REPUBLIC ACT NO. 5527 - AN ACT REQUIRING THE
Compensation and Traveling Expenses of Council
REGISTRATION OF MEDICAL TECHNOLOGISTS, DEFINING
THEIR PRACTICE, AND FOR OTHER PURPOSES.
Section 1. Title.—This Act may be also cited as the Philippine Medical
Technology Act of 1969.
Section 2. Definition of Terms.—As used in this Act, the following
terms shall mean:
(a) "Medical Technology".—An auxiliary branch of laboratory
medicine which deals with the examination by various chemical,
microscopic, bacteriologic and other medical laboratory procedures or
technic which will aid the physician in the diagnosis, study and
treatment of disease and in the promotion of health in general.
(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, secretions 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 a 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 Technician".—A person who not being a graduate
of Bachelor of Science in Medical Technology/ Bachelor of Science
in Hygiene, but having passed the corresponding civil service
examination, performs the work of medical technology under the
supervision of a registered medical technologist and/or qualified
pathologist.
(e) "Accredited Medical Technology Training Laboratory—A
clinical laboratory, office, agency, clinic, hospital or sanitarium duly
approved by the Department of Health or its authorized agency.
(f) "Recognized School of Medical 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".—The Board of Examiners for Medical
Technology established under this Act.
Section 3. Council of Medical Technology Education, Its
Composition.—There is hereby established a Council of Medical
Technology Education, hereafter referred to as Council, which shall be
composed of the Secretary of Education or Director of Private
Education as Chairman, the Director of the Bureau of Research and
Laboratories of the Department of Health as Vice-Chairman, and the
Chairman and two members of the Board of Medical Technology, the
dean of ,the Institute of Hygiene of the University of the Philippines,
a representative of the deans or heads of the private schools of medical
technology, and the presidents of the Philippine Association of Medical
Technologists and the Philippine Society of Pathologists, as members.
Section 4.
Members.—The chairman and members of the Council shall be entitled
to a twenty-five pesos per diem for every meeting actually
attended: Provided, That the number of meetings authorized with
a per diem shall not exceed two in a month: And Provided,
further, That officials receiving regular salaries from the Government
shall not receive per diem. In addition the chairman and members of the
council shall be entitled to traveling expenses in connection with their
official duties.
Section 5. Functions of the Council of Medical Technology
Education.—The functions of the Council shall be:
(a) To recommend the minimum required curriculum for the
course of medical technology.
(b) To determine and prescribe the number of students to be
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, a
list of facilities available for instruction, a list of their recent
graduates and new admissions, on or "before the month of June.
(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 into an undergraduate internship
students who have satisfactorily completed three years of the medical
technology course or its equivalent and to collect from said students
the amount of five pesos each which money accrue to the operating
fund of the council.
(g) Formulate and recommend approval of refresher 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.
Section 6. Minimum Required Course.—The medical technology
course shall be at least four years, including a 12-month satisfctory
internship in accredited laboratories, and shall include the following
subjects:
English Biochemistry
Spanish Gross Anatomy
Social Science Histology
General Zoology Physiology
Botany Clinical Parasitology
Mathematics General Pathology
College Physics Microbiology
 General Chemistry Biostatistics
Qualitative Chemistry Clinical Laboratory Methods
including hemotology, serology, blood
banking, clinical microscopy, applied
Quantitative Chemistry microbiology, and parasitology,
histopathologic techniques, and
cyto-technology.
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.
Section 7. Board of Examiners for Medical Technology.— There is
hereby created a Board of Examiners for Medical Technology which
shall hereafter be referred to as the Board composed of a chairman who
is a pathologist appointed by the President of the Philippines from a list
submitted by the Philippine Society of Pathologists and two members
who are registered medical technologists appointed by the President of
the Philippines from among a list submitted by the Philippine
Association of Medical Technologists each one to serve a term of three
years: Provided, That the first Board to be created one member who
shall act as chairman shall serve for three years, one member for two
years and the third member for one year: And provided, further, That
the first members of the Board of Examiners for Medical Technology
shall be issued a certificate of registration as Medical Technologist
without prior examination in accordance with the provisions of this Act.
No member shall be allowed more than one reappointment. The
President of the Philippines shall fill the vacancy that may occur but the
appointee shall serve only the unexpired term of the incapacitated
member.
Section 8. Qualifications of Examiners.—No person shall be appointed
a member of the Board of Examiners for Medical Technology unless he
or she (1) is a Filipino citizen; (2) is of good moral character; (3) is a
qualified pathologist or duly registered medical technologist of the
Philippines with the degree of Bachelor of Science in Medical
Technology/Bachelor of Science in Hygiene; (4) has been in the
practice of laboratory medicine or medical technology for at least ten
years prior to his appointment, and (5) is not a member of the faculty of
any medical technology school, or have any pecuniary interest, direct
or indirect, in such institution: Provided, however, That for the first
three years following the approval of this Act, the requirement
mentioned in number four (4) shall be reduced to five years.
Section 9. Executive Officer of the Board.—The Commissioner of Civil
Service shall be the Executive Officer of the Board, and shall conduct
the examinations given by it. The 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.
Section 10. Compensation of Members of the Board of Examiners for
Medical Technology.—Each member of the Board shall receive a sum
of ten pesos for each applicant examined and five pesos for each
applicant granted a certificate of registration without examination.
Section 11. Functions and Duties of the Board.—The Board is vested
with authority and required, conformably with the provisions of this
Act, to:
(a) Administer the provisions of this Act;
(b) Administer oaths in connection with the administration of
this Act;
(c) Issue, suspend and revoke certificates of registration for the
practice of medical technology;
(d) Look into conditions affecting the practice of medical
technology in the Philippines and, whenever necessary, adopt such
measures as may be deemed proper for the maintenance of good
ethics and standards in the practice of medical technology;
(e) 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; and
(f) 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.
Section 12. Removal of Board Members.—Any member of the Board
may be removed by the President of the Philippines for neglect of duty,
incompetency, malpractice or unprofessional, unethical, immoral or
dishonorable conduct after having been given opportunity to defend
himself in a proper 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.
Section 13. Accreditation of Schools of Medical Technology and of
Training Laboratories.—Department of Education shall approve
schools of medical technology in accordance with the provisions of this
Act. The Department of Health or its authorized agency shall upon
recommendation of the Council of Medical Technology Education
approve laboratories for accreditation as training laboratories for
Medical Technology students or postgraduate trainees upon satisfactory
evidence that said laboratories possess qualified personnel and are
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.
Section 14. Inhibition Against the Practice of Medical
Technology.—No person shall practice or offer to practice medical
technology as denned in this Act without having previously obtained a
valid certificate of registration from the Board provided that
registration shall not be required of the following:
(a) Duly registered physicians.
(b) Medical technologists from other countries, called in for
consultation or as visiting or exchange professors to colleges or
universities: Provided, That they are only practicing the said function.
(c) 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.
Section 15. 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.
Section 16. Qualification for Examination.—Every applicant for
examination under this Act, shall, prior to the date thereof, furnish the
Board satisfactory proof that he or she:
(a) Is in good health and is of good moral character;
(b) Has completed a course of at least four years leading to the
degrees of Bachelor of Science in Medical Technology or Bachelor of
Science in Hygiene conferred by a recognized school, college or
university in accordance with this Act and all other persons having
graduated from other paramedical professions who are actually
performing medical technology for the last five years prior to the
enactment of this Act provided they meet the minimum requirements
mentioned in Section Six except the one year undergraduate
internship or practical training.
Section 17. Scope of Examination.—The examination question shall
cover the following subjects with their respective relative weights:
Clinical Chemistry 20%
Microbiology and Parasitology 20%
Hematology 20%
Blood Banking and Serology 20%
Clinical Microscopy (Urinalysis and other body fluids) 10%
Histopathologic Technique 10%
The Board shall prepare the schedule of subjects for examination and to
submit the same to the Commissioner of Civil Service for publication at
least four months before the date of examination. The Board shall
compute the general average of each examinee according to the
above-mentioned relative weights of the subjects: 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 Council.
Section 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
Section 19. Ratings in the Examination.—In order to pass the
examination, a candidate must obtain a general average of at least
seventy-five per cent in the written test, with no rating below fifty per
cent in any of the major subjects: Provided, That the candidate has not
failed in at least sixty per cent of the subjects computed according to
their relative weights. No further examination will be given an
applicant who has not qualified after three examinations, unless and
until he shall have completed 12 months refresher course in an
accredited medical technology school or 12-month postgraduate
training in an accredited laboratory:Provided, That graduate of
paramedical professions 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 after his failure to qualify for the third time.
Section 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 upon the practice of
medical technology in the Philippines.
Section 21. Issuance of Certificate of Registration.— Every applicant
who has satisfactorily passed the required examination, shall be issued
a certificate of registration as Medical Technologist: Provided, That no
such certificate shall be issued to any successful applicant who has not
attained the age of twenty-one years. All certificates shall be signed by
all the members of the Board and attested by its Secretary. The duly
registered medical technologist shall be required to display his
certificate of registration in the place where he works. Upon application
filed after the approval of this Act not later than ninety days after the
Board shall have been fully constituted, the Board shall issue a
certificate of registration without examination to persons who have
been graduated with a Bachelor of Science in Hygiene and/or Bachelor
of Science in Medical Technology in duly recognized schools of
medical technology in the Philippines or foreign countries who have
been in the practice of medical technology for at least three years at the
time of the passage of this Act in laboratories in the Philippines or in
foreign countries duly accredited by the Bureau of Research and
Laboratories, Department of Health, and also to all other persons
having graduated from other paramedical professions who are already
civil service eligible by authority of the other Boards of profession and
who are actually performing medical technology practice for the last
five years prior to the enactment of this Act.
Section 22. Fees.—The Board shall charge each applicant for
examination and registration the sum of fifty pesos and 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 sum of ten pesos. 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.
Section 23. Refusal to Issue Certificate.—The Board shall refuse to
issue a certificate of registration to any person convicted by a court of
competent jurisdiction of any criminal offense involving moral
turpitude, or any person guilty of immoral or dishonorable conduct, or
of unsound mind, or incurable communicable disease, and in such case
shall give to the applicant a written statement setting forth the reason
for its action, which statement shall be incorporated in the record of the
Board.
Section 24. Administrative Investigation-Revocation or Suspension of
Certificates:—Administrative investigations shall be conducted by at
least two members of the Board with one legal officer sitting during the
investigation. The existing rules of evidence shall be observed during
all administrative proceedings, the respondents shall be entitled to be
represented by counsel, or be heard in person, to have 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 the causes mentioned in the
next preceding section or for causes enumerated in section twenty-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. The 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.
(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 ;

Section 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.
Section 26. Reinstatement, Reissue or Replacement of
Certificates.—The Board may, upon application and for reason deemed
proper and sufficient, reissue any revoked registration certificate. The
suspension of a certificate of registration shall be automatically lifted
upon the expiration of the period of suspension and said certificate shall
be re-issued 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.
Section 27. Foreign Reciprocity.—No foreigner shall be admitted to
examination, or be given a 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 a citizen permits Filipino Medical
Technologists to practice within territorial limits on the same basis as
the subjects or citizens of said country or state.
Section 28. Roster of Medical Technologists.—A roster of Medical
Technologists shall, be prepared annually by the Secretary of the Board,
commencing on the year following 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 Heads and all
bureaus, offices and instrumentalities of the Department of Health and
to such other offices, private or governmental, and to the public upon
request.
Section 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 by a 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:
(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 who shall violate any provision of this Act; or
(k) Any person or corporate body who shall violate the rules
and regulations of 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.
Section 30. Separability Clause.—If any provision of this Act or the
application of such provision to any person or circumstance is declared
invalid by a court of competent jurisdiction, the remainder of this Act
or of the application of such provision to other persons or
circumstances shall not be affected by such declaration.
Section 31. Repealing Clause.—All Acts, executive orders, rules and
regulations, or parts thereof 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 Law of 1956 (R.A.
1517).
Section 32. Effectivity.-This Act shall take effect upon its approval.
Approved: June 21, 1969.

(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;
REPUBLIC ACT NO. 4688 - AN ACT REGULATING THE
OPERATION AND MAINTENANCE OF CLINICAL
LABORATORIES AND REQUIRING THE REGISTRATION OF
THE SAME WITH THE DEPARTMENT OF HEALTH,
PROVIDING PENALTY FOR THE VIOLATION THEREOF,
AND FOR OTHER PURPOSES
SECTION 1. Any person, firm or corporation, operating and
maintaining a clinical laboratory in which body fluids, tissues,
secretions, excretions and radioactivity from beings or animals are
analyzed for the determination of the presence of pathologic
organisms, processes and/or conditions in the persons or animals
from which they were obtained, shall register and secure a license
annually at the office of the Secretary of Health: provided, that
government hospital laboratories doing routine or minimum
laboratory examinations shall be exempt from the provisions of this
section if their services are extensions of government regional or
central laboratories.
SECTION 2. It shall be unlawful for any person to be
professionally in-charge of a registered clinical laboratory unless he
is a licensed physician duly qualified in laboratory medicine and
authorized by the Secretary of Health, such authorization to be
renewed annually.
No license shall be granted or renewed by the Secretary of Health
for the operation and maintenance of a clinical laboratory unless
such laboratory is under the administration, direction and
supervision of an authorized physician, as provided for in the
preceding paragraph.
SECTION 3. The Secretary of Health, through the Bureau of
Research and Laboratories shall be charged with the responsibility
of strictly enforcing the provisions of this Act and shall be
authorized to issue such rules and regulations as may be necessary
to carry out its provisions.
SECTION 4. Any person, firm or corporation who violates
any provisions of this Act or the rules and regulations issued
thereunder by the Secretary of Health shall be punished with
imprisonment for not less than one month but not more than one
year, or by a fine of not less than one thousand pesos nor more than
five thousand pesos, or both such fine and imprisonment, at the
discretion of the court.
SECTION 5. If any section or part of this Act shall be
adjudged by any court of competent jurisdiction to be invalid, the
judgment shall not affect, impair, or invalidate the remainder
thereof.
SECTION 6. The sum of fifty thousand pesos, or so mush
thereof as may be necessary, is hereby authorized to be appropriated,
out of any funds in the National Treasury not otherwise
appropriated, to carry into effect the provisions of this Act.
SECTION 7. All Acts or parts of Acts which are inconsistent
with the provisions of this Act are hereby repealed.
SECTION 8. This Act shall take effect upon its approval.
Approved: June 18, 1966
DOH ADMINISTRATIVE ORDER NO. 2007-0027: REVISED
RULES AND REGULATIONS GOVERNING THE LICENSURE
AND REGULATION OF CLINICAL LABORATORIES IN THE
PHILIPPINES
I. RATIONALE
One of the main thrusts of current health sector reforms under
FOURmula One (F1) for health 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 of Health, providing
penalty for the violation thereof, and for other purposes”,
mandated the DOH to look after public welfare by effectively
enforcing and updating the current regulations to improve
laboratory performance.
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.
2001, 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.
II. OBJECTIVE
This Order is promulgated to prescribe a revised minimum standard
for clinical laboratories. This 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 examinations 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, test for sexually transmitted infections,
and cervical cancer screening using Pap smears, shall be exempted
from the provisions of this Order.
IV. DEFINITION OF TERMS
For purposes of this Order, the following terms and acronyms shall
have the following definition:
1. Applicant – a natural or juridical person who intends to operate a
clinical laboratory
2. BHFS – acronym for the Bureau of Health Facilities and
Services
3. CHD – acronym for the Center for Health Development
4. Clinical laboratory – a facility where tests are done on
specimens form the human body to obtain information about the
health status of a patient for the prevention, diagnosis and treatment
of diseases. These 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 of
laboratory investigations. 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.
5. 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.
6. DOH – acronym for the Department of Health
7. 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 performance of the laboratory shall be assessed through
the closeness of its results to be pre–determined value or to the
reference value generated by the participating laboratories through
peer group analysis.
8. 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.
9. Institution – a corporate body or establishment organized for an
educational, medical, charitable or similar purpose.
10. 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.
11. Licensee – the individual, agency, partnership or corporation to
whom the license is issued and upon who rests compliance with this
Order.
12. LTO – acronym for License to Operate. It also refers to the
license.
13. Mobile Clinical Laboratory – a laboratory testing unit that
moves from testing site to another testing site, or has a temporary
testing location. It shall have a base laboratory.
14. Monitoring Examinations – tests done in series on patients as
a guide for treatment or follow–up of their condition.
15. NRL – acronym for the National Reference Laboratory. It is
a laboratory in a government hospital which has 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 of EQAS; evaluation of diagnostic kits and
reagents. An NRL may or may not be part of a general clinical
laboratory.
16. POL – acronym for Physician’s Office Laboratory. It is an
individual doctor’s office/clinic wherein laboratory examinations
are performed.
17. 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.
18. 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.
19. Satellite Testing Site – any testing site that performs laboratory
examinations under the administrative control of a licensed
laboratory, but performed outside the physical confines of that
laboratory.
20. 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 “sta’tim” which means
immediately.
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 Pathology – includes Clinical Chemistry,
Hematology, Immunohematology, Microbiology,
Immunology, Clinical Microscopy, Endocrinology, Molecular
Biology, Cytogenetics, Toxicology and Therapeutic Drug
Monitoring and other similar disciplines.
2. Anatomic Pathology – includes Surgical Pathology,
Immunohistopathology, Cytology, Autopsy, Forensic
Pathology and Molecular Pathology.
C. Classification by Institutional Character
1. Institution Based – 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 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:
(1) Routine Hematology [Complete Blood Count – includes
Hemoglobin Mass Concentration, Erythrocyte Volume Fraction
(Hematocrit), Leucocyte Number Concentration (White Blood Cell
or WBC count) and Leucocyte Number Fraction (Differential
count)
(2) Qualitative Platelet Determination
(3) Routine Urinalysis
(4) Routine Fecalysis
(5) Blood typing – for hospital based
(b) Secondary Category – provides the minimum service
capabilities of a primary category laboratory plus the following:
(1) Routine Clinical Chemistry – includes Blood Glucose Substance
Concentration, Blood Urea Nitrogen concentration, Blood Uric
Acid Substance Concentration, Blood Creatinine Concentration,
Blood Total Cholesterol Concentration
(2) Quantitative Platelet Determination
(3) Cross matching – for hospital based
(4) Gram Staining – for hospital based
(5) KOH – for hospital based
(c) Tertiary Category – provides the minimum service capabilities
of a secondary category laboratory plus the following:
(1) Special Chemistry
(2) Special Hematology, including coagulation procedures
(3) Immunology
(4) Microbiology – culture and sensitivity
(5) Aerobic and anaerobic (for hospital and 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 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 of laboratory.
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 allowed to register 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 U.S.A. and the World Health 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 GUIDELINES
1. Standards
Every clinical laboratory shall be organized to provide quality,
effective and efficient laboratory services.
(a) Human Resource
(1) 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.
(2) The head of the laboratory shall have administrative and
technical supervision of the activities in the laboratory.
(3) The head of the laboratory shall supervise the staff in
accordance to the standards set by the Philippine Society of
Pathologists.
(4) There shall be an adequate number of medical technologists and
other health professionals with documented training and experience
to conduct the laboratory procedures. The number of staff shall
depend on the workload and the services being provided.
(5) 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
(1) There shall be available and operational equipment to provide
the laboratory examinations that the laboratory is licensed for.
(2) There shall be a calibration, preventive maintenance and repair
program for the equipment.
(3) There shall be a contingency plan in case of equipment
breakdown.
(c) Glassware, Reagents and Supplies
(1) There shall be available reagents, glassware and supplies for the
laboratory examinations to be provided.
(2) There shall be an inventory control of the reagents, glassware
and supplies.
(3) The reagents, glassware and supplies shall be stored under the
required conditions.
(d) Administrative Policies and Procedures – The clinical
laboratory shall have written policies and procedures for the
provision of laboratory services and for the operation and
maintenance of the laboratory.
(e) Technical Procedures – 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
(1) There shall be an Internal Quality Assurance Program which
shall include:
i. An Internal Quality Control Program for technical
procedure
ii. An Internal Quality Assurance Program for inputs,
processes and outputs
iii. A Continuous Quality Improvement Program covering all
aspects of laboratory performance.
(2) The clinical laboratory shall participate in an EQAP
administered by designated NRL or in other local and international
EQAP approved by the DOH.
(g) Communication and Records
(1) There shall be procedures for the receipt and performance of
routine and STAT requests for laboratory examinations.
(2) There shall be procedures for the reporting of results of routine
and STAT laboratory examinations, including critical values that
would impact on patient care.
(3) All laboratory reports on various examinations of specimens
shall bear the name of 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
E–Commerce Law.
(4) There shall be procedures for the reporting of workload, quality
control, inventory control, work schedule and assignments.
(5) There shall be procedures for the reporting and analysis of
incidents, adverse events and in handling complaints.
(6) 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
(1) The clinical laboratory shall conform to all applicable local and
national regulations for the construction, renovation, maintenance
and repair of clinical laboratories.
(2) The laboratory shall conform to the required space for the
conduct of its activities.
(3) There shall be well–ventilated, lighted, clean, safe and
functional areas based on the services provided.
(4) There shall be a program of proper maintenance and monitoring
of physical plant and facilities
(5) There shall be procedures for the proper disposal of waste and
hazardous substances.
(6) 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 the laboratory services
needed.
2. LTO (License to Operate)
(a) The LTO is issued in the name of the licensee and is
non–transferable, whether voluntarily and 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 is 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 face 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 time at a prominent place within the
laboratory premises.
(e) Hospital based clinical laboratories shall be licensed as part of
the hospital through the One–Stop–Shop Licensure for Hospitals
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 (1) LTO.
(h) A satellite laboratory outside the premises where the central
laboratory is situated shall be required to secure a separate LTO.
(i) Mobile clinical laboratories shall be licensed as part of the main
clinical laboratory and shall be permitted to collect specimens only.
It shall be allowed to operate only within one hundred (100) km
radius from its main laboratory.
(j) The LTO may be 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 violation of, or failure to comply
with any of the terms and conditions and provisions of these rules
and regulations.
VII. 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 or at the DOH website
(www.doh.gov.ph).
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 of LTO
1. Applicants can acquire the prescribed application form for LTO
form 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 CHD that has jurisdiction over the existing
or proposed clinical laboratory. The applicant shall be required to
pay a non–refundable application fee for LTO upon submission of
the accomplished form.
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 of LTO
1. 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 LTO 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 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 LTO 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 inspection at any
reasonable time.
2. The licensee shall ensure the accessibility of the premises and
facilities where the laboratory examinations are being performed
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 CHD Director or his authorized
representative(s).
4. An inspection tool, which prescribed the standards, criteria and
technical requirements for the issuance of LTO, shall be utilized.
E. Monitoring
1. 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 determine
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.
5. The CHD concerned shall submit a quarterly summary of the
violations to the BHFS stating the name of the clinical laboratory,
location, its corresponding violation and the course of action taken.
6. The Provincial, City and Municipal Health Officers are enjoined
to report to the BHFS/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 of license 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
performance of clinical laboratory examinations and procedures;
E. Deviation from the standard test procedures including use of
expired reagents;
F. 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 technologists 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 form of the referring laboratory;
K. Performing and reporting tests in a specialty or subspecialty in
which the laboratory is not licensed;
L. Giving and receiving any commission, bonus, kickback or rebate
or engaging in an split–fee arrangement in any form whatsoever
with any facility, physician, organization, agency or person, either
directly or indirectly, for patients referred to an 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 of licensees who are found violating the
provision 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 (1) 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
firm 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 Health 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 transcripts
of hearings on which the decision is based, with the Office of the
Health Secretary for review. The decision of the Office of the
Health Secretary is final and executory.
XIII. REPEALING CLAUSE
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 (15) 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
Approved: August 22, 2007
ADMINISTRATIVE ORDER No. 2021-0037: NEW RULES
AND REGULATIONS GOVERNING THE REGULATION OF
CLINICAL LABORATORIES IN THE PHILIPPINES
I. RATIONALE
By virtue of 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 of
Health, Providing Penalty for the Violation Thereof, and for Other
Purposes,” the Department of Health (DOH) through the Bureau of
Medical Services, now known as the Health Facilities and Services
Regulatory Bureau (HFSRB), was mandated to ensure public health,
safety and welfare through enforcement of the Act and was
authorized to issue such rules and regulations as may be necessary
to carry out the law. Clinical laboratory services play an important
role in the diagnosis, treatment, prevention and control of disease.
Thus, it is imperative that the laboratories generate accurate, precise
and reliable laboratory test results in a timely manner to aid the
physicians in assuring the quality of patient care.
Through the years, several laboratory technological advancements
have been introduced. As such, certain provisions in the current
Administrative Order (AO) No. 2007-0027, dated August 22, 2007,
titled “Revised Rules and Regulations Governing the Licensure and
Regulation of Clinical Laboratories in the Philippines,” may have
become outdated. This policy is being issued to align the laboratory
procedures with the requirements of AO 2020-0047 titled “Rules
and Regulations Governing the Licensure of Primary Care Facilities
in the Philippines.” The necessity to review the current AO and to
revise and update the minimum standards and technical
requirements for licensing clinical laboratories in the Philippines is
aligned with the main objective of Republic Act No. 11223 or the
Universal Health Care Act which is to guarantee access to quality
and affordable health products, devices, facilities and services.
II. OBJECTIVE
These rules and regulations shall serve as the new guidelines in the
licensing of diagnostic clinical laboratories in the Philippines which
shall ensure accountability of the laboratory on generation of
accurate, precise and reliable laboratory results in a timely manner
through continuous compliance.
III. SCOPE OF APPLICATION
This Order shall apply to all individuals, agencies, partnerships or
corporations, whether private or government-owned, involved in
the application for DOH license to operate and those in the
operation of diagnostic clinical laboratories in the Philippines.
This Order shall also apply to the Bangsamoro Autonomous Region
in Muslim Mindanao (BARMM) subject to the applicable
provisions of RA 11054 or the “Bangsamoro Organic Act” and
subsequent rules and policies issued by the Bangsamoro
Government.
IV. DEFINITION OF TERMS
A. Applicant — refers to any natural juridical person, government
instrumentalities/agencies, partnership, corporation or agency
seeking a license to operate and maintain a clinical laboratory.
B. Assessment Tool — the checklist which prescribes the
minimum standards and requirements for licensure of a clinical
laboratory.
C. Clinical Laboratory (CL) — a facility that is involved in the (a)
pre-analytical, (b) analytical, (c) and post-analytical procedures,
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. These tests include, but are not
limited to, the following disciplines: anatomic pathology, clinical
chemistry, clinical microscopy, endocrinology, hematology,
immunology and serology, microbiology, toxicology, as well as
molecular and nuclear diagnostics.
D. Department of Health - License to Operate (DOH-LTO) — a
formal authorization issued by the DOH to an individual,
partnership, corporation, association or any government agency/unit
seeking to perform laboratory tests in compliance with the
requirements prescribed in this Order.
E. Department of Health - Permit to Construct (DOH-PTC) —
a permit issued by DOH through HFSRB or Center for Health
Development-Regulation, Licensing and Enforcement Division
(CHD-RLED) to an applicant who will establish and operate a
hospital or other health facility, upon compliance with required
documents prior to the actual construction of the said facility. A
DOH-PTC is also required for hospitals and other health facilities
with substantial alteration, expansion, renovation, increase in the
number of beds, transfer of site, or for additional services (add-ons)
beyond their service capability. It is a prerequisite for License to
Operate.
F. External Quality Assessment Program (EQAP) — a program
where participating CL are given unknown samples for analysis.
These samples should be treated as ordinary human specimens for
the usual processing and examination. The quality of performance
of the CL shall be assessed through the closeness of its results to
the pre-determined value or reference value generated by the
participating CL through peer group analysis.
G. Initial Application — refer to applications by newly
constructed health facilities, or those with changes in the
circumstances of the facility, such as, but not limited to, change of
ownership, transfer of site, increase in beds or for additional
services beyond their service capability and major alterations or
renovations
H. Mobile Clinical Laboratory (MCL) — a laboratory testing
unit capable of performing limited CL diagnostic procedures. It
moves from one testing site to another, and it has a DOH-licensed
CL as its main laboratory.
I. National External Quality Assessment Scheme (NEQAS) —
an EQAP activity conducted by the National Reference
Laboratories to assess the quality of performance and accuracy of
the results of laboratories.
J. National Reference Laboratory (NRL) — the highest level of
laboratory in the country performing highly complex procedures,
including confirmatory testing, that is not commonly performed by
the lower level of laboratory. It is the responsible entity for
facilitating NEQAS to ensure compliance to quality standards for
regulation and licensing ofall laboratories in the Philippines.
K. Physician’s Office Laboratory (POL) — refers to a doctor’s
office/clinic wherein CL examinations are performed for the
purpose of monitoring the doctor’s patients only, wherein NO
official results shall be issued. In this Order, POL within the
premises of a DOH-regulated facility shall be under the supervision
of the CL.
L. Point of Care Testing (POCT) — refers to diagnostic testing
done at or near the site of patient care rather than in the CL. It may
be in the emergency room, operating suites, wards, and ambulances.
M. Satellite Clinical Laboratory (SCL) — refers to an extension
of the main CL located within the facility’s compound or premises.
It shall have the same service capability as the main laboratory.
N. Referral Tests — refers to CL tests that are either sent-out or
outsourced to other DOH-licensed CL with the same or higher
service capability.
V. GENERAL GUIDELINES
A. All CL shall secure DOH-LTO prior to its operation and must
comply with the minimum regulatory standards and requirements at
all times.
B. The DOH-LTO shall be secured from the DOH regulatory office
in accordance with DOH guidelines.
C. Only DOH-licensed institution-based CL may have a SCL which
shall be located within the premises of the regulated health facility.
D. A DOH-licensed CL may have MCL services as listed in Section
IV of Annex A, provided, they adhere to the standard testing
protocols.
E. The DOH-licensed CL shall not perform any examinations or
testing beyond its authorized service capability. However, it may be
allowed to offer laboratory services other than the respective
stipulated minimum services, such as but not limited to, MCL, SCL,
confirmatory testing for Glucose-6-Phosphate Dehydrogenase
(G6PD) Deficiency, and Rapid HIV Diagnostic Algorithm
(rHIVda), provided that the additional services have been approved
and indicated as add-on services in the DOH-LTO of the CL.
F. Unit/Section of health facilities performing diagnostic CL tests
such as, but not limited to, arterial blood gas and/or
Radioimmunoassay for thyroid function tests and Prostate Specific
Antigen shall be under the DOH-licensed CL.
G. The head of the CL shall be a pathologist certified by a
professional organization recognized as the Accredited Professional
Organizations/Accredited Integrated Professional Organizations of
the Professional Regulation Commission. The head of laboratory
shall ensure the optimal overall operations and maintenance of the
CL and if applicable, of its SCL and MCL.
H. There shall be an adequate number of competent personnel
assigned in the different services provided by the DOH-licensed CL,
which includes the MCL, SCL, remote collection activities, if
applicable.
I. CLs that are operated and maintained exclusively for research and
teaching purposes shall be required to register with the
DOH-HFSRB.
J. The DOH designated NRL shall be covered by the license of the
CL of the hospital where they are affiliated with. Independent
NRLs, or those designated by DOH but are not affiliated with any
DOH-regulated health facility, shall secure a DOH-LTO from
HFSRB.
K. All CLs shall make their prices for laboratory services accessible
to the public as mandated by the UHC law and related DOH
issuances.
L. At the Central Office, the Director IV, or in his/her absence or
unavailability or when delegated, the Director III of HFSRB, shall
approve the issuance of the DOH-LTO of the CL.
M. At the CHD, the Director IV, shall approve the issuance ofthe
DOH-LTO of the CL.
N. In the advent of new technologies or diagnostic platforms that
shall affect the current licensing standards for CL, Department
Circulars shall be issued, as needed, as supplements to this Order.
O. The CL shall be compliant with the prescribed standards and
requirements (Annex A), Assessment Tool for Licensing Clinical
Laboratories (Annex B1 and B2) and other relevant laws and
issuances. These standards shall also apply to MCL and SCL.
P. The DOH-LTO may be revoked, suspended or modified in full or
in part for any 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
VI. SPECIFIC GUIDELINES
A. Classification of Clinical Laboratories
1. Classification by Ownership
a. 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.
b. Private — privately owned, established and operated with
funds through donation, principal, investment or other means,
by any individual, corporation, association or organization.
2. Classification by Institutional Character
a. Institution-based —a laboratory that is located within the
premises and operates as part of a DOH licensed health
facility.
b. Non-institution based — a laboratory that operates
independently and is not attached to any DOH licensed health
facility.
3. Classification by Function
a. Clinical Pathology — deals with the chemical and cellular
analyses of blood and other body fluids (includes, but not
limited to, clinical chemistry, clinical microscopy,
toxicology, therapeutic drug monitoring, immunology
and serology, hematology and coagulation), identification
and examination of microbes and parasites
(bacteriology/parasitology/mycology/virology).
b. Anatomic Pathology — provides processing and
 examination of surgical specimens as to the physical
appearance and microscopic structure of tissues, such as, but
not limited to, surgical pathology, cytopathology,
immunohistochemical techniques, autopsies and forensic
pathology.
c. Molecular Pathology — deals with the analysis of certain
genes, proteins and other molecules in samples from organs,
tissues or bodily fluids in order to diagnose disease and/or to
guide the prevention and treatment of disease based on the
principles, techniques and tools of molecular biology as they
are applied to diagnostic medicine in the laboratory.
4. Classification by Service Capability
a. Clinical Laboratory for Clinical and Anatomic
Pathology
b. Clinical Laboratory for Anatomic Pathology only —
provides services for any of the following, but not limited to:
cytology and histopathology.
c. Clinical Laboratory for Molecular Pathology only —
provides services for genetics, immuno/hematopathology and
infectious disease. COVID-19 testing laboratories shall be
covered by another Order.
VII. PROCEDURAL GUIDELINES
A. Permit to Construct (PTC)
1. A completely filled out application form for DOH-PTC
(downloadable at www.hfsrb.doh.gov.ph), whether manual or
online, shall be submitted to the DOH regulatory offices, as
specified in Section V. B of this Order.
2. A DOH-PTC shall be required for construction of new CL and
for renovation or expansion of existing CL, including change in
ownership and transfer of location.
3. The application shall be processed in accordance with the
procedural guidelines set forth in A.O. No. 2016-0042, also known
as, “Guidelines in the Application for Department of Health Permit
to Construct (DOH-PTC).”
B. License to Operate (LTO)
1. Any person, firm or corporation desiring to establish, operate and
maintain CL shall submit an accomplished application form to
HFSRB/CHD-RLED in accordance with the current DOH
guidelines, whether manual or through the Online Licensing and
Regulatory System (OLRS), once it is fully functional.
2. A complete application for DOH-LTO of CL shall consists of the
following:
a. Completely filled out application Form 1 and its attachments
(downloadable at www.hfsrb.doh.gov.ph);
i. Notarized Acknowledgement
ii. Any of the following proof of ownership and name of
health facility
 DTI/SEC/CDA Registration including Articles of
Incorporation/Cooperation and By-Laws
 Enabling Act/LGU Resolution (for government
health facility)
iii. Accomplished Self-Assessment Tool
iv. Health Facility Geographic Form
b. Copy of official receipt payment.
c. Certificate from NRL-SLH/SACCL for rHIVdA Confirmatory, if
applicable.
d. Certificate from Newborn Screening Reference Center (NSRC),
if applicable.
3. Upon receipt of the complete application forms, the
HFSRB/CHD-RLED representative, in accordance with the current
DOH guidelines, reviews the application and conducts an on-site
assessment of the laboratory to determine full compliance with the
standards and technical requirements.
4. If, upon assessment, the laboratory is not fully compliant with the
licensing requirements, the HFSRB/CHD-RLED, in accordance
with the current DOH guidelines, shall provide a written report
outlining the laboratory’s deficiencies. The laboratory must comply
with the deficiencies within thirty (30) days. Otherwise, the
application shall automatically be denied.
5. The DOH-LTO, whether initial or renewal, shall only be issued
after the HFSRB/CHD-RLED, in accordance with the current DOH
guidelines, has determined that the laboratory is fully compliant.
6. Submitted complete applications that are not processed within
twenty (20) days by the HFSRB/CHD-RLED, in accordance with
the current DOH guidelines, due to force majeure, shall
automatically be granted the LTO, and a post-licensing visit shall
be scheduled.
7. Only DOH licensed CL identified by the program and has
already secured a certificate of “Certified rHIVda Confirmatory
Laboratory (CrCL)” from the NRL-SLH/SACCL or its designated
regional counterpart, shall be allowed to apply for a license CrCL.
8. A DOH-licensed hospital-based tertiary CL, already certified by
the NSRC, may apply as a G6PD Deficiency confirmatory
laboratory to HFSRB.
9. For institution-based CL, the One-Stop Shop (OSS) Licensing
System, pursuant to Administrative Order No. 2018-0016 dated
June 4, 2018, titled “Revised Guidelines in the Implementation of
the One-Stop Shop Licensing System,” shall
10. The DOH-LTO is non-transferable and a new application for
DOH-LTO shall be required in case of change of ownership or
transfer of location.
11. The HFSRB/CHD-RLED, in accordance with the current DOH
guidelines, shall be notified in writing of any change in
management name, ownership, or headship or laboratory personnel.
Failure to notify of any substantial change in the condition of the
laboratory, i.e. changes in the physical plant, equipment, or
personnel, in writing within fifteen (15) days, may be a basis for the
suspension or revocation of the DOH-LTO.
12. Different branch(es) of a CL, even if owned by the same entity
shall secure separate DOH-LTO.
13. Application for DOH-LTO shall be in compliance with AO No.
2019-0004 dated April 30, 2019, titled “Guidelines on the Annual
Cut-off Dates for Receipt of Complete Applications for Regulatory
Authorizations Issued by the Department of Health.”
14. The DOH-LTO shall be placed in an area that can be readily
seen by the public, at all times.
C. Certificate of Registration (COR)
1. COR is required for research and teaching laboratories.
2. Applicants shall submit an accomplished registration form
(downloadable at www.hfsrb.doh.gov.ph) together with the
necessary attachments to HFSRB, which includes Annex for
services.
3. The applicant shall be required to pay a non-refundable
application fee before submission of the requirements as part of
complete application.
4. The HFSRB shall evaluate and accept applications based on the
due execution of forms and completeness of attachments.
D. Validity
1. The DOH-LTO is valid for one (1) year.
2. COR for CL that is operated and maintained exclusively for
research and teaching purposes shall be required to register with the
DOH-HFSRB every three (3) years.
E. Fees
1. All fees shall follow the prescribed fees by the DOH.
2. All fees/checks shall be paid to the order of DOH Central Office/
CHD Cashier, whichever is applicable in person, through postal
money order or online payments approved by the DOH.
F. Monitoring
1. Authorized representatives from the HFSRB/CHD-RLED in
accordance with the current DOH guidelines, may conduct
unannounced on-site visits of licensed CL and registered research
and teaching laboratories to monitor and document the continuous
compliance of the CL to the set standards.
2. If upon monitoring visit, the CL is found to be violating any of
the rules and regulations stated herein relative to its operation, the
HFSRB/CHD-RLED in accordance with the current DOH
guidelines, may immediately impose preventive suspension.
3. CL that are operated and maintained exclusively for research and
teaching purposes shall not issue official results for diagnostic
purposes. They may be monitored to ensure that they are not
operating beyond allowed capabilities.
VIII. ROLES AND RESPONSIBILITIES
A. Health Facilities and Services and Regulatory Bureau shall;
1. Set standards for the regulation of CL and strictly enforce the
provisions of this Order.
2. Disseminate regulatory policies, standards and forms for
information and guidelines of the DOH-CHDs.
3. Provide consultation and technical assistance to stakeholders,
including regulatory officers from the DOH-CHDs in line with the
regulation of CL.
4. Respond promptly to complaints relative to the operation of CL
under its jurisdiction.
B. Center for Health Development — Regulatory, Licensing,
and Enforcement Division shall;
1. Strictly enforce the provisions of this Order.
2. Submit quarterly report on Suspension/Revocation/ Cease and
Desist Order issued on CL not later than the 15th day of the
following month after the covered quarter.
3. Provide consultation and technical assistance to stakeholders in
line with the regulation of CL.
5. Respond promptly to complaints relative to the operation of CL
under its jurisdiction.
C. National Reference Laboratories shall;
1. Provide laboratory reference/referral services for confirmatory
testing.
2. Train laboratory personnel and recognize other training
institutions.
3. Maintain the National External Quality Assessment Scheme
(NEQAS).
4. Perform technical evaluation of reagents and diagnostic kits.
D. DOH-Licensed Clinical Laboratories shall;
1. Continuously comply with the rules and regulations, licensing
standards and requirements for CL, as provided in this Order and
related issuances.
2. Participate in EQAP that may be administered by a designated
NRL or other local and international EQAP approved by the DOH,
surveys and other activities that will be required from them by the
DOH.
3. Intimes of Pandemic of Public Health Event, be mandated to
submit timely reports and data.
IX. VIOLATIONS, SANCTIONS AND APPEAL
A. A CL shall be sanctioned and penalized by the HFSRB/CHD
Director upon violation of any of these guidelines and its related
issuances and laws, or upon committal (commission/omission) of
prohibited acts (Annex C) by the persons owning or operating the
CL, and/or the persons under their authority.
B. For non-institution-based CL that are not under the OSSOLS,
the following are the penalties and sanctions that shall be imposed
for the commission of any of the violations in this Order and other
relevant issuances:
i. 1st offense: Stern warning
ii. 2nd offense: Thirty thousand pesos (Php 30,000.00)
iii. 3rd offense: Fifty thousand pesos (Php 50,000.00)
iv. 4th offense: Revocation of DOH-LTO
C. For CL that are part of hospitals and other facilities that are
subject to comply with the OSS licensure system, AO No.
2007-0022, dated June 6, 2007, titled “Violations under the
One-Stop Shop Licensure System for Hospitals,” sanctions shall be
governed by the aforementioned Order.
D. Any person who operates a CL without securing the necessary
DOH-PTC and corresponding DOH-LTO shall be issued a
Cease-and-Desist Order (CDO) and shall pay the administrative
penalty of Fifty thousand pesos (Php50,000.00).
E. Section 4 of Republic Act No. 4688 shall still be imposable aside
from the administrative penalty provided in this Order.
F. In case of complaints, the CL, upon receipt of such by
HFSRB/CHD-RLED shall be given due process wherein an
investigation shall be conducted and the appropriate sanctions for
its violation/s. A 60-day preventive suspension may be given to the
CL during the investigation depending on the seriousness of the
violation.
G. Any CL or any of its personnel not amenable with the decision
of the HFSRB/CHD-RLED may, within ten (10) days after the
receipt of notice of decision, file a notice of appeal to the Head of
the Health Regulation Team (HRT). All pertinent documents and
records of the appellant shall then be elevated by
HFSRB/CHD-RLED to the HRT. The decision of the Head of the
HRT, if still contested may be brought on a final appeal to the
Secretary of Health, whose decision shall be final and executory.
H. CL with revoked licenses can only re-apply after one year from
the date of LTO revocation.
I. Any person authorized or licensed to conduct clinical laboratory
tests, who issues false or fraudulent laboratory test results
knowingly, willfully or through gross negligence shall not be
allowed to own, manage, operate, or be an analyst of any
DOH-licensed CL.
X. TRANSITORY PROVISIONS
A. All existing licensed CL shall be given three (3) years to comply
with the physical plant requirements from the date of effectivity of
this Order.
B. All existing licensed CL shall be given two (2) years to fully
offer the additional services for each category with corresponding
personnel and equipment from the date of effectivity of this Order.
C. For new CL, this Order shall be immediately applicable.
D. For CL currently headed by Anatomic Pathologists with an
associate Clinical Pathologist or Clinical Pathologists heading
tertiary CL with Anatomic Pathology services, such headships shall
be retained until his/her eventual retirement, resignation or
replacement. Thereafter, all CL shall be headed by a pathologist
certified in Clinical Pathology by the Board of Pathology of the
Philippine Society of Pathologists, except for tertiary CL with
anatomic pathology service which shall be headed by a pathologist
certified in both Anatomic and Clinical Pathology.
XI. REPEALING CLAUSE
These rules and regulations shall rescind Administrative Order No.
2007-0027 titled “Revised Rules and Regulations Governing the
Licensure and Regulation of Clinical Laboratories in the
Philippines,” all administrative orders and previous issuances
inconsistent thereof.
XII. SEPARABILITY
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.
XIII. EFFECTIVITY
This Order shall take effect fifteen (15) days following its
publication in a newspaper of general circulation and upon filing
three (3) copies to the University of the Philippines Law Center.
FRANCISCO T. DUQUE III, MD, MSc
Secretary of Health
Approved: June 11, 2021
REPUBLIC ACT No. 1517 - AN ACT REGULATING THE
COLLECTION, PROCESSING AND SALE OF HUMAN BLOOD,
AND THE ESTABLISHMENT AND OPERATION OF BLOOD
BANKS AND BLOOD PROCESSING LABORATORIES
“BLOOD BANK ACT”
Section 1. In order to promote public health, it is declared a national
policy to prevent trafficking in human blood and its products and
derivatives.
Section 2. As used in this Act:
"Blood" means human blood, processed or unprocessed, and
includes its products and derivatives.
"Person" includes corporations, partnerships, associations, and
organizations.
"Cost" means the actual purchase price of unprocessed blood and
its handling charges, such as those for its collection, processing, storage,
transportation, and sale, and a reasonable allowance for spoilage.
Section 3. It shall be the unlawful for any person to establish or operate
a blood bank or blood processing laboratory, or to collect or process
blood if he is not a licensed physician, or to sell blood collected from
another person, even if authorized by the latter, without first securing a
license from the Department of Health: Provided, That in cases of
emergency, blood transfusion shall be allowed under the responsibility
of the attending physician without such license: And Provided,
further, That persons operating blood banks and blood processing
laboratories on the date of the approval of this Act may continue to
operate and same if they secure such license within sixty days from the
date of the issuance of the rules and regulations provided for in section
five hereof.
No license shall be granted or renewed by the Department of
Health for the establishment or operation of a blood bank or blood
processing laboratory unless such bank or laboratory be established or
operated in accordance with accepted scientific standards, is under the
administration, direction and supervision of a licensed and qualified
physician, and blood is collected and/or processed therein by licensed
physicians or under their direct supervision and responsibility.
No license shall be granted or renewed by said Department for
the collection and/or processing of blood unless the licensee complies
with the requirements herein above established for blood banks and
blood processing laboratories.
Section 4. Blood banks and processing laboratories shall be operated
on a non-profit basis. Blood collecting or processing by other blood
collectors or processors or by individual physicians shall also be on a
non-profit basis. Blood shall be sold by such banks and laboratories,
other blood collectors or processors, and individual physicians at cost.
Section 5. The Secretary of Health is charged with the responsibility of
strictly enforcing this Act, and shall issue such rules and regulations as
may be necessary to carry out its provisions, including rules and
regulations prescribing, from time to time, the maximum ceilings for
handling charges of blood, such as charges for its collection, processing,
storage, transportation, and sale, and a reasonable allowance for
spoilage, which shall be considered as part of the cost of blood.
Section 6. Any person who violates any provision of this Act or of the
rules and regulations issued thereunder shall be punished by
imprisonment for not less than one month and not more than one year
or by a fine of not less than one hundred pesos and not more than one
thousand pesos or by both such fine and imprisonment in the discretion
of the court.
Section 7. This Act shall take effect upon its approval.
Approved: June 16, 1956
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.
Section 1. Title. — This Act shall be known as the "National
Blood Services Act of 1994."
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;
(d) to inform 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 formal education
system in all public and private schools, in the elementary, high
school and college levels as well as the non-formal education
system;
(f) 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 of blood;
(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 of blood; and
(l) to require upgrading of blood banks/centers to include
preventive services and education to control spread of blood
transfusion transmissible diseases.
Section 3. Definitions. — For purposes of this Act, the
following terms shall mean:
(a) Blood/blood product — refers to human blood, processed
or unprocessed and includes blood components, its products and
derivatives;
(b) 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 transfusion transmissible
diseases;
(c) Commercial blood bank — a blood bank that exists for
profit;
(d) Hospital-based 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 Health to recruit and screen
donors and collect blood;
(f) Voluntary blood donor — 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) Secretary of Health — the Secretary of Health or any other
person to whom the Secretary delegates the responsibility of
carrying out the provisions of this Act; 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) Public 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 government units (particularly the
barangays), non-governmental organizations, all medical
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
nonmonetary incentives as may be determined by the
Department.
(b) Promotion 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-formal education curricula.
(c) Professional Education. — The Department, the PBCC, the
Philippine Society of Hematology 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 of Blood 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.
The Secretary shall set the standards for the scientific and
professional establishment and operation of blood 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 organizations 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 (₱25,000,000), by the
Philippine Amusement and Gaming Corporation (PAGCOR)
with an initial amount of at least Twenty-five million pesos
(₱25,000,000), by the trust liability account of the Duty Free
Shop (Duty Free Philippines) with an initial amount of at least
Twenty million pesos (₱20,000,000) 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 of blood 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 effectivity of this Act, 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. — The 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 the 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 of
blood, 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 than Five thousand pesos (P5,000) nor more than Fifty
thousand pesos (₱50,000), 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 (1) day nor more than twenty (20) years or a fine of not less
than Fifty thousand pesos (₱50,000) nor more than Five hundred
thousand pesos (₱500,000), 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. — If 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. 1517 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: May 5, 1994