2014/LSIF/PD/008 Building Blocks and Challenges to Implementing a National Blood Program in Malaysia

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1 2014/LSIF/PD/008 Building Blocks and Challenges to Implementing a National Blood Program in Malaysia Submitted by: Malaysia Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain Manila, Philippines 30 September 1 October 2014

2 Session II: Building Blocks and Challenges to Implementing a National Blood Program in Malaysia Dr Faraizah Abd Karim

3 Facts on Malaysia Population Area : 29,714.7 million : 330,252 sq.km Age <15 yrs : 26% >65 yrs : 5.5% Health budget : 8.39% (RM 22 billion) Per Capita income : RM 34,126

4 Annual Expenditure Health programme RM 22 Billion 8.3% of total government expenditure Blood Transfusion approximate : RM 100 million

5 Present Organization MOH National Blood Centre Kuala Lumpur Hospital Pathology Dept Collection /Screening Centre/Blood Bank

6 National Blood Service National Blood Centre : 1 Hospitals : 132 (MOH) Collection centre 120 Processing centre 110 Screening centre 16 Hospital blood banks 346 (include private hospitals) 5

7 Collection and Screening Center in Malaysia Kedah/Perlis Kelantan HSB HRPZ 9 Terengganu P Pinang HPP HSNZ 3 Perak HRPB 4 Pahang HTAA 13 PD SelangN 8 N or Sembilan Melaka 5 Hosp Melaka 1 Johor HSAJB 11 Sarawak HUS, H Miri, H Sibu, H Bintulu 15 Sabah HQE, HDoK, H Tawau 21 Collection sites 120 & Screening centre 16 Number of collection only in the state

8 Policy Blood Transfusion Service 1. Procurement of blood from voluntary nonremunerated blood donors 2. Mandatory screening test: HIV, HBV, HCV and Syphilis. 3. Only screened blood to be transfused 4. All blood banks should be under the perview of a medical practitioner. 5. Blood donor criteria; regular review of criteria, no discrimination of any kind 6. Quality management system/good manufacturing practices employed in all process and procedure

9 Blood Collection (Malaysia) Axis Title year No of blood collected

10 Replacement donors from % 30% 30% 30% %of replacement donor 25% 20% 15% 10% 18% 5% 0% 4.50% 1.% 0.86% A dramatic drop in replacement donors between 1980 to 2005

11 Blood donation rate : 21.9 per 1000 population Replacement donors : % 10

12 Screening of Blood Donors in Malaysia Syphilis : 1950 s Wasserman/Kahn test 1970 VDRL/TPHA 1994 RPR/TPHA Malaria : Endemic areas using blood films HBV : 1974 Immunodiffusion test (IEOP) 1979 RIA 1986 EIA HIV : 1986 EIA (HIV 1) 1992 EIA (HIV 1 and 2) 2000 EIA (group O) 2006 Combo test (P24Ag/Anti HIV) HCV : 1991 EIA (HKL) 1995 EIA (whole country) 2009 Combo (Ag/Antibody) vcjd : 2002 Donor deferral

13 Testing of blood donation 1. Nucleic acid testing (NAT) Individual NAT for every donated blood HIV, HBV and HCV Wilayah Persekutuan Kuala Lumpur Selangor Negeri Sembilan Pahang Barat Melaka Kedah Perlis Kelantan Nov 2007 OCT 2012

14 HIV Series1 HBV Series2 Series3 HCV Series4 Sypilis Presentation Title Presenter Name Date Subject Business Use 13 Only

15

16 Contract Fractionation Started in 1991 Plasma sent to Australia (CSL) Products : IVIG FVIII concentrate Prothrombin complex concentrate(pcc) Albumin Volume of plasma (2013) = 32,350 kg

17 Plasma for fractionation to CSL, ,190 32, ,338 30,602 29,295 25,772 26,130 26, ,754 22,107 Plasma (L) ,214 18,301 14,125 11,786 12, , ,630 4,693 5,275 6,668 7, JUMLAH Penang Malacca PDN

18 Quality Management Programme 1. Accreditation of the Blood Transfusion service started in 2004 : NATA 2. Accreditation of Laboratory by Department of Standards Malaysia since ISO certification since National internal audit programme 5. National indicators since 1980 s 6. Proficiency testing: NEQAP since 80 s 7. Haemovigilance since 2002

19 New Organization Ministry of Health Medical Development Division National Blood Centre National Transfusion Committee Northern Regional Centre Southern Regional Centre Central East Melaka Sabah Sarawak Hospital Bld Bank Hospital Bld Bank Hospital Bld Bank Hospital Bld Bank

20 Challenges 1. To increase to 3% (From 653,124 to 891,441) 2. Increase donor retention from 60% to 70% 3. Improvement in the safety and quality of products and services 1. No replacement donation 2. All donated blood are ID NAT tested 19

21 Challenges and future plans 4. Consolidation of the service 1. To reduce number of collection centres/ processing lab/ screening lab to 7 regional blood centres. 2. Efficient organization- clear line of authority, responsibility and accountability. 3. Maximise trained personnel - Inadequate trained personnel 4. Inadequate number of transfusion specialist

22 Thank you 21

23 Overview of National Blood Service Orientation of the Blood Transfusion Service Directions to speaker: Please use this slide to describe how National Blood Service is structured (National Blood Service Policy, Regulatory Body?); describe the focus on the Quality System; describe centralization/regionalization, if any; Serology and Nucleic Acid Testing, if any; breakdown of volunteer vs. family/replacement blood donors

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