CLIN LAB LAW

Question 1

CLINICAL LABORATORY LAW

Answer 1

RA 4688

Question 2

Current AO that we are using.

Answer 2

ADMINISTRATIVE ORDER 2021-0037

Question 3

Date of Approval:

Answer 3

JUNE 18, 1966

Question 4

All laboratories should be licensed and regulated by the____ (except______ laboratories doing minimum lab exams).

Answer 4

DOH

government

Question 5

________ should be in-charge of the laboratories.

Answer 5

Licensed Physicians

Question 6

_________is the one in-charge with the implementation of this act and to issue rules and regulations

Answer 6

DOH-BRL

Question 7

Punishment for violators

Answer 7

(1 month - 1 year imprisonment // 1,000 - 5,000 pesos fine)

Question 8

Php______ from National Treasury are appropriated to carry out this act

Answer 8

50,000

Question 9

New Rules and Regulation governing the regulation of Clinical Laboratories in the Philippines

Answer 9

ADMINISTRATIVE ORDER 2021-0037

Question 10

a facility that is involved in the pre-analytical, analytical, and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases.

Answer 10

CLINICAL LABORATORY

Question 11

RA 4688 also known as

Answer 11

Clinical Laboratory Law of 1966

Question 12

services play an important roles in diagnosis, treatment, prevention, and control of disease

Answer 12

Clinical Laboratory

Question 13

CLs must generate (3) results.

Answer 13

accurate, precise, and reliable

Question 14

Revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines.

Answer 14

AO 2007-0027

Question 15

This is a laboratory law prior to RA 4688 and is ALREADY AMENDED.

Answer 15

AO 2007-0027

Question 16

(HFSRB)

Answer 16

HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Question 17

Set standards for the regulation of clinical laboratories.

Strictly enforce the provisions of this Order.

Answer 17

HFSRB

Question 18

Disseminate regulatory policies, standards and forms.

Respond promptly to complaints.

Answer 18

HFSRB

Question 19

(CHD-RLED)

Answer 19

CENTER FOR HEALTH DEVELOPMENT - REGULATORY LICENSING, AND ENFORCEMENT DIVISION

Question 20

Strictly enforce the provision of this Order.

Submit quarterly report on Suspension/Revocation/Cease and Desist Order issued on CL.

Respond promptly to complaints.

Answer 20

CENTER FOR HEALTH DEVELOPMENT - REGULATORY LICENSING, AND ENFORCEMENT DIVISION (CHD-RLED)

Question 21

(NRL)

Answer 21

NATIONAL REFERENCE LABORATORY

Question 22

Provide laboratory reference/referral services for confirmatory testing.

Train laboratory personnel and recognize other training institutions.

Answer 22

NATIONAL REFERENCE LABORATORY (NRL)

Question 23

Perform technical evaluation of reagents and diagnostic kits.

Answer 23

NATIONAL REFERENCE LABORATORY (NRL)

Question 24

Maintain the National External Quality Assessment Scheme (NEQAS).

Answer 24

NATIONAL REFERENCE LABORATORY (NRL)

Question 25

are the ones creating the NEQAS.

Answer 25

NRL

Question 26

An external quality assessment program (EQAP) activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories

Answer 26

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEMES (NEQAS)

Question 27

Participating CLs are given unknown samples for analysis. Quality of performance shall be assessed through the closeness of results to the predetermined value or reference value generated by the participating CL through peer group analysis

Answer 27

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEMES (NEQAS)

Question 28

(DOH-LTO)

Answer 28

DEPARTMENT OF HEALTH - LICENSE TO OPERATE

Question 29

A formal authorization issued by 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 29

DEPARTMENT OF HEALTH - LICENSE TO OPERATE

Question 30

A permit issued by DOH through HFSRB or 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.

Answer 30

DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT

Question 31

required for substantial alteration, expansion, renovation, increase in the number of beds, transfer of site, or for additional services (add-ons) beyond their service capability

Answer 31

DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT

Question 32

Prerequisite for LTO.

Answer 32

DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT

Question 33

A laboratory testing unit capable of performing limited CL diagnostic procedure and collection of specimens

Answer 33

MOBILE CLINICAL LABORATORY

Question 34

MCL Diagnostic procedure are:

Answer 34

Urinalysis Fecalysis Pregnancy test Basic Serologic rapid tests

Question 35

Moves from one testing site to another (needs MOA). Within the same region, at a maximum of (____) kilometers radius, from the address of the DOH-Licensed CL

Answer 35

100km MOBILE CLINICAL LABORATORY

Question 36

MCL Has a DOH-Licensed____ as its main laboratory.

Answer 36

CL

Question 37

An extension of the main CL located within the facility’s compound or premises. Shall have the same service capability as the main laboratory.

Answer 37

SATELLITE CLINICAL LABORATORY

Question 38

Doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only.

Answer 38

PHYSICIAN’S OFFICE LABORATORY

Question 39

NO official results shall be issued. POL within the premises of a DOH-regulated facility shall be under the supervision of the CL.

Answer 39

PHYSICIAN’S OFFICE LABORATORY

Question 40

Diagnostic testing done at or near the site of patient care rather than the CL.

Answer 40

POINT OF CARE TESTING

Question 41

May be in the emergency room, operating suites, wards and ambulances. Does not need to secure a license from RLED or BHFS.

Answer 41

POINT OF CARE TESTING

Question 42

CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability (needs_____)

Answer 42

REFERRAL TESTS MOA

Question 43

All CL shall secure______ prior to operation.

Answer 43

DOH-LTO

Question 44

CLs for teaching and research: Register with_____

Answer 44

HFSRB

Question 45

NRLs : license is part of the hospital where it is affiliated : secure LTO from HFSRB

Answer 45

Institution-based Independent

Question 46

All laboratory prices must be accessible (as mandated by the_______)

Answer 46

Universal Health Care Law

Question 47

XI. CLASSIFICATION OF CLINICAL LABORATORIES FISO

Answer 47

Function Institutional character Service capability Ownership

Question 48

Ownership

Answer 48

Government Private

Question 49

Institutional Character

Answer 49

Institution-based (attached to hospitals, schools, etc.) Non-institution based (independent, e.g Lab ng Bayan)

Question 50

Function

Answer 50

Clinical Pathology Anatomic Pathology Molecular Pathology

Question 51

Service Capability

Answer 51

Primary Secondary Tertiary Special

Question 52

XIV. SANCTIONS 1st violation: 2nd violation: 3rd violation: 4th violation:

Answer 52

written warning Php 30, 000 fine Php 50, 000 fine Suspension or revocation of LTO

Question 53

PROCEDURAL GUIDELINES • On-site assessment If not fully compliant, lab must comply with the deficiencies within____ days (if not, application will be denied) • If fully compliant, LTO will be issued.

Answer 53

License to Operate 30

Question 54

______ or _______ must be notified in writing in cases of change in management name, ownership, headship or lab personnel Failure to notify within____ days shall be a bias for suspension/revocation of license.

Answer 54

HFSRB or CHD-RLED 15

Question 55

Different branches of a clinical laboratory even if owned by the same entity shall secure separate____

Answer 55

LTOs

Question 56

LTO must be placed in an area readily seen by the public Validity:

Answer 56

1 year

Question 57

Certificate of Registration (COR) is required for research and teaching laboratories Renewed every____

Answer 57

3 years

Question 58

Any person who operated a CL w/o DOH-PTC and DOH-LTO shall be issued a______ and shall pay the administrative penalty of _______

Answer 58

Cease-and-Desist Order (CDO) Fifty thousand pesos (Php 50, 000)

Question 59

Due process during investigation:____ days preventive suspension may be given to the CL

Answer 59

60

Question 60

Appeal: File a notice of appeal to the Head of the _______ within 10 days after receipt of the decision ___ Head's decision is appealable to the________ whose decision shall be final and executor

Answer 60

Health Regulation Team (HRT) DOH Secretary

Question 61

CL with revoked licenses can only re-apply after_______ from the date of LTO revocation

Answer 61

one year

Question 62

NRLs in QC

Answer 62

• Lung Center of the Philippines (QC) • East Avenue Medical Center (QC) • National Kidney and Transplant Institute (QC) • Philippine Heart Center (QC)

Question 63

NRL in muntinlupa

Answer 63

Research Institute for Tropical Medicine (Muntinlupa)

Question 64

NRL in Manila

Answer 64

San Lazaro Hospital/ STD AIDS Central Cooperative Laboratory

Question 65

Clinical Laboratory for Anatomic Pathology only Provides services for any of the following, but not limited to:

Answer 65

cytology histopathology

Question 66

Clinical Laboratory for Molecular Pathology only Provides services for (3)

Answer 66

genetics immuno/hematopathology infectious disease COVID-19 testing laboratories shall be covered by another Order.