CLIN LAB Flashcards
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
RA 4688
When was RA 4688 approved ?
June 18, 1966
Who approved the RA 4688?
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.
Section 1
Register and secure a license from the office of the Secretary of Health.
Section 1
It shall be unlawful for any person to be professionally incharge 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
Laboratory must be under the supervision of an authorized physician/ pathologist by the Secretary of Health.
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
Laboratory should be subjected through an inspection by the Bureau of Research and Laboratories - annually.
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
Violation of provision shall be punished with: imprisonment
1 month - 1 year imprisonment
Violation of provision shall be punished with: fine
1000 - 5000 pesos fine
A facility subdivided into different sections where common diagnostic procedures are done by specialized health professionals
Clinical Laboratory
Clinical Laboratory is regulated by the _______________________ and Services under DOH. To prevent the operation of substandard, improperly managed and poorly equipped clinical laboratories
Bureau of Health Facilities
Ownership: Operated and maintained by a government unit
Government
Ownership: Owned, operated, and established by any individual, corporation, association, or organization
Private
Function: bodily fluids ( urine, blood, saliva)
Clinical Pathology
Clinical Chemistry, Hematology, Immunohematology, serology, parasitology, bacteriology, mycology, clinical microscopy, Toxicology, Therapeutic drug monitoring, Blood banking, Lab endocrinology and other similar discipline
Clinical Pathology
Function: organs/ tissues (acquired through surgery)
Anatomic Pathology
Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology, Molecular Pathology
Anatomic Pathology
2 types of Institutional Character
Institution-based
Freestanding
A laboratory that operates within the premises and is a part of an institution
Institution-based
Must operate under a clinical pathologist
Freestanding
A laboratory that does not form part of any other
Freestanding
Minimum space required in Primary
10 sq.m.
Minimum space required in Secondary
20 sq.m.
Minimum space required in Tertiary
60 sq.m.
- Routine Hematology
- Routine Urinalysis
- Routine Fecalysis
- Qualitative Platelet
- Blood typing (hospital-based)
PRIMARY
Freestanding cannot operate blood
typing (T or F)
T
- Routine Chemistry
- Quantitative Platelet
- Cross-matching; Gram staining; KOH (hospital-based)
SECONDARY
- Special Chemistry
- Special Hematology
- ImmunologySerology
- Microbiology
- Institution based
TERTIARY
monitors the spread of sexually transmitted disease
Social hygiene clinics
Provides highly specialized lab services not provided by a general clinical lab
Institution or Freestanding
Operates under the DOH
Special Clinical Labortories
A laboratory in a government hospital which is
designated to provide special functions and services
such as:
* Confirmatory testing
* Surveillance
* Resolution of conflicts
* Training and research
* Evaluation of kits and reagents
* External quality assessment program
National Reference Laboratory
NRLs: Hematology, Immunohematology, Automated
Urinalysis, Immunopathology
National Kidney and Transplant Institute
NRLs: Toxicology
*East Avenue Medical Center
Clinical Chemistry
*Lung Center of the Philippines:
- infections
*Tuberculosis ,Mycology, Transfusion-
transmissible infections, Bacterial Diseases,
Antimicrobial Resistance, Influenza, Malaria,
Measles and other exanthems, Rotavirus, Polio
*Research Institute for Tropical Medicine
confirmation of HIV/AIDS and other
sexually-transmitted infections
*San Lazaro Hospital/STD-AIDS Central Cooperative
Laboratory:
A testing site that performs laboratory
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
- Hematology
- Immuno-hematology (BB) - Blood Banking
- Immuno-serology
- Clinical Microscopy (Uri-Para) - Urinalysis
Parasitology - Clinical chemistry
- Microbiology (Bacteriology)
- Histo-pathology - Anatomic
- Molecular Biology Department - Covid-19