MT LAWS - RA 4688

Clinical Laboratory Law

Republic Act 4688 aka ________

operation

maintenance

clinical laboratories

registration

department of health

RA 4688: Act regulating the _________ and ________ of ____________ and requiring the _________ of the same with the __________, providing penalty for the violation thereof, and for other purposes

8

How many sections comprise RA 4688?

June 18, 1966

Date of approval of RA 4688

clinical laboratory

register

annually

Secretary of Health

Section 1: Any person, firm or corporation, operating and maintaining a ____________ in which body fluids, tissues, secretions, excretions and

radioactivity from beings or animals are analyzed for the determination of the presence of organisms, processes

and/or conditions in the persons or animals from which they were

obtained, shall __________ and secure a license _________ at the office of

the ______________

government hospital

routine

government

regional

central

Section 1: ___________

laboratories doing _________ or minimum laboratory examinations shall

be exempt from the provisions of this section if their services are

extensions of __________, __________, or ____________ laboratories.

physician

laboratory medicine

Secretary of Health

annually

Section 2: It shall be unlawful for any person to be professionally in-charge of a

registered clinical laboratory unless he is a licensed _________ duly

qualified in __________ and authorized by the ______________, such authorization to be renewed ____________.

granted

physician

Section 2: No license shall be __________ 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 _________, as provided for in the preceding paragraph.

Secretary of Health

Bureau of Research and Laboratories

Section 3: The ____________, through the _______________ 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.

1 month

1 year

Section 4: imprisonment for not less than _________ but not more than __________

1000 pesos

5000 pesos

Section 4: fee of not less than __________ but not more than _________

imprisonment

fine

both

Section 4: 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 ___________ for not less than 1 month but not more than 1 year, or by a ________ of not less than 1000 pesos nor more than 5000 pesos, or ________ at the discretion of the court.

adjudged

invalid

affect

Section 5: If any section or part of this Act shall be __________ by any court of competent jurisdiction to be _________ , the judgment shall not __________, impair, or invalidate the remainder thereof.

50,000 pesos

National Treasury

Section 6: The sum of _________, or so much thereof as may be

necessary, is hereby authorized to be appropriated, out of any funds

in the ____________ not otherwise appropriated, to carry into effect the provisions of this Act.

inconsistent

repealed

Section 7: All Acts or parts of Acts which are __________ with the provisions of

this Act are hereby ___________.

approval

Section 8: This Act shall take effect upon its _________.

• Administrative Order No. 201, Series of 1973

• Administrative Order No. 290, Series of 1976

• Administrative Order No. 52, Series of 1983

• Administrative Order No. 49 B, Series of 1988

• Executive Order No. 102, Series of 1999

• Administrative Order No. 2001-0059

Enumerate old and amended implementing guidelines

102

1999

DOH

Executive Order No. ________, Series of _______: Redirecting the Functions & Operations of ________

2001-0059

Administrative Order No. _______-________: Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical

Laboratories in the Philippines

• Administrative Order No. 2007-0027

• Administrative Order No. 2007-0027-A

• Administrative Order No. 2008-0002

• Administrative Order No. 2008-0007

Enumerate current implementing guidelines

2007-0027

Revised

Administrative Order No. _______-_______: ________ Rules and Regulations Governing the Licensure and Regulation of

Clinical Laboratories in the Philippines

2007-0027-A

Amendment

Administrative Order No. _______-_______-________:

_____________ to Administrative Order No. 2007-0027

2008-0002

Posting

Diagnostic

Administrative Order No. _______-_______: _________ of Schedule of Fees for Laboratory and Other _________ Services

of Hospitals and other Health Facilities

2008-0007

General

Special

Administrative Order No. 2008-0007: Schedule of Fees for the Licensure of _________ Clinical Laboratories and

the Registration of _________ Clinical Laboratories

Health Facilities and Services Regulatory Bureau

What does HFSRB stand for?

HFSRB

What is the specific department of DOH in charge of licensing and

regulation of all health facilities including Clinical Laboratories?

Bureau of Health Facilities and Services

HFSRB was formerly known as BHFS which stood for _________

Building 15 DOH San Lazaro Compound Rizal Avenue Sta. Cruz Manila

Where is HFSRB located?

Francisco Duque

Which DOH secretary signed AO 2007-007?

AO 2007-007

What was signed by then DOH Sec. Francisco Duque?

AO 2007-007

What promulgated to prescribe a revised minimum standard for

clinical laboratories?

AO 2007-007

What ensured accuracy and precision of laboratory examinations in

order to safeguard public health and safety?

applicant

natural or juridical person who intends to operate a clinical laboratory

Bureau of Health Facilities and Services

BHFS

Center for Health Development

CHD

Clinical Laboratory

facility where tests are done on specimens from

human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases

critical values

panic values originally described by Lundberg as "life

threatening" unless something is done promptly and for which

some corrective action could be undertaken

Department of Health

DOH

External Quality Assessment Program; program where

EQAP

EQAP

program where

participating laboratories are given unknown samples for analysis

inspection tool

checklist used by regulatory officers during inspection

visits to evaluate compliance of clinical laboratory to minimum

standards and technical requirements

institution

corporate body or establishment organized for an

educational, medical, charitable or similar purpose

license

issued by DOH to an individual, agency, partnership or

corporation that operates a clinical laboratory upon compliance

with the requirements set forth

licensee

individual, agency, partnership or corporation to whom

the license is issued and upon whom rests compliance

License to Operate

LTO

LTO

also refers to the license

mobile clinical laboratory

laboratory testing unit that moves from testing site to another testing site, or has a temporary testing

location

mobile clinical laboratory

shall have a base laboratory

monitoring examinations

tests done in series on patients as a guide

for treatment or follow up of their condition

National Reference Laboratory

NRL

NRL

laboratory in a government

hospital designated by DOH to provide special functions and services for specific disease areas

National Kidney and Transplant Institute

NKTI

NKTI

NRL for hematology

NKTI

NRL for immunohematology

NKTI

NRL for urinalysis

STD/AIDs Central Cooperative Laboratory

SACCL

SACCL

NRL for serology

Lung Center of the Philippines

LCP

LCP

NRL for clinical chemistry

East Avenue Medical Center

EAMC

EAMC

NRL for drug testing

EAMC

NRL for water microbiology

EAMC

NRL for micronutrient assay

Research Institute of Tropical Medicine

RITM

RITM

NRL for microbiology

RITM

NRL for parasitology

Physician's Office Laboratory

POL

POL

individual doctor's office/clinic

wherein laboratory examinations are performed

Point of Care Testing

POCT

POCT

diagnostic testing at or near the site of patient care rather than in clinical laboratory

POCT

includes bedside

testing, outpatient and home care

routine tests

basic, commonly requested tests in the laboratory,

the results of which are not required to be released immediately

upon completion

satellite testing site

any testing site that performs laboratory

examinations under the administrative control of a licensed

laboratory, but performed outside the physical confines of that

laboratory

stat tests

done on urgent cases, results of which shall be released

immediately, within one (1) hour after the procedure

immediately

STAT is an

abbreviation for sta'tim which means ___________.

1.) ownership

2.) function

3.) institutional character

4.) service capability

Enumerate the 4 types of classification of laboratories

government

operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipal), any other political unit or any department, division, board

or agency thereof

private

owned, established and operated by any individual,

corporation, association or organization

clinical pathology

Classification including clinical chemistry

clinical pathology

Classification including hematology

clinical pathology

Classification including immunohematology

clinical pathology

Classification including

clinical pathology

Classification including microbiology

clinical pathology

Classification including immunology

clinical pathology

Classification including clinical microscopy

clinical pathology

Classification including endocrinology

clinical pathology

Classification including molecular biology

clinical pathology

Classification including cytogenetics

clinical pathology

Classification including toxicology and therapeutic drug monitoring

anatomic pathology

Classification including surgical pathology

anatomic pathology

Classification including immunohistopathology

anatomic pathology

Classification including cytology

anatomic pathology

Classification including autopsy

anatomic pathology

Classification including forensic pathology

anatomic pathology

Classification including molecular pathology

institution-based

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

free-standing

a laboratory that does not form part of any other

institution

General Clinical Laboratory

primary, secondary, tertiary, limited service capability (institution based)

Special Clinical Laboratory

a laboratory that offers highly

specialized laboratory services that are usually not provided by a

general clinical laboratory

Primary

Service capability: routine hematology (cbc, hemoglobin, hematocrit, wbc count, wbc differential count)