Unit 3: RA 4688 Flashcards
What is RA 4688?
Clinical Laboratory Law
In the clinical laboratory, a registered medical technologist can
function as: (3)
Chief Medical Technologist
Supervisor
Section Head
1 Registered Medical Technologist can supervise how many Medical Laboratory Technicians?
2
Enumerate the 4 importance of a clinical laboratory.
- Allows proper storage of specimen
- Aids in diagnosis of diseases
- Houses the necessary materials
- Provides services to the public in terms of lab procedures
What are the two types of laboratory?
Hospital-based Laboratory
Free Standing Laboratory
UST Hospital Clinical Laboratory, East Avenue Clinical Lab, and
Providence Hospital Clinical Laboratory are all what type of laboratory?
Hospital-based Laboratory
Hi Precision Laboratory, Pro Lab Diagnostics, and ACE Diagnostics are all what type of laboratory?
Free Standing Laboratory
True or False: CLinical laboratories should be regulated and licensed.
True
Initially, laboratories were regulated and licensed under what?
Bureau of Research and Laboratories
Who is now in charge of regulating and licensing laboratories?
Department of Health
Bureau of Research and Laboratories was changed to?
Bureau of Health Facilities and Services
Where is Bureau of Health Facilities and Services located?
San Lazaro
What is the AO prescribing minimum standards for clinical laboratories to ensure the accuracy and precision of laboratory examinations to safeguard public health?
AO 2021-0037
Who signed AO 2021-0037?
Dr. Francisco Duque
Results are near the actual value.
Accuracy
Clinical laboratories are the “____________________” of health
because of its importance precisely in doing procedures producing laboratory results that aid physicians in diagnosis, treatment,
and maintenance of health or promotion of health in general.
nerve centers
Values are close to one another even after running the test several
times.
Precision
True or False: MedTechs are responsible for diagnosing diseases.
False
As per RA ________, diagnosis is not part of our practice as
medtechs.
RA 5527
What is the Clinical Laboratory Law?
RA 4688
How many sections does RA 4688 have?
8 sections
When was RA 4688 approved?
June 18, 1966
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
RA 4688
What section is referred to below:
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.
Section 1
Securing and registering a license at the Office of the Secretary
of Health must occur _____________.
annually
When are laboratories exempted from the requirement of registration?
If they are just an extension of government, regional, or central
laboratories
What section satisfies the condition below:
The Department of Health (DOH) satellite lab will operate under
their department.
Section 1
What section satisfies the condition below:
Satellite laboratory that is an extension of East Avenue Medical
Center, a government hospital, will operate under the license of a
government hospital.
Section 1
What section is referred to below:
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.
Section 2
What section is referred to below:
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.
Section 2
Manages and supervises the clinical laboratory
Pathologist
What are the two types of laboratory (in terms of specimen)?
Clinical Laboratory
Anatomic Laboratory
How many laboratories can a pathologist manage?
4 laboratories
How many blood banks can a pathologist manage?
2 blood banks
What section is referred to below:
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.
Section 3
Who shall be in charge 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?
Office of the Secretary (Bureau of Research and Laboratories -
now: Bureau of Health Facilities and Services)
What section is referred to below:
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.
Section 4
According to Section 4, how long should the imprisonment for the
violation of the RA 4468 be?
not less than one month but not more than one year
According to Section 4, how much should the fine for the violation
of the RA 4468 be?
not less than 1000 but not more than 5000
What section is referred to below:
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.
Section 5
What section is referred to below:
The sum of fifty thousand pesos, or so must 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.
Section 6
What section is referred to below:
All Acts or parts of Acts which are inconsistent with the provisions
of this Act are hereby repealed.
Section 7
What section is referred to below:
This Act shall take effect upon its approval.
Section 8
Enumerate the 6 old and amended implementing guidelines.
- AO No. 201, Series of 1973
- AO No. 209, Series of 1976
- AO No. 52, Series of 1983
- AO No. 49 - B, Series of 1988
- Executive Order No. 102, Series of 1999
- AO No. 59, Series of 2001
What implementing guideline is described:
Redirecting the Functions & Operations of DOH
Executive Order No. 102, Series of 1999
Rules & Regulations Governing The Establishment, Operation &
Maintenance of Clinical Laboratories in the Philippines
Administrative Order No. 59, Series of 2001
Revised Rules and Regulations Governing the Licensure and
Regulation of Clinical Laboratories in the Philippines
Administrative Order No. 2007-0027
Amendment to Administrative Order No. 2007-0027
Administrative Order No. 2007-0027-A
Posting of Schedule of Fees for Laboratory and Other Diagnostic
Services of Hospitals and other Health Facilities
Administrative Order No. 2008-0002
Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories
Administrative Order No. 2008-0007
New Rules and Regulation Governing the Regulation of Clinical
Laboratories in the Philippines
ADMINISTRATIVE ORDER NO. 2021-0037
Specific department of DOH in-charge of licensing and regulation
of all health facilities including Clinical Laboratories
Health Facilities and Services Regulatory Bureau
(formerly Bureau of Health Facilities and Services )
This is in charge of all clinical laboratory licensing and related
concerns.
Health Facilities and Services Regulatory Bureau
(formerly Bureau of Health Facilities and Services )
The necessity to review the current AO and to revise and update
the minimum standards and technical requirements for licensing
clinical laboratories in the Philippines is aligned with the main
objective of _______________.
RA 1123
What is RA 1123?
Universal Health Care Act
This guarantees access to quality and affordable health products,
devices, facilities and services.
RA 11223 - Universal Health Care Act
Natural or juridical person who intends to operate a clinical laboratory
Applicant
CHD means…
Center for Health Development
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
Clinical Laboratory
Panic values originally described by Lundberg as “lifethreatening”
unless something is done promptly and for which some corrective
action could be undertaken
Critical Values
Lundberg described critical values as “____________________”
life-threatening
EQAP stands for…
External Quality Assessment Program
The program where participating laboratories are given unknown
samples for analysis
External Quality Assessment Program
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
Corporate body or establishment organized for an educational,
medical, charitable or similar purpose
Institution
Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the
requirements set forth
License