Regulations on Blood Service Facilities

Policy, purpose, and regulatory focus

The Order protects and promotes public health by ensuring available licensed blood service facilities with adequate staff, equipment and resources to perform required functions safely, efficiently and effectively (II. OBJECTIVE).
Blood services are regulated to ensure safe and efficient blood banking and transfusion practices and to support the state’s responsibility to provide the public with safe and adequate blood through an efficient blood services network (Background/Rationale).
Blood service facility regulation is aligned with health sector reforms emphasizing regulatory functions separated from programming functions and improved achievement of national voluntary blood services goals (Background/Rationale).

Coverage and defined blood terms

The Order applies to all government and private blood service facilities engaged in blood banking and transfusion services (III. SCOPE).
“Act” means Republic Act No. 7719, also known as the National Blood Services Act of 1994, unless otherwise specified (IV. DEFINITION OF TERMS).
“ATO” refers to the Authority to Operate, a format permit issued by the DOH-CHD to an individual, partnership, corporation or association to a BCU/BS (IV. DEFINITION OF TERMS).
“LTO” refers to the License to Operate, a formal authority issued by the DOH to an individual, partnership, corporation or association to operate a BB/BC (IV. DEFINITION OF TERMS).
“BSF” means the blood service facility—a unit, agency or institution providing blood products; types of BSF include BS, BCU, Hospital BB and BC (Regional, Sub-national and National) (IV. DEFINITION OF TERMS).
The Order defines blood services network and facilities, including “Blood Services Network,” “CHD,” “DOH,” “End-User Hospital,” and “End-User Non-hospital Health Facility”, as well as key concepts such as TTIs and Voluntary, Non-Remunerated Blood Donor (IV. DEFINITION OF TERMS).

Blood service network requirements

Every BSF must be an integral part of a blood services network and must be guided by administrative issuances governing the establishment and operation of blood services networks (V.A.1).
Each BC has responsibility for and authority over the conduct and close supervision of affiliated BCU/BS within its blood service network (V.A.1.a).
The head of the BC (or designated staff) must conduct on-site periodic evaluation of each affiliated BB, BCU and BS (V.A.1.b).
All BSF must comply with standards and technical requirements embedded in inspection tools, and these tools must be posted at the DOH website (doh.gov.ph) (V.A.2).
Blood must be collected only from qualified healthy voluntary non-remunerated blood donors (V.A.3).
Testing for TTIs must be based on DOH-prescribed methodology, and the NCBS determines and periodically reviews the number of infections screened and the detection method (V.A.4).
TTI testing must be performed at National, Sub-national and designated Regional BCs, including PNRC BCs, with designations determined by the NCBS pursuant to Administrative Order No. 2005-0002 (V.A.5).
Units of blood issued by Philippine BCs under the Philippine blood services network must not be retested by end-user hospitals and other health facilities for TTIs; issuing BCs must ensure issued units are tested and found negative to TTIs (V.A.6).
Blood and blood products for transfusion must be obtained only from licensed and authorized BSF (V.A.7).

Classification and service capabilities of BSF

BSF classification includes ownership, institutional character, and service capability (V.B).

Ownership

Government BSF are operated and maintained partially or wholly by a national, provincial, city or municipal government or other political unit, or by a department/division/board/agency, or a government-owned or controlled corporation (V.B.1.b.1).
Private BSF (for hospital-based BSF only) are privately owned and established/operated through donation, capital or other means by an individual, corporation, association, or organization (V.B.1.b.2).

Institutional character

Hospital-based BSF are located within a hospital premises (V.B.2.b.1).
Non-hospital-based BSF are government-owned or PNRC-owned facilities located outside hospital premises consistent with the NVBSP Strategic Plan (V.B.2.b.2).

Service capability

BS must conduct advocacy/promotion of voluntary blood donation and healthy lifestyle, provide whole blood and packed red cells, and provide storage/issuance/transport/distribution; if hospital-based, BS provides compatibility testing of red cell units (V.B.1.c.1).
BCU must conduct advocacy/promotion, recruit/retain/care for voluntary donors, screen/select donors, provide health education and counseling, collect blood (mobile or facility-based), and transport blood to BC for testing/processing; if hospital-based, BCU provides compatibility testing of red cell units (V.B.1.c.2).
BCU/BS provides all services stipulated under BCU and BS (V.B.1.c.3).
BB must conduct advocacy/promotion, store and issue whole blood and blood components obtained from a BC, and provide compatibility testing, Direct Coombs Test, red cell antibody screening, investigation of transfusion reactions, and assist the HBTC in post-transfusion surveillance (hemovigilance) (V.B.1.c.4).
BC must conduct advocacy/promotion, recruit/retain/care for donors, collect blood, conduct health education/counseling, test units for TTIs, process/provide blood components, and store/issue/transport/distribute whole blood and/or blood products to hospitals and other health facilities (V.B.1.c.5).

Standards, technical requirements, and governance

BSF must appoint and allocate personnel who are suitably qualified, skilled and/or trained to assume responsibilities, authority, accountability and functions for their positions (V.B.2.a).
Services must be provided in an environment that promotes safety, has adequate space, meets client needs, and conforms to the current Manual of Standards issued by the DOH (V.B.2.b).
All equipment and instruments necessary for safe and effective service must be available and properly maintained (V.B.2.c).
Reagents and glassware used by a BSF must meet minimum requirements for sensitivity and specificity of testing reagents and testing procedures recommended by the technical committee of the NVBSP (V.B.2.d).
BSF must have a system for reporting and recording results of BSF examinations (V.B.2.e).
BSF must implement a quality assurance program and continuous quality improvement (V.B.2.f.1).
BSF must participate in an External Quality Assessment Program administered by designated National Reference Laboratories (NRL) or another external assessment program approved by the DOH-NVBSP (V.B.2.f.2).
BSF must have a system in outsourcing examinations and blood components (V.B.2.g).
All hospital-based BB, BCU and/or BS must establish a Hospital Blood Transfusion Committee (HBTC) (V.B.2.h).
All BSF must comply with policies and guidelines of the NVBSP (V.B.2.i).

License/authority rules and service fees

Hospital-based BBs, BCUs, and BS must be licensed or authorized through the One-Stop-Shop Licensure for Hospitals; they are not required to obtain a separate LTO or ATO (V.B.3.a).
The documents required for BB licensure or BCU/BS authorization must be submitted together with other documentary requirements for hospital LTO (V.B.3.a).
The LTO/ATO is granted based on prescribed documentary and technical requirements and specific conditions/limitations established during inspection (V.B.3.b).
The LTO/ATO and any rights under the license/authorization cannot be assigned or otherwise transferred directly or indirectly to any party (V.B.3.c).
The LTO/ATO must be displayed at all times in a prominent place within the BSF premises (V.B.3.d).
The CHD must be notified within fifteen (15) calendar days of any change in management, name or ownership; if there is transfer of location, a new application for LTO/ATO is required (V.B.3.e).
A separate LTO/ATO is required for each BSF or branch maintained in separate premises even if operated by the same management (V.B.3.f).
BSF may collect a reasonable service fee for every issued blood/blood product, not greater than the maximum fees prescribed by the DOH; the NVBSP periodically reviews the maximum allowable service fee, including basic requirements and special tests covered (V.B.4.a).
Maximum allowable fees must be placed in an area readily seen by the public (V.B.4.b).
The NVBSP determines basic donor screening and blood testing procedures through analysis of research information (including disease prevalence and risk estimates), consultation with technical experts, and evaluation of optimum benefits from the expected cost of tests (V.B.4.c).

Application, inspection, approval, and renewal

Applicants must request relevant information and prescribed forms from the CHD with jurisdiction over the proposed BSF location, in person or through mail, email or intern (VI.A.1).
Applicants must accomplish required documents and submit them to the CHD (VI.A.2).
BSF licensing/authorization requires documentary requirements including: Certificate of inclusion in the Regional Blood Services Network approved by the identified lead blood center in the region; duly accomplished and notarized application form; DTI/SEC registration (initial); list of personnel with photocopy of valid PRC card; location map (initial); floor diagram; list of equipment with serial number, brand, date of purchase, number of units, and operational status; NVBSP Annual Blood Report (renewal); and Certificate of participation in EQAS in previous year (renewal) (VI.A.2.a-i).
The CHD Director (or authorized representative) reviews submitted documents for completeness, authenticity, and compliance (VI.A.3).
Applicants must pay appropriate fees based on the current prescribed DOH schedule of fees to the CHD Cashier in person or through postal money order; BCU/BS operating as BCU/BS must pay the corresponding fee for BCU (VI.A.4).
The CHD Director (or authorized representatives) inspects the BSF within thirty (30) calendar days from application to determine compliance with standards and technical requirements (VI.B.1).
After inspection, the inspection team prepares an official summary of findings and recommends approval or disapproval (VI.B.2).
The CHD Director approves or disapproves issuance of LTO/ATO (VI.C.1).
If approved, the BSF is registered and LTO/ATO is issued within fifteen (15) calendar days (VI.C.1.a).
If disapproved, the applicant receives a copy of inspection findings and recommendations within fifteen (15) days from inspection (VI.C.1.b).
An application not processed within the thirty (30) calendar day inspection/processing period is considered approved (VI.C.1.c).
Renewal of LTO/ATO must be done every three (3) years; hospital BSF must renew annually as part of the One-Stop-Shop licensure for hospitals (VI.D.1).
Renewal application must be filed from October 1 until November 30 of the last year of the LTO/ATO validity period to the CHD with jurisdiction (VI.D.2).
Renewal is allowed only if the BSF continues to comply with prescribed standards and technical requirements (VI.D.3).

Validity period, monitoring, and operational closure

An LTO/ATO to operate a BSF is valid for three (3) years, beginning January 1 of the first year and ending December 31 of the third year of the validity period (VII. VALIDITY).
As part of hospital licensure, the authority to operate for a BB/BCU/BS is valid for one (1) year from January 1 to December 31 (VII. VALIDITY).
The BHFS/CHD Director (or authorized representative) may monitor and conduct on-site visits to BSF at any time (VIII. MONITORING).
BSF must make available to the monitoring team all pertinent records needed to determine compliance with Republic Act No. 7719 and these rules (VIII. MONITORING).
The CHD Director (or authorized representative) must immediately close BSF that operate without an LTO/ATO and may seek assistance of any government agency to enforce closure (XIV. CLOSURE).

Violations, investigation, administrative action, and penalties

Violations include: material false statements in the application (IX.A); misrepresentation of facts or falsification of documents or records (IX.B); refusal to make available books, accounts, and operation records to authorized BHFS/CHD personnel (IX.C); charging blood service fees above DOH maximums (IX.D); collecting blood from paid or remunerated donors whether payment comes from the hospital or from the patient/relatives (IX.E); and refusal to participate in EQAS conducted by designated NRLs (IX.F).
Upon filing of duly sworn charges or complaints against a BSF or its personnel for violation of Republic Act No. 7719 or these rules, the BHFS/CHD Director (or authorized representative) must investigate and verify whether the BSF/personnel are guilty (XI. INVESTIGATION AND HEARING).
If the BSF or personnel are found violating the Act or these rules after investigation and hearing, the CHD Director must suspend the LTO/ATO for a definite or indefinite period or revoke the LTO/ATO, without prejudice to criminal action (XI. INVESTIGATION AND HEARING).
The CHD Director must suspend or revoke LTO/ATO upon violation; the CHD Director must notify the BSF/personnel by registered mail of the particular reasons for denial or revocation (XII. SUSPENSION REVOCATION).
Any aggrieved BSF or personnel may file a notice of appeal to the Office of the Secretary through BHFS, within thirty (30) calendar days from receipt of notice, and must serve a copy on the CHD (XIII. APPEAL).
Upon appeal, the CHD Director must promptly certify and file with the Office of the Secretary a copy of the decision including the transcript of hearings for review (XIII. APPEAL).
The Office of the Secretary’s decision is final and executory (XIII. APPEAL).

Criminal penalties upon conviction

A BSF that collects service fees greater than maximum prescribed by DOH must have its LTO/ATO suspended or revoked by the CHD Director; responsible individuals/corporations/associations/organizations are subject to imprisonment of not less than one (1) month but not more than six (6) months, or a fine of not less than five thousand pesos (P5,000), or both, at the discretion of the judicial authority (XV.A. PENAL PROVISION).
A person or entity that establishes and manages a BSF without securing required LTO/ATO, or violates any provision of these rules, is subject to imprisonment of not less than twelve (12) years but not more than twenty (20) years, or a fine of not less than fifty thousand pesos (P50,000) but not more than five hundred thousand pesos (P500,000), or both, at the discretion of the judicial authority (XV.B. PENAL PROVISION).
The head of the BSF and personnel responsible for dispensing/transfusing unscreened, incompletely tested and/or contaminated blood or failing to dispose within forty-eight (48) hours blood confirmed contaminated with TTIs are subject to imprisonment for ten (10) years; this is without prejudice to filing criminal charges under the Revised Penal Code (XV.C. PENAL PROVISION).

Administrative sanctions (after notice and hearing; with Secretary approval)

After due notice and hearing, and upon approval of the Secretary, the CHD Director may impose: PHP 5,000 for any BSF that fails to submit the application for renewal of LTO/ATO within three (3) months prior to the expiration of the existing license (XV.D.1).
The CHD Director may recommend to the PRC the revocation or invalidation of a health professional’s certificate of registration/licensure if the professional is found violating Republic Act No. 7719 or these rules (XV.D.2).

Transitory, publication, separability, and repeals

Previously licensed hospital-based and PNRC BCs already performing blood testing and processing may continue as such until December 31, 2009; by 2010, there must be a nationally coordinated blood service network with only the designated BCs performing centralized testing and processing (X. TRANSITORY PROVISIONS).
The CHD must annually publish or post a list of licensed/authorized BSF by classification on the DOH website (XVI. PUBLICATION).
If any provision or part of the Order is declared unauthorized or invalid, the remaining provisions remain valid and effective (XVII. SEPARABILITY CLAUSE).
The Order repeals and supersedes all administrative orders and previous issuances inconsistent with it (XVIII. REPEALING CLAUSE).