(1) UNIT 2: RA 4688 Flashcards by 3sha Ann

Q

RA 4688 is otherwise known as ___

A

Clinical Laboratory Law

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Q

RA6488 is comprised of how many sections?

A

8

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Q

RA4688 is approved on ___

A

June 18, 1966

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Q

An Act Regulating the Operation and Maintenance of Clinical Laboratories of Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation thereof, and for other purposes

A

RA 4688; Clinical Laboratory Law

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Q

Identify the Section of RA4688:

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions, and radioactivity from humans or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: Provided, That government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories.

A

Section 1

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Q

Identify the Section of RA4688:

It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually.

A

Section 2

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Q

Identify the Section of RA4688:

No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician as provided for in the preceding paragraph.

A

Section 2

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Q

Identify the Section of RA4688:

The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.

A

Section 3

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Q

Identify the Section of RA4688:

Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court.

A

Section 4

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Q

Identify the Section of RA4688:

If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof.

A

Section 5

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Q

Identify the Section of RA4688:

The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act.

A

Section 6

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Q

Identify the Section of RA4688:

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

A

Section 7

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Q

Identify the Section of RA4688:

This Act shall take effect upon its approval.

A

Section 8

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Q

Amendment of RA4688 that redirects the functions and operations of DOH

A

EO no. 102, s. 1999

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Q

Amendment of RA4688 which states the rule and regulations governing the establishment, operation, and maintenance of clinical laboratories in the Philippines

A

AO no. 59, s. 2001

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Q

Implementing guideline of RA4688 that provides the revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines

A

AO no. 27, s. 2007
AO No. 2007-0027

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Q

Implementing guideline of RA4688 that amends AO 2007-0027

A

AO No. 2007-0027-A

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Q

Implementing guidelines of RA4688 that mandates the posting of schedule of fees for laboratory and other diagnostic services of hospitals and other health facilities

A

AO No. 2008-0002

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Q

Implementing guidelines of RA4688 that mandates the posting of schedule of fees for the licensure of general clinical laboratories and the registration of special clinical laboratories

A

AO No. 2008-0007

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Q

New rules and regulation governing the regulation of clinical laboratories in the Philippines that is used at present and is updated related to COVID-19

A

AO No. 2021-0037

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Q

Specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories

A

Health Facilities & Services Regulatory Bureau

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Q

Health Facilities & Services Regulatory Bureau is formerly known as ___

A

Bureau of Health Facilities & Services (BHFS)

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Q

In charge of all clinical laboratory licensing and related concerns

A

Health Facilities and Service Regulatory Bureau (HFSRB)

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Q

Region-based licensing and regulation division of HFSRB

A

Regulatory Licensing Enforcement Division (RLED)

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AO 2021-0037 is signed by ___

Former DOH Sec. Francisco Duque

Provides the necessity to revies the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned to RA11223 which is to guarantee access to quality and affordable health products, devices, facilities, and services

AO 2021-0037

Identify the term: Natural or judicial person who intends to operate a clinical laboratory

Applicant

What does HFSRB mean?

Health Facilities and Services Regulatory Bureau

What does CHD mean?

Center for Health Development

Identify the term: Facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis, and treatment of disease

Clinical Laboratory

Identify the term: Panic values originally described by Lundberg as "life-threatening" unless something is done promptly and for which some corrective action could be undertaken

Critical Values

What does DOH mean?

Department of Health

What does EQAP mean?

External Quality Assessment Program

Program where participating laboratories are given unknown samples for analysis

External Quality Assessment Program (EQAP)

Identify the term: Checklist used by regulatory officers during inspection visits to evaluate compliance of clinical laboratory to minimum standards and technical requirements

Assessment tool

Assessment tool for licensing a general clinical laboratory

AO 2021-0037 Annex B1

Equipment/instruments/glassware/supplies/reagents per area of activity/service capability of general clinical laboratory

AO 2021-0037 Annex B2

Prohibited acts in the operations of clinical laboratories

AO 2021-0037 Annex C

Planning and design guidelines for general clinical laboratory

AO 2021-0037 Annex D1

Checklist for review of floor plans general clinical laboratory

AO 2021-0037 Annex D2

Guidelines in securing for remote collection permit for clinical laboratories

AO 2021-0037 Annex E

Application form for certificate of registration for research and teaching clinical laboratory

AO 2021-0037 Annex F

Identify the term: Corporate body or establishment organized for an educational, medical, charitable or similar purpose

Institution

Identify the term: Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the requirements set forth

License

Identify the term: Individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance

Licensee

Identify the term: Also refers to the license

License to Operate (LTO)

Identify the term: Laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location; shall have a base laboratory

Mobile Clinical Laboratory

Identify the term: Tests done in series of patients as a guide for treatment or follow-up of their condition

Monitoring Examinations

T/F: mobile clinical laboratories do not need base laboratories as they are already equipped enough

F

Identify the term: Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas

National Reference Laboratory (NRL)

NRL for hematology, immunohematology, urinalysis

National Kidney and Transplant Institute (NKTI)

NRL for serology

STD/AIDS Central Cooperative Laboratory (SACCL)

NRL for Clinical Chemistry

Lung Center of the Philippines (LCP)

NRL for drug testing, water microbiology, micronutrient assay

East Avenue Medical Center (EAMC)

NRL for microbiology and parasitology

Research Institute of Tropical Medicine (RITM)

Identify the term: Individual doctor's office/clinic wherein laboratory examinations are performed

Physician's Office Laboratory (POL)

Identify the term: Diagnostic testing at or near the site of patient care rather than in clinical laboratory; includes bedside testing, outpatient and home care

Point of Care Testing (POCT)

Identify the term: Basic, commonly requested tests in the laboratory, the result of which are not required to be released immediately upon completion

Routine Tests

Identify the term: Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

Satellite Testing Site

Identify the term: Done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure

STAT tests

STAT is an abbreviation for ___ which means immediateley

sta'tim

Meaning of STAT

Short turn around time

Two classifications of laboratories based on ownership

Government Private

Operated and maintained, partially or wholly, by the national government, a local government unit, any other political unit or any department, division, board or agency thereof

Government Laboratories

Owned, established, and operated by any individual, corporation, association, or organization

Private Laboratories

Classification of laboratories based on function

Clinical Pathology Anatomic Pathology

Includes clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, endocrinology, molecular biology, cytogenetics, toxicology and therapeutic drug monitoring and other similar disciplines

Clinical Pathology

Includes surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology, and molecular pathology

Anatomic Pathology

Classifications of laboratories based on institutional character

Institution based Free-standing

A laboratory that operates within the premises and as part of an institution, such as but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center

Institution based laboratory

A laboratory that does not form part of any other institution

Free-standing

Types of general clinical laboratory

Primary Secondary Tertiary Limited Service Capability (institution-based)

A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory

Special Clinical Laboratory

Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics

Limited Service Capability Laboratory

T/F: clinical laboratories exclusive for research and teaching purposes shall be exempted from the licensing requirement but shall be required to register

T

T/F: NRLs have different licensing process aside from the clinical laboratory of the hospital

F (it is already covered by the license of the hospital)

POL is required to secure a LTO when it undertakes any or all of which activities?

1. issue official laboratory results 2. perform more than monitoring examinations 3. cater not only to the physician's own patients

T/F: POCT (in hospital) required of licensing under management of clinical laboratory

T

Head of laboratory

Pathologist

Minimum duty in laboratories

4 MTs for 8 hours (3 for each 8 hours + 1 reliever) 3 MTs for 12 hours (2 for each 12 hours + 1 reliever)

Minimum technical working area for physical facilities according to AO 2007-0027

Primary: 10 sq m Secondary: 20 sq m Tertiary: 60 sq m

Criteria for renewal of license

Satisfactory performance rating

Basis for suspension/revocation of license

Refusal to participate in EQAS-NRL

Recordings should be kept in file for at least ___

1 year

Anatomic and forensic pathology reports are kept for ___

Permanently kept

Schedule of renewal of LTO

First day of October to last day of November

Renewal of LTO should be processed not later than ___ after expiration date of LTO

5 working days

T/F: LTO is automatically cancelled without notice when there is a failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in the license

T

Shall conduct announced inspections at any reasonable time

Center for Health Development (CHD)

Prescribes the standards, criteria, and technical requirements for the issuance of LTO

Inspection tool/Self assessment tool

___ shall investigate the complaint

HFSRB/CHD Director

1st offense penalty as per AO 2021-0037

Stern warning

2nd offense penalty as per AO 2021-0037d

P30 000

3rd offense penalty as per AO 2021-0037

P50 000

4th offense penalty as per AO 2021-0037

Revocation of DOH-LTO

If offender is firm or corporation, the ___ shall be liable to the penalty imposed

Managing head and/or owner(s)

Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a ___ and shall pay the administrative penalty of ___

Cease-and-desist order (CDO) P50 000

Implementing guideline of RA4688 which provides the guidelines in securing a license to operate a COVID-19 testing laboratory in the Philippines

AO 2020-0014

Implementing guideline which amends to the AO 2020-0014

AO 2020-0014-A

Implementing guidelines which amends to the AO 2020-0014-A

AO 2020-0014-B

Minimum number of personnel in COVID-19 labs

7

Minimum number of pathologist in COVID-19 labs

1

Minimum number of analyst in COVID-19 labs

3 (3 or 2 MTs & 1 allied health)

Minimum number of lab aide in COVID-19 labs

1

Minimum number of receptionist in COVID-19 labs

1

Minimum number of encoder in COVID-19 labs

1

Each personnel in COVID-19 lab must be trained for ___

Biosafety and biosecurity Molecular diagnostic techniques

Fit testing or respirator should have ___ efficacy

95%

Personnel of COVID-19 lab should have annual ___

Medical exam w/ influenza vaccination

Biosafety cabinet class and type required for specimen preparation

Biological safety cabinet class II type A2