Clinical Laboratories

Question 1

An act regulated the operation and maintenance of clinical laborayories and requiring the registration of the same with the department of health, providing penalty for the violation thereof, and for other purposes

Answer 1

R.A. No. 4688

Question 2

Duly qualified in laboratory medicine and authorized by the Secretary of Health

Answer 2

Licensed physician

Question 3

Any person who violates this Act shall be punished with

Answer 3

1 month to 1 year imprisonment or a fine of 1k to 5k or both

Question 4

RA. No. 4688 was approved on

Answer 4

June 18, 1966

Question 5

New rules and regulations governing the regulation of clinical laboratories in the Philippines

Answer 5

DOH Administrative Order No. 2021-0037

Question 6

R.A. No. 4688 s. 1966 was mandated through

Answer 6

Bureau of Medical Services

Question 7

Bureau of Medical Services is now known as the

Answer 7

Health Facilities and Services Regulatory Bureau

Question 8

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

Answer 8

A.O No. 2007-0027 dated August 22, 2007

Question 9

Rules and regulations governing the licensure of Primary Care Facilities in the Philippines

Answer 9

A.O. No. 2020-0047

Question 10

Universal Health Care Act

Answer 10

R.A. No. 11223

Question 11

BARMM

Answer 11

Bangsamoro Autonomous Region in Muslim Mindanao

Question 12

HFSRB

Answer 12

Health Facilities and Services Regulatory Bureau

Question 13

Bangsamoro Organic Act

Answer 13

R.A No. 11054

Question 14

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

Answer 14

Applicant

Question 15

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

Answer 15

Assessment tool

Question 16

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.

Answer 16

Clinical Laboratory

Question 17

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

Answer 17

DOH-LTO

Question 18

A permit issued by DOH to an applicant who will establish and operate a hospital or other health facility; It is a prerequisite for License to Operate.

Answer 18

DOH-PTC

Question 19

A program where participating CL are given unknown samples for analysis. These samples should be treated as ordinary human specimens for the usual processing and examination. The quality of performance of the CL shall be assessed through the closeness of its results through a pre determined value or reference value generated by the participating CL through peer group analysis

Answer 19

EXTERNAL QUALITY ASSESSMENT PROGRAM (EQAP)

Question 20

A laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH-license CL as its main laboratory

Answer 20

MOBILE CLINICAL LABORATORY

Question 21

An EQAP activity conducted by the National Reference Laboratories to assess the quality performance and accuracy of the results of laboratories.

Answer 21

NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME (NEQAS)

Question 22

Refers to a Doctor’s office/clinic wherein CL examination are performed for the purpose of monitoring the Doctor’s patient only, wherein NO official results shall be issued.

Answer 22

PHYSICIAN’S OFFICE LABORATORY (POL)

Question 23

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

Answer 23

POINT-OF-CARE TESTING (POCT)

Question 24

Refers to an extension of the main CL located within the facilities, compound or premises. It shall have the same service capability as the main laboratory.

Answer 24

SATELLITE CLINICAL LABORATORY (SCL)

Question 25

Refers to CL tests that are either sent out or outsourced to other DOH licensed CL withthe same or higher service capability

Answer 25

REFERRAL TEST

Question 26

Classification by Ownership

Answer 26

• Government
• Private

Question 27

Classification by Institutional Character

Answer 27

• Institution-based
• Non-institution-based

Question 28

Classification by Function

Answer 28

• Clinical Pathology
• Anatomic Pathology
• Molecular Pathology

Question 29

Also known as Guidelines in the Application for Department of Health Permit to Construct (DOH-PTC)

Answer 29

A.O. NO. 2016-0042

Question 30

Guidelines on the Anual Cut-off Dates for Receipt of Complete Applications for Regulatory Authorizations Issued by the Department of Health

Answer 30

A.O. NO. 2019-0004
April 30, 2019

Question 31

DOH A.O. NO. 2021-0037 was adopted on?

Answer 31

June 11, 2021
Sgd. Francisco T. Duque III, MD, MSc.

Question 32

“Implementation of External Quality Assessment as a Regulatory Requirement for Licensing of Clinical Laboratories”

Answer 32

DOH DPEARTMENT MEMORANDUM NO. 2009-0086-B

Question 33

DOH D.M. NO. 2009-0086 was issued on

Answer 33

September 8, 2014
Sgd. ATTY. NICOLAS B. LUTERO III, CESO III

Question 34

Certificate issued after submission of test results.

Answer 34

Certificate of Participation

Question 35

Certificate issued after passing the prescribed rating set by respective NRL providers.

Answer 35

Certificate of Proficiency