September 20, 1971
ADMINISTRATIVE ORDER
No. 156 series 1971
REVISED RULES AND
REGULATION GOVERNING THE COLLECTION, PROCESSING AND SALE OF HUMAN BLOOD AND THE
ESTABLISHMENT AND OPERATION OF BLOOD BANKS AND BLOOD PROCESSING LABORATORIES
Section 1
Purpose and Title
The Rules and Regulation
promulgated as Department of Health Administrative Order No. 56 series 1959
pursuant to Section 5 of Republic Act No. 1517, approved on June 16, 1956, are
hereby revised and shall be known as “REVISED RULES AND REGULATION GOVERNING
THE COLLECTION, PROCESSING AND SALE OF HUMAN BLOOD AND THE ESTABLISHMENT AND
OPERATION OF BLOOD BANKS AND BLOOD PROCESSING LABORATORIES IN THE PHILIPPINES,”
they are hereby promulgated for the purpose of safeguarding and promotion public
health and welfare by preventing improper collection, processing and sale of
human blood or its product to the public.
Section 2
Scope
The regulation embodied
herein shall apply to the collection, processing and sale of human blood and
the establishment and the operation of blood banks and blood processing
laboratories in the Philippines, including those already in operation in all
government or private hospitals.
Section 3
Basic License
Recruitment
Any person desiring to
establish or operate a blood bank and/or Blood Processing Laboratory or
desiring authority to collect, process and distribute, whether for free or for
sale human blood, shall submit to the Bureau of Research and Laboratories, a
sworn application in the form prepared by the said Bureau and containing, among
others, the following data: the place, municipality and province where it is to
be established; the name of the establishment, the name or names of person or
person in charge; and the name, citizenship, and domicile of the owner, administrator or manager. The
application should be accompanied by a copy of the partnership or corporation
papers if the applicant is a partnership or corporation. An inspector of the
Bureau of Research and Laboratories shall, upon receipt of said application,
inspect the establishment and verify if the applicant has complied with the
requirements prescribed in these regulations. The application will then be
forwarded by the Director of Bureau of Research and Laboratories to the
Secretary of Health for approval and signature of the necessary license or for
any other appropriate action.
Section 4
A fee of one hundred pesos
(P100.00) shall be charged to every license issued by the Bureau of Research
and Laboratories, to open or operate a blood bank or processing laboratory or
to distribute human blood whether for free or for sale. This license shall be
subject to renewal within the last 2 months of each year upon payment of a
renewal fee of fifty (P50.00). A grace period of two (2) months is allowed
subject to a levy of ten pesos (P10.00) fine within the first two months of the
next year. After this grace period the license will be considered to have
lapsed and a new license shall be applied for.
Section 5
No Blood Bank or Blood
Processing Laboratory 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 the proper license from the Bureau of Research and Laboratories
properly signed by the Secretary of Health, except in case of emergencies due
to severe hemorrhage where there is an immediate danger to the patient’s life,
as provided for in Section 3 of R.A. No. 1515.
Section 6
No blood is to be
dispensed except upon the presentation of a proper prescription, or request
from the attending physician or hospital authority or another blood bank, which
shall be kept on file and subject or open to inspection.
Section 7
No person is permitted to
operate, manage or supervise a blood bank unless he or she is a licensed
physician duly registered with the Board of Medical Examiners of the Republic
of the Philippines to practices the medical profession in this country and must
have had training in blood bank operations in accredited blood banking
institutions.
Section 8
Unless otherwise
specified, the words hereinafter mentioned shall have the following meanings:
a. Blood – means human blood, processed or unprocessed and
includes its products and derivatives.
b. Persons – includes individuals, corporations, association,
societies and organizations.
c. Costs – means the actual purchase price of unprocessed
blood and its handling charges, such as those for its collection, processing,
storage, transportation and sale and reasonable allowance for spoilage.
d. Blood Bank – blood processing laboratory or service where any
two or more of the following are done.
1. Solicitation and screening of blood donors
2. Collection of blood for transfusion
3. Processing and storage of blood
4. Transport and issuance to hospitals, to clinics and
health centers
e. Closed system – means a system which permits the transfer of
material from one container to another entirely within the system, without
contamination and exposure to outside air.
f. Philippines – when used in geographical sense includes all the
territories and possession of the Republic of the Philippines.
g. Products and
derivatives – whole blood,
concentrated red cells, plasma and its fractions, platelet concentrates, etc.
Section 9
Interpretations
Except as specifically
authorized by the Secretary of Health in writing, no interpretation of the
meaning of the regulations by any officer or employee of the office of the
Secretary of Health other than a written interpretation by the Secretary of
Justice will be recognized to be binding upon the Secretary of Health.
Section 10
Application for
Licenses
a. Application for
license shall be filed in a form “Application or Blood and Processing
Laboratory” with the Office of the Bureau of Research and Laboratories for
screening and approval.
b. Each application
shall be signed under oath or affirmation by the applicant or a person duly
authorized to act for and on his behalf.
Section 11
General Requirements
for Issuance of License
An application for license
will be approved if:
a. The application
is for non–profit basis, i.e., blood shall be sold at cost. The regular charge
shall not be less or more than that set by the Bureau of Research and
Laboratories from time to time in consultation with the appropriate specialty
societies.
b. The laboratory
establishment satisfied the scientific standards as contained in Section 13 and
14 hereof.
c. No material false
statement or misstatements of conditions verified on inspection have been made
in the application.
Section 12
Terms and Conditions of
License
a. Neither the
license as herein granted nor any right under the license shall be assigned or
otherwise transferred to an unauthorized party in violation of the provisions
of these regulations.
b. Any Blood Bank or
Blood Processing Laboratory desiring to transfer to another place shall report
this fact to the Bureau of Research and Laboratories, stating the new place and
site of the establishment within ten (10) days after transfer after subject to
re– inspection. Likewise, any blood bank or blood processing laboratory
desiring to stop operation should notify the Bureau of Research and
Laboratories of this fact stating the date it will or stopped operation.
c. Any blood bank
physician who decides to terminate services or transfer supervision should
inform the Bureau of Research and Laboratories.
Section 13
Requirements for a
Blood Bank and/or Blood Processing Laboratory
a. Personnel
Blood
banks and blood processing laboratories shall be under the direction and
supervision of a licensed and qualified physician with training in blood
processing and operation in an accredited blood bank. All technical assistants
involved in the technical aspects of blood banking operation should be either
registered physicians or registered Medical Technologists. No qualified
physician will be given permits to operate more than four (4) geographically
separate, blood banks and/or clinical laboratories except in localities where
other factors like lack of qualified physicians and the needs of public health
have to be considered.
b. Physical
plant
(1) Work rooms must be housed in a permanent building
constructed of strong materials, preferably concrete or semi–concrete. Floor
must be concrete, tiled or linoleum finish. It must also have adequate
drainage.
(2) Work rooms should be well–ventilated with adequate
provisions for either natural or artificial lighting.
(3) Should be relatively dust–free, preferably air conditioned.
(4) Should have adequate supply of water for washing and
cleaning facilities such as for scrubbing of hands, washing glass containers,
utensils, and other glassware used in the laboratory
(5) A separate space must be provided for the bleeding or
collection of blood which should be well lighted and well ventilated and
situated on the cool portion of the building. The ideal temperature is from 75o–80oF.
(6) The laboratory should likewise be clean and should be
located just adjacent to the bleeding area.
c. Equipment
(1)
For
preliminary testing of donors:
(a) Blood pressure apparatus
(b) Stethoscope
(c) Weight scale
(d) Disposable or autoclave lancets, needles for making
punctures for collecting blood for hematologic examinations.
(e) Hemoglobin determination apparatus or hematocrit
(f) Miscellaneous glassware slides, etc.
(g) Clinical thermometer
(2)
For
Bleeding Area:
(a)
Bleeding tables
or bed
(b)
Blanket to cover
donor when needed
(c)
Bedside table
with containers for sterile, cotton, sponges, spirit of ammonia
(d)
Tourniquet
(e)
Autoclaved or
disposable syringes, needles
(f)
Special blood
containers with measured anticoagulants, sterile and pyrogen free solutions
(g)
Disposable
plastic blood donor sets
(h)
Emergency tray
containing vasopressor drugs, atropine and cardio – respiratory stimulant and
intravenous fluids and infusion set.
(i)
Blood Collection
Scale
(3)
Storage
Room
(a)
Blood
refrigerator, with automatic thermoregulatory of adequate capacity. Temperature
of refrigerator must be automatically maintained between 2o – 8oC.
it must be provided with at least a laboratory thermometer which much be read
and recorded every 12 hours. If possible, an alarm system must be incorporated
to extreme temperature. The refrigerator must be used exclusively for storage
of blood.
(4)
For the
Blood Processing Laboratory (Minimum required equipment)
(a)
Clinical
centrifuge for serology work.
(b)
Waterbath for 37oC
and 56oC with motoring thermometer
(c)
Microscope,
compound
(d)
Shaking machine
for serological tests
(e)
Miscellaneous
laboratory glasswares, slides, etc.
(f)
Close system for
blood components
(5)
For maintenance
of Sterile supplies
With
the adequate use of expendable blood containers, donor sets, transfusion sets
and other expandable assemblies, the list of equipment mentioned above, under
minimum equipment, are all that is required. However, if reusable equipment and
supplies are to be used, the following additional facilities are required:
(a)
Adequate washing
facilities
(b)
Autoclave and hot
air sterilizer
(6) For fractionation of blood components other than
packed red cells and plasma, there should be a refrigerator centrifuge torsion
balance.
d. Reagents
(1) ABO typing sera
(2) Rh typing sera
(3) Bovine albumin and/or Coomb’s reagent or enzyme like
Ficin or Papain or trypsin etc.
(4) Antigen for the acceptable serological tests.
(5) Copper sulfate if there’s not hematocrit or
hemoglobinometer
(6) Giemsa’s or Wright’s stains
Section 14
Minimum Requirements
for the Collection, Processing and Disposal of citrated Whole Blood (Human)
a. Donor
requirement
Determination
of the suitability of the donor shall be the responsibility of a physician–in –charge
of the blood bank and shall be done by him or under his supervision with the
assistance of the necessary trained attendant. Only those person who are in
physical condition to give blood may serve as blood donors. Donors shall be
free diseases past or present transmissible by blood transfusion (particularly
malaria, other protozoal diseases, syphilis, infectious hepatitis and acute
upper respiratory disease) as far as can be determined from donor’s personal
history and from such physical examination and laboratory tests as appear
necessary for each donor on the day the blood is obtained.
b. Other
requirements of donors
(1)
Age must be
between 18 – 55 (18 – 20 – written parental or guardian consent)
(2)
Mouth temperature
must not exceed 99.5oF or 37.3oC.
(3)
Hemoglobin level
must not be less than 12g/100ml of blood or hematocrit of 36 or with Cu2SO4
at 1:053
(4)
Systolic blood
pressure must be between 100 to 160 mmHg. Provided the diastolic pressure is
not over 100.
(5)
Donor who is
pregnant or who has delivered within the past year should not be accepted.
(6)
Donors, male or
female should weigh at least 110 lbs. to give one pint of blood.
(7)
Donors may give ½
pint of blood every 3 to 4 weeks and 1 pint every 6 to 8 weeks provided they
satisfy all other requirements.
(8)
A history of
viral hepatitis or any history of jaundice, malaria shall disqualify donors.
(9)
Donors who have a
history of the following diseases: diabetes, active tuberculosis, undulant
fever, viral infection, filariasis, those under hypertensive therapy, those
that show effects of alcohol, syphilis, those under treatment for rabies,
should not be accepted.
(10)
Person who has
had tooth extractions within 3 days should not be allowed to give blood.
(11)
Persons who
received blood transfusion within 6 months should not be allowed to give blood.
(12)
Persons who have
received within 2 weeks viral or bacterial vaccine immunizations should not be
allowed to give blood.
(13)
Persons who are
receiving current penicillin therapy should not be allowed to give blood.
(14)
Fasting is not a
requirement for blood donation
c. Collection
of the Blood
(1)
Bleeding of
donors – drawing blood from the donor shall be the responsibility of the
licensed physician in–charge and shall be done by him or under his direct
supervision with the assistance of the necessary trained attendants; the
drawing shall be performed in a suitable bleeding area located in the licensed
laboratory or blood bank.
Apparatus
or instruments such as lancets, needles, syringes, or other bloodletting
device, capable of transmitting infection from one person to another shall be
autoclaved for 30 minutes at 121.5oC (15lb. pressure) or sterilized
by dry heat for two hours at 170oC. The method employed for the
removal of blood from the donor shall conform to the accepted standards of
aseptic surgery and shall be made in a closed system.
(2)
The Blood
containers and anticoagulant solutions:
The
bloodletting device used for the removal of the blood and the receiving unit,
which is commercially available in three sizes, shall contain a pyrogen free
anticoagulant solution of either of the following:
(a) NIH – ACD Solution Formula A or B
(b) CPD Solution
(c) Heparin
(3)
Collection and
Storage of Blood
(a)
Technic of
Bleeding – should be in accordance with accepted standards.
(b)
Plastic Blood
Containers – plastic blood containers are preferred to bottles since it
provides a closed sterile system, where the donor tubing, needle and the blood
containers are integral part of a set. It also allows multiple cross – matching
without contamination of the main container. In addition, no pilot tubes are
necessary.
(c)
Precautions – if
any sign of syncope develops during or after blood collection, constant direct
medical attention of the donor is necessary until vasomotor stability of
cardiac status is assess as satisfactory.
(d)
Labelling – the
label of the blood container must contain the following:
·
Name and address
of Blood Bank and permit number
·
Content of bottle
·
Donor’s name or
serial number
·
ABO type
·
Rh Type when
required
·
Date of extraction
·
Date of
expiration
·
Result of
specific serological test
·
Must contain a
warning in bold type as follows:
Caution:
–
Keep continuously at 2o – 8oC
–
Crossmatch before
use
–
A filter must be
used in the administration
–
Do not add other
medication to the bottle of blood
When
pilot tubes are used, labels must carry the same serial number as the main
blood container.
(e)
Storage – blood
should be stored in a refrigerator that is exclusively used for blood or any of
its components at a temperature range of 2o to 8oC. If
the refrigerator temperatures exceed 15oC for at least 8 hours, all
blood stored at that time should be condemned for use. If at any time, the
temperature goes below the desired level and if there is any evidence of
freezing of blood in the container, all such blood should be discarded.
Blood
should never be heated not allowed to freeze – blood should not be exposed to
direct sunlight nor allowed to come in direct contact with dry ice or any other
freezer object. Do not add anything to blood containers.
d. The
Serological Test
At
least a VDRL or any acceptable serological test for syphilis shall be made on
the specimen of blood taken from the donor at the time of bleeding and the
blood shall not be used for transfusion unless the result of the test is non –
reactive. Specific serological test should follow the standard procedure
required. Interpretation of the serological reaction should conform to that
recognized by the Bureau of Research and Laboratories.
e. Determination
of Blood groups
Each
donor’s blood must be securely attached to the donor’s bottle and must not be
detached until grouping and cross – matching tests have been done and recorded.
A generally accepted technique must be used for each grouping test and with
both anti–A and anti–B grouping serum of acceptable avidity and potency as
defined by the Bureau of Research and Laboratories. Provisions of reverse
typing should be available.
f. Determination
of the Rh type
Typing
the donor cells for the Rh factors may be carried out if desired using typing
serum of satisfactory avidity and potency and with a technique designed for the
test serum. The results of the tests must be recorded on the donor’s personal
history card and on the final container label.
g. Use of
Group “O” Blood other than “O” recipient
Group
specific blood must be the rule in transfusion. If Group “O” blood must be used
for non–“O” recipients, low titer “O” blood must be used with titer of anti–A
and anti– B to be not more than 1:100.
h. Expiration
date
The
expiration date for blood preserved in one of the Acid – Citrate Dextrose (ACD)
anticoagulant solution, shall not exceed 21 days from the date of bleeding the
donor and for containers with CPD shall not exceed 28
days.
i. The label for
whole blood and packed red cells must provide for information as required in
accordance with Section 14, subsection 4.
Colors
to designate the various blood groups used internationally may be used in the
following scheme:
A – Blue
B – Yellow
AB – Pink
O – White
j. Re–issue
of Blood
Blood
that has been removed from storage and sent to another bank or hospital may be
returned for re–issue only under the following conditions:
1. Blood collected
in bottles – blood may be reissued provided:
(a)
There is no
evidence of puncture
(b)
Re–issue after
quarantine period of 24 hours and no evidence of hemolysis seen.
(c)
Pilot tube is
attached.
2. Blood collected
in plastic containers – may be re–issued under the following conditions:
(a) The seal must be broken
(b) Reissue after a quarantine period of 24 hours and no
evidence of hemolysis seen.
(c) Sufficient integral donor tubing is left with the bag.
k. Records
Blood
banks and blood processing laboratories shall maintain a permanent record to
show the donor’s name, card number, and all data pertaining to the donor. It
must show that the blood was stored under required condition of temperature,
the result of blood grouping, blood typing, serologic and other tests. It must
show for whom the blood was issued and the date of issue. Provisions must be
made for recording reactions if any have occurred. Records must be kept of the
quantity of blood in storage, disposed or transferred.
Section 15
Blood banking facilities
and processing laboratories shall be subject to regular inspections and records
be made available to determine compliance with above regulations.
Section 16
All existing Blood Banks
and/or Blood Processing Laboratories shall comply with the requirements of
these regulations within thirty (30) days, after receipt of notice.
Section 17
Blood banks and/or blood
processing laboratories whose license has been revoked under Section 23 hereof
shall not be allowed to reopen without first securing a new permit which may be
issued upon payment of a fee of One Hundred (P100.00) pesos and upon
satisfactory evidence that such owner or administrator has already complied with
the requirements prescribed in those regulation.
Section 18
Expiration
Each specific license
shall expire at the end of December of the year stated therein.
Section 19
Renewal
a. Application for
renewal of license shall be filed in accordance with the preceding section 3
hereon.
b. In any case in
which a license, prior to the expiration of an existing license, has filed an
application in proper form for renewal or for a new license, such existing
license shall not expire until the application for renewal has been finally
approved by the Secretary of Health.
Section 20
Inalienability of
License
No license issued or
granted in accordance with these regulations shall be transferred, assigned or
in any manner disposed of either voluntary or involuntary, directly or
indirectly, through transfer of control to any person, without the consent in
writing of the Secretary of Health. The owner of the blood bank shall furnish
the Secretary of Health the necessary and full information pertaining to the
transfer.
Section 21
Inspection
a. Each license
shall afford to give the Secretary of Health or his duly authorized
representative, at all reasonable time opportunity to inspect the premises and
facilities wherein the blood is being processed or stored.
b. Each license
shall make available to the Secretary of Health or his authorized
representative for inspection, records kept by him pursuant to these
regulations.
c. Directors of
Regional Health regions, provincial, city, and Municipal Health Officers are
hereby empowered to report the existence of unlicensed blood banks or any
private party processing blood without proper permit or license to the Bureau
of Research and Laboratories.
Section 22
Tests
Each license shall perform
or permit the Secretary of Health or his authorized representative to perform
such tests as he deems appropriate or necessary for the administration of these
regulations.
Section 23
Modification and
Revocation of License
a. Any license may
be revoked or suspended in whole or in part, for any material false statement
in the application or because of conditions revealed by such application or
statement of fact or any report record of inspection which would warrant the
Secretary of Health to refuse to grant a permit on an original application, or
for a violation of, or failure to observe any of these terms and provisions of
these regulations.
b. Except in cases
of willfulness or those in which the public health interest, or safety requires
otherwise, no permit shall be suspended or revoked unless, prior to the
institution of proceeding therefore, facts or conduct which may warrant such
action shall have been called to the attention of licensee in writing and the
licensee shall have been accorded an opportunity to demonstrate or achieve
compliance with all lawful requirements.
Section 24
Violations
Any person who violates
any provision of the rules and regulations shall be punished by imprisonment
for not less than one month and not more than one year or by a fine of not less
than one hundred pesos and not more than one thousand pesos or by both such
fine and imprisonment in the discretion of the court.
Section 25
Effectivity
These regulations shall
take effect immediately.
AMADEO H. CRUZ, M.D,
C.P.H.
Secretary of Health
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