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(NAR) VOL. 15 NOS. 1-2 / JANUARY - MARCH 2004
I. BACKGROUND/RATIONALE
Republic Act 7719 otherwise known as the "National Blood Services Act of 1994" was enacted to promote safe and efficient blood banking and transfusion practices in the Philippines through the creation of the National Voluntary Blood Services Program. To carry out the provisions of Republic Act 7719, Administrative Order No. 9, s. 1995 "Rules and Regulations Implementing Republic Act 7719" was formulated. Under Sections 36 and 37, the Regional Health Directors shall authorize Blood Collection Units and Blood Stations according to the prescribed standards and procedures.
To strengthen the systems and procedures in the regulation of Blood Collection Units and Blood Stations, Sections 36 and 37 of Administrative Order No. 9, s. 1995 is hereby amended.
II. OBJECTIVE
These rules and regulations are promulgated 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 the required functions safely, efficiently and effectively.
These rules and regulations shall apply to all government and private Blood Collection Units and Blood Stations.
IV. DEFINITION OF TERMS
Act - R.A. 7719 also known as the National Blood Services Act of 1994, unless herein specified.
Authority to Operate - a formal permit issued by the DOH-Center for Health Development to an individual partnership, corporation or association which has complied with all the technical requirements as prescribed in this issuance and in the Manual of Standards for Blood Collection Units/Blood Stations in the Philippines.
BHFS - refers to the Bureau of Health Facilities and Services
Blood - refers to human blood for transfusion.
Blood Component - refers to whole blood, red cells, granulocytes, plasma, platelets, cryoprecipitate and cryosupernate.
Blood Derivative or Plasma Fraction - partially purified plasma protein made under pharmaceutical manufacturing conditions, including coagulation factors, immunoglobulin and albumin.
Blood Product - a therapeutic substance derived from whole blood of plasma.
Blood Transfusion Services - set of activities related to blood transfusion such as but not limited to, motivation and recruitment of donors, blood collection, testing and screening of donor blood, compatibility testing, preparation of blood components, storage, distribution, administration of blood components, investigation of blood transfusion reactions, inventory control, and quality assurance.
BSF - refers to Blood Service Facility
CHD - refers to the Center of Health Development, which is the DOH Regional Field Office.
DOH - refers to the Department of Health.
NVBSP - refers to the National Voluntary Blood Services Program.
PNRC - refers to the Philippine National Red Cross.
Secretary - refers to the Secretary of Health.
Voluntary Non-remunerated Blood Donor - a donor who gives blood freely and voluntarily without receiving money or any form of payment.
V. CLASSIFICATION OF BLOOD COLLECTION UNITS AND BLOOD STATIONS
Blood Collection Units and Blood Stations shall be classified as follows:
1. Ownership:
1.1 Government - operated and maintained partially or wholly by a national, provincial, city or municipal government or other political unit or by any department, division, board, agency or instrumentality thereof;
1.2 Private - privately owned, established and operated hospital based Blood Collection Unit/Blood Station with funds through donation, capital or other means, by an individual, corporation, association or organization.
2. Institutional Character:
2.1 Hospital-based - located within the premises of a hospital.
2.2 Non-hospital-based - located outside the premises of a hospital consistent with the NVBSP Strategic Plan.
3. Service Capability:
3.1 Blood Station - a BSF authorized by the CHD to perform the following:
- Provision of whole blood and packed red cells.
- Storage, issuance, transport and distribution of whole blood and packed red cells.
- Compatibility testing of red cell units, if hospital based.
3.2 Blood Collection Unit - a BSF authorized by the CHD to perfrom the following:
- Recruitment and retention of voluntary blood donors.
- Screening and selection of voluntary blood donors.
- Conduct of health education and counseling services.
- Collection of blood.
- Transport of blood to Referral Blood Center for testing and processing.
- Compatibility testing of red cell units, if hospital based.
VI. TECHNICAL REQUIREMENTS
All Blood Collection Units and Blood Stations are required to comply with the requirements for authorization that are stated in the Annex.
VII. PROCEDURAL GUIDELINES
A. Application for Initial/Renewal of Authority to Operate
A.1 Applicant requests for relevant information and prescribed form from the CHD under whose jurisdiction the proposed Blood Collection Unit/Blood Station is located, in person, on internet or through mail.
A.2 Applicant accomplishes the required documents and submits them to the CHD.
A.2.1 Initial Authority to Operate
A.2.1.1 Certificate of inclusion in the Regional Blood Services Network approved by the Regional Director upon the recommendation of the designated lead BSF of the Zonal/Regional Blood Services Network.
A.2.1.2 Duly accomplished and notarized Application Form for Authority to Operate.
A.2.1.3 DTI/SEC registration (for private Blood Collection Unit/Blood Station)
A.2.1.4 Photocopies of Professional Regulation Commission Certificates of personnel
A.2.1.5 Location map of Blood Collection Unit/Blood Station
A.2.1.6 Floor diagram of the Blood Collection Unit/Blood Station and its premises
A.2.1.7 List of equipment to include serial number, brand, date of purchase, number of units and operational status.
A.2.1.8 List of glasswares and supplies.
A.2.1.9 Composition of Hospital Blood Transfusion Committee (for hospital based only)
A.2.2 Renewal of Authority to Operate
A.2.2.1 Duly accomplished application Form for Renewal of Authority to Operate
A.2.2.2 List of personnel
A.2.2.3 Change in location, address, if applicable
A.2.2.4 List of equipment
A.2.2.5 Annual accomplishment report (previous year) utilizing the NVBSP standardized monitoring forms.
A.2.2.6 Recommendation from the lead BSF of the Zonal/Regional Blood Services Network.
A.3 The CHD reviews the documents for completeness, authenticity and compliance with authorization requirements.
B. Payments of Fees
B.1 The CHD prepares the order of payment.
B.2 The applicant pays the corresponding fees to the Cashier of the CHD in person or through postal money order.
B.3 The authorization fees shall follow the current prescribed DOH schedule of fees.
C.1 The CHD together with the lead BSF of the Zonal/Regional Blood Services Network surveys the Blood Collection Unit/Blood Station to determine compliance with standards and technical requirements.
C.2 The CHD prepares official summary of findings and recommends approval or disapproval after survey.
C.3 The Director of the CHD approves or disapproves the issuance of authority to operate.
C.3.1 If approved, the CHD registers the Blood Collection Unit/Blood Station and issues an authority to operate to the applicant.
C.3.2 If disapproved, the CHD sends the findings and recommendations to the applicant. The applicant makes necessary corrections in the Blood Collection Unit/Blood Station within fifteen (15) days from the time of survey. Failure to comply within fifteen (15) days shall be a ground for denial of application for initial and suspension/revocation of authority to operate.
D. Monitoring
The BHFS with the lead BSF of the Zonal/Regional Blood Services Network shall conduct on site monitoring visits of Blood Collection Unit and Blood Station. The monitoring visits shall document the overall quality of Blood Collection Unit and Blood Station.
The authority to operate shall be valid for a period of one (1) year.
X. MAXIMUM ALLOWABLE SERVICE FEES
Violation of the National Blood Services Act or the rules and regulations issued in pursuance thereto, including the commission of the following acts by individual, corporation, association, or organization operating the Blood Collection Unit/Blood Station, or persons under their authority:
XII. INVESTIGATION AND HEARING OF CHARGES OR COMPLAINTS
Upon filing of charges or complaints duly sworn to by any individual, corporation, association, or organization against any Blood Collection Unit/Blood Station or any of its personnel who has violated or is violating the provisions of R.A. 7719 or any of these rules and regulations, the DOH-Legal Division/BHFS for Blood Collection/Blood Station respectively shall investigate and verify if the facility concerned or any of its personnel is guilty of the charges or complaints. If upon investigation and hearing, the Blood Collection Unit/Blood Station concerned or any of its personnel is found violating the provisions of R.A. 7719 or any of these rules and regulations, the Director of the CHD shall suspend the authority to operate for a definite or indefinite period of time, revoke the authority to operate without prejudice to taking the case to judicial authorities for criminal action.
XIII. APPEAL
Any Blood Collection Unit/Blood Station or any of its personnel aggrieved by the decision of the DOH-Legal Division/BHFS/CHD may within thirty (30) days after receipt of notice of the decision, file a notice of appeal with the Office of the Secretary, and serve a copy of the notice of appeal to the DOH Legal Division/BHFS/CHD. Thereupon, the DOH Legal Division/BHFS/CHD shall promptly certify and file a copy of the decision, including the transcript of the hearings on which the decision is based, with the Office of the Secretary for review. The decision of the Office of the Secretary shall be final and executory.
XIV. ADMINISTRATIVE LIABILITIES
The Director of the DOH-Legal Division/BHFS/CHD may impose the following administrative liabilities:
XV. OPERATING WITHOUT AN AUTHORITY TO OPERATE
The CHD shall immediately close all Blood Collection Unit/Blood Station without an authority to operate and may seek assistance of any government agency to effectively enforce the closure.
XVI. PUBLICATION
A list of authorized Blood Collection Unit/Blood Station shall be published by the CHD periodically at the local newspaper (not necessarily a publication of nationwide circulation) by the respective CHDs.
XVII. SEPARABILITY CLAUSE
In the event that any section, paragraph, sentences, clause or word of this order is declared invalid for whatever, any reason, other provisions thereof shall not be affected thereby.
XVIII. REPEALING CLAUSE
These rules and regulations shall repeal and supersede all administrative orders and other issuances inconsistent thereof.
XIX. EFFECTIVITY
These rules and regulations shall take effect upon approval and publication in a newspaper of general circulation.
Adopted: 14 Oct. 2003
(SGD.) MANUEL M. DAYRIT, M.D., M.Sc.
Secretary
TECHNICAL REQUIREMENTS FOR AUTHORITY TO OPERATE
I. PROMOTION OF VOLUNTARY BLOOD DONATION
