QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2008-0008)
DOH AO 2008-0008 is promulgated to carry out and operationalize the National Blood Services Act (RA 7719) by setting rules and regulations governing the regulation of blood service facilities (BSFs). Its purpose is to protect and promote public health by ensuring that licensed blood service facilities have adequate staff, equipment, and resources to perform blood banking and transfusion functions safely, efficiently, and effectively.
It applies to all government and private blood service facilities engaged in blood banking and transfusion services, i.e., the different types of BSFs such as BS, BCU, Hospital Blood Banks (Hospital BB), and Blood Centers (BC).
LTO (License to Operate) is the formal authority issued by DOH to operate a BB/BC. ATO (Authority to Operate) is a format permit issued by DOH-CHD to an individual/partnership/corporation/association to a BCU/BS.
Blood must be collected only from qualified healthy voluntary non-remunerated blood donors. TTI testing must follow DOH-prescribed methodology, with the specific number of infections to screen and detection methods periodically determined and reviewed by the NCBS.
All units of blood issued by Philippine BCs/Regional/Sub-national BCs/PNRC under the Philippine Blood Services Network shall not be retested for TTIs by end-user hospitals and other health facilities. The responsibility is on the issuing BCs to ensure units are tested and found negative.
Ownership may be Government (operated/maintained by government units or government-owned or controlled corporations) or Private (for hospital-based BSFs only). Institutional character may be Hospital-based (within hospital premises) or Non-hospital-based (government-owned or PNRC-owned BSF outside hospital premises consistent with NVBSP Strategic Plan).
A BCU provides advocacy/promotes voluntary donation and healthy lifestyle; recruits/retains/cares for voluntary donors; screens and selects donors; conducts health education/counselling; collects blood (mobile or facility-based) from qualified voluntary non-remunerated donors; transports blood to BC for testing and processing; and conducts compatibility testing of red cell units if hospital-based.
A BB (including hospital-based BBs) provides storage and issuance of whole blood and components obtained from a BC, plus: compatibility testing and red cell units; Direct Coombs Test; red cell antibody screening; investigation of transfusion reactions; and assistance to the HBTC for post-transfusion surveillance (hemovigilance).
A BC must conduct testing of units of blood for TTIs; process and provide blood components; and handle storage, issuance, transport, and distribution of whole blood and/or blood products to hospitals and other health facilities.
They must allocate suitably qualified personnel; provide a safe environment with adequate space and conform to the DOH Manual of Standards; ensure availability and proper maintenance of equipment and instruments; use reagents/glassware meeting minimum sensitivity/specificity requirements and recommended procedures; have systems for recording/reporting results; implement a quality assurance program including continuous quality improvement and participation in External Quality Assessment; and comply with outsourcing policies where applicable. Hospital-based BB/BCU/BS must establish an HBTC.
All BSFs must participate in an External Quality Assessment Program administered by designated National Reference Laboratories (NRLs) or other external assessment programs approved by DOH-NVBSP.
The CHD must inspect within thirty (30) calendar days from the time of application. If the application for LTO/ATO is not processed within that thirty (30)-day period, it is considered approved.
LTO/ATO is generally renewed every three (3) years. For hospitals, all hospital-based BSFs must renew their LTO/ATO annually as part of the One-Stop-Shop licensure. The renewal application is filed from October 1 until November last day of the last year of validity.
LTO/ATO is valid for three (3) years, beginning January 1 of the first year up to December 31 of the third year. For hospital license to operate/authority to operate, it is valid for one (1) year, from January 1 to December 31.
Examples include: material false statements in the application; misrepresentation of facts or falsification of documents/records; refusal to make available books/accounts/records to BHFS/CHD; charging blood service fees above the maximum DOH fees; collecting blood from paid/remunerated donors; and refusal to participate in EQAS.
AO provides that collecting fees greater than the maximum may lead to suspension or revocation of LTO/ATO upon conviction. Operating/managing a BSF without securing the necessary LTO/ATO, or violating any provision, may carry heavy penalties: imprisonment of not less than 12 years but not more than 20 years, and/or a fine of not less than ₱50,000 but not more than ₱500,000. Dispensing or transfusing unscreened/incompletely tested/contaminated blood (or failing to dispose within 48 hours after confirmatory testing) may result in imprisonment of 10 years for responsible individuals, without prejudice to other criminal charges.