Clinical Lab Law RA.4688

Question 1

The central governmental agency authorized to regulate the operation and maintenance of lab

Answer 1

DOH

Question 2

Formulate rules and regulations

Answer 2

The secretary of DOH through the director of BRL

Bureau of Research and Laboratory

Question 3

The 1st implementing rules and regulation

Answer 3

AO 201 s. 1973

Question 4

Redirecting the Functions & Operations of the DOH

Answer 4

EO 102 s. 1999

Question 5

Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

Answer 5

AO 59 s. 2001

Question 6

Revised Rules & Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

Answer 6

AO 27 s. 2007

Question 7

I. Rationale
The registration operation and maintenance of Clin. Lab. In the Phils.
Preventing substandard, Improperly managed and poorly equipped clinical laboratories

Answer 7

AO No. 0027 s. 2007

Question 8

Objective

Promulgated to prescribe a revised minimum standard for clinical laboratories

Answer 8

AO No. 0027 s. 2007

Question 9

III. Scope & Coverage
Applies to all entities performing the activities and functions of clinical labs

Excludes government laboratories doing laboratory examinations limited to AFB microscopy, malaria screening and cervical cancer screening; declared as extension of a licensed government clinical lab

Answer 9

AO No. 0027 s. 2007

Question 10

who intends to operate a clinical lab

Answer 10

Applicant

Question 11

BHFS

Answer 11

Bureau of Health Facilities & Services

Question 12

CHD

Answer 12

Center for Health Development

Question 13

panic values that needs for some corrective action

Answer 13

Critical values

Question 14

EQAP

Answer 14

External Quality Assurance Program

Question 15

checklist used by regulatory officer

Answer 15

Inspection Tool

Question 16

any corporate body organized for educational, medical, charitable or similar purpose

Answer 16

Institution

Question 17

document issued by DOH to applicant upon compliance

Answer 17

License

Question 18

whom the license is issued

Answer 18

Licensee

Question 19

moves from testing site but affiliated with base lab

Answer 19

Mobile Clinical Laboratory

Question 20

series of tests on patients

Answer 20

Monitoring Examinations

Question 21

gov’t hospital lab designated by DOH and may or may not be a part of general clinical lab

Answer 21

National Reference Laboratory

Question 22

Dengue, Influenza, TB and Malaria

NRL for confirmatory testing of blood units.

Answer 22

RITM Research Institute for Tropical Medicine

Question 23

HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls).

Answer 23

SLH San Lazaro Hospital

Question 24

Toxicology and Micronutrient Assay

Answer 24

East Avenue Medical Center

Question 25

Hematology / Immunohematology

Answer 25

NKTI National Kidney and Transplant Institute

Question 26

Biochemistry

Answer 26

Lung Center of the Philippines

Question 27

POL

Answer 27

Physician Office Laboratory

Question 28

POCT

Answer 28

Point of Care Testing (at or near the site of the patient)

Question 29

basic, commonly requested tests

Answer 29

Routine Test

Question 30

– any testing site that performs lab exams outside the physical confines of the base lab

Answer 30

Satellite Testing Site

Question 31

– urgent tests and to be released within one hour after procedure

Answer 31

STAT Tests

Question 32

3 Classification of Laboratories

Answer 32

Classification by Ownership Classification by Function Classification by Institutional Character

Question 33

CC, Hema, Micro-Para, Mycology, CM

Answer 33

Clinical Pathology

Question 34

Includes surgical pathology, histochemistry, immunopathology, cytology and post-mortem examinations

Answer 34

Anatomic Pathology

Question 35

Includes all medico-legal examinations

Answer 35

Forensic Pathology

Question 36

Classification by Service Capability ``` Routine hematology (CBC) – Hb, Hct, WBC & Differential count Qualitative platelet determination Routine urinalysis Routine fecalysis Blood typing ```

Answer 36

1. General Clinical Laboratory | Primary

Question 37

``` primary lab services + Routine clinical chemistry – includes blood glucose, BUN, BUA, Crea & total cholesterol Quantitative platelet determination Cross matching Gram staining KOH ```

Answer 37

Secondary

Question 38

``` secondary lab services + special chemistry special hematology immunology/serology Microbiology (C/S) ```

Answer 38

Tertiary

Question 39

– i.e. dialysis centers & social hygiene clinics Note: Labs can be permitted to offer other lab services provided they comply with reqt’s with respect to, staff, equipment, reagents and supplies and listed under its LTO

Answer 39

Limited Service Capability (for institution based only)

Question 40

``` offers highly specialized laboratory services that are usually not provided by a general clinical laboratory Assisted Reproduction Technology Labs Molecular and Cellular Technology Molecular Biology Molecular Pathology Forensic Pathology Anatomic Pathology ```

Answer 40

. Special Clinical Laboratory

Question 41

exempted but needs to be registered w/ BHFS

Answer 41

Clinical labs operated and maintained for research and teaching purposes

Question 42

are required to register w/ BHFS w/o being licensed (if not subject to other AO)

Answer 42

. Special clinical labs

Question 43

designated by DOH shall be covered by license of the clinical lab of the hospital

Answer 43

NRL- (??)

Question 44

– required of license if doing any or all of the ff: Issue official lab results Perform more than monitoring exams Cater not only to physician’s own patients

Answer 44

POL

Question 45

LTO | CHD

Answer 45

License to Operate | Center for Health Development

Question 46

Non-infectious dry waste

Answer 46

black

Question 47

Non-infectious wet waste

Answer 47

green

Question 48

Infectious and pathological waste

Answer 48

yellow

Question 49

chemical waste with heavy metals

Answer 49

yellow w/ black band

Question 50

radioactive waste

Answer 50

orange

Question 51

Pressurized containers and sharps

Answer 51

red

Question 52

Work space reqt’s 1º 2º 3º

Answer 52

10 m2 20 m2 60 m2

Question 53

Managed by licensed Physician certified by the Philippine Board of Pathology

Answer 53

Staffing

Question 54

“Any clinical laboratory weather attached or unattached to a hospital or clinic performing not more than 800 examinations a month should have atleast one medical technologist For every other additional 800 or fraction thereof, another medical technologist should be hired”

Answer 54

A.O. no 290 S. 1976 – Moraleta p. 64