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TRANSFUSION MEDICINE IN ESTONIA 2011

TRANSFUSION MEDICINE IN ESTONIA 2011. Tatjana Plahhova Quality Manager North Estonia Medical Centre Blood Centre. R EPUBLIC OF E STONIA. AREA 45 227 square km POPULATION 1,3 1 million CAPITAL CITY Tallinn ( 400 000) DONORS 2, 9 % of population.

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TRANSFUSION MEDICINE IN ESTONIA 2011

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  1. TRANSFUSION MEDICINE IN ESTONIA2011 Tatjana Plahhova Quality Manager North Estonia Medical Centre Blood Centre

  2. REPUBLICOF ESTONIA AREA 45 227 square km POPULATION 1,31million CAPITAL CITY Tallinn ( 400 000) DONORS 2,9 % of population

  3. STRUCTURE AND ORGANIZATION OF ESTONIAN TM The BTS in Estonia is organized according to the regional principle. TheBlood Centres are part of the HospitalsFoundations. - North-Estonian MedicalCentreBlood Centre - Tartu University Clinic BC - Pärnu Hospital BC - East-Viru Hospital BC 4 mobile teams 226 blooddonationplaces(100 NEBC) 630 bloodcollectionsessions(250 NEBC) The BloodCentres operate only according to the activity license.

  4. PERSONNEL Estonian TM - 140 84 - North-Estonian MedicalCentreBlood Centre 32 - Tartu University Clinic Blood Centre 15 - Pärnu Hospital Blood Centre 9 - East-Viru Hospital Blood Centre

  5. STRUCTURE AND ORGANIZATION OF ESTONIAN TM(2) There are 25 hospitals in Estonia. 2 Regional Hospitals in Tallinn and in Tartu 10Central Hospitals 13Local Hospitals 14 Hospital Blood Banks 16Hospital Transfusion Committee 6703 Hospital beds

  6. LEGISLATION Law • Blood Act, 2005 • Medicinal Products Act • Health Services Organization Act • Prevention of Infectious Diseases Act  • Medical Device Act

  7. LEGISLATION(2) Regulations • GMP for BC • Laboratory Diagnosis of Infectious Diseases • Quality Control of Blood Products • Donor Selection • Haemovigilance • Clinical Use of blood • National BTS Information System • Approval of the Procedure for the Manufacture of Medicinal Products • Requirements for Issue of Activity Licences for Manufacture, Wholesale or Retail Trade of Medicinal Products and Procedure for Application and Revocation of Activity Licenses • Approval of the Procedure for Storage and Transport of Medicinal Products

  8. Cost of the blood products The prices for the blood products (as well as for the health care services) are determined by the Central Sick Fund and are confirmed by the Government. The hospitals have agreements with the Sick Fund for one calendar year. The cost of the blood products are included in the yearly budget of the hospitals. The blood centers sell blood products to the hospitals- hospitals pay to the blood centers according to the invoice.

  9. RESPONSIBLE INSTITUTIONS The Health Care Department of the MOSA isresponsible for legislation in the area of blood supply and bloodsafety in the blood transfusion chain. State Agency of Medicines is responsible institution forinspection of the blood centres. State Agency of Medicinesissuesactivitylicensetothe BloodCentre. Thelicenseis valid maximum 5 years.

  10. REFERENCE LABORATORY Estonia has: - one HIV Reference Laboratory - part of the West – Tallinn CentralHospital - oneHepatitis Reference Laboratory - part of the Tartu UniversityClinic HIV and Hepatitis Reference Laboratory – carryoutconfirmatory testingofdonorblood. - oneImmunohaematology Reference Laboratory- part of the North-Estonian MedicalCentreBlood Centre. Patientanalyses and compatibilitytesting.

  11. DONORS AND BLOOD DONATIONS2011 Donor recruitment in Estonia is based on the voluntary non-remuneratedblood donation.  All donations are voluntary and unpaid  NEBC EST Donors 20 536 36 200 First time donors 4306 (20%) 8058 (22 %) Donations32 695 56 216 Collected wholeblood units 31 055 54 234 MT collected units 14516 (47%) 25 060 (46 %) Apheresis 1640 1982

  12. BLOOD DONATIONS 2011

  13. BLOOD TESTING Blood-borne infections markers carry out - North-Estonia Medical Centre Blood Centre - Tartu University Clinic BC Blood group serology All BC

  14. BLOOD TESTING(2) Each blood unit is testing individually for next blood-borne infections markers: HIVAg/Ab Combo) ARCHITECT (Abbott Diagnostics) HBsAg ARCHITECT (Abbott Diagnostics) Anti – HCV ARCHITECT (Abbott Diagnostics) Syphilis ARCHITECT (Abbott Diagnostics) HIV RNA, HCV RNA, HBV-DNA PCR testing, minipool 6 HIV1-RNA HCV-RNA Roche Diagnostics (COBAS Taq Screen) HBV-DNA

  15. BLOOD TESTING(3) Blood group serology All donations are tested individually: - ABO - Rh(D) - K-antigeen - Irregular erythrocyte antibody Techno Twin Station (DiaMed) – NEBC Manually - other BC

  16. PREVALENS OF INFECTIONS MARKERS 2011 Number of confirmed positive donors HCV43 donors HBV 12 donors HIV 3 donors Confirmed positive donors per 1000 donations HCV0,76 HBV0,2 HIV0,05 First time CP donors 89 - 92% HIV CP20 - 34 years old (M/W1,5/1) HCV/HBV CP 20 - 44 years old (M/W-2/1)

  17. Donation • Donor calling system (by post, e-mail, SMS, phone: • Before each donation: - donor fill in a detailed health questionnaire (manual or electronic and by Internet) - donor Hb controll - on the basis of the questionnaire and the interview the physician /nurse accepts or defers the donor • Blood collection: - the blood samples are taken before collection - use “close system” - standard donation 450 ml  10 % of blood - use CPD anticoagulant solution

  18. COMPONENT PREPARATION • Whole blood centrifugation - high spin centrifugation • Whole blood separation BC removed – Dual Plus • Plasma freezing procedure - core temperature of plasma decreases below -30C within 60 minutes • Platelete Afereesis - Haemonetic • Multicomponent (Apheresis RC + PL) • All components storage in quarantine before realizing • No FFP Quarantine • PL storage BacT/ALERT

  19. COMPONENT PREPARATION (2) • RC – BC removed in additive solution (SAGM) • Component filtration – for children 100% • Irradiation - Hospital oder • Inactivation procedure (Intersept) - PL Afereesis

  20. COMPONENT REALIS • Standard blood component label ISBT 128

  21. Component label ISBT 128

  22. BLOOD COMPONENTS STOCK (1)

  23. BLOOD COMPONENTS STOCK (2)

  24. CLINICAL USE • RC – 53 691 units • FFP – 26 883 units • PL – 6238 units • RC / FFP – 2 / 1

  25. THE QUALITY SYSTEM • Quality management and Process controll • Personnel and Organisation • Documentation • Premises • Equipment and Materjal • Quality monitoring and Quality controll • Deviations, complaints, adverse events or reactions, recall, corrective and preventive actions • Self-inspection , audits, improvement • Donor session • Processing • Storage and distribution

  26. THE QUALITY SYSTEM

  27. Documentation I II III IV QM , GMP Guides SOP s Records

  28. EVI development

  29. EVIdevelopment Gennet Lab • EVI implementedin 4 Centres,4 Mobiles,8 Hospitals • www.EVI – beginningofdevelopment • web-basedEstonianBloodBank.

  30. STRUCTURE AND ORGANIZATION OF NEBC There are the blood collection location places: • Blood Centre, the main place Ädala Str. 2 • Blood Centre, DoonoriFoorum Narva mnt. 5 • Mobile collection (aproximately 100 collection places) • The DoonoriFoorum blood collection (6 beds) and a mobile collection unit (6 beds) runs under the supervision of responsible personnel of the Blood Centre. • The collected blood units are brought to the Blood Centre the same day.

  31. STRUCTURE AND ORGANIZATIONOF NEBC (2)

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