Regulations on Blood Service Facilities

To protect and promote public health by ensuring the availability of licensed blood service facilities with competent staff, proper equipment, and resources to operate safely, efficiently, and effectively.

Applies to all government and private blood service facilities involved in blood banking and transfusion services.

"Act": Republic Act 7719.
"Authority to Operate (ATO)": Permit issued by the DOH-CHD for BCU/BS operations.
"Blood Bank (BB)", "Blood Center (BC)", "Blood Collection Unit (BCU)", "Blood Station (BS)": Various types of blood service facilities.
Others include terms such as Blood Product, Blood Component, Blood Services Network, External Quality Assessment Scheme (EQAS), Licensed clinical laboratories, etc.
"Voluntary, Non-Remunerated Blood Donor": Donor who gives blood freely without payment.

All BSFs must be part of a designated blood services network.
BCs have supervisory authority over affiliated BCU/BS.
Compliance with DOH standards and technical requirements is mandatory.
Blood must be collected only from qualified voluntary, non-remunerated donors.
Testing for Transfusion-Transmitted Infections (TTIs) must follow DOH-prescribed methodologies.
Testing centralized at designated BCs; no retesting by end-user hospitals.
Blood and blood products must come only from licensed facilities.

Classification by ownership (government or private), institutional character (hospital or non-hospital based), and service capability.
Service capabilities outlined per facility type (BS, BCU, BB, BC) including donor recruitment, advocacy, blood collection, testing, processing, compatibility testing, investigation of transfusion reactions, and hemovigilance.
BSFs must appoint qualified personnel, maintain suitable environments, ensure maintenance of equipment, use appropriate reagents, maintain records, implement quality assurance, participate in EQAS, and establish Hospital Blood Transfusion Committees (HBTC) for hospital-based units.
Licensure procedures defined, including integration with hospital licensing for hospital-based facilities.
Maximum allowable service fees regulated and subject to periodic review by NVBSP.

Application procedures include submission of documentation such as inclusion in regional networks, personnel list, equipment lists, and participation in quality assurance.
CHD conducts inspections within 30 days.
LTO/ATO issued or disapproved within 15 days post-inspection.
Renewal every three years (or annually for hospital-based BSFs as part of hospital license renewal).

LTO/ATO valid for three years (one year for hospital-based BSFs under hospital licensure).

BHFS/CHD authorized to conduct unannounced on-site visits to evaluate compliance.

Include false statements, misrepresentation, refusal to provide records, charging excessive fees, collecting paid blood donations, refusal to participate in EQAS.

Previously licensed BCs allowed to operate until December 31, 2009; after which only designated BCs perform centralized testing and processing.

Complaints against BSFs or personnel investigated by BHFS/CHD.
Violations may result in suspension or revocation of licenses and referral for criminal action.

Fines and imprisonment for overcharging, operating without license, dispensing contaminated blood, or failure to properly dispose of contaminated blood.
Administrative sanctions include monetary penalties and possible revocation of professional licenses.

Rules take effect 15 days after publication in a newspaper of general circulation.