RA 4688

CLINICAL LAB
ACT OF 1966

RA 4688

6/18/66

Clinical lab
act of 1966
 AO 2007-0027
Revised rules & regulations governing
the registration and licensing of
clinical lab in the Philippines
8/22/07
Authority: BHFS
Scope: All clinical lab in the
Philippines except governing lab
performing microscopy works for
DOH
a. AFB screening
b. Malarial smear
c. Screening for STDs & cervical
cancer (Pap‟s)
 CLASSIFICATION OF
LABORATORIES
1. OWNERSHIP
A. GOVERNMENT
B. PRIVATE

2. FUNCTION
A. CLINICAL PATHOLOGY
B. ANATOMICAL PATHOLOGY

3. INSTITUTIONAL CHARACTER
A. INSTITUTION-BASED
B. FREE-STANDING

4. SERVICE CAPABILITY
- GENERAL CLINICAL LAB = 1‟,
2‟, 3‟, LIMITED SERVICE
CAPABILITY LAB
- - SPECIAL LAB
 1‟ LABORATORY

ROUTINE HEMATOLOGY: HGB, HCT, WBC, WBC

DIFFERENTIAL
ROUTINE UA & FA
QUALITATIVE PLATELET
BLOOD TYPING (HOSPITAL-BASED)
 2‟ LABORATORY

1‟ LAB PLUS THE FF:

QUANTITATIVE PLATELET CROSS-MATCHING
GRAM STAIN/KOH ROUTINE CHEMISTRY:
GLUCOSE, UREA, URIC ACID, CHOLESTEROL
3‟ LABORATORY
2‟ LAB PLUS THE FF:
SPECIAL CHEMISTRY
SPECIAL HEMATOLOGY:
COAGULATION STUDIES
IMMUNOLOGY AND
SEROLOGY CULTURE AND
SENSITIVITY
 LIMITED
SERVICE
CAPABILITY LAB
EXAMPLES: LAB IN DIALYSIS
CENTER SOCIAL HYGIENE LAB
CLINIC
 SPECIAL LAB
MOLECULAR BIOLOGY
ASSISTED REPRODUCTIVE TECHNOLOGY
 STAT
“STATIM” IMMEDIATELY W/IN 1 HR
 GENERAL REQUIREMENTS
(LAB)
1. LTO FROM BHFS

2. TEACHING/RESEARCH LAB = EXEMPTED BUT MUST

REGISTER

3. SPECIAL LAB = MUST REGISTER

4. POL: PHYSICIAN OFFICE LAB = SECURE LICENSE IF

- ISSUE OFFICIAL RECEIPT
- CATER TO OTHER PATIENTS
- PERFORM TESTS OTHER THAN MONITORING

5. POCT = DIAGNOSTIC TESTS DONE AT OR NEAR

PATIENT CARE
- BEDSIDE TESTING
- SUPERVISED & MANAGED BY LICENSED LAB
 1. HUMAN RESOURCE
- HEAD: PATHOLOGIST
- STAFF: RMTS
2. EQUIPMENT
3. REAGENT & SUPPLIES
4. PHYSICAL PLAN: - WELL-LIGHTED,
SPECIFIC
WELL-VENTILATED, SUPPLY OF H2O
A. 1‟ LAB = 10 M2 REQUIREME
B. 2‟ LAB = 20 M2
C. 3‟ LAB = 60 M2
5. ADMINISTRATIVE POLICIES
NTS (LAB)
6. TECHNICAL PROCEDURES
7. QA (PRE/ANALYTICAL/POST) & QC
(ANALYTICAL)
 MOBILE LAB
COLLECT SPECIMENS ALLOWED TO
OPERATE W/IN 100 KM RADIUS FROM
MAIN LAB
 LICENSE (LAB)
LICENSE NO.
VALIDITY
NAME OF LAB
OWNER
HEAD
LOCATION
SERVICE CAPABILITY
 RENEWAL OF
LICENSE
NONHOSPITAL-BASED LAB:
OCTOBER-NOVEMBER PROCESSED
NOT LATER THAN 5 DAYS AFTER
EXPIRATION
VIOLATION
FINE OF P1,000-5,000
IMPRISONMENT FOR NOT LESS
THAN 1 MONTH