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MT Laws > CLIN LAB LAW > Flashcards

CLIN LAB LAW Flashcards

1
Q

CLINICAL LABORATORY LAW

A

RA 4688

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2
Q

Current AO that we are using.

A

ADMINISTRATIVE ORDER 2021-0037

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3
Q

Date of Approval:

A

JUNE 18, 1966

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4
Q

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

A

DOH

government

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5
Q

________ should be in-charge of the laboratories.

A

Licensed Physicians

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6
Q

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

A

DOH-BRL

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7
Q

Punishment for violators

A

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

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8
Q

Php______ from National Treasury are appropriated to carry out this act

A

50,000

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9
Q

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

A

ADMINISTRATIVE ORDER 2021-0037

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10
Q

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.

A

CLINICAL LABORATORY

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11
Q

RA 4688 also known as

A

Clinical Laboratory Law of 1966

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12
Q

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

A

Clinical Laboratory

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13
Q

CLs must generate (3) results.

A

accurate, precise, and reliable

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14
Q

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

A

AO 2007-0027

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15
Q

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

A

AO 2007-0027

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16
Q

(HFSRB)

A

HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

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17
Q

Set standards for the regulation of clinical laboratories.

Strictly enforce the provisions of this Order.

A

HFSRB

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18
Q

Disseminate regulatory policies, standards and forms.

Respond promptly to complaints.

A

HFSRB

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19
Q

(CHD-RLED)

A

CENTER FOR HEALTH DEVELOPMENT - REGULATORY LICENSING, AND ENFORCEMENT DIVISION

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20
Q

Strictly enforce the provision of this Order.

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

Respond promptly to complaints.

A

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

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21
Q

(NRL)

A

NATIONAL REFERENCE LABORATORY

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22
Q

Provide laboratory reference/referral services for confirmatory testing.

Train laboratory personnel and recognize other training institutions.

A

NATIONAL REFERENCE LABORATORY (NRL)

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23
Q

Perform technical evaluation of reagents and diagnostic kits.

A

NATIONAL REFERENCE LABORATORY (NRL)

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24
Q

Maintain the National External Quality Assessment Scheme (NEQAS).

A

NATIONAL REFERENCE LABORATORY (NRL)

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25
Q

are the ones creating the NEQAS.

A

NRL

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26
Q

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

A

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEMES (NEQAS)

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27
Q

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

A

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEMES (NEQAS)

28
Q

(DOH-LTO)

A

DEPARTMENT OF HEALTH - LICENSE TO OPERATE

29
Q

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.

A

DEPARTMENT OF HEALTH - LICENSE TO OPERATE

30
Q

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.

A

DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT

31
Q

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

A

DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT

32
Q

Prerequisite for LTO.

A

DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT

33
Q

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

A

MOBILE CLINICAL LABORATORY

34
Q

MCL Diagnostic procedure are:

A

Urinalysis
Fecalysis
Pregnancy test
Basic Serologic rapid tests

35
Q

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

A

100km

MOBILE CLINICAL LABORATORY

36
Q

MCL

Has a DOH-Licensed____ as its main laboratory.

A

CL

37
Q

An extension of the main CL located within the facility’s compound or premises.

Shall have the same service capability as the main laboratory.

A

SATELLITE CLINICAL LABORATORY

38
Q

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

A

PHYSICIAN’S OFFICE LABORATORY

39
Q

NO official results shall be issued.

POL within the premises of a DOH-regulated facility shall be under the supervision of the CL.

A

PHYSICIAN’S OFFICE LABORATORY

40
Q

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

A

POINT OF CARE TESTING

41
Q

May be in the emergency room, operating suites, wards and ambulances.

Does not need to secure a license from RLED or BHFS.

A

POINT OF CARE TESTING

42
Q

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

A

REFERRAL TESTS

MOA

43
Q

All CL shall secure______ prior to operation.

A

DOH-LTO

44
Q

CLs for teaching and research: Register with_____

A

HFSRB

45
Q

NRLs
: license is part of the hospital where it is affiliated

: secure LTO from HFSRB

A

Institution-based

Independent

46
Q

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

A

Universal Health Care Law

47
Q

XI. CLASSIFICATION OF CLINICAL LABORATORIES

FISO

A

Function
Institutional character
Service capability
Ownership

48
Q

Ownership

A

Government
Private

49
Q

Institutional Character

A

Institution-based
(attached to hospitals, schools, etc.)

Non-institution based
(independent, e.g Lab ng Bayan)

50
Q

Function

A

Clinical Pathology
Anatomic Pathology
Molecular Pathology

51
Q

Service Capability

A

Primary
Secondary
Tertiary
Special

52
Q

XIV. SANCTIONS

1st violation:
2nd violation:
3rd violation:
4th violation:

A

written warning

Php 30, 000 fine

Php 50, 000 fine

Suspension or revocation of LTO

53
Q

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.

A

License to Operate

30

54
Q

______ 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.

A

HFSRB or CHD-RLED

15

55
Q

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

A

LTOs

56
Q

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

Validity:

A

1 year

57
Q

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

Renewed every____

A

3 years

58
Q

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

A

Cease-and-Desist Order (CDO)

Fifty thousand pesos (Php 50, 000)

59
Q

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

A

60

60
Q

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

A

Health Regulation Team (HRT)

DOH Secretary

61
Q

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

A

one year

62
Q

NRLs in QC

A

• Lung Center of the Philippines (QC)

• East Avenue Medical Center (QC)

• National Kidney and Transplant Institute (QC)

• Philippine Heart Center (QC)

63
Q

NRL in muntinlupa

A

Research Institute for Tropical Medicine (Muntinlupa)

64
Q

NRL in Manila

A

San Lazaro Hospital/ STD AIDS Central Cooperative Laboratory

65
Q

Clinical Laboratory for Anatomic Pathology only

Provides services for any of the following, but not limited to:

A

cytology
histopathology

66
Q

Clinical Laboratory for Molecular Pathology only

Provides services for (3)

A

genetics
immuno/hematopathology
infectious disease

COVID-19 testing laboratories shall be covered by another Order.

MT Laws (28 decks)

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