August 8, 1994
ADMINISTRATIVE ORDER
No. 36 series 1994
RULES
AND REGULATIONS IMPLEMENTING REPUBLIC ACT NO. 7719 OTHERWISE KNOWN AS THE “NATIONAL
BLOOD SERVICES ACT OF 1994”
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
opted.
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 R.A. 7719 to facilitate compliance
therewith and achieve the objective 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 provision of this Act;
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/CENTER – a blood
bank/center 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/CENTER – a blood bank/center 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;
12. BLOOD COLLECTION UNIT – an institution or facility duly authorized by the
Department of Health to recruit and screen donors and collect blood;
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 R.A. 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;
Chapter II
NATIONAL VOLUNTARY BLOOD SERVICES PROGRAM
Section 5
NATIONAL PROGRAM
COMMITTEE
1. Composition
A
National Voluntary Blood Services Program Committee is hereby created and shall
be chaired by the Secretary of Health. It shall be composed of, but not limited
to, 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 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 necessary to the operations of the
Committee.
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 taking into consideration the
1992 National Blood Services Program Directional Plan of the Department;
b. Operationalization and institutionalization of the
National Voluntary Blood Services Program including budgetary allocation for
program activities;
c. Monitoring and evaluation of the National Voluntary
Blood Services Program including budgetary allocation for program activities;
d. Creation of multi–sectoral sub–committees such as, but
not limited to, advocacy and promotion, programming, monitoring and evaluation
and curriculum development
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 such shall coordinate the Voluntary Blood
Services Program activities in the region.
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 of Health 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 operations 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 counseling 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 pan
incorporation the activities and needs of the other Department units and
services involved in the blood services programs such as, but not limited to,
the Bureau of Licensure and Regulation, and Hospital Operation and Management
Service;
e. Provision of secretariat services to the National
Voluntary Blood Service Program Committee and as such shall:
(1) Collate and review all annual operational plans,
proposed budgets of the different 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
Service 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 (P 25,000,000.00)
c. The Philippine Amusement and Gaming Corporation with
the initial amount of at least twenty–five million pesos (P 25,000,000.00)
d. The trust liability account of the Duty Free Shop with
the initial amount of at least twenty million pesos (P 20,000,000.00)
e. The contributions of other agencies such as civic and
charitable organizations
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 the
facility. Use of funds shall be based on the operational plan of the different
sub–committees and blood service facilities concerned.
Chapter III
PROMOTION OF VOLUNTARY BLOOD DONATION
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, the
·
Department of
Education, Culture and Sports
·
Department of
Social Welfare and Development
·
Philippine
National Red Cross
·
Philippine Blood
Coordinating Council
·
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,
coordination, monitoring and evaluation of the national advocacy and promotion
activities;
3. Regional
Counterpart
The
Regional Advocacy and Promotion sub–committees 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.
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 shall be
composed of members including, but not limited to, the representatives from
the:
Department of Health
Philippine Society of Hematology and Blood Transfusion
Philippine Society of Pathologists
Philippine Association 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
The
National Voluntary Blood Service 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 and
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 teachers on the utilization of such materials and methods;
F. Monitoring
of the use and effectiveness of such material and methods in terms of process
and product and continuing revision of such as necessary.
G. Preparing
and submission of the National Voluntary Blood Services Unit of the annual
budgetary requirements for the promotion of voluntary blood services in the
schools.
3. Training
Programs and Technical Assistance
The
Department shall likewise provide training programs and technical assistance to
enable communities, schools, industrial and business sectors, barangays,
military groups 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 Technologist
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.
2. Functions
A. Encouragement
of all medical and other health professional association and societies to
conduct training 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 program of the different medical subspecialties.
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 Gynecology and
Pathology
· Hematology
Consultant
· Representative
from the Nursing service
· Hospital Medical
Training Officer
· 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.
Chapter IV
BLOOD SERVICES NETWORK AND BLOOD 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, official 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 service facilities according to geographic
location, to complementary tasks and other related undertakings;
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.
Section 13
BLOOD DONOR RECRUITMENT
The Department shall adopt
a system of procedures or programs to promote blood donor recruitment and
ensure the increase in the number of 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 he 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
1. Composition
The Monitoring and Evaluation sub–committee shall be composed of,
but not limited to, representatives of the Hospital Operations 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.
2. Functions
It shall be tasked to:
a. 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;
b. Establish
a criteria indicators to monitor the progress or success in meeting the targets
of the program as envisioned in the strategic plan;
c. Monitor
and evaluate all activities of the Program and recommend ways by which targets
could be met;
d. 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.
e. The
National Monitoring and Evaluation sub–committee shall be responsible for
reviewing and recommending changes on the non–monetary incentives for voluntary
blood donors.
Section 15
DEPARTMENT OF HEALTH
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 requirement in the area by providing technical assistance,
training and mobilizing resources and other similar forms of assistance.
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 director/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.
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. Planning 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 service 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
The Department, through
the Bureau of Licensure and Regulation, shall require private hospitals to
submit their 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 Licensure and Regulation,
a Voluntary Blood Donation Program Plan. The application for 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.
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 the upgrading their facilities
or chapter 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 counseling 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, in
coordination with the PNRC, shall grant seals of excellence in recognition of
outstanding service of blood 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 Department shall
affect the phasing–out of all commercial blood banks over a period of two (2)
years, extendable for a maximum period of (2) year after the effectivity of
R.A. 7719. The decision to extend shall be based on the result of a careful study
and review of the blood supply and demand and public safety.
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 prescribed by the Department, which shall be limited to the
necessary expenses entailed in the collection and processing of blood and
reasonable fees for maintaining and upgrading facilities and services. Blood
shall be collected from healthy 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 Health Facilities Standards and Regulations, and as such, it is
hereby authorized to issue orders and circulars providing for implementation
details and specific technical requirements related to licensing and
regulation.
Section 28
CATEGORIES OF BLOOD
SERVICE CAPABILITIES
Blood service capabilities
shall be classified into categories as follows:
A.
BLOOD
BANK/CENTER:
A Blood Bank/Center 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:
1. Category
A when it can and is performing the following:
a. Promotion
of voluntary blood donation and donor recruitment
b. Storage
of blood already screened by the blood bank or blood center
c. Provision
of whole blood and packed RBC only to the hospital it serves
d. Compatibility
testing (hospital based only)
2.
Category
B when it can and is performing the following:
a. Recruitment
of voluntary blood donors
b. Donor
screening and selection
c. Blood
collection
d. Basic
blood screening and testing
e. Provision
of whole blood and packed RBC to the hospital it serves and to the network of
blood banks with which it is affiliated.
f. Issuance,
transport and distribution of blood
g. Storage
of blood and blood products
h. Compatibility
testing (hospital – based)
i. Health
education and counseling
3. Category
C when it can and is performing the following:
a. Recruitment
of voluntary blood donors
b. Donor
screening and selection
c. Blood
collection
d. Basic
blood screening and testing
e. Preparation
of blood components
f. Issuance,
transport and distribution of blood and blood products
g. Storage
of blood/blood products
h. Compatibility
testing (hospital–based)
i. Health
education and counseling
B. BLOOD
COLLECTION UNITS
In
coordination with other related or appropriate agencies, the Blood
Banks/Centers shall organize and establish Blood Collection Units (BCU) which
is authorized to perform the following:
1. Recruitment of
voluntary blood donors
2. Screening of
blood donors
3. Provision of
health education and counselling
4. Collection and
transport of blood to Blood Banks/Centers to which it is attached
C. BLOOD
STATION
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 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.
(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, EQUIPMENT AND SUPPLIES
a. All Blood
Banks/Center shall operate and maintain blood bank services under good physical
conditions and with adequate physical facilities, equipment and supplies.
Specifications for these shall be defined in appropriate BRL Bureau Orders and
shall be included in the Manual on Standard Operating Procedures on Blood
Services of the BRL (Section 39).
b. All Blood
Banks/Centers, Blood Collection Units and Blood Stations shall have a regular
schedule, and a written record, of maintenance and service of all equipment 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. This
shall include, but shall not be limited to, 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 and other supplies.
5. QUALITY
CONTROL
All
the technical staff of 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 assess based
on their compliance with quality control standards set by the BRL, including
but not limited to, the use of quality reagents, techniques and equipment; the
presence of an adequately trained and competent Quality Assurance Officer; the
acceptability of procedures and arrangements for internal and externa
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 recording, 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
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 person authorized to handle
transport or issue blood.
Blood
shall be issued only to authorize Blood Stations except during emergency
conditions such as disasters and major accidents, breakdown of equipment 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
Blood
Banks/Centers shall have organized Blood Transfusion Committees. The names of
committee members, their corresponding qualifications and tasks and functions
shall be submitted upon application for license.
9. PREVENTIVE
SERVICES
All
Blood Banks/Centers shall have adequate and effective health education and
counseling 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 clinics, 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.
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 Blood
Bank/Center to operate may be renewed only if it shall have complied with all
the requirements for a new license with the following additions or
modifications:
1. All the technical
staff of the Blood Bank/Center shall have passed the basic proficiency tests
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 (BRL
Blood Services Form No. 3)
6. The inspection
visit shall have confirmed that the Blood Bank/Center has continued to operate
under good physical conditions and according to prescribed technical and
operating standards.
7. The Blood
Bank/Center has been shown to collet only the allowable service fee for each
blood unit dispensed.
Section 31
TERMS AND CONDITIONS OF
LICENSING
The following are the
terms and conditions of licensing:
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 Health 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 28 or 29, 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–transferrable, directly or
indirectly.
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 Director of the Bureau of
Research and Laboratories.
8. A non–refundable
license fee of six hundred pesos (P600) shall be charged on application for a
license to open and operate a Blood Bank/Center and four hundred pesos (P400)
for renewal of license.
A
non–refundable proficiency testing fee shall also be charged to cover the cost
of materials and supplies especially reagents used during the proficiency
testing. The proficiency test fess shall be two thousand 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.
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 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 or a
foundation);
b. Names and
qualifications of proposed staff, including certified true copies of PRC
certificate of registration and professional license; PSP or PSHBT
certification; results of proficiency tests, and other certificates of
training, as appropriate and applicable;
c. Floor diagram of
proposed premises;
d. List of equipment
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 Stations (Names of medical technologists in–charge and complete
addresses);
h. List of Blood
Collection Units (Names of head, qualifications 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 and notarized BRL Blood Services Form No. 2
(Application for Renewal of Blood Center License) together with the following
supporting documents:
a. Names,
qualification and proofs of qualifications of new staff and any staff changes
(e.g. resignations, additional trainings or qualifications for existing staff);
b. Changes
(improvements or deterioration) in existing physical facilities and functioning
of facilities and equipment;
c. Newly acquired
equipment and facilities;
d. Annual Report on
Blood Services for the previous year (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 shall 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 also be visited within the year to confirm
that blood operations have been ceased.
b. Only inspector who have satisfactorily completed the
BRL Course for Blood Bank/Center Inspectors are qualified to inspect Blood
Banks/Center 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 if applicants have fulfilled
all the basic written requirements.
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 may 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 for renewal within the prescribed two–month period shall
be considered as “Blood Banks/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.
c. Applicants for renewal of 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 LICENSES
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
banks/centers submit a plant 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.
Section 35
APPEALS AND REPORTS ON
VIOLATION
Reports and appeals on
violations or R.A. 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 36
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 counseling; blood collection, handling and transport; and
management of blood collection activities and problems.
2. A Blood
Collection Unit shall have adequate and proper equipment and supplies of good
quality to be able to perform donor recruitment and screening; health education
and counseling; blood collection, handling and transport; and management of any
reactions according to the 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 equipment and instruments
used in blood bank services.
3. A Blood
Collection Unit may be statistic or mobile. Physical arrangements for both
kinds during collection shall 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.
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 year 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 BCU shall be renewed yearly, signed by the Regional Health Director, and
issue 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 hospital premises, government or private; or within
the premises of the 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 a
written and readily available contingency plan for all Blood Stations in case
of problems such as instrument or equipment breakdown.
5. All Blood
Stations shall have a regular schedule, and a written record of maintenance and
service of all equipment and instruments used in 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 operated 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 to be found
to be below the standards set by the BRL in its Standard Operating Procedure
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 adapted to
the Philippine situation through a Standard Operating Procedure 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.
Until the time when the
update SOP manual is available, the procedures and standards incorporated in A.O.
57 s. 1989 (Sections 10, 11, 12 & 13), B.O. No. 5 s. 1990 (Section 6), A.O.
122 s. 1992, Bureau Circulars No. 2 s. 1990, No. 2 s. 1991 and No. 4 s. 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 investigations and remedial action when error occurs, in cooperation
with the head of the units affected.
Section 41
CONFIRMATION OF
VOLUNTARY WORKS
1. 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.
2. 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 41
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 direct 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 equipment and materials or supplies, are complied with;
4. That the required
test for hemoglobin, syphilis, HIV, hepatitis and for presence of malarial
parasites and compatibility testing including cross–matching are also performed
before transfusion.
Chapter IX
IMPORTATION OF BLOOD BANK EQUIPMENT AND SUPPLIES
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 Health Facilities and 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.
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 may be allowed to be imported
tax– and duty –free under the provisions of R.A. 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 FOR VIOLATIONS
Section 46
PENALTIES
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.
3. Fine of
five thousand (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 office within two (2) months prior to the expiration 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 R.A. No. 7719 and the herein Rules, by the
Professional Regulation Commission upon recommendation of the Secretary.
Section 48
REPEALING CLAUSE
These Rules and
Regulations shall supersede all previous Administrative and Bureau Orders and
Circulars of the Department. The provision of any Department or BRL order and
circular or other issuances inconsistent with these Rules and Regulations are
hereby repealed or modified accordingly.
Section 49
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
JUAN M. FLAVIER, MD,
MPH
SECRETARY OF HEALTH
(This Administrative Order is very similar to the Administrative Order No. 9 series of 1995 by Jaime Galvez - Tan. Those in yellow text are the difference.)
(This Administrative Order is very similar to the Administrative Order No. 9 series of 1995 by Jaime Galvez - Tan. Those in yellow text are the difference.)
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