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Medical Technology Laws and Bioethics > RA 4688: Clinical Laboratory Law > Flashcards

RA 4688: Clinical Laboratory Law Flashcards

1
Q

An act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the Department of Health, providing penalty for the violation thereof, and for other purposes.

A

RA 4688

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2
Q

When was RA 4688 approved?

A

June 18, 1966

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3
Q

RA 4688 was signed by ________.

A

Pres. Ferdinand E. Marcos

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4
Q

Administrative and Executive Orders issued in relation to RA 4688

Revised Rules and Regulations Governing the Registration, Operations and Maintenance of Clinical Laboratories in the Philippines

A
  • AO 201 s. 1973
  • AO 49-B s. 1988
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5
Q

Administrative and Executive Orders issued in relation to RA 4688

Amending Section II Subsection A of Administrative Order No. 201, Series of 1973 Concerning Requirements for a Clinical Laboratory

A

AO 290 s. 1976

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6
Q

Administrative and Executive Orders issued in relation to RA 4688

Redirecting the Functions and Operations of the DOH

A

EO 102 s. 1999

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7
Q

Administrative and Executive Orders issued in relation to RA 4688

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

A

AO 59 s. 2001

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8
Q

Administrative and Executive Orders issued in relation to RA 4688

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

A

AO 27 s. 2007

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9
Q

Administrative and Executive Orders issued in relation to RA 4688

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

A

AO no. 2021-0037

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10
Q

Who signed AO 2021-0037?

A

Francisco Duque

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11
Q

DOH-LTO

A

Department of Health - License to Operate

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12
Q

DOH-PTC

A

Department of Health - Permit to Construct

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13
Q

HFSRB

A

Health Facilities and Services and Regulatory Bureau

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14
Q

CHD-RLED

A

Center for Health Development - Regulation, Licensing, and Enforcement Division

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15
Q

OLRS

A

Online Licensing and Regulatory System

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16
Q

OSSOLS

A

One-Stop Shop Online Licensing System

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17
Q

A facility that is involved in the preanalytical, 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

18
Q

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

A

Applicant

19
Q

The checklist which prescribes the minimum standards and requirements for licensure of clinical laboratory.

A

Assessment Tool

20
Q

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.

A

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

21
Q

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.

A

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

22
Q

A program where participating CL are given unknown samples for analysis.

A

External Quality Assessment Program (EQAP)

23
Q

Refer to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovations.

A

Initial Application

24
Q

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 as its main laboratory.

A

Mobile Clinical Laboratory (MCL)

25
Q

An 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 Scheme (NEQAS)

26
Q

The highest level of laboratory in the country performing highly complex procedures, including confirmatory testing. It is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines.

A

National Reference Laboratory (NRL)

27
Q

NRL for Dengue, Influenza, Tuberculosis and other Mycobacteria,
Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases; NRL for confirmatory testing of blood donors and blood units.

A

Research Institute for Tropical Medicine (RITM)

28
Q

NRL for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases

A

San Lazaro Hospital (SACCL)

29
Q

NRL for Environmental and Occupational Health; Toxicology and Micronutrient Assay.

A

East Avenue Medical Center

30
Q

NRL for Hematology including Immunohematology and Immunopathology and Anatomic Pathology

A

National Kidney and Transplant Institute

31
Q

NRL Anatomic Pathology of Cardiac Diseases

A

Philippine Heart Center

32
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines

33
Q

It refers to a doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only, wherein no official results shall be issued. In this Order, POL within the premises of a DOH-regulated facility shall be under the supervision of the CL.

A

Physician’s Office Laboratory (POL)

34
Q

It refers to diagnostic testing done at or near the site of patient care rather than in the CL. It may be in the emergency room, operating suites, wards, and ambulances.

A

Point of Care Testing (POCT)

35
Q

It refers to CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability.

A

Referral Tests

36
Q

It refers to an extension of the main CL located within the facility’s compound or premises. It shall have the same service capability as the main laboratory.

A

Satellite Clinical Laboratory (SCL)

37
Q

It is required for the construction of new CL, renovation or expansion of existing CL, including change in ownership and transfer of location.

A

DOH-PTC

38
Q

It is required for research and teaching laboratories.

A

Certificate of Registration (COR)

39
Q

The DOH-LTO is valid for ________.

A

1 year

40
Q

The COR for CL that is operated for reserach and teaching purposes shall be required to register with the DOH-HFSRB every _______.

A

3 years

Medical Technology Laws and Bioethics (7 decks)

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