Week 4: The Clinical Laboratory And Its Law Flashcards
Also known as Clinical Laboratory Act of 1966
REPUBLIC ACT NO. 4688
When was RA no.4688 created?
June 18, 1966
AN ACT REGULATING THE OPERATION AND
MAINTENANCE OF CLINICAL LABORATORIES AND REQUIRING THE REGUSTRATION OF THE SAME WITH THE DEPARTMENTS OF HEALTH, PROVIDING PENALTY AND VIOLATION THEREOF, AND FOR OTHER PURPOSES
REPUBLIC ACT NO. 4688/CLINICAL LABORATORY
ACT OF 1966
A type of classification of clinical laboratories based on the roles or image projected by the clients.
CLASSIFICATION BASED ON SERVICE CAPACITY
Working are for medical technologist
CLINICAL LABORATORY
Clinical laboratory practitioner
CLINICAL LABORATORY STAFF
One of the inherent qualities of a registered medical technologist who is working in a clinical laboratory
COMPENTENCY
An act regulating the operation and maintenance of clinical laboratories and requiring registration of the same with the Department of Health
REPUBLIC ACT NO. 4688
UNDER WHAT ADMINISTRATIVE ORDER NO. OF THE REVISED RULES AND REGULATIONS GOVERNING THE LICENSING AND REGULATION OF LABORATORIES IN THE PHILIPPINES, CAN CLINICAL LABORATORIES BE CLASSIFIED BASED ON?
ADMINISTRATIVE ORDER NO. 2007-0027
Give the 4 classification of clinical laboratories
- BASED ON OWNERSHIP
- BASED ON FUNCTION
- BASED ON INSTITUTIONAL CHARACTER
- BASED ON SERVICE CAPACITY
- Clinical laboratories may be considered GOVERNMENT-OWNED or PRIVATE.
- Government owned laboratories are those which are maintained, partially or wholly, by either the national or local government.
- Private laboratories are established, operated, and maintained by individual, corporation, or association without any affinity with the government.
BASED ON OWNERSHIP
2 types of Laboratory Based on Function
CLINICAL PATHOLOGY FUNCTION and ANATOMIC PATHOLOGY FUNCTION
clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetic, toxicology, and therapeutic drug monitoring.
CLINICAL PATHOLOGY FUNCTION
surgical, immunology, histopathologic cytologic, autopsy procedure, forensic, and molecular pathologic techniques
ANATOMIC PATHOLOGY FUNCTION
Institute based clinical laboratory and Free-standing laboratory
BASED ON INSTITUTIONAL CHARACTER
This clinical laboratory operates within the premises and as part of institution such as hospital, clinic, school, or medical facility. E.g. Department of Pathology of the National Kidney and Transplant Institute.
Institute based clinical laboratory
Has no affinity with any other institution. For instances, the Hi-Precision Diagnostic laboratory is considered free-standing
Free-standing laboratory
Primary, Secondary, Tertiary and Limited-service capability
BASED ON SERVICE CAPABILITY
– provides the following minimum service capabilities:
I. Routine Hematology: CBC
II. Qualitative Platelet Determination
III. Routine Urinalysis, Fecalysis
IV. Blood typing – Hospital-based
Primary Category
- provides the following minimum service
capabilities of primary lab + the ff:
I. Routine Clinical Chemistry
II. Quantitative Platelet Determination
III. Cross matching, Gram Staining, KOH - Hospital-based
Secondary Category
provides the following minimum service capabilities of secondary lab + the ff:
I. Special chemistry
II. Special hematology, including coagulation procedures
III. Immunology
IV. Microbiology – culture and sensitivity
● Aerobic and Anaerobic – hospital-based
● Aerobic or Anaerobic – non-hospital-based
Tertiary Category
provides lab test required for a particular service in institutions such as but not limited to, dialysis center & hygiene clinics
Limited-service capability (institution-based)
A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory.
BASED ON SERVICE CAPABILITY (SPECIALIZED CLINICAL LABORATORY)
- Handle organisms that are unlikely to cause human diseases.
- Personnel are expected to wear the standard PPE such as mask, gloves, and laboratory gown.
Biosafety level 1
