Rules on Blood Collection Unit Authorization

Legal basis, policy, and intent

Republic Act No. 7719 is the National Blood Services Act of 1994, enacted to promote safe and efficient blood banking and transfusion practices through the creation of the National Voluntary Blood Services Program.
Administrative Order No. 9, s. 1995 implements Republic Act No. 7719, and Sections 36 and 37 direct authorization of Blood Collection Units and Blood Stations by Regional Health Directors under prescribed standards and procedures.
These rules strengthen and amend the authorization system by amending Sections 36 and 37 of Administrative Order No. 9, s. 1995.
The rules 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 required functions safely, efficiently, and effectively.

Core definitions and key entities

The term Act refers to R.A. 7719 (National Blood Services Act of 1994).
Authority to Operate means a formal permit issued by the DOH-Center for Health Development to an individual, partnership, corporation, or association that has complied with technical requirements under this issuance and 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 includes whole blood, red cells, granulocytes, plasma, platelets, cryoprecipitate, and cryosupernate.
Blood Derivative or Plasma Fraction covers partially purified plasma protein made under pharmaceutical manufacturing conditions, including coagulation factors, immunoglobulin, and albumin.
Blood Product means a therapeutic substance derived from whole blood or plasma.
Blood Transfusion Services covers activities related to blood transfusion, including (among others) donor motivation and recruitment, blood collection, testing and screening of donor blood, compatibility testing, component preparation, storage, distribution, administration, investigation of transfusion reactions, inventory control, and quality assurance.
BSF refers to Blood Service Facility.
CHD refers to the Center of Health Development, 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 means a donor who gives blood freely and voluntarily without receiving money or any form of payment.

Classification and permitted service capability

Blood Collection Units and Blood Stations are classified by ownership, institutional character, and service capability.
Under ownership:
- Government entities are operated and maintained partially or wholly by national, provincial, city, or municipal governments or other political units, or by any department/division/board/agency/instrumentality thereof.
- Private entities are privately owned hospital-based Blood Collection Unit/Blood Station with funds through donation, capital, or other means, by an individual, corporation, association, or organization.
Under institutional character:
- Hospital-based means located within the premises of a hospital.
- Non-hospital-based means located outside the hospital premises consistent with the NVBSP Strategic Plan.
Under service capability:
- A Blood Station is authorized by the CHD to provide whole blood and packed red cells, store/issue/transport/distribute whole blood and packed red cells, and conduct compatibility testing of red cell units if hospital based.
- A Blood Collection Unit is authorized by the CHD to recruit and retain voluntary blood donors, screen and select voluntary blood donors, conduct health education and counseling services, collect blood, transport blood to a Referral Blood Center for testing and processing, and conduct compatibility testing of red cell units if hospital based.

Authorization requirements and staffing standards

All Blood Collection Units and Blood Stations must comply with the technical requirements in the Annex to be authorized.
Blood must be collected only from healthy voluntary non-remunerated blood donors.
Blood Collection Units must have a documented system of recruitment, retention, screening, and selection of voluntary non-remunerated blood donors.
Staffing minimums apply as follows:
- For a Blood Collection Unit:
  - A hospital-based Blood Collection Unit head must be an authorized physician certified in Clinical Pathology by the Philippines Board of Pathology, or an authorized physician with formal training of at least three (3) months in blood banking recognized by the NVBSP, or in areas where pathologists are not available, an authorized physician authorized to head the clinical laboratory of that hospital; alternatively, an authorized physician with at least one (1) year experience in a Blood Bank/Center performing blood collection activities recognized by the NVBSP.
  - A non-hospital-based Blood Collection Unit head must be an authorized physician with at least one (1) year experience in a Blood Bank/Center recognized by the NVBSP, or an authorized physician with formal training of at least three (3) months in basic blood banking services recognized by the NVBSP; alternatively, in areas where pathologists are not available, an authorized physician authorized to head the clinical laboratory of that hospital.
- For a Blood Station:
  - A hospital-based Blood Station head must be an authorized physician certified in Clinical Pathology by the Philippine Board of Pathology, or an authorized physician with at least three (3) months training in basic blood banking services recognized by the NVBSP, or in areas where pathologists are not available, an authorized physician authorized to head the clinical laboratory of that hospital; alternatively, an authorized physician with at least one (1) year on-the-job experience in a Blood Bank/Center recognized by the NVBSP.
- Each Blood Collection Unit/Blood Station must have Medical Technologists working on shifts to cover a 24-hour service; they must be duly registered with the PRC, have a valid professional authority, and have at least one (1) year on-the-job training/experience in blood banking services.
- A Blood Collection Unit must employ one (1) qualified and trained Donor Recruitment Officer; the training must be recognized by the NVBSP.
- A Blood Collection Unit/Blood Station must designate and train at least one (1) medical technologist as a Quality Assurance Officer; the Quality Assurance Officer of the affiliated Blood Bank/Center in the Blood Services Network shall recognize such training.
Physical facilities must be housed in a well-lighted and well-ventilated area with adequate water, adequate space with accessible and clearly demarcated fire exits, a smooth flow of activities and movement, and a technical working area exclusively for Blood Collection Unit/Blood Station activities; the physical plant must be well maintained.
Equipment requirements apply based on Blood Station versus Blood Collection Unit and whether hospital-based or non-hospital-based, including requirements for controlled blood refrigeration at 2-6AC with temperature recorder and alarm system, temperature tools, blood collection and handling equipment, calibration and generator capacity (at least 10 KVA), and written maintenance and contingency programs when equipment becomes incapacitated or unavailable.
The Annex requires quality assurance/control through a QA Program including Internal Quality Control of Procedures and Products, with a designated Quality Assurance Officer, and monitoring by the affiliated Blood Bank/Center in the Blood Services Network.
Biosafety precautions must be observed at all times.
Recording, reporting, and documentation must follow the NVBSP standard formats and procedures, and Blood Collection Units must:
- Submit a schedule of bleeding and target area of donor recruitment that clearly follows geographical area agreements with other Blood Collection Units within the catchment area of the relevant Blood Bank/Center.
- Express agreement to submit the blood collected and the list of donors to its attached Blood Bank/Center at the end of the collection day.

Applying, paying, surveying, and approving

An applicant must request relevant information and the prescribed form from the CHD having jurisdiction over the proposed Blood Collection Unit/Blood Station, in person, on the internet, or through mail.
An applicant must accomplish the required documents and submit them to the CHD.
For initial Authority to Operate, applicants must submit:
- 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 and notarized Application Form for Authority to Operate.
- DTI/SEC registration (for private Blood Collection Unit/Blood Station).
- Photocopies of Professional Regulation Commission Certificates of personnel.
- A location map.
- A floor diagram of the Blood Collection Unit/Blood Station and its premises.
- A list of equipment including serial number, brand, date of purchase, number of units, and operational status.
- A list of glasswares and supplies.
- Composition of the Hospital Blood Transfusion Committee (for hospital-based only).
For renewal Authority to Operate, applicants must submit:
- A duly accomplished application form for renewal of Authority to Operate.
- A list of personnel.
- A change in location/address if applicable.
- A list of equipment.
- An Annual accomplishment report (previous year) using NVBSP standardized monitoring forms.
- A recommendation from the lead BSF of the Zonal/Regional Blood Services Network.
The CHD reviews submitted documents for completeness, authenticity, and compliance with authorization requirements.
The CHD prepares the order of payment.
The applicant pays the corresponding fees to the Cashier of the CHD in person or through postal money order.
Authorization fees must follow the current prescribed DOH schedule of fees.
The CHD, together with the lead BSF of the Zonal/Regional Blood Services Network, surveys the facility to determine compliance with standards and technical requirements.
The CHD prepares an official summary of findings and recommends approval or disapproval after the survey.
The Director of the CHD approves or disapproves issuance of Authority to Operate.
If approved, the CHD registers the facility and issues the Authority to Operate to the applicant.
If disapproved, the CHD sends findings and recommendations to the applicant.
The applicant must correct deficiencies within fifteen (15) days from the time of survey; failure to comply within fifteen (15) days is a ground for denial of the initial application and for suspension/revocation of Authority to Operate.
The BHFS, with the lead BSF of the Zonal/Regional Blood Services Network, conducts on-site monitoring visits to document overall quality.

Authority to operate conditions and renewal

Authority to operate is granted only upon compliance with the requirements of this Administrative Order.
Any deficiencies incurred during the validity of the authority must be immediately corrected, otherwise the authority is considered null and void.
Authority to operate and any right under the authority 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 fifteen (15) days of any substantial change in the condition of the authority is a basis for suspension or revocation.
A separate authority to operate is required for each Blood Collection Unit/Blood Station or branch maintained in separate premises, even if operated by the same management.
Each Blood Bank must closely supervise the affiliated Blood Collection Unit/Blood Station within the Blood Service Network and guarantee compliance with prescribed documentary and technical requirements.
The head of the Blood Bank or designated staff must conduct on-site visits of each satellite Blood Collection Unit/Blood Station at least four (4) times a year or whenever necessary, such as when a problem arises.
The authority to operate and prescribed maximum allowable fees must be placed in an area readily seen by the public.
Copies of these rules and regulations and other relevant DOH issuances must be readily available for guidance of all personnel.
Authority to operate is renewed every year.
Renewal application must be filed ninety (90) days before the expiry date of the CHD under whose jurisdiction the facility is located.
Renewal may be granted only if the facility complies with the authorization requirements.

Validity, maximum service fees, and fee calculation

Authority to operate is valid for one (1) year.
Blood Collection Units and Blood Stations must be operated and maintained on a non-profit basis.
They may collect a reasonable service fee for every blood/blood product issued, provided the fee is not greater than the maximum fees prescribed by the DOH.
The maximum allowable service fees must be adjusted from time to time, specifying basic requirements and special tests covered by the service fees.
The BHFS through the NVBSP determines the basic donor screening and blood testing procedures by analyzing research information such as disease prevalence studies and risk estimates, consulting technical experts, and evaluating optimum benefits versus expected cost of tests.
The maximum allowable service fee must be calculated by the NVBSP using a study of direct and indirect costs of running a standard Blood Collection Unit/Blood Station with basic minimum staffing, facilities, and maximum workload.
Direct costs must include expenses for collecting and processing blood from donor recruitment, blood collection and screening, storage and distribution, with allowance for spoilage, and professional services; direct costs must exclude cost of cross-matching and other special screening and complete compatibility testing.
Indirect costs must include reasonable expenses to maintain and upgrade services, including salary of staff and repair of equipment.
Direct and indirect costs must be estimated for every unit of blood collected, processed, and distributed.

Violations, investigation, suspension, and appeal

Violations include:
- Any material false statement in the application.
- Misrepresentation of facts or falsification of documents or records.
- Change of location, management, name, or ownership without informing the CHD in writing.
- Refusal to allow survey by the Regional Blood Center Assessment Team at an appropriate time.
- Refusal to make books, accounts, and operation records available to an authorized person from the BHFS/CHD.
- Charging blood service fees above the maximum fees set by DOH.
- Collection of blood that is paid or remunerated whether payment comes from the hospital or from the patient/relatives.
- Dispensing or transfusing unscreened, incompletely tested, and/or contaminated blood.
- Failure to dispose contaminated blood within an appropriate time.
- Any act contrary to accepted blood banking practices.
Charges or complaints must be duly sworn and filed by any individual, corporation, association, or organization against a Blood Collection Unit/Blood Station or its personnel for violation of R.A. 7719 or these rules and regulations.
Upon filing, the DOH-Legal Division/BHFS for Blood Collection/Blood Station respectively shall investigate and verify whether the facility or personnel is guilty of the charges.
After investigation and hearing, if the facility or personnel is found violating R.A. 7719 or these rules and regulations, the Director of the CHD shall suspend the Authority to Operate for a definite or indefinite period of time and shall revoke the Authority to Operate, without prejudice to taking the case to judicial authorities for criminal action.
Appeals must be filed within thirty (30) days from receipt of notice of the decision.
An aggrieved Blood Collection Unit/Blood Station or personnel files a notice of appeal with the Office of the Secretary and serves a copy on the DOH Legal Division/BHFS/CHD.
The DOH Legal Division/BHFS/CHD must certify and file with the Office of the Secretary a copy of the decision, including the transcript of hearings, for review.
The decision of the Office of the Secretary is final and executory.

Administrative liabilities and closure for no authority

The Director of the DOH-Legal Division/BHFS/CHD may impose:
- PHP 3,000 penalty for any Blood Collection Unit/Blood Station operating without securing an authorization from the CHD.
- A recommendation to the Professional Regulation Commission to revoke the certificate of registration or to invalidate the authority of any health professional found violating R.A. 7719 or these rules and regulations.
- Suspension or revocation of authority to operate upon violation of the National Blood Service Act or its rules and regulations.
The CHD must immediately close all Blood Collection Unit/Blood Stations without an authority to operate.
The CHD may seek assistance from any government agency to enforce the closure.

Publication, separability, and supersession

The CHD must publish a list of authorized Blood Collection Unit/Blood Stations periodically in a local newspaper (not necessarily nationwide circulation).
A separability clause provides that if any section, paragraph, sentence, clause, or word is declared invalid, the remainder remains effective.
A repealing/supersession clause provides that these rules and regulations repeal and supersede all inconsistent administrative orders and other issuances.