August 8, 1994

DOH ADMINISTRATIVE ORDER NO. 1994-0036

 

Pursuant to Section 11 of Republic Act No. 7719, otherwise known as the National Blood Services Act of 1994, passed by the Senate and the House of Representatives on 28 April 1994 which took effect on 12 May 1994, the following Rules and Regulations are hereby adopted. cIaCTS

CHAPTER I

Title and Application

SECTION 1. Title. —

These rules shall be known as the "Rules and Regulations Implementing Republic Act No. 7719 otherwise known as the NATIONAL BLOOD SERVICES ACT OF 1994.

SECTION 2. Purpose. —

These Rules and Regulations are adopted prescribing the principles, guidelines, procedures and standards for the implementation of RA 7719 to facilitate compliance therewith and achieve the objectives thereof.

SECTION 3. Scope. —

These Rules shall apply to all hospitals, entities, establishments or institutions, government-owned and operated or private, engaged in blood transfusion services in the Philippines, whether full time or part time, local or foreign.

SECTION 4. Definition of Terms. —

As used in these Rules and Regulations, the terms below shall be defined as follows:

1. Act — Republic Act 7719 otherwise known as the "National Blood Services Act of 1994", unless herein specified;

2. Department — the Department of Health;

3. Secretary of Health — the Secretary of Health or any other person to whom the Secretary delegates the responsibility of carrying out the provisions of this Act; ITcCaS

4. Blood/Blood Product — refers to human blood, processed or unprocessed and includes blood components, its products and derivatives;

5. Blood Transfusion Services — a set of activities and functions related to blood transfusion such as, but not limited, to motivation and recruitment of donors, blood collection, testing and screening of donor blood, preparation of blood components, storage and distribution of blood and components, inventory control and quality assurance;

6. Blood Bank/Center — a laboratory or institution with the capability to recruit and screen blood donors, collect, process, store, transport and issue blood for transfusion and provide information and/or education on blood transmissible diseases;

7. National Blood Center — refers to the central institution of the National Voluntary Blood Services Program and serves as a base for development of a network of regional blood centers, also sets as the regional blood center for the region in which it is situated;

8. Regional Blood Center — refers to the laboratory or an institution with the responsibility of ensuring a safe, stable and cost-effective supply of blood and blood products to fulfill the needs of patients in the region; it serves as a base for the development of a network of blood banks in the region;

9. Hospital-Based Blood Bank — a blood bank which is located and performing blood bank services within the premises of a hospital and which can perform compatibility testing of blood;

10. Non-Hospital-Based Blood Bank — a blood bank which is not located and not performing blood bank services within the premises of a hospital and is not part of a hospital;

11. Commercial Blood Bank — a blood bank that exists for profit, money or any material gain earned out of sale of, or exchange for blood or blood products which profit, money or any material gain are not used solely for the operation and maintenance of the blood bank service; SAHaTc

12. Blood Collection Unit — an institution or facility duly authorized by the Department of Health to recruit and screen donors and collect blood for the blood bank to which it is attached;

13. Blood Station — a government or private hospital or a Philippine National Red Cross chapter which has not been licensed as a blood center but has been authorized by the Department to store and issue blood and blood products, and perform compatibility testing, when necessary, according to specific regulations in Section 40 hereby;

14. Blood Service Facility — any unit, office, institution providing any of the blood transfusion services, which can be a Blood Bank/Center, a Blood Collection Unit or a Blood Station;

15. Voluntary Blood Donor — an individual who donates blood on one's own volition or initiative and not induced, directly or indirectly in any manner whatsoever, by any monetary compensation;

16. Walking Blood Donor — an individual who has been screened by history and physical examination found to be fit to donate blood, and included in the list of qualified voluntary donors referred to in Section 4, paragraph (e) of RA No. 7719, who is ready to donate blood when needed in his or her community;

17. Blood Transfusion Transmissible Diseases — diseases which may be transmitted through blood transfusion, including but not limited to Acquired Immune Deficiency Syndrome (AIDS), hepatitis B, hepatitis C, malaria and syphilis. IcDESA

CHAPTER II

National Voluntary Blood Services Program

SECTION 5. National Program Committee. —

1. Composition. A National Voluntary Blood Services Committee is hereby created and shall be chaired by the Secretary of Health. It shall be composed of the Heads of the following Offices and associations:

— Department of Education, Culture and Sports

— Department of Interior and Local Government

— Department of Finance

— Department of Social Welfare and Development

— Professional Regulation Commission

— Philippine National Red Cross

— Philippine Blood Coordinating Council

— Philippine Society of Hematology and Blood Transfusion

— Philippine Society of Pathologists

— Philippine Medical Association

— Philippine Hospital Association

— Philippine Nursing Association

— Philippine Association of Medical Technologists; and,

The Secretary of Health may designate such other members from other societies and cooperating or donor agencies as may be deemed necessary to the operations of the Committee. cDAITS

2. The National Voluntary Blood Services Program Committee shall be responsible for the following:

A. Formulation of a five-year Directional/Strategic Plan of the National Voluntary Blood Services Program;

B. Operationalization and institutionalization of the National Voluntary Blood Service Program including budgetary allocation for program activities;

C. Monitoring and evaluation of the National Voluntary Blood Services Program activities;

D. Creation of multi-sectoral technical sub-committees such as, but not limited to,

— Advocacy and Promotion

— Programming

— Monitoring and Evaluation

— Curriculum Development

— Professional Education

E. Generation of multi-sectoral and inter-disciplinary support for national activities focused on blood services including the organization of the National Blood Congress.

3. Meetings. The National Voluntary Blood Services Program Committee shall meet at least quarterly. Unscheduled or emergency meetings shall be called upon the discretion of the chairperson.

SECTION 6. Field Representative of the National Committee. —

The Regional Health Director shall be the field representative of the National Voluntary Blood Services Program Committee and as such shall:

1. Chair the Regional Blood Services Network and coordinate the National Blood Services Program activities in the region; EcHTDI

2. Review and recommend for funding the annual consolidated Regional Blood Services Operational Plan.

SECTION 7. National Voluntary Blood Services Unit. —

1. The Secretary of Health shall institutionalize a National Voluntary Blood Services Unit within the organizational structure of the Office for Hospital Facilities, Standards and Regulation of the Department.

2. The unit, as the program management arm of the Department, shall be responsible for the following:

A. Integration and coordination of all voluntary blood service program efforts such as, but not limited to, integration of blood service facilities operation and upgrading;

B. Development of training, information, education and communication (IEC) materials, program guidelines and standards especially on preventive services, and pre- and post-donation counselling for blood transfusion transmissible diseases in coordination with other health programs and units in the Department;

C. Provision of technical assistance and training in designing and implementing a voluntary blood donation program in private hospitals;

D. Preparation of the blood services operational plan incorporating the activities and needs of the other Department units and services involved in the blood services program such as, but not limited to, the Bureau of Licensure and Regulation, and Hospital Operation and Management Service; LexLib

E. Provision of secretariat services to the National Voluntary Blood Service Program Committees and as such shall:

(1) Collate and review all annual operational plans, proposed budgets of the different technical sub-committees at the national and sub-national levels.

(2) Propose priorities for budgetary allocation.

(3) Prepare the consolidated annual National Voluntary Blood Services Program Plan which shall be submitted during the first quarter meeting of the National Program Committee for approval.

(4) Coordinate and document all National Voluntary Blood Services Program Committee and Sub-Committee meetings and activities.

SECTION 8. Program Funding. —

1. The funds for the National Voluntary Blood Services Program shall be provided by:

A. The budgetary allocation of the Department;

B. The Philippine Charity Sweepstakes Office with the initial amount of at least twenty-five million pesos (P25,000,000.00).

C. The Philippine Amusement and Gaming Corporation with the initial amount of at least twenty-five million pesos (25,000,000.00).

D. The trust liability account of the Duty Free Shop with the initial amount of at least twenty million pesos (P20,000,000.00).

E. The contributions of such other agencies as civic and charitable organizations. HEITAD

2. The National Voluntary Blood Services Program Committee shall work out a plan with the Philippine Charity Sweepstakes Office, Philippine Amusement and Gaming Corporation and Duty Free Shop and similar civic and charitable organizations for continued funding and material support.

3. The utilization of the fund shall be based on the consolidated and approved National Voluntary Blood Services Program Committee Plan.

4. The Department shall allocate an annual budget for personnel, capital outlay, infrastructure, maintenance, operating and other expenses to be used by the program.

5. A trust fund shall be established for the National Voluntary Blood Services Program at the national level and at the level of the different blood service facilities of the Department out of the donations generated by the office and/or facility. Use of` funds shall be based on the operational plan of the different technical sub-committees and blood service facilities concerned.

CHAPTER III

Promotion of Voluntary Blood Donation and Rational Use of Blood

SECTION 9. Public Information and Education. —

1. Composition. The National Advocacy and Promotion Sub-Committee shall be composed of representatives of the:

— Department of Health

— Department of Education, Culture and Sports

— Department of Social Welfare and Development

— Philippine National Red Cross

— Philippine Blood Coordinating Council CaDSHE

— Philippine Information Agency

— Kapisanan ng mga Brodkaster sa Pilipinas

— National Press Club

The National Voluntary Blood Services Committee may designate such other members from similar organizations whose activities are related to advocacy and promotion of voluntary blood donation as may be deemed necessary to the functions of the Sub-Committee.

2. Functions. The National Advocacy and Promotion Sub-Committee shall be responsible for the following:

A. Preparation of a five-year advocacy and promotion plan based on the National Voluntary Blood Services Program five-year directional/strategic plan which shall be submitted to the Secretary of Health for approval;

B. Formulation of designs for non-monetary or non-profit oriented incentives for voluntary blood donors such as, but not limited to, Blood Assurance Plans;

C. Planning, implementation, monitoring and evaluation of the national advocacy and promotion activities.

3. Regional Counterpart. The Regional Advocacy and Promotion Sub-Committee shall be created in each region of the country with similar corresponding composition as that of the National Advocacy and Promotion Sub-Committee but may be expanded to include other organizations. In turn, the Regional Advocacy and Promotion Sub-Committee shall encourage the creation of similar committees at the provincial and city levels. cEISAD

The Regional Advocacy and Promotion Sub-Committee shall be chaired by the representative of the Department of Health and shall have the following responsibilities:

A. Formulation of the regional advocacy and promotion operational plan which shall be submitted to the Regional Health Director for approval and endorsement to the National Voluntary Blood Services Program Committee;

B. Implementation, monitoring and evaluation of the regional advocacy and promotion activities.

SECTION 10. Promotion in Schools and Communities. —

1. Composition. The National Voluntary Blood Services Program Sub-Committee on Curriculum Development shall be chaired by the Secretary of Education and composed of representatives from the:

— Department of Health

— Philippine Society of Hematology and Blood Transfusion

— Philippine Society of Pathologists

— Philippine Society of Medical Technologists

— Philippine Association of Schools of Medical Technology and Public Health

— Philippine Nursing Association

— Association of Philippine Medical Colleges

— Philippine Medical Association

— Philippine National Red Cross AaHTIE

The National Voluntary Blood Services Committee may designate such other members from similar organizations whose activities are related to curriculum development of voluntary blood donation as may be deemed necessary to the operations of the Sub-Committee.

2. Functions

A. Preparation of the syllabus, course content and training module on the subject of voluntary blood donation which shall be incorporated in the health subjects of all schools, public or private, and in all levels of education, formal or informal.

B. Operationalization of the policy "to promote and encourage voluntary blood donation by the citizenry and to instill public consciousness of the principle that blood donation is a humanitarian act" in all school curricula.

C. Continuous and sustained upgrading of the curriculum training module.

D. Provision of training programs and technical assistance to enable communities, schools, industrial and business sites, barangays and military camps and local government units to implement their own voluntary blood donation programs.

E. Orientation and/or training of teaches on the utilization of such materials and methods.

F. Monitoring of the use and effectiveness of such materials and methods in terms of process and product and continuing revision of such as necessary.

G. Preparation and submission to the National Voluntary Blood Services Unit of the annual budgetary requirements for the promotion of voluntary blood services in the schools. SaHTCE

3. Training Programs and Technical Assistance. The Department shall likewise provide training programs and technical assistance to enable communities, schools, industrial and business sites, barangays, military camps and local government units to implement their own voluntary blood donation programs.

SECTION 11. Professional Education and Rational Use of Blood and Blood Products. —

1. Composition. The National Voluntary Blood Services Program Sub-Committee on Professional Education shall be composed of representatives of the:

— Department of Health

— Professional Regulation Commission

— Philippine Medical Association

— Philippine Hospital Association

— Philippine Society of Hematology and Blood Transfusion

— Philippine Society of Pathologists

— Philippine Blood Coordinating Council

— Philippine Nursing Association

— Philippine Association of Medical Technologists

The National Voluntary Blood Services Committee may designate such other members from similar organizations whose activities are related to professional education and rational use of blood and blood products as may be deemed necessary to the operations of the Sub-Committee. cCAIaD

2. Functions.

A. Encouragement of all medical and other health professional associations and societies to conduct trainings and seminars on the rational use of blood and blood products including the benefits of voluntary blood donation for their respective members as part of the continuing professional education.

B. Making compulsory the conduct of continuing professional education on the rational use of blood and merits of voluntary blood donation for the hospital medical and paramedical staff.

C. Inclusion of the rational use of blood and the merits of the voluntary blood donation in the residency training programs of the different medical subspecialities.

3. Hospital Blood Transfusion Committee. To assist the National Voluntary Services Program Sub-Committee in ensuring the rational use of blood and blood products and the promotion of the merits of voluntary blood donation, the Department shall require the establishment of a Hospital Blood Transfusion Committee as a prerequisite for licensure of teaching/training hospitals.

The Hospital Blood Transfusion Committee shall be composed of, but not limited to, physicians from the Department of Pediatrics, Medicine, Surgery, Obstetrics, and Pathology, the Hematology consultant, representatives from the nursing service, the Hospital Medical Training Officer and the Blood Service Quality Assurance Officer.

The Hospital Blood Transfusion Committee shall be primarily responsible for the establishment of hospital policies and guidelines for blood transfusion therapy and monitoring and audit of the use of blood and blood products within the facility according to the Standard Operating Manual on Blood Services of the BRL (Section 39). ACcISa

CHAPTER IV

Establishment of Blood Services Network and Donor Recruitment

SECTION 12. Establishment of Blood Services Network. —

There shall be established, in coordination with the Regional hospitals and medical centers, representatives of the private hospitals, local PNRC, officials of the local government units, various civic, religious and other organizations, a Regional Blood Services Network which shall be chaired by the Regional Health Director. The Regional Blood Services Network shall be the venue for:

1. Review of the existing blood services network and blood requirements in the area.

2. Formulation of a design of an effective blood donor recruitment campaign sustained blood collection and equitable distribution scheme to include the concept of a clearing house for the region and sharing of blood bank facilities.

3. Designation and authorization of different blood banks and collection units according to geographic location, to complementary tasks and other related undertaking.

4. Review of the annual consolidated Regional Blood Services Operational Plan which will be recommended for funding to the National Program Committee.

5. Formulation of uniform guidelines in the implementation of the networking scheme, including recommendation to the Bureau of Research and Laboratories as to the maximum rates to be charged for the cost of providing blood. aIAHcE

SECTION 13. Donor Recruitment. —

The Department shall adopt a system of procedures or programs to promote donor recruitment and ensure the increase in the number and retention of voluntary blood donors as follows:

1. The Department shall coordinate with heads of agencies, institutions, offices, organizations, business establishments and communities, be they government or non-government, and encourage them to actively participate in donor recruitment in order to secure commitments to regular blood donations in their particularly designated blood services facility;

2. The Department in collaboration with the Philippine National Red Cross shall be the lead agency in the celebration of the Blood Donor's Week, which shall be held annually from July 11 to 17. During the Blood Donor's Week, the Department, in coordination with other agencies, shall adopt a program or system of awards, rites, ceremonies or activities in special recognition of the voluntary blood donors;

3. The Department shall coordinate the professionalization of voluntary blood donors, health educators and donor recruiters through organized training activities;

4. The Department shall encourage and convince local government units to pass ordinances or resolutions that will promote the walking blood donor concept such as, but not limited to, the mandatory keeping of a list of qualified voluntary blood donors in the government hospitals, rural health units, health centers and barangays, and the conduct of mass blood typing activities in areas where there are no adequate blood service facilities.

CHAPTER V

Upgrading of Services and Facilities

SECTION 14. Monitoring and Evaluation Sub-Committee. —

Composition. The Monitoring and Evaluation Sub-Committee shall be composed of, but not limited to, representatives of the Hospital Operation and Management Service, the Bureau of Licensure and Regulation and Bureau of Research and Laboratories or other members as designated by the Secretary of Health. EICSDT

Function. It shall be tasked to:

1. Design a development plan for upgrading the different blood banks and collection units, including the provision for cold chain facilities in support of the Blood Services Network;

2. Establish criteria of indicators to monitor the progress or success in meeting the targets of the program as envisioned in the strategic plan;

3. Monitor and evaluate all activities of the Program and recommend ways by which targets could be met;

4. Coordinate all studies, reports and reviews related to the upgrading of blood service facilities;

5. Study the feasibility of establishing a Plasma Fractionation Plant at some opportune time and recommend to the NVBSP Committee of such plan in order to meet the national requirements for special plasma derivatives;

6. The National Monitoring and Evaluation Sub-Committee shall be responsible for the reviewing and recommending changes on the non-monetary incentives for voluntary blood donors.

SECTION 15. DOH Regional Hospitals and Medical Centers. —

All DOH regional hospitals and medical centers shall be upgraded in accordance with the development plan designed by the Monitoring and Evaluation Sub-Committee as provided for in the previous section.

SECTION 16. Provincial and District Hospitals. —

The Department shall assist in the upgrading of provincial and district hospitals to meet the blood transfusion services requirements in the area by providing technical assistance, training, mobilizing resources and other similar forms of assistance. acCTSE

SECTION 17. Blood Centers. —

Strategically located blood centers shall be established in support of the networking scheme. They shall be identified as follows:

1. A National Blood Center shall be established under the Office of the Secretary of Health to serve as a base for the development of a network of regional blood centers to meet the national requirements for blood and blood products. It should be accommodated in a separate building, preferably near a large general or teaching hospital. In addition to the usually blood bank activities, the National Blood Center will have the following special responsibilities:

A. Planning and organizing the different blood centers of the National Voluntary Blood Services Program;

B. Evolving standard procedures and quality control tests for the regional blood centers and all categories of blood banks, including the blood collection units;

C. Training the directors/heads, the medical technologists, and the blood donor recruiters/organizers of the newly developed/existing blood centers and blood banks;

D. Establishing an active research program for the development or adaptation of new technologies and for the assessment of the real needs of the country;

E. Maintaining a national reference laboratory for blood group serology;

F. Providing the country with those blood products that are not produced at large scale at the regional level. HEIcDT

2. The blood bank facilities of the regional hospitals and medical centers shall be upgraded to enable them to function as the lead blood banks and referral center for component preparation and other laboratory tests in the region following the networking scheme. They shall be referred to as Regional Blood Centers with similar range of activities as that of the National Blood Center but on a smaller scale. These activities include:

A. Planing and coordination between the blood center and the different hospital blood banks it serves to meet not only the ordinary requirements for blood and blood products but also to serve the unexpected demands of emergencies;

B. Providing consultation services to the different hospitals it serves on transfusion and transfusion-related problems;

C. Training and education of the staff of the different blood banks it serves, including the teaching of clinicians in the field of transfusion medicine;

D. Supervising the different blood banks in its region and assist in introducing new standardized techniques and procedures;

E. Acting as a referral center for the entire region it serves.

SECTION 18. Licensing of Private Hospitals. —

Together with other requirements as contained in this IRR for licensure, all private hospitals shall submit to the Department through the Bureau of Licensure and Regulation, a Voluntary Blood Donation Program Plan.

SECTION 19. Licensing of Government Hospitals. —

Together with other requirements as contained in this IRR for licensure, all government hospitals shall submit to the Department, through the Bureau of Licensure and Regulation, a Voluntary Blood Donation Program Plan. The application for the renewal of their licenses shall be accompanied by the following:

1. Preceding year's voluntary blood donation program report according to the format designed by the Monitoring and Evaluation Sub-Committee. DcaSIH

2. Bureau of Licensure and Regulation monitoring visit report for the preceding year.

SECTION 20. Philippine National Red Cross. —

The Department shall assist the PNRC in mobilizing resources and in upgrading their facilities or chapters by facilitating linkages with private or government hospitals with laboratory facilities and trained personnel.

SECTION 21. Preventive Services. —

All blood service facilities shall provide preventive health services such as education and pre- and post-donation counselling on blood transfusion transmissible diseases in line with the guidelines and standards of the National Voluntary Blood Services Unit.

SECTION 22. Hospital Budget for Blood. —

It is the responsibility of the transfusing hospitals to provide the necessary blood and blood products to patients. All hospitals are therefore required to set aside a budget for this purpose.

SECTION 23. Recognition Awards. —

The Department shall grant seals of excellence in recognition of outstanding service facilities to be awarded in a formal ceremony as part of the Blood Donor's Week.

CHAPTER VI

Phase-Out of Commercial Blood Banks

SECTION 24. Process of Phasing-Out. —

The Secretary of Health shall effect the phasing-out of all commercial blood banks over a period of two (2) years, extendable for a maximum period of two (2) years after the effectivity of Republic Act 7719. The decision to extend shall take into consideration the result of a careful study and review of the blood supply and demand and the assurance of public safety. aDHScI

SECTION 25. Options for Commercial Blood Banks. —

The Department hereby encourages the commercial blood banks to:

1. Convert to solely clinical laboratories in order to ensure job security of their personnel and allow a reasonable return on their investment on training and equipment; or,

2. Shift to other forms of business/investment schemes.

CHAPTER VII

Non-Profit Operation

SECTION 26. Operation and Maintenance of Blood Service Facilities. —

The operation and maintenance of all blood service facilities and any other entities, agencies, establishments engaged in blood services and covered by these Rules shall be non-profit, provided that, service fees may be collected, but not greater than the amount to be prescribed by the Secretary of Health, which shall be limited to the necessary expenses entailed in the collection and processing of blood. Blood shall be collected from health voluntary donors only.

CHAPTER VIII

Regulation of Blood Services

SECTION 27. Regulatory Authority. —

The licensing and regulatory functions of the Department of Health regulating blood services shall be exercised through the Bureau of Research and Laboratories (BRL) in the Office of Hospital Facilities, Standards and Regulation, as such, it is hereby authorized to issue orders and circulars providing for implementation details and specific technical requirements related to licensing and regulation. SaICcT

SECTION 28. Categories of Blood Service Capabilities. —

Blood service capabilities shall be classified into categories as follows:

1. Blood Banks — A blood bank may either be hospital-based or non-hospital based in the case of the Red Cross and shall be classified as Category A, B or C when it meets the following minimum required capabilities as follows:

A. Category A when it can and is performing the following:

1. Promotion of voluntary blood donation and donor recruitment

2. Storage of blood already screened by the blood bank or blood center

3. Provision of whole blood and packed RBC only to the hospital it serves

4. Compatibility testing (hospital based only)

B. Category B when it can and is performing the following:

1. Recruitment of voluntary blood donors

2. Donor screening and selection

3. Blood collection

4. Basic blood screening and testing

5. Provision of whole blood and packed RBC to the hospital it serves and to the network of blood banks with which it is affiliated

6. Issuance, transport and distribution of blood

7. Storage of blood and blood products aSTcCE

8. Compatibility testing (hospital-based)

9. Health education and counselling

C. Category C when it can and is performing the following:

1. Recruitment of voluntary blood donors

2. Donor screening and selection

3. Blood Collection

4. Basic blood screening and testing

5. Preparation of blood components

6. Issuance, transport and distribution of blood and blood products

7. Storage of blood/blood products

8. Compatibility testing (hospital-based)

9. Health education and counselling

2. Blood Collection Units — In support of the Blood Services Network, the Blood Centers shall organize and establish Blood Collection Units which are authorized to perform the following:

A. Recruitment of voluntary blood donors

B. Screening of blood donors

C. Provision of health education and counselling

D. Collection and transport of blood to Blood Centers to which it is attached aHCSTD

3. Blood Stations — All other hospitals and PNRC chapters rendering blood services not classified as a Blood Bank/Center or Blood Collection Unit may be allowed by these rules to store blood and blood products, subject to regulation by the BRL. Further, duly-authorized Blood Stations (BS) shall be properly identified and specified for each Blood Bank/Center.

SECTION 29. Requirements for New License. —

1. The Blood Bank/Center may be granted a license to operate only if it shall have complied with the following minimum requirements:

A. It shall be under the supervision and management of a physician certified by the Philippine Board of Pathology in Clinical Pathology or the Philippine Board of Hematology and Blood Transfusion for all blood centers and Category B and C blood banks. In the case of the Philippine National Red Cross Category A and B blood banks and Category A hospital-based blood banks, the supervision and management shall be under a competent physician duly registered by the Professional Regulation Commission with a valid professional license and who has at least six (6) months of training in transfusion medicine in an institution recognized by BRL.

B. All Blood Centers and Blood Banks shall be manned by Medical Technologists duly registered by the Professional Regulation Commission with a valid certificate and valid professional license except for the already existing blood banks of the Philippine National Red Cross where medical technicians will be allowed. They are either rotating or permanently assigned depending on the categories of blood bank:

1. For Category A, medical technologists are rotating and can handle other sections of the laboratory during the tour of duty.

2. For Category B, medical technologists are rotating but handle only the Blood Bank during the tour of duty. caIACE

3. For Category C, at least one senior medical technologist who has undergone 3 months of training in blood banking shall be permanently assigned to the Blood Bank. The other medical technologists are rotating from other sections of the laboratory but handle only the blood bank during the tour of duty.

2. Staff Development Plan. The Blood Bank/Center shall prepare a one (1) year staff development plan for all categories of personnel.

3. Physical Facilities, Equipments and Supplies.

A. All Blood Banks/Centers shall operate and maintain blood bank services under good physical conditions and with adequate physical facilities, equipments and supplies. Specifications for these shall be defined in appropriate BRL Bureau Orders and the Revised Technical Standards and shall be included in the Manual on Standard Operating Procedures on Blood Services of the BRL (Section 39).

B. All Blood Banks/Center, Blood Collection Units and Blood Stations shall have regular schedule, and a written record, of maintenance and service of all equipments and instruments used in blood bank services.

C. There shall also be a written and readily available contingency program in case an instrument or equipment becomes incapacitated or unavailable.

4. Biosafety. Safety precautions shall be followed in all Blood Banks/Centers at all times. These shall include, but not limited to, the prominent display of easily understandable posters on safety procedures; wearing of protective clothing and gadgets such as laboratory gowns, gloves, masks, and eye protectors; and adherence to clear and acceptable procedures and physical arrangements for decontamination and disposal of contaminated materials such as blood, equipment, clothing, other supplies. ADTEaI

5. Quality Control. The Blood Bank/Center shall have satisfactorily passed the minimum proficiency test given by the BRL or any of its certified proficiency testing agencies.

Adequacy of quality control procedures of each Blood Bank/Center shall be assessed based on their compliance with quality control standards set by the BRL, including but not limited to, the use of quality reagents, techniques and equipments; the presence of an adequately trained and competent Quality Assurance Officer; the acceptability of procedures and arrangements for internal and external quality control monitoring activities; the acceptability of equipment calibration and maintenance procedures; the adequacy of documentation of accountability in key steps and procedures; and the acceptability of procedures for reporting errors and instituting remedial action.

6. Recording, Reporting and Documentation Requirements. All Blood Banks/Centers shall follow standard reporting and documentation formats and procedures and other documentation requirements of the BRL which shall be described in appropriate BRL Bureau Orders and included in the SOP Manual on Blood Services of the BRL (Section 39).

All the entries in the application forms, logbooks, reports and other written documents should be certified true and correct according to the applicant's personal knowledge.

7. Blood Distribution and Transport Requirements. Blood shall be distributed to the hospitals, not to individuals or patients.

The blood distribution scheme of each Blood Bank/Center shall be clearly described and shall include the complete list of authorized Blood Stations strategically located to provide maximum equitable distribution of blood to its catchment area and the names and qualifications of the persons authorized to handle, transport or issue blood. HSDIaC

Blood shall be issued only to authorized Blood Stations except during emergency conditions such as disasters and major accidents, breakdown of equipments or facilities in other Blood Banks/Centers, and other similar circumstances subject to the conditions specified in Section 42 of this IRR.

The Blood Bank Center shall have adequate facilities and arrangements for keeping blood and blood products under appropriate refrigeration during transport and storage following the principles of an unbroken cold storage chain.

8. Blood Transfusion Committee. All hospitals with Category B and C blood banks must have an organized Blood Transfusion Committee. The names of committee members, their corresponding qualifications and tasks and functions shall be submitted upon application for license.

9. Preventive Services. All hospitals with Category B and C blood banks shall have adequate and effective health education and counselling services and materials. Health education should cover the benefits of blood donation; the social behaviors that increase the risk of acquiring blood-borne diseases; and the effective measures of preventing disease transmission.

Counselling of donors found to have infectious blood-borne diseases should include advice on the nature of the disease, the basic treatment and management options and referral to clinic, hospitals or physicians for continuing treatment and clinical management. The principle of confidentiality, especially for AIDS patients, shall be upheld.

10. Networking. Blood Banks/Centers shall have clear arrangements for continuing staff training on blood banking and rational blood use, sharing of manpower and other resources, geographical coordination of donor recruitment, complete list of authorized strategically-located Blood Collection Units and laboratory referral arrangements. acIASE

11. All blood banks shall be required to join the Blood Services Network of their respective locality to ensure an adequate and safe blood supply.

12. Only duly licensed hospitals, the Philippine National Red Cross, and agencies/corporations which are registered with the Securities and Exchange Commission as non-profit agencies and corporations maybe licensed to operate a blood bank.

SECTION 30. Requirements for Renewal of License. —

The license of a Blood Bank/Center to operate may be renewed only after compliance with all the requirements for a new license subject to the following additions or modifications:

1. The Blood Bank/Center shall have passed the basic proficiency test the previous year.

2. All medical technologists, including new staff, shall have acquired at least 30 CPE units each year.

3. The Blood Bank/Center shall have achieved at least 70% of the staff development plan targets.

4. The Blood Bank/Center shall have bled only voluntary blood donors the previous year, including those bled in its authorized Blood Collection Units.

5. The complete annual report of the preceding year's operations shall have been submitted on or before January 31 of the succeeding year, following the required format (Revised BRL Blood Services Form No. 3).

6. The inspection visit shall have confirmed that the Blood Bank/Center including the attached collection unit has continued to operate under good physical conditions and according to prescribed technical and operating standards. EcTIDA

7. The Blood Bank/Center has been shown to collect only the allowable service fee for each blood unit dispensed.

SECTION 31. Terms and Conditions. —

The licensing of Blood Banks/Centers shall be subject to the following terms and conditions:

1. In regions outside the National Capital Region, the Regional Health Director shall be the designated representative of the Director of the BRL in the licensing and regulation of Blood Banks/Centers.

2. Applications for new license shall be addressed and submitted to the Director of the BRL. Applications for renewal of license shall be officially addressed to the Director of the BRL and submitted for Blood Banks/Centers in Metro Manila, directly to the BRL or, for Blood Banks/Centers in other regions, to the Regional Health Directors.

3. A license to operate a Blood Bank/Center shall be valid for one year from the date of issue and shall be signed by the Undersecretary of Health for Hospital Facilities, Standards and Regulations and issued to persons, agencies or corporations who have successfully complied with all of the standards and requirements listed in Section 29 or 30, as appropriate.

4. The exact date of expiration of the license shall be printed on the license.

5. Assessment of a Blood Bank/Center for initial licensing and renewal of license shall involve evaluation of documents and at least once a year actual inspection of the facility by authorized BRL inspectors.

6. The license, as well as the rights under the license, is non-transferable, directly or indirectly. cDECIA

7. The license of the Blood Bank/Center shall be displayed in a conspicuous place within the Blood Bank/Center. A notice shall be posted informing the public that complaints about the services may be addressed to the Bureau of Research and Laboratories.

8. A non-refundable license fee of six hundred pesos (600) shall be charged on application for a license to open and operate a Blood Bank/Center and four hundred pesos (400) for renewal of license.

A non-refundable proficiency testing fee shall also be charged to cover for the cost of materials and supplies especially reagents used during the proficiency testing. The proficiency test fee shall be three hundred pesos (P300) per bank/center.

The fees shall be uniform for both government and private Blood Banks/Centers and shall be adjusted by the BRL through appropriate Bureau Orders as necessary. All fees shall be payable to the Bureau of Research and Laboratories.

9. The terms and conditions of the license shall be subject to amendments or modifications by the Secretary of Health through a revision of these rules and regulations when called for by public health safety and interest.

SECTION 32. The Licensing Process. —

The following shall be the process of licensing:

1. Initial Application. Any person, agency or corporation desiring to operate a Blood Bank/Center shall submit to the BRL a duly-accomplished and notarized Revised BRL Blood Services Form No. 1 (Application for New Blood Center License) together with the following supporting documents:

A. Certified true copy of Securities and Exchange Commission registration (if a corporation of a foundation); HaAIES

B. Names and qualifications of proposed staff, including certified true copies of PRC certificate of registration and professional license; PSP or PSHBT certification; certification of staff; results of proficiency tests and other certificates of training, as appropriated and applicable;

C. Floor diagram of proposed premises;

D. List of equipments for blood services;

E. Certified true copy of hospital license for preceding year (hospital-based only);

F. Biosafety and Quality Control arrangements and procedures;

G. List of Blood Collection Units (Names of heads and complete addresses);

H. List of Blood Stations (Names of medical technologists in-charge and complete addresses);

I. Names and tasks of the members of the BTC (hospital-based only).

2. Application for Renewal of License. Any person, agency, or corporation desiring to renew its license to operate a Blood Bank/Center shall submit to the BRL or the Regional Health Director, as appropriate, a duly-accomplished notarized Revised BRL Blood Services Form No. 2 (Application for Renewal of Blood Center License) together with the following documents:

A. Names, qualifications and proofs of qualifications of new staff and any staff changes (e.g., resignations, additional trainings, or qualifications for existing staff); CScTED

B. Changes (improvements or deterioration) in existing physical facilities and functioning of facilities and equipments;

C. Newly acquired equipments and facilities;

D. Annual Report on Blood Services for the previous year (Revised BRL Blood Services Form No. 3);

E. Names and addresses of regular blood donors who donate at least twice a year;

F. Any changes in the list of authorized Blood Collection Units and Blood Stations (deletions or additions only);

G. Any other changes in blood banking operations and services.

3. Inspection.

A. Each Blood Bank/Center, to include the affiliated or attached static blood collection units must be visited by an authorized BRL inspector at least once before initial licensing and once a year for the renewal of license. Those who failed to apply for renewal of license within the prescribed period shall be visited within the year to confirm that blood operations have ceased.

B. Only inspectors who have satisfactorily completed the BRL Course for Blood Bank inspectors are qualified to inspect Blood Banks/Centers and other blood service facilities. A blood bank inspector shall be entitled to basic per diem expenses and two hundred pesos (P200) honorarium for Blood Service facility inspected.

C. For applicants desiring to open a Blood Bank/Center (i.e., new license), inspection shall be done only of applicants who have fulfilled all the basic written requirements. AaIDCS

D. Inspection of licensed blood bank/center shall be done while its activities are going on and shall be unannounced. Each licensee shall make available all records and documents as may be required by the inspectors.

4. Timetable for Application and Inspection.

A. Applications for new license can be submitted any time.

B. Applications for renewal of license should be submitted within the two (2) months prior to the expiration date of the current license. Blood Banks/Centers which fail to submit an application renewal within the prescribed two-month period shall be considered as "Blood Bank/Centers Operating Without a License" when their current license expires and shall be subject to the penalties for such violation.

C. Blood Banks/Centers which have submitted their application for renewal of license within the prescribed two (2) months period but have not yet been inspected shall be given six (6) weeks extension grace period after expiration of their current license. During the six (6) weeks extension period, their license shall be considered valid.

5. Release.

A. Licenses shall be released only to the heads of the Blood Bank/Center or their officially designated representatives not later than two (2) weeks after the completion of the inspection visit.

B. Applicants for new license who, upon inspection, did not meet all of the prescribed standards shall receive a letter from the Director of the BRL or the Regional Health Director stating the requirements which the Blood Bank/Center failed to meet. SDHCac

C. Applicants for renewal of the license who, upon inspection, did not meet all of the prescribed standards shall receive, aside from the letter stating their deficiencies, an order signed by the BRL Director or respective Regional Health Director, to cease blood banking operations immediately. These blood centers shall also be revisited within one month after release of the order to stop operations for confirmation of compliance with the order.

SECTION 33. Transition Period for Confirmation of License. —

1995-1996 shall be the transition years for confirmation of compliance to the new licensure requirements of existing Blood Banks/Centers. During this transition period, the documents, forms and process for renewal of licenses shall follow the procedures for new licenses.

Existing Blood Banks/Centers which will fail to meet all of the new or additional requirements may still be allowed to operate within this two-year period provided such blood banks/centers submit an undertaking to upgrade their services and facilities according to the prescribed standards.

Starting January 1, 1997, all licensure requirements will be imposed without exemption.

SECTION 34. Phase Out of Commercial Blood Banks. —

No new license shall be issued for a commercial blood bank.

Beginning January 1, 1996, no renewal of license of commercial blood banks will be allowed. The commercial blood banks will continue to operate during the transition period upon the authority of the Secretary of Health subject to continuous monitoring by the BRL. TCaSAH

SECTION 35. Appeals and Reports on Violations. —

Reports and appeals on violations of RA 7719 and these Rules and regulations shall be addressed to the Secretary of Health.

SECTION 36. Allowable Service Fees. —

1. The blood service facility can charge a minimal service fee for every blood or blood product issued only to provide operational funds for the Blood Banks/Centers, Blood Collection Units and Blood Stations. The service fee shall cover all the expenses incurred in collecting and processing the blood (donor recruitment, blood collection, blood screening and component preparation, storing and transportation and allowance for spoilage) including professional services rendered but shall not include the costs of cross-matching and other special screening and compatibility tests.

2. The BRL Director, in consultation with professional societies, shall issue Bureau Orders on the maximum allowable service fees for blood services, and shall be adjusted from time to time, whenever deemed reasonable, specifying the basic requirements and special tests not covered by the service fee.

SECTION 37. Authorization of Blood Collection Units. —

The Regional Health Directors, including the Regional Health Director of the National Capital Region, shall authorize Blood Collection Units (BCU) according to the following standards and procedures:

1. A Blood Collection Unit upon recommendation of the appropriate Blood Service Network should have at least three (3) professional staff: two PRC-registered nurses, and one PRC registered medical technologist. They should have had at least 8 weeks training under an agency duly-recognized by the BRL on voluntary donor recruitment and screening; voluntary donor holding and motivation; health education and counselling; blood collection, handling and transport; and management of blood collection activities and problems. aTCAcI

2. A Blood Collection Unit must have the following features as described in the SOP Manual on Blood Services; adequate and proper equipment and supplies of good quality to be able to perform donor recruitment and screening; health education and counselling; blood collection, handling and transport; and management of any reactions according to BRL standards described in the SOP Manual on Blood Services (Section 38) as well as accepted medical practice.

There shall be written and readily available contingency plan for all Blood Collection Units in case of problems such as instrument or equipment breakdown.

All Blood Collection Units shall have a regular schedule, and a written record, of maintenance and service of all equipments and instruments used in blood bank services.

3. A Blood Collection Unit can be static or mobile Physical arrangements for both kinds during collection should be comfortable, clean and adequate. There is no need to get any authority for mobile BCU. The request for authority to open a static blood collection unit should be initiated by the Head of the Blood Bank/Center with which it is affiliated. Such request shall be endorsed by the appropriate Blood Services Network.

4. The Blood Collection Unit shall be clearly attached to a network of one Blood Bank/Center which has confirmed its recognition of the coordination and cooperation arrangements with the BCU. Such confirmation may be contained in an appropriate certificate.

5. The BCU shall submit its schedule of bleeding and target area of donor recruitment that clearly follows geographical area agreements with other BCUs within the catchment of the relevant Blood Bank/Center. aAHISE

6. The BCU shall express agreement to submit the blood bags collected and the list of donors to its attached Blood Bank/Center at the end of the collection day. Authorization can be withdrawn if the BCU fails to execute this agreement.

7. Each BCU shall be visited at least once a month by the head of the Blood Bank/Center it coordinates with or by a duly designated Blood Bank/Center health staff.

8. Authorization as a Blood Collection Unit shall be renewed yearly, signed by the Regional Health Director, and issued to the head of the BCU.

9. The authority to operate the BCU shall be revoked by the Regional Health Director should the procedures and services be found to be below the standards set by the BRL in its Standard Operating Procedures Manual on Blood Services (Section 39).

SECTION 38. Authorization of Blood Stations. —

The Regional Health Directors, including the Regional Health Director of the National Capital Region, shall authorize Blood Stations according to the following standards and procedures:

1. Blood Stations may be located only within the hospital premises, government or private; or within the premises of Philippine National Red Cross chapters.

2. A Blood Station shall be under the responsibility of a PRC-registered medical technologist with a valid certificate of registration and a valid professional license.

3. A Blood Station shall have at least one properly functioning blood refrigerator with twenty-four (24) hours power supply.

4. There shall be written and readily available contingency plan for all Blood Stations in case of problems such as instrument or equipment breakdown. CIaHDc

5. All Blood Stations shall have a regular schedule, and a written record, of maintenance and service of all equipments and all instruments used in the blood bank services.

6. Blood shall be issued only to patients confined within the hospital that houses the station or to hospitals within the area, unless called for by emergency conditions as listed in Section 29 (6).

7. The authority to operate a Blood Station shall be renewed yearly, signed by the Regional Health Director and issued to the agency that operates the Blood Bank/Center that will distribute the blood bags to the station, with a copy furnished to the chief of the hospital where the Blood Station is located and the medical technologist-in-charge.

8. Each blood station shall be visited at least once a year by the head of the Blood Bank/Center that distributes blood to the station or by a duly designated Blood Bank/Center health staff. A record of such visit shall be open for inspection by the BRL, or its duly authorized representative.

9. The authority to operate the Blood Station shall be revoked by the Regional Health Director should blood storage, handling, issuance, distribution or disposal be found to be below the standards set by the BRL in its Standard Operating Procedures Manual on Blood Services (Section 38).

SECTION 39. Standard Operating Manual. —

Standards for donor recruitment and screening; for all laboratory and blood processing tests and procedures; for handling and disposal of blood and other biosafety procedures; for inventory and recording procedures; for networking, blood collection and distribution; and all quality assurance/quality control measures shall follow international guidelines promoted by the World Health Organization and the International Society of Blood Transfusion. Such guidelines shall be adopted to the Philippine situation through a Standard Operating Procedures Manual (SOP Manual) on Blood Services which shall be developed, pretested and printed by the BRL within six (6) months after the effectivity of these Implementing Rules and Regulations. The Manual shall be formally signed and dated by the Director of the BRL. This manual shall then be incorporated as an integral part of these Rules and Regulations. DCHIAS

Until the time when the updated SOP Manual is available, the procedures and standards incorporated in AO 57 S. of 1989 (Sections 10, 11, 12 and 13), BO No. 5 S. of 1990 (Section 6), AO 122 S. of 1992, Bureau Circulars No. 2 S. of 1990, No. 2 S. of 1991, and No. 4 S. of 1994, of the BRL which are not in conflict with these Rules and Regulations shall continue to be in effect.

Such a manual shall be reviewed and revised periodically. In its revisions, the previous editions shall be collected back by the BRL and precautions taken to ensure that all relevant key persons are informed of the changes and the effectivity of these changes.

SECTION 40. Quality Assurance Officer. —

A Quality Assurance Officer recognized for his/her integrity and organizational abilities shall be assigned or designated and trained for each blood service facility by the BRL. He/she shall organize all documents relating to quality assurance and, in coordination with the head of the blood service facility, shall make sure that the required, recognized standards are instituted and followed according to national specifications. He/she shall periodically review quality control procedures and monitor compliance with standard procedures. He/she shall initiate investigation and remedial action when errors occur, in cooperation with the head of the units affected.

SECTION 41. Confirmation of Voluntary Donors. —

Paid blood donors who are usually brought in by relatives of patients should be carefully selected out and blacklisted from the roster of donors. This can be done through careful history and physical examination of donors. Donors which show multiple needle punctures on the arms and those whose complete names and relations to the patient are unknown to the patient or his relatives should be immediately rejected. CAaDTH

The Quality Assurance Officer shall countercheck donors who regularly donate to the Blood Bank/Center as part of his/her regular monitoring of Blood Bank/Center operations.

SECTION 42. Emergency Blood Transfusion. —

Blood collection and immediate transfusion in hospitals without a license as a Blood Bank/Center may be allowed in an emergency situation subject to the following conditions:

1. That the medical/surgical condition poses an immediate threat to the patient's life;

2. That the collection and transfusion is done under the supervision and with the full responsibility of the attending physician;

3. That the existing standards and specifications for donor screening including history and physical examination, on asepsis and biosafety, and on the use of proper and good quality equipments and materials or supplies, are complied with;

4. That the required tests for hemoglobin, syphilis, AIDS, hepatitis and for presence of malarial parasites and compatibility testing including cross-matching are also performed either before or during transfusion.

CHAPTER IX

Importation of Blood Bank Equipments, Blood Bags and Reagents

SECTION 43. Certification of Importation Privileges. —

An annual list of Blood Banks/Centers and hospitals participating actively in the National Voluntary Blood Services Program shall be prepared by the National Voluntary Blood Services Unit. This list, duly approved and certified by the Undersecretary of Health for Hospital Facilities, Standards and Regulations and duly noted by the Directors of the Bureau of Research and Laboratories and the Bureau of Licensing and Regulation of the Department, shall be submitted to the Department of Finance and the Bureau of Customs before January 31 of every year. ETCcSa

SECTION 44. Equipment and Materials Covered. —

The BRL, in consultation with the Department of Finance and Bureau of Customs, shall enumerate in an appropriate Bureau Circular the detailed list of equipment, blood bags and reagents with specifications as necessary, which shall be allowed to be imported tax and duty-free under the provisions of RA 7719. The list shall be modified by the BRL as necessary.

SECTION 45. Process of Importation and Exemption. —

A Blood Bank/Center or hospital, included in the list of banks/centers and hospitals actively participating in the National Voluntary Blood Services Program, wishing to import equipment and materials tax and duty free shall submit to the Secretary of Health a letter of intent enclosing the list of equipment and materials with the necessary specifications and justifications for their use. The BRL Director shall certify that the list of equipment and materials requested are included in the list of allowable equipment and supplies and that these are necessary for the voluntary blood services program of the particular Blood Bank/Center or hospital. The Undersecretary of Health for Hospital Facilities, Standards and Regulations shall sign a recommendation for tax and duty free exemption addressed to the Commissioner of Customs.

CHAPTER X

Penalties

SECTION 46. Penalties. —

The Secretary of Health, through the BRL after due notice and hearing, may impose the following administrative sanctions:

1. Upon complaint of any person and after due notice and hearing, any blood bank/center which shall collect charges and fees greater than the maximum prescribed by the Department shall have its license suspended or revoked by the Secretary.

2. The head of the Blood Bank/Center and the necessary trained personnel under the head's direct supervision found responsible for dispensing, transfusing, and failing to dispose within forty-eight (48) hours blood which have been proven contaminated with blood transfusion transmissible diseases shall be imprisoned for ten (10) years. This without prejudice to the filing of criminal charges under the Revised Penal Code. DaTICE

3. Fine of five thousand pesos (P5,000) for the head or owner of the Blood Bank/Center which fails to submit the application for renewal of license to the BRL or its designated offices within two (2) months prior to the expiration of the existing license.

4. Fine of three thousand pesos (P3,000) for the head of a Blood Collection Unit or Blood Station which shall operate without securing authorization from the Department or its designated offices.

5. Revocation or suspension of Blood Bank/Center license or Blood Collection Unit or Blood Station authorization for:

A. Misrepresentation of facts or falsification of documents or records

B. Refusal of entry for inspection

C. Refusal to make available its books, accounts and records of operations

D. Failure to inform the BRL or its authorized representatives about changes in Blood Bank/Center, Blood Collection Unit or Blood Station location, facilities, services or operations.

6. Recommendation to revoke the certificate of registration or to suspend said certificate to practice the profession and to invalidate the professional license of any health professional involved in misrepresentation of facts or falsification of documents or records especially medical, laboratory or inspection results and certificates, or in violation of RA No. 7719 and the herein Rules by the Professional Regulation Commission upon recommendation of the Secretary.

SECTION 47. Repealing Clause. —

These Rules and Regulations shall supersede all previous Administrative and Bureau Orders and Circulars of the Department. The provisions of any law, executive order, presidential decree, Department or BRL order and circular, or other issuances inconsistent with these Rules and Regulations are hereby repealed or modified accordingly. CEASaT

SECTION 48. Effectivity Clause. —

These Rules and Regulations shall take effect fifteen (15) days after its publication in the Official Gazette or in two (2) national newspapers of general circulation.

Approved on this twelfth day of August nineteen hundred and ninety-four.

(SGD.) JUAN M. FLAVIER, MD, MPHSecretary