Regional Master-Plan On the development of the laboratory sector in the Republic of Kazakhstan

1. Ministry of health and social development of Republic of Kazakhstan Republican State Enterprise the "Republican center of development of health protection" republican state enterprise on rights for an economic conduct «Republican center of development of health protection»Z.Sadvokasova Regional Master-Plan On the development of the laboratory sector in the Republic of Kazakhstan

2. Creating a multi-level structure of the laboratory network • The multilevel structure of the laboratory network, as part of a network of hospitals and primary health care organizations, proposed under the relevant master plan will lead to a more rational, efficient and rapid system of laboratory services, based on the principles of international best practice. • Each region of the Republic of Kazakhstan is considered individually, taking into account regional peculiarities, including socio-economic, geographic, demographic and health, the level of medical care.

3. Comparison of some of the data of Kazakhstan with Australia and Canada • Australia and Canada are similar to Kazakhstan for some indicators • The population density in Kazakhstan is higher than in those countries • GDP per capita is lower than Kazakhstan, more than 2 times • Life expectancy is lower by nearly 9 years • Number of beds is higher in 1.5-2 times 3

4. The vision of the master plan for the development of laboratory services in the Republic of Kazakhstan • The active role of laboratory services in the effective management of ambulatory and stationary structures in the optimization of diagnosis and hospitalization • Timely and affordable laboratory services contribute to improve the overall life expectancy of> 70 years • Public and private expenses for laboratory services in person must be> $ 30. Per year by 2020 (real costs - $ 6-7. US) • Creating a system of laboratory experts on standards development process and the quality of training and education based on international standards adapted to the conditions of Kazakhstan • 2025 on key health indicators for Kazakhstan to enter the 30 developed countries 4

5. The objectives of the master plan for the improvement of laboratory service Promoting a healthy lifestyle Diagnostics Supervision Laboratory services Treatment Prevention 5

6. The system of referral scheme On the alleged scheme of movement of the patient affect the determinants of health systems - a possible structure of primary care laboratory diagnostics, hospital, availability of specialized personnel, level of training, organizational communication, cultural, social and political factors The regional committee of the health regions patient direction Portal of the Bureau of hospitalization patient hospital clinic Clinical and diagnostic tests required for admission

7. The objectives of the master plan to improve Laboratory services The optimal model of services for medical laboratory services Network Defense, focused on the patient for emergency, routine, long-term care, care for the mother and newborn "Emergency" (hot) laboratories in hospitals to assist in the urgent and critical conditions "Routine" (cold), specialized laboratories, including clinical, microbiological, immunological and histopathological studies on the treatment site (IML) Regional / central / national / reference laboratory implementation of laboratory diagnosis of the most complex, socially significant and   rare diseases with an educational base For all studies provided: Accreditation Excellent infrastructure, equipped with IT technologies Fully integrated logistics system Research and development in the field of education and training Transparent cost and pricing measures Service agreement / contract Clinical testing 7

8. The objectives of the master plan for the improvement of laboratory service • Analysis of the situation • Vision, infrastructure, LIS, structure, time, produce a result (optimization of waiting times of laboratory results), logistics, service plans, financing, • The financial and geographical accessibility, fast, efficient and easy service • Lower the cost of services by increasing productivity • Reliability and quality (accreditation, transparent, credible and reliable results) • The approach to streamline the parameters of laboratory tests to avoid duplication • The centralization and automation of laboratory services 8

9. Analysis ofthesituation • Around 2200 laboratories in the Republic of Kazakhstan (Beschastnykh), 6-19 tests / person. - A range of laboratory tests by regions • Laboratory (hematology, immunology, biochemistry, microbiology, histology, etc.): -Lack of coordination, standardization -Spraying powers and resources -Duplication of laboratory studies (in outpatient and inpatient), often discrepancies indicators -Invalid research quality at a low level of automation technology -Low levels of credibility and reliability of results due to outdated equipment and techniques, the limited list of results -The low level of the development of drug information system -The lack of infection control and management of data -Lack of centralization of laboratory tests, reagents and consumables, waste management -The lack of a common approach to ensure quality and safety in the lab 11

10. Laboratory Service in Kazakhstan • Clinical Laboratory provides practical health care for about 80% of the diagnostic information needed for timely diagnosis and monitoring the effectiveness of the treatment. •         Laboratory data are of great importance for physicians in the assessment of the state of health of the patient, accurate diagnosis, treatment plan, and the subsequent monitoring of treatment effectiveness, which ultimately reduce the indicators of preventable morbidity and mortality. •          In the Republic of laboratory services provided by laboratories that are part of health care institutions: hospitals, clinics, many medical clinics, some FAP- ah. •         Total in the country as of 01.01.15, the functioning of laboratories in 2145, including 1709 conducted clinical and diagnostic tests, 142 - biochemical, 157 - bacteriological, 69 - serology, 54 - cytological, 14 - radioisotope studies. •         Laboratories employs more than 1.2 thousand. Doctors, 7.2 thousand. Lab. Staffing doctors to laboratory technicians is 89%. •         In 2014 it carried out more than 451 million. Parameters of laboratory tests, including 52.8% on an outpatient basis. 10

11. Security lab 100 thousand. Population 12 Number of laboratory 100 000

12. Comparative analysis of laboratory tests 13

13. Pareto analysis of stationary laboratories at institutions 14

14. The objectives of the regional master plan for the laboratory sector For the patient, availability, promptness, quality results of laboratory studies: • sampling tests carried out at the place of medical care (ambulance, hospital) to conduct a certain (approved) list of research; • All laboratory results are quality assurance and accreditation; • timing of research for 'hot' and 'cold' results are guaranteed by terms of performance, which could have a potential negative impact on the quality of patient management; • It has timely access to professional advice for laboratory medicine, including guidance on the appropriate use and interpretation of the analysis that do not meet the clinical picture For the responsible person carrying out laboratory tests: • to achieve an appropriate level of learning and understanding of research results; • test at the place of treatment is appropriate, correct and has a guarantee of quality; • direct access to the consultation on clinical pathology helps the patient to feel independent. For medical organization: • in addition to routine laboratory services, it is necessary to ensure the implementation and the availability of more advanced services of laboratory medicine for the clinical responsibility for complex hematological, metabolic, infectious and other states; • professional advice, support the process of the clinical management of the patient, including critically ill patients and patients in critical condition; • consultations and meetings on histopathology, oncology and other specialties. 9

15. Existing problems In the laboratory network 15

16. Master Plan - Implementation • The policy of the Ministry of Health and Social Protection of the Republic of Kazakhstan • Revision of the draft regional master plan for the laboratory sector • Deciding on 2-3 areas in which reform is implemented • The budget for the regions and 2-3 overall budget for laboratory costs • Ready project for areas serving model • Mid-2016 • The newlegislation • The AutonomyAct lab • Labour Law / Taxes / Fees • The law on data management • payment Plans • Mid-2016 • 2-3 as an example of the field • Decision on areas • implementation Plan • Technical evaluation / due diligence State • Tender public-private partnership / outsourcing / governance • Beginning 2017 • Completionof all programs • Every six months 3-4 additional areas • Parallel: Quality Management / accreditationprocedures • Training / education / association of laboratory professionals • Checking the lessons learned during the implementation of the first examples • Final implementation of end 2017 16

17. Master Plan - Factors for the introduction and implementation of modern laboratory services • Fast, efficient and streamlined service • Amendments and additions to laws and regulations (taxes on the import of chemicals / equipment, permission to export samples (genetics, other tests are rare), warranty list of the analyzes and studies in the framework of SBP at every level of care) • Training, education and training • Patient satisfaction with fast and high-quality laboratory research • Reducing the cost of laboratory services through collaboration, increased productivity • The independence of the activities of laboratory services • Providing accreditation of quality, accuracy, reliability and transparency of laboratory results • Implementation of logistics, laboratory information system (LIS) 17

18. Master plans for the development of laboratory services in the region up to 2025(developed in collaboration with the consulting company SanigestInternacional until 2025) • Reform of laboratory service in terms of availability, creating a multi-level system, phasing out routine method, automation and centralization of laboratory research, active implementation of laboratory information system. • The new draft Regulation on the activities of organizations and (or) structural units of health care organizations performing laboratory diagnosis, as well as the amount and type of their studies, taking into account international best practices (RoK Government № 1566 of December 21, 2011) 18

19. Multi-level structure of the network laboratory services Point fence + basic laboratory research • Rural • Interdistrict Express Microbiology Standard laboratory Special laboratory Cytology • Regional TB Diagnotics blood • National Medical genetic • Reference laboratory 19

20. Future multi-level structure of laboratory services(Draft Regulation on the activities of healthcare organizations performing laboratory diagnosis) • Points fence (PP) biomaterial with providing certain basic set of studies on the level of outpatient organizations, some hospitals. • Centralized medical laboratories type I and type II are organized in clinical diagnostic centers and multidisciplinary hospitals. • Regional / or central laboratory (reference laboratory) in regional hospitals with the implementation of more sophisticated laboratory tests, including infectious. • Specialized Laboratory (microbiology / bacteriological, cytological, etc.) - In the regional centers at specialized clinics or in the regional and national laboratories. • National Laboratory - in the cities of Almaty and Astana with the performance of laboratory diagnosis of the most complex, socially significant and rare diseases, and educational platform for the representatives of other laboratories as telemedicine and online mode. 20

21. Recommended structure laboratories (By level of care) • Points fence with a list of studies on the treatment site in the ADF, hospitals needed to ensure further transportation to the central laboratory. • Each regional / multi-profile hospital should have a centralized laboratory countryside. • In the regional center there should be one central laboratory (at the regional hospital and diagnostic center) with the centralization of microbiology and cytology; or in specialized clinics. 21

22. Terms oftransport Specimen Collection Packing tips with LIS data in a shipping container that is suitable for the environment   Storage: in the refrigerator.   Check availability of samples to be transported Packaging and storage The fence material for laboratory research   Bar coding and registration data to the LIS. Delivery of the transport containers in a sequence (e.g., 1-10 sampling points in mini / central laboratory for 2-3 hours). Date of the receipt and delivery of samples (the documents on transportation). Driver training transport of dangerous biological materials. Transportation Unpacking and storage The signing of the receipt of the samples driver.   Check for damage.   Unpacking the transport containers.   Register access via the bar code.   Storage: in the refrigerator. Assays Analyzing the registered samples. Sending results using bar code by the LIS to the point of sampling (a doctor) and the official database. 22

23. primary fence primary fence primary fence Offeredlogisticslaboratorynetwork primary fence primary fence primary fence primary fence centralized primary fence regional / reference primary fence primary fence 23

24. The existing laboratory network Kyzylorda region 24

25. The recommended structure of the laboratory network in the Kyzylorda region 25

26. The implementation of the order of the Ministry of Health and Social Development of the Republic of Kazakhstan approving the Regulations on the activities of organizations and (or) structural units of health care organizations offering laboratory diagnostics • For further development of sustainable laboratory capacity, by means of which will be provided access to fast, affordable and high-quality diagnostic tests at all levels of medical care, in addition to measures to restructure the hospital sector, the development of primary health care to include measures to restructure the laboratory sector, providing: - The creation of a multi-level system of laboratory services, - Activation of the processes of automation and centralization of laboratory research, - The introduction of modern high-quality low-cost methods of laboratory research, accredited 26

27. The future of modern laboratory services in Kazakhstan • The presence of the laboratory system, which contributes to the effective management of ambulatory and stationary structures (to avoid duplication of laboratory tests on the basis of centralized laboratory diagnostics) • Organization and storage of laboratory results of the Bank for the analysis of data from epidemiological studies and health planning • Establishment of the Center laboratory expertise, develops national standards processes and the quality of training and education in line with international standards; • Implementation of optimal structures and processes laboratory services, in connection with what will be achieved: - expansion of the scope and range of laboratory research, the - improving the quality and reducing the time waiting for the results of research, - introduction of bonus schemes for the promotion of medical practitioners. • The introduction of the electronic system of management of patients including laboratory tests in a database of e-health • Expenditure in the budget (public + private expenses) - 30 US dollars per capita per year by 2020 • Modern laboratory infrastructure and processes that contribute to achieving the overall life expectancy of up to 70 years or more; 27

28. Auxiliary devices for ...... .. fully automated systems ... ... ….. ... .. No longer need in 10-20 years: A system "lab on a chip" Future laboratory - the introduction of innovative technologies 28

29. Thank you for attention !