Policy and purpose statement
- Republic Act No. 7719 declares state policies to:
- Promote and encourage voluntary blood donation by the citizenry.
- Provide for adequate, safe, affordable and equitable distribution of blood and blood products.
- Mandate the Department of Health to establish and organize a National Blood Transfusion Network to rationalize and improve the promotion of an adequate and safe supply of blood.
- Republic Act No. 7719 also supports a National Voluntary Services Program (NVBSP), implemented through cooperation with the Philippine National Red Cross (PNRC), the Philippine Blood Coordinating Council (PBCC), and other agencies and organizations.
- DOH Administrative Order No. 2005-0002 is anchored on a strategy of centralizing collection, testing, and processing of blood and blood components to improve efficiency and competency.
Scope: covered facilities nationwide
- These Rules and Regulations cover all facilities, both government and private, that provide blood services, all over the country.
Core definitions for blood services
- A Blood Service Facility (BSF) is a unit, agency, or institution providing blood products.
- A Blood Station (BS) is a BSF duly authorized by the DOH Center for Health Development (CHD) pursuant to A.O. 101-A, s. 2003, with capabilities to:
- Provide whole blood and packed red cells.
- Store and issue whole blood and packed red cells.
- Conduct compatibility testing of red cell units if hospital-based.
- A Blood Collection Unit (BCU) is a BSF duly authorized by the DOH CHD pursuant to A.O. 101-A, s. 2003, with capabilities to:
- Recruit and retain voluntary blood donors.
- Screen and select qualified voluntary blood donors.
- Provide health education and counseling.
- Collect blood from qualified voluntary blood donors.
- Transport collected blood units to blood centers for testing, processing, and distribution to hospitals and other health facilities.
- An Apheresis Facility is a BSF where whole blood is removed, a selected component is separated, and the remainder is returned to the donor.
- A Hospital Blood Bank is a blood service facility in a hospital duly licensed by the DOH Bureau of Health Facilities and Services (BHFS), with capabilities to:
- Store whole blood and components obtained from a blood center or another hospital.
- Conduct compatibility testing of red cell units.
- Perform Direct Coombs Test.
- Do red cell antibody screening.
- Investigate transfusion reactions.
- Assist the Hospital Blood Transfusion Committee (HBTC) in post-transfusion surveillance (hemovigilance).
- A Blood Center is a blood service facility licensed by the DOH BHFS, with capabilities to:
- Recruit/retain and care for voluntary blood donors.
- Collect blood (mobile or facility-based) from qualified voluntary blood donors.
- Process and provide blood components.
- Store, issue, transport, and distribute whole blood and/or blood products to hospitals and other health facilities.
- For National and Subnational and selected Regional Blood Centers only, test units for five infectious disease markers: Anti-HIV 1/2, Anti-HCV, HBsAg, Syphilis, Malaria.
- Blood centers are classified into Regional, Subnational and National, with classification determined by the National Council for Blood Services (NCBS).
- An End-User Hospital (EU) is a hospital with a licensed clinical laboratory capable of red cell typing and cross-matching, which does not have any blood service facility but receives blood and blood components for transfusion as needed.
- An End-User Non-Hospital Health Facility is a licensed/accredited non-hospital health facility without a licensed clinical laboratory that administers blood transfusion.
- A Blood Services Network is an informal organization composed of designated blood centers, hospital blood banks, blood stations, and end-user hospitals established to meet blood needs of a specific geographical area.
Philippine National Blood Services structure
- The Blood Services Network consists of:
- National Council for Blood Services and various committees.
- Philippine National Blood Services (National, Subnational and Regional Blood Centers).
- Authorized Blood Collection Units and Apheresis Facilities.
- Hospital Blood Banks and Blood Stations (government and private).
- End-User Hospitals and Non-Hospital Health Facilities (government and private).
- National Reference Laboratories for Immunology and Immunohematology.
- The National Council for Blood Services (NCBS) is the governing body of the Philippine National Blood Services.
- The NCBS is chaired by the Secretary of Health and is composed (but not limited to) heads or representatives of:
- Philippine National Red Cross
- Philippine Blood Coordinating Council
- Philippine Society of Pathologists
- Philippine Society of Hematology and Blood Transfusion
- Director (or Chief Executive Officer) of the Philippine Blood Center
- The NCBS establishes committees whose functions are defined in a separate administrative issuance, including:
- Executive Committee
- Technical Committee
- Committee on Public Education and Advocacy
- Committee on Professional Education
- Committee on Curriculum Development
- Committee on Finance
- Committee on Information Technology
- Other committees as necessary
- The NCBS creates a Secretariat composed of staff from either the Philippine Blood Center or the DOH National Center for Health Facility Development (NCHFD).
- The NCBS meets at least quarterly or as necessary depending on the chairperson’s discretion, and non-DOH members are entitled to per diems for meetings attended.
- The NCBS approves policies and standards covering the PNBS, including:
- Policies governing PNBS operation and blood product utilization by hospitals and other health services.
- Standards, Standard Operating Procedures, and guidelines for donor recruitment; collection, transport, testing, processing, issuance, administration; and monitoring of blood transfusion practices.
- Directional/strategic plans for the NVBSP.
- Allocation of funds and monitoring of fund utilization.
- Development of capabilities as needed.
- Creation of other standing and special committees.
- Certification of importation privileges.
- The PNBS operates under NCBS supervision and includes blood centers, including:
- The Philippine Blood Center in Metro Manila, designated by the NCBS, with functions including donor recruitment/retention and care; collection; testing for infectious disease markers; processing; pheresis; storage/issuance/transport/distribution; quality assurance of sub-national and selected regional centers; training and research; special confirmatory and reference immunohematologic examinations; manufacture and provision of typing sera and reagent red cells; preparation of special plasma derivatives; and ensuring safe supply through adequate distribution and delivery.
- Subnational and Regional Blood Centers for Luzon, Visayas and Mindanao, with functions including donor recruitment/retention; collection; testing for infectious disease markers (for subnational and selected regional centers); processing; pheresis; storage/issuance/transport/distribution; quality assurance and supervision by subnational centers of regional centers; training and research; special confirmatory and reference immunohematologic examinations; and ensuring safe supply through adequate distribution and delivery.
- Authorized Blood Collection Units and Apheresis Facilities must be supervised by a National, Subnational, or Regional Blood Center, and perform donor recruitment/retention and care; screening and selection; health education and counseling; collection; and transport to the blood center for testing and processing.
- Hospitals establish blood service structures based on size and complexity, through:
- A Hospital Blood Bank, Hospital Blood Station, or End-User Hospital; with service capabilities set by the defined terms.
- Each hospital must establish and maintain a proper audit and inventory system to ensure adequate and safe blood supply, including emergencies.
- End-User Licensed/Accredited Non-Hospital Health Facilities (including renal dialysis centers, ambulatory surgical clinics, and birthing centers that provide transfusion) must establish and maintain a proper audit and inventory system to ensure adequate and safe supply of blood to patients.
- The NCBS designates National Reference Laboratories consistent with DOH Department Order 301-I s. 1999:
- Immunology NRL for confirmatory testing of blood donors and blood units: Research Institute for Tropical Medicine (RITM).
- Immunohematology NRL: National Kidney and Transplant Institute (NKTI).
- NCBS may transfer or change designations as need arises.
Funding and trust fund mechanics
- NCBS is supported by funds from:
- Budgetary allocation from the National Government.
- Financing agencies Philippine Charity Sweepstakes Office (PCSO) and Philippine Amusement and Gaming Corporation (PAGCOR).
- Reimbursement from PhilHealth, directly or through hospitals.
- Blood Service Fees from government and private hospitals for units of blood provided and services rendered.
- NCBS may also receive collaborative support from:
- National Donor Agencies and Foundations
- International Development and Donor Organizations
- Contributions from Local Government Units
- A trust fund must be established for the National Voluntary Blood Services Program and for operations of the Philippine National Blood Services, sourced from blood service fees, donations, and revenues generated by blood service facilities.
- DOH must allocate an annual budget for personnel, capital outlay, infrastructure, maintenance, operating expenses, and other expenses to implement the NVBSP and PNBS operations.
- NCBS must work out plans for continued funding and material support from the National Government and National Government Financing Agencies such as PCSO and PAGCOR, and plans for funding from national donor agencies/foundations and international development and donor organizations.
- Blood centers receive service fees to reimburse actual costs of providing blood products and services, and a Memorandum of Agreement (MOA) must be signed between blood centers and hospitals/health facilities.
- PhilHealth must reimburse the Philippine Blood Center, subnational and regional blood centers for services and blood products, and reimbursement for blood transfusion expenses to hospitals/patients must be based on criteria that:
- The blood unit is collected from a voluntary blood donor only.
- The blood unit is tested at the Philippine Blood Center, Subnational Blood Centers, and selected Regional Blood Centers only.
- The blood unit is transfused in accordance with indications for rational blood use.
General operational rules and guidelines
- Voluntary blood donations must be aggressively promoted for both mobile and health facility-based collection.
- Blood must be collected from qualified healthy voluntary blood donors only.
- The PNBS must ensure availability of quality health care by establishing appropriate capabilities and competencies in each unit.
- Hospitals and other health facilities must not retest blood units issued under the PNBS network; all units of blood issued by the Philippine Blood Center, Subnational Blood Centers and Regional Blood Centers need not be retested for Transfusion-Transmitted infections (TTIs) by hospitals.
- Blood centers must ensure that units issued are tested and found negative for TTIs.
- When retesting is warranted by the attending physician, the retests must use reagents as recommended by the NVBSP Technical Committee and the tests must be charged corresponding laboratory fees.
- Hospitals and other health facilities must use blood and blood products for transfusion only from licensed and authorized blood centers.
Operationalization: management, procurement, compliance
- NCBS approves the organizational structure and staffing of:
- The Philippine Blood Center (Metro Manila).
- Subnational and Regional Blood Centers (for Luzon, Visayas and Mindanao).
- NVBSP personnel may be reassigned to the national and subnational blood centers and, if necessary, to selected regional blood centers.
- New personnel must be hired as needed.
- NVBSP-procured equipment and vehicles must be centralized in the national, subnational, and regional blood centers.
- The Philippine Blood Center must create a Bids and Awards Committee (BAC) whose composition and functions follow the existing Procurement Law.
- The Philippine Blood Center, in consultation with the Department of Finance and the Bureau of Customs, must prepare a detailed list of equipment, blood bags, and reagents and complete specifications needed, and this list may be allowed to be imported tax-and duty-free under Republic Act No. 7719.
- The detailed list may be modified periodically as necessary, and the list together with the application for exemption from customs duties and taxes must be filed with the Revenue Office, Department of Finance, Manila by authorized participants who may avail of the privilege.
Separability and effect of invalid provisions
- Provisions declared invalid or unconstitutional do not affect the validity of other provisions unless otherwise specified.
Rescission, repeal, and immediate effectivity
- DOH Administrative Order No. 2005-0002 provides immediate effectivity.
- Administrative Order No. 9, s. 1995 is rescinded, repealed, and modified accordingly for specific sections, namely:
- Section 4. Definition of Terms
- Section 5. National Program Committee
- Section 6. Field Representative of National Committee
- Section 7. DOH Program Management
- Section 8. Program Funding
- Section 12. Establishment of Blood Services Network
- Section 14. Monitoring and Evaluation Sub-Committee
- Section 15. DOH Regional Hospitals and Medical Centers
- Section 16. Provincial and District Hospitals
- Section 17. Blood Banks/Center with Special Functions
- Section 25. Operation and Maintenance of Blood Service Facilities
- Section 35. Allowable Service Fees
- Section 38. Standard Operating Manual
- Section 39. Quality Assurance Officer
- Section 40. Confirmation of Voluntary Donors
- Section 41. Emergency Blood Transfusion
- Section 42. Certification of Importation Privileges
- Section 43. Equipment and Materials Covered
- Section 44. Application for Tax Exemption.