QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 101-A, S. 2003)
R.A. 7719 (National Blood Services Act of 1994) provides the statutory basis, and DOH Administrative Order No. 9, s. 1995 implemented it; DOH Administrative Order No. 101-A, s. 2003 amends the rules on authorization under Sections 36 and 37 of A.O. No. 9, s. 1995.
Under the issuance, the CHD (Center for Health Development), through the Director of the CHD, approves or disapproves issuance of the authority to operate after review and survey.
All government and private Blood Collection Units and Blood Stations.
They may be classified as Government (operated/maintained by government or its instrumentalities) or Private (privately owned, established, and operated hospital-based Blood Collection Unit/Blood Station funded through donation, capital, or other means).
As Hospital-based (located within a hospital premises) or Non-hospital-based (located outside the premises of a hospital consistent with the NVBSP Strategic Plan).
Blood Station (authorized to provide whole blood and packed red cells; store/issue/transport/distribute whole blood and packed red cells; and compatibility testing of red cells if hospital-based). Blood Collection Unit (authorized to recruit/retain voluntary donors; screen/select donors; conduct health education/counseling; collect blood; transport blood to a referral blood center for testing/processing; and compatibility testing only if hospital-based).
The applicant must submit DTI/SEC registration (for private entities), along with a notarized application form and other technical/documentary requirements under the issuance.
A Certificate of inclusion in the Regional Blood Services Network approved by the Regional Director upon recommendation of the designated lead BSF of the Zonal/Regional Blood Services Network.
A duly accomplished renewal application form; list of personnel; changes in location/address if applicable; list of equipment; annual accomplishment report using NVBSP standardized monitoring forms; and recommendation from the lead BSF of the Zonal/Regional Blood Services Network.
The CHD reviews documents for completeness, authenticity, and compliance; issues an order of payment for required fees; conducts a survey with the lead BSF to determine compliance; the CHD Director approves or disapproves. If disapproved, findings are sent to the applicant who must correct deficiencies within 15 days; failure to comply grounds denial for initial applications or suspension/revocation for renewals.
Failure to comply within 15 days is a ground for denial of the initial application and for suspension/revocation of authority to operate.
The order provides that any deficiencies incurred during the validity of the authority must be immediately corrected; otherwise, the authority shall be considered null and void.
No. The authority to operate and any right under it cannot be assigned or transferred directly or indirectly to any party.
The CHD must be notified of any change in management, name, or ownership. For transfer of location, a new application for authority to operate is required.
Failure to report in writing within 15 days of any substantial change may be a basis for suspension or revocation of the authority to operate.
At least four (4) times a year or whenever necessary, such as when a problem arises.
One (1) year.
At least ninety (90) days before the expiry date with the CHD having jurisdiction.
Examples include: charging blood service fees above the maximum DOH fees; dispensing/transfusing unscreened, incompletely tested, and/or contaminated blood; collecting from remunerated donors; or charging fees above DOH maximum.
Upon sworn complaint, DOH-Legal Division/BHFS (for the specific type) investigates and verifies violations. If found guilty, the Director of the CHD may suspend for a definite or indefinite period, or revoke the authority to operate, without prejudice to criminal action.