HUNGARIAN NATIONAL BLOOD TRANSFUSION SERVICE. Dr. Klara Baroti-Tóth, PhD IPFA/PEI 19 th International Workshop Budapest, May, 2012.

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1 HUNGARIAN NATIONAL BLOOD TRANSFUSION SERVICE Dr. Klara Baroti-Tóth, PhD IPFA/PEI 19 th International Workshop Budapest, May, 212.

2 BLOOD DONATION G I V I N G I S G O O D ORGAN COORDINATION OFFICE T R A N S P L A N T S S A V E L I V E S The office is responsible for all Hungarian organ and tissue procurement coordination from the cadaver donor report through the end of retrieval, in accordance with Governmental Decree 323/26 (XII.23) by operating three level of the transplant donor coordination network (national, regional and hospital coordinators). The HNBTS serves as contracting partner in the Eurotransplant preliminary cooperation agreement. STEM CELL DONOR REGISTRY T H E O N E A M O N G M I L L I O N S The Hungarian Stem Cell Donor Registry (former Hungarian Bone Marrow Donor Registry) hosted by the HNBTS inks clinical care to worldwide stem cell networks of unrelated donor registries (BMDW and WMDA). The HSCDR is responsible for finding an unrelated donor for Hungarian patients who need stem cell transplantation, and offers donor search for international patients among the 63 Hungarian registered volunteer stem cell donors.

3 Blood transfusion is regulated 1. The blood (22/98/EC, 33/24/EC, 25/61/EC, 25/62/EC) and GMP, IVD, etc. directives have been implemented into the Hungarian decrees (e.g. 3/25. EüM, etc.) by the Minister of Health, 2. Standards on Blood collection/ processing and screening of donor samples, Blood Products, Storage/ Algorithms of confirmatory process, Transfusion regulatory for physicion Council of Transfusiology and Haematology as a professional adviser blood board of Ministry of Health 3. Standards on each of processes in blood establishments

Structure and function ~ 13 people are employed (MDs:~1; other degrees:~1; technical staff:~8) There are 5 regional blood centers and 18 local blood banks with different functions.

4 Structure and function ~ 13 people are employed (MDs:~1; other degrees:~1; technical staff:~8) There are 5 regional blood centers and 18 local blood banks with different functions. 18 BBs primarily deal with the collection of whole blood. Virus- and blood group serological examinations of donor samples are screened in 2 laboratories (Budapest, Debrecen) and the preparation of blood products are processed by the 5 regional blood centres. The clinical transfusiologycal examinations are carried out in each of our institutes.

5 Recent Activities are coordinated by the Headquaters 1. Organisation of preparative - and clinical transfusiology, and the preparation of blood products for hospitals, Treatment with blood components and plasma derivatives is fully covered by the health insurance system. Education of technical staff, postgraduate training for medical doctors, and specialist in transfusiology Collaboration with the Hungarian Red Cross on the organisation of voluntary, unpaid whole blood donor system, % 2 8 HNBTS H Red Cross

Recent Activities are coordinated by the Headquaters 2. There is a national administration registering the amounts of stocks at different locations.

6 Recent Activities are coordinated by the Headquaters 2. There is a national administration registering the amounts of stocks at different locations. Az OVSz Központi Diszpécserszolgálatának szállítási gyakorlata. Transportaion service of Headquarters Dispatch Department of HNBTS Where are the stocks located? % Hospital Dep Hospital Blood Bank Blood Bank The remaining part of régiókból blood products are sending to régiókba the centre, because of the ratio of blood donation is higher in countyside.

7 Recent Activities are coordinated by the Headquaters 3. Q D Headquaters QA-QC (4 4) Senior Auditor QA-QC system The Quality System is based on Good Manufacturing Practice in transfusion services. All activities are involved in the QS e.g. policy, responsibilities, quality planning, quality control, quality assurance and quality improvement. Blood Establishments Blood Collection Places Senior Quality Officers (6) Quality Officers (17) We have an authorizied person (QDir) who is responsible for the good quality of products and results in the whole country. Quality Manuals have been prepared for steps of processing and examinations in blood banks. Audit protocols are issued to control the work at every levels. The Quality Policy of the HNBTS is determined by th e Headquarters.

8 Recent Activities are coordinated by the Headquaters 4. Auditing for GMP compliance Audit protocols are issued to control the work at every level. Since 23 our service has a systematic, well defined, periodicaly repeated audit system, that has been published in our standards. Each of the auditor prepare a plan for the new year, and at the end of the year they have to finalize their program and send a report into the QA-QC Dept. The detected mistakes or nonconformance event can not be solved by the staff at regional level, the departments of headquaters are responsible for repairing the mechanisms. Internal audit Vendor audit QA-QC Dept Blood Establishments Blood Collection Places belong to the HNBTS (18) Internal audit Blood Collection Places belong to the Hospital Blood bank (23) Vendor audit

9 Recent Activities are coordinated by the Headquaters 5. Confirmatory tests of viruses, and quality control of blood products, immunhaematology are controlled by special laboratories of the Headquarters, that are independent from the regular screening laboratories. All laboratories participate in national (internal and external) and international quality control systems e.g. VQC, EC., etc.

10 Screening of donors All EU countries are allowed to make extra tests. Obligatory tests (ABBOTT CMIA on Architect) HBsAg, a-hcv, a-hiv 1-2 Extra tests Syphilis TP, a-hbc (at the first donation) All plasma pools for fractionation have been tested for HCV RNA (NAT) in the factory since 2.

11 Haemovigilance system Data collection was based in 1972 by the Decree of Health Ministry. Since that time written reports about transfusion have been sent to the HNBTS. In 1998 the new version of Transfusion Regulation (2 nd edition of the last version) was published and it standardized the documentation regarding blood transfusion. In 2 Transfusion Committes were established in hospitals. 1 1

12 Licensing, certification and accreditation Two institutes are responsible for the authorisation and control of blood supply activities in Hungary. The licence for the operation of clinical transfusiology is issued by the Executive Office of Chief Medical Officer, while the manufacturing authorisation for the processing of blood products is issued by Directorate of General of National Institute of Pharmacy on Pharmaceutical Law. Bi-annual inspections are a substantial element, performed by the Inspectorate of the Agency for National Institute of Pharmacy (first event in 22).

13 [Unit] Collected Whole Blood

14 Donation in Hungary Population ~ 1.1. in in 211. [donation/1 inhabitants] 6, 49,67 48,97 48,79 48,61 49,83 5, 4, 43,28 41,82 41,94 41,61 38,56 41,83 42,51 3, 2, 1,,

15 , , [Unit] First donation

16 Issued blood products RBCs PLT FFP Whole Blood [Unit] year

17 Using of Red Blood Cells [unit] Prepared RBCs Issued RBCs [year]

18 FFP for fractionation WB ( Unit) FFP ( Unit ) FFP ( kg ) 18

19 Using of FFP Hungary self-sufficient with blood components except of F VIII, it is imported 5 %/year. All plasma pools for fractionation have been tested for HCV RNA (NAT) in the factory since Unit/year Transfused FFP FFP for fractionation

20 Verified positive donors in HIV HBsAg HBsAg+a-HBc HCV Syphilis HIV-1-2 HBsAg HBsAg+a-HBc HCV Syphilis 21 HIV positives have been registered in the whole country since 1985.

21 Prevalence/1 donations of different agents in ,5,4,3,2, HIV-1-2,23 -,142,191,181,48,118 HBsAg,4851,434,1895,2153,484,37,2426 HCV,579,3963,3127,3517,3128,3558,2473 Syphilis,1831,265,1634,1699,1732,1337,113 HIV-1-2 HBsAg HCV Syphilis

22 Transfusion safety in Hungary HBsAg Syphilis HCV HIV

23 Milestones HNBTS was reorganized, 2.Implementationof a-hbc screening in the first time donors, 21.The Dispatch Department was established in the Headquarters, 23.Unique QSystem was implemented, 23. Automated Whole Blood separation, 25. EU directives ( mother, etc.) were implemented in the Hungarian decrees, 27. Detection of bacterial contamination with BacTalert technique. 28. Unique IT system (eprogesa), one donor register in the country, 28. Use of male FFP for transfusion to prevent TRALI, 28. PLTs from 4 BCs, 29. PLTs are resuspended in additive solution, screening laboratories and 5 blood establishments with preparation of blood components, 212. Change of image of our service (logo)

Hungarian National Blood Transfusion Service

Hungarian National Blood Transfusion Service Review Article Übersichtsarbeit Transfus Med Hemother 2006;33:415 419 DOI: 10.1159/000095119 Received: August 10, 2006 Accepted: August 10, 2006 Published online: September 18, 2006 Hungarian National