ACCLMU Activities Report

Activities of the Association of Clinical Chemistry and Laboratory Medicine of Ukraine

2007

1. «Basic directions of laboratory services development at the current stage in Ukraine» were developed (May 2007).
2. Participation in a meeting of regional experts on clinical laboratory diagnosis (Kyiv, 26 June 2007).
3. «Passport of diagnostic laboratory» was created (June 2007).
4. Participation in laboratory service passportization (July 1 – December 31, 2007).
5. The following regulatory documents were developed:
– Statute of the ACCLMU;
– Regulatory document for a local center of the ACCLMU;
– Regulatory document for membership in the ACCLMU (July-August 2007).
6. Statutory Conference of the ACCLMU took place in Kyiv on September 6, 2007.
7. ACCLMU took an active part in Scientific and Practical Symposium «Fundamental problems for improvement of laboratory implementation of medical care» within the framework of the Days of Laboratory Medicine in Russia (Moscow, October 10-12, 2007).
8. «Ministry of Health of Ukraine actions plans for improvement of laboratory services until 2013» were developed (October 2007).
9. Analysis of laboratory services in Dnipropetrovs’k region for 9 months of 2007 was participated.
10. Unscheduled audit for compliance with licensing conditions in business and medical practice for PP (single proprietor firm) «Diagnostika SL» was participated (Dnipropetrovs’k, December 3-4, 2007).
11. School-Seminar with International Participation «Modern technologies of management and quality control of clinical laboratory» was carried out (Kyiv, December 10-14, 2007).

2008

12. Meeting of the Association of Clinical Chemistry and Laboratory Medicine Ukraine was held (Kyiv, February 9, 2008).
13. The following documents were developed and submitted to the Ministry of Health of Ukraine (January-March 2008):
– Conception of the State Program «Organization of centralized regional clinical diagnostic laboratories by network principle», and
– Conception of the State Program «Providing family physician with adequate and rapid methods of laboratory diagnosis».
14. Development of the following conceptions of the State Dedicated Programs was participated:
– «State Dedicated Program of reduction of mortality and disability from hematologic diseases for 2009-2013», and
– «State Dedicated Program of development of Blood Service for 2009».
15. Scientific Seminar «Laboratory Medicine and Priorities of the Ministry of Health in 2008» was organized (Lviv, April 10-11, 2008).
16. ACCLMU members group including Prof. G. Lunyova, O. Kheylomskyi, T. Gavrilenko, T. Sol’s’ka within a Working group has elaborated project of the Order of the Ministry of Health of Ukraine «On the determination of the expertises (tests) range, ratification of order of realisation of the State control for compliance of medical devices for in vitro diagnostics and for technical requirements for quality of medical products for in vitro diagnostics» (April-May 2008).
17. The Association took an active part in the meeting of the Council of the Russian Association of Medical Laboratory Diagnostics and in the First All-Russian Congress of Clinical Laboratory Specialists «Fundamentals, clinical aspects and new technologies of modern laboratory medicine» (Moscow, May 27-28, 2008).
18. Scientific-and-Practical Conference «Modern immunogenetic methods in medicine» was held (Lviv, June 2-3, 2008).
19. On-site analysis of current structure of laboratory services effectiveness, of status of laboratory service and of staff training in the Ivano-Frankivs’k region was carried out (Ivano-Frankivs’k, June 26-27, 2008).
20. Ivano-Frankivs’k local center of Association of Clinical Chemistry and Laboratory Medicine of Ukraine has carried out Scientific-and-Practical Seminar «Current issues of laboratory services in Prykarpat’tya» (Ivano-Frankivs’k, June 26, 2008).
21. Roundtable discussion on the professional associations’ role in Russia and in Ukraine within the framework of reform of laboratory services was held in the Laboratory Center of Saint-Petersburg Medical University (Saint-Petersburg , July 1, 2008).
22. Exchange of experience on the centralization of laboratory research in medical facilities and private medical centers of St. Petersburg was carried out (Saint-Petersburg, July 2-4, 2008).
23. Meeting of Donetsk center of Association of Clinical Chemistry and Laboratory Medicine of Ukraine on the centralization of laboratory research was held (Donetsk, July 7, 2008).
24. Analysis of activities, conditions and availability of laboratory equipment and reagents in Kharkiv centralized laboratory was carried out to implement the project «Centralization of laboratory research by a network principle» (Kharkiv, July 17, 2008).
25. Academy of Medical Sciences of Ukraine and ACCLMU have jointly organized and carried out VII Scientific Seminar «Functional and laboratory diagnosics: new methods and modern standards» (Kyiv, September 9-10, 2008).
26. In cooperation with the National Academy of Medical Sciences of Ukraine, VII Scientific and Practical Seminar “Functional and Laboratory Diagnostics: New Mwthods and Modern Standards” was organized and carried out (Kyiv, September 9-10, 2008).
27. Presentation at Staff Meeting of the Ministry of Health of Ukraine concerning “Organizational, Structural, and Legal Problems of the Laboratory Service at the Present Stage and Means of Its Rational Development” was made (Kyiv, September 12, 2008).
28. As a co-organizer, organization and carrying out I International Specialized Exhibition “LABComplEX” were actively participated (Kyiv, October 1-3, 2008).
29. Scientific and Practical Symposium “Laboratory Medicine: Innovation Technologies in Analytics, Diagnostics, Education, and Organization” at the I.M. Sechenov Moscow Medical Academy was actively participated (Moscow, October 7-9, 2008).
30. Presentation “Standardization in Laboratory Practice – Background of the Evidence Based Medicine” was made at IV Congress of Specialists of Social Medicine and Healthcare Organization of Ukraine (Zhytomyr, October 23-24, 2008).
31. Materials for the Meeting of the Working Group of the Ministry of Health of Ukraine on the development of the Concept of the State Program of the Laboratory Service Development for 2009-2013 (November, 2008).
32. Meeting with the German Medical Society was carried out (Berlin, November 26, 2008).
33. Meeting of the Ternopil’ regional centre of the ACCLMU was conducted (Ternopil’, December 18, 2008).
34. Analysis of conformity of texts of the Technical Reglaments of Ukraine concerning medical devices, active implantable medical devices, and medical devices for in vitro diagnostics adopted by the Decisions of the Cabinet of Ministers of Ukraine No. 536 from 11.06.08, No. 621 from 09.07.08, and No. 641 from 16.07.08, respectively, to the EC Directives 93/42/EEC, 90/385/EEC, and 98/79/EC, respectively.

2009

35. Project documentation for implementation of centralization of laboratory tests at the Kharkiv City Central Clinical Diagnostics Laboratory was prepared.
36. Statute of the Centralized Regional Clinical Diagnostics Laboratory was prepared.
37. Dnipropetrovs’k regional centre of ACCLMU has carried out analysis of efficiency of actual structure of the laboratory service, of the laboratory services provision, and of personal training level within Dnipropetrovs’k region for 2008 (Dnipropetrovs’k, March 12, 2009).
38. Inspection of production facilities of the Joint-Stock Company “Reagent” and discussion on the problems of further improvement of production quality and of extension of cooperation of the Company with ACCLMU specialists were carried out.
39. An active part in changing educational programs of specialists (biologists) of laboratory medicine according to the requirements of the European Association of Clinical Chemistry and Laboratory Medicine at the P.L. Shupik National Medical Academy of Post-graduate Education (NMAPE) was taken (hearings on this problem took part at the Meeting of the Educational and Methodological Commission of the Council of the NMAPE on April 1, 2009, at the Meeting of the Faculty of Teachers Training on April 16, 2009, and at the Educational and Methodological Conference of the NMAPE on May 5, 2009).
40. Analysis of the existing system of regulation of the medical devices for in vitro diagnostics market in Ukraine and in EC countries was carried out.
41. Meeting of the Council of the ACCLMU was conducted (Kyiv, April 24, 2009).
42. Meeting with the Society of Clinical Biology of France was carried out.
43. Project of the Order on Conducting the Attestation of the Specialists with Higher non-Medical Education Employed in the Healthcare System of Ukraine was developed (Order of the Ministry of Health of Ukraine No. 588 from 12.08.09).
44. Set of documents for creation of the Technical Committee on standardization 166 (TC166) “Clinical laboratory researches and systems for diagnostics of in vitro” at the State Committee of Ukraine on technical regulation and consumer policy (DSSU) was created and sent to the DSSU; TC166 was created by the Order of the DSSU No. 313 from 03.09.09; TC166 Secretariat functions were delegated to the ACCLMU.
45. The following international standards were prepared for legalization in Ukraine:
• ISO 15193:2008
• ISO 15194:2008
• ISO 15195:2008
• ISO 15198:2008
• ISO 20776-1:2008
• ISO/TR 22869:2008
46. Generalization of results of passportization of the National Laboratory Service of Ukraine was carried out.
47. With the purpose of integration of common laboratory space meeting modern healthcare requirements, proposals concerning creation of four-level laboratory diagnostics system within the framework of the Concept of the Laboratory Tests Centralization were submitted to the Ministry of Health of Ukraine.
48. An active part in the creation and in the meetings of the Working Group of the Ministry of Health of Ukraine on the development of the Reform Concept of the National Laboratory Service of Ukraine was taken.
49. Recommendations concerning the Reference Centre of Counteraction and Efforts against Virus Respiratory Diseases were developed and submitted to the Ministry of Health of Ukraine.
50. Recommendations concerning laboratory diagnostics of the virus respiratory diseases were developed and submitted to the Ministry of Health of Ukraine.
51. As a co-organizer, an active part was taken in preparation and carrying out of II International Specialized Exhibition “LABComplEX-2009” (Kyiv, September 30 – October 2, 2009).
52. Scientific and Practical Conference “Reform of the Laboratory Service as a Part of Healthcare System of Ukraine” was conducted (Kyiv, September 30 – October 2, 2009).

2010

53. Project of the Order of the Ministry of Health of Ukraine was developed with main regulations corresponding to fundamental directions of the National Laboratory Service of Ukraine for today (Order of the Ministry of Health of Ukraine №96 from 10.02.10).
54. Meetings of boards concerning organization and efficiency of activities of laboratories were participated, proposals concerning structural reconstruction of the laboratory services system in regions were submitted for taking into account during preparation of project of the Concept of the State Special-Purpose Programme of the Laboratory Service Development.
55. The following documents were developed and submitted to the Ministry of Health of Ukraine:
• the Concept of the State Special-Purpose Programme of the Laboratory Service Development in Ukraine for 2011-2016;
• the State Special-Purpose Programme of the Laboratory Service Development in Ukraine for 2011-2016;
• the Passport of the State Special-Purpose Programme of the Laboratory Service Development in Ukraine for 2011-2016;
• actions for the realization of the the Concept of the Laboratory Service Development in Ukraine for 2011-2016;
• tables of equipping the laboratories of the general healthcare institutions of different levels of medical care.
56. Project of Statute of the Institute of Laboratory Medicine (ILM) of the Kharkiv Medical Academy of Post-graduate Education of Ukraine (KhMAPE) and of its structure was developed; the ILM of the KhMAPE was organized by the Order of the KhMAPE No. 152 from 21.06.10.
57. Discussion on the project of the Concept of Quality Management of Clinical Laboratory Tests was participated actively.
58. Scientific and Practical Conference “Medical Laboratory & Innovations in Medicine” and Exhibition of Laboratory Equipment and Reagents were organized and carried out (Kyiv, April 21-22, 2010).
59. Meeting of the Council of the ACCLMU was conducted (Kyiv, April 20, 2010).
60. Round-table discussion “12 Questions for Overcoming of Epidemy of Virus Hepatitis in Ukraine” organized jointly by the World Health Organization, by the International Foundation “Renaissance”, and by the Ministry of Health of Ukraine was participated (Kyiv, May 19-20, 2010).
61. Meeting on optimization of activity of the Centralized Clinical Diagnostics Laboratory of the Diagnostics Centre “Morshinkurort” was participated (Morshin, June 12-13, 2010).
62. International Scientific and Practical Seminar “Actual Problems of Oncomarkers Usage for Diagnosis of Ovary Tumors” was organized and conducted by the L’viv regional center of the ACCLMU (L’viv, June 24, 2010).
63. Scientific and Practical Seminar “Modern Principles of Diagnosis and Monitoring of Chronic Liver Diseases”was organized and conducted by the L’viv regional center of the ACCLMU (L’viv, June 24, 2010).
64. Development of document “Temporary Branch Standards Concerning Quality Assurance of Clinical Laboratory Tests” placed for discussion at the Ministry of Health of Ukraine website was actively participated.
65. First meeting of the Working Group of the DSSU concerning common tasks in the field of standardization, metrology, quality assurance systems, conformity assessment, and accreditation of laboratories dealing with samples of biological origin, of laboratories of quality control of pharmaceutical and veterinary preparations, of laboratories of sanitary-hygienic service, and of laboratories of control of drugs and precursors was actively participated.
66. With active participation of ACCLMU, the Board of the Ministry of Health of Ukraine has adopted the following tasks (Kyiv, August 5, 2011):
• to develop project of the Concept of development of the the National Laboratory Service of Ukraine for 2011-2016 and the “Branch standards of quality assurance of clinical laboratory tests”;
• to include harmonized international standards in the area of clinical laboratory diagnostics into the Annual Plan of Standards Development.
67. First meeting of the Working Group on laboratories accreditation at the National Agency of Accreditation of Ukraine (NAAU) was actively participated (Kyiv, August, 2010).
68. Statute of the TC166 was developed and adopted by the Order of the DSSU No. 366 from 13.08.10.
69. First meeting of the TC166 chaired by Vice-Minister of Health of Ukraine V.P. Lysak was organized and carried out (Kyiv, September 21, 2010).
70. Scientific and Practical Conference “Flu: Epidemiology, Diagnosis, Treatment. Social and Medical Aspects” was participated (Kyiv, September 24, 2010).
71. As a co-organizer, organization and carrying out I International Forum of Healthcare Industry “MEDComplEX-2010” were actively participated (Kyiv, September 28 – October 1, 2010).
72. As a co-organizer, organization and carrying out of International Forum “Integrated Provision of Laboratories” and of Exhibition “LABComplEX-2010” were actively participated (Kyiv, September 28 – October 1, 2010).
73. Scientific and Practical Conference “Diagnostics and Organization Problems Concerning Creation of System of Quality Assurance of linical Laboratory Tests” was organized and conducted (Kyiv, September 28-29, 2010).
74. IV (VIII) Congress of the Scientific Society of Clinical Laboratory Diagnostics, Scientific and Practical Conference “”, and Specialized Exhibition “Interlabdiagnostics-2010” within the framework of National Days of Laboratory Medicine of Russia – 2010 were actively participated (Moscow, October 5-7, 2010).
75. With active participation of ACCLMU, Sub-Committee 09 “Medicine” (SC-09) of the Technical Committee of Accreditation (TCA) of the National Agency of Accreditation of Ukraine (NAAU) was organized by the Order of the NAAU No. 218 from 28.10.10.
76. National Scientific and Practical Conference on the problems of HIV-infection/AIDS with international participation “For Each Life – Together!” was participated (Kyiv, November 17-19, 2010).
77. With the assistance of the Kyiv Central Healthcare and Medical Provision Administration and of the Program of the Program for Appropriate Technology in Health (PATH), Working Meeting on the Results of the Monitoring Visits and of the Evaluation of Indicators of Tuberculosis Detection in General Healthcare Network of Kyiv was organized and carried out (Kyiv, December 8, 2010).

2011

78. With active participation of ACCLMU, set of documents concerning inclusion of speciality 14.01.39 “Clinical laboratory diagnostics” into the List of scientific specialities for scientific degrees of the Candidate of Sciences and of the Doctor of Sciences obtaining was prepared and adopted by the Decisions of the Presidium of the Higher Attestation Commission of Ukraine No. 46-09/1 from 26.01.11 and No. 31-09/2 from 23.02.11.
79. In close cooperation with ILM KhMAPE, scientific programme “Scientific substantiation of creation of the system of quality assurance of clinical laboratory tests and laboratory services” was developed and adopted by the Order of the Ministry of Health of Ukraine No. 119 from 02.03.11.
80. In close cooperation with the Ukrainian Association of Bio-Medical Engineers and Technologists, scientific journal “Biomedical Engineering” was founded (Registration Certificate of the Ministry of Justice of Ukraine No. 17522-6272 R from 04.03.11).
81. An active part was taken in the International Conference “Boosting Ukraine’s Participation in the EU 7th Framework Programme on Research: Achievements and Perspectives” (Kyiv, April 6, 2011).
82. An active part was taken in the work of XII Ukrainian Scientific and Practical Conference dedicated to actual questions of clinical laboratory immunology, allergology and immune rehabilitation (Kyiv, April 12-13, 2011).
83. The Conference-Exhibition “Medical Laboratory” and the Scientific and Practical Conference with International Participation “Actual Questions of Laboratory Medicine” were organized and carried out (Kyiv, April 19-21, 2011).
84. Meeting of the Council of ACCLMU was conducted (Kyiv, April 20, 2011).
85. Scientific seminar “New technologies in regenerative medicine: world experience of stem cells usage” was participated (Kyiv, May 13, 2011).
86. 21 th International Congress of Clinical Chemistry and Laboratory Medicine, 19th European Congress of Clinical Chemistry and Laboratory Medicine and eighth annual meeting of experts in Clinical Chemistry and Laboratory Medicine Society of Germany were participated (Germany, Berlin, 15-19 May 2011).
87. European Conference on the formulation of national strategies in the testing and control of chlamydial infection and human papillomavirus (Latvia, Jurmala, 26-27 May 2011) was participated.
88. “Concept of laboratory services of medical institutions in Kyiv. Creation of Laboratory Medicine” was drafted. In order to attract wider public to discuss the project concept, this draft concept of laboratory services in Kyiv was published on July 1, 2011, at the website the Department of Health.
89. Discussion of the Program “The state of laboratory services in Kiev and prospects for its further development” at the Board of the Department of Health of the Kyiv City State Administration was participated, and the project concept were presented (Kyiv, June 10, 2011).
90. Following the decision of the Board of the Department of Health of the Kyiv City State Administration, the analysis of comments and suggestions on the draft Concept was carried out.
91. Affiliated membership in the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) were acquired (July 7, 2011).
92. Affiliated membership in the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC) were acquired (July 20, 2011).
93. Working group on the reformation of laboratory services in Kiev (Order № 336 of the Department of Health of the Kyiv City State Administration from 19.08.2011) established according to the decision of the Board of the Department of Health of the Kyiv City State Administration and in order to create conditions to ensure the quality of laboratory services for the population of Kyiv was participated. Working Group is elaborating a plan of measures for reformation of laboratory services in Kiev.
94. In collaboration with TC 166 “Clinical laboratory tests and diagnostic system in vitro», the National Standards of Ukraine (DSTU) “SYSTEM OF CLINICAL DIAGNOSTIC INVESTIGATIONS IN VITRO (Clinical Laboratory Diagnostics). General Provisions” and “Clinical Diagnostic Investigations  IN VITRO. Key provisions and general requirements for the order of carrying out” were drafted.
95. Organizational arrangements for the International Forum “Complex support of laboratories”, in which framework, during September 27-30, 2011, 4-th International Specialized exhibition of complex support of laboratories LABComplEX-2011 and Scientific Conference “Modern management of medical laboratories.”

2012

96. At the extended meeting at the Chef Health Directorate of the Kiev City on January 31, 2012, a draft of Concept of reformation of laboratory services of healthcare facilities in Kyiv during 2011-2015 was approved ,and materials were provided for the Chef Directorate for the economics and investments of the Executive Committee of the Kyiv City Council within the framework of the implementation of strategic initiatives approved by the Kiev City State Administration on 16.09.2010 No. 732.
97. Lviv regional ACCLMU center has done a report on “The Concept of the laboratory support of Euro-2012” at the XVIII GalMED medical exhibition; Seminar of heads of clinical diagnostic laboratories and Workshop for training family physicians to perform rapid laboratory tests were organized and carried out (Lviv, March 28-30, 2012).
98. Analytic materials and presentation were prepared for the Workshop-Meeting of the Ministry of Health of Ukraine “Current issues of reforming primary health care on the basis of family medicine in the Ukraine and of the organization of the laboratory in terms of health care reform” (Kyiv, April 10-11, 2012).
99. Scientific and practical conference with international participation “Current issues of Laboratory Medicine” was organized and carried out (Pusha-Ozerna, April 24-25, 2012).
100. Draft of the National Standard of Ukraine “System of clinical in vitro diagnostic tests (clinical laboratory diagnostics)» was prepared. Developers: V. Protsenko, A. Ivkov, M.Tyuhtina, B. Rogozhyn, H. Lunyova, A. Kheilomskyi.
101. An active part in the Round table on health issues with representatives of the Chief Health Directorate of the Kiev City State Administration and with the official delegation of Moscow was taken, and a report “Program of reform of laboratory services of healthcare facilities of the Kyiv City” was done (Kyiv, September 13, 2012).
102. As co-organizer, an active part in the preparation and carrying out of the 3rd International Healthcare Industry Forum and of the Exhibition «MEDCompEX-2012″ was taken (Kyiv, September 25-27, 2012).
103. As co-organizer, an active part in the preparation and carrying out of the International Forum “Complex support of laboratories” and of the 5th International specialized exhibition «LABCompEX-2012″ was taken (Kyiv, September 25-27, 2012).
104. Scientific and practical conference with international participation “The role of the modern laboratory in medical diagnostic process” was organized and carried out (Kyiv, September 26-27, 2012).
105. Joint meeting of the ACCLMU Council, of Subcommittee 09 “Medicine” of Technical Committee for accreditation of the National Agency for Accreditation of Ukraine, and of Technical Committee for standardization 166 was carried out (Kyiv, September 27, 2012).
106. The seminar “Training of auditors for testing laboratories accreditation” was participated which was conducted by the National Agency for Accreditation of Ukraine (Kiev, September 27-28, 2012).
107. In cooperation with the American Society for Clinical Pathology (ASCP), Workshop “Review and comparison of residency training programs in clinical pathology / clinical laboratory diagnostics which are used for medical training in the U.S., Europe, and Ukraine” for teachers of departments of clinical laboratory diagnostics was carried out (Kiev, December 3-7, 2012).

2013

108. Organizational meeting of the interdepartmental working group to develop the Concept of the laboratory network of the State Sanitary and Epidemiological Service of Ukraine according to the Order of Ministry of Health of Ukraine of 09.01.2013 No. 2-Adm “On the establishment of an interdepartmental working group” was participated actively (Kiev, January 16, 2013).
109. Within the working group at the Ministry of Health of Ukraine, Technical Committee for standardization 166 “Clinical laboratory testing and diagnostic system for in vitro» participated drafting of the Law of Ukraine “On medical devices”.
110. On behalf of the Ministry of Health of Ukraine, Technical Committee for standardization 166 made identical translations of the following documents:

  • EC Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and
  • Directive of the European Parliament and of the Council 98/79/EC of 27 October 1998 concerning medical devices for the diagnosis in vitro.

111. On behalf of the Ministry of Health of Ukraine (Order No. 264 of 04.04.2013), Technical Committee for standardization 166 developed lists of standards for the implementation of national standards in the field of conformity assessment of medical products, harmonized with international ones:

  • European standards
  • Standards of International Organization for Standardization and
  • Standards of GHTF.

112. Preparation and carrying out of the International Medical Forum were actively participated by ACCLMU as a co-organizer (Kyiv, April 16-19, 2013).
113. Scientific and Practical Conference with international participation “Medical effectiveness of modern clinical laboratories” was organized and carried out (Kyiv, April 16-17, 2013).
114. The Electoral General Meeting of ACCLMU was carried out (Kyiv, April 17, 2013).
115. Joint public meetings of the Ministry of Health of Ukraine and of Sub-Committee 09 “Medicine” of Technical Committee for Accreditation of the National Agency for Accreditation of Ukraine “Licensing of medical practice and accreditation of medical facilities today” was participated (Kyiv, April 23, 2013).
116. EUROMEDLAB Exhibition, IFCC – EFLM European Congress of Clinical Chemistry and Laboratory Medicine, and Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) were participated (Milano, Italy, May 19-23, 2013).
117. ACCLMU experts have participated a joint workshop together with experts from the American Society of Clinical Pathologists (ASCP), with Ukrainian specialists of quality control and management of medical services of the Ministry of Health of Ukraine, and with experts of Sub-Committee 09 “Medicine” of Technical Committee for Accreditation of the National Agency for Accreditation of Ukraine, concerning the algorithm of preparation of medical laboratories for accreditation; in particular, set of necessary regulations was established to be the basis for the implementation of accreditation procedures, and the need in further workshops for professional trainers, heads of medical laboratories was found (Kyiv, June 17-19, 2013).
118. Memorandum of Cooperation between American International Health Alliance (AIHA), the Ministry of Health of Ukraine, and the ACCLMU was drafted (July 2013).
119. XVII Forum “National Days of Laboratory Medicine of Russia – 2013” and All-Russian Scientific Conference “Effective laboratory medicine: analysis methods and tools, organization approaches and standards of practice” were participated (Moscow, September 30 – October 4, 2013).
120. Scientific and Practical Conference with international participation “Accreditation – a guarantee of quality and competence of medical laboratories” was organized and carried out in cooperation with leading specialists of the American Society of Clinical Pathologists (ASCP) and of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) within the framework of the VI International specialized exhibition and forum «LABCompEX-2013″ (Kyiv, 15-17 October 2013).
121. In cooperation with Danylo Halytsky Lviv National Medical University, Scientific and Practical Conference with international participation “Days of Laboratory Medicine in Lviv” was organized and hosted in Danylo Halytsky Lviv National Medical University (Lviv, October 24, 2013).
122. Memorandum of Cooperation between the American Society of Clinical Pathologists (ASCP), Ministry of Health of Ukraine, and the ACCLMU was drafted (October – November 2013).
123. The Meetings Program for Stakeholders on Blood Safety (Kyiv, 29-30 October 2013) and the Round Table on Voluntary Blood Donation were participated (Kyiv, October 31, 2013).
124. Seminar “Problems in the system of technical regulation to ensure quality of care” at the State Enterprise “Ukrainian Research, Development, and Training Center for Standartization, Certification, and Quality Problems” (UkrRDTC) was participated (Kyiv, October 31, 2013).
124. Ukrainian Society for Clinical Laboratory Diagnostics Symposium (with international participation) “The role of laboratory data in diagnosing and monitoring the treatment of internal diseases and sanatorium rehabilitation” was participated (Kyiv, November 5-6, 2013).
125. The meeting for discussion of the draft of the Decision of Cabinet of Ministers of Ukraine “On Technical Regulation (TR) on the safety of cosmetic products” at the UkrRDTC was participated (Kyiv, November 14, 2013).
126. The Workshop “Metrology in Chemistry. Implementation of technical requirements of ISO/IEC 17025″ organized by the European Commission Joint Research Centre Institute for Reference Materials and Measurements Knowledge Transfer and Standards for Security Unit (training course TrainMiC) was participated (Kharkov, November 18-20, 2013).
127. In cooperation with Technical Committee for Standardization 166, 44 projects of national standards and guidelines were developed and submitted to the state examination, including ISO 15189:2012 «Medical Laboratory. Requirements for quality and competence” and EN ISO 15195:2003 “Laboratory Medicine. Requirements for reference measurement laboratories”.

2014

128. Discussion of the report on the activities of the PC-09 “Medicine” of TCA of NAAU for 2013 was held (January 2014).
129. Participation in the development of the working plan of the PC-09 “Medicine” of TCA of NAAU on the preparation of clinical diagnostic (medical) laboratories to accreditation for compliance of ISO 15189:2012 “Medical laboratories. Requirements for quality and competence” in 2014 (February 2014).
130. Participation in the joint meeting of the PC-09 “Medicine” of TCA of NAAU and of the Ministry of Health of Ukraine (Kyiv, February 13, 2014)
131. Appeal of the ACCLMU to the Russian Association of Medical Laboratory Diagnostics, to the All-Russian Scientific and Practical Society of Clinical Laboratory Diagnostics, to laboratory medicine professionals of associations and societies of CIS, to the EFCC, the IFCC, and the ASCP concerning the aggressive actions of the Russian Federation was prepared (March 2014).
132. Participation in the round table and in plenary sessions of the Seminar with international participation “Modern aspects of immunohematology and of blood screening” (Kyiv, April 24-25, 2014).
133. A letter to the Prime Minister of Ukraine A. Yatsenyuk was sent concerning the activities of the National Accreditation Agency of Ukraine (NAAU) contradicting European practices and legislation of Ukraine, and the proposal to establish a working group involving professional community associations to draft program and concept of development of the priority fields of standardization, certification, and harmonization of national legislation with EU one (No. 11 from April 28, 2014).
134. Joint meeting of the Ministry of Health of Ukraine, the ACCLMU and the American Society of Clinical Pathologists (ASCP) representatives for correction of the text of the Memorandum of Cooperation between the American Society of Clinical Pathologists (ASCP), the Ministry of Health of Ukraine and the ACCLMU was held (Kyiv, July 11, 2014).
135. Project concerning creation of centers of laboratory medicine as part of health care reform in Kyiv City was sent to Kiev Mayor, Head of Kyiv City State Administration V. Klitschko (No. 12 from July 26, 2014).
136. The ACCLMU President, Prof. Lunyova G.G. and the ACCLMU Vice President, Assoc. Prof. Protsenko V.M. took part in an open competition to select experts to the Strategic Advisory Group on Health announced by Ministry of Health of Ukraine to organize, implement and support healthcare reform in Ukraine for the period 2015-2025 (July 2014).
137. A letter to the Prime Minister of Ukraine A. Yatsenyuk was sent concerning imitation of European integration by NAAU and concerning the regulation of medical devices market (No. 13 from August 1, 2014).
138. Scientific and Practical Conference with international participation “Medical effectiveness of current clinical laboratories” was organized and carried out within the framework of the V Anniversary International Medical Forum “Innovations in Medicine – National Health” (Kyiv, October 14-15, 2014).
139. Meeting of the Council of the ACCLMU was conducted (Kyiv, October 14, 2014).
140. Meeting of the Presidium of the Technical Committee for Accreditation of NAAU was actively participated.
141. Seminar for maintenance of the competencies of auditors and experts carrying out accreditation of personnel certification bodies devoted to the discussion on ISO 17024:2012 “Conformity assessment – General requirements for bodies operating certification of persons” was actively participated (Kyiv, December 22, 2014).
142. Active participation in the work of TC 166 to develop versions of 53 national standards of Ukraine (DSTU, DSTU-N etc.).

2015

143. Active participation in the Seminar “Accreditation of medical and clinical laboratories” co-organized by TAIEX and NAAU (Kyiv, 5-6 February 2015).
144. In cooperation with the American Society of Clinical Pathologists (ASCP) and with the P.L. Shupyk NMAPE, Seminar “Implementation of newest technologies into the educational process during the preparation of interns and residents in specialties clinical laboratory diagnostics and clinical chemistry” was organized and carried out (Kyiv, 9-11 February 2015).
145. Organizational measures for the preparation of the Scientific and Practical Conference with International Participation “Laboratory diagnostics in internal medicine” within the framework of the VI International Health Forum “Innovations in Medicine – Health of the Nation” were taken (Kyiv, 15-16 April 2015).
146. A joint meeting-seminar of the Chief Extraordinary Experts in clinical laboratory diagnostics, of the ACCLMU Board, and of the Heads of the ACCLMU regional centers concerning laboratory support of diagnostic and treatment process for soldiers and patients in ATO zones, concerning issues in the work of clinical diagnostic laboratories of several regions of Ukraine in 2014 (Cherkasy, Chernihiv, Chernivtsi, and Mykolaiv regions) (Kyiv, April 15, 2015).
147. With the assistance of the ACCLMU, annual scientific conference “Prospects for the Diagnosis and Treatment of Hematological Diseases” was organized and held (Kyiv, 14-15 May 2015).
148. Participation in the work of 21 International and European Congress for Clinical Chemistry and Laboratory Medicine and in the exhibition «EuroMedLab – 2015″ (France, 21-25 June 2015).
– Participation in 4 plenary sessions, 11 satellite symposia, 5 educational seminars and interactive sessions.
– Poster presentation (France, June 24, 2015).
– Meetings with leading experts of IFCC and EFLM.
149. Active participation in the meeting of the Presidium of the Technical Accreditation Committee of the NAAU (Kyiv, 15 July 2015).
150. Together with TC 166, an active part was taken in the Scientific and Practical Conference “Standardization is the Basis of the Ukraine’s European Future” organized by the Ministry of Economic Development and the National Institute for Standardization (Kyiv, 24 September 2015).
151. Together with TC 166, the next stage of development of projects of national standards of Ukraine (DSTU, DSTU-N and others) was completed (9 October 2015).
152. Together with TC 166, an active part was taken in the Conference “Standards – a Language which unites” organized by the National Institute for Standardization (Kyiv, 13 October 2015).
153. Scientific and Practical Conference with international participation “The Organization of Medical Laboratories in Accordance with Modern International Standards” was held within the framework of the VIII International Exhibition LABComplEX (Kyiv, 20-21 October 2015).
154. An active part was taken in the meeting of the SC-09 “Medicine” TCA NAAU (Kyiv, 21 October 2015).
155. An active part was taken in the work of TC 166 concerning development of 54 drafts of national standards of Ukraine (DSTU, DSTU-N and others).

2016

156. Participation in the General Conference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), where talks were held on further cooperation with the President of IFCC Maurizio Ferrari and with IFCC young scientists working group; one of the largest automated laboratories of Madrid was visited (Madrid, 18-23 March 2016).
157. As part of the medical exhibition GalMED 2016, the Lviv regional center of the ACCLMU has organized and hosted a scientific-practical conference dedicated to the diagnosis of melanoma, to genomic diagnostics, and to issues of resistance to antibiotics (Lviv, April 13, 2016).
158. In collaboration with the National Research Center for Radiation Medicine of NAMS of Ukraine, annual scientific conference “Prospects for the diagnosis and treatment of hematological diseases” was organized and held (Kyiv, 14-15 April 2016).
159. Preparations were made for the Extraordinary ACCLMU General Meeting and for the merger of the Public Organization “Association of Clinical Chemistry and Laboratory Medicine of Ukraine” and All-Ukrainian Public Organization “Ukrainian Society of Clinical Laboratory Diagnostics”.
160. The Scientific and practical conference with international participation “Building dialogue clinicians and specialists in clinical laboratory diagnostics: Modern methods of laboratory diagnosis of socially dangerous diseases” was organized and held within the VII International Medical Forum “Laboratory diagnostics in the clinic of internal diseases” within the VII International Medical Forum “Innovations in medicine – health of the nation”(Kyiv, 19-20 April 2016).
161. Participation in the meeting of the PC-09 “Medicine” TCA NAAU (Kyiv, April 21, 2016).
162. ACCLMU Coordinator of young professionals Kheylomska T.O. made a working meeting with interns on the professional development of young professionals, using the experience of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the ACCLMU (Kyiv, 17 May 2016).
163. Discussion concerning the optimization of the preanalytical stage of laboratory tests at the medical laboratory of the City Clinical Hospital No. 9 of Minsk, Belarus Republic. Workshop was attended by the ACCLMU President prof. Luneva G.G. and Head of medical laboratory of the City Clinical Hospital No. 9 Oganova O.G.
(Minsk, 11-13 July 2016).
164. A meeting was held with NAAU administration. The meeting was attended by Deputy Chairman of NAAU Krasyuk V.V., Head of Laboratory Accreditation Department Martsynchyk S.G., specialist of NAAU Shevchenko L.Yu., Chairman of the SC-09 “Medicine” of TCA of NAAU Kheylomskyi A.B., ACCLMU President Luneva G.G., and ACCLMU coordinator of young professionals Kheylomska T.O. The meeting was devoted to the programs of accreditation of medical laboratories, to the establishment of the requirements for the qualification of auditors and experts and of confirmation procedures, and to the discussion of the Order of MOH No. 644 of 10.01.2015 “On Approval of the Concept of quality management system for medical laboratories of Ukraine in accordance with international standards and of Plan of activities for its implementation “(Kyiv, July 29, 2016).
165. The experience of implementation of ISO 15189 into the practice of medical laboratories ALAB-laboratoria was studied (Warsaw, 15-17 August 2016).
166. The Ukrainian-Swedish training “Preparation of grants and publications, bioethics” was participated (Kyiv, 25-26 August 2016).
167. A memorial evening devoted to the 90th anniversary of the prominent specialist in the field of clinical laboratory diagnostics, Prof., D.Sc., MD K. A. Zakhariya. The organizers were the Department of Clinical Laboratory Diagnostics of the Danylo Galician’s Lviv National Medical University and Lviv regional center of the ACCLMU (Lviv, September 23, 2016).
168. A meeting with the Associate Director of the Euro-Asia region, Head of the International department of laboratories for AIDS of the Institute for Global Health, Problems of AIDS and tuberculosis, D.Sc., MD Favorov M.O. concerning the ACCLMU cooperation with the US Centers of Disease Control and Prevention (CDC) was held (Kyiv, 29 September 2016).
169. ACCLMU President Prof. Luneva G.G. has presented the report “DSTU EN ISO 15189:2015 – the roadmap for laboratory tests quality” at a meeting at the Ministry of Health of Ukraine “Condition of the Blood Transfusion Service of Ukraine and Preconditions for Its Reformation” (Kyiv, September 30, 2016).
172. A meeting of the organizing committee on preparation for the General Meeting of the ACCLMU on October 20, 2016 was held (Kyiv, October 6, 2016).
173. The Scientific and practical conference with international participation “DSTU EN ISO 15189:2015 – the roadmap for laboratory tests quality” was organized and held within the IX International exhibition of complex support of laboratories LABComplEX were organized and held (Kyiv, October 19-20, 2016).
174. An active part was taken in the seminar “Training for Strategic Management: Developing a National Laboratory Policy and Strategic Plan for the Laboratory. Implementation, Monitoring, and Evaluation” as part of the implementation of the Global Health Security Agenda in the area “System of National Laboratories” and Emergency Plan For AIDS Relief (PEPFAR) in cooperation with the Center for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) (Kyiv, 7-11 November 2016).
175. An active part was taken in the Second Meeting of Partners of the Regional Office of the WHO Initiative “Good Laboratory – good health: Improving the quality of laboratory services at the WHO European Region” (Tbilisi, Georgia, December 1-2, 2016)
176. As a member of the technical working group on working out the roadmap on the implementation of the Global Health Security Agenda in the area “System of National Laboratories”, the meeting of the Ukraine Ministry of Health and the WHO on the assessment of the laboratory network of the public health system in view of its further optimization (Kyiv, December 14-23, 2016).

2017

177. Participation in the international seminar “Basics of quality control in laboratories. Development of documents” as part of the implementation of the Global Health Security Agenda in the area “System of National Laboratories” and Emergency Plan For AIDS Relief (PEPFAR), together with the Centers for Disease Control and Prevention (CDC) and the Institute for Clinical and laboratory US standards (CLSI) (Kyiv, February 20-23, 2017).
178. Active participation in the workshop on the development and management of laboratory networks “Network of Public Health Laboratories in Ukraine” as part of the implementation of the Global Health Security Agenda in the area “System of National Laboratories” and in the activities of its jointly support together with the Centers for Disease Control and Prevention (CDC) and the USA Association of Public Health Laboratories (APHL) (Kyiv, March 21-23, 2017).
179. Preparations and program of the Scientific and Practical Conference with International Participation “Problems of Cardiovascular Diseases in the Focus of Clinicians and Laboratory Medicine Specialists” in the framework of the VIII International Medical Forum “Innovations in Medicine – Health of the Nation” and the Ыpecialized Уxhibition of Дaboratory Уquipment (Kyivб April 25-26, 2017).

Since the very first days after its creation, ACCLMU actively cooperates with the Committee on Health of the Verkhovna Rada of Ukraine, with the Ministry of Health of Ukraine, with the State Inspectorate for quality control of medicines of the Ministry of Health of Ukraine, with the National Accreditation Agency of Ukraine, and with regional and municipal departments of health to address key issues to improve functioning laboratory services, to introduce new modern criteria and requirements of clinical diagnostic laboratories meeting the latest EU directives and international standards etc. To achieve these objectives, consultations with the Ministry of Economy of Ukraine, with the State Inspectorate of Ukraine on Consumer Protection, with the SC “Ukrmetrteststandard”, with the leading institutes of NAS of Ukraine and NAMS of Ukraine, with the State Committee for Control of HIV/AIDS and other socially dangerous diseases, with the Blood service, and with Sanitary-epidemiologic service of Ukraine.

Activities program of the Association of Clinical Chemistry and Laboratory Medicine of Ukraine for 2008 – 2011

1. Development of the Association, local centers creation, and new members recruitment;
2. Further cooperation of the Association with the laboratory service of the Academy of Medical Sciences of Ukraine, of the National Academy of Sciences of Ukraine, of the Sanitary-Epidemiological Service of Ukraine etc.
3. Establishment of cooperation with other leading professional medical associations, holding the Conference “Usage of the modern methods of the laboratory diagnostics in medical standards”.
4. Establishment of contacts with national associations of EU countries, of the USA, of CIS countries, and with the international organizations (IFCC, AACC, EC -4 etc.).
5. Establishment of cooperation with different branches of government (Verkhovna Rada, Cabinet of Ministers, Ministry of Health etc.).
6. Participation in reformation and development of clinical and laboratory diagnostics service.
7. Active participation in the elaboration of the legislative project on the laboratory service and of the governmental program for the development of the clinical laboratory diagnostics in Ukraine.
7.1. Proposing mechanism of reorganization of structure of laboratory service to the Ministry of Health of Ukraine.
8. Creation of organizational, methodological, control, and analysis center of laboratory medicine together with reference laboratories network;
8.1. Finding of possible bases for the arrangement of reference laboratories (e.g., clinical laboratory diagnostical departments, leading laboratories of the Academy of Medical Sciences and of Ministry of Health of Ukraine etc.).
9. Participation in the working out of the regulatory framework for the laboratory service to process the following paragraphs:
a) organizational and regulatory questions;
b) quality assurance of laboratory tests;
c) elaborating of specialized clinical laboratory standards;
d) centralization of laboratories and laboratory tests;
e) introduction of changes to the nomenclature of specialties in clinical laboratory diagnostics;
f) certification and accreditation of clinical laboratories according to the European and international requirements/standards (ISO, EN, IVDD etc.).
10. Participation in the development of methodological background of clinical laboratory diagnostics.
10.1. Particicpation in implementation and certification of standard (IFCC, AACC) testing methods and elaboration of methodological recommendations for their usage.
11. Elaborating of project of state and private systems of quality management of clinical diagnostical laboratory tests.
11.1. Implementation of intralaboratory quality control system for clinical diagnostic tests;
11.2. Implementation of external system for clinical laboratory tests quality assessment;
11.3. Particicpation in the Consultative Seminar of the Chief Extraordinary Experts in Clinical Laboratory Diagnostics on problems of laboratory tests quality control.
12. Studying the questions and elaboration of the proposals for laboratory tests centralization.
12.1. Project elaboration and economical subtantiation for certain regions;
12.2. Development of proposals on automation of pre-analytical stage and on introduction of closed-type systems for blood samples collection;
12.3. Introduction of laboratory informational systems into the practice of clinical diagnostic laboratory.
13. Development of criteria and requirements of standards for production and certification of reagents, test-systems, measurement instruments and other equipment.
14. Elaboration of actions on technical, financial, administrative support and computerization of laboratory network.
15. Elaboration of conception of staff training for laboratory service and of continuous medical education system.
16. Initiation of consideration of questions of status, professional training and possibility of certification for specialists with higher non-medical education (biologists, chemists, biochemists, microbiologists etc.).
17. Initiation of creation of specialized Council and of PhD degrees asquiring in “Clinical Laboratory Diagnostics” speciality.
18. Unification of terms and definitions used in laboratory medicine.
19. Active participation in the creation and operation of the Institute of Laboratory Medicine and of the Center for Laboratory Medicine.
20. Creation of Ukrainian Journal of Clinical Chemistry and Laboratory Medicine.
21. Creation of the Technical Committee for Standardization “Clinical laboratory tests and in vitro diagnostic test systems» (similar to ISO/TC 212), approval of the Statute and of the Working Program of this TC.

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