CLINICAL LABORATORY LAWS AND LABORATORY MANAGEMENT

Question 1

Clinical Laboratory Law

Answer 1

REPUBLIC ACT 4688

Question 2

Rules and Regulations Governing the Establishment, Operation, and Maintenance of CL in the Philippines

Answer 2

ADMINISTRATIVE ORDER #59 S. 2001

Question 3

Revised Rules and Regulations Governing the Licensure and Regulation of CL in the Philippines

Answer 3

ADMINISTRATIVE ORDER #27 S. 2007

Question 4

New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

Answer 4

ADMINISTRATIVE ORDER #37 S. 2021

Question 5

deals with the chemical and cellular analyses of blood and other body fluids

o Chemistry, Microscopy, Microbiology, ISBB

Answer 5

Clinical Pathology

Question 6

provides processing and examination of surgical specimens

o Surgical pathology, Cytopathology, Immunohistochemical techniques, Autopsy, Forensic pathology

Answer 6

Anatomical Pathology

Question 7

analysis of genes, SPECIFIC proteins, and other molecules based on principles, techniques, and tools of molecular biology (AO 37)

Answer 7

Molecular Pathology

Question 8

Hospital Based (revised by newer AO as)

Answer 8

institution-Based

Question 9

Non-hospital Based (revised by newer AO as)

Answer 9

Free-Standing / independent lab

Question 10

UA, FA, FOBT, PT (rapid test kits – lateral flow), Wet smear for trichomonas

Answer 10

Clinical Microscopy
Primary (Minimum service capability)

Question 11

FBS & RBS, OGTT, LP (TC, HDL, LDL, TG), BUN/CREA, BUA,

Answer 11

Clinical Chemistry
Primary (Minimum service capability)

Question 12

SERUM ELEC (Na,K,Cl), ALT, AST

Answer 12

Clinical Chemistry
Secondary (+) Primary

Question 13

Other CC examinations, Hospital based: ABG

Answer 13

Clinical Chemistry
Tertiary-Secondary (+)

Question 14

CBC (Hgb, Hct, RBC, WBC w/ diff count, Quanti Plt count), forward and reverse ABO grouping, Rh typing (tube method)

Answer 14

Hematology
Primary (Minimum service capability)

Question 15

For hospital based: coagulation studies (PT/PTT)

Answer 15

Hematology
Secondary (+) Primary

Question 16

Dengue, Syph, HepB & HIV screening (using rapid test kits)

Answer 16

Serology/ Immunology
Primary (Minimum service capability)

Question 17

Any machine based serological and immunological
testing such as, but not limited to:
Tumor markers,
Thyroid function test, & Hepatitisprofile

Answer 17

Serology/ Immunology
Tertiary-Secondary (+)

Question 18

TB (DSSM) or Nucleic Acid Amplification Test – for government facilities

Answer 18

Microbiology
Primary (Minimum service capability)

Question 19

Gram stain, KOH

Answer 19

Microbiology
Secondary (+) Primary

Question 20

Culture and sensitivity (aerobic and anaerobic)

Answer 20

Microbiology
Tertiary-Secondary (+)

Question 21

PAP smear

Answer 21

Anatomic Pathology
Secondary (+) Primary

Question 22

For hospital based: Histopathology and cytology

Answer 22

Anatomic Pathology
Tertiary-Secondary (+)

Question 23

Provides 1 or 2 specialized tests that are not classified under Anatomic or Molecular Pathology as exemplified below:
Hormones
Trace Metals
Tumor Markers
Allergy Panel

This classification shall also apply to facilities offering DOH
program related tests, e.g.,
Kato Katz for
Schistosomiasis
Malarial smear
Filarial smear
Slit-skin smear

Answer 23

Clinical Microscopy
Clinical Chemistry
Hematology
Serology/Immunology
Microbiology
Anatomic Pathology