Association of Clinical Chemistry and Laboratory Medicine of Ukraine were established in May, 2007. It was legally registered at the Ministry of Justice of Ukraine (certificate No. 2836) as public not-for-profit organization uniting Ukrainian specialists in the field of laboratory medicine (physicians, biologists, laboratory technicians, pathologists, haematologists, biochemists, cytologists, histologists, immunologists, toxicologists, microbiologists, etc.), of blood service laboratory diagnostics, of sanitary and epidemiological service, and of forensic and radiation medicine on the basis of common professional interests. Among members of 24 regional Association centres headed by chief regional specialists and by leading experts in the field of laboratory diagnostics, there are more then 1500 heads and managerial staff of clinical diagnostic and R&D laboratories including those of National Academy of Sciences of Ukraine and Academy of Medical Sciences of Ukraine, and also practitioners, researchers, professors, and specialists in the field of development, production, and standardization of equipment, reagents, and diagnostic kits. The main tasks of ACCLMU are as follows:

• Consolidation of citizens for development of theory and practice of clinical chemistry (biochemistry) and laboratory medicine, development of international cooperation in this area;
• Satisfaction and protection of legislative, social, professional, economic, creative, age, national, cultural and other common interests of members of the Association;
• Introduction of measurements quality assurance system in Ukrainian clinicodiagnostic laboratories, irrespective of its ownership, according to international standards (ISO15189, ISO15190, ISO15193, etc.);
• Together with the state authorities, creation of medical laboratories accreditation system which meets international standards (ISO/IEC17000, ISO/IEC17011, ISO/IEC17020, ISO/IEC17021, etc.);
• Promotion of state and public value of specialists in the field of clinical chemistry and laboratory medicine, assistance in increase of prestige of this profession, improvement of level and quality of medical services available to all the Ukrainians.

Administration of Association of Clinical Chemistry and Laboratory Medicine (ACCLMU):

• President of Association - Prof. Lunova Ganna Gennadiyivna, Head of Chair of Clinical Laboratory Diagnostics of P.L. Shupik’s National Medical Academy of Post-graduate Education, Chief Extraordinary Expert in Clinical Laboratory Diagnostics of Ministry of Health of Ukraine;
• Honourable ACCLMU President - Prof. Bazarnova Mariya Antonivna;
• Head of Council of the Association - Kheylomskyi Oleksandr Borysovych;
• Vice-president of ACCLMU - Prof. Gavrilenko Tetyana Illinichna, Head of Laboratory of Immunology of M.D. Strazhesko’s Institute of Cardiology, Academy of Medical Sciences of Ukraine;;
• Vice-president of ACCLMU - Mihalchuk Galyna Andriyivna, Head of Centralized Laboratory of Oleksandrivska Municipal Hospital, Kiev, Head of ACCLMU Kiev city centre;
• Vice-president of ACCLMU - Dr. Protsenko Volodymyr Mykolayovych, Associated Professor of Faculty of Clinical Biochemistry of Kharkiv Medical Academy of Post-graduate Education;
• Vice-president - Dr. Yastremska Oksana Ostapivna, Associated Professor of Faculty of Clinical Laboratory Diagnostics of D. Galytsky’s National Medical University, Lviv;
• Vice-president - Dr. Polishko Tetyana Mykolayivna, Head of ACCLMU Dnepropetrovsk regional centre and Chef Expert in Clinical Laboratory Diagnostics of the Dnepropetrovsk region;
• Head of Secretariat - Produsevich Lydiya Volodymyrivna, Head of ACCLMU Kiev regional centre and Chief Extraordinary Expert in Clinical Laboratory Diagnostics of Kiev region;
• Head of Revision Committee - Ponur Bogdan Oleksiyovyych, Chief Expert in Clinical Laboratory Diagnostics of Ministry of Defence of Ukraine, Head of Laboratory Centre of Central Military Clinical Hospital, Colonel of Medical Service.

We invite all the interested to cooperation!

Association of Clinical Chemistry and Laboratory Medicine of Ukraine
18 Chigorina St., Kiev 01042, Ukraine

Contact phones:
+380442210843;
+380444092075;

Fax: +380444831922

www.acclmu.org.ua
info[at]acclmu.org.ua
acclmu[at]i.ua

 Activities of the Association of Clinical Chemistry and Laboratory Medicine of Ukraine for the period from May 2007 to September 2008

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 certification (July 1 - December 31, 2007).
5. The following regulatory documents were developed:

- Statute of the Association of Clinical Chemistry and Laboratory Medicine of Ukraine,
- Regulatory document for a local center of the Association
- Regulatory document for membership in the Association (July-August 2007)

6. Statutory Conference of the Association of Clinical Chemistry and Laboratory Medicine of Ukraine took place in Kyiv on September 6, 2007.
7. Association 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 events for improvement of laboratory services to 2013» were developed (October 2007).
9. Analysis of laboratory services in Dnipropetrovs’k region was made for 9 months of 2007. An unscheduled audit for compliance with licensing conditions in business and medical practice for PP (single proprietor firm) «Diagnostika SL» in Dnipropetrovs’k was carried out during December 3-4, 2007.
10. School-Seminar with International Participation «Modern technologies of management and quality control of clinical laboratory» was carried out (Kyiv, December 10-14, 2007).
11. Meeting of the Association of Clinical Chemistry and Laboratory Medicine Ukraine was held (Kyiv, February 9, 2008).
12. The following documents were developed:

- 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» (January-March 2008).

13. Scientific Seminar «Laboratory Medicine and Priorities of the Ministry of Health in 2008» was organized (Lviv, April 10-11, 2008).
14. ACCLMU members group including Hanna G. Lunyova, Oleksandr B. Kheylomskyi, Tetyana I. Gavrilenko, Tetyana V. Sol’s’ka wihtin a Working group elaborated project of 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).
15. The Association took part in the meeting 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).
16. Scientific-and-Practical Conference «Modern immunogenetic methods in medicine» was held in Lviv on June 2-3, 2008.
17. 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 (June 26-27, 2008).
18. Presentations at the Scientific-and-Practical Seminar of Ivano-Frankivs’k local center of Association of Clinical Chemistry and Laboratory Medicine of Ukraine «Current issues of laboratory services in Prykarpat’tya» were made (June 26, 2008).
19. 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 (July 1, 2008). There was an exchange of experience on the centralization of laboratory research in medical facilities and private medical centers of St. Petersburg (July 2-4, 2008).
20. Meeting of Donetsk center of Association of Clinical Chemistry and Laboratory Medicine of Ukraine on the centralization of laboratory research in Donetsk was held on July 7, 2008.
21. 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» in Kharkiv (July 17, 2008).
22. Academy of Medical Sciences of Ukraine and the Association of Clinical Chemistry and Laboratory Medicine of Ukraine had organized and carried out VII Scientific Seminar «Functional and laboratory diagnosics: new methods and modern standards» (Kyiv, September 9-10, 2008).
From the first days of its existence, the Association actively cooperates with the Parliamentary Committee of Public Health, with the Ministry of Health of Ukraine, and with the Ukrainian Academy of Medical Sciences, with regional and municipal Departments of Health to address important issues of laboratory services, new modern requirements and criteria for activities of clinical diagnostic laboratories that meet the latest EU directives and standards.
To achieve this purpose, Association consults with:

- Derzhspozhyvstandart and Ukrmetrteststandart,
- leading institutions of the Ministry of agricultural policy,
- Sanitary-Epidemiological Service of Ukraine

and develops a mechanism for legalization of ISO/IEC fundamental standards prepared for implementation, including:

- ISO 15189:2007 Medical laboratories — Particular requirements for quality and competence;
- ISO/TR 22869:2008 Clinical Laboratories – Guide for Implementation of NM ISO 15189:2007 in the Laboratory;
- ISO/IEC 17021:2006 Conformity assessment — Requirements for bodies providing audit and certification of management systems;
- ISO 15195:2008 Laboratory medicine - Requirements for reference measurement laboratories;
- ISO 15193:2008 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures;
- ISO 15194:2008 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials;
- ISO 15198:2008 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer;
- ISO 20776-1:2008 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases.

Activities program of the Association of Clinical Chemistry and Laboratory Medicine of Ukraine for 2008 - 2010

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.