FOR AN ADEQUATE SUPPLY OF SAFE BLOOD, REGULATING BLOOD BANKS, AND PROVIDING PENALTIES FOR VIOLATION THEREOF” (May 15, 1994) REPUBLIC ACT NO. 7719 • Title: “National Blood Services Act of 1994”. • This Act shall supersede Republic Act No. 1517 entitled “Blood Bank Act.” REPUBLIC ACT NO. 7719 • TERMS BLOOD- REFERS TO THE HUMAN BLOOD USED FOR TRANSFUSION. BLOOD PRODUCTS- REFERS TO THE THERAPEUTIC SUBSTANCES DERIVED FROM WHOLE BLOOD OR PLASMA AND ARE ALSO BLOOD COMPONENTS. REPUBLIC ACT NO. 7719 BLOOD COMPONENTS: • FRESH WHOLE BLOOD (FWB)- BLOOD COLLECTED WITHIN 24 HOURS, STORED IN A BLOOD BAG WITH AN APPROPIRATE ANTICOAGULANT. AFTER 48 HOURS IT IS CALLED WHOLE BLOOD (WB). (STORAGE: BLOODBANK REF) • PACKED RED BLOOD CELLS (PRBC)- AKA RED CELL CONCENTRATE, CONCENTRATED RED CELLS OR PLASMA REDUCED BLOOD. PREPARED BY SEPARATING THE PLASMA AND REDCELL BY CENTRIGUATION USING SPECIAL CENTRIFUGE. (STORAGE: BLOOD BANK REF) REPUBLIC ACT NO. 7719 • PLATELET CONCENTRATE (PC)- AKA RANDOM DONOR DONOR PLATELETS, SUSPENDED IN A SMALL AMOUNT OF PLASMA DERIVED FROM WB 8 HOURS AFTER COLLECTION. (STORAGE: ROOM TEMP WITH CONSTANT AGITATION. • FRESH FROZEN PLASMA (FFP)- NON-CELLULAR FLUID PORTION SEPARATED FROM WB AFTER 6-8 HRS OF COLLECTION. (STORAGE: FREEZER) REPUBLIC ACT NO. 7719 Mandates of R.A. No. 7719 • to promote and encourage voluntary blood donation. • blood donation is: • A humanitarian act. • A non-profit blood collection. • A professional medical service. • Not a sale of a commodity. • to curb the hazards caused by the commercial sale of blood. REPUBLIC ACT NO. 7719 Axioms provided under R.A. No. 7719: 1. Blood shall be collected from healthy voluntary donors only. 2. All commercial blood banks shall be phased-out. 3. All BSFs shall operate on a non-profit basis. 4. All BSFs shall be registered and issued a license to operate. 5. All BSFs shall be under the management of a licensed and qualified physician.(Pathologist/ Licensed Physician w/3 month training) Administrative Order. No. 2008-0008
Rules and Regulations Governing the Regulation of Blood Service
Facilities
(May 02, 2008)
• This AO shall apply to all government and private BSF.
Administrative Order. No. 2008-0008 Classification of BSF: 1. Ownership (Govt./Private) 2. Institutional Character (Hosp./Non-Hosp. based) 3. Service Capability a. Blood Station (BS) a. Storage, issuance, transport & distribution of blood b. Blood Collection Unit (BCU) a. Collection of blood c. BS-BCU d. Blood Bank (BB) e. Blood Centers a. Testing units of TTIs b. All blood units screened by BCs shall not be retested for TTIs by the end-user hospitals. a. If found infected with any of the TTIs, the blood unit must be discarded within 48 hours. CLASSIFICATION OF BLOOD SERVICE FACILITIES • OWNERSHIP -GOVERNMENT -PRIVATE • INSTITUTIONAL CHARACTER -HOSPITAL BASED -NON HOSPITAL BASED CLASSIFICATION OF BLOOD SERVICE FACILITIES • SERVICE CAPABILITY 1.BLOOD STATION (BS) -ADVOCACY AND PROMOTION OF VOLUNTARY BLOOD DONATION -STORAGE, ISSUANCE, TRANSPORT AND DISTRIBUTION OF WB AND PRBC -COMPATIBILITY TESTING (IF HOSPITAL BASED) CLASSIFICATION OF BLOOD SERVICE FACILITIES • SERVICE CAPABILITY 2.BLOOD COLLECTION UNIT (BCU) - ADVOCACY AND PROMOTION OF VOLUNTARY BLOOD DONATION AND HEALTHY LIFESTYLE. - RECRUITMENT, RETENTION AND CARE OF VOLUNTARY BLOOD DONORS. - SCREENING AND SELECTING VOLUNTARY BLOOD DONORS - CONDUCT HEALTH EDUCATION AND COUNSELING - BLOOD COLLECTION - TRANSPORT OF BLOOD TO BLOOD CENTERS FOR SCREENING. - COMPATIBILITY TESTING OF BLOOD UNITS IF HOSPITAL BASED. CLASSIFICATION OF BLOOD SERVICE FACILITIES • SERVICE CAPABILITY
3.BLOOD STATION (BS) WITH BLOOD COLLECTION UNIT (BS/BCU)
-ALL SERVICES STATED IN BCU AND BS. CLASSIFICATION OF BLOOD SERVICE FACILITIES • SERVICE CAPABILITY 4.BLOOD BANK (BB) -ADVOCACY AND PROMOTION OF VOLUNTARY BLOOD DONATION AND HEALTHY LIFESTYLE - STOARAGE AND ISSUANCE OF OF BLOOD FROM BC - THE FOLLOWING SERVICES SHALL ALSO BE PROVIDED: A. COMPATIBILITY TESTING B. DIRECT COOMBS TEST C. RED CELL ANTIBODY SCREENING D. INVESTIGATION OF TRANSFUSION REACTIONS E. ASSIST THE HOSPITAL BLOOD TRANSFUSION COMMITTEE (HBTC) IN POST TRANSFUSION SURVEILANCE OR HEMOVIGILANCE. CLASSIFICATION OF BLOOD SERVICE FACILITIES • SERVICE CAPABILITY 5.BLOOD CENTER (BC) -SUPERVISION OF BS AND BCU WITHIN ITS BLOOD SERVICE NETWORK - ADVOCACY AND PROMOTION OF VOLUNTARY BLOOD DONATION AND HEALTHY LIFESTYLE. - RECRUITMENT, RETENTION AND CARE OF VOLUNTARY BLOOD DONORS. - BLOOD COLLECTION - CONDUCT HEALTH EDUCATION AND COUNSELING - TESTING UNITS FOR TTIs - PROCESSING AND PROVISION OF BLOOD COMPONENTS - STORAGE, ISSUANCE, TRANSPORT AND DISTRIBUTION OF BLOOD UNITS. Administrative Order. No. 2008-0008 • 5 CORE TEST (WHO) 1. HIV 2. Serum Hepatitis (HbsAg) 3. Hepatitis C 4. Test for Syphilis 5. Malaria Administrative Order. No. 2008-0008 • NOTE: • LTO- FOR BB AND BC • ATO- BCU LTO/ATO IS VALID FOR 3 YEARS IF PART OF THE HOSPITAL LICENSED 1 YEAR. Administrative Order. No. 2008-0008 • RECORDS All records in BB are kept Permanently Administrative Order. No. 2008-0008 • INVESTIGATION The HFSRB and CHD, thru its director or his authorized representative, is authorized to investigate complaints against BSF or any of its personnel who violated R.A. No. 7719 and its implementing rules and regulations. It can impose the penalty of reprimand, suspension or revocation of ATO/LTO. Administrative Order. No. 2008-0008 • APPEAL For those complaint decided by the CHD, an aggrieved party may file an appeal to the Secretary of Health of the DOH within 30 days from receipt of the decision. The decision of the Secretary of Health shall be final and executory.