RA 7719 – National Blood Services Act of 1994

Legislative Background and Historical Context

• RA 7719, officially titled the “National Blood Services Act of 1994,” enacted to overhaul the former Blood Bank Act (RA 1517, 1956)

  • Passed through Senate Bill No. 1011 and House Bill No. 879 during the 9th Congress.

  • Signed into law: ext{April 28, 1994}

  • Approved by President Fidel V. Ramos: ext{May 15, 1994}

  • Published in the Official Gazette: ext{Aug 18, 1994}

  • Effectivity date: ext{Aug 23, 1994} (15 days after publication).

  • Implementing Rules & Regulations (IRR) released via DOH Administrative Order No. 9, Series of 1995 on ext{Apr 28, 1995} (10 chapters, 50 sections).

• Supreme-Court-upheld case: Rodolfo S. Beltran v. DOH Secretary – owners of commercial blood banks challenged the phase-out clause; the Court sustained DOH, reaffirming public-health primacy.

Events Preceding the Act (Risk Catalysts)

• 1979 – AIDS first described; global alarm on blood safety.

• 1982 – First transfusion-associated AIDS case (infant).

• 1984 – First Philippine HIV infection recorded.

• 1985 – ISBT guideline: mandatory AIDS testing for donor blood.

• 1989 – DOH AO 57-s-1989: updated blood-bank guidelines; required Hep B & HIV tests; mandated pathologist/hematologist supervision.

• 1992 – DOH AO 118-A-s-1992: created National Blood Services Program (NBSP) – focus on adequate, equitable, safe blood.

“Project to Evaluate the Safety of the Philippine Blood Banking System” (Jan 1994, New Tropical Medicine Foundation + USAID)

• Data on 1992 collections:

  • 64.4\% – commercial blood banks.

  • 14.5\% – Philippine National Red Cross (PNRC).

  • 13.7\% – government hospital-based banks.

  • 7.4\% – private hospital-based banks.

• Only 24 licensed commercial blood banks, yet each produced:

  • \approx 5\times more units than PNRC.

  • \approx 15\times more than government-run banks.

• Paid-donor prevalence:

  • 99.6\% of commercial-bank donors remunerated.

  • 77.0\% of private hospital-bank donors remunerated.

• Infection risk: blood bought from paid donors \approx 3\times more likely to carry malaria, syphilis, Hep B, or HIV.

Declaration of Policy (Section 2): State Commitments

• Promote voluntary donation; view donation as humanitarian.

• Blood transfusion = professional medical service, not commodity sale.

• Provide adequate, safe, affordable, equitable blood supply.

• Public education to curb hazards of commercial sale.

• Integrate voluntary-donation principles in formal & non-formal curricula.

• Mobilize multi-sector community participation.

• Mandate DOH to build a National Blood Transfusion Service Network.

• Financial assistance/reimbursement for non-profit blood services.

• Require all collection units & banks to be non-profit.

• Establish scientific standards & regulate all collection/storage activities.

• Upgrade banks to include preventive services & TTI-control education.

Key Legal Features & Phase-Out Mechanism

• Total sections: 15.

• Mandatory phase-out of all commercial blood banks within 2 years of effectivity (target: Aug 23, 1996).

• Explicit repeal of RA 1517.

Fundamental Definitions

• Blood – human blood for transfusion.

• Blood products / components – therapeutic derivatives (whole blood, packed RBC, granulocytes, plasma, platelets, cryoprecipitate, cryosupernate, etc.).

• Fresh Whole Blood (FWB) – collected within 24 h; becomes Whole Blood (WB) after 48 h.

• Packed Red Blood Cells (PRC) – plasma-reduced via gravity or centrifugation (+2^\circ\text{C} to +6^\circ\text{C}).

• Washed RBC – saline-washed to remove proteins/antibodies/electrolytes.

• Granulocyte concentrate – via apheresis.

• Leukocyte-depleted RBC – passed through 3rd-generation filter.

• Platelet concentrate (random donor) – prepared within 8 h; stored +20^\circ\text{C}–+24^\circ\text{C} with agitation.

• Cryoprecipitate – cold-insoluble fraction; prepared by thawing FFP 1^\circ–6^\circ\text{C} then refreezing within 1 h.

• Cryosupernate – plasma left after cryoprecipitate removal; contains most clotting factors.

• Fresh Frozen Plasma (FFP) – frozen within 6–8 h; stored \le -30^\circ\text{C}.

Blood Service Facilities (BSF)

Classification by Ownership

• Government-owned – national, LGU, or any public subdivision/agency.

• Private-owned – individual, corporation, association, organization.

Classification by Institutional Character

• Hospital-based – within hospital premises.

• Non-hospital-based – stand-alone; may be government or PNRC.

Classification by Service Capability

1. Blood Station (BS)

   • Voluntary-donation promotion; storage, issuance, transport of whole blood/PRC.

   • Compatibility testing (if hospital-based).

2. Blood Collection Unit (BCU)

   • Advocacy; donor recruitment/selection/counselling.

   • Mobile or in-house collection; transports blood to Blood Center for testing.

3. BS/BCU (Hybrid) – performs all BS and BCU functions.

4. Blood Bank (BB)

   • Advocacy plus storage/issuance of whole blood/components.

   • Performs compatibility testing, Direct Coombs, antibody screen, transfusion-reaction investigation, hemovigilance.

5. Blood Center (BC)

   • Full spectrum: donor management, collection, TTI testing, component processing, storage, distribution.

Transfusion-Transmissible Infection (TTI) Screening

• Mandatory tests in BCs only:

  • HIV 1/2 antibody,

  • Hepatitis B surface antigen (HBsAg),

  • Hepatitis C antibody (anti-HCV),

  • Malaria,

  • Syphilis.

• End-user hospitals must not retest; issuing BC bears responsibility for negativity certification.

• Under RA 11166 (2018), recipients may request a second HIV test.

Supervision, Management, Staffing Requirements

• Hospital-based BS: headed by Board-certified pathologist; if unavailable, the hospital’s clinical-laboratory physician after ≥3-month blood-bank training.

• Non-hospital BS: physician with ≥3 months formal basic-blood-bank training.

• Non-hospital BCU/BC/BS-BCU: physician with DOH-recognized formal training.

• BCs & Blood Banks: pathologist (Philippine Board of Pathology) or hematologist (Philippine Board of Hematology) with BSF experience.

Licensing Framework

• Authority to Operate (ATO) – permit for BCU or BS.

• License to Operate (LTO) – permit for Blood Banks or Blood Centers.

• Application filed with DOH – Health Facilities & Services Regulatory Bureau (HFSRB) or corresponding Center for Health Development (CHD).

• Inspection timeline:

  • CHD inspects within 30 days of application.

  • Post-inspection: approve & release ATO/LTO within 15 days or disapprove with written findings.

  • If unacted after 30 days → deemed approved (automatic approval clause).

• Validity:

  • Stand-alone BSF ATO/LTO – 3 years.

  • If integrated into a hospital license – 1 year.

• Non-transferable; new application needed for change of location.

• Emergencies: unlicensed hospitals may collect/transfuse under attending physician’s responsibility, subject to DOH conditions.

Inspection & Monitoring Powers

• HFSRB & CHD directors/representatives may conduct regular on-site visits; full access to records.

• Absence of ATO/LTO → immediate closure; agencies may enlist police/other authorities.

Violations, Administrative Sanctions, and Criminal Liabilities

Administrative penalties (reprimand, suspension, revocation) for:
a. Material falsehoods in application.
b. Misrepresentation/falsification of records.
c. Denial of record access to inspectors.
d. Charging fees above DOH-set maximum.
e. Collecting blood from paid/remunerated donors.
f. Refusal to participate in External Quality Assessment Scheme (EQAS).

• Appeals: aggrieved parties may elevate CHD decisions to DOH Secretary within 30 days; Secretary’s ruling is final & executory.

Criminal offenses (after notice & hearing):
a. Collecting charges above DOH ceiling → possible license suspension/revocation.
b. Operating a blood bank without LTO or failing DOH standards.
c. Heads/personnel dispensing or transfusing blood proven contaminated with TTI & not disposing within 48 h.

Basic Physiological Requirements for Blood Donors

• Weight: ≥ 110\;\text{lb} (≈ 50\;\text{kg}) → dictates collection volume.

• Pulse: 60–100\;\text{bpm}, regular.

• Blood Pressure: 90–160\;\text{mmHg} systolic / 60–100\;\text{mmHg} diastolic.

• Hemoglobin: ≥ 125\;\text{g/L} (≈ 12.5\;\text{g/dL}).

Ethical & Public-Health Significance

• Frames blood as altruistic resource, combating commodification.

• Strengthens constitutional right to health (Art. II Sec. 15, 1987 Constitution) → State obligation to make transfusion safe.

• Educational insertion cultivates long-term voluntary donor culture.

• Phasing out commercial banks reduces paid-donor model, thus lowering TTIs, ensuring equitable access, and harmonising with WHO advocacy for 100 % voluntary, non-remunerated donation.

Linkage to Broader Topics / Previous Lectures

• Bioethics: aligns with principles of beneficence (promoting welfare of recipients) and justice (fair distribution without financial coercion).

• Public-health law: similar regulatory rationales in Food & Drug, Pharmacy, HIV/AIDS statutes (RA 11166) – surveillance, licensing, and penalty structures.

• Case-law illustration: Beltran v. DOH underscores police-power supremacy over proprietary interests when public health is at stake.

Practical Implications for Medical Technologists & Health Facilities

• Strict adherence to non-profit operations and full documentation; expect unannounced inspections.

• Mandatory participation in EQAS to maintain licensure and quality.

• Ensure donor qualification per physiologic criteria; deviations expose facility to sanctions.

• End-user hospitals must trust BC screening—repeat testing barred (except patient-initiated HIV re-test under RA 11166).

Quick Timeline Recap

• 2\ \text{Apr 1994} – RA 7719 enacted by Congress.
• 28\ \text{Apr 1994} – Final legislative approval.
• 15\ \text{May 1994} – Presidential signing.
• 18\ \text{Aug 1994} – Publication.
• 23\ \text{Aug 1994} – Effectivity (start of 2-year commercial-bank phase-out countdown).
• 28\ \text{Apr 1995} – DOH issues IRR (AO 9-s-1995).

Mnemonic Aids / Exam Tips

• "VANS FACES" for Section 2 policy clauses:
  V – Voluntary donation
  A – Adequate & Affordable supply
  N – Network (National Blood Transfusion Service Network)
  S – Scientific standards / Safety regulation
  F – Formal education integration
  A – Assistance to non-profits
  C – Community mobilisation
  E – Equitable distribution
  S – Services are not sales (blood ≠ commodity)

• Recall 5 TTIs via “H^2 MS” (HIV, Hep B, Hep C, Malaria, Syphilis).

• Administrative vs criminal penalties: link “Paper lies & price gouge” (false statements, over-charging) to admin; “No license + dirty blood” to criminal.