Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 101-A, S. 2003)
The primary objective is to protect and promote the health of the people by ensuring available authorized Blood Collection Units and Blood Stations with adequate staff, equipment, and resources to perform all required functions safely, efficiently, and effectively.
The rules and regulations apply to all government and private Blood Collection Units and Blood Stations in the Philippines.
They are classified by (1) Ownership - government or private, (2) Institutional Character - hospital-based or non-hospital-based, and (3) Service Capability - Blood Station or Blood Collection Unit.
Republic Act 7719, also known as the National Blood Services Act of 1994, is the legal basis.
It is a formal permit issued by the DOH-Center for Health Development to an entity that has complied with the prescribed technical requirements for operating a Blood Collection Unit or Blood Station.
A hospital-based Blood Collection Unit must have an authorized physician certified in Clinical Pathology by the Philippine Board of Pathology to head it, medical technologists with at least one year of blood banking experience, a trained Donor Recruitment Officer, and a designated Quality Assurance Officer.
The applicant must request and complete the application form, submit required documents including certification and licenses, pay applicable fees, and undergo a survey by the CHD and lead Blood Service Facility to evaluate compliance with standards.
A penalty of three thousand pesos (₱3,000) may be imposed, and the CHD may order immediate closure. There may also be suspension or revocation of authority, and referral to professional regulatory bodies for revocation of licenses.
Violations include making false statements in applications, failure to inform CHD about changes, charging fees above the prescribed maximum, collection of blood from paid donors, dispensing unscreened or contaminated blood, refusal of surveys, and other violations of blood banking practices.
The CHD conducts surveys, approves or disapproves Authority to Operate, monitors compliance through site visits, prepares official findings, publishes authorized lists, and enforces penalties for violations.
The facilities must be well-lighted, well-ventilated with adequate water supply, sufficient space for activities, clearly marked fire exits, and maintenance of smooth flow for people and supplies. The working area must be exclusive for Blood Collection Unit/Station activities.
Any individual, corporation, association, or organization can file sworn complaints. The DOH Legal Division or BHFS investigates, and if violations are found, the CHD may suspend or revoke the Authority to Operate and initiate criminal proceedings if necessary.
An aggrieved party may file a notice of appeal within 30 days to the Office of the Secretary with a copy to the DOH Legal Division/BHFS/CHD. The Secretary's decision is final and executory.
They must only collect blood from healthy voluntary non-remunerated donors, with a documented system of recruitment, retention, screening, and selection. Paid donors are prohibited.