January 3, 1989
ADMINISTRATIVE ORDER
No. 57 series 1989
REVISED RULES AND REGULATION GOVERNING THE COLLECTION,
PROCESSING AND PROVISION OF HUMAN BLOOD AND THE ESTABLISHMENT AND OPERATION OF
BLOOD BANKS
Section 1
Title
These rules shall be known
as “Revised rules and regulations governing the collection, processing
and provision of human blood and the establishment and operation of blood
banks.”
Section 2
Authority
These rules and
regulations are issued to implement the Blood Bank Law (R.A. 1517)
consistent with Executive Order No. 119 (Reorganization Act of the Ministry
of Health)
Section 3
Purpose
These rules and regulation
are promulgated to protect and promote the health of the people by preventing
the operation and maintenance of sub–standard, improperly managed and poorly–equipped
blood banks and by elevating the quality of blood banking services and blood
products.
Section 4
Scope
1. These regulations
shall apply to all entities performing the activities and functions of blood
banks in the Philippines including those in all government or private
hospitals.
2. A blood bank or
blood processing center is an institution or laboratory in which any three (3)
or more of the following are done (referred to as blood bank):
(a) Recruitment and screening of blood donors
(b) Collection of blood for transfusion
(c) Processing and/or storage of blood
(d) Transport and/or issuance to hospitals
(e) Compatibility testing of blood
Section 5
Regulatory authority
The Department of Health
through the Bureau of Research and Laboratories in the Office of Standards and
Regulations shall exercise the licensing and regulatory functions under these
rules and regulations.
Section 6
Classification of Blood
Banks
1. For purposes of
service extent and level, the blood banks are both (1) primary (2) secondary
(3) tertiary depending on the range of blood bank services provided and the
presence of certain manpower, equipment and facilities required. The minimum
services required for each respective category of blood bank shall be:
(a) Primary Category
(1) Donor screening and selection
(2) Collection and processing of blood
(3) Storage of blood
(4) Transport and issuance of blood
(5) Compatibility testing (for hospital)
(6) Transfusion of whole blood (for hospital)
(b) Secondary Category
(1) Services required for Primary Category
(2) Provision of packed red cells, plasma and platelet
rich plasma
(3) Investigations for transfusion reaction (for hospitals)
(c) Tertiary Category
(1) Services required for Primary category
(2) Services required for Secondary category
(3) Provision of blood components, products or derivatives
not included in secondary category
(4) Investigations of incompatible crossmatches (for
hospitals)
2. For purposes of
institutional character, Blood Banks may be classified into hospital blood
banks or free standing (non–hospital) blood banks depending on whether or not
they operate within a licensed hospital.
3. The permit issued
shall state or indicate the institutional type (hospital or free standing) and
category (primary, secondary or tertiary) of the blood bank.
Section 7
License to Operate a
Blood Bank
1. No Blood Bank
shall be allowed to operate nor any person allowed to collect, process and
distribute human blood either for sale or for free without having secured a
proper and valid license issued by the Bureau of Research and Laboratories.
2. The following are
not required to obtain a license to operate a blood bank:
(a) In cases of emergency, physician in hospitals with a
license for a secondary or tertiary category of laboratory may be allowed to
extract and transfuse blood immediately for their own patients provided:
(1)
Donors are
screened under medical supervision including history, physical examination and
tests for hemoglobin level, presence of malarial parasites and serologic test
for syphilis.
(2)
Collection of
blood is done under aseptic condition into proper plastic blood bags.
(3)
Compatibility
testing including cross matching shall follow acceptable standards.
(4)
The blood
transfusion shall be medically supervised. A hospital with a laboratory
licensed as secondary or tertiary category may screen donors and collect blood
provided such blood is processed in duly licensed blood bank.
A
hospital with a laboratory licensed as secondary or tertiary category may
screen donors and collect blood provided such blood is processed in a duly
licensed blood bank.
Section 8
Licensed requirements
for a Blood Bank
(Technical Standards)
1. All Blood Banks
shall be required to demonstrate compliance with the following Technical
Standards as requirement to licensing:
(a) The blood shall be under the competent supervision and
management by a physicians licensed and duly registered with the Board of
Medicine (PRC) and duly authorized by the Undersecretary of Health for
Standards and Regulation.
(b) The Blood Bank shall be adequately staffed by
qualified and trained personnel with at least one (1) medical technologist
registered with the Board of Medical Technology (PRC).
(c) The physical plant shall be housed in well–lighted and
ventilated, dust free areas with an adequate supply of water. The space should
be sufficient to accommodate the various activities of the blood bank.
(d) The blood bank shall have the equipment, furniture,
glassware, plastic blood bags, reagents, and other supplies needed to properly
undertake the required services.
2. The Bureau of
Research and Laboratories shall evaluate compliance with such technical
standards in accordance to minimum requirements for such category of blood bank
and other requirements as may be promulgated under these Rules and Regulations.
Section 9
Management of Blood
Bank
The Head (Chief, Director,
Physician–In–charge, etc.) is the person who assumes technical and
administrative supervision and control of activities in the blood bank.
1. For all
categories of blood banks, the head shall be licensed physician certified by
the Philippine Board of Pathology in Clinical Pathology or Blood Banking of
Philippine Board of Hematology and Blood Transfusion provided that:
(a)
This shall be
mandatory for all categories of free standing blood banks and all secondary and
tertiary categories of hospital blood banks.
(b)
This shall be
voluntary for all primary category hospital blood banks. For those blood banks
unable to comply with the above requirement, they may be headed by a licensed
physician who has completed at least three (3) months of training in blood
banking including quality control and management in an acceptable institution
and passed an examination given or approved by the Bureau of Research and
Laboratories.
2.
A certified
Pathologist or Hematologist may be authorized to head and manage not more than
two (2) blood banks.
3.
A physician under
9.1 paragraph (2) may be authorized to head only one (1) hospital blood bank
(primary category).
Section 10
Requirements for the
collection, processing and disposition of Blood and Blood products
1. Donor
requirements
(a)
Determination of
the suitability of the donor shall be the responsibility of the head of the
blood bank and shall be done by him or under his supervision with the
assistance of the necessary trained personnel.
(b)
Blood donors
shall be in good physical condition and free of diseases transmissible by blood
transfusion as far as can be determined from the donor’s personal history and
from such physical examination and laboratory tests as prescribed by the Bureau
of Research and Laboratories.
2.
Collection
of Blood
(a) Drawing blood from donors shall be the responsibility
of the Head and shall be done by him or under his direct supervision with the
assistance of the necessary trained personnel
(b) The drawing shall be performed in a suitable bleeding
areas located in the blood bank.
(c) The expiration date for preserved blood shall be
specified in the label in accordance with the anticoagulant used as specified
in the Technical requirements.
3.
Whole Blood
and Blood products
(a)
The preparation
of whole blood and blood products shall be according to standard procedures
acceptable to the Bureau of Research and Laboratories
(b)
The
characteristics, quality or components, quality of cellular elements, properties
and other specifications of whole blood and blood product s shall be prescribed
by the Bureau of Research and Laboratories and compliance with such
specification shall be determined by periodic Quality Control Test (Section 13).
4.
Dispensing
of blood
Blood
or its products is to be dispensed only upon the presentation of a proper
request from the attending physician or hospital authority or another blood
bank, which shall be kept on file and subject to inspection.
5.
Records
(a)
Blood Banks shall
maintain a permanent record to show the donor’s name, card number, data pertaining
to the donor, the result of blood grouping, serologic and other screening
tests, for whom the blood was issued, and the date of issue.
(b)
Provisions must
be made for recording reactions if any have occurred.
(c)
Records must be
kept of the quantity of blood in storage, disposed or transferred daily, and
temperature of storage.
6.
Labels
All
blood containers shall have labels which shall contain data specified in the
technical requirements
Section 11
Reporting
Each blood bank shall
report annually the volume of blood collected and utilized or otherwise
disposed of and any adverse reactions that have occurred in accordance with the
format prescribed by the Bureau of Research and Laboratories.
Section 12
Quality Control Tests
The Director of the Bureau
of Research and Laboratories or his representative is hereby authorized to
conduct such quality control tests as he does appropriate or necessary for the
administration of these regulations, for the control of operations and as
criteria for the renewal license. These include tests on blood products to
determine if they comply with specifications prescribed by the Bureau of
Research and Laboratories.
Section 13
Donor Registries
1. The Bureau of
Research and Laboratories may establish control donor
registries of rare blood types or hazardous donors as the Director may deem
necessary.
2. Each blood bank
shall establish such registries for the supply of rare blood and protection
recipients
Section 14
Blood Bank Rates
1. Blood Banks
should be operated on a non–profit basis. The fees charged shall be based on
actual cost including expenses for recruitment of donors, collections,
processing, storage and transportation of blood with reasonable allowance for
spoilage and professional services rendered.
2. The Bureau of
Research and Laboratories shall prescribe from time to time the maximum rates
for blood and the products in consultation with the appropriate professional
societies.
Section 15
Basic License
Requirements
1. Any person, firm
or corporation desiring to establish or operate and maintain a blood bank shall
submit to the Bureau of Research and Laboratories a sworn petition/application
on the prescribed form containing among others the following data:
(a)
Name, citizenship
and domicile of the Head of the Blood Bank
(b)
Place,
municipality and province where it is to be established
(c)
Name of the
establishment
(d)
Name, citizenship
and domicile of the owner
(e)
Scope of the
nature of work to be undertaken
(f)
Statement of duly
notarized that applicant has complied with all business requirement under
existing laws or ordinances that are necessary in pursuance of the activity for
which license is herein applied for.
2. If the applicant
is a partnership or corporation, it must be duly registered existing laws and
that the copy of its registration papers be attached to the corresponding
petition.
Section 16
Applicant for License
1. An application
for a license shall be filed by the owner in a form “Petition to
Establish/Operate a Blood Bank” together with the application to Head of Blood
Bank and Information Sheet with the Office of the Bureau of Research and
Laboratories for screening and approval.
2. Each application
shall be signed under oath or affirmation by the applicant or a person duly
authorized to act for and on his behalf.
3. The license free
should be submitted together with the application.
4. Within 60 days
after receipt of said application, an inspector of the Bureau of Research and
Laboratories shall inspect the establishment and verify if the applicant has
complied with the requirements prescribed in these regulations.
5. Any false
statement in the application or failure to comply with the requirements may
serve as basis for refusal to issue a license to operate a blood bank.
Section 17
License Fees
1. A non–refundable
fee shall be charged for every application for a license to open and operate a
blood bank with government and private.
2. A non–refundable
fee shall be charged on application for renewal filed during the first three
(3) months of each year.
3. All fees shall be
payable to the Bureau of Research and Laboratories in accordance with the
following schedule:
For
new licenses:
(a)
Primary Category P200.00
(b)
Secondary
Category P300.00
(c)
Tertiary Category P500.00
4. A penalty of
P100.00 for late renewal shall be charged in addition to the renewal fee for
all blood bank categories; if the application is filed during the next (2)
months after March 31.
5. After the fifth
month un–renewed license shall be considered lapsed, and a new license shall be
applied for.
Section 18
Inspection
Blood Banks and their
facilities shall be subject to regular inspection and records made available to
determine compliance with above regulations
1. Each license
shall afford to give the Director of the Bureau of Research and Laboratories or
his duly authorized representative at any reasonable time opportunity to
inspect the premises and facilities wherein blood bank activities are being
performed.
2. Each license
shall make available to the Director of the Bureau of Research and Laboratories
or his duly authorized representative of inspection, records kept pursuant to these
regulations.
3. The Director of
the Bureau of Research and Laboratories of his representative may be assisted
by duly designated experts from professional associations in such inspections.
4. Directors of
Regional Health Office, Provincial, City and Municipal Health Offices are
hereby empowered to report the existence of unlicensed blood banks or any
private party processing blood without proper permit or license and/or
violations of these rules to the Bureau of Research and Laboratories.
Section 19
Issuance of a License
An applicant for a license
will be approved and issued by the Undersecretary of Health for Standards and
Regulation if
1. The blood bank
shall be operated on a non–profit basis;
2. The blood bank
has satisfied the standards and requirements promulgated by the Bureau of
Research and Laboratories and paid the license fee;
3. The owner/manager
must not have had any record of illegal operation of a blood bank or the head a
record of connection with a blood bank that has been illegally operated.
Section 20
Terms and Condition of
License
1. The license is
granted on the basis of specific conditions and limitations in compliance with
certain requirements as established during the inspection and defined in the
issuance of the license.
2. The license as
herein granted as well as any right under the license shall not be assigned or
otherwise transferred directly or indirectly to an authorized party.
3. The owner or a
blood bank desiring to transfer to another place shall inform in writing the
Bureau of Research and Laboratories within fifteen (15) days after such
transfer. The blood bank in its new location shall be subject to re–inspection
and should comply with these rules.
4. A blood bank
desiring to stop operation should notify in writing the Bureau of Research and Laboratories
of this fact starting the date of termination.
5. A blood bank
physician who decides to terminate services or transfer supervision should
inform in writing the Bureau of Research and Laboratories within fifteen (15)
days of such termination or transfer.
6. Failure to report
in writing 15 days of any substantial change of conditions of the license may
be the basis for suspension or revocation of the license.
Section 21
Exhibition of license
and Rules and regulations
The license of the blood bank
must be placed in a conspicuous place within the blood bank. The head of the
blood bank must likewise place his certificates of his specialty. A notice must
be posted informing the public that complaints about the services may be
addressed to the Bureau of Research and Laboratories. A copy of this Rules and
regulations and related Bureau orders should be readily available for guidance
of all personnel of the blood bank.
Section 22
Expiration of License
Each specific license of
the blood bank shall expire on the last day of December of the year stated
herein including the authorization of the head.
Section 23
Renewal
1. Application for
renewal of the license shall be filled during the first three months of the
current year.
2. The Bureau of
Research and Laboratories shall process applications for renewal of license
upon receipt thereof provided that blood banks may continue operations during
the pendency of final action on their application, unless otherwise advised or
ordered by the Director of the Bureau of Research and Laboratories to cease
operation.
3. A blood bank
whose license has been suspended or revoked shall not be allowed to reopen
without first securing a new permit which shall be issued upon payment of the
required fee and upon satisfactory evidence that such owner has already
complied with requirements prescribed in these regulations.
Section 24
Publication of list of
Blood Banks
1. A list of
licensed blood banks according to their type and category shall be published
periodically and made available to any person, agency or organization for
legitimate purposes.
2. The results of
quality control testing shall likewise be published
Section 25
Modification and
revocation of license
The terms and conditions
of each license shall be subject to amendments of modification by means of amendments
to these regulations as the Secretary of Health may deem necessary. Except in
cases of willful or repeated violations hereof, or where public health interest
or safety requires otherwise, no license shall be modified, suspended or
revoked unless prior notice has been made and the corresponding investigation
conducted.
Section 26
Violations
1. The license to
operate a blood bank may be suspended or revoked by the Undersecretary of
Health for Standards and Regulation upon violation of the Blood Bank Law (R.A.
1517) or the rules and regulations issued in pursuance thereto or the
commission of the following acts by the persons owning or operating a blood
bank and the persons under their authority.
(a)
Operation of a
blood bank without a certified Pathologist or Hematologist or a qualified
licensed Physician authorized by the Undersecretary of Health for Standards and
Regulation as Head without employing a duly registered Medical Technologist;
(b)
Any false
statement in the application;
(c)
Change of
ownership, location, head of Blood Bank or personnel without informing the
Bureau of Research and Laboratories in writing;
(d)
Refusal to allow
inspection of the Blood Bank by persons authorized by the Director of the
Bureau of Research and Laboratories during reasonable hours;
(e)
Refusal to
perform quality control tests or submit samples of blood products for quality
control evaluation as required by the Bureau of Research and Laboratories.
(f)
Imposing charges
on blood products higher than those promulgated by the Bureau of Research and
Laboratories.
(g)
Failure to
correct deficiencies within a reasonable time after due notice from the Bureau
of Research and Laboratories.
2. Any person who
operated a blood bank without the proper license from the Bureau of Research
and Laboratories or violated any provision of these Rules and Regulations shall
upon conviction be punished with an imprisonment for not less than one (1)
month but not more than one (1) year or a fine not less than one hundred pesos
(P100.00) but not more than one thousand pesos (P1,000.00) or both such fine
and imprisonment at the discretion of the court. Provided, however, that if the
offender is a firm or corporation, the head and owners thereof shall be liable
to the penalty imposed herein.
Section 27
Investigations of
Charges and Complaints
Upon the filing of a
complaint or charges duly sworn by any person, interested party or corporation,
against a blood bank or any of its personnel to the effect that one or more of
such personnel of an approved blood bank have violated or are violating R.A.
1517 or the provision of these regulations, the Undersecretary of Health for
Standards and Regulations or his duly authorized representatives shall
investigate the complaints or charges and verify if the licensed blood bank
concerned or any of its personnel is guilty of the charges. If upon
investigations, a person or persons are found violating the provision of R.A.
1517 or any of these regulations, the Undersecretary of Health for Standards
and Regulations shall suspend for a definite or indefinite period of time or
cancel or revoke the license blood bank and the authority of the offending
person or persons, without prejudice to taking the case to judicial authorities
for criminal action.
Section 29
Effectivity
These rules and regulation
shall take effect 15 days after publication in the Official Gazette or a
newspaper of general circulation and shall supersede all issuances inconsistent
thereof.
ALFREDO R.A. BENGZON,
M.D.
Secretary of Health
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