, 2006. - S. 175-176.
- Tarasenko O.A., Tarasenko Yu.F. The system of culling of prepared products in the blood service based on the results of testing donor blood for markers of infectious diseases. – Abstracts of the XIV International Conference “New Information Technologies in Medicine, Biology, Pharmacology and Ecology”. - M.. 2006. - S. 178.
- Tarasenko O.A., Zakharov V.V. Quarantine of hemocomponents in reducing the risk of post-transfusion hemotransmissible diseases. - Materials of the V Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2007. -S. 25.
- Tarasenko O.A., Zakharov V.V., Tarasenko Yu.F. The effectiveness of a new algorithm for laboratory examination of blood donors and its components and the use of prepared products in the prevention of nosocomial infections. - Abstracts of the V Scientific-practical conference “Nosocomial infections in hospitals of various profiles, prevention, treatment of complications. - M., 2007. - S. 46-47.
- Tarasenko O.A., Kundelsky R.V. Economic aspects of the centralization of laboratory research for blood service institutions - Proceedings of the scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis." - 2008. -S. 23-25.
- Tarasenko O.A., Torshin V.A. Modern solutions in laboratory express diagnostics of critical conditions. - Abstracts of the scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis." - 2008. - S. 25-26.
- Tarasenko O.A. The view of a doctor of clinical laboratory diagnostics on the issues of licensing activities related to the use of pathogens of infectious diseases in ensuring the prevention of nosocomial infections. - Abstracts of the VI Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - 2008. -S. 55-56.
- Tarasenko O.A., Olshansky A.Ya., Gukasyan I.A., Bondarenko V.A., Tarasenko Yu.F. The presence of total anti-HBcor antibodies in blood serum samples of donors that do not contain HBsAg. - Abstracts of the VI Scientific and Practical Conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications." - M., 2008. - S. 56-57.
- Tarasenko O.A., Osipova O.N. Fundamentals of biosafety of medical personnel at the preanalytical stage of laboratory research. - Abstracts of the VI Scientific-practical conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications" - M., 2008. - P. 57-58.
- Tarasenko O.A., Troshin A.N., Kundelsky V.R. Economic aspects of the centralization of laboratory divisions of the blood service // Healthcare and medical equipment. - 2005. - No. 4. - S. 34.
- Tarasenko O.A. Staffing of clinical diagnostic laboratories: legislative base // Health care and medical equipment. - 2005. - No. 7. - S. 32 - 34.
- Tarasenko O.A. Problems of admission to work in clinical diagnostic (including microbiological) laboratories of medical and preventive institutions for specialists with higher education // Laboratory medicine. - 2005. - No. 7. - S. 15-16.
- Tarasenko O.A. Prevention of hemotransmissible diseases in the blood service of the city of Moscow. - Materials of the city seminar "Actual issues of prevention of bloodborne infections in a multidisciplinary hospital." - M., 2006. -S.19-22.
- Tarasenko O.A., Osipova O.N., Tarasenko Yu.F., Eremina M.V. Standard operating procedures for conducting the preanalytical stage of the activities of clinical diagnostic laboratories // Handbook of the head of the CDL. - 2007. - No. 4. - S. 13-19; No. 5. - S. 23-28; No. 6.- S. 11-14.
- Tarasenko O.A., Tarasenko Yu.F., Zakharov V.V. Laboratory aspects of ensuring the infectious safety of blood transfusions // Sterilization and hospital infections. -2007. - No. 2 (4). - S. 18-23.
- Tarasenko O.A. A look at the licensing of activities related to the use of pathogens of infectious diseases from the clinical diagnostic laboratory // Sterilization and hospital infections. - 2007. - No. 4 (6). - S. 17-19.
- Oprishchenko S.A., Tarasenko O.A., Tarasenko Yu.F. The use of laboratory technologies in the blood service to ensure the infectious safety of hemocomponents.// Healthcare and medical technologies. - M. - 2008. - No. 5. - S. 24-26.
- Tarasenko O.A., Novikov V.A., Osipova O.N., Emmanuel A.V. Implementation of international standards of the ISO system in Russia - problems and prospects // Clinical and laboratory consultation. - 2008. - No. 6 (25). -FROM. 4-7.
- Tarasenko O.A. Preliminary determination of the blood group. Screening studies for HIV. Performance of the functions of the head of the CDL // Reference book of the head of the CDL. - 2008. - No. 9. - S. 24-26.
- Tarasenko O.A. Modern laboratory technologies in ensuring the prevention of the development of post-transfusion infectious complications. Sterilization and hospital infections. - 2009. - No. 1. - S. 42-45.
- Tarasenko O.A. Laboratory technologies in ensuring the infectious safety of blood transfusions // Handbook of the head of the CDL. - 2009. - No. 1. - S. 10-15.
- Tarasenko O.A., Emanuel V.L., Emanuel A.V. Organization of work of a quality specialist // Medicine and quality. Quality management in healthcare and social development. - 2009. - No. 5. - S. 111-117.
- Tarasenko O.A., Golovastova G.I. Medical and economic solution to the problems of ensuring the quality of laboratory diagnostics // Medical Alphabet. Laboratory - 2009. - No. 2. pp. 4-5.
- Tarasenko O.A., Golovastova G.I., Emanuel V.L. Import-substituting products for high-tech clinical and diagnostic laboratories // Handbook of the head of the CDL. - 2009. - No. 7. С23-28.
- Tarasenko O.A. Mayorova O.A., Shubina Yu.F. Effective laboratory methods in reducing the risk of transfusion-transmissible transmission of viral hepatitis C// Medical Alphabet. Epidemiology and sanitation. - 2009. - No. 1. pp. 8-10.
- Tarasenko O.A. Responsibilities of a paramedic, laboratory assistant. License to work with microorganisms of the 3rd-4th pathogenicity groups. Disposal of waste from healthcare facilities. Working with immersion oil Issuance of milk // Directory of the head of the CDL. - 2009. - No. 6. pp. 26-28.
- Tarasenko O.A., Shubina Yu.F. Effective laboratory diagnosis of viral hepatitis C in ensuring epidemic well-being - Proceedings of the scientific-practical conference "Laboratory medicine in the light of the Concept for the development of healthcare in Russia until 2020. - 2009. - P. 242.
- Tarasenko O.A. Features of the organization of the work of laboratories for examining patients in hospitals in emergency conditions - Proceedings of the scientific-practical conference "Laboratory medicine in the light of the Concept for the development of health care in Russia until 2020. - 2009. - P. 247-248
- Tarasenko O.A., Osipova O.N. Staffing model for centralized clinical diagnostic laboratories - Proceedings of the scientific-practical conference "Laboratory medicine in the light of the Concept for the development of health care in Russia until 2020. - 2009. - P. 258-259.
- Tarasenko O.A., Kryukov A.I., Pavlov N.V., Varshavsky Yu.V., Palchun V.T., Kunelskaya N.L., Khamzalieva R.B., Izotova G.N., Turovsky A. .B., Kirasirova E.A., Romanenko S.G., Garov E.V. Therapeutic and diagnostic algorithm for the pathology of ENT organs: Methodological recommendations No. 14. - M .: "Department of Health of the City of Moscow", 2007. - 62 p.
LIST OF ABBREVIATIONS
ALT - alanine aminotransferase
HCV - viral hepatitis C
DZM - Department of Health of the City of Moscow
DNA - deoxyribonucleic acid
ELISA - enzyme immunoassay
ISO - International Organization for Standardization
ICLA - immunochemiluminescent assay
KDL - clinical diagnostic laboratory
KLD - clinical laboratory diagnostics
RNA - ribonucleic acid
QMS - quality management system
SPK - blood transfusion station
CKDL - centralized clinical diagnostic laboratory
anti-HCV - antibodies to hepatitis C virus
HBsAg - hepatitis B surface antigen
HBV - hepatitis B virus
HCV - hepatitis C virus
HIV - human immunodeficiency virus
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1 Scientific and methodological approaches to ensuring state control of the quality, efficiency and safety of circulation of medical devices for in vitro diagnostics Dr. med. Tarasenko Olga Anatolyevna Deputy General Director of the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor Slide 1
2 Criteria for evaluating health care as a sphere of non-material production (M.A. Godkov) Health care Laboratory Social orientation Coincidence of production and consumption time Possibility of transportation and storage of services The need for personal contact between the doctor and the patient Performance Reproducibility and accuracy Yes Yes No Yes "Piece" Doctor-patient Good Yes Not always Possible No Tens, hundreds, thousands Very high
3 Federal Law 323 "On the fundamentals of the health of citizens" Article 87. Quality control and safety of medical activities 1. Quality control and safety of medical activities is carried out in the following forms: 1) state control; 2) departmental control; 3) internal control. 2. Control of the quality and safety of medical activities is carried out by: 1) compliance with the requirements for the implementation of medical activities established by the legislation of the Russian Federation; 2) determining the quality indicators of the activities of medical organizations; 3) observance of the volume, terms and conditions for the provision of medical care, quality control of medical care by compulsory medical insurance funds and insurance medical organizations in accordance with the legislation of the Russian Federation on compulsory medical insurance; 4) creating a system for evaluating the activities of medical workers involved in the provision of medical services; 5) creation of information systems in the field of healthcare, providing, among other things, personalized accounting in the implementation of medical activities. slide 3
4 Control and supervision in the field of circulation of medical devices Control and supervision measures in the field of circulation of medical devices State registration of medical devices Control over the entire life cycle of medical devices (technical and clinical trials, toxicological studies, sales, storage, operation, disposal, etc. ) Monitoring the safety of medical devices Licensing the production and maintenance of medical equipment (except for cases when the specified activity is carried out to meet the own needs of legal entities and individual entrepreneurs)
5 Circulation of medical devices Medical devices Technical tests Toxicological studies Clinical trials Import, export Manufacturing Production State registration Examination of quality, efficiency and safety Conformity assessment State control Storage Transportation Disposal/destruction Repair Use, operation, maintenance Installation Implementation
6 Legal basis for the control of circulation of medical devices State control throughout the entire period of circulation of medical devices (MI) clinical trials, storage, installation, adjustment, operation, including maintenance, repair, use, disposal or destruction (clause 3 of article 95 of the Federal Law from the Federal Law "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation) Implemented by the Federal Service for Surveillance in the Sphere of Healthcare (Roszdravnadzor) (Order of the Ministry of Health of the Russian Federation dated n "On Approval of the Administrative Regulations for the Performance of the State Function of Controlling the Circulation of Medical Devices") Currently, mainly, verification of compliance with the requirements of regulatory, technical and operational documentation is carried out (clause 12d of the Decree of the Government of the Russian Federation dated "On approval of the Regulations on state control over the circulation of medical devices") Slide 6
7 Why documentary verification of the diagnostic laboratory is not enough? With the same set of documents for the same analytical system in different laboratories, there is a different level of quality of the analysis results: different conditions for the delivery and storage of reagents; features of equipment operation; organization and level of service; professional level of personnel, etc. It is impossible to detect non-compliance with the requirements of operational documentation without implementation of objective indicators Slide 7 A quantitative assessment of the compliance of the operational and manufacturer-declared characteristics of the analytical system is required
8 Methodology for post-registration control VLK WQA B CV biodatabase1.htm VLK-intralaboratory quality control VQA-external quality assessment system B- systematic error CV- random error (TEa) Total error - integral indicator of analytical quality Slide 8 8
9 Slide 9 PREVENTION OF FAULTY RESULTS AND PATIENT HEALTH RISK - HAVE A WORKABLE RESEARCH QUALITY MANAGEMENT SYSTEM IN A LABORATORY WITH CLEAR AND ATTACHABLE CRITERIA
10 GOST Clinical laboratory technologies. Requirements for the quality of clinical laboratory studies. Part 2. Evaluation of the analytical reliability of research methods (accuracy, sensitivity, specificity) is designed to establish objectively valid methods and criteria for the analytical reliability of clinical laboratory studies. Indicators of analytical reliability are collected in a table of Differentiated Biologically Based Accuracy Criteria (Appendix 3 GOST). Slide 10
11 Total error (TEa) integral indicator of analytical quality The most common indicator corresponding to analytical reliability according to GOST, the degree of reliability of laboratory data on the analyte under study TEa = B + 1.96xCV - allows you to simultaneously evaluate the systematic error (B) and random error (CV) for each analyte in the laboratory Statistical ranking will allow you to evaluate the performance of various analytical systems in real conditions of various laboratories Slide 11 TEa assessment stimulates analytical quality planning in the laboratory service of the Russian Federation
12 Slide 12 CHARACTERISTICS OF THE LABORATORY INVITED
13 General characteristics A large laboratory as part of a private diagnostic center Implemented a quality management system with clear and precise criteria Automated analyzers from leading manufacturers Abbott, ACL and other closed systems
14 Slide 14 METHODOLOGY AND RESULTS OF THE INSPECTION OF ROSZDRAVNADZOR
15 Choice of analytes To assess the correctness and reproducibility of control data, the following analytes were selected: Aspartate aminotransferase (AST), Bilirubin, Glucose, Iron, Luteinizing Hormone, Thyrotropin, Inorganic Phosphorus, Cholesterol, Activated Partial Thromboplastin Time or APTT, Prothrombin Time. slide 15
16 Documentary sources of data for verification The following documents were obtained for verification: Registration certificates Operational documentation Results of microclimate control in the premises where the devices are installed. Results of monitoring the storage conditions of reagents. Documents confirming the ongoing maintenance of equipment Calibration data of instruments VLC results with reference to instruments (by serial number, inventory number) and reagents (series) WQA results Slide 16
17 Slide 17 Analytical Reliability Control Data Set (1) 100 consecutive control measurements performed on the same instrument in one CM series for each of the selected analytes were used to calculate CV. The errors identified by the laboratory in the VLC were not used in the calculations.
18 Analytical Reliability Control Data Set (2) Slide 18
19 Laboratory results Reagent name Instrument name Laboratory results Appendix B GOST R level (minimum) Target values, % Level 2 (baseline) Target values, % Level 3 (optimal) Target values, % CV B CV B CV B CV B Aspartate aminotransferase (AST) Abbott ARCHITECT 2.20% 3.69% 8.93 8.06 5.95 5.37 2.98 2.89 APTT ACL Top 2 6.26% 2.22% 2.03 3 .38 1.35 2.25 0.68 1.13 Abbott ARCHITECT bilirubin 6.74% 8.33% 19.2 14.93 12.8 9.95 6.4 4.98 Abbott ARCHITECT glucose 2.43% 2.26% 4.88 3.78 3.25 2.52 1.63 1.26 Abbott ARCHITECT iron 9.10% 5.88% 19.88 13.21 13.25 8.81 6.63 4, 4 Luteinizing hormone Abbott ARCHITECT 4.46% 5.47% 10.88 11.76 7.25 7.84 3.63 3.92 Prothrombin time ACL Top 2 3.48% 3.31% 3 2.96 2 1 .97 1 0.99 Thyrotropin Abbott ARCHITECT 3.35% 7.14% 14.78 12.59 9.45 8.4 4.83 4.2 Inorganic phosphorus Abbott ARCHITECT 2.65% 0.81-5.51 % 6.38 4.75 4.25 3.17 2.13 1.58 Cholesterol Abbott ARCHITECT 2.57% 2.60% 4.5 6.13 3 4.09 1.5 2.04 Slide 19
20 Causes of variation in the deviation (B) of the analyte Phosphorus inorg. according to EQAS (1) Control measurement value (mm/l) Mean value of the comparison group (mm/l) Slide 20 Value for each point Avg. value for each concentration Value for each point Avg. value for each concentration Bias, % Bias, % 0.67 0.649 3.24% 0.64 0.654 2.14% 0.66 0.66 0.658 0.65 0.30% 0.46% 1.18 1, 2 1.67% 1.18 1.21 2.48% 1.22 1.19 1.23 1.21 0.81% -1.65% 1.98 2.03 2.46% 1.96 2 .03 3.45% 2.01 1.98 2.02 2.03 0.50% -2.14% 2.61 2.73 4.40% 2.57 2.72 5.51% 2.64 2.61 2.71 2.72 2.58% -4.17%
21 Additional questions for reporting the analyte Phosphorus, inorganic Is an inorganic phosphorus concentration of 2.7 mm/L critical for making a diagnostic decision? Is there a tendency for the Abbott Architect analyzer to underestimate results relative to the mean in the comparison group for other analytes. slide 21
22 Problem of reproducibility (CV) of coagulometry results APTT analyte (CV GOST = 2.03%) Prothrombin time (CV GOST=3.00%) Control material Lyphochek Coagulation Control (Level 1) Lyphochek Coagulation Control (Level 2) Lab data Unity data WEB (N=20) Laboratory data Unity WEB data (N=27) Mean 26.65 26.39 11.17 11.33 SD 1.03 1.35 0.19 0.42 CV 3.85% 5.10 % 1.66% 3.70% Mean 56.93 55.59 33.28 33.13 SD 3.56 3.06 1.16 1.45 CV 6.26% 5.50% 3.48% 4, 40% Slide 22
23 Thus, in pursuance of the Federal Law of the Federal Law on the Protection of the Health of Citizens and the Decree of the Government of the Russian Federation dated, a methodology was developed to test the effectiveness of the use of medical devices in the practice of a clinical laboratory. The methodology is based on an assessment of the analytical reliability (accuracy and reproducibility of control measurements) of the used automated systems. The practical use of the technique has shown that it is an important tool in assessing the quality of laboratory work, allowing during the test to identify errors that may be the cause of incorrect diagnosis and treatment. Carrying out checks according to the developed methodology will, on the one hand, increase the interest of laboratories in planning the quality of research, on the other hand, limit the use of analytical systems with low reliability of results Slide 23
24 Thank you for your attention! slide 24
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Tarasenko, Olga A. The quality management system of the clinical diagnostic laboratory of the blood service of the metropolis: dissertation ... Doctor of Medical Sciences: 14.02.03 / Tarasenko Olga Anatolyevna; [Place of protection: Federal State Institution Federal Medical Biophysical Center]. - Moscow, 2011. - 269 p.: ill.
Introduction
Literature review 6
Quality management in healthcare 15
A retrospective analysis of the use of laboratory methods for diagnosing infectious diseases to ensure the safety of hemorrhagic fusions. 33
Laboratory research methods in ensuring the infectious safety of transfusion therapy 34
The effectiveness of the introduction of scientific developments and advanced technologies into the practice of blood service laboratories 47
Materials and methods 52
Regulatory framework for ensuring the infectious safety of hemorrhagic fusion 52
Laboratory research methods 56
Retrospective analysis of detectability of hemocontact infections in blood donors 64
Statistical processing of research results 66
Results and discussion 69
Legislative basis for the activities of the CDL 69
Model of the quality management system of the centralized clinical diagnostic laboratory of the Blood transfusion station of the Moscow City Health Department 85
Personnel management and training, requirements for personnel 1 TsSDYa ... 88
Internal audits 100
Criteria for selecting equipment for the CDL blood service 115
Criteria for the selection of diagnostic test systems for the detection of bloodborne infections in the blood service 124
Laboratory diagnostics of hemocontact infections in CCDL 143
Economic aspects of centralization 170
Bibliographic List 196
Introduction to work
The relevance of research
Healthcare is a sphere where problems and results of activities of many other areas intersect and concentrate [Vyalkov A.I., 2001, Gafurov A.F., 2006, Grebennikova I.V., 2004, Roitman M.P., 1992]. To create a viable, modern, human-friendly health industry [Svitkin M.Z., 1999, Togunov I.A., 1996, Togunov I.A., 1998, Togunov I.A., 1999, Otdelnova K.A., 1991] requires the mobilization of the intellectual potential and efforts of not only medical professionals, but also all related industries [Reinhard Z., 1998, Enthoven, 1991]. One of the most important areas for ensuring the protection of public health is the improvement of the system of quality and safety of medical care, based on the principles of standardization and certification. At the same time, the lack of a functioning system of standardization and certification in healthcare limits the possibilities for strategic planning of the industry and its transparency.
Among the International Quality Standards, a group of standards in the field of the quality management system should be singled out, covering the issues of guaranteeing by the manufacturer of products strict compliance with established regulations and procedures at all stages of the product/service life cycle. Modern, more stringent requirements of the quality management system for many medical industries, including the blood service, dictate the need to clearly navigate these standards.
The most important subdivision of blood service institutions, which ensures the quality of hemocomponents and blood preparations, and, consequently, the safety of recipients and medical personnel, is the clinical diagnostic laboratory. Decree of the Government of the Russian Federation of May 10, 2007 No. 280 on the Federal Target Program "Prevention and Control of Socially Significant Diseases (2007 - 2011)" set the task of reducing the incidence of acute viral hepatitis B to 2.7 cases per 100 thousand of the population, reducing the incidence of acute viral hepatitis C to 3.8 cases per 100 thousand of the population, using a set of measures, including improving the quality of diagnosis. The evolution of the methodology for laboratory diagnosis of blood-contact-transmissible infections reflects the general trends in the development of the system for diagnosing infectious diseases. It includes: the introduction of highly sensitive methods for the indication of antigens and antibodies; their quantitative determination; testing of viral RNA and DNA in a qualitative and quantitative way; determination of genetic variants and mutant forms of viruses. At the same time, the need to identify one or another serological marker to solve specific problems facing the practitioner determines the appropriateness of using the appropriate indication method. A feature of the work of clinical diagnostic laboratories of the blood service is the need not only to determine the health status of the donor, but also to ensure the quality of prepared hemocomponents and blood products. For the effective operation of a blood service institution, algorithms for laboratory diagnostics and, based on their results, algorithms for culling blood products and admitting donors to donations are required.
Purpose of the study
Develop and implement the functioning and continuous improvement of the quality management system of clinical diagnostic laboratories of blood service institutions of the metropolis to ensure biological safety, high quality, reliability, objectivity of research and provide guarantees to the donor/recipient of the most complete satisfaction of the needs that form his confidence in the activities of the laboratory.
Research objectives
1. Develop and implement a quality management system for a clinical diagnostic laboratory that allows:
To carry out the transition from the performance of the functional duties of QLD specialists to the policy of ensuring the quality management system;
Efficient use of specialists of various profiles;
To provide KDL with quality medical products through the developed system for managing the purchase of services and materials.
2. To increase the infectious safety of donation through the implementation in blood service institutions of the developed algorithms for examining donors, culling of blood components, rejection from donation based on the results of laboratory tests for the presence of markers of blood-contact - blood-borne infections.
3. Evaluate the medical and economic efficiency of the implementation of algorithms.
4. Evaluate the economic efficiency of the centralized and decentralized systems for the organization of clinical diagnostic laboratories of the blood service.
Scientific novelty
For the first time, a quality management system was developed for clinical diagnostic laboratories of blood service institutions.
Requirements for the training and management of personnel of clinical diagnostic laboratories of blood service institutions working in the quality management system have been developed.
Criteria have been developed for the selection of reagents, consumables and equipment within the framework of the functioning of the quality management system.
For the first time, algorithms have been developed for examining donors, culling blood components, and rejecting donors based on the results of laboratory tests for the presence of markers of blood-contact-transmissible infections.
The medical and economic efficiency of the introduction of the developed algorithms for the laboratory diagnosis of blood-contact-transmissible infections in blood donors has been proven.
A system has been developed for calculating the effectiveness of creating clinical diagnostic laboratories, carrying out centralization and decentralization of laboratory research.
A system of effective centralization of laboratory research has been created for the blood service institutions of the metropolis.
Practical significance of the study
The implementation of the developed quality management system of the clinical diagnostic laboratory will ensure the transition from the performance of the functional duties of QLD specialists to the policy of ensuring the quality management system, including the introduction of the functions of a representative of the quality management and auditors, as well as the involvement of specialists of various profiles in the activities of the laboratory necessary to ensure the QMS.
On the basis of the developed management system for the purchase of services and materials, an adequate provision of CDL with high-quality medical products is justified.
The introduction of newly developed algorithms for examining donors, culling blood components, and rejecting donation based on the results of a study for blood-borne blood-borne infections made it possible to reduce the residual risk of infection in recipients during blood transfusions by more than 6 times .
The centralization of laboratory tests in blood service institutions will make it possible to save more than 700 million rubles a year.
Provisions for defense
1. The introduction of a quality management system in clinical diagnostic laboratories of blood service institutions makes it possible to ensure the transition from the performance of functional duties of QLD specialists aimed at the technical execution of laboratory tests to the policy of ensuring the quality system of clinical laboratory diagnostics processes with the introduction of the function of a quality management representative, chief and internal auditors, ensuring the efficient use of human resources through the rational placement of equipment, personnel, rationalization and intensification of labor.
2. The introduction into the activities of blood service institutions of the developed algorithms for examining donors, culling of hemocomponents, and rejection from donation based on the results of a study for blood-contact bloodborne infections can improve the safety of donation.
3. The medical and economic efficiency of the implementation of the developed algorithms for the laboratory diagnosis of bloodborne infections is to reduce the residual risk of post-transfusion infection, reduce the incidence in this spectrum of pathology and reduce the cost of treatment.
4. The developed calculation system, which is based on the study of the dependence of the cost of donor blood tests to ensure the infectious safety of various amounts of daily donations at various levels of laboratory automation, allows us to evaluate the effectiveness of the centralization of laboratory tests for all blood service institutions.
5. The cost-effectiveness of organizing a laboratory for the study of at least 200 blood samples per day for the determination of markers of 4 blood-contact-transmissible diseases is shown.
Implementation of research results
The developed algorithms for the laboratory diagnosis of blood-contact-transfusion-transmissible infections in blood donors formed the basis of the Order of the Moscow City Health Department No. 513 dated November 29, 2007 "On strengthening measures aimed at reducing the risk of developing post-transfusion complications" and introduced into the activities of the SEC of the Moscow Health Department, Federal State Institution "Rosplasma" of the FMBA of Russia, the Hematological Research Center of the Russian Academy of Medical Sciences and other institutions of the blood service of Russia.
The developed quality management system has been introduced into the activities of the centralized clinical diagnostic laboratory of the Blood Transfusion Station of the Moscow City Health Department. During the certification of the laboratory in the GOST R system, a certificate of conformity No. ROSS RU.IS65.K00054 dated 02.04.2009 was issued.
The economic model of centralization of laboratory research has been introduced into the activities of the blood service of the Moscow City Health Department, which resulted in the creation of a centralized clinical diagnostic laboratory of the SEC.
The materials of the dissertation research are used in the process of training physicians and biologists of KLD in the cycles of improvement and professional retraining at the departments of clinical laboratory diagnostics of the State Educational Institution of Higher Professional Education of the State Medical Institution of Higher Professional Education of the Russian State Medical University of Roszdrav and the Federal State Educational Institution of the IPK of the Federal Medical and Biological Agency of Russia.
The author analyzed the current documentation in the field of clinical laboratory diagnostics and blood service institutions, developed a quality management system for the clinical diagnostic laboratory of the blood service, algorithms for examining donors, culling of hemocomponents, rejection from donation based on the results of laboratory tests for the presence of markers of blood-contact-transmissible infections, criteria selection of equipment, diagnostic test systems, requirements for personnel and aspects of effective personnel management, developed an architectural and planning solution for the laboratory, assessed the effectiveness of the centralization of laboratory research, which resulted in the creation of the Central Clinical Laboratory, organized the work of laboratory staff to test donated blood for markers of infectious diseases followed by work on the analysis of the obtained data, their statistical processing and interpretation of the results.
She calculated the residual risk of transfusion-transmissible transmission of viral hepatitis C in the period before and after the introduction of blood testing of donors for the presence of HCV RNA.
The author independently conducted an analytical review of domestic and foreign literature on the problem under study, compiled a research program, collected medical, social, and clinical and statistical information. Planning, drawing up a program of mathematical and statistical processing of the material and the processing itself were carried out with the personal participation of the author. The interim results of the study were systematically reviewed by scientific advisors. Analysis, interpretation, presentation of the obtained data, formulation of conclusions and practical recommendations are completely performed by the author personally. The share of the author's participation in the accumulation of information is up to 100%, mathematical and statistical processing - more than 80%, in the generalization and analysis of the material - 100%.
Approbation
Approbation took place on March 22, 2010. at a joint scientific and practical conference of a team of employees of the Department of Clinical Laboratory Diagnostics of the Faculty of Postgraduate Medical Education, the Department for the Development of Laboratory Technologies of the State Educational Establishment of Higher Professional Education of the Russian State Medical University of Roszdrav, the centralized clinical diagnostic laboratory of the blood transfusion station of the Moscow Health Department, the laboratory department of the NIISP named after. N.V. Sklifosovsky, laboratory department of the MHC AIDS of the Moscow City Health Department.
The results of the study were reported at: XIII International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology" (Moscow, 2005); XIV International Conference "New Information Technologies in Medicine, Biology, Pharmacology and Ecology" (Moscow, 2006); I Scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis" (Moscow, 2008); II Scientific-practical conference "Modern technologies and methods for diagnosing various groups of diseases, laboratory analysis" (Moscow, 2009); VI scientific-practical conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications" (Moscow, 2008); V Scientific-practical conference "Nosocomial infections in hospitals of various profiles, prevention, treatment of complications" (Moscow, 2007); Scientific-practical symposium "Volume, organization and economics of laboratory support of medical care in the context of healthcare modernization" (Moscow, 2006); scientific and practical symposium "Key problems of improving the laboratory support of medical care" (Moscow, 2007); scientific and practical symposium "Laboratory medicine: innovative technologies in analytics, diagnostics, education, organization" (Moscow, 2008); scientific-practical conference "Laboratory medicine in the light of the Concept for the development of health care in Russia until 2020" (Moscow, 2009); collegiums of the Moscow Department of Health, meetings and seminars held by the organizational and methodological department for laboratory diagnostics of the Moscow Department of Health.
Publications
Scope and structure of the dissertation
The dissertation work is presented on 273 typewritten pages and consists of an introduction, literature review, results of own research and their discussion, conclusion, conclusions, bibliographic list including 239 domestic and 60 foreign sources. The work contains 8 appendices, illustrated with 19 tables and 15 figures.
Retrospective analysis of the use of laboratory methods for diagnosing infectious diseases to ensure the safety of hemorrhagic fusion
A prerequisite for improving the quality of medical care is its management 124, 247, 276. 266]. However, a literal interpretation of the civil legislation of the Russian Federation leads to the conclusion that we are talking about the performance of work and the provision of services, but not about assistance. The right to health protection and medical care is a constitutional right of citizens of the Russian Federation (Article 41), but the term “services” (Article 8, Article 74) with the adjective “medical” is not used in the text of the Basic Law. The first mention of medical services appears in the Law “On Health Insurance of Citizens in the Russian Federation”, is somewhat specified in the “Fundamentals of Legislation on the Protection of the Health of Citizens in the Russian Federation” and finally gains legitimacy with the introduction of part two of the Civil Code of the Russian Federation (Chapter 39) .
In other words, the obligations of the state to fulfill the requirements of citizens exercising their constitutional rights “to health care and medical care” are implemented “in the field of ... healthcare” by providing “ public services» federal government agencies or other organizations, and, according to the Constitution, regardless of the legal form and form of ownership, unless otherwise provided by law.
In the documentation of the quality management system of the Novosibirsk NIITO, a medical service is understood as an event or a set of measures aimed at the prevention of diseases, their diagnosis and treatment, which have an independent complete value and a certain cost. Medical care is interpreted as a set of measures, including medical services, organizational and technical measures. sanitary and anti-epidemic measures, laboratory and diagnostic studies, drug provision, etc., aimed at meeting the needs of the population in maintaining and restoring health.
Thus, the concept of "medical care" is broader than "medical service" and it is assumed that in the future there may be medical organizations specialized in providing a narrow range of services, or even a single type of service, that will be included in the overall process of providing medical care.
There are two other significant differences that need to be mentioned. A service is an act that benefits another person. Be sure to benefit, and be sure - to another. Meanwhile, but by definition, "help - assisting someone in something." “Assistance” implies the active actions of the subject who is being helped, and a certain degree of their influence on the result. Moreover, the benefits of assistance are assumed, but not mentioned, and it cannot be guaranteed by an isolated action (work, service) of the subject participating in the process of providing assistance.
The current stage of Russia's development requires the medical community to realize that every doctor is the main link in ensuring the proper quality of medical care for the population, and this becomes a criterion in the public mind.
The traditional quality of this or that kind of activity is evaluated, first of all, by its results. However, if the quality of activity is determined only after the fact, then the possibility of influencing the optimization of the activity itself in its process is lost. Modern quality management is built on the basis of the postulate that quality management activities cannot be effective after the product has been produced, this activity must be carried out during the random production. Also important are the quality assurance activities that precede the process of producing a good or service.
One of the most important directions in ensuring the protection of public health is the improvement of the system of quality and safety of medical care, based on the principles of standardization and certification. At the same time, the lack of a functioning system of standardization and certification in healthcare limits the possibilities for strategic planning of the industry and its transparency.
The International Organization for Standardization (ISO) is a worldwide organization for national organizations on standardization (committees - members of ISO). The development of International Standards is usually carried out by ISO technical committees, on which each member body has the right to be represented. International organizations, governmental and national governments with ties to ISO also take part in the work. International quality standards developed by ISO can be divided into two groups: 1. Product standards, which include requirements for quality, safety, reliability, economy, etc. this type of product, as well as some aspects of the specifics of its arbitrariness! va. 2. Standard in the field of quality management system (QMS), covering the issues of guaranteeing the manufacturer of products strict compliance with established regulations and procedures at all stages of the life cycle of products (services). Modern, more stringent requirements of the quality management system for many medical industries, including the Blood Service, dictate the need to clearly navigate these standards. The most popular among the latter were the ISO 9000 series standards. According to the literature, at the end of 2006, 897866 certificates were valid in 170 countries of the world according to the requirements of the ISO 9001:2000 standard. The first version of these standards was developed in 1987 by a specially created within ISO technical committee X? 176 "Quality management and quality assurance" . The first version of the ISO 9000 series of standards contained universal requirements for quality management systems of enterprises, regardless of their industry affiliation. A breakthrough in the field of quality in medicine is associated with the name of Donabedian. The International Organization for Standardization (ISO) has developed and published the "Principles of Quality Management". This document presents the eight quality management principles on which the quality management system standards of the revised ISO 9000:2000 series are based. These principles can be used top management as a framework for managing their organizations in order to improve their performance. The principles are derived from the collective experience and knowledge of international experts who participate in ISO Technical Committee 176 Quality Management and Quality Assurance, which is responsible for the development and maintenance of the ISO 9000 series of standards.
The effectiveness of the introduction of scientific developments and advanced technologies into the practice of blood service laboratories
In the previous sections of the literature review, the stages of development and implementation of IFL for the diagnosis of viral hepatitis, HIV infection are presented in sufficient detail in order to justify the introduction of more advanced modern modular NA1 technologies, which will undoubtedly reduce the residual risk of infection of recipients in the blood service.
Currently, enzyme immunoassay is widely used in diagnostics, including in the Blood Service. IFL - screening of donor blood for markers of HIV infections, viral hepatitis B and C is mandatory all over the world, and in Western Europe, the USA, Canada, Japan, Australia, New Zealand, Singapore and Hong Kong, plasma and blood of donors who are in the period of immunological windows are additionally subjected to NAT - screening for the purpose of culling. International experience with NAT-screening of donated blood shows that after its application on a national scale, the residual risk of viral infections after transfusion has significantly decreased.
The creation of international NAT standards made it possible to apply various methods, devices and test systems for NAT blood screening. GTCR is one of the leading methods of molecular diagnostics, which, along with ELISA, biochemical, cytological, cultural and various physicochemical methods, should be presented in all major clinical diagnostic laboratories. The Special Effort ELISA Lab can accommodate a set of small NAT diagnostic instruments. Gsamplification diagnostic methods are compatible with other diagnostic studies, for example, with ELISA, biochemical, cytological, bacteriological, etc., if the same material is used for the study.
In the vast majority of cases, mini-pools are created for NAT-screening of donor blood using automatic samplers Tesan, Hamilton, and others. The introduction of NAT-testing of donor blood is a call of the times. With varying frequency, donors with viremia are identified in different countries, but without serological signs of hemocontact infection. The frequency of occurrence of NAT-positive among ELISA-negative donors in the blood center of Sacramento (USA) for hepatitis C virus is 1:169,500, for HIV - 1:566,328. In France, this figure for the hepatitis C virus is 1:3,187,562, for HIV - 1:1,594,000. In Germany, for the hepatitis C virus - 1:1 411 183, for HIV - 1:5 455 831, for the hepatitis B virus - 1: 430 854. It should be noted that the prevalence of infection markers among potential donors in developed and developing countries differs by 10 -! 000 times. In order to improve the safety of gn and smotransfusion therapy, the leading blood centers, enterprises for the production of blood products in Russia can and should introduce gene diagnostic technologies.
The introduction of NAT-testing of donor blood is a call of the times. Ten years ago, the results of the experience of using PCR at the Paul Ehrlich Institute were published.
The authors note that the efforts to establish PCR testing were driven primarily by the demands of plasma product manufacturers who wanted to use PCR testing from early 1997. Moreover, it became apparent that the Paul Ehrlich Institute, a government agency established to manage the production of blood and its products intended to apply PCR testing for erythromass.
Having calculated the probability of “residual risk” in blood donors during the “long-term conversion window” at the institute with a total number of donations of 270,000 per year, the authors conclude that their data show the importance of the contribution of PCR testing to the safety of the blood service, even with a good selection of donors. .
The authors point out THAT their main goal in establishing PCR screening of donors was to ensure that test results are available within 1 day so that high quality blood products can be marketed as quickly as possible. This was achieved by nulling the samples followed by PCR testing performed at the same time as serological testing. Over the past 10 years, in Europe, the USA, Canada, Japan, and Australia, results have been obtained on additional NAT testing of many millions of donated blood units, which make it possible to detect virus-containing seronegative donations. Such mass NAT-screening became possible thanks to the NAT-mi or pool-testing technology, which reduces material costs by dozens of times and speeds up the process, allows you to get the results of NAT-testing by the time the blood components are sold.
Since July 1, 1999, the European Union has allowed the use of plasma and its preparations in clinics only if they are negative for HCV RNA through NAT testing. Data on the first experience of manual minipool PCR testing of donated blood in Russia for HIV. HCV and HBV was obtained from a plasma study in 200] 217.
In subsequent years, this technology is being gradually introduced in many laboratories in Russia during the screening examination of donor blood. It seems important that already a few years after the European Union allowed the use of plasma and its preparations in clinics only if they are negative for HCV RNA through NAT testing. there were reports about the inexpediency of large-scale implementation of NAT-technologies. Thus, when reviewing the results of the experience of using NAT in North America for two: HIV and HCV, the plasma of 16.3 million dopas was examined. 62 positive samples were found (1:263,000 for HIVI AND 1:2100,000 for HCV). The authors note in their paper that implementing NAT is not cost-effective because the reduction in residual risk for H1V-1, 2, and HCV in the United States is extremely low at 1:2,000,000 donations.
Perhaps their point of view has a right to exist. But the choice of certain methods and technologies should be determined not only by economic factors, but also by the prevalence among the population of the population in certain territories of those infections that are mandatory when examining donor blood.
Model of the quality management system of the centralized clinical diagnostic laboratory of the blood transfusion station of the Department of Health of the city of Moscow
Confirmatory HCV test (HCV Immunoblotting). A set of LIL HCV reagents (Nearmednk Plus, Russia) was used to confirm the presence of antibodies to the hepatitis C virus in serum and plasma. High-quality recombinant antigens and synthetic peptides from the cor region, from the B-2 hypervarnable region, from the NS3 helical region, as well as from the NS4A, NS4B, NS5A regions of HCV are applied in the form of discrete lines on a nylon membrane, which is attached to a plastic substrate. The membrane was also covered with 4 control lines (internal controls!): antistreptovidin (immobilized streptovidin), antibodies to human IgG (corresponds to 3+ positive control in staining intensity) and two lines of immobilized human IgG immunoglobulins (corresponding to 1+ positive control in staining intensity and critical level +). The test sample was incubated in a tray with a test strip. If antibodies to HCV are present in the sample, the latter bind to antigens deposited on the membrane. The detection of specific immune complexes is based on the principle of ELISA.
Arcliilect-system models 2000 and 4000 (Abbotl Diagnostics division, USA) were used for laboratory diagnostics of HIV infection, hepatitis B and C, and syphilis.
Fully automated system for ELISA The analyzer uses CM (A) technology (chemiluminescent immunoassay using a suspension of paramagnetic microparticles). Diagiosticums "HBsAg", "Anti-HCV", "HIV Ag / Ad Combo" were used in the work. Polymerase chain reaction (" Cobas-Amplicor", Roche, Switzerland). The automatic analyzer "Cobas-Amplicor" combines five different instruments: a thermal cycler, a thermostat, a wash photometer and an automatic dispenser. The instrument provides fully automated quality control: temperature control of thermal cyclers, sufficient quantity and expiration dates of reagents, internal control of amplification and detection reactions.Biomaterial processing was carried out according to the procedure.The test material is processed with a leading buffer when extracting DNA for hepatitis B and RNA for HIV and hepatitis C. The reaction mixture was mixed and placed in a thermal cycler, where denaturation cycles, annealing and extension. allows you to detect reaction products using as a conjugate - avidin-labeled enzyme. A feature of "Cobas-Amplicor" is a fully automated research process. The presence of the enzyme amperase in the wash buffer. destroying DNA fragments after completion of the study cycle, completely eliminates the contamination of subsequent analyzes.
Cobas s 201 system and cobas TaqScrecn test. The cobas s 201 platform (Roche Instrument Center, Rolkreuz, Switzerland) consists of an automated system for auditing donor samples using a pipette (Microlab Star IVD.Hamilton, Reno. NV), automated sample preparation using the Cobas AmpHPrep device (CAP) and automated amplification (PCR in real time) and detection in the Cobas TaqMan (CTM) analyzer. The cobas TaqScreen MPX test (Roche Molecular Systems, Brancliburg, NJ) is a NAT test for use in the cobas s 201 platform that detects HIV-1, HIV-2, and HCV RNA and HBV DNA in plasma samples from human group M, HIV-I group O and H1V-2), negative kit control A reactive result indicates the likely presence of HBV, HCV, HIV (one or more) in the sample.
The automated system "TIGRIS", manufactured by "Chiron Healthcare Ireland Limited, Gen-Probe Incorporated", (Ireland, USA), allows testing three pathogens simultaneously in one sample - HBV, I4CV, HIV - in a fully automatic mode in the modification of transcripton-mediated amplification. Retrospective analysis of the detection of germ-contact infections in blood donors
To conduct a retrospective analysis of the detection of bloodborne infections in blood donations, the database of the single donor center of the SEC DZM was used, which has information about donors, their donations and the results of laboratory blood tests of donors from the blood transfusion station of the DZM, 15 blood transfusion departments of medical institutions of the DZM and the department state registration of diseases. Scheme of interaction and information exchange structural divisions blood service of the Department of Health of the city of Moscow is shown in Figure 1.
Criteria for the selection of diagnostic test systems for the detection of bloodborne infections in the blood service
High performance of the machine - as already noted, full performance for two machines makes it possible to study 180 sera for four infections in one setting, and accordingly -360 in two, and 540 - in three. The Evolis machine is built on the principle of a "working cell", which allows you to adjust the system for optimal performance. Combining several Evolis "work cells" into single system allows you to transfer the container with the studied sera from one device to another without additional description of their identification) and boats.
Optimal orientation to perform mock test processing and fast time to obtain results - the Evolis analyzer, consisting of blocks for 4 plates, is most optimally oriented to perform a test package (up to 4 testons at the same time) for all sera under study, t.s. the tasks of testing donor blood, which is examined for 4 infections. The execution time for such a package of tests, provided that it was performed from one test tube, was 3 hours 34 minutes.
Simplicity and convenience of work for the operator - laboratory assistants note simplicity, ease, visibility and convenience in working with the software. In general, the tests showed the high efficiency of the use of automatic machines in the laboratory practice of the blood transfusion service: Exception " human factor» at the most possible common mistakes - the use of pre-created barcodes printed on reagent containers and sample tubes eliminates errors due to possible mix-up of samples and reagents; automatic analysis eliminates the possibility of not adding or incorrectly adding reagents. Error tracking system for all stages of analysis, from sample introduction (including identification of samples containing "clots") and reagents to the final measurement step, guarantees the reliability of the results, with the software marking unreliable results in the report and displaying them in the "event" log . Significant reduction in labor costs - the operator only forms the task AND loads the reagents, which in this machine takes no more than 25-30 minutes, all other stages of the analysis do not require the presence of personnel. Improving the safety of personnel - the use of automated systems dramatically reduces the likelihood of potential infection of personnel due to a sharp reduction in the time of contact with infectious material. Improving the quality of tests performed due to the standardized execution procedure when using the machine, the presence of a built-in quality control system allows you to evaluate the reproducibility of test results when working with test systems from different manufacturers of different series during the laboratory process The possibility of integrating the machine into a specific information database of the laboratory showed that The software allows using a unified LIS interface for bidirectional information exchange with any modern external information infrastructure. From the standpoint of quality assurance, it is necessary to carry out daily monitoring of the state of the production environment. Bvolis devices take this into account and when printing protocols, data on temperature, humidity in production premises and directly in the device blocks are printed. Also, due to the identification of reagents on board, the name of the test systems used, their series, and number are entered into the protocols. best before date. With regard to the specifics of the CKDL, the additional advantages of this analyzer, we believe that: - if there are 4 such machines, taking into account their performance, the laboratory will be able to issue final results on the same day, while performing a permutation of positive results. Samples already tested for infectious markers will be transferred to the biochemical department of the ICSD; - the compactness of the devices allows them to be easily placed in the premises of the laboratory; - the design of devices in which testing is carried out behind a tightly closed transparent cover does not require the equipment of rooms with boxes, which leads to significant savings in equipping the laboratory; - block and compact design of devices (designed for 4 tablets per block), as well as the existing function of reloading samples, allows testing as they arrive, a. without waiting for the entire volume of sera to arrive, which increases the speed of issuing results; - extremely important" that in case of a problem with the device, the block design of the automata and the existing "emergency" function! suspension” allows you to continue performing analyzes on other machines without losing tests, which ensures the continuity of the laboratory; - high performance of the device and the available function of performing analyzes without the participation of an operator makes it possible to increase the volume and range of research by 2.5-3 times in emergency situations. Thus, the tests of the devices made it possible, after the purchase of the equipment, to adapt it to the specific needs of the Central Clinical Laboratory and subsequently effectively use the blood service laboratories in practice, ensuring effective quality control of not only the tests performed, but also the conditions of the production environment and directly the employees working on these devices.