RA 4688 - CLINICAL LABORATORY ACT OF 1966 QUESTIONS ANSWERED CORRECTLY LATEST UPDATE
2026
What is RA 4688? - Answers Clinical Laboratory Act of 1966
What is the full title of RA 4688? - Answers 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.
Who must clinical laboratories seek permission from? - Answers Health Facilities and Services
Regulatory Bureau (HFSRB) through DOH
Who must head a clinical laboratory? - Answers A duly registered physician
What is the latest IRR under Clinical Lab? - Answers AO No. 37 s. 2021
What is a clinical laboratory? - Answers A facility involved in the pre-analytical, analytical, and post-
analytical phases where tests are performed on human specimens to obtain information for
prevention, diagnosis, and treatment of diseases.
What are the three phases involved in laboratory testing procedures? - Answers Pre-analytical phase,
Analytical phase, Post-analytical phase
Which government agency must approve and accredit a laboratory before it can operate? - Answers
Department of Health (DOH)
What bureau must permission be sought from to establish a clinical laboratory? - Answers Health
Facilities and Services Regulatory Bureau (HFSRB)
What Philippine law regulates the operation and maintenance of clinical laboratories? - Answers
Republic Act No. 4688
What section of RA 4688 mandates registration and licensing of laboratories? - Answers Section 1 -
Registration and Licensing
What section of RA 4688 requires that a laboratory must be headed by a duly registered physician? -
Answers Section 2
When was RA 4688 approved? - Answers June 18, 1966
What is the penalty of imprisonment under RA 4688 for violations? - Answers Not less than one (1)
month but not more than one (1) year
What is the monetary fine imposed under RA 4688 for violations? - Answers Not less than ₱1,000 but
not more than ₱5,000
Which government clinical laboratories are excluded from RA 4688 mandates? - Answers
Government clinical laboratories performing microscopy for specific DOH programs such as malaria
screening and AFB microscopy
Which national laboratory is spared from securing a license to operate under AO 2007-0027-A when
performing TB cultures? - Answers National Tuberculosis Reference Laboratory (NTRL)
What type of laboratories are exempted from RA 4688 mandates? - Answers Special laboratories
such as research labs, teaching labs, genetics labs, immunohematology labs, and molecular labs
What is the latest Administrative Order that serves as the Implementing Rules and Regulations (IRR)
for clinical laboratories? - Answers Administrative Order No. 37 s. 2021
What is the External Quality Assessment Program (EQAP)? - Answers A program where participating
clinical laboratories are given unknown samples for analysis and assessed based on closeness to
reference value.
What is the National External Quality Assessment Scheme (NEQAS)? - Answers An EQAP activity
conducted by National Reference Laboratories to assess laboratory performance and accuracy.
What is the highest level of laboratory performing highly complex procedures? - Answers National
Reference Laboratory (NRL)
What is a Physician's Office Laboratory (POL)? - Answers A doctor's office/clinic where laboratory
examinations are performed only for monitoring patients and no official results are issued.
What is Point of Care Testing (POCT)? - Answers Diagnostic testing done at or near the site of patient
care instead of inside the clinical laboratory.
What is a Satellite Clinical Laboratory (SCL)? - Answers An extension of the main clinical laboratory
located within the facility's compound with the same service capability.
What are Referral Tests? - Answers Clinical laboratory tests that are sent-out or outsourced to other
DOH-licensed laboratories with same or higher service capability.
What classification is given to clinical laboratories owned wholly or partially by national or local
government units? - Answers Government-Owned
2026
What is RA 4688? - Answers Clinical Laboratory Act of 1966
What is the full title of RA 4688? - Answers 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.
Who must clinical laboratories seek permission from? - Answers Health Facilities and Services
Regulatory Bureau (HFSRB) through DOH
Who must head a clinical laboratory? - Answers A duly registered physician
What is the latest IRR under Clinical Lab? - Answers AO No. 37 s. 2021
What is a clinical laboratory? - Answers A facility involved in the pre-analytical, analytical, and post-
analytical phases where tests are performed on human specimens to obtain information for
prevention, diagnosis, and treatment of diseases.
What are the three phases involved in laboratory testing procedures? - Answers Pre-analytical phase,
Analytical phase, Post-analytical phase
Which government agency must approve and accredit a laboratory before it can operate? - Answers
Department of Health (DOH)
What bureau must permission be sought from to establish a clinical laboratory? - Answers Health
Facilities and Services Regulatory Bureau (HFSRB)
What Philippine law regulates the operation and maintenance of clinical laboratories? - Answers
Republic Act No. 4688
What section of RA 4688 mandates registration and licensing of laboratories? - Answers Section 1 -
Registration and Licensing
What section of RA 4688 requires that a laboratory must be headed by a duly registered physician? -
Answers Section 2
When was RA 4688 approved? - Answers June 18, 1966
What is the penalty of imprisonment under RA 4688 for violations? - Answers Not less than one (1)
month but not more than one (1) year
What is the monetary fine imposed under RA 4688 for violations? - Answers Not less than ₱1,000 but
not more than ₱5,000
Which government clinical laboratories are excluded from RA 4688 mandates? - Answers
Government clinical laboratories performing microscopy for specific DOH programs such as malaria
screening and AFB microscopy
Which national laboratory is spared from securing a license to operate under AO 2007-0027-A when
performing TB cultures? - Answers National Tuberculosis Reference Laboratory (NTRL)
What type of laboratories are exempted from RA 4688 mandates? - Answers Special laboratories
such as research labs, teaching labs, genetics labs, immunohematology labs, and molecular labs
What is the latest Administrative Order that serves as the Implementing Rules and Regulations (IRR)
for clinical laboratories? - Answers Administrative Order No. 37 s. 2021
What is the External Quality Assessment Program (EQAP)? - Answers A program where participating
clinical laboratories are given unknown samples for analysis and assessed based on closeness to
reference value.
What is the National External Quality Assessment Scheme (NEQAS)? - Answers An EQAP activity
conducted by National Reference Laboratories to assess laboratory performance and accuracy.
What is the highest level of laboratory performing highly complex procedures? - Answers National
Reference Laboratory (NRL)
What is a Physician's Office Laboratory (POL)? - Answers A doctor's office/clinic where laboratory
examinations are performed only for monitoring patients and no official results are issued.
What is Point of Care Testing (POCT)? - Answers Diagnostic testing done at or near the site of patient
care instead of inside the clinical laboratory.
What is a Satellite Clinical Laboratory (SCL)? - Answers An extension of the main clinical laboratory
located within the facility's compound with the same service capability.
What are Referral Tests? - Answers Clinical laboratory tests that are sent-out or outsourced to other
DOH-licensed laboratories with same or higher service capability.
What classification is given to clinical laboratories owned wholly or partially by national or local
government units? - Answers Government-Owned
