MEDTECH LAWS AND BIOETHICS

WEEK 5: PRELIMS issue such rules and regulations as may be necessary to carry out its
provisions.
R.A. 4688 CLINICAL LABORATORY ACT OF 1966
SECTION 4. Any person, firm or corporation who violates any
DATE OF APPROVAL: JUNE 18, 1966
provisions of this Act or the rules and regulations issued thereunder
NUMBER OF SECTIONS: 8 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
TERM: ___________________________________ less than one thousand pesos nor more than five thousand pesos, or
AN ACT REGULATING THE OPERATION AND MAINTENANCE OF both such fine and imprisonment, at the discretion of the court.
CLINICAL LABORATORIES AND REQUIRING THE
SECTION 5. If any section or part of this Act shall be adjudged by
REGISTRATION OF THE SAME WITH THE DEPARTMENT OF
any court of competent jurisdiction to be invalid, the judgment shall
HEALTH, PROVIDING PENALTY FOR THE VIOLATION
not affect, impair, or invalidate the remainder thereof.
THEREOF, AND FOR OTHER PURPOSES
SECTION 6. The sum of fifty thousand pesos, or so mush thereof as
SECTION 1. Any person, firm or corporation, operating and
may be necessary, is hereby authorized to be appropriated, out of any
maintaining a clinical laboratory in which body fluids, tissues,
funds in the National Treasury not otherwise appropriated, to carry
secretions, excretions and radioactivity from beings or animals are
into effect the provisions of this Act.
analyzed for the determination of the presence of pathologic
organisms, processes and/or conditions in the persons or animals SECTION 7. All Acts or parts of Acts which are inconsistent with the
from which they were obtained, shall register and secure a license provisions of this Act are hereby repealed.
annually at the office of the Secretary of Health: provided, that
SECTION 8. This Act shall take effect upon its approval.
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. OTHER CLINICAL LABORATORY LAWS TO TAKE NOTE

SECTION 2. It shall be unlawful for any person to be professionally BASIC LICENSE REQUIREMENT – Any person, firm or corporation
in-charge of a registered clinical laboratory unless he is a licensed desiring to establish or operate and maintain a clinical laboratory shall
physician duly qualified in laboratory medicine and authorized by the submit to the Secretary of Health, thru the Bureau of Research and
Secretary of Health, such authorization to be renewed annually. Laboratories, a sworn petition/application, said form prepared and
adopted therefore, and containing, among others, the following data:
No license shall be granted or renewed by the Secretary of Health for
the operation and maintenance of a clinical laboratory unless such  The name, citizenship and domicile of the head of the
laboratory is under the administration, direction and supervision of an laboratory
authorized physician, as provided for in the preceding paragraph.  The place, municipality and province where it is to be
established
SECTION 3. The Secretary of Health, through the Bureau of  The name of the establishment
Research and Laboratories shall be charged with the responsibility of  The name, citizenship and domicile of the owner
strictly enforcing the provisions of this Act and shall be authorized to  Scope and nature of work to be undertaken
MEDTECH LAWS AND BIOETHICS
 Statement that applicant has complied with all business blood banking, radioisotope laboratory and laboratory
requirements under other existing laws or ordinances endocrinology and similar disciplines
 Tax clearance for the proceeding year
Anatomical Pathology includes surgical pathology, histochemistry,
An inspector of the Bureau of Research and Laboratories shall, immunopathology, cytology and post-mortem examinations
upon receipt of said application, inspect within 60 days the
Forensic Pathology includes all medico-legal examinations
establishment and verify if the applicant has complied with the
requirements prescribed in these regulations. The license will (b) “Head”, “Chief”, “Director”, or “In-Charge” of the Laboratory
henceforth be issued, signed and approved by the Secretary of should be a duly licensed physician and registered with the
Health if the application is found to be meritorious; otherwise the Medical Board of Examiners of the Philippines, and qualified in
same shall be returned without action. laboratory medicine by having been certified by the Philippine
Board of Pathology either in Anatomical Pathology, Clinical
FEES- A fee of P100 shall be charged for every license issued to
Pathology or both; provided that in areas where there are no
open and operate a clinical laboratory, payable to the Bureau of
pathologist, the laboratory may be supervised by a licensed
Research and Laboratories. This license shall be subject to
physician with training in laboratory medicine as the Director of
renewal within the last two (2) months of each year upon payment
Bureau of Research and Laboratories may consider sufficiently
of a renewal fee of P50. A grace period of two (2) months is
adequate depending on the activities performed, and that he is
allowed for renewal subject to a fine of P10. Thereafter, the
authorized by the Secretary of Health as head or in-charge of
license will be considered to have lapsed and new license shall be
such laboratory.
applied for. All government laboratories are exempted from paying
these fees. (c) Personnel
No person is permitted to manage, administer or supervise a 1. “Associate Pathologist”- A licensed physician and qualified in
clinical laboratory unless he is a physician, licensed and duly laboratory medicine as certified by the Philippine Board of
registered with the Board of Medical Examiners of the Republic of Pathology either in Anatomical Pathology, Clinical Pathology or
the Philippines, qualified in laboratory in laboratory medicine and both who is under the direct supervision of the Head, Chief,
duly recognized by the Secretary of Health, such authorization to Director or In-charge of a clinical laboratory.
be renewed annually. This authorization shall be exempted from
any fees. 2. “Pathology Assistant”- A duly licensed physician and registered
with the Philippine Board of Medical Examiners, with at least one
DEFINITION OF TERMS (1) year training in laboratory medicine, and who shall be under
the direct supervision of the head, or associate pathologist of the
a) The term “clinical laboratories” shall mean to include any or all
laboratory, as the case may be.
of the following: (1) Clinical Pathology, (2) Anatomical Pathology,
and (3) Forensic Pathology. 3. “Medical Technologist”- must be a licensed Medical
Technologist duly registered in the Board of Examiners for
I. FUNCTION- It may perform any or all of the following:
Medical Technology who shall be directly under supervision of a
Clinical Pathology includes clinical chemistry, hematology, clinical registered pathologist, or a licensed physician authorized by the
microscopy, microbiology, serology, immunohematology and
MEDTECH LAWS AND BIOETHICS
Secretary of Health as head of the laboratory in places where 8. IMMUNOLOGY, MICROBIOLOGY
there are no pathologists.
4. “Laboratory Technician”- must have completed at least two
Note:
years of college work with at least 12 units of laboratory subjects,
and one year of training in an accredited laboratory; or without  A certified pathologist may be authorized to manage or
college work but with at least ten years training and expertise in a supervise or be an associate in not more than four (4) clinical
duly approved clinical laboratory. The laboratory technicians will laboratories/blood banks
be under the supervision of the medical technologists and under  A physician who is not certified pathologist may be authorized
the overall supervision of the head of the laboratory or his to manage or supervise only one (1) hospital laboratory
associate or assistant.
5. “Laboratory Aide”- should be at least high school graduates and
who shall assist the medical technologist or laboratory technicians The minimum number of examinations or samples of each section to
but whose activities should be limited to non-technician accommodate interns are as follows:
procedures.
a. Clinical Chemistry- 3000 exam/annum
II. INSTITUTIONAL CHARACTER are either:
b. Clinical Microscopy
 Hospital laboratory that operates within a hospital
1. Urinalysis (complete analysis) - 1500 samples/annum
 Free-standing (non-hospital) laboratory that operate on its
own or as a part of an activity other than a hospital 2. Parasitology (direct fecal smear and concentration test or
Kato thick smear) – 1500 samples/ annum
SERVICE CAPABILITIES
c. Microbiology
 Free-standing clinical laboratory shall be managed by a
licensed physician, certified by the Philippine Board of 1. Gram staining, acid-fast staining – 800 samples/annum
Pathology in either Anatomic or Clinical Pathology or both
2. Isolation and identification of organisms-
 Hospital clinical laboratory in areas where Pathologists are
not available, shall be managed by a physician with training of 1000 samples/annum
at least three (3) months in laboratory medicine, quality control
d. Hematology
and laboratory management and authorized by the Bureau of
Research and Laboratories. 1. Peripheral blood study to include hemoglobin, white cell
1. ROUTINE HEMA, UA, FA count Schilling, hematocrit and red cell morphology or CBC –
2. BLOOD TYPING 1200 samples/annum
3. QUALITATIVE PLATELET COUNT
4. ROUTINE CHEMISTRY 2. Sedimentation rate, platelet count, bleeding and clotting
5. CROSSMATCHING, GRAM STAIN, KOH time, malarial smears and other tests – 800 samples/annum
6. QUANTITATIVE PLATELET COUNT e. Blood Banking and Serology
7. SPECIAL HEMATOLOGY, SPECIAL CHEMISTRY
MEDTECH LAWS AND BIOETHICS
1. Typing -900 tests/annum  Hemoglobinometer or its equivalent
 Differential blood cell counter or its equivalent
2. Complete cross-matching – 600 tests/annum
3. Serology SECONDARY CATEGORY
 All those in PRIMARY CATEGORY plus:
VDRL - 300 tests/annum  Refrigerator
 Photometer or its equivalent
Widal test – 300 tests/annum  Water bath or its equivalent
 Timer or its equivalent
f. Histopathology – 500 tissues/annum
Cytology – 500 tissues/annum
TERTIARY CATEGORY
 All those in SECONDARY CATEGORY plus:
 Incubator
PHYSICAL FACILITIES  Balance, trip/analytical
 Rotator
1. The clinical laboratory shall be well-ventilated, adequately lighted,
 Serofuge or its equivalent
clean and safe.
 Autoclave
2. The working space shall be sufficient to accommodate its activities  Drying oven
and allow for smooth and coordinated work flow.  Biosafety cabinet or its equivalent

3. There shall be an adequate water supply.

REPORTING OF RESULTS
4. The working space for all categories of clinical laboratories (both
hospital and non-hospital based) shall have at least the following 1. All laboratory reports on various examinations of specimens shall
measurements: bear the name of the registered medical technologist and the
pathologist and duly signed by both.
CATEGORY SPACE (in sq. m.)
PRIMARY 10 2. No person in the laboratory shall issue a report, orally, or in writing,
SECONDARY 20 whole or portions, thereof without a directive from the pathologist or
TERTIARY (to include a 60 his authorized associate to the requesting physician or his authorized
separate, enclosed and representative except in emergency cases when the results may be
adequately ventilated room for released as authorized by the pathologist.
Microbiology)
RECORDING
EQUIPMENT/INSTRUMENTS
There shall be a system of accurate recording to ensure quality
PRIMARY CATEGORY
results.
 Clinical centrifuge
 Hemocytometer 1. There shall be an adequate and effective system of recording
 Microhematocrit centrifuge requests and reports of all specimens submitted and examined.
 Microscope with oil immersion objective
MEDTECH LAWS AND BIOETHICS
2. There shall be provisions for filing, storage and accession of all NO LICENSE: 1 MONTH TO 1 YEAR IMPRISONMENT
reports. (OWNER/SUPERVISOR)
3. All laboratory records shall be kept on file for at least one (1) year;
however, records of anatomic and forensic pathology shall be kept
OTHER PERTINENT LAWS
permanently in the laboratory.
 AO NO. 20 s. 1976
LICENSE: UNDER DOH----HEALTH FACILITIES AND SERVICES
-amended Section 11 of AO No. 201 s. 1973
BUREAU
-PATHOLOGIST: can handle not more than 3 CLINICAL
RENEWAL: UNDER DOH----CHD (REGIONAL DOH) LABORATORIES or BLOOD BANKS
-PHYSICIAN: can handle only 1 CLINICAL LABORATORY

VALIDITY OF LICENSE  AO NO. 59 s. 2001

-implements provisions regarding the rules and regulations on
LICENSE TO OPERATE A CLINICAL LABORATORY: 1 YEAR the operation, maintenance, and establishment of clinical
(EXPIRES EVERY DECEMBER 31ST) laboratories in the Philippines
RENEWAL: 90 DAYS BEFORE EXPIRY DATE
 DEPARTMENT MEMORANDUM ORDER NO. 2009-0086
INSPECTION: EVERY 2 YEARS (BIENNIAL INSPECTION) -prescribed rules and regulations regarding the implementation
of internal and external quality control programs as the
requirement for licensing of clinical laboratories
CHANGES IN THE CLINICAL LABORATORY (LOCATION,
OWNERSHIP, SUPERVISION, ADDITION OF SERVICES)  DEPARTMENT MEMORANDUM ORDER NO. 2009-0086
-requires a clinical lab to participate in the National External
-write a letter to DOH 15 DAYS prior to implementation of changes Quality Assessment Scheme (NEQAS) administered by
designated reference laboratories

LABORATORY REQUEST/S: must be signed by the REQUESTING  DEPARTMENT ORDER NO. 393 s.2000
PHYSICIAN  RESEARCH INSTITUTE FOR TROPICAL MEDICINE
LABORATORY RESULTS: must be signed by the PATHOLOGIST (RITM)
and MEDTECH -NATIONAL REFERENCE LAB FOR: DENGUE,
INFLUENZA, TUBERCULOSIS AND OTHER
*before A.O 27 s. 2007: only manual signatures are allowed MYCOBACTERIA, MALARIA AND OTHER
PARASITES, BACTERIAL ENTERIC DISEASES,
*after A.O 27 s. 2007: FACSIMILE (rubber stamp,
MEASLES AND OTHER VIRAL EXANTHEMA,
electronically signed out, scanned signatures)
MYCOLOGY, ENTEROVIRUSES, ANTIMICROBIAL
MEDTECH LAWS AND BIOETHICS
RESISTANCE AND EMERGING DISEASES; BIOSAFETY Laboratories that PERSONAL
CONFIRMATORY TESTING OF BLOOD UNITS LEVEL 3 LAB handle RISK GROUP PROTECTIVE
 SAN LAZARO HOSPITAL (SLH) 3 organisms that EQUIPMENT
-NATIONAL REFERENCE LAB FOR: HIV/AIDS, are considered SECONDARY
indigenous or BARRIERS
HEPATITIS, SYPHILIS AND OTHER SEXUALLY-
exotic agents BIOSAFETY CABINET
TRANSMITTED INFECTIONS with the WITH GAS-TIGHT
 EAST AVENUE MEDICAL CENTER (EAMC) potential to be AEROSOL
-NATIONAL REFERENCE LAB FOR: transmitted via GENERATION
ENVIRONMENTAL AND OCCUPATIONAL HEALTH, respiratory CHAMBER, ACCESS
TOXICOLOGY AND MICRONUTRIENT ASSAY routes TO THE LAB IS
 NATIONAL KIDNEY AND TRANSPLANT INSTITUTE CONTROLLED
(NKTI) BIOSAFETY Laboratories that FULL-BODY, AIR-
-NATIONAL REFERENCE LAB FOR: HEMATOLOGY LEVEL 4 LAB handle extremely SUPPLIED
dangerous and POSITIVE-PRESSURE
INCLUDING IMMUNOHEMATOLOGY,
exotic agents UNITS, PROVIDED
IMMUNOPATHOLOGY AND ANATOMIC that can be WITH SPECIALIZED
PATHOLOGY transmitted VENTILATION AND
 LUNG CENTER OF THE PHILIPPINES (LCP) through the air; WASTE MANAGEMENT
-NATIONAL REFERENCE LAB FOR: BIOCHEMISTRY have no available SYSTEM
AND CLINICAL CHEMISTRY vaccine or
therapeutic care,
TYPE OF DESCRIPTION PROTECTION and are under
LABORATORY RISK GROUP 4
BIOSAFETY Laboratories that PERSONAL classification
LEVEL 1 LAB handle organisms PROTECTIVE
considered by WHO EQUIPMENT
as RISK GROUP 1 RISK AGENT RISK EXAMPLE AGENTS
(unlikely to GROUP DESCRIPTION
cause human RISK Agents that are  Bacillus
diseases) GROUP 1 not associated subtilis
BIOSAFETY Laboratories that PERSONAL (RG-1) with diseases in  Escherichia coli
LEVEL 2 LAB handle broad- PROTECTIVE healthy adult  Adeno-associated
spectrum of EQUIPMENT humans viruses
moderate-risk SECONDARY
agents or RISK BARRIERS (ex: RISK Agents that are  Staphylococcus
GROUP 2; normally sink, waste GROUP 2 associated with aureus
process human- decontamination (RG-2) human diseases  Salmonella spp.
derived specimens facilities, that are rarely  Herpes Simplex
biosafety serious and for Virus (HSV)
cabinet) which preventive
MEDTECH LAWS AND BIOETHICS
or therapeutic  Adenovirus
interventions
are often
available
RISK Agents that are  Mycobacterium
GROUP 3 associated with tuberculosis
(RG-3) serious or  Bacillus
lethal human anthracis
diseases for  HIV
which preventive
or therapeutic
interventions
may be available
RISK Agents that are  Ebola virus
GROUP 4 likely to cause  Marburg virus
(RG-4) serious or  Lassa virus
lethal human
diseases for
which preventive
or therapeutic
interventions
are not usually
available