medtech law 2

R.A. 4688

is the law for governing the all existing clinical laboraties in the philippines.

june 18, 1966

when was the R.A. 4788 was approved?

THE CLINICAL LABORATORY LAW OF 1966

R.A. 4688 IS ALSO KNOWN AS

body fluid, excretion, secretion, radioactive

What kinds of specimens are included under clinical laboratories in Section 1

license

What does Section 1 of RA 4688 require from clinical laboratories to operate?

office of the secretary of health

where should they renew the license?

routine
minimal procedure

the laboratory who are excepted under government are the one who performs

licensed physician

What type of professional must be in charge of a registered clinical laboratory?

laboratory medicine

In which field must that physician be qualified to supervised a clinical laboratory?

secretary of health

Who must authorize the physician in charge for the clinical laboratory?

anually

How often must that authorization be renewed?

supervised, directed, administrated

What must a laboratory have under such a physician for the license to be granted or renewed

secretary of health

Who is responsible for enforcing RA 4688?

bureau of research and laboratories

Through what institution does the Secretary of Health enforce the law?

provision (law and regulations)

What must be strictly enforced according to Section 3

secretary of health

Who is authorized to issue rules and regulations

1month to 1 year

jail duration of thos ewho violates 4688

1-5k

fine cost who violates ra 4688

national treasury

in section 6, Where does the money come from?
From which treasury fund is this drawn?

AO no. 59, S, 2001

to further improve laboratory quality and performance, what was the AO replaced before it became A0 27S. 2007

lundberg

in critical values, who describe panic values as life-threatening

LTO

what type of license is required?

inspection tool

the checklist used by the regulatory officer

Panic values

critical values is also known as

life-threatening

lundberg describe panic values as

external quality assessment program

program where known laboratories are given urine to analize

mobile clinical laboratory

a laboratory testing unit that moves other places

monitoring examination

test done in series to guid the medication of patient

national reference laboratory

NRL MEANS

physicians office laboratory

an room for office for licensed physician where clinical laboratory examination are performed

pont of care

diagnostic testing near the patient lnown as

routine test

commonly requested test in the laboratory

national reference laboratory

the laboratory which are designed by doh to provide special function

satellite testing site

A testing facility located outside the main clinical laboratory, but linked and managed by the licensed main laboratory.

stat

test are done urgently

government and private

classification of laboratories by ownership

clinical pathology
anatomic pathology

laboratory classification by function

free standing
institutional based

different type of laboratory that are intitutional character

primary

a type of laboratory that provides minimum service capabilities

routine fecalysis
routine urinalysis
routine hematology
qualitative platelet determination
blood typing

procedure done in primary laboratory

secondary

Can perform everything a Primary Lab does PLUS additional tests

routine clinical chemistry
qualitative platelet determination
cross matching
gram straining
koh

test done in secondary lab

tertiary

• Highest service capability.

• Performs all tests of Primary & Secondary PLUS specialized tests.

• Usually found in big hospitals and medical centers.

special chemistry
special hematology
immunology
microbiology

procedure done in tertiary clinical labrotary

specialized clinical laboratory

• A laboratory that performs highly specialized tests not usually available in general clinical labs.

HIV CONFIMATORY

TOXICOLOGY lab
MOLECULAR BIOLOGY/DNA LAB
drug testing

procedure done in specialized clinical laboratory

bureau of health facilities and servies

the LTO should be issued only to clinical laboratories that comply with the standard and requirements formulated by:

research and teaching purposes

the laboratory who are excepted from license but are required to get registered by the bureau of health facilities sercives

DOH

the nrl si designated by

bhfs
chd

an applicant can acquired registration through

beginning of act to last day nov

non hospital absed laboratory are required to get license or lto through what month duration

san lazaro hospital

hospital of nrl for hiv/aids, sexually transmitted disease, hepatitis

research institute for tropical medicine

NRL for dengue, influenza, tubeculosis, malaria, mycobacteria.
confirmatory test for blood donor and blood units

philippine lung center

designated through dpo number. 2009 - 5148

national kidney and transplant institute

NRL for hematology and immunohematology

LICENSEE

TO WHOM THE LICENSE IS ISSUED