MT Laws - RA 4688 (2)

RA 4688

Clinical lab act of 1966 6/18/66

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'

1' laboratory

Routine hematology: Hgb

2' laboratory

1' lab plus the ff: Quantitative platelet Cross-matching Gram stain/KOH Routine chemistry: Glucose

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 licence 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

Specific requirements (Lab)

1. Human resource

• Head: Pathologist

• Staff: RMTs

2. Equipment

3. Reagent & supplies

4. Physical plan:

• Well-lighted

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