Medical Technology

Laws and Bioethics

A WORK TEXTBOOK

Gamaliel lssamar De Vera

Ma. Frieda Z. Hapan
Edilberto P. Manahan
Medical Technology Laws
and Bioethics

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Medical Technology Laws
and Bioethics

Gamaliel lssamar De Vera , MSMT

Ma. Fri eda Z. Hapan, PhD
Edilberto P. Manahan, PhD
Gregorio L. Martin I, PhD
Rodolfo R. Rabor, MSMT

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PART I
MEDICAL TECHNOLOGY LAWS
AND OTHER RELATED LAWS
UNIT1
RA 5527: The Philippine Medical Technology Act of 1969 ............... 2
UNIT 2
RA 4688: The Clinical Laboratory Law of 1966 ................................... 33
UNIT 3
RA 7719: The National Blood Services Act of 1994 ............................ 57
UNIT 4
RA 11166: Philippine HIV and Aids Policy Act of 2018 ........................119
UNIT 5
RA 9165: Comprehensive Dangerous Drugs Act of 2002 .............. 161
UNIT 6
RA 9288: Newborn Screening Act of 2004 ......................................... 211
UNIT7
RA 7170: Organ Donation Act of 1991 .................................................. 225
UNIT 8
RA 10912: Continuing Professional Development Act of 2016 .... 239
UNIT 9
RA 10173: Data Privacy Act of 2012 ...................................................... 253

PART II
HEALTH, HEALTH CARE, BIOETHICS,
AND PROFESSIONAL ETHICS
Unit 10
The Concept of Health .............................................................................. 278
UNIT11
The Calling of the Health Care Provider ............................................. 287
UNIT12
Introduction to Bioethics ........................................................................... 301
UNIT 13
Profesional Ethics and Professional Conduct .....................................315
References ....................................................................................................327
Appendix .........................................................................................................331

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 T.HE PHILIPPINE MEDICAL TECHNOLOGY
ACTOF1969

INTRODUCTION
RA 5527 is the governing law for all medical technologists in the country. It embodies different
provisions about the practice. Likewise, guidelines on licensure examination are also integrated. It
contains 32 sections and was already amended three times by the following: RA 6 138 (August 3 1,
1970), PD 498 (June 28, 1974) and PD 1534 (June 11, 1978).
RA 5527 is an Act Requiring the Registration of Medical Technologist, Defining 'Ui.eir Practice,
and for O ther Purposes.

INTENDED LEARNING OUTCOMES

At the end of this unit, the students are expected to:
I. discuss medical technology practice in the Philippines
2. analyze different cases related to medical technology practice
3. evaluate current status of medical technologists in the Philippines
4. design a curriculum for medical technology tailored to international demands

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 RA5527 -
The Pnllipplne Medical Technology Act ot 1969

SECTION HEADING DETAILS

Title This Act may be also cited as the Philippine Medical
Technology Act of 1969.
Definition of As used in this Act, the following tenns shall mean:
Tenns a. Practice ofMedical Technology
A person shall be deemed to be in the practice of medical
technology within the meaning of this Act, who shall for a
fee, salary or other compensation or reward paid or given
directly or indirectly through another, renders any of the
following professional services for the purpose of aiding
the physician in the diagnosis, study and treatment of
diseases and in the promotion of health in general:
I. Examination of tissues, secretions and excretions
of the human body and body fluids by various
electronic, chemical, microscopic, bacteriologic,
hematologic,serologic, immunologic, nuclear, and
other laboratory procedures and techniques either
manual or automated;
2. Blood banking procedures and techniques;
3. Parasitologic, Mycologic and Microbiologic
procedures and techniques;
4. Histopathologic and Cytotechnology; provided
that nothing in this paragraph shall l inhibit a
duly registered medical laboratory technician
from perfonning histopathologic techniques and
procedures.
S. Clinical research involving patients or human beings
requiring the use of and/ or application of medical
technology knowledge and procedures;
6. Preparations and standardization of reagents,
standards, stains and others, provided such reagents,
standards, stains and others are exclusively for the use
of their laboratory;
7. Clinical laboratory quality control;
8. Collection and preservation of specimens;

Provided, That any person who has passed the

corresponding Board examination for the practice of a
profession already regula ted by existing law, shall not
be subject to the provisions of the last four preceding
paragraphs if the perfonnance of such acts or services is
merely incidental to his profession.

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

SECTION HEADING DETAILS

b. Pathologist
A duly registered physician who is specially trained
in methods of laboratory medicine, or the gross and
microscopic study and interpretation of tissues, secretion
and excretions of the human body and its functions in
order to diagnose disease, follow its course, determine
the effectivity of treatment, ascertain cause of death and
advance medicine by means of research.

c. Medical Technologist
A person who engages in the work of medical technology
under the supervision of a pathologist or licensed
physician authorized by the Department of Health in
places where there is no pathologist and who having
passed the prescribed course ( Bachelor of Science in
Medical Technology/ Bachelor of Science in Hygiene) of
training and examination is registered under the provision
of this Act.

d. Medical Laboratory Technicians

A person certified and registered with the Board as
qualified to assist a medical technologist and/ or qualified
pathologist in the practice of medical technology as
defined in this Act.
e. Accredited Medical Technology Training Laboratory
A clinical laboratory, office, agency, clinic, hospital or
sanitarium duly approved by the Department of H ealth2
or its authorized agency.
f. Recognized School ofMedical Technology
Any school, college, or university which offers a course
in Medical Technology approved by the Department of
Education in accordance with the requirements under
this Act, upon recommendation of the council of medical
technology education.
g. Council
The council of medical technology education established
under this Act.
h. Board
1he Board of Examiners for Medical Technology
established under this Act.

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 RA5527 -
The Pnllipplne Medical Technology Act ot 1969

SECTION HEADING DETAILS

Council of There is hereby established a Council of Medical Technology
Medical Education, hereafter referred to as Council, which shall be
Technology composed of the:
Education, Its Clrairman - Director of Higher Education
Composition Vice Cliairman - Chairman of the Professional Regulation
Commission
Members:
Director of the Bureau of Research and Laboratories of the
Department of Health
Chairman and two (2) members of the Board of Medical
Technology
Representative of the Deans of Schools of Medical
Technology and Public Health
Presidents of the Philippine Society of Pathologists ( PSP)
and the Philippine Association of Medical Technologists
(PAMET)
Compensation For every meeting actually attended:
and Traveling • Chairman shall be entitled to a fifty pesos (PS0.00) per
Expenses diem
of Council • Members shall be entitled to twenty-five pesos (P25.00).
Members Each regardless of whether or not they receive regular salaries
from the government.
In addition, the Chainnan and members of the Council shall be
entitled to traveling expenses in connection with their official
duties.
Functions of The functions of the Council shall be:
the Council a. To recommend the minimum required curriculum for the
ofMedical course of medical technology.
Technology b. To determine and prescribe the number of students to be
Education allowed to take up the medical technology course in each
school, taking into account the student-instructor ratio and
the availability of facilities for instruction.
c. To approve medical technology schools meeting the
requirements and recommend closure of those found to be
substandard.
d. To require all medical technology schools to submit an
annual report, including the total number of students and
instructors, list of facilities available for instruction, a list
of their recent graduates and new admissions, on or before
the month ofJune.

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

SECTION HEADING DETAILS

e. To inspect, when necessary, the different medical
technology schools in the country in order to determine
whether a high standard of education is maintained in said
institutions.
f. To certify for admission in to an undergraduate internship,
students who have satisfactorily completed three years
of the medical technology course or its equivalent and to
collect from said student the amount of five pesos each
which money accrue to the operating fund of the Council.
g. Formulate and recommend approval of refresl,er course for
applicants who shall have failed the Board Examination
for the third time.
h. To promulgate and prescribe and enforce necessary rules
and regulations for the proper implementation of the
foregoing functions.
Minimum The medical technology course shall be at least four years,
Required including a 12-month satisfactory internship in accredited
Course laboratories, and shall include the following subjects:
English Clinical Parasitology
Biochemistry Microbiology
Spanish General Pathology
Gross Anatomy Clinical Laboratory Methods:
Social Science H ematology
Histology Serology
General Zoology Blood Banking
Physiology Clinical Microscopy
Botany Applied Microbiology
Mathematics Parasitology
College Physics Histopathologic techniques
General Chemistry Cytotechnology
Biostatistics

The Council is hereby authorized, subject to the approval of

the Secretary of Education to change, remove from or add to
the subjects listed above as the needs and demands of progress
in the science of medical technology may require.

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 RA5527 -
The Pnllipplne Medical Technology Act ot 1969

SECTION HEADING DETAILS

Medical There is hereby created a Medical Technology Board
Technology under the Professional Regulation Commission, which shall
Board thereafter be referred to as the Board composed of a:
( 1) One Chairman who is a pathologist
(2) Two members who are registered medical technologists

"'ho appoints:
They shall be appointed by the President of the Republic
of the Philippines upon recommendation of the Professional
Regulation Commission.
Term of Office:
The Chairman and members of the Board shall hold office for
three (3) years after appointments or until their successors
shall have been appointed and duly qualified:
Provided, That the incumbent members will continue to serve
until the expiration of their terms. In case of death, disability,
or removal of a member of the Board, his successor shall serve
only the balance of his term.
Qualifications of No person shall be appointed as member of the Board of
Examiners Examiners for Medical Technology unless he or she is
is a Filipino citizen;
is of good moral character;
is a qualified Pathologist, or a duly registered medical
technologist of the Philippines with the degree of Bachelor
of Science in Medical Technology/ Bachelor of Science in
Hygiene/ Public H ealth;
has been in practice oflaboratory medicine or medical
technology for at least ten ( 10) years prior to his
appointment, and;
is not a member of the faculty of any medical technology
school for at least two (2) years prior to appointment or
having any pecuniary interest direct or indirect in such
institution:
Provided, however, That for the first three years following the
approval of this Act, the requirements mentioned in number
four ( 4) shall be reduced to five years.

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MEDICAL TECHNOLOGY LAWS AND BIOETHICS
History of Medical Laboratory Science
> Ruth Heinemann – application of natural, physical, and biological sciences
> Anne Fagelson (1961) –
> Walters – health profession concerned with performing laboratory analyses in
view of obtaining information necessary in diagnosis and treatment of disease as
well as maintenance of good health
> Philippine MedTech Act – auxiliary branch of laboratory medicine which deals with
examination of various chemical, microscopic, bacteriologic, and other medical
procedures, technique which will aid in physician for diagnosis, study, and
treatment of disease and in promotion of health in general

What is uniting meaning of them?

diagnosis and
performance/
samples results treatment by
analysis
physician

> 460 B.C, Greek physician, Hippocrates

o formulated Hippocratic Oath, code of ethics for practicing physicians
o describe 4 humors: blood, black and yellow bile, and phlegm ; were felt to
be source of person’s disposition and disease in ancient times

> 600 BC, Hindu Physicians

o Polyuria in diabetes was noted
o Sweet taste of diabetic urine
o Ebers Papyrus – book for treatment of diseases contains description of 3
stages of hookworm infection

> Ruth Williams

o Medical technologist
o Believes that medical technology began from Medieval Period (1096-1438)
as supported by fact that urinalysis was a fad
o Early Hindu doctors made “scientific observation” that urine of certain
individuals attract ants, and that such urine has sweetish taste
o QUACKS, calling them doctors reaped fortunes from diagnosing diseases
by appearance of urine

> Anne Fagelson

o Prefers to date medical technology from 14th century when prominent Italian
physician at University of Bologna employed one, ALESSANDRA GILIANI to
perform tasks now under domain of medical technology
o Unfortunately, the young lady died from laboratory acquired infection
> Antonie Van Leeuwenhoek (1632-1723)
o Invented and improved compound microscope
o First to describe RBC, to see protozoa, and to classify bacteria according to
shape
o Invention of microscope led to rapid progress of microbiology and
pathology

> Hermann Fehling

o Performed first quantitative test in urine sugar in 1848

> Middle of 15th century

o Aniline Dyes were used in staining microorganisms
o Bacterial staining and microscopic study on bacteria were made possible

Establishment of Laboratories
> First Chemical Laboratory
o Established at University of Michigan by Dr. Douglas (not identified)
o Dr. Douglas pioneered laboratory instruction in this well-equipped
laboratory

> 1878, Dr. William H. Welch

o Established another laboratory at Bellevue Hospital Medical College
o Gave first laboratory course in pathology offered in American Medical
School

> 1885
o Dr. Welch became first professor of pathology at John Hopkins University

> First Clinical Laboratory

o Opened in 1896 at John Hopkins Hospital by Dr. William Osler
o In this laboratory, routine examinations were carried out, special attention
being given to search for malarial parasites in blood
o Clinical laboratory was also opened at University of Pennsylvania in 1896
(William Pepper Laboratory)

> 1908, Dr. James C. Todd

o Wrote the book “A Manual of Clinical Diagnosis”
o Retitled “Clinical Diagnosis by Laboratory Methods” in its 6th edition by Dr.
Todd and Dr. Arthur Sanford
o book became standard reference for laboratories
> 1915
o state legislature of Pennsylvania enacted law requiring all hospitals and
institutions to have adequate laboratory and to employ full time laboratory
technician

> World War I

o an impact factor in growth of clinical laboratory and produced great
demand for technicians
o demand for technicians in clinical laboratories continued, so practicing
physicians with knowledge on laboratory works began to teach their
assistants to do some tests for them

> 1919 census

o 100 technicians, all male, were employed in United States
o This increased to 3500 in 1920
o In 1922, 3035 hospitals had clinical laboratories

> University of Minnesota

o One of first schools for training laboratory workers was established here
o Course bulletin titled “Courses in Medical Technology for Clinical and
Laboratory Technicians” was issued in 1922
o First to offer a degree level program in 1923

> 1931
o Denver Society of Clinical Pathologists were organized

> 1936
o American Board of Pathology was established

> World War II

o Marked effects in laboratory medicine
o Use of blood increased and “closed system” of blood collection was widely
used
o Instrumentation advanced and these instruments paved measurement of
intensity of color produced
o Automated equipment appeared and quality control programs became
common

History of Medical Technology in Philippines

> MT practice was introduced by 26th Medical Infantry of 6th US Army
> First Clinical Laboratory in Philippines – Quiricada St., Sta. Cruz, Manila (Manila
Public Health) offered training programs to high school graduates as early as
February 1944
> 1943
o US Army left in June
o Endorsed it to National Department of Health
o The department rendered laboratory non-functional for sometime
> Dr. Pio De Roda
o Organized Manila Public Health laboratory from remnants of deserted
laboratory
o October 1, 1945 – With Dr. Mariano Icasiano as his assistant and who was
then Manila City Health Officer
> 1947
o By Dr. Pio de Roda and Dr. Prudencia Sta. Ana
o Training of high school graduates to work as medical technicians
o No period of training was set and no certificates were given
> 1954
o 6 months laboratory training with certificate upon completion was given to
trainees
o Dr. Sta Ana prepared syllabus for training programs
> Rev. Fr. Lorenzo Rodriguez
o Decided to offer it as course because of popularity of medical technology
among pharmacy students
> June 17, 1957
o Temporary permit was issued by Dept of Education for 1st – 3rd yr students in
UST
> June 1960
o Permit for internship program was issued to UST
> June 14, 1961
o Full recognition of 4 yrs BS Medical Technology course in UST was given
> Many schools followed to offer BSMT course
> DECS and CHED – 47 colleges and universities offering the course

> University of the Philippines

o Offers similar course but degree being conferred as BS Public Health
> 1962
o CEU produced its 1st batch of BSMT graduates through efforts of Mrs.
Purificacion Sunico-Suaco and approved by CEU Prexy Carmen de Luna
> July 5, 1962
o Bureau of Education approved BSMT course in FEU through efforts of Dr.
Horacio Ylagan and Dr. Serafin Juliano
> 1963
o FEU produced its 1st batch of BSMT graduates
Post Graduate Studies
> offered to BSMT graduates
> MS in Medical Technology
o UST Graduate School
o Philippine Women’s Univeristy
o Manila Central University
> MS in Public Health (1 yr, non thesis degree)
o University of the Philippines

Amendments of RA 5527
> Senate Bill 2722
o Hon. Senator Edgardo Angara (15th Congress) Feb 28, 2011
o This shall be known as the Philippine Medical Technology Act of 2011
o This is an act regulating and modernizing the practice of medical
technology (medical laboratory science) in the Philippines, repealing for
this purpose Republic Act nos. 5572 and 6132 and Presidential Decree nos.
498 and 1534, and for other purposes
o It has 38 sections
o Legislative status: Pending in the Committee
> House Bill 3502
o Hon. Leopoldo N. Bataoil (16th Congress)
o This is an act regulating and modernizing the practice of medical
technology (medical laboratory science) in the Philippines, repealing for
this purpose Republic Act nos. 5572 and 6132 and Presidential Decree nos.
498 and 1534, and for other purposes
o It has 38 sections
o Legislative status: Approved by the Committee on Appropriations on
February 4, 2015
> Senate Bill 2473
o Hon. Senator Teofisto Guingona III (16th Congress) November 27, 2014
o This shall be known as the Philippine Medical Technology Act of 2014
o This is an act regulating and modernizing the practice of medical
technology (medical laboratory science) in the Philippines, repealing for
this purpose Republic Act nos. 5572 and 6132 and Presidential Decree nos.
498 and 1534, and for other purposes
o It has 38 sections
o Legislative status: Pending in the Committee
> House Bill 2049
o Hon. Leopoldo N. Bataoil (17th Congress) July 27, 2016
o This is an act regulating and modernizing the practice of medical
technology (medical laboratory science) in the Philippines, repealing for
this purpose Republic Act nos. 5572 and 6132 and Presidential Decree nos.
498 and 1534, and for other purposes
 o It has 37 sections
o Main Topics Addressed
- Creation of Medical Technology Board with composition
- Expansion of the scope of the medical technology practice: molecular
and cytogenic technologies, drug testing, phlebotomy, and teaching of
professional course
- Creation of a Technical Committee for Medical Technology under CHED
and Continuing Professional Development Council for Medical
Technology Education under PRC
o Legislative status: Pending in the Committee
> Senate Bill 1891
o Hon. Senator Antonio Trillanes (17th Congress) July 26, 2018
o This shall be known as the Philippine Medical Technology Act of 2018
o This is an act regulating and modernizing the practice of medical
technology (medical laboratory science) in the Philippines, repealing for
this purpose Republic Act nos. 5572 and 6132 and Presidential Decree nos.
498 and 1534, and for other purposes
o It has 40 sections
o Legislative status: Pending in the Committee
 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

SECTION HEADING DETAILS

Executive The Commissioner of Civil Service shall be the Executive
Officer of the Officer of the Board, and shall conduct the examinations
Board given by it. 1he Secretary of the Board of Examiners appointed
in accordance with Section ten of Act Numbered Four
Thousand Seven, as amended, shall also be the Secretary of
the Board. He shall keep a register of all persons to whom
certificates of registration have been granted.
10 Compensation Each member of the Board shall receive a sum of ten pesos
of Members (P 10.00) for each applicant examined and five pesos ( PS.DO)
of the Board for each applicant granted a certificate of registration without
of Examiners examination.
for Medical
Technology
II Functions and The Board is vested with authority and required, confonnably
Duties of the with the provisions of this Act, to:
Board Administer the provisions of this Act;
Administer oaths in connection with the administration of
this Act;
Issue, suspend and revoke certificates of registration for
the practice of medical technology and medical laboratory
technician;
Look into conditions affecting the practice of medical
technology in the Philippines and, whenever necessary,
adopt such a measure as may be deemed proper for the
maintenance of good ethic and standards in the practice of
medical technology;
Investigate such violations of this Act or of the rules
and regulations issued thereunder as may come to the
knowledge of the Board and, for this purpose issue
subpoena and subpoena duces tecum to secure appearance
of witnesses and production of documents in connection
with charges presented to the Board;
Draft such rules and regulations as may be necessary
to carry out the provisions of this Act: Provided, that
the same shall be issued only after the approval of the
President of the Philippines;

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 RA5527: -
The Pnllipplne Medical Technology Act ot 1969

SECTION HEADING DETAILS

To determine the adequacy of the technical staff of all
clinical laboratories and blood banks before they could
be licensed with the Department of H ealth in accordance
withR.A.No.4655and 15 17;
To prescribe the qualifications and training of medical
technologists as to special fields of the profession and
supervise their specialty examination conducted by
the professional organization of medical technologists
accredited by the Professional Regulation Commission;
To classify and prescribe the qualification and training of
the technical staff of clinical laboratories as to: Medical
Technologist; Senior Medical Technologist; Medical
Technologist and Medical Laboratory Technician.
12 Removal of Any member of the Board may be removed by the President
Board Members of the Philippines for:
neglect of duty
incompetency
malpractice
unprofessional, unethical, immoral or dishonorable
conduct
after having been given opportunity to defend himselfin a
proper and administrative investigation: Provided, that during
the process of investigation, the President shall have the power
to suspend such member under investigation and appoint a
temporary member in his place.
13 Accreditation Department of Education shall approve schools of medical
of Schools technology in accordance with the provisions of this Act. 1he
of Medical Department of H ealth or its authorized agency shall upon
Technology recommendation of the Council of Medical Technology
and ofTraining Education approve laboratories for accreditation as training
Laboratories laboratories for Medical Technology students or postgraduate
trainees upon satisfactory evidence that said laboratories
possess qualified personnel and properly equipped to carry out
laboratory procedures commonly required in the following
fields: bacteriology, serology, parasitology, hematology, and
biochemistry, and that the scope of activities of said laboratory
offer sufficient training in said laboratory procedures.

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

SECTION HEADING DETAILS

14 Inhibition No person shall practice or offer to practice medical technology
Against the as defined in this Act without having previously obtained a
Practice of valid certificate of registration from the Board provided that
Medical registration shall not be required of the following:
Technology Duly registered physicians
Medical technologist from other countries called in for
consultation or as visiting or exchange professors to
colleges or universities, provided, they are only practicing
the said function
Medical technologists in the service of the United States
Armed Forces stationed in the Philippines rendering
services as such for members of the said forces only
IS Examination Except as otherwise specifically allowed under the
provisions of this Act, all applicants for registration as
medical technologists shall be required to undergo a written
examination which shall be given by the Board annually in
the greater Manila area, Cebu and Davao during the month
of August or September on such days and places as the Board
may designate. Written notices of such examination shall be
published in at least three newspapers of national circulation
by the Secretary of the Board at least thirty days prior to the
date of examination.
16 Qualification for Every applicant examination under this Act, shall, prior to the
Examination date thereof, furnish the Board satisfactory proof that he or she:
is in good health and is of good moral character;
has completed a course of at least four ( 4) years leading to
the degree of Bachelor of Science in Medical Technology
or Bachelor of Science in Public Health conferred by a
recognized school, college or university in accordance with
this Decree
Take note: Prior to June 2 1, 1969, one is eligible to take
the board examination ifhe is a graduate of some o ther
profession but has been actually perfonning medical
technology for the last five (5) years prior to the date of the
examinations.

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 RA5527 -
The Pnllipplne Medical Technology Act ot 1969

SECTION HEADING DETAILS

17 Scope of The examination questions shall cover the following subjects
Examination with their respective relative weights:
Major Subjects:

Clinical Chemistry 20%

Microbiology and Parasitology 20%
Blood Banking and Serology 20%
H ematology 20%

Minor Subjects:

Clinical Microscopy (Urinalysis I 0%

and other body fluids)
Histopathologic Techniques, I 0%
Cytotechnology, Medical
Technology Laws, Related Laws
and its implementing rules, and
the Code of Ethics

The Board shall prepare the schedule of subjects for

examination and to submit the same to the Commissioner
of the Professional Regulation Commission for publication
at least thir ty (30) days before the date of examination. The
Board shall compute the general average of each examinee
according to the above-mentioned relative weights of each
subject. Provided, however, that the Board may change, add to
or remove from the list of subjects or weights above as progress
in the science of Medical Technology may require, subject to
the prior approval of the Professional Regulation Commission,
and publication of the change or amendment at least three ( 3)
months prior to the da te of examination in which the same is to
take effect.
18 Report of Rating The Board shall, within one hundred and twenty days after the
date of completion of the examination, report the result thereof
to the Commissioner of Civil Service, who shall submit such
result to the President of the Philippines for approval.

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19 Rating in the In order to pass the examination, a candidate must obtain a:
Examination general average of at least seventy-five percent in the
written test
no rating below fifty percent in any of the major subjects
Provi,led, 1hat the candidate has not failed in at least sixty
percent of the subjects computed according to their relative
weights.
No further examinations, unless and until he shall have
completed 12 months refresher course in an accredited
laboratory:
Provi,led, 1hat graduate of paramedical profession other
than Bachelor of Science in Medical Technology/ Bachelor
of Science in Hygiene admitted to an examination under
the provisions of this Act shall not be given further
examinations unJer the provisions of this Act after his
failure to qualify for the third time.
20 Oath Taking All successful examinees shall be required to take a professional
oath before the Board or before any person authorized to
administer oaths prior to entering the practice of medical
technology in the Philippines.
21 Issuance of Every applicant who has satisfactorily passed the required
Certificate of examination for medical technologist shall be issued a
Registration certificate of registration as such:
Provi,led, 1hat no such certificate shall be issued to any
successful applicant who has not attained the age oftwenty-
one (2 1)years.
All certificate shall be signed by the members of the Board
and by the Commissioner of the Professional Regulation
Commission.
1he duly registered medical technologists shall be required
to display his certificate of registration in the place where
he works.
Provi,led, that upon application filed and the payment of
the required fee of one hundred and fifteen pesos (Pl 15.00)
the Board shall issue a certificate of registration as medical
technologist without examination to persons who have been
graduated with Bachelor of Science in Medical Technology/
Bachelor of Science in Public H ealth in duly recognized
schools of medical technology in the Philippines or in any
foreign country.

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Provided, That in case of the latter, the standard of medical
technology education is substantially the same as ours,
and in addition shall have been in the practice of medical
technology for at least three (3) years prior to the filing of the
application in laboratories in the Philippines duly accredited
by the Bureau of Research and Laboratories, Department of
H ealth, or in foreign countries if such performance began
prior to June 2 1, 1969 and also to all other persons who
having graduated from other professions have been actually
performing medical technology practice for the last eight ( 8)
years prior to filing of the application, Provided, that such
performance began prior to June 2 1, 1969.
Provided, further, that the Board shall likewise issue a
certificate of registration as medical laboratory technician
without examination to any person who upon application and
payment of the required fee of fifty pesos (P 500.00) show
evidence satisfactory to the Board that:
1. H e or she passed the civil service examination for medical
technician given on March 2 1, 1964; or
2. H as finished a two-year college course and has at least one
( 1) year of experience as medical laboratory technician,
Provided, that for every year of deficiency in college
attainment two (2) years of experience may be substituted;
Provided, further, that an applicant who has at least ten
( 10) years of experience as medical laboratory technician
as of the date of approval of this Decree regardless of his
academic attainment may qualify for registration without
examination; or
3. H as failed to pass the board examination for medical
technology but had obtained a general rating of at least
70%. Provided, finally, that a registered medical laboratory
technician when employed in the government shall have
the equivalent civil service eligibility not lower than
second (2nd) grade.
22 Fees The Board shall charge each applicant for examination and
registration the sum of fifty pesos (PS0.00) for each certificate
of registration issued without prior examination in accordance
with the provisions of this Act the sum of twenty-five pesos;
for issuance of a new certificate to replace certificate lost,
destroyed or mutilated, the Board shall charge the swn of ten
pesos (P 10.00 ). All such fees shall be paid to the disbursing
officer of the Civil Service Commission who shall pay from the
receipts thereof, all authorized expenses of the Board including
the compensation of each member.
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23 Refusal to issue The Board shall refuse to issue a certificate of registration to
Certificate any person:
coiwicted by the court of competent jurisdiction of any
criminal offense involving moral turpitude
guilty of immoral or dishonorable conduct
unsound mind
incurable communicable disease
In such shall be given to the applicant a written statement
setting forth the reason for its action, which statement shall be
incorporated in the record of the Board.
24 Administrative Administrative investigation shall be conducted by at least two
Investigation: members of the Board with one legal officer sitting during all
Revocation or administrative proceedings, the respondents shall be entitled
Suspension of to be represented by counsel or be heard Jin person, to have
Certificates a speedy and public hearing, to confront and cross-examine
witnesses against him or her, and to all other rights guaranteed
by the Constitution.
The Board may, after giving proper notice and hearing to the
party concerned reprimand an erring medical technologist
or revoke or suspend his certificate of registration for causes
mentioned in the next preceding section or for causes
enumerated in section tv.renty-nine (29) of this Act, or for
unprofessional conduct, malpractice, incompetency, or serious
ignorance or gross negligence in the practice of medical
technology.
No penalty of revocation shall be imposed unless there is a
unanimous vote of all the three members of the Board.
1he Board may, by majority vote, impose the penalty of
reprimand or suspension, the latter however not to exceed
two years.
When the penalty of suspension or revocation is imposed
by the Board the medical technologist shall be required to
surrender his certificate of registration within thirty days
after the decision becomes final, under the pain of perpetual
disqualification from the practice of medical technology in the
Philippines for inexcusable failure to do so. The suspension
shall run from the date of such surrender.

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25 Appeal The revocation or suspension of a certificate made by the Board
shall be subject to appeal to the Civil Service Commissioner
whose decision shall become final thirty days after its
promulgation, unless the respondent within the same period
has appealed to the office of the President of the Philippines.
26 Reinstatement, The Board may, upon application and for reason deemed
Reissue or proper and sufficient, reissue any revoked registration
Replacement of certificate. The suspension of a certificate shall be re-issued
Certificate to the medical technologist concerned upon request without
prejudice to further actions by the Board for violation of the
provisions of this Act or conditions imposed by the Board
upon the medical technologist during the period of suspension.
27 Foreign No foreigner shall be admitted to examination, or be given a
Reciprocity certificate of registration or be entitled to any of the rights and
privileges under this Act, unless the country or state of which
he is a subject or citizen permits Filipino Medical Technologist
to practice within its territorial limits on the same as the subject
or citizens of said country or state.
28 Roster of A roster of Medical Technologist shall be prepared annually by
Medical tl,e Secretary of the Board, commencing on the year following
Technologist that in which this Act shall become effective.
This roster shall contain the name, address and citizenship of
each registered Medical Technologist, date of registration or
issuance of certificate, and other data which in the opinion of
the Board are pertinent.
The roster shall be open to public inspection and copies thereof
shall be mailed to each person included therein, placed on file
in the Office of the President, furnished all Department H eads
and all bureau, offices and instrumentalities of the Department
of H ealth and to such other offices, private or governmental,
and to the public upon request.

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29 Penal Provisions Without prejudice to the provision of the Medical Act of
1959 as amended relating to illegal practice of Medicine, the
following shall be punished bya fine of not less than two
thousand pesos nor more than five thousand pesos, or
imprisonment for not less than six months nor more than
two years, or both, in the discretion of the court:
a. Any person who shall practice Medical Technology in the
Philippines without being registered or exempted from
registration in accordance with the provisions of this Act;
b. Any medical technologist, even if duly registered, who shall
practice medical technology in the Philippines without
the necessary supervision of a qualified pathologist or
physician authorized by the Department of Health;
c. Any medical technologist who shall knowingly make a
fraudulent laboratory report;
d. Any duly registered medical technologist who shall refuse
or fail, after due warning by the Board to display his
certificate of registration in the place where he works;
e. Any person presenting or attempting to use as his own, the
certificate of registration of another;
f. Any person who shall give any false or fraudulent
evidence of any kind to the Board or any member thereof
in obtaining a certificate of registration as Medical
Technologist;
g. Any person who shall impersonate any registrant of like or
the same name;
h. Any person who shall attempt to use a revoked or
suspended certificate of registration;
i. Any person who shall in connection with his name or
otherwise, assume, use or advertise any title or description
tending to convey the impression that he is a Medical
Technologist without holding a valid certificate of
registration;
j. Any person or corporate body who shall allow anyone who
is not a registered medical technologist/ medical laboratory
technician to engage in the practice of medical technology
or recommend for appointment anyone to the position
of medical technologist/ medical laboratory technician
knowing that he is not registered as such.

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k. Any person or corporate body who shall violate the rules
and regulations of the Board or orders promulgated by
it after having been duly approved and issued by the
President of the Philippines upon recommendation of the
Commissioner of Civil Service for the purpose of carrying
out the provisions of this Act.
30 Separability All acts, executive, rules and regulations, or parts thereof
Clause inconsistent with the provisions to any persons or
circumstances is declare invalid by a court of competent
jurisdiction, the remainder of this Act of the application of
such provisions to other persons or circumstances shall not be
affected by such declaration.
31 Repealing All acts, executive, rules and regulations, or parts thereof
Clause inconsistent with the provisions of this Act are hereby
repealed: Provided, however, that nothing in this Act shall be
construed as repealing or amending any portion of the Medical
Act of 1959 (R.A. 2382, as amended by R.A. 4224), the
Clinical Laboratory Act of 1966 ( R.A. 4688 ), and the Blood
Banking Lawof 1956 (R.A. 15 17).
32 Effectivity This Act shall take effect upon its approval. Approved,June 2 I,
1969.

References (RA 5527):

1. https://wwv-1.prc.gov.ph/

2. https://thecorpusjuris.com/legislative/republic-acts/ra-no-5527.php

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Philippine Medical Technology Act of 1969

(RA 5527 - June 21 , 1969

Section I Title Section 17 Scope of Examination

Section 2 Definition of Terms Section 18 Report of Rating

Section 3 Council of Medical Section 19 Ratings in the Examination

Technology Education

Section 4 Compensation and Traveling Section 20 Oath Taking

Expenses of Council Members

Section S Functions of the Council of Section 2 1 Issuance of Certificate of

MT Education Registration

Section 6 Minimum Required Course Section 22 Fees

Section 7 Medical Technology Board Section 23 Refusal to Issue Certificate

Section 8 Qualification of Examiners Section 24 Administrative Investigation

Section 9 Executive Officef of the Board Section 25 Appeal

Section 10 Compensation of Members Section 26 Reinstatement, Reissue or

of the Board of Examiners for Replacement of Certificate
Medical Technology

Section 11 Functions and Duties of the Section 27 Foreign Reciprocity

Board

Section 12 Removal of Board Members Section 28 Roster of Medical

Technologists

Section 13 Accreditation of Schools of Section 29 Penal Provision

MT and Training

Section 14 Inhibition against the Practice Section 30 Separability Clause

ofMT

Section 15 Examination Section 3 1 Repealing Clause

Section 16 Qualification for Examination Section 32 Effectivity

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Nardito Moraleta, PAMET second president is pioneering in the approval of

RA 5527 during the presidency of Ferdinand Marcos. This law was approved on
June 21, 1969.
PD 498, the second revision made on June 28, 1974 (Martial Law), amended 11
sections of the original law and this was worked upon by Felix Asprer, another
PAMET president.
Currently, the following amendments are being undertaken:

House Bill 3502 : H on. Leopoldo N. Bataoil

House Bill 2049 : Hon. Leopoldo N. Bataoil
Main Topic Addressed
I. Creation of Medical Technology Board with homogenous composition
2. Expansion of the scope of Medical Technology Practice: molecular and
cytogenetic technologies , drug testing, phlebotomy and teaching of
professional course
3. Creation of Technical Committee for Medical Technology Education
under CHED and Continuing Professional Development Council for
Medical Technology Education under PRC
Senate Bill 2722: Hon Senator Edgardo Angara
This is shall be known as the Philippine Medical Technology Act of2011
An act regulating and modernizing the practice of medical technology
(medical laboratory science) in the Philippines, repealing for this purpose
republic act nos. 5572 and 6132 and presidential decree nos. 498 and 1534,
and for other purposes
It has 38 sections
15th Congress
Filed on February 28, 2011
Legislative status: pending in the committee
Senate Bill 2473: H on. Senator Teofisto Guingona Ill
This is shall be known as the Philippine Medical Technology Act
of2014.
An act regulating and modernizing the practice of medical technology
(Medical Laboratory Science) in the Philippines repealing for this purpose,
Republic Act 5527 and RA6138 and Presidential Decree 498 and 1534, and
for other purpose It has 38 sections.
Legislative status: pending in the committee

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Senate Bill 1891: H on. Senator Antonio Trillanes
Filed during onjuly26, 20 18
This is shall be known as the Philippine Medical Technology Act of2018
An act regulating and modernizing the practice of medical technology in the Philippines,
providing funds therefor and for other related purposes . H as 40 sections
Legislative stan1s: pending in the committee

Medical Technology Llcensure Examination

Revised Matrix/ Table of Specifications (TOS) for the Licensure Examination
(Finalized with PASMETH and PAMET)
(released by the PRC Board of Medical Technology)

Table of Specifications serves as guidelines to the board of examiners on what to include in the
board examination. This also provides higher educational institutions ideas on what to include on
their respective course plans. Likewise, board examinees may also be enlightened on what to focus
during their reviews and preparations. Below is a standardize outline of the content of the board
examinations with their corresponding relative weights.

M ICRO BIO LOGY (70%) WEIGHT (%)

1 BACTERIOLOGY 49%
1.1 Collection, Transport, Processing and staining of specimens 5%
1.2 Culture Media 5%
1.3. Bacteria (Aerobes)
1.3. 1 Morphology and staining characteristics 5%
1.3.2. culturalcharacteristics 5%
1.3.3. Work up for identification, biochemical, differential and 14%
confirmatory tests
1.3.4. Serologic/molecular tests 3%
1.3.S. SusceptibilityTests 4%
1.3.6. Bacteriologic examination of water, food, milk and 2%
utensils
1.4. Anaerobes 2%
1.5 Mycobateria 2%
1.6. Other bacteria with unusual growth 2%
requirements(Spirochetes, Chlamydia, Mycoplasma,
Rickettsia)
2 .MYCOLOGY 4%
2.1 Collection, transport and examination of clinical specimens 2%
2.2. Culture 2%
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3 VIROLOGY 4%
3. 1. General characteristics, transmission of diseases 2%
3.2. Collection, transport and examination of clinical specimens 2%
4 EQUIPMENT AND INSTRUMENTATION 5%
4. 1. Manual 3%
4.2.Automated 2%
S QUALITY ASSURANCE AND SAFETY 8%
5. 1. Collection of Specimen 2%
5.2. Quality Control 2%
5.3. Safety- Patient/Staff 2%
5.4. Safety- Workplace/Environment 2%
SUBTOTAL 70%
PARASITOLOGY (30%)
6 PARASITES 21%
Life Cycle, Morphological characteristics, epidemiology, prevention
and control
6. 1. Nematodes 5%
6.2. Trematodes 5%
6.3. Cestodes 5%
6.4. Protozoa 5%
6.5. Ectoparasites 1%
7 PARASITOLOGICTECHNIQUES 5%
7. 1. Routine 2%
7.2. Concentration 2%
7.3. Others 1%
8 QUALITY ASSURANCE 4%
8. 1. Collection and Preservation of Specimen 2%
8.2. Quality Control 2%
SUBTOTAL 30%
TOTAL 100%

CLINICALCHEJ\HSTRY
I Specimen Collection 5%
2 Instrumentation 5%
3 Reagent Preparation and Laboratory mathematics 5%
4 Quality Assurance 10%
S Metabolic Blood Tests ( Principles, Procedures, Diseases/Disorders, SO%
Reference Values)
5. 1. Water balance and electrolytes 8%

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5.2. NPN and other metabolic intermediaries and inorganic ions 6%

5.3. carbohydrates 6%
5.4. lipids and dysproteinemia 8%
S.S. specific proteins 6%
5.6. liver function tests 6%
5.7. Clinical enzymology 8%
6 Endocrinology and Toxicology (Principles, Procedures , Disease 16%
and Reference
6. 1. Endocrinology
6. 1. 1. 1hyroid H ormones 4%
6. 1.2. Sex H ormones 3%
6. 1.3. O ther hormones (Pituitary and Adrenal) 3%
6.2. Toxicology and 1herapeutic Drug Monitoring (TDM)
6.2. 1. Substance of Abuse 2%
6.2.2. Other poisons / toxic agents ( Alcohol, carbon 2%
monoxide, mercury and lead and arsenic
6.2.3. TDM anticonvulsants and other drugs 2%
7 Blood gas analysis and o ther tests ( principles, Procedures, diseases/ 4%
disorders, reference values)
8 Laboratory Safety 5%
TOTAL 100%

HEMATOLOGY
1 Blood Collection, anticoagulants and others 5%
2 Hematology tests and procedures 30%
2. 1.Routine 15%
2.2. Automation 10%
2.3. Special 5%
3 Hematopoeisis 40%
3. 1. H ematopoiesisingeneral 6%
3.2. Erythropoiesis and RBC 12%
3.3. Leukopopeisis and WBC 12%
3.4. Thrombopoiesis and Platelets 10%
4 Coagulation (Principle, procedures, disease) 20%
4.1. H emostasis 1heories, Concepts and Mechanism 2%
4.2. Coagulation procedures/ tests 8%
4.3. Coagulation factors diseases/ disorders and reference values 10%
S Quality Assurance 5%
TOTAL 100%

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BLOOD BANKING (50%)

l ABO and Rh Blood Group System 5%
2 O ther Major Blood Group System: Kell, Duffy, Kidd, Lewis, MNSs, 3%
Lutheran, P, I
3 Minor Blood Group Systems: Diego, Cartwright, Chido, XG, Scianna, 1%
Gerbich, Milton, Knops, Bg, Indian, etc.
4 BasicGenetics 2%
Blood Donor Selection and Processing 5%
Blood Preservation and banking 5%
7 Component preparation 5%
Transfusion therapy 2%
Transfusion reactions 3%
10 Transfusion transmitted diseases 3%
11 Techniques and procedures: typing, compatibility testing, antibody 8%
detection and identification
12 Hemoly tic Disease of the Newborn (HDN) and Autoimmune 4%
Hemolytic Anemia
13 Quality management (structure, set up / Equipment LIS) 4%
SUBTOTAL 50%
IMMUNOLOGY AND SEROLOGY(50%)
14 H istorical Background
15 Natural (Innate) immunity, including role of macrophages, monocytes
and ganulocytes
16 Acquired immunity, humoral responses, immunogens,
immunoglobulins, B cells
17 Acquired immunity, cellular responses, T cells, Cytokines and
chemokines
18 Complement System
19 MHC, HLA, Transplantation
20 Immunologic Tests for the detection of antigens and antibodies, IS
principles, procedures
20. 1. Bacterial Infections and STD
20.2. Viral Infections
20.3 Fungal Infections
20.4. Parasitic hifections
20.S. Autoimmune disorders
2 1 Tumor immunology (Tumor Markers)
22 H ypersensitivity

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23 Instrumentation and Quality Management

Subtotal 50%
TOTAL 100%

CLINICAL MICROSCOPY
Urine 53%
1.1 Anatomy and physiology of the kidney, Fonnation of Urine 5%
1.2. lvlacroscopic examination l0%
1.3. Chemical Analyses 18%
1.4. Microscopic examination 15%
1.5. Pregnancy Testing 2%
1.6. Renal Calculi 3%
Feces 3%
O ther Body Fluids 2 1%
3. 1. CSF 5%
3.2. Seminal Fluid 5%
3.3. Amniotic Fluid 3%
3.4. Gastric Fluid and Duodenal Content 2%
3.5. Spun,m and Bronchial Washings 2%
3.6. Synovial Fluid 2%
3.7. Peritoneal, Pleural and Pericardia! Fluids 2%
4 Collection, preservation and H andling of specimens l0%
Microscopic, automation and other instruments 5%
Quality assurance and laboratory safety 5%
Total 100%

HISTOPATHO LOGY, MT LAWS, RELATED LAWS AND CODE

1--listo pathology (65%)
Histology and Pathology 10%
1.1. Terminologies 4%
1. 2. Etiology of disease 2%
1.3. Signs, symptoms and course of disease 2%
1.4. Cellular and tissue changes 2%
2 Histopathologic techniques and procedures 35%
2. 1. Preservation and handling of specimen l0%
2.2. Tissue Processing and Procedures

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2.2. 1. Routine-Manual 7%
2.2.2. Routine -Automation 5%
2.2.3. Special 3%
2.3. Staining
2.3. L Routine 5%
2.3.2. Special (Immunohistochemistry) 5%
3 Cytologic Techniques and Procedures 8%
3. 1. Preservation and handling of specimen 2%
3.2. Processing
3.2. 1. Manual 2%
3.2.2. Automation 2%
3.3. Staining 2%
4 Autopsy 2%
4.1. Tenninologies 1%
4.2. Handling Processing and Documentation 1%
S Quality Assurance 10%
SUBTOTAL 65%
MT Laws Related Laws and Code of Ethics
6 MTLaws 10%
7 Laboratory Management l0%
8 Related Laws ID%
9 Code of Ethics Including Bioethics 5%
SUBTOTAL 35%
TOTAL 100%

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Schedule of Medical Technology Board Examination

-
Venues: Manila, Cebu, Davao and Baguio
Schedule: August/ September, March
Requirements for Board Exam Application:
I. Original and photocopies ofTranscript of Records with Special Order and Date of Graduation
with SCANNED PICTURES AND WITH REMARKS "FOR BOARD EXAMINATION
PURPOSES ONLY". (Graduates of government schools and institutions/ programs
accredited by recognized accredited agencies under the FAAP are exempted from SO [BJ).
Graduates ofNew Schools/ Degree Programs must submit School Recognition and / or Permit
to Operate.
2. Original and photocopy ofNSO-issued Birth Certificate (ifNSO copy is not clear, bring copy
from the Local Civil Registrar).
3. Original and photocopies ofNSO-issued Marriage Contract (for married female only; ifNSO
copy is not clear, bring copy from Local Civil Registrar).
4. Four (4) passport size colored pictures in white background with complete name tag.
S. Current Community Tax Certificate (Cedula)
6. Other specific requirements as required by the Commission or the Professional Regulatory
Board.

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 RA5527 -
The Pnllipplne Medical Technology Act ot 1969

Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ Score:
Seat Number: Section: Date:

A. Multiple Choice (20 items), Choose the CORRECT answer from the given choices,
1. A medical technician can work in a laboratory ONLY under the
supervision of a registered medical technologist. The ratio of a registered
medical technologist to medical technicians at a time in a clinical
laboratory is _ :
a. 2:1 c. 1:2
b. 1:3 d. 1:4
2. Which among the following is NOT a practice of Medical Technology?
a. Be a phlebotomist in a medical institution
b. Interpret laboratory results
c. Supervise medical technology interns
d. Perform special test in clinical chemistry
3. All of the following are career opportunities for medical technology
graduates and board passers, EXCEPT:
a. hematology specialist c. laboratory head
b. phlebotomist d. high school science teacher
4. According to PD 1534 which amended RA 5527, the chairman of the
PRC holds what position in the Council of MT Education:
a. Secretary c. Vice Chainnan
b. Chairman d. Treasurer
5. A medical laboratory technician may be employed in a clinical
laboratory only if he/she will be working under the supervision of the

a. proprietor of the laboratory

b. registered medical technologist
c. laboratory administrator
d. clinical laboratory technician
6. An examinee who fails for the 3rd time may be allowed to take the
examination again when one year of which of the following has been
satisfied?
a. employment as medical laboratory aide
b. externship in primary hospital clinical laboratory
c. preceptorship in a private laboratory
d. postgraduate training in an accredited clinical laboratory
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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

7. 1he relative weight of a major subject in the medical technology board exam is
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a. 10% c. 15%

b. 20% d. 5%
8. Which among the following subjects is NOT included in the scope of
examination for the local board examination for medical technologist?
a. Phannacology c. MTLE
b. Clinical Chemistry d. Hematology
9. All are true about the scope of Medical Technology Board Examination,
EXCEPT:
a. Clinical Microscopy comprise 20% of the total grade
b. H istopathologic techniques and MTLE comprise I 0% of the total grade
c. Microbiology and Parasitology comprise 20% of the total grade
d. Blood banking and Serology comprise 20% of the total grade
10. 1he executive officer of the Medical Technology Board:
a. Director of CHED
b. Chairman of the Board
c. Commissioner of PRC
d. Commissioner on CPE Council
11 . 1he number of sections in the original MT law:
a. 16 c. 35
b. 32 d. 42
12. As stipulated in section 5 of RA 5527, a refresher course is given for applicants
who have failed the board exam for the:
a. fourthtime c. thirdtime
b. fifth time d. second time
13. If the Chairman of the Board was appointed on 1998, on what year will his term
of office supposedly end?
a. 200 1 c. 2005
b. 2003 d. 2007
14. Who usually appoints the officers of the Board of Medical Technology?
a. PRC Commissioner c. Philippine President
b. PAMET President d. CH ED Director

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 RA5527: -
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15. Who among the PAMET presidents currently hold a position in the Medical
Technology Board?
a. Leila Florento c. Shirley Crn1..1da
b. Marian Tantingco d. Marilyn Atieni.a
16. What is the Main importance of the approval of RA 5527?
a. Medical Technology became a popular pre-medical course.
b. All Medical Technologists became professionals.
c. All Medical Technologists received higher salary.
d. All Medical Technologists were able to own and head different laboratories.
17. In the present ti.tne, at what months is the Medical Technology Board
Examination held'.
i. April iii. October

ii. March iv. September

a. i and iii only c. ii and iv only

b. ii and iii only d. allexcepti

18. Philippine President who approved RA 5527:
a. Gloria Macapagal-Arroyo c. Ferdinand Marcos
b. Fidel Ramos d. Diosdado Macapagal
_ _ 19. What course offered in the University of the Philippines entitles their graduates
to get the Medical Technology Board Examination?
a. BS Biology c. BS Public H ealth
b. BS Microbiology d. BS Environmental Science
20. 1he MT Board Officers should be in the practice of laboratory medicine for at
least _ _ prior to his appointment.
a. 2years c. ! 0years
b. Syears d. !Syears

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

B. Critical-Thinking Questions. Answer the following questions briefly but substantially.

I. Three BSMT graduates took the board examinations and obtained the following rating.
Who among them passed or failed? Justify your answer. Calculate the general weighted
average and decide.

SUBJECTS A B C
Clinical Chemistry 92 76 75
Microbiology-Parasitology 87 86 71
H ematology 86 49 77
Blood Banking - Serology Immunology 76 77 81
Clinical Microscopy 81 89 70
MTLE- Histopathology 80 85 71

2. Which among the fo llowing can be done by a 20 year old board MT graduate who
recently topped the MT licensure examination? Justify your answer.
a. attend the oath taking
b. apply for job as a phlebotomist in the laboratory
c. set-up a laboratory and head

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 RA5527 -
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3. Can a Filipino medical technologist who has been working abroad for more than 3 years
be removed from the roster of licensed medical technologist? Justify your answer.

C. Course Inquiry Projects

Choose one among the following topics and conduct an interview. Make a computerized
write-up and reflection based on the responses gathered from interview.
1. Job satisfaction oflocal medical technologists
2. Performance of different schools in Ii censure examination over the past 10 years
3. Effective strategies in topping board examination
4. Adequacy of internship training to meet global standards
S. Relevance of in-house review and the existence of review centers

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 THE CLINICAL LABORATORY LAW OF 1966

INTRODUCTION
RA 4688 is the governing law for all existing clinical laboratories in the Philippines. It embodies
policies and guidelines in the proper operations of the different types of laboratories. Moreover,
the law provides instructions necessary for license to operate so as to ensure that every laboratory
is operating legally. The law also provides mechanism of quality assurance that must always be
practiced.
This law was approved on June I 8, 1966 and was ratified by President Ferdinand E. Marcos.
Administrative and executive orders were issued to supplement the law and inclucl.ed the following:
AO 201 s. 1973, AO 290 s. 1976,AO 52 s. 1983, AO 49-B s. 1988, EO 102 s. 1999 (R~directing
the Functions and Operations of the DOH), AO 59 s. 2001 (Rules and Regula tions Governing
the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippinesj, AO
27 s. 2007 (Revised Rules and Regulations Governing the Licensure and Regulation of' CClinical
Laboratories in the Philippines)

INTENDED LEARNING OUTCOMES

At the end of this unit, the students are expected to:

1. differentiate the types of clinical laboratories in the Philippines

2. discuss the different issues arising from clinical laboratories
3. create a miniature laboratory following the correct DOH guideline

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

AO 27 s . 2007: Revised Rules and Regulations Governing the Llcensure

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and Regulation of Clinical Laboratories In the Phlllpplnes

I. Rationale
One of the main thrusts of current health sector reforms under FOUR.mula One (F 1) for
H ealth is regulation. The main objective of regulatory reforms is to ensure access to quality
and affordable health products, devices, facilities and services, especially those commonly
used by the poor.
Physicians utilize laboratory work-ups in aid of diagnosis and management of patients.
Accuracy of laboratory results is important in assuring and improving the quality of patient
care. Republic Act No. 4688 s. 1966, "An Act Regulating the Operation and Maintenance
of Clinical Laboratories and Requiring the Registration of the Same with the Department
ofH ealth, Providing Penalty for the Violation 1hereof, and for Other Purposes", mandated
the DOH to look after public welfare by effectively enforcing and updating the current
regulations to improve laboratory perfonnance.
Advances in technology necessitate the need to update the minimum standards and
technical requirements for clinical laboratories. Current regulatory issuances on this matter
may no longer be relevant. One of these is Administrative Order No. 59 s. 200 1, entitled:
•Rules and Regulations Governing the Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines''. Thus, this Order revises such issuance in order to
ensure the quality of services of clinical laboratories nationwide.
IL OBJECTIVE
This Order is promulgated to prescribe a revised minimum standard for clinical
laboratories. 1his shall also ensure accuracy and precision of laboratory examinations in
order to safeguard public health and safety.
III. SCOPE AND COVERAGE
This Administrative Order shall apply to all individuals, agencies, partnerships or
corporations that operate clinical laboratories in the Philippines performing examination
and analysis of samples of tissues, fluids, secretions, excretions, or other materials from the
human body that would yield relevant laboratory information, which physicians use for the
prevention, diagnosis, and treatment of diseases, and the management and promotion of
personal and public health.
Government clinical laboratories, doing microscopy work only for specific DOH programs
such as but not limited to malaria screening, acid fast bacilli microscopy, tests for sexually
transmitted infections, and cervical cancer screening using Pap smears, shall be exempted
from the provisions of this Order.

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 RA468 -
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Iv. DEFINITION OF TERMS

For purposes of this Order, the following terms and acronyms shall have the following
definition:

Applicant a natural or juridical person who intends to operate a clinical

laboratory
BHFS acronym for the Bureau of H ealth Facilities and Services
CHD acronym for the Center for H ealth Development
Clinical Laboratory a facility where tests are done on specimens from the human
body to obtain information about the health status of a patient
for the prevention, diagnosis and treatment of diseases.
1hese tests include, but are not limited to, the following
disciplines: clinical chemistry, hematology, immunohematology,
microbiology, immunology, clinical microscopy, histopathology,
cytology, toxicology, endocrinology, molecular biology, and
cytogenetics.
Other functions of the clinical laboratory are to provide
consultative advisory services covering all aspects oflaboratory
investigation including the interpretation of results and advice
on further appropriate investigation.
Facilities that are involved in the pre-analytical processes, such
as the collection, handling or preparation of specimens, or act as
a mailing or distribution center, such as in a laboratory network
or system are also considered to be a part of a clinical laboratory.
The total testing process includes pre-analytical, analytical and
post-analytical procedures.
Critical Values panic values originally described by Lundberg as • life.
threatening" unless something is done promptly and for which
some corrective action could be undertaken.
DOH acronym for the Department of H ealth
EQAP acronym for External Quality Assessment Program. It is a
program where participating laboratories are given unknown
samples for analysis. These samples are to be treated as ordinary
human specimens for the usual processing and examination.
The quality of perfonnance of the laboratory shall be assessed
through the closeness of its results to the pre-detennined
value or to the reference value generated by the participating
laboratories through peer group analysis.

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Inspection Tool the checklist used by the regulatory officers during inspection
visit(s) to evaluate compliance of a clinical laboratory to the
minimum standards and technical requirements.
Institu tion a corporate body or establishment organized for an educational,
medical, charitable, or similar purpose.
License the document issued by the DOH to an individual, agency,
partnership or corporation that operates a clinical laboratory
upon compliance with the requirements set forth in this Order.
Licensee the individual, agency, partnership or corporation to whom the
license is issued and upon whom rests compliance with this
Order.
LTO acronym for License to Operate. It also refers to the license.
Mobile Clinical a laboratory testing unit that moves from testing site to another
Laboratory testing site, or has a temporary testing location. It shall have a
base laboratory.
M onitoring tests done in series on patients as a guide for treatment or
Examinations follow-up of their condition.
NRL acronym for the National Reference Laboratory. It is a
laboratory in a government hospital which had been designated
by the DOH to provide special functions and services for
specific disease areas. These functions include provision of
referral services such as confirmatory testing, surveillance,
resolution of conflicting results between or among laboratories;
training; research, implementation ofEQAS; evaluation of
diagnostic kits and reagents. An NRL may or may not be part of
a general clinical laboratory.
POL acronym for Physician's Office Laboratory. It is an individual
doctor's office/ clinic wherein laboratory examinations are
performed.
POCT acronym for Point of Care Testing. It is a diagnostic testing at or
near the site of patient care rather than in the clinical laboratory.
It includes bedside testing, outpatient and home care.
Routine Tests the basic, commonly requested tests in the laboratory, the
results of which are not required to be released immediately
upon completion. It shall follow the usual procedures and
system in the laboratory.
Satellite Testing any testing site that performs laboratory examinations under the
Site administrative control of a licensed laboratory, but performed
outside the physical confines of that laboratory.
STAT Tests tests done on urgent cases, the results of which shall be released
immediately, within one ( 1) hour after the procedure. STAT is
an abbreviation for sta'tim which means immediately.
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 RA468 -
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V. CLASSIFICATION OF CLINICAL LABORATORIES

A. Classification by Ownership
1. Government - operated and maintained, partially or wholly, by the national
government, a local government unit (provincial, city or municipal), any other
political unit or any department, division, board or agency thereof
2. Private - owned, established and operated by any individual, corporation,
association or organization
B. Classification by Function
1. Clinical Patl10logy - includes Clinical Chemistry, H ematology,
lmmunohematology, Microbiology, Immunology, Clinical Microscopy,
Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic
Drug Monitoring and other similar disciplines
2. Anatomic Patlrology - includes Surgical Pathology, lmmunohistopathology,
Cytology, Autopsy, Forensic Pathology and Molecular Pathology
C. Classification by Institutional Character

1. Institution Ba5ed - a laboratory that operates within the premises and as part of
an institution, such as but not limited to hospital, medical clinic, school, medical
facility for overseas workers and seafarers, birthing home, psychiatric facility,
drug rehabilitation center
2. Freestanding- a laboratory that does not form part of any other institution
D. Classification by Service Capability
1. General Clinical Laboratory
(a) Primary Category - provides the following minimum service capabilities:
i. Routine Hematology [Complete Blood Count - includes
H emoglobin Mass Concentration, Erythrocyte Volume Fraction
( H ematocrit), Leucocyte Number Concentration (White Blood Cell
or WBC Count) and Leucocyte Type Number Fraction (Differential
Count)
ii. Qualitative Platelet Determination
iii. Routine Urinalysis
iv. Routine Fecalysis
v. Blood Typing- for hospital based
(b) Secondary Category - provides the minimum service capabilities of a
primary category laboratory plus the following:
i. Routine Clinical Chemistry - includes Blood Glucose Substance
Concentration, Blood Urea Nitrogen Concentration, Blood Uric

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 PARTI
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Acid Substance Concentration, Blood Creatinine Concentration,

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Blood Total Cholesterol Concentration
ii. Quantitative Platelet Determination
iii. Cross Matching - for hospital based
iv. Gram Staining - for hospital based
v. KOH - for hospital based
(c) Tertiary Category - provides the minimum' service capabilities of a
secondary category laboratory plus the following:
i. Special Chemistry
ii. Special Hematology, including coagulation procedures
iii. Immunology
iv. Microbiology- culture and sensitivity
aerobic and anaerobic (for hospital based)
aerobic or anaerobic (for non-hospital based)
A clinical laboratory, licensed under any of the above category, shall be
permitted to offer laboratory services other than the respective stipulated
minimum services, provided that, they comply with the requirements
with respect to staff, equipment, reagents and supplies for such additional
services, provided further, that such additional services are listed under its
LTO.
(d) Limited Service Capability (for institution.based only) - provides the
laboratory tests required for a particular service in institutions such as but
not limited to dialysis centers and social hygiene clinics.
2. Special Clinical Laboratory
A laboratory that offers highly specialized laboratory services that are usually
not provided by a general clinical laboratory.
VI. GUIDELINES
A. General Guidelines
1. The LTO shall be issued only to clinical laboratories that comply with the
standards and technical requirements formulated by the BHFS.
2. Clinical laboratories that are operated and maintained exclusively for research
and teaching purposes shall be exempted from the licensing requirement of this
Order but shall be required to register with the BHFS.
3. Special clinical laboratories that are not subject to the provisions of other
administrative orders, such as but not limited to, Assisted Reproduction
Technology Laboratories, Molecular and Cellular Technology, Molecular

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Biology, Molecular Pathology, Forensic Pathology, Anatomic Pathology

laboratories operating independent of a clinical laboratory are required to register
with the BHFS without being licensed under the provisions of this Order. Such
procedure shall subsist until the appropriate regulation for such purpose is
subsequently promulgated. A pathologist or a licensed physician who is trained
in the management, principles and methodology of the specialized services that
are being provided shall head this type oflaboratory.
4. The NRL designated by the DOH shall be covered by the license of the clinical
laboratory of the hospital where they are respectively assigned. The NRL that is
physically independent from the clinical laboratory of the hospital where they are
respectively assigned shall be alhwed to regis ter only with the BHFS, provided
that, they are duly accredited or certified by an international accrediting or
certifying body, such as but not limited to, the Center for Disease Control of the
US.A and the World H ealth Organization and/ or local accrediting or certifying
body recognized by the DOH.
5. A POL is required to secure a clinical laboratory license when it undertakes any
or all of the following activities:
( a) Issue official laboratory results;
(b) Perform more than monitoring examinations; and,
(c) Cater not only to the physician's own patients.
Examinations performed in a POL shall only be permitted when they are used
for monitoring patients.
6. A POCT, conducted in a hospital, is required to be under the management and
supervision of the licensed clinical laboratory of the respective hospital.
B. SPECIFIC GUIDE LINES
I. Standards
Every clinical laboratory shall be organized to provide quality, effective and
efficient laboratory services.
(a) Human Resource
i. Every clinical laboratory shall be headed and managed by a
pathologist, certified either as a Clinical Pathologist, an Anatomic
Pathologist, or both by the Philippine Board of Pathology.
ii. The head of the laboratory shall have administrative and technical
supervision of the activities in the laboratory.
iii. The head of the laboratory shall supervise the staff in accordance to
the standards set by the Philippine Society of Pathologists.
iv. There shall be an adequate number of medical technologists and
other health professionals with documented training and experience

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 PARTI
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to conduct the laboratory procedures. 1he number of staff shall

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depend on the workload and the services being provided.
v. There shall be staff development and continuing education program
at all levels of organization to upgrade the knowledge, attitude and
skills of staff.

(b) Equipment
i. There shall be available and operational equipment to provide the
laboratory examinations that the laboratory is licensed for.
ii. There shall be a calibration, preventive maintenance and repair
program for the equipment.
iii. There shall be a contingency plan in case of equipment breakdown.
(c) Glassware, Reagents and Supplies
i. There shall be available reagents, glassware and supplies for the
laboratory examinations to be provided.
ii. There shall be an inventory control of the reagents, glassware and
supplies.
iii. The reagents, glassware and supplies shall be stored under the
required conditions.
(d) Administrative Policies anJ Procedures
The clinical laboratory shall have written policies and procedures for the
provision oflaboratory services and for the operation and maintenance of
the laboratory.
(e) Technical Proced ures
There shall be documented technical procedures for services provided in
each Section of the laboratory, which will ensure the quality of laboratory
results.
(f) Quality Assurance Program
i. There shall be an Internal Quality Assurance Program which shall
include:
a) An Internal Quality Control Program for technical procedures
b) An Internal Quality Assurance Program for inputs, processes
and outputs
c) A Continuous Quality Improvement Program covering all
aspects oflaboratoryperformance.
ii. The clinical laboratory shall participate in an EQAP administered by
designated NRL or in other local and international EQAP approved
by the DO H .

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(g) Communication and Records

i. There shall be procedures for the receipt and performance of routine
and STAT requests for laboratory examinations.
ii. There shall be procedures for the reporting of results of routine and
STAT laboratory examinations, including critical values that would
impact on patient care.
iii. All laboratory reports on various examinations of specimens shall
bear the name and facsimile signature of the pathologist who shall
be accountable for the reliability of the results. The reports shall also
bear the name and signature of the registered medical technologist(s)
who have performed the examinations. Electronic signatures shall be
permitted in accordance to the provisions of the £ -Commerce Law.
iv. There shall be procedures for the reporting of workload, quality
control, inventory control, work schedule and assignments.
v. There shall be procedures for the reporting and analysis of incidents,
adverse events, and in handling complaints.
vi. The retention of laboratory records shall be in accordance to the
standards promulgated by the DOH or by competent authorities for
such purposes.
(h) Physical Facilities/ Work Environment

i. The clinical laboratory shall conform to all applicable local and

national regulations for the construction, renovation, maintenance
and repair of clinical laboratories.
ii. The laboratory shall conform to the required space for the conduct of
its activities.
iii. There shall be well-ventilated, lighted, clean, safe and functional areas
based on the services provided.
iv. There shall be a program of proper maintenance and monitoring of
physical plant and facilities.
v. There shall be procedures for the proper disposal of waste and
hazardous substances.
vi. There shall be policy guidelines on laboratory biosafety and
biosecurity.
(i) Referral of Examinations Outside of the Clinical Laboratory
When laboratory examinations are referred to and provided by an outside
laboratory, the head of the referring clinical laboratory shall obtain
assurance of the quality of services provided through a Memorandum of
Agreement or its equivalent with a licensed clinical laboratory performing

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

2. LTO
-
(a) The LTO is issued in the name of the licensee and is non-transferable, whether
voluntarily or involuntarily, through sale, assignment or any other means. The license
is not valid for any premise/ location other than that which is stipulated therein.
(b) The LTO issued to a clinical laboratory, unless sooner suspended or revoked, is valid
for one year and expires on the date set forth by the CHD, as stipulated on the fade
of the license.
( c) The LTO issued to a non-hospital based clinical laboratory shall specifically stipulate
the following: name of the clinical laboratory, name/ s of the owner or operator, head
of the laboratory, service capability, period of validity, license number, and, location
wherein the laboratory procedures are to be performed.
( d) The LTO issued to a non-hospital based clinical laboratory must be displayed at all
times at a prominent place within the laboratory premises.
(e) H ospital based clinical laboratories shall be licensed as part of the hospital through
the One-Stop-Shop Licensure for H ospitals and are therefore not required to obtain
a separate license.
(f) The capability to perform HIV testing and / or drinking water analysis shall be
specifically indicated in the LTO, as issued by the CHD.
(g) The clinical laboratory and its satellite services within the same compound shall have
one( l ) LTO.
(h) A satellite laboratory outside the premises where the central laboratory is situated
shall be required to secure a separate LTD.
(i) Mobile clinical laboratories shall be licensed as part of the main clinical laboratory
and shall be pennitted to collect specimens only. It shall be allowed to operate only
within one hundred ( 100) km radius from its main laboratory.
(j) Changes that would substantially affect the conditions of a clinical laboratory, as
set forth in its LTO, shall be reported to the concerned CHD within two (2) weeks
from the initial date of implementation. The report shall be in writing, signed by the
licensee, and submitted to the concerned CHD for notation.
(k) 1he LTO maybe revoked, suspended or modified in full or in part for any material
false statement by the applicant, or as shown by the record of inspection or for a
violation of, or failure to comply with any of the terms and conditions and provisions
of these rules and regulations.
VIL PROCEDURAL GUIDELINES
A. Registration for Special Clinical Laboratories, National Reference Laboratories,
Research and Teaching Laboratories
1. Applicants can acquire the prescribed Application Form for Registration from
the BHFS, CHD that has jurisdiction over the existing or proposed clinical
laboratory, orat the DOH website (www.doh.gov.ph).
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2. The accomplished form together with the necessary attachments is to be

submitted to the BHFS or through the CHD that has jurisdiction over the
existing or proposed clinical laboratory. The applicant shall be required to pay a
non-refundable application fee for Certificate of Registration upon submission
of the accomplished form and documentary requirements.
3. The BHFS shall evaluate and accept applications based on due execution of
forms and completeness of attachments
B. Procedures for Application for Initial/ Renewal ofLTO
I. Applicants can acquire the prescribed application form for LTO from the BHFS,
CHD that has jurisdiction over the existing or proposed clinical laboratory, or at
the DOH website (www.doh.gov.ph).
2. The accomplished form together with the necessary attachments is to be
submitted to the CH D that has jurisdiction over the existing or proposed clinical
laboratory. The applicant shall be required to pay a non-refundable application
fee for LTD upon submission of the accomplished fonn.
3. The CHD that has jurisdiction over the existing or proposed clinical laboratory
shall conduct inspections in accordance with licensing requirements, as provided
for under this Order and the One-Stop-Shop Licensure System for Hospitals.
C. Renewal ofLTO
I. Renewal of hospital based clinical laboratories shall be in accordance with the
licensing process under the One-Stop-Shop Licensure System for Hospitals.
2. Non-hospital based clinical laboratories shall file applications for renewal of
LTD beginning on the first day of October until the last day of November of
the current year. A discount on the renewal fee shall be granted if a complete
application is filed during this period.
3. Renewal of license for compliant clinical laboratories shall be processed not later
than five (5) working days after the expiration date of its license.
4. The LTD of a clinical laboratory shall be automatically cancelled without notice
when it fails to submit a duly accomplished application form and to pay the
proper fee on or before the expiration date stated in its license.
D. Inspection
1. The CHD shall conduct an announced licensure inspections at any reasonable
time.
2. The licensee shall ensure the accessibility of the premises and facilities where
the laboratory examinations are being perfonned for the inspection of the CHD
Director or his authorized representative(s) at any reasonable time.
3. The licensee shall ensure the availability of all pertinent records for checking/
review of the CH D Director or his authorized representative(s).

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MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

4. An inspection tool, which prescribes the standards, criteria and technical

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requirements for the issuance ofLTO, shall be utilized.
E. Monitoring
I. All clinical laboratories shall be monitored regularly.
2. The BHFS or the CHD Director or his authorized representative(s) shall
monitor clinical laboratories through monitoring visits to the laboratory at any
reasonable time.
3. All clinical laboratories shall ensure that all laboratory records, premises and
facilities are made available to the BHFS or the CHD Director or his authorized
representative(s) in order to detennine compliance with the provisions of this
Order.
4. A Notice of Violation for non-compliant clinical laboratories shall be issued
immediately after monitoring the clinical laboratory.
S. The CHD concerned shall submit a quarterly summary of the violations to
theBHFS stating the name of the clinical laboratory, location, its corresponding
violation and the course of action taken.
6. The Provincial, City and Municipal H ealth Officers are enjoined to report to
theBHFS/ CHD the existence of unlicensed clinical laboratories or any private
party performing laboratory examinations without proper license and/ or
violations to these rules and regulations.
VIII. SCHEDULE OF FEES
(a) A non-refundable fee shall be charged for the initial application / renewal oflicense to
operate a clinical laboratory, either government or private.
(b) All fees/ checks shall be paid to the order of DOH in person or through postal money
order.
(c) All fees, surcharges and discounts shall follow the current DOH prescribed schedule
of fees.
IX. VIOLATIONS
Violation of Republic Act 4688 or these rules and regulations and/ or commission of the
following acts by personnel operating the clinical laboratory under this authority shall be
penalized:
a. Refusal of any clinical laboratory to participate in an EQAP conducted by the
designated NRL or other external proficiency program approved by the DOH;
b. Issuance of a report, orally or in writing, in whole or portions thereof, which is not in
accordance with the documented procedure approved by the head of the laboratory;
c. Permitting unauthorized persons to perform technical procedures;
d. Demonstrating incompetence or making consistent errors in the perfonnance of
clinical laboratory examinations and procedures;
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e. Deviation from the standard test procedures including use of expired reagents;

£ Reporting/ release of erroneous results;

g. Lending or using the name of the licensed clinical laboratory or the head of the
laboratory or medical technologist to an unlicensed clinical laboratory;

h. Unauthorized use of the name and signature of the pathologist and medical
technologist to secure LTO;

i. Reporting a test result for a clinical specimen even if the test was not actually
performed;

j. Transferring of results of tests done in an outside clinical laboratory to the result fonn
ofthe referring laboratory;

k. Perfonning and reporting tests in a specialty or subspecialty in which the laboratory

is not licensed;

I. Giving and receiving any commission, bonus, kickback or rebate or engaging in

any split-fee arrangement in any form whatsoever with any facility, physician,
organi1.ation, agency or person, either directly or indirectly, for patients referred to a
clinical laboratory licensed by the DOH.
X. INVESTIGATION OF COMPLAINTS
(a) The BHFS or the CHD Director or his authorized representative(s) shall investigate
the complaint and verify if the laboratory concerned or any of its personnel is
accountable for an alleged violation.
(b) The CHD Director or his authorized representative( s), after investigation, shall
suspend, cancel or revoke for a determined period of time the LTO oflicensees who
are found violating the provisions of R.A. 4688 or this Order, without prejudice
to taking the case to judicial authority for criminal action. The CHD shall seek the
assistance of any law enforcement agency to execute the closure of any erring clinical
laboratory, when necessary.
XI. PENALTY
Any person who operates a clinical laboratory without the proper license from the DOH
shall upon conviction be subject to imprisonment for not less than one ( I) month or a fine
of not less than Php 1,000.00 and not more than Php 5,000.00 or both at the discretion
of the court. Provided however, that if the offender is a finn or corporation, the managing
head and/ or owner(s) thereof shall be liable to the penalty imposed herein.
XII. APPEAL
The decision of the BHFS/ CHD may be appealed to the Office of the H ealth Secretary
within ten ( 10) days after receipt of the notice of the decision. Thereupon, the BHFS shall
promptly certify and file a copy of the decision, including all documents and transcript of
hearings on which the decision is based, with the Office of the Health Secretary for review.
The decision of the Office of the H ealth Secretary is final and executory.

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XIII. REPEALING CLAUSE

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Provisions from previous issuances that are inconsistent or contrary to the provisions of
this Order are hereby rescinded and modified accordingly.
XIV. SEPARABILITY CLAUSE
In the event that any provision or part of this Order be declared unauthorized or rendered
invalid by any court of law or competent authority, those provisions not affected by such
declaration shall remain valid and effective.
XV. EFFECTIVITY
This Order shall take effect fifteen ( I 5) days after its approval and publication in the official
gazette or newspaper of general circulation.

FRANCISCO T.DUQUE III, M.D., MSc

Secretary of Health

Reference (RA 4688):

http://lcp.gov.ph/images/Admin_Order_2007 _0027.pdf

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 RA468 : -
THE CLINICAL LABORATORY LAW OF 1966

CLASSIFICATION OF LABORATORIES
According to According to Function According to
ownership Institutional character
a. Govenunent a. Clinical Pathology a. Institution Based
b. Private b. Anatom ic b. Free standing
Pathology

ACCORDING TO SERVICE CAPABILITY

Primary Category Secondary Category Tertiary Category
laboratory Laboratory laboratory
1. Routine 1. Io laboratory 1. 2o laboratory
H ematology examination examination
2. Routine Urinalysis 2. Routine Chemistry 2. Special Chemistr y
3. Routine Fecalysis 3. Quantitative 3. Special Hematology
4. Q ualita tive Platelet Platelet 4. Immunology/
detennination de te nnination Serology
5. Blood Typing - HB 4· Crossmatching - S. Microbiology
HB
a. aerobic/ non
5. Gram staining/ aerobic- HE
KOH - HB
b. aerobic/ non
aerobic - NHB

O ther Classification of Laboratories:

I. Limited Service Capability (institution-based)
- dialysiscenters

- social hygiene clinics

2. Special Clinical Laboratory
- Assistant Reproduction Technology Laboratory
- Molecular and Cellular Technology
- Molecular Biology
- Molecular, Forensic and Anatom ic Pathology

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MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

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3. National Reference Laboratory (NRL)
- laboratory in a government hospital which had been designated by DOH to provide
special functions and services:
a. Confirmatory testing d. Training and Research

b. Surveillance e. Evaluation of Kits and reagents

c. Resolution of Conflicts f. External Quality Assessment Program
4. Satellite Testing Site
- any testing site that performs laboratory examinations under the administrative control
of a licensed laboratory but perfonned outside the physical confines of the laboratory
S. Mobile Clinical Laboratory
- a laboratory testing unit that moves from testing site to another testing site or has a
temporary testing location but shall have a base laboratory
- shall be licensed as part of the main clinical laboratory and is permitted to collect
specimens only
- shall be alhwed to operate only within 100 km radius from its main laboratory

ISSUES ARISING FROM THE LICENSE TO OPERATE

LTD
• issued in the name of the licensee and is NON TRANSFERABLE
• issued ONLY to laboratories that comply with the standards set forth by the
BH FS
NOT valid for any location other than that which is stipulated therein
VALIDITY: I year and expires on the date set forth by the CHD
displayed at all times on a CONSPICUOUS place within the laboratory

License to O perate a Clinica l l aboratory

Name ofthe Clinical Laboratory
Name of the Owner or operator
Head of the laboratory
Type of Services offered
Period ofValidity
License Number
Location wherein the laboratory procedures are to be perfonned

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THE CLINICAL LABORATORY LAW OF 1966

ISSUE# I. Are the following laboratories required to have a separate license to operate?
a. H ospital Based Clinical Laboratories:
Answer: NO, they shall be licensed as part of the hospital through "ONE-STOP-SH OP"
Licensure for hospital
b. Satellite Laboratories outside the premises of a central laboratory
Answer: YES, they shall be REQUIRED to secure a separate License to Operate.

ISSUE# 2. ls it required to indicate special procedures in the license to operate?

Answer: YES, the CHD issues a License to Operate with the inclusion of procedures like HIV
testing and Drinking Water Analysis

ISSUE# 3. Are all types of laboratories covered by the provisions ofRA4688?

Answer: NO, there are some exemptions:
I. Government Clinical Laboratories performing:
a. Malaria Screening c. Tests for STD
b. AFB Microscopy d. Cervical Cancer Screening (Pap)
2. Clinical Laboratories for Research and Teaching Purposes
3. Physician's Office Laboratory (POL)

ISSUE # 4. Are there restrictions in the operations of the following?

a. Physician Office Laboratory ( POL)
Answer: YES, it is required to secure a license ifit undertakes the following:
Issue an official laboratory result
• Perform more than the monitoring examination
• Cater not only to the physician's own patients
b. Point of Care Testing ( POCT)
Answer: YES, if conducted in the hospital, is required to be under the management and
supervision ofa licensed clinical laboratory of the respective hospital

TOP 10 VIOLATIONS TO RA 4688

1. Refusal to participate in an EQAP
2. Issuance of a report ( orally or in writing) which is NOT in accordance with the documented
procedure approved by the head of the laboratory
3. Permitting UNAUTH ORIZED PERSONS to perform technical procedures

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

4. INCOMPETENCE: consistent errors in laboratory examinations

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S. SUBSTANDARD test procedures: use of expired reagents
6. ERRONEOUS RESULTS:
a. Tamperedresult
b. Result from an UNTESTED specimen
7. Lending or using the name of licensed clinical laboratory or licensed personnel to an
unlicensed clinical laboratory
8. Unauthorized use of the name and signature of pathologist and medical technologist to secure
LTO
9. Transferring of results of tests done in an outside clinical laboratory to a result form of the
referring laboratory
I 0. Performing and reporting tests in a specialty or subspecialty in which the laboratory is NOT
licensed

PENALTY: a. IMPRISONMENT: I month to I year

b. FINE: Pl,000- PS,000

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Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ Score:
Seat Number: Section: Date:

A. Multiple Choice (20 items). Choose the CORRECT an swer from the given
choices.
I. Provided a duplicate copy is on file in the medical records, all requests
and reports in the clinical laboratory shall be kept on file for at least

a. fiveyears c. oneyear
b. sixmonths d. indefinitely

2. Which among the following types of laboratory would have the most
number of examinations?
a. Io laboratory c. 3 o laboratory
b. 2 o laboratory d. 4 o laboratory
3. All laboratory requests shall be considered as CONSULTATION
between the
a. medical technologist and the pathologist
b. requesting physician and the medical technologist
c. requesting physician and the pathologist
d. patient and the pathologist
4. Any clinical laboratory, whether attached or unattached to a hospital or
clinic, performing NOT more than 800 examinations a month should
have at least
a. two medical technologists
b. one medical technologist and one medical laboratory technician
c. one medical technologist
d. two medical technologists and two medical laboratory technician
S. A medical technologist is NOT allo...,'ed by the law to _ _ _ _.
a. head a clinical laboratory
b. supervise another medical technologist
c. supervise a section of the clinical laboratory
d. own a clinical laboratory

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MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

6. A medical technologist can supervise ONLY _ _ _ _ __

a. one medical technician at one time
b. four medical technicians at one time
c. two medical technicians at one time
d. three medical technicians at one time
7. The central governmental agency authorized to regulate the operation and
maintenance of laboratory through the issuance of license: (AO 59 s 2001) is
th,
a. DOH through the Bureau of Research and Laboratory
b. H ead of clinical laboratories
c. Philippine Society of Pathologists
d. PAMET
8. A clinical laboratory is EXEMPTED from obtaining a license ifit _ _ _ .
a. does only simple laboratory test
b. perfonns less than SO examinations
c. is fully automated
d. is being used solely for academic training
9. The clinical laboratory law requires that _ _ _ _~
a. the pathologist owns the clinical laboratory
b. the clinical laboratory is owned by the medical technologist
c. the clinical laboratory has a pathologist, medical technologist, and a medical
laboratory technician
d. the clinical laboratory is headed by a pathologist
10. Laboratory reports must be given by the medical technologist ONLY to

a. patient's family
b. requesting physician
c. medicaldirector
d. patient
11 . The license of the clinical laboratory MUST be placed _ _ _ .
a. at the office of the medical director
b. at the Out-Patient Department or ER
c. at the conspicuous place within the laboratory
d. must be kept in the library

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12. Republic Act #4688 took effect upon its approval on _ _ _ _ .

a. June 18, 1966 c. June28,1966
b. June 18, 1968 d. June 28, 1968
13. Minimum Required space in square meters for a 3o category laboratory is

a. 10 C 40
b. 20 d. 60
14. In an automated laboratory, the ratio between the number of examinations
performed per month and the required number of registered medical
technologists hired shall be determined on a case-to-case basis by the _ __
based on AO 49-B s. 1988.
a. Hospital Medical Director
b. PAMEr President
c. BRL Director
d. Chief Medical Technologist
15. In clinics with in-patients and hospitals less than SO beds, who may assume the
responsibility of covering night duty in the laboratory?
a. registered medical technologist
b. physician in charge
c. medical laboratory technician
d. chief medical laboratory aid
16. A pathologist maybe authorized to MANAGE and SUPERVISE and/ or be an
associate pathologist in NOT more than _ _ clinical laboratories/ blood
banks based on AO 59 s. 200 1.
,. I C 3
b. 2 d. 4
17. The owner or his representative of any clinical laboratory desiring to transfer a
registered clinical laboratory to another place shall inform the BHFS in writing
within how many days after the transfer has been completed?
a. 15 c. 45
b. 30 d. 90
18. Failure to infonn BRL regarding changes in ownership and heads of the
laboratory will mean _ _ _ _~
a. chance for license renewal
b. revocation of the license of the clinical laboratory
c. suspension of the license of the clinical laboratory
d. reorganization of the whole clinical laboratory

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 PARTI
MEDICAL TECHNOLOGY LAWS AND OTHER RELATED LAWS

19. 1he NRL which is involved in the external quality control should give a clinical
laboratory a perfonnance rating of _ _ _ _before it can be allowed to
renew its license to operate:
a. good c. satisfactory

b. fair d. excellent
_ _ 20. Which among these examinations is NOT done in a non hospital based
secondary type oflaboratory?
a. routinefecalysis c. hematocrit determination
b. totalcholesterol d. crossmatching

B. IDENTIFICATION. Identify the following National Reference Laboratories (NRL) in

the Philippines.
I. NRL for Biochemistry (Clinical Chemistry)
2. N RL for Environmental and Occupational H ealth; Toxicology
and Micronutrient Assay.
3. N RL for HN / AIDS, Hepatitis, Syphilis and other Sexually
Transmitted Infections (STis).
4. NRL for H ematology including lmmunohematology,
lmmunopathology and Anatomic Pathology
5. NRL for Dengue , Influenza, Tuberculosis and other
Mycobacteria , Malaria and other parasites, Bacterial enteric
diseases, Measles and other Viral exanthems, Mycology,
Enteroviruses, Antimicrobial resistance and Emerging
Diseases

C. Critical Thinking Questions. Answer the following questions briefly but substantially.
I. In a certain laboratory, a result was signed by a registered medical technologist and an
e-signature ( stamped signature) of the pathologist was affixed only. ls the act justified?
Explain your answer.

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2. ls a "sent-out" strategy allowed in cases a laboratory run-out of reagents? Justify your

3. Should an owner hire an under-board in his laboratory? Explain your answer. If yes what
will be his / her job description?

4. Can a medical technician can perfonn laboratory tests and issue a result in situation when
the RMT was absent on his duty? Justify your answer.

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S. A laboratory consistently issues doubtful results. It was found out that it has been using
expired reagents. Can the laboratory be sanctioned? Justify your answer.

6. What is NEQAS / EQAS? What important role does it play in the regulation of clinical
laboratories?

D. Course Inquiry Projects. Choose o ne from these two projects and submit your work in
a computerized form using short bond paper/ s.
1. Research about a clinical laboratory and examine its organizational chart. Illustrate the
organizational chart and indicate the function of each person in each position.
2. Survey the services offered in at least 10 different laboratories of the same category.
Compare their prices. What accounts for the variations? ls over pricing an issue in clinical
laboratories?

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 RA 7719 :
THE N~T(ONAL BLOOD SERVICES ACT OF 1994

INTRODUCTION
The rising problems on blood transmissible diseases has alerted public health through the past
years. It has been linked to blood commercialization. hi this context, health advocates advise an
alternative way to reduce cases through healthy blood donation from donors. RA 7719 which
repealed the Blood Banking Law, RA 1517, stresses the relevance ofvoluntary donation in lessening
problems diseases acquired through blood transfusion. It focuses on safeguarding blood donation
and promoting adequate supply of safe blood by preventing improper collection, processing and
sale of human blood and its products to the public. Its dogma operates on the id ~a that blood
donation is a humanitarian act.

INTENDED LEARNING OUTCOMES

At the end of this unit, the students are expected to:
At the end of this unit, the students are expected to:
I. discuss the relevance of donor screening and selection
2. enumerate the different types of blood banks and differentiate them
3. create health promotional materials for the prevention ofblood transmissible diseases
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Republic of the Philippines

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Congress of the Philippines
Metro Manila

Second Regular Session

Begun and held in Metro Manila, on Monday, the twenty-sixth day ofJuly,
nineteen hundred and ninety-three.

REPUBLIC ACT NO. 7719

AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR

AN ADEQUATE SUPPLY OF SAFE BLOOD, REGULATING BLOOD BANKS, AND
PROVIDING PENALTIES FOR VIOLATION THEREOF

Be it enacted by the Senate and House of Representatives of the Pliilippine.s in Congress assembled:

SECTION 1. Title. - This Act shall be known as the "National Blood Services Act of l 994~
SECTION 2. Declaration of Policy. - In order to promote public health, it is hereby declared the
policy of the State:
a. 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;
b. to lay down the legal principle that the provision of blood for transfusion is a professional
medical service and not a sale of a commodity;
c. to provide for adequate, safe, affordable and equitable distribution of supply of blood and
blood products;
cl. to infonn the public of the need for voluntary blood donation to curb the hazards caused by
the commercial sale of blood;
e. to teach the benefits and rationale of voluntary blood donation in the existing health subjects
of the fonnal education system in all public and private schools, in the elementary, high school
and college levels as well as the non-fonnal education system;
£ to mobilize all sectors of the community to participate in mechanisms for voluntary and non-
profit collection of blood;
g. to mandate the Department of Health to establish and organize a National Blood Transfusion
Service Network in order to rationalize and improve the provision of adequate and safe supply
ofblood;

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THE NATIONAL BLOOD SERVICES ACT OF 1994

h. to provide for adequate assistance to institutions promoting voluntary blood donation and
providing non-profit blood services, either through a system of reimbursement for costs
from patients who can afford to pay, or donations from governmental and non-governmental
entities:
i. to require all blood collection units and blood banks/centers to operate on a non.profit basis;
j. to establish scientific and professional standards for the operation of blood collection units
and blood banks/ centers in the Philippines;
k. to regulate and ensure the safety of all activities related to the collection, storage and banking
ofblood; and
I. to require upgrading ofblood banks/centers to include preventive services and education to
control spread ofblood transfusion transmissible diseases.
SECTION 3.Definitions. - For purposes of this Act, the following terms shall mean:
a. Blood/ bl ood product - refers to human blood, processed or unprocessed and includes
blood components, its products and derivatives;
b. Blood bank/ cen ter - 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 transfusion transmissible diseases;
c. Comm ercial blood bank - a blood bank that exists for profit;

d. H ospital-base d blood bank - a blood bank which is located within the premises of a hospital
and which can perform compatibility testing of blood;
e. Blood collection unit - an institution or facility duly authorized by the Department of
H ealth to recruit and screen donors and collect blood;
f. Voluntary bl ood do nor - one who donates blood on one's own volition or initiative and
without monetary compensation;
g. Department - the Department of Health;
h. Blood transfusion transmissible diseases - diseases which may be transmitted as a result of
blood transfusion, including AIDS, Hepatitis-B, Malaria and Syphilis;
i. Secre tary of Health - the Secretary of H ealth or any other person to whom the Secretary
delegates the responsibility of carrying out the provisions of this Act; and
j. Walking Blood Donor - an individual included in the list of qualified voluntary blood donors
referred to in Section 4, paragraph (e), who is ready to donate blood when needed in his/ her
community.
SECTION 4. Promotion of Voluntary Blood Donation. - In order to ensure adequate supply of
human blood, voluntary blood donation shall be promoted through the following:
a. P u blic Education . - Through an organized and sustained nationwide public education
campaign by the Department, the Philippine National Red Cross (PNRC) and the Philippine
Blood Coordinating Council ( PBCC), as the lead agencies, other government agencies, local

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government units (particularly the barangays), non-governmental organizations, all medical

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organizations, all public and private hospitals, all health and health-related institutions, print
and broadcast media as well as other sectors. The Department is hereby authorized to set aside
funds and generate financial support for all sectors involved in the collection and processing
of blood from voluntary blood donors through a system of reimbursement for costs for
patients who can afford to pay or from donations from government and private institutions.
Voluntary donors shall likewise be provided non monetary incentives as may be determined
by the Department.
b. Promotio n in Schools. - The benefits and rationale of voluntary blood donation shall be
included and given emphasis in health subjects of schools, both public and private, at the
elementary, high school and college levels. The Department of Education, Culture and Sports
shall also require such inclusion in its non-fonnal education curricula.
c. Professional Education. - The Department, the PBCC, the Philippine SocietyofH ematology
and Blood Transfusion (PSHBT), the Philippine Society of Pathologists (PSP), the Philippine
Medical Association (PMA), the Philippine Association of Medical Technologists (PAMET)
and the Philippine Nursing Association (PNA) are encouraged to conduct for their respective
members and as part of the continuing medical education, trainings on the rational use of
blood and blood products including the merits of voluntary blood donation.
d. Establishment ofBlood Services Network. - Blood centers shall be strategically established
in every province and city nationwide within the framework of a National Blood Transfusion
Service Network spearheaded by the Department, in coordination with the PNRC. The
collection of blood in various areas in the community, such as schools, business enterprises,
barangays, and military camps shall be promoted.
1he Secretary shall set the standards for the scientific and professional establishment and
operation ofblood banks/ centers and collection units. The Department shall provide training
programs and technical assistance to enable communities, schools, industrial and business
sites, barangays, military camps and local government units to implement their own voluntary
blood donation programs.
e. Walking Blood Donors. - In areas where there may be inadequate blood banking facilities,
the walking blood donor concept shall be encouraged and all government hospitals, rural-
health units, health centers and barangays in these areas shall be required to keep at all times a
list of qualified voluntary blood donors with their specified blood typing.
SECTION 5, National Voluntary Blood Services Program. - The Department, in cooperation with
the PNRC and PBCC and other government agencies and non-governmental organii.ations
shall plan and implement a National Voluntary Blood Services Program (NVBSP) to meet in an
evolutionary manner, the needs for blood transfusion in all regions of the country. Funds for this
purpose shall be provided by the Government through the budgetary allocation of the Department,
by the Philippine Charity Sweepstakes Office (PCSO) with an initial amount of at least Twenty-
five million pesos (P2S,OOO,OO0), by the Philippine Amusement and Gaming Corporation
(PAGCOR) with an initial amount of at least Twenty-five million pesos (P25,000,000), by the
trust liability account of the Duty Free Shop (Duty Free Philippines) with an initial amount of at

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least Twenty million pesos (P20,000,000) and through contributions of other agencies such as
civic organizations.
SECTION 6. Upgrading of Services and Facilities. - All blood banks/ centers shall provide
preventive health services such as education and counselling on blood transfusion transmissible
diseases. All government hospitals, including those that have been devolved, shall be required
to establish voluntary blood donation programs and all private hospitals shall be encouraged to
establish voluntary blood donation programs.
The Department, in consultation with the PSHBT and the PSP, shall also establish guidelines for
the rational use ofblood and blood products.
SECTION 7. Phase-out of Commercial Blood Banks. - All commercial blood banks shall be phased.
out over a period of two (2) years after the effectivityofthisAct, extendable to a maximum period
of two (2) years by the Secretary.
SECTION 8.Non-Profit Operation. -All blood banks/ centers shall operate on a non-profit basis:
Provided, That they may collect service fees not greater than the maximum prescribed by the
Department which shall be limited to the necessary expenses entailed in collecting and processing
of blood. Blood shall be collected from healthy voluntary donors only.
SECTION 9. Regulation of Blood Services. - It shall be unlawful for any person to establish
and operate a blood bank/ center unless it is registered and issued a license to operate by the
Department: Provided, That in case of emergencies, blood collection and transfusion under the
responsibility of the attending physician shall be allowed in hospitals without such license under
certain conditions prescribed by the Department. No license shall be granted or renewed by
the Department for the establishment and operation of a blood bank/ center unless it complies
with the standards prescribed by the Department. Such blood bank/ center shall be under the
management of a licensed and qualified physician duly authorized by the Department.
SECTION 10. Importation of Blood Bank Equipment, Blood Bags and Reagents. - Upon the
effectivity of this Act, equipment, blood bags and reagents used for the screening and testing of
donors, collection and processing and storage of blood shall be imported tax.and duty-free by the
PNRC, blood banks and hospitals participating actively in the National Voluntary Blood Services
Program. This provision shall be implemented by the rules and regulations to be promulgated by
the Department in consultation and coordination with the Department of Finance.
SECTION 11. Rules and Regulations. -1he implementation of the provisions of this Act shall be
in accordance with the rules and regulations to be promulgated by the Secretary, within sixty ( 60)
days from the approval hereof. The existing Revised Rules and Regulations Governing the Collection,
Processing and Provision of Human Blood and tlie Establishment and Operation of Blood Banks
shall remain in force unless amended or revised by the Secretary. The rules and regulations shall
prescribe from time to time the maximum ceiling for fees for the provision ofblood, including its
collection, processing and storage, professional services and a reasonable allowance for spoilage.
SECTION 12. Penalties. - 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.
Any person or persons who shall be responsible for the above violation shall suffer the penalty of
imprisonment of not less than one ( 1) month nor more than six ( 6) months, or a fine of not less

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than Five thousand pesos (PS,000) nor more than Fifty thousand pesos (PS0,000), or both at the
- discretion of the competent court.
Any person who shall establish and operate a blood bank without securing any license to operate
from the Department or who fails to comply with the standards prescribed by the Department
referred to in Section 9 hereof shall suffer the penalty of imprisonment of not less than twelve ( 12)
years and one ( I) day nor more than twenty (20) years or a fine of not less than Fifty thousand
pesos (PS0.000) nor more than Five hundred thousand pesos (PS00,000 ), or both at the discretion
of the competent court.
The Secretary, after due notice and hearing, may impose administrative sanctions such as, but
not limited to, fines, suspension, or revocation of license to operate a blood bank/ center and to
recommend the suspension or revocation of the license to practice the profession when applicable.
The head of the blood bank 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 is without prejudice to the filing of criminal charges under
the Revised Penal Code.
SECTION 13. Separability Clause. - lf any provision of this Act is declared invalid, the other
provisions hereof not affected thereby shall remain in force and effect.
SECTION 14. Repealing Clause. - This Act shall supersede Republic Act No. 1S 17 entitled ~Blood
Bank Act." The provisions of any law, executive order, presidential decree or other issuances
inconsistent with this Act are hereby repealed or modified accordingly.
SECTION 15. Effectivity Clause. - This Act shall take effect after fifteen ( 15) days following its
publication in the Official Gazette or in two ( 2) national newspapers of general circulation.

Approved,
(Sgd.) JOSE C. DE VENECIA,JR.
Speaker of the House
of Representatives

This Act which is a consolidation of Senate Bill No. 10 11 and H ouse Bill No. 879 was finally passed
by the Senate and the H ouse of Representatives on April 28, 1994.

(Sgd.) CAMILOL.SABIO
Secretary General
House of Representatives
Approved: MAY 5, 1994

(Sgd.) FIDEL V. RAMOS

President of the Philippines

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28April 1995
Administrative Order No. 9. S 1995

SUBJECT: Rules and Regulations hnplementing Republic Act No. 77 19 otherwise known as the
"NATIONAL BLOOD SERVICES ACT of 1994"
Pursuant to Section 11 ofRepublicAct No. 77 19, otherwise known as the National Blood Services
Act of 1994, passed by the Senate and the H ouse of Representatives on 28 April 1994 which took
effect on 12 May 1994, the following Rules and Regulation are hereby adopted.

Republic Act No. 7719

AN ACT PROMOTING VO LUNTARY BLOOD DONATION, PROVIDING FOR

AN ADEQUATE SUPP LY OF SAFE BLOOD, REGULATING BLOOD BANKS,AND
PROVIDING PENALTIES FOR VIOLATION THEREOF.

Be it enacted by tlie Senate and House of Representatives of the Philippine.s Congress assembled:

CHAPTER I
TITLE AND APPLICATION

SECTION 1. Title. - 1hese Rules shall be known as the "Rules and Regulations Implementing
Republic Act No. 77 19 otherwise known as the NATIONAL BLOOD SERVICES ACT of l 994~
SECTION 2. Purpose. - These Rules and Regulation are adopted prescribing the principles,
guidelines, procedures and standards for the implementation ofR.A. 77 19 to facilitate compliance
therewith and achieve the objectives thereof.
SECTION 3. Scope. - These Rules shall apply to all hospitals, entities, establishments or
institutions, government owned and operated or private, engaged in blood transfusion services in
the Philippines whether full time or part time, local or foreign.
SECTION 4. Definition of Terms -As used in these Rules and Regulations, the terms below shall
be defines as follows:
1. ACT - republic Act 77 19 otherwise known as the "National Blood Services Act of 1994",
unless herein specified;
2. DEPARTMENT - the Department of H ealth;
3. SECRETARY OF HEALT H - the Secretary of H ealth or any other person to whom the
Secretary delegates the responsibility of carrying out the provisions of this Act;

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4. BLOOD/BLOOD PRODUCT - refers to human blood, processed or unprocessed and

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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. H OSP ITAL-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;
8. NO N-HOSPITAL-BASED BANK/CENTER - a blood bank/center which is not located
and not perfonning blood bank services, within the premises of a hospital and is not part of a
hospital;
9. COMMERCIAL BLOOD BANK- a blood bank that exist for profit, money or any material
gain earned out of sale, or exchange for, blood or blood products which profit, money or any
material gain are not used for the operation and maintenance of the blood bank service;
10. BLOOD COLLECTION UNIT - an institution or facility duly authorized by the
Department of Health to recruit and screen donors and collect blood;
11. 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;
12. 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;
13. 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;
14. 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) ofR.A. No. 7719, who is ready to donate blood
when needed in his or her community;
15. BLOOD TRANSFUSI ON TRANSMISSIBLE DISEASES - diseases which maybe
transmitted through blood transfusion, including, but not limited to, Acquired Immune
Deficiency Syndrome (AIDS), hepatitis B, hepatitis C, malaria and syphilis;

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16. BLOOD BANKING EQUIPl\1.ENT - essential laboratory machines, instruments and their
accessories used in the different steps in the blood banking process such as those used to
centrifuge blood or separate blood into its various components; preserve blood or blood
products in cold storage or freezer; and perfonn blood test such as hemoglobin test and
screening tests for blood transmissible diseases. These equipment also include those used in
specific supportive processes such as sterilization and sanitary disposal of blood and blood
products.
17. BLOOD BAGS - sterile, sturdy plastic bags containing anti-coagulants which are especially
designed for blood collection and transfusion. Blood bags can either be single or multiple
types and have an integral sterile needle and collection tubing.
18. REAGENTS - substances employed to detect or measure another substance or convert one
substance to another by means of the reaction that it causes. In blood banking, the reagents
used are those necessary to measure hemoglobin; screen for blood transmissible diseases such
as HIV, hepatitis, malaria, syphilis, among others; identify blood groupings; and perform
cross-matching and other immunohematologic examinations.

CHAPTERII
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 H ealth. It shall be composed of, but not
limited to, the heads of the following Offices and associations:

- Department of Education, Culture and Sports

- Department oflnterior 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 H ematology and Blood Transfusion

- Philippine Society of Pathologists

- Philippine Medical Association
- Philippine H ospital Association
- Philippine Association of Medical Technologist, and

- Representatives from other societies and cooperating or donor agencies.

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2. FUNCTIONS: The National Voluntary Blood Services Program Committee shall be

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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 activities;
d. Creation 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. DOH Program Management
I. NATIONAL VOLUNTARY BLOOD SERVICES UNIT:
1he Secretary of Health shall institutionalize a National Voluntary Blood Services Unit within
the organizational structure of the Office of H ealth Facility Standards and Regulation of the
Department.
2. FUNCTIONS: 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 specially 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 design and implementing a voluntary
blood donation program in private hospitals;
d. Preparation of the blood services operational plan incorporating the activities and needs
of the other Department units and services involved in the blood services programs such
as, but not limited to, the Bureau of Licensure and Regulation, and H ospital Operation
and Management Service;
e. Provision of secretariat services to the National Voluntary Blood Service Program

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Committee and such as 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 Services Program Committee and
Sub-committee meetings and activities.
SECTION 8. Program Funding
I. The funds for the National Voluntary Blood Services Program shall be provided by:
a. The budgetary allocation of the Department
b. The Philippine Charity Sweepstakes Office with the initial amount of at least twenty.five
million pesos (P25,000,000.00);
c. The Philippine.Amusement and Gaming Corporation with the initial amount of at least
twenty-five million pesos (25,000,000.00);
d. The trust liability account of the Duty Free Shop with the initial amount of at least twenty
million pesos (P20,000,000.00);
e. The contribution 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,
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
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.

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CHAPTERIII
-
PROMOTION OF VOLUNTARY BLOOD DONATION

SECTION 9. Public Information and Education

I. COMPOSITION: The National Advocacy and Promotion Sub-committee shall be
composed of, but not limited to, representative of the Department of H ealth, the Philippine
National Red Cross (PNRC), the Philippine Blood Coordinating Council (PBCC), the
Philippine lnfonnationAgency, and other similar organizations whose activities are related to
advocacy and promotion of voluntary blood donation.
2. FUNCTION: 1he 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 H ealth 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-committee
shall be created in each region of the country with similar corresponding composition as that
of the National Advocacy and Promotion Sub-committee but may be expanded to include
other organizations. In turn, the Regional Advocacy and Promotion Sub-committee shall
encourage the creation of similar committees at the provincial and city levels.
The Regional Advocacy and Promotion Sub-committee shall be chaired by the representative
of the Department of H ealth and shall have the following responsibilities:
a. Formulation of the regional advocacy and promotion operational plan which shall be
submitted to the Regional H ealth 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
I. 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 H ealth
- Philippine Society of H ematology and Blood Transfusion
- Philippine Society of Pathologists

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- Philippine Association of Medical Technologists

- Philippine Association of Schools of medical Technology and Public H eal th
- Philippine Nursing Association
- Association of Philippine Medical Colleges
- Philippine Medical Association
- Philippine National Red Cross
2. FUNCTIONS: This Sub.committee shall be responsible for the following:
a. Development, printing and distribution of instrnctional materials and methods focused
on voluntary blood donation for integration into the health subjects of all schools, public
or private, and at all levels of education, fonnal or non-formal;
b. Orientation and/ or training of teachers on the utiliz.ation of such materials and methods;
c. Monitoring of the use and effectiveness of such materials and methods in terms of process
and product, and continuing revision of such as necessary;
d. Preparation and submission to the National Voluntary Blood Services Unit of the annual
budgetary requirements for the promotion of voluntary blood services in the schools.
3. TRAINING PROGRAMS AND TECHNICALASSISTANCE:
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
I. ROLE OF THE PRC:
The Professional Regulation Commission (PRC) shall encourage all medical and other health
other health professional associations and societies especially those accredited by the PRC
to conduct trainings on 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.
The PRC shall provide equivalent continuing professional education units for all training
courses on rational use of blood and blood products.
2. ROLE OF PROFESSIONAL SOCIETIES AND ASSOCIATION:
All medical and other health professional association and societies whose activities are related
to professional education and blood transfusion shall be encouraged to conduct trainings and
seminars on the rational use ofblood and blood products including the dangers of commercial
blood and the benefits of voluntary blood donation for their respective members as part of
their continuing professional education activities and residency programs.
Though Sub-committees created by the National Voluntary Blood Services Program
Committee, technical manuals and training modules for health professionals on the Rational

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Use of Blood and Blood Products and Blood Transfusion Medicine" shall be developed
-
involving various professional societies and association.
3. ROLE OF T HE DEPARTMEN T OF HEALTH:
The Secretary of H ealth shall ensure the conduct of trainings on rational use of blood and
blood products, on the practice ofblood transfusion medicine, and on the merits of voluntary
blood donation for health personnel.
1he Department shall require training hospital to conduct continuing professional education
programs and trainings on the rational use of blood and blood and blood products and the
merits of voluntary blood donation as one of the prerequisite for Ii censure ofhospitals. lt shall
also provide guidelines for the inclusion of the rational blood and blood product use and the
merits of voluntary blood donation in the examination for residency training admission and
the monitoring of such activities in hospitals.
1he Department shall require the establishment of a hospital Blood Transfusion Committee
as a prerequisite for licensure of teaching/ training hospitals and hospital with blood banks/
centers.
4. COMPOSITION AND FUNCTIONS OF T HE HOSPITAL BLOOD TRANSFUSION
COMMITTEE:
The H ospital Blood Transfusion Committee shall be composed of, but not limited to:
- Physicians from the Department of Pediatrics, Medicine, Surgery, Obstetrics and
Gynecology, and Pathology
- The Hematology consultant
- Representatives from the nursing service
- The H ospital Medical Training Officer and
- The Blood Services Quality Assurance Officer
1he H ospitalBloodTransfusionCommitteeshallbeprimarilyresponsiblefortheestablishment
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 (Section38 ).

CHAPTERIV
BLOOD SERVICES NETWORK AND BLOOD DONOR RECRUITMENT

SECTION 12. Establishment of Blood Services Network - There shall be established, in coordination
with the local ONRC, a Regional Blood Services Network which shall be chaired by the Regional
H ealth Director. The Regional Blood Services Network which shall be the venue for the following:
I. Review of the existing linkages among blood service facilities and requirements for blood
within their respective region;

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2. Fonnulation ofa design for a blood collection and distribution scheme for the region;
3. Designation and authoriz.ation of different blood service facilities according to geographic
location, to complementary task 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.
SECTION 13. Blood Donor Recrnitment - The Department shall adopt a system of procedures
or programs to promote blood donor recruitment and ensure the increase in the number and
retention of voluntary blood donors as follows:
1. The Department shall coordinate with the heads of agencies, institutions, offices, organiz.ations,
business establishments and communities, be they government or non-government, and
e ncourage them to actively participate in donor recruitment in order to 1secure commitme nts
to regular blood donation in their particularly designated blood services facility;
2. The Department in collaboration with the Philippine National Red Cross shall be the lead
agency in the celebration of the Blood Donor's Week which shall be held annually on the
second week ofJuly. 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 recrniters 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 m ass blood
typing activities in areas where are no adequate blood services facilities.

CHAPTERV
UPGRAD ING OF SERVICES AND FACILITIES

SECTION 14. Monitoring and Evaluation Sub-committee

I. COMPOSITION: The Monitoring and Evaluation Sub-committee shall be composed of,
but not limited to, representatives from the:
- DepartmentofHealth
- DepartmentofEducation
- Philippine National Red Cross
- Philippine Blood Coordinating Council
- Other agencies, professional organizations and societies

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This Sub-committee may require status reports, when deemed appropriate, from various agency
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units such as, but not limited to, the Hospital Operation and Management Service, the Bureau of
Ii censure and Regulation and the bureau of Research and Laboratories of the Department.
2. FUNCTIONS: The Monitoring and Evaluation Sub-committee shall:
a. Design an upgrading and development plan to ensure, at all times, better quality blood
services;

b. Set a criteria of indicators to monitor the progress or success in meeting the requirements
of upgrading of blood services facilities;
c. Monitor all continuing professional education activities;

d. Coordinate all studies and reviews related to the upgrading of blood service facilities.
e. Review the non-monetary incentives for voluntary blood donors and recommended
changes when necessary.
SECTION 15. Department of Health Regional Hospitals and Medical Centers -As much possible,
all regional hospitals and medical centers of the Department shall be upgraded to Hospital-Based
Category B Blood Banks/Centers in accordance with the requirements of Sections 28 and 29 of
these hnplementing Rules and Regulations.
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
especially by providing technical assistance training and mobilizing resources.
SECTION 17. Blood Banks/ Centers with Special Functions - Strategically located Blood Banks/
Centers shall be identified as follows;

I. One Blood bank/Center shall be designated as the National Blood Center and shall be
developed to be able to perfonn more specialized functions such as, but not limited to:
a. preparation of special plasma derivatives;
b. perfonnance of special confirmatory and reference blood tests;
c. conduct of highly technical specialist on-the-job training courses;

d. conduct of research and special studies;

2. At least one Blood Bank/Center in every geographical region shall be designated as the
Regional Blood Center and shall be developed to perform special functions such as, but not
limited to:

a. preparation and distribution of blood components for other hospitals within the region;
b. training and supervisory functions over the other Blood Banks/ Centers within the
region;
c. research.
SECTION 18. Licensing of Private Hospitals - The Department, through the Bureau ofLicensure
and Regulation, shall require private hospitals to submit their Voluntary Blood Donation Program
Plan.

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SECTION 19, Licensing of Government Hospitals - The Department, through the Bureau of
Licensure and Regulation, shall require all government hospitals to submit a Voluntary Blood
Donation Program Plan. 1he application for renewal of their licenses shall be accompanied by the
following:
I. Preceding year's voluntary blood donation program report according to the format designed
by the Monitoring and Evaluation Sub.committee

2. Bureau of Li censure and Regulation monitoring visit report for the preceding year
SECTION 20. Philippine National R ed Cross - The Department shall assist the PNRC in
mobilizing resources and in upgrading their facilities or chapters by facilitating linkages with
private or government hospitals with laboratory facilities and trained personnel.
SECTION 21. Preventive Services - All blood services 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. Recognition Awards - 1he Department, in coordination with the PNRC, shall grant
seals of excellence in recognition of outstanding service ofblood service facilities to be awarded in
a formal ceremony as part of Blood Donor's Week.

CHAPTER VI
PHASE-OUT OF COMMERCIAL BLOOD BANKS

SECTION 23. Process of Plwsing-Out - The Department shall effect the phasing.out of all
commercial blood banks over a period of two (2) years, extendible for a maximum period of (2)
years 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 24. Options for Commercial Blood Banks - 1he Department shall encourage and assist
existing commercial blood banks to 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.

Chapter VII
NON-PROFIT OPERATION

SECTION 25. Operations 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

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the necessary expenses entailed in the collection and processing of blood and reasonable fees for
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maintaining and upgrading facilities and services. Blood shall be collected from healthy voluntary
donors only.
The BRL Director shall issue Bureau Orders on the schedule of standard fees as stated in
section 35.

CHAPTER VIII
REGULATION OF BLOOD SERVICES

SECTION 26. Regulatory Authority - The licensing and regulatory functions of the Department
of H ealth regulating blood services shall be exercised through the Bureau of Research and
Laboratories (BRL) in the Office for H ealth Facilities Standards and Regulation, 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 27. 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 and may be licensed as Category A or B when it meets the minimum required
service capabilities set forth hereunder:
1. A blood bank/ center shall be considered non-hospital Based Category A when it can and
is performing the following:
a. Recruitment of voluntary donors
b. Health education and counseling

c. Donor screening and selection

d. Blood collection
e. Basic blood screening and testing
f. Provision of whole blood and packed RBC

g. Issuance, transport and distribution of blood/ blood products

h. Storage ofblood/ blood products
2. Non-hospital Based Category B when, in addition to those perfonned under the Non-
hospital Based Category A it is capable of providing in addition to whole blood, all blood
products and components.

3. H ospital-Based Category A when, in addition to those perfonned under the Non-hospital

Based Category A, it is capable of performing compatibility testing.

4. H ospital-Based Category B when, in addition to those performed under the Hospital-

Based Category Ait is capable of providing, in addition to whole blood, all blood products

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and components; and performing investigation of transfusion reactions and resolution of

incompatible cross-matching results.
B. BLOOD COLLECTION UNITS: In coordination with other related or appropriate
agencies, the Blood Banks/ Center or Blood Collection Unit ( BCV) which are authorized to
perfonn the following:
1. Recruitment of voluntary blood donors
2. Screening of blood donors
3. Provision of health education and counseling
4. Collection and transport of blood to Blood Banks/ Centers
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 28. Requirements for New License -A Blood Bank/Center may be granted a license to
operate only ifit shall have complied with the following minimum requirements:
1. MINIMUM NUMBER AND QUALIFICATION OF PERSONNEL: The minimum
number of staff with their corresponding qualifications for each category of Blood Bank/
Center shall be as follows:
a. CATEGORY (A] HOSPITAL AND NON-HOSPITAL BASED BLOOD BANK/
CENTER:
The overall supervision and management shall be under a competent physician duly
registered by the Professional Regulation Commission ( PRC) with a valid certificate
of registration and valid professional license, who has at least six ( 6) months training
in blood banking services under an institution or agency recognized by the BRL.
The Blood Bank/ Center shall have at least one other ( 1) Trained Medical
Technologist duly registered by the PRC a valid certificate and a valid professional
license, who has at least one (1) year on-the-job training or experience in blood
banking services under an institution or agency recognized by the BRL.
1he Blood Bank/Center shall also have at least one other ( 1) Medical Technologist
or Medical Laboratory Technician duly registered by the PRC with a valid certificate
and a valid professional license. Pursuant to the Medical Technology Law (RA No.
005527), the Medical Laboratory Technician shall be under the responsibility of the
Trained Medical Technologist.
b. CATEGORY (BJ NON-HOSPITAL BASED BLOOD BANK/ CENTER:
The minimum personnel requirements for Category A Blood Banks/ Centers
(Section 28[2al) shall also be required of Category B Non-hospital Based Blood
Banks/ Centers. In addition to the foregoing, the laboratory and blood processing
section of the Category B Non-hospital Based Blood Bank/ Center shall be managed

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by and under the direct and regular supervision and of a PRC-registered and licensed
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physician certified by the Philippine Board of Pathology in Clinical or Anatomical
pathology with at least 6 months additional training in blood banking from a training
institution recognized by the BRL, and/ or the Philippine Board of H ematology and
Blood Transfusion in Blood Banking. H owever, if the overall supervisor of the Blood
Bank/Center is already a pathologist trained in blood banking or hematologist, this
additional requirement will not be necessary.
c. CATEGORY [B] HOSPITAL BASED BLOOD BANK/ CENTER:
The overall supervision and management shall be under a PRC-registered and
licensed physician with a valid certificate in Clinical or Anatomical Pathology from
the Philippine Board of Pathology from the Philippine Board of Pathology with
at least 6 months additional training in blood banking from a training institution
recognized by the BRL, and or a certificate in Blood Banking from the Philippine
Board of H ematology.
The Blood Banks/ Center in this category shall also have one ( 1) Trained Medical
Technologist and one ( I ) other Medical Technologist or other Medical Laboratory
Technician with the same qualifications as those required for a category A Blood
Bank/Ce nter.
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 banks services under good
physician conditions and with adequate physician 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 BRI
(Section38).

b. All Blood Bank/ Centers, Blood Collection unit 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.
S. QUALITY CONTROL: All the technical staff of the Blood Bank/Center shall have
satisfactory passed the minimum proficiency test given by the BRL or any of its certified

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proficiency testing agencies. Adequacy of quality control procedures of each Blood Bank/
Center shall be assessed based on their compliance with quality control standards set by the
BRL, including but not limited to, the use of quality reagents, techniques and equipment; the
presence of an adequately trained and competent Quality Assurance Officer; the acceptability
of procedures and arrangements for internal and external quality control monitoring activities;
the acceptability of equipment calibration and maintenance procedures; the adequacy
of documentation of accountability in key steps and procedures; and the acceptability of
procedures for reporting errors and instituting remedial action.
6. RECORDING, REPORTING AND DOCUMENTATION REQUIREMENTS: All
Blood Banks/ Centers shall follow standard 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 38) .
All the entries in the application forms, logbooks, reports and other written documents should
betrneandcorrect.
7. BLOOD DISTRIBUTION AND TRANSPORT REQUIREMENTS:
Blood shall be distributed to the hospitals, not to individuals or patients.
The blood distribution scheme of each Blood Bank/Center shall be clearly described
and shall include the complete list of authorized Blood Stations strategically located to
provide maximum equitable distribution of blood to its catchment area and the names
and qualifications of the persons authorized to handle, transport or issue blood.
Blood shall be issued only to authorized 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.
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.
No untrained person shall be allowed to handle, transport or issue blood and blood
products.
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.

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Counseling of donors found to have infectious blood-home diseases should include advice
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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 Unit and laboratory referral arrangements.
SECTION 29. Requirements for Renewal of License
1he license of a 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:
I. All the technical staff of the Blood Bank/Center shall have passed the basic proficiency tests
the previous year.
2. The Blood Bank/ Center shall have achieved at least 70% of the staff development plan targets.
3. 1he Blood Bank/ Center shall have bled only voluntary blood donors the previous year,
including those bled in its authorized Blood Collection Units.
4. 1he complete annual report of the preceding year's operations shall have been submitted
on or before January 3 1 of the succeeding year, following the required fonnat (BRL Blood
Services Form No. 3).
S. 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.
6. 1he Blood Bank/Center has been shown to collect only the allowable service fee for each
blood unit dispensed.
SECTION 30. 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
Bank/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 Bank/ Centers in Metro Manila, directly to the BRL, or, for Blood Bank/
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 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. 1he exact date of expiration of the license shall be printed on the license.

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S. 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. 1he license, as well as the rights under the license, is non-transferable, 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
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 of
license to open and operate a Blood Bank/Center and four hundred pesos ( P400) for renewal
of license. The license fee shall cover the cost of inspection and printing of special license
certificates and other required forms and documents.
A non-refundable proficiency testing fee shall also be charged to cover the costs of materials
and supplies especially reagents used during the proficiency testing. The proficiency test fee
shall be two hundred pesos (P200) per bank/ center.
The fees shall be uniform for both government and private Blood Bank/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 31. 7111: Licensing Procrn - The following shall be the process oflicensing:
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
Service 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 PSH BT 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. Biosafetyand Quality Control arrangements and procedures;
f. List of blood Collection Units (names of heads, qualifications and complete addresses);
g. List of blood Stations (Names of Medical technologists in-charge and complete
addresses);
h. 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

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Services Form No. 2 (Application for Renewal of Blood Center License) together with the
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following supporting documents:
a. Names, qualifications and proofs of qualifications of new staff and any staff charges (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. Certified true copy of hospital license for preceding year (hospital-based only);
f. Names and addresses of regular blood donors who donate at least twice a year;
g. Any changes in the list of authorized Blood Collection Units and Blood Stations ( deletions
or additions only);
h. 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 oflicense within the prescribed period shall also be visited within the
year to confirm that blood operations have ceased.
b. Only inspectors who have satisfactory completed the BRL Course for Blood Bank/ Center
Inspectors are qualified to inspect Blood Bank/ Centers and other blood service facilities.
A productivity incentive pay of fifty pesos (PSO) for every blood bank/center inspected
properly and thoroughly may be allmved subject to the usual auditing and accounting
procedures and to availability of funds of the agency where the inspector comes from.
c. For applicants desiring to open a Blood Bank/Center (i.e. new license), inspection shall
be done only of applicants who have fulfilled all the basic written requirements.
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 authorized BRL inspectors upon presentation of a valid
inspection mission order signed by the Secretary or his authorized representative.
4. TIMETABLE FORAPPLICATION 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 Bank/ Centers which fail to submit an
application for renewal within the prescribed two-month period shall be considered as
KBlood Bank/ Centers operating without license~ when their current license expires and
shall be subject to the penalties for such violation.

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5. RELEASE:
a. License 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. Applications for new license who, upon inspection, did not meet all 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 visited within one month after
release of the order to stop operations for confirmation of compliance with the order.
SECTION 32, Transition Period for Confirmation of License - 1he years nineteen ninety-five to
nineteen ninety-six ( 1995-1996) shall be the transition years for confirmation of compliance to
the new Ii.censure requirements of existing Blood Bank/Centers. During this transition period, the
documents, forms and process for renewal of licenses shall follow the procedures for new licenses.
Existing Blood Bank/Centers which fail to meet all the new or additional requirements may still
be allowed to operate within this two-year period provided such banks/centers submit a plan to
upgrade their services and facilities according to the prescribed standards.
Startingjanuary 1, 1997, all Ii.censure requirements will be imposed without exemption.
SECTION 33. Phase-out of Commercial Blood Banks - No new license shall be issued for a
commercial blood bank. Renewal oflicense of existing commercial blood banks beginningjanuary
1, 1995 shall be upon compliance with the new requirements under these Rules and Regulations
subject to the provisions of Section 32 hereof.
SECTION 34. Appeals and Reports on Violations - Reports on violations of R.A. 7719 and these
Rules and Regulations shall be addressed to the Secretary of H ealth and the National Director of
the Bureau of Research and Laboratories.
1he Secretary or the National Director of the BRL may request for police assistance from
the National Bureau of Investigation and/or the Philippine National Police for the effective
enforcement of RA 7719 and its Implementing Rules and Regulations.
SECTION 35, Allowable Service Fees

1. 1he blood service facility may collect reasonable service fee for every blood or blood product
issued which shall not be greater than the maximum prescribed by the Deparhnent of H ealth
and implemented through an appropriate BRL Bureau order issued by the Director of the
BRL. The maximum allowable service fee shall be adjusted from time to time specifying the
basic requirements and special tests not covered by the service fee.
2. These shall determine the basic required donor and blood screening tests and procedures
through analysis of research information such as disease prevalence studies and risk estimates,
consultation with technical experts and careful evaluation of the optimum benefits from the
expected cost of these tests.
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3. The maximum allowable service fee shall be calculated by the BRL based on a study of the
-
direct and indirect costs of running a standard blood bank with basic, minimum staffing and
facilities and corresponding maximum workload. Direct costs shall include those expenses
incurred in collecting and processing blood from donor recruitment, blood collection, blood
screening, component preparation, storage and distribution, with allowance of spoilage,
and professional services. 1hese shall not include cost of cross-matching and other special
screening and compatibility testing. Indirect costs shall include reasonable expenses needed
to maintain and upgrade services such as salary of staff and repair of equipment.
4. The direct and indirect costs shall be estimated for every unit ofblood collected, processed
and distributed.
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:
I. A Blood Collection Unit shall have at least one PRC.registered physician and one PRC.
registered medical technologist, both with valid certificate of registration and valid
professional license. Both should have one ( 1) month training on voluntarydonorrecruitment
and screening; voluntary donor holding and motivation; health education and counseling
blood collection, handling and transport; and management ofblood collection activities and
problems. Such training shall be done by an agency duly recognized by the BRL.
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).
There shall be a written and readily available contingency plan for all Blood Collection Units
in case of problems such as instrnment 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 static or mobile. Physical arrangements for both kinds during
collection shall be comfortable, dean and adequate.
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 confinnation may be contained in an appropriate certificate.
5. The BCU shall submit its schedule of bleeding and target area of donor recrnitment 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.
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8. Authoriz.ation as a BCV shall be renewed yearly, signed by the Regional H ealth 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 38).
SECTION 37. Authorization of Blood Stations - The Regional H ealth 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 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 lest one properly functioning blood refrigerator with twenty-
four (24) hours power supply.
4. 1here shall be a written and readily available contingency plan for all Blood Stations in case of
problems such as instrument or equipment breakdown.
S. 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 28 (6).
7. The au thority to operate a Blood Station shall be renewed yearly, signed by the Regional
H ealth Director and issued to the agency that operates the Blood Bank/Center that will
distribute the blood bags to the station with a copy furnished to the chief of the hospital where
the Blood Station is located and the name of 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 H ealth Director
should blood storage, handling, issuance, distribution or disposal be found to be below the
standards set by the BRL in its Standard Operating Procedures Manual on Blood Services
(Section38).
SECTION 38. 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
procedures Manual (SOP Manual) on Blood Services which shall be developed, pre-tested

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and printed by the BRL within six ( 6) months after the effectivity of these Implementing Rules
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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 updated SOP Manual is available, the procedures and standards
incorporated in AO 57s. 1989 (Sections 10, 11 , 12 &13) BO No.s. 1990 (Section6),AO 122
s. 1992,Bureau Circulars No. 2 s. 1990,No. 2s. 199 1,andNo. 4 s. 1994,oftheBRLwhichare
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 39. Quality Assurance Officers - A Quality Assurance Officer recognized for his/her
integrity and organi1.ational abilities shall be assigned or designated and trained for each blood
service facility by the BRL. H e/ 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. H e/ she shall
periodically review quality control procedures and monitor compliance with standard procedures.
He / she shall initiate investigation and remedial action in cooperation with the head of the units
affected.
SECTION 40. Cmifimiation ofVolimtary Donors
I. Paid blood donors who are usually brought in by relatives of patients should be carefully
selected out and blacklisted from the roster of donors. 1his 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 counter-check donors who regularly donate to the Blood
Bank/ Center as part of his/ her regular monitoring Blood Bank/Center operations.
SECTION 41. Emergency Blood Transfusions - 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:
I. 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 tests for hemoglobin, syphilis, HIV, hepatitis and for presence of malarial
parasites and compatibility testing including cross-matching are also performed before
transfusion.

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CHAPTERIX
IMPORTANT OF BLOOD BANK EQUIPMENT AND SUPPLIES

SECTION 42. Certification of Important Privileges - An annual list of Blood Bank/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 H ealth Facilities Standards and Regulations and duly noted
by the Directors of the Bureau of Research and laboratories and the Bureau of Licensing and
Regulation of the Department, shall be submitted to the Department of Finance and the Bureau
of Customs before January 31 ofeveryyear.
SECTION 43. 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 RA 77 19. the list shall be modified by
the BRL as necessary.
SECTION 44. Application for Tax Exemption
1. A letter of intent enclosing the list of equipment and material with the necessary specifications
and justification for their use shall be submitted to the Secretary of Health. 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. 1he Secretary of H ealth
or his duly authorized representatives shall sign a recommendation for tax- and tax-free
exemption addressed to the Secretary of Finance.
2. An application for exemption from customs duties and taxes shall then be filed with the
Revenue Office, Department of Finance, manila. 1he PNRC, blood bank/ centers, hospitals
and other institutions participating actively in the National Voluntary Blood Services Program
may avail of the tax duly exemption mentioned herein, upon certification and appropriate
endorsement by the Secretary of H ealth or his duly-authorized representative.
SECTION 45. Other Documentation Requirements - For expeditious processing, the application
shall also include a certification from the Department of trade and Industry that the proposed
importations are not locally available in sufficient quality, comparable quality and reasonable price.
SECTION 46. lnspection - The Department of Finance may conduct pre/ post-inspection of the
facilities and imported articles released duty- and tax.free in accordance with these Rules and
Regulations in line with the monitoring functions of said office. Said findings/ report shall be
furnished the Department of Health.

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CHAPTERX
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PENALTIES FOR VIOLATIONS

SECTION 47. Penalties

I. OVERCHARGING
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.

Any person or persons who shall be responsible for the above violation shall suffer the
PENALTY OF IMPRISONMENT of not less tlian one (1) month or more than six (6)
months, or a FINE of not less than Five Tl,ousand pesos (PS,000) but not more than Fifty
thousand pesos (PS 0,000), or both at the discretion of the competent court.
2. NO LICENSE TO OPERATE
Any person who shall establish and operate a Blood Bank/Center without securing a license
to operate from the Department or who fails to comply with the standards prescribed by
the department referred to in Section 9 of RA No. 7719, shall suffer the PENALTY OF
IMPRISONMENT of not less than twelve ( 12) years and 011e day nor more than twenty
(2 0) years or a FINE not less tl,anfifty tl10usa11d pesos (PS0,000) but not more than five
hundred thousand pesos (PS00,000), or both at the discretion of the competent court.
3. TRANSFUSION OF CONTAMINATED BLOOD
1he 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. 1his without prejudice to the
filing of criminal charges under the Revised Penal Code.
4. All important accorded duty- and tax-free release pursuant to this Order shall not be
transferred or disposed of in any manner whatsoever to any person or entity without prior
approval of the Deparhnent of Finance. The penalty provided for under existing laws or any
revenue shall be imposed in any violation of the provisions of this Order.
S. The Secretary or his duly-authorized representative, after due notice and hearing, may also
impose the following administrative sanctions:
a. penalty of Five thousand pesos (PS,000) for the head or the owner of the Blood Bank/
Center which fails to submit the application for renewal of license to the BRL or its
designated officers within two (2) months prior to the expiration of the existing license;
b. Penalty 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;

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c. Revocation or suspension of Blood Bank/ Center license or Blood Collection Unit or

Blood Station authoriz.ation for:
- Misrepresentation of facts or falsification of documents or record
- Refusal of entry for inspection
- Refusal to make available its books, accounts and records of operations
- Failure to inform the BRL or its authorized representative about changes in Blood Bank/
Center Collection Unit or Blood Station location, facilities, services or operations;

d. Recommendations to revoke the certificate of registration or to suspend said certificate to

practice the profession and to invalidate the professional lice nse of any health professional
involved in misreprese ntation of facts or falsification of documents or records especially
medical, laboratory or inspection results and certificates, or in violation of RA NO. 7719
and the herein Rules, by the Professional Regulation Commission upon recommendation
of the Secretary.
SECTION 48. Repealing Clause - These Rules and Regulations shall supersede all previous
Administrative and Bureau Orders and Circulars of the Department. The provisions of any
Departme nt 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 newspaper of general circulation.
SECTION SO. Approval - Approved on this twenty-eighth day of April nineteen hundred and
ninety-five.

12M1y 1998
Administrative Order No. 17-A. S 1998

SUBJECT: Amendment to Section 26 to 32 of Administrative Order No. 9 s. 1995 to e known

as Requirements and Procedures for a License to Operate a Blood Bank/Blood Center in the
Philippines.
Provisions of Chapter VIII Section 26 to 32 of the Administrative Order No. 9 series of 1995 dated
April 28, 1995: Rules and Regulations Implementing Republic Act 77 19, otherwise known as the
"National Blood Services Act of 1994~ dated August 1994, are hereby amended to be known as
the "Requirements and Procedures for a License to operate a Blood Bank/Blood Center (BB/ BC)
in the Philippines.
SECTION 1. Title- This Administrative Order shall be known as Requirements and Procedures
A

for a License to Operate a Blood Bank/ Blood Center ( BB/ BC) in the Philippines.
SECTION 2. Regulatory Authority - This Administrative Order is issued pursuant to Republic
Act 7719 (National Blood Services Act of 1994) and its Implementing Rules and Regulations

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(A.O. #9 s. 1995) consistent with E.O. 119 (Reorganization Act of the Ministry of H ealth). The
licensing and regulatory functions of the Department of H ealth for Blood Service Facilities shall
be exercised through the Bureau of Research and Laboratories (BRL) under the Office for H ealth
Facilities, Standards and Regulation (OH FSR). As such, it is hereby authorized to issue orders
and circulars providing for the implementation details and specific technical and administrative
requirements related to licensing and regulation.

SECTION 3. Purpose - This Administrative Order is being issued to enforce RA 77 19 to protect

and promote the health of the people by preventing the operation and maintenance of substandard
Blood bank/ Blood Center in the country.
SECTION 4. Scope - These requirements and procedures shall apply to all establishments, owned
and operated by the government and non-government agencies and private individuals engaged
in blood banking and transfusion services within the geographical boundaries of the Philippines.
SECTIONS. Service Capabilitie.s of Blood Bank/ Blood Center

NO N HOSPITAL BASED
Category A Category B
I. Recruihnent and retention of voluntary I. H ealth Education and Counseling
blood donors 2. Donor Screening and Selection
2. H ealth Education and Counseling 3. Provision of whole blood, packed red
3. Donor Screening and Selection blood cells and other blood components
4. Blood Collection 4. Storage of whole blood and blood
S. Blood Testing for blood transmissible products
diseases S. Issuance, transport and distribution of
6. Provision of whole blood and packed red whole blood and blood products
blood cells
7. Storage of whole blood and packed red
blood cells
8. Issuance, transport and distribution of
whole blood and packed red blood cells

HOSPITA L BASED
Category A Category B
I. All of the above ( Category A - Non I . All of the above (CategoryB - Non
Hospital Based) H ospital Based)
2. CompatibilityTesting 2. Compatibility, investigation of transfusion
reaction and resolution ofincompatible
crossmatches
3. Preliminary investigation oftransfusion
reactions
4. Resolution ofincompatible crossmatches
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THE NATIONAL BLOOD SERVICES ACT OF 1994 •

SECTION 6. Operation and Maintenance ofBlood Bank/Cwter

6. 1. The operation and maintenance of Blood Bank/ Blood Center shall be on a NON-PROFIT
basis. Blood shall be collected only from H EALTHY VO LUNTARY DONORS. Service
fees may be collected but not greater than the amount prescribed by the Department of
H ealth.
6.2. Any individual , firm, corporation, entity or institution shall not be allowed to operate
a blood bank/blood center nor allowed to collect, process and distribute human blood
without having secured a proper and valid license issued by the Bureau of Research and
Laboratories.
6.3. In Emergency Cases wherein the medical/surgical condition poses an immediate threat
to patient's life, blood collection and immediate transfusion in hospitals without a license
to operate a blood bank/ center may be allowed provided that the donor selection, blood
collection, blood screening and compatibility testing shall follow existing acceptable
standards.
6.4. A Blood Bank/ Blood Center whose license has been revoked or suspended shall not
be allowed to reopen without first securing a new license which shall be issued upon
satisfactory evidence that the owner has already completed the requirements prescribed.
SECTION 7. Requirements for a License to Operate - All Blood Banks/ Blood Centers should have
granted a license to operate only if the following have been complied with:
7.1. RequirementsforNEW"License
7. 1.1. PreLicensingRequirements
Compliance to the Guidelines for the Establishment of Regional Blood Services
Network as embodied under the National Policies governing the implementation
of the National Policies governing the implementation of the Philippines Blood
Banking System issued as separate Administrative Order.
7. 1. 2. LicensingRequirements
Any individual, firm or corporation, entity, establishment and institution desiring
to establish or operate and maintain a blood bank/blood center shall submit to the
Bureau of Research and Laboratories (BRL) the following:
7. 1.2. 1. Documents
a. Duly accomplished and notarized Petition/ Application Fonn (BRL -BSF
(BB/ BC) Form No. 1);
b. Blood Services Network Documents (Administrative Order # 9 s. 1995)
Chapter 8. Sec. 28, ltem 10):
b.1. Certificate of Inclusion in the Official Blood Services Network of the
National Blood Services Network of the National Voluntary Blood
Services Program Unit (NVBSP);

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b.2. List of Blood Collection Units and Blood Stations within their network
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to include names of their respective personnel.
c. Certificate of Registration
c. 1. ls corporation/ Foundation Proprietorship/ Ownership-Certified True
Copy of SEC (Securities and Exchange Commission Registration
c.2. If Single Proprietorship/ Ownership Certified True Copy of DTI
(Domestic Trade and Industry Registration
d. Photocopies of PRC Certificates of Personnel of the Blood Services Facilities
d. 1. Additional requirement for the Head of the Blood Bank/ Blood Center
If Pathologist: Specialty Board Certificate issued by the Philippine
Board of Pathologists
If Hematologist: Specialty Board Certificate issued by the Philippine
Board of H ematology and Blood Transfusion
e. Location Map of the Blood Bank/ Blood Center
f. Floor diagram of the Blood Bank/ Blood Center and its premises
g. List of Equipment- to include serial number, brand, date of purchase, number
of units and operational status
h. List of glasswares and supplies, and
i. If H ospital-Based - documented organized Blood Transfusion Committee
7.1.2.2. H uman Resource Requirement
1he minimum number of staff with their corresponding qualification for each
category of Blood Bank/Blood Centers shall be as follows:
A. H EAD (for both Category A and B H ospital Based and Non-H ospital Based):
The overall supervision and management shall be under a registered physician
duly licensed by the Professional Regulation Commission Certified in Clinical
Pathology by the Philippine Board of Pathology or Blood Banking by the
Philippine Board of H ematology and Blood Transfusion.
B. TECHNICAL STAFF
Medical Technologists
The Blood Bank/ Blood Center shall have Medical Technologists who shall
work on a shifting to cover a 24-hour service. Medical Technologists must be
duly registered by the PRC with valid professional license ( PRC ID Card) and
with at least one ( I) year on the job training or experience in blood banking
services.

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RA7719: -
Point of Difference Category A Category B
Number of RMT Atleast4 AtleastS
Number ofRMT / shift !AM 2AM
!PM !PM
!Night I Night
I Off duty I Off duty
Donor Recrnitment Officer ( For both Category A and B Blood Bank/
Center

The Blood Bank/Blood Center shall also have at least ONE ( 1)

designated Donor Recruitment Officer who is either a Registered MD/
RMT/ RN.
7. 1.2.3. Physica!Plant
The physical plant shall be housed in a well-lighted and well.ventilated area with
an adequate supply of water.
The space shall be sufficient to accommodate the various activities of the blood
bank/center with provisions for accessible and dearly demarcated fire exits.
The physical arrangement should allow for the smooth and orderly flow of
activities and movement of people and supplies.
The technical or working area shall be exclusively for the use of the blood bank/
center and its related activities.
7. 1.2.4. Equipment, Reagents, Glassware and Supplies
The blood bank / center shall have the equipment, reagents, glassware, blood bags
and other supplies needed top properly undertake the required services.
Table 1,2 and 3 presents the minimum requirements respectively for equipment/
instruments, reagents, glassware and supplies necessary to undertake the required
services.
7 .2. Requirements for Renewal of License
The license ofa Blood Bank/ Center to operate may be renewed onlyifit shall have complied
with all the requirements for a new license with the following additions or modifications:
7.2.1. Documents
a. Duly accomplished Application Form for Renewal of License (BRL-BSF
(BB/ BC Form No.2);

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b. Changes in the list of authorized Blood Collection Units and Blood Station
-
( deletions or additions only) within their network;
c. Names, qualifications and proofs of qualification of new staff and any staff
development ( e.g. additional trainings or qualifications for existing staff,
resignations);
d. Changes in location or address, if applicable;
e. Changes in existing physical facilities and equipment;
£ Newly acquired equipment and facilities;
g. Annual accomplishment report on blood services of the previous year;
h. Names and addresses ofblood donors with rare blood types;
i. Documented changes in Blood Banking Standard Operating Procedures;
j. Passed Rating in the External Quality Assessment or Proficiency Testing of
the previous year;
k. Documented accomplishment of at least 70% of the staff development plan
targets for the previous year.
SECTION 8. License Fees and Charges
8.1. The license fees and charges shall be unifonn for both government and non government
blood banks/ centers and shall be adjusted only by the BRL through the appropriate official
issuances as the need arise.
8.2. All fees / charges shall be payable to the Bureau of Research and Laboratories.
8.3. License Fee
a. A non-refundable fee of six hundred pesos (P600.00) shall be charged for every
application for a new license to operate a blood bank/ center.
b. A non-refundable fee of four hundred pesos (P400.00) shall be charged for every
accepted application for renewal of license.
c. The license fee shall cover the cost ofinspection and printing of license certificates and
other required fonns and documents. Subsequent or separate issuances shall cover the
allowable fees and charges ( e.g. proficiency testing fee, blood service fee, etc.)
8.4. Charges
a. A penalty of five thousand pesos (P 5000.00) for blood banks/ blood centers which fail
to submit the application for renewal of license to the BRL within two (2) months
prior to the expiration of the existing licensing. (Administrative Order No. 9, s. 1995,
ChapterX)
b. Blood Banks/ Blood Centers which fail to submit an application for renewal within the
two (2) months period shall be considered as "BLOOD BANKS/ BLOOD CENTERS
OPERATING WITH OUT A LICENSE" when their current license expires and shall

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be subject to the penalties for such violation. (Administrative Order No. 9 s. 1995,
Chapter X, Sec. 47, Item 2)
SECTION 9. Terms and Conditions of Licensing -A license is granted on the basis of compliance
to certain requirements as established during the inspection and defined in the issuance of the
license.
The following are the terms and conditions of the license:
9.1. A license to operate a Blood Bank/Center shall be signed by the Undersecretary of Health
for H ealth Facilities, Standards and Regulations. It shall be issued to persons, agencies,
corporations who successfully complied with all the requirements.
9.2. The license is valid fora J\1AXIMUM OF ONE ( 1) YEAR from the date of issue. The exact
date of expiration of the license shall be printed on the license.
9.3. The license, as well as the rights under the license, is NON TRANSFERRABLE, directly or
indirectly.
9.4. The license of the Blood Bank/Center shall be displayed in a CONSPICUOUS place within
the Blood Bank/Center. A notice shall be posted infonning the public that complaints
about the services may be addressed to the ChiefofHospital (if hospital-based) or to the
H ead of the Blood Bank/Center (if non-hospital based) or to the Director of the Bureau of
Research and Laboratories
9.5. Blood Collection Unit (s) and Blood Station (s) linked with the Blood Bank/Center Blood
Services Network will function under the license of their parent Blood Bank/Center.
SECTION 10. Licensing Procedure
10.1. FilingofApplication
The following are procedures to be followed when applying for a license:
a. A duly accomplished and notarized Petition/Application Form (BRL-BSF (BB/BC)
Form No. I or Application for Renewal of License (BRL -BSF ( BB/ BC) Form No. 2)
together with all the required supporting documents shall be addressed and submitted
to the Bureau of Research and Laboratories (BRL) - Division ofLaboratory Regulation
and Development (DLRD);
b. Application for a new license may be submitted anytime.
c. Applications for renewal oflicense should be submitted WITHIN TWO (2) MONTHS
prior to the expiration of the current license.
10.2. Document Screening and Approval
a. DLRD screens and evaluates the documents for completeness and authenticity. If
complete, application is accepted and approved. A charge slip is issued and the applicant
pays the corresponding license fee at the BRL Cahier Section.
b. lf documents are incomplete, a letter is sent to the applicant informing him/ her of
items for compliance and with a directive to complete said items for compliance within
such period of time as may be warranted under the circumstances.
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10.3. Inspection
-
a. Assessment of Blood Bank/Center for a new license to operate and renewal license shall
involve an actual inspection of the facility and evaluation of documents by authorized
BRL-Blood Bank Inspectors at least once a year or as may be ordered by the Director.
b. Only inspectors who have satisfactorily completed the BRL Training Course for Blood
Bank Inspectors are qualified to inspect Blood Bank/Centers and other blood service
facilities.
c. Inspection shall be doneonlyifapplicants have complied with all the basic requirements.
d. Each Blood Bank/Center shall be visited by authorized BRL-Blood Bank Inspector at
least once before initial licensing and once a year for the renewal of license. Those who
failed to apply for renewal within the prescribed period shall also be visited within the
year to confirm that blood operations have ceased.
e. Inspection oflicensed blood bank/ center shall be done unannounced while its activities
are going on.
f. Each licensee shall make available records and documents as may be required by the
authorized BRL Blood Bank Inspectors upon presentation of a valid inspection mission
order signed by the Secretary of H ealth or its authorized representative.
g. Applicants for license to operate who, upon inspection, did not meet all the prescribed
standards shall receive a letter from the BRL stating the requirements which the Blood
Bank/Blood Center failed to meet. These Blood Bank/ Blood Center shall be revisited
at least once after release of the order for confirmation of compliance with the order.
10.3. 1. Documents Required on htspection
a. Copies of Manual of Standards for Blood Banks/ Blood Centers, Blood
Collection Units, Blood Stations in the Philippines
b. Donor Forms:
L Donor History and Physical Examination
2. Donor Medical Declaration Form and Development Plan for at least
ONE ( l )year
c. Book of Accounts of Cash Books or Official Receipts showing collection
of allowable service fee for each blood unit dispensed.
d. Minutes of Meetings of H ospital Blood Transfusion Committee
e. Manual/ Logbooks on:
1. Quality System Manual (Administrative SOPs Manual
I. I. BB/ BC Organizational Objectives, Policies and Guidelines
which will include the following:
a. Guidelines for provision of Health Education Pre and
Post - Donation Counseling Services for Blood Donors
(AO #9 s. 1995, Chapter Vlll, Sec. 28, Item 9)
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b. Guidelines for referrals of blood donors for further

medical evaluation (AO #9 s. 1995, Chapter Vlll, Sec. 28,
ltem9)
c. Blood Distribution and Transport Guidelines (AO #9 s.
1995, Chapter VII, Sec. 28,ltem 7)
1.2. BB/ BC Organi1.ation and Personnel Job Delineation, Level of
Responsibility, Task Delegation and Coordination
1.3. Personnel Development and Competency Evaluation
2. Technical Procedures Manual (Technical SOPs)
3. Biosafety and Waste Management Manual
4. Equipment Maintenance and Repair Logbook/Record
S. Quality Management Records
6. Records of Blood Donations
6. 1. Donor Selection Record
6.2. Blood Collection Record
7. Laboratory Processing of Donor Blood
7. 1. Records ofTests on Donor Blood Sample
7 .2. Labelling
7.3. Records of Component Preparation
8. Records of Blood Transfusion
8. 1. Records of Blood Transfusion Requests
8.2. Records of Compatibility Tests
8.3. Records of Issue for Transfusion
8.4. Records of Transfusion Complications
9. Storage, Transport and Issue of Blood
9.1. Records of Blood Storage
9.2. Records of Transport and Issue of Blood and Blood
Components
9.3. Records of Emergency Issue of Blood
9.4. Transport Records
9.5. Records of Blood and Components Received from other
facilities
10. Records of Errors and Accidents

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11 . Summary Records
-
11 . 1. Annual Blood Collection and Utilization
I 0.3.2. External Quality Assessment
The BRL shall conduct a YEARLY External Quality Assessment/ Proficiency
Testing to all licensed Blood Banks/ Centers. A Blood Bank/ Center who
got a SATISFACTORY rating will be given a Quality Assurance Citation
Certificate. Supervisory visits will be conducted as necessary to blood banks/
centers who failed in the External Quality Assessment.
SECTION I I. Issuance ofLicense - Immediately after approval and evaluation, license is prepared
and issued directly to the HEAD of the Blood Bank or his representative (personally or by mail).
SECTION 12. Validity of License - Each license shall expire on its anniversary date of the year
stated.
SECTION 13, Transition Period for Confirma tion of Licenses - May 28, 1998 to July 31, 1998
shall be transition period for the confirmation of compliance to the new licensure requirements
of existing Blood Banks/ Blood Centers following the new BSF categorization. The BRL-DLRD
shall issue certificates to existing blood service facilities on the NVBSP-Blood Services Network
guidelines to continue operation until confirmation oflicenses/ certificates of authority to operate.
SECTION 14. Publication ofthe List ofLicensed Blood Banks/ Centers-An annual updated list
oflicensed blood banks/ centers shall be published at least ONCE a year in a newspaper of general
circulation.
SECTION 15. Penalties for Violations - Non- compliance to these requirements shall be
regarded as a violation under RA 77 19 and thus is subject to the penalties as provided for in said
law as implemented by Department of H ealth (A.O. No. 9 s. 1995, Chapter X, Section 47)
IS. I. IN addition to A.O. No. 9 s. 1995, Chapter X, Section 47, Item I, Documented blood
collection from paid donors; blood collection without the supervision of a physician; non-
performance of the required blood testing; and disposal of blood units to unauthorized
persons shall be cause for the cancellation, revocation or suspension of the license.
SECTION 16. Appeals aml Reports on Violations - Approved on: May 12, 1998

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Administrative Order No. 2008- 0008

ADMINISTRATIVE ORDER
No. 2008 - 0008

RULES AND REGULATIONS GOVERNING THE REGULATION

OF BLOOD SERVICE FACILITIES

I. BACKGROUND/ RATIONALE
RepublicAct7719 otherwise known as the "National Blood ServicesActof l 994"was passed
to ensure safe and efficient Blood Banking and transfusion practices in the Philippines. To
carry out the provision of Republic Act 77 19, Administrative Order No. 9 s. 1995 "Rules
and Regulation Implementing Republic Act 7719" was formulated. Chapter Vlll of the
said Administrative Order addresses the regulation of blood services by the Bureau of
Research and Laboratories. This was amended by Administrative Order No. 17-A series
1998 otherwise known as the "Requirements and Procedures for a License to Operate a
BB/ BC in the Philippines."' The "Rules and Regulations Governing Authorization ofBCU
and BS"' was formulated and approved in 2003.
In January 2005, Administrative Order No. 2005-0002 "Rules and Regulations for the
Establishment of the Philippine National Blood Services Amending pertinent provisions
of Administrative Order No. 9 s. 1995" was formulated pursuant to Section 5 and 6 of R.A.
7719. This Administrative Order established the National Council for Blood Services and
the Philippine National Blood Services. It also defined the new functions and/ or service
capabilities of the different blood service facilities, including hospital BBs and BCs, as well
as those of the end-user hospitals and other health facilities. With these newly delineated
functions and service capabilities of blood service facilities, it is imperative that relevant
provisions of A.O. No. 9 s. 1995 and A.O. No. 17-A s. 1998 be revised.
Regulation is one of the main thrusts of current health sector reforms under FOURmula
One (F I) for health. The main objective of regulatory reforms is to ensure access to quality
and affordable health products, devices, facilities and services especially those commonly
used by the poor. It is the responsibility of the state to provide the public with safe and
adequate blood through an efficient blood services network. With the separation of the
regulator functions from the programming functions, it is envisioned that the goals of the
national voluntary blood services program shall be better achieved.
II. OBJECTIVE
These rules and regulations are promulgated to protect and promote the health of the people
by ensuring available licensed blood service facilities with adequate staff, equipment and
resources to perform all the required functions safely, efficiently and effectively.

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Ill. SCOPE
-
The rules and regulations embodied herein shall apply to all government and private blood
service facilities engaged in blood banking and transfusion services.
IV. DEFINITION OF TERMS
A. Act - Republic Act (R.A.) 7719, also known as the National Blood Services Act of
1994, unless herein specified.

B. ATO - refers to the Authority to Operate. It is a formal permit issued by the DOH-
C H D to an individual, partnership, corporation or association to a BCU/ BS.
C. BB - refers to the Blood Bank
D. BC - refers to the Blood Center
E. BHFS- refers to the Bureau of Health Facilities and Services
F. Blood - refers to the human blood for transfusion

G. Blood Component- refers, but not limited to whole blood, red cells, granulocytes,
plasma, platelets, cryoprecipitate and cryosupernate prepared in a BC.
H . BCU - refers to the Blood Collection Unit

I. Blood product - a therapeutic substance derived from whole blood or plasma.

J. BS - refers to the Blood Station
K. BSF - refers to the blood service facility. It is a unit, agency or institution providing
blood products. The types ofBSF are BS, BCU, Hospital BB and BC (Regional, Sub-
national and National).
L. Blood Services Network - an organization composed of the designated BCs,
hospital BBs, BC Us, BSs, end-user hospitals, and other health facilities established to
provide for the blood needs of a specific geographical area.

M. CHD - refers to the Center for Health Development, which is the DOH Regional
Field Office
N. DOH - refers to the Department of Health

0. End-Use Hospital - a hospital with a licensed clinical laboratory capable of red cell
typing and cross- matching and which does not have any BSF but only receives blood
and blood components for blood transfusion as needed.

P. End-User N on - hospital Health facility - a license/ accredited non- hospital health

facility without a licensed clinical laboratory but administers blood transfusion such
as a dialysis clinic and birthing home under the supervision of a licensed physician/ s.
Q EQAS- refers to External Quality Assessment Scheme
R. HBTC - refers to the H ospital Blood Transfusion Committee

S. LTO - refers to the License to Operate. It is a fonnal authority issued by the DOH to
an individual, partnership, corporation, or association to operate a BB/BC.
T. NCBS- refers to the National Council for Blood Services
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U. NVBSP - refers to the National Voluntary Blood Services Program

V. PNRC - refers to the Philippine National Red Cross
W TTI - refers to the Transfusion - Transmitted Infections

X. Voluntary, Non - remunerated Blood Donor - a donor who gives blood freely and
voluntarily without receiving money or any fonn of payment.
V. POLICIES AND GUIDELINES
A. General Guidelines
I. Every BSF shall be an integral part of a blood services network and guided by
administrative issuances governing the establishment and operation of blood
services networks.
a. Each BC shall have responsibility for and authority over the conduct and close
supervision of the BCU/ BS affiliated with its Blood Service Network.
b. The head of the BC or his designated staff shall conduct on site periodic
evaluation of each affiliated BB, BCU and BS.
2. All BSF are required to comply with the standards and technical requirements
embodied in the inspection tools. It shall be posted at the DOH website: www.
doh.gov.ph
3. Blood shall be collected from qualified healthy voluntary non-remunerated
blood donors only.
4. Testing for TTls shall be based on the DOH prescribed methodology. The
number of infections to be screened as well as the method for their detection
shall be determined and reviewed periodically by the NCBS.
5. Testing for TTls shall be done at the National, Sub-national and designated
Regional BCs including PNRC BCs. Such designation shall be detennined by
the NCBS pursuant to A.O. 2005- 0002.
6. All units ofblood issued by the Philippine BC, Sub- national BCs, Regional BCs,
and PNRC under the Philippine National Blood Services Network shall not be
retested for TTls by the end-user hospitals and other health facilities. It is the
responsibility of the issuing BCs to ensure that all units ofblood issued have been
tested and found to be negative to TTls.
7. Blood and blood products for transfusion shall be obtained from licensed and
authorized BSF only.

B. Specific Guidelines
1. Classification ofBSF
a. Ownership
( I ) Government - operated and maintained partially or wholly by a
national, provincial, city or municipal government or other political
unit, by any department, division, board or agency thereof or by a
government owned or controlled corporation

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(2) Private (for hospital-based BSF only) - privately owned, established

- and operated with funds through donation, capital or other means, by an
individual, corporation, association, or organization
b. Institutional Character
( I ) Hospital- based- a BSF located within the premises of a hospital
(2) Non- hospital based - a government- owned or PNRC-owned BSF
located outside the premises of a hospital consistent with the NVBSP
Strategic Plan.
c. Service Capability
( I) BS
a. Advocacy and promotion of voluntary blood donation and healthy
lifestyle;
b. Provision of whole blood and packed red cells;
c. Storage, issuance, transport and distribution of whole blood and
packed red cells;
d. Compatibility testing of red cell units, if hospital based.
(2) BCU
a. Advocacy and promotion of voluntary blood donation and healthy
lifestyle;
b. Recruitment, re tention and care of voluntary blood donors;
c. Screening and selection of voluntary blood donors;
d. Conduct of health education and counseling services;
e. Collection of blood (mobile or facility - based) from qualified
voluntary blood donors;
f. Transport ofblood to BC for testing and processing;
g. Compatibility testing to red cell units, if hospital based.
(3) BCU/ BS- all services stipulated under BCV and BS
(4) BB
a. Advocacy and promotion of voluntary blood donation and healthy
life;
b. Storage and issuance of whole blood and blood components
obtained from a BC;
c. The following services shall also be provided:
i. Compatibility testing of red cell units
ii. Direct Coombs test
iii. Red cell antibody screening
iv. Investigation of transfusion reactions

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v. Assist the HBTC in the conduct of post-transfusion

surveillance (hemovigilance)
(5) BC
a. Advocacy and promotion of voluntary blood donation and healthy
lifestyle;
b. Recruitment, retention and care of voluntary blood donors;
c. Collection of blood (mobile or facility-based) from qualified
voluntary blood donors;
d. Conduct health education and counseling
e. Testing of units of blood for TI ls
f. Processing and provision ofblood components
g. Storage, issuance, transport and distribution of units of whole
blood and/ or blood products to hospitals and other health facilities
2. Standards and Technical Requirements
a. The BSF appoints and allocates personnel who are suitable qualified, skilled
and/or trained to assume the responsibilities, authority, accountability and
function of the position.
b. Services are provided in an environment that promotes safety, has adequate
space, meets the needs of clients, service providers and other stakeholders,
and conforms to the current Manual of Standards issued by the DOH.
c. All equipment and instrnments necessary for the safe and effective provision
of services are available and are properly maintained.
d. All reagents and glassware to be used by the BSF shall be based on the
minimum requirement for sensitivity and specificity of testing reagents as
well as the testing procedures as recommended by the technical committee
oftheNVBSP.
e. There shall be a system of reporting and recording of results of BSF
examinations.
£ 1he BSF shall put into practice a quality assurance program.
( I) There shall be a policy on quality assurance program and continuous
quality improvement
(2) The BSF shall participate in an External Quality Assessment Program
Administered by the designated National Reference Laboratories
(NRL) or other external assessment program approved by the DOH-
NVBSP.
g. There shall be a system in outsourcing of examinations and blood
components.
h. All hospital-based BB, BCU and/ or BS shall establish a HBTC.
i. All BSF shall comply with policies and guidelines of the NVBSP.

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3. LTO/ ATO
-
a. Hospital based BBs, BCUs, BS shall be licensed or authorized to operate
through the One-Stop-Shop Licensure for Hospitals and are therefore not
required to obtain a separate LTO or ATO. 1he required documents for the
Ii censure of the BB or the authorization of the BCV or BS shall be submitted
to the CHD, along with other documentary requirements for the hospital
LTD.
b. The LTO/ ATO shall be granted in accordance with prescribed documentary
and technical requirements and on the basis of specific conditions and
limitations established during inspection.
c. The LTO/ ATO as well as any right under the license/ authorii.ation cannot
be assigned or otherwise transferred directly or indirectly to any party.
d. The LTO/ ATO must be displayed at all times at a prominent place within
the premises
e. The CHD shall be notified within fifteen ( 15) calendar days of any change
in management, name or ownership. In cases of transfer of location, a new
application for LTO / ATO shall be required.
£ A separate LTO / ATO shall be required for each BSF or branch maintained
in separate premises even if operated by the same management.
4. Maximum Allowable Service Fees
a. The BSF may collect a reasonable service fee for every blood/ blood products
issued, which shall not be greater than the maximum fees prescribed by the
DOH. The NVBSP shall periodically review the maximum allowable service
fee specifying the basic requirements and special tests covered by the service
fee.
b. The prescribed maximum allowable fees shall be placed in an area readily
seen by the public.
c. 1he basic donor screening and blood testing procedures shall be detennined
by the NVBSP through analysis of research information such as disease
prevalence studies and risk estimates, consultation with the technical
experts, and careful evaluation of the optimum benefits from the expected
cost of these tests.
VI. PROCEDURAL GUIDELINES
A. Application for LTO for BCs and BBs and ATO for BCU and BS
1. Applicant requests for relevant infonnation and prescribed form from the CHD
under whose jurisdiction the proposed BSF is located, in person or through mail,
email or internet
2. Applicant accomplished required documents and submits them to the CHD.
Documentary requirements for the issuance of LTO/ ATO:
a. Certificate of Inclusion in the Regional Blood Services Network approved
by the identified Lead Blood Center in the region
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b. Duly accomplished and notarized Application Form

c. DTI/ SEC registration (initial)
d. List of personnel with photocopy of valid PRC card
e. Location map (initial)
£ Floor diagram
g. List of equipment-with serial number, brand, date of purchase, number of
units and operational status
h. NVBSP Annual Report (renewal)
i. Certificate of participation in EQAS in previous year (renewal)
3. The CH D Director or his authorized representative(s) reviews documents for
completeness, authenticity and compliance with the requirements
4. The applicant pays the appropriate fees, based on the current prescribed DOH
schedule of fees, to the CHD Cashier in person or through postal money order. BSF
operating as BCV/ BS shall be charged the corresponding fee for BCU
B. Inspection
I. 1he CHD Director of his authorized representative(s) inspects the BSF within
thirty (30) calendar days from the time of application to determine compliance
with standards and technical requirements.
2. 1he CH D inspection team prepares official summaryoffindingsand recommends
approval or disapproval after inspection.
C. Issuance ofLTO/ ATO
I. 1he CH D Director approves or disapproves the issuance ofLTO/ ATO.
a. If approved, the BSF is registered and an LTO/ ATO is issued to the applicant
within fifteen ( I 5) calendar days.
b. If disapproved, a copy of inspection findings and recommendation is
provided to the applicant within fifteen ( IS) calendar days from the time of
inspection.
c. An application for an LTO/ ATO that is not processed within the thirty (30)
calendar day period is considered approved
D. Renewal ofLTO / ATO
1. The LTO/ ATO shall be renewed every three (3) years. All hospital BSF shall
renew their LTO/ ATO annually as part of the One-Stop-Shop licensure for
hospitals.
2. Application for renewal of LTO/ ATO shall be filed on the first day of October
until the last day of November on the last year of the LTO validity period to the
CHD under which jurisdiction the BSF is located.
3. 1he LTO/ ATO may be renewed only ifit complies with the prescribed standards
and technical requirements.

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VII. VALIDITY OF LICENSE TO OPERATE

-
The LTO/ ATO to operate a BSF shall be valid for a period of three (3) years, beginning
on January I of the first year of the validity period to December 3 1 of the third year of the
validity period.
As part of the hospital license to operate, the license to operate/ authority to operate
a BB/ BCU/ BS shall be valid for a period one ( 1) year, beginning January 1 to
December 3 1.
VIII. MONITORING
The BHFS/ C H D Director or his au thorized representative(s) is au thorized to monitor
and conduct on- site visits to the BSF at any given time. The BSF shall make available to
the monitoring team all pertinent records to detennine the level of compliance with the
National Blood Services Act and these rules and regulations.
IX. VIOLATIONS
Violations of the National Blood Services Act or the rules and regulations issued in
pursuance thereto, include the commission of the following acts by individual, corporation,
association, or organization operating the BSF, or persons under their authority:
a. Any material false statement in the application
b. Misrepresentation of facts or falsification of documents or records
c. Refusal to make available its books, accounts and records of operation to an
authorized person from the BHFS/ CHD
d. Charging of blood service fees above the maximum fees set by the DOH
e. Collection ofblood from paid or remunerated donor whether payment comes from
the hospital or from the patient/ relatives
f. Refusal to participate in EQAS conducted by the designated National Reference
Laboratories
X. TRANSITORYPROVISIONS
All previously licensed hospital based and PNRCBCsalreadyperfonning the blood testing
and processing shall be allowed to operate as such until December 3 1, 2009. By2010, there
shall be a nationally coordinated blood service network with only the designated BCs
perfonning the centralized testing and processing.
XI. INVESTIGATION AND HEARING OF CHARGES OR COMPLAINTS
Upon filing of charges or complaints duly sworn to by any individual, corporation,
association, or organization against any BSF or any of its personnel who has violated or
is violating the provisions of R.A. 77 19 or any of these rules and regulations, the BH FS/
CHD Director or his authorized representative (s) shall investigate and verify if the BSF
concerned or any of its personnel is guilty of charges or complaints. If upon investigation
and hearing, the BSF concerned or any of its personnel is found violating the provision of
R.A. 77 19 or any of these rules and regulations, the CHD Director shall suspend the LTO/
ATO for a definite or indefinite period of time, or revoke the LTO / ATO withou t prejudice
to taking the case to judicial authorities for criminal action.
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