AO 2021 0037

Question 1

— refers to any natural juridical person, government
instrumentalities/agencies, partnership, corporation or agency seeking a license to
operate and maintain a clinical laboratory

Answer 1

Applicant

Question 2

— the checklist which prescribes the minimum standards and
requirements for licensure of a clinical laboratory

Answer 2

Assessment Tool

Question 3

— a formal authorization issued
by the DOH to an individual, partnership, corporation, association or any government
agency/unit seeking to perform laboratory tests in compliance with the requirements
prescribed in this Order.

Answer 3

Department of Health - License to Operate (DOH-LTO)

Question 4

— a permit issued by DOH
through HFSRB or Center for Health Development-Regulation, Licensing and
Enforcement Division (CHD-RLED) to an applicant who will establish and operate a
hospital or other health facility, upon compliance with required documents prior to the
actual construction of the said facility. It is also required for hospitals and
other health facilities with substantial alteration, expansion, renovation, increase in the
number of beds, transfer ofsite, or for additional services (add-ons) beyond their service
capability. It is a prerequisite for License to Operate.

Answer 4

Department of Health - Permit to Construct (DOH-PTC)

Question 5

a program where participating CL are
given unknown samples for analysis. These samples should be treated as ordinary
human specimens for the usual processing and examination. The quality of performance
of the CL shall be assessed through the closeness of its results to the pre-determined
value or reference value generated by the participating CL through peer group analysis.

Answer 5

External Quality Assessment Program (EQAP)

Question 6

a laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another,and it has a
DOH-licensed CL asits main laboratory.

Answer 6

Mobile Clinical Laboratory (MCL)

Question 7

4 Classification of Clinical Laboratories

Answer 7

1. Classification by Ownership
2. Classification by Institutional Character
3. Classification by Function
4. Classification by Service Capability

Question 8

Classification of Clinical Laboratories
1. Classification by Ownership
(2)

Answer 8

Government
Private

Question 9

Classification of Clinical Laboratories

Classification by Institutional Character
(2)

Answer 9

a. Institution-based
b. Non-institution based

Question 10

Classification of Clinical Laboratories

3 Classification by Function

Answer 10

a. Clinical Pathology
b. Anatomic Pathology
¢. Molecular Pathology

Question 11

PROCEDURAL GUIDELINES

Answer 11

A. Permit to Construct (PTC)
B. License to Operate (LTO)
C. Certificate of Registration (COR)
D. Validity
E. Fees
F. Monitoring

Question 12

PERSONNEL

Answer 12

A. Head of the Laboratory (HOL)
B. Registered Medical Technologist (RMT)
C. Support Staff
D. POCT Coordinator
E. POCT Operator
F. MCL Personnel

Question 13

5 section in clinical laboratory

Answer 13

Clinical Chemistry
Clinical Microbiology
Hematology
Blood banking
Clinical Microscopy
Histopathology
•Immunology/Serology