1 MIDTERMS - CLIN LAB LAW Flashcards
Clinical Laboratory Law of 1966
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.
Clinical Laboratory Law of 1966
Clinical Laboratory Law of 1966 is Approved
June 18, 1966
Clinical Laboratory Law of 1966 is Approved by
President Ferdinand Edralin Marcos
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.
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 1
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 2
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 3
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 4
Clin Lab is regulated by ___ to prevent the
operation of substandard, improperly managed
and poorly equipped clinical laboratories
Bureau of Health Facilities
and Services under DOH
Based on Ownership:
Operated and maintained by a government
unit.
GOVERNMENT
Based on Ownership:
Owned, operated, and established by any
individual, corporation, association, or
organization.
PRIVATE
Based on Function
Clinical Chemistry, Hematology,
Immunohematology, etc.
CLINICAL PATHOLOGY
Based on Function
Surgical Pathology, Immunohistopathology,
Cytology, Autopsy, Forensic Pathology,
Molecular Pathology
ANATOMIC PATHOLOGY
Based on Institutional Character:
A laboratory that operates within the premises
and is a part of an institution.
INSTITUTION-BASED
Based on Institutional Character:
A laboratory that does not form part of any
other institution.
FREESTANDING
Based on Service Capability:
60 sq.m.
(minimum space
required)
Tertiary
Based on Service Capability:
10 sq.m.
(minimum space
required)
primary
Based on Service Capability:
20 sq.m.
(minimum space
required)
SECONDARY
Primary Lab Sections:
Routine Hematology
Routine Urinalysis
Routine Fecalysis
Qualitative Platelet
Blood Typing (hospitalbased)
Secondary Lab Sections:
All tests in primary lab
Routine Chemistry
Quantitative Platelet
Cross-matching, Gram
staining
KOH (hospitalbased)
Tertiary Lab Sections:
All tests in secondary lab
Special Chemistry
Special Hematology
Immunology-Serology
Limited Service Capability
Dialysis centers
Social hygiene clinics
Provides highly specialized lab services not
provided by a general clinical lab
SPECIAL CLINICAL LABORATORIES
- A laboratory in a government hospital which is
designated to provide special functions and
services
NATIONAL REFERENCE LABORATORY
A laboratory in a government hospital which is
designated to provide special functions and
services such as:
Ø Confirmatory testing
Ø Surveillance
Ø Resolution of conflicts
Ø Training and research
Ø Evaluation of kits and reagents
External quality assessment program
NRLS IN THE PHILIPPINES
– Hematology,
Immunohematology, Automated Urinalysis,
Immunopathology
NATIONAL KIDNEY AND TRANSPLANT
INSTITUTE –
NRLS IN THE PHILIPPINES
Toxicology
EAST AVENUE MEDICAL CENTER
NRLS IN THE PHILIPPINES
–Clinical
Chemistry
LUNG CENTER OF THE PHILIPPINES
NRLS IN THE PHILIPPINES
– Tuberculosis, Mycology, Transfusion transmissible infections, Bacterial Diseases,
Antimicrobial Resistance, Influenza, Malaria,
Measles and other exanthems, Rotavirus, Polio
RESEARCH INSTITUTE FOR TROPICAL MEDICINE
NRLS IN THE PHILIPPINES
–HIV/AIDS and
other sexually-transmitted infections
SAN LAZARO HOSPITAL/STD-AIDS CENTRAL
COOPERATIVE LABORATORY
- A testing site that performs lab examinations
under the control of a licensed laboratory but
outside the physical confines of the laboratory.
SATELLITE TESTING SITE
A laboratory testing unit that moves from one
testing site to another.
* Must have a base laboratory
* Must collect specimens only
* Must operate only within a 100-km radius from
its base laboratory
MOBILE CLINICAL LABORATORY
Sections/Departments of Mobile Clin Lab:
- Hematology
- Immuno-hematology (BB)
- Immuno-serology
- Clinical Microscopy (Uri-Para)
- Clinical Chemistry
- Microbiology (Bacteriology)
- Histo-pathology
