Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2008-0008)
The primary objective is to protect and promote public health by ensuring that licensed blood service facilities have adequate staff, equipment, and resources to safely, efficiently, and effectively perform all required functions.
They apply to all government and private blood service facilities engaged in blood banking and transfusion services.
LTO means License to Operate, a formal authority issued by the DOH to operate a Blood Bank (BB) or Blood Center (BC). ATO means Authority to Operate, a permit issued to operate a Blood Collection Unit (BCU) or Blood Station (BS).
Violators are subject to imprisonment of 12 to 20 years, a fine of 50,000 to 500,000 pesos, or both, at the discretion of the judicial authority.
The LTO/ATO of the BSF may be suspended or revoked, and responsible individuals may be imprisoned from one to six months, fined at least five thousand pesos, or both.
The BHFS/CHD Director or authorized representatives are authorized to conduct inspections and monitoring visits at any time.
A BC is responsible for advocacy and promotion of voluntary donation, recruitment and care of blood donors, blood collection, testing blood for transfusion-transmitted infections, processing blood components, and distribution of blood and products to hospitals and health facilities.
For independent blood service facilities, the LTO/ATO is valid for three years, from January 1 of the first year to December 31 of the third year. For hospital-based facilities, it is valid for one year, aligned with hospital licensure.
The CHD Director can suspend or revoke the LTO/ATO, notify the facility of reasons, and can refer the case for criminal prosecution. They may also recommend administrative sanctions against responsible personnel.
The NCBS determines and periodically reviews the number of transfusion-transmitted infections to be screened and the testing methods to be used, designating specific Blood Centers responsible for testing.
Blood must be collected only from qualified healthy voluntary non-remunerated donors, meaning donors who give freely without receiving money or any form of payment.
The types include Blood Stations (BS), Blood Collection Units (BCUs), Hospital Blood Banks (BB), and Blood Centers (BC), which may be regional, sub-national, or national.
The head and responsible personnel shall be imprisoned for ten years and may face additional criminal charges under the Revised Penal Code.
Facilities may collect reasonable service fees not exceeding DOH-prescribed maximums. The fee schedule must be posted in a place visible to the public.