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
LTO stands for…
License to Operate
Individual, agency, partnership or corporation to whom the license
is issued and upon whom rests compliance
Licensee
Laboratory testing unit that moves from testing site to another
testing site, or has a temporary testing location
Mobile Clinical Laboratory
True or False: Mobile Clinical Laboratories move from one place
to another. It doesn’t need a base laboratory.
False
Tests done in series on patients as a guide for treatment or
follow-up of their condition Monitoring Examinations
Monitoring Examinations
NRL stands for…
National Reference Laboratory
Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas
National Reference Laboratory
The laboratories doing more complicated procedures. They all
have their own unique expertise.
National Reference Laboratory
What is the National Reference Laboratory for Hematology, Immunohematology, Urinalysis?
NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI)
What is the National Reference Laboratory for Serology, HIV-positive samples, and other STD diseases?
STD/AIDS CENTRAL COOPERATIVE LABORATORY (SACCL)
What is the National Reference Laboratory 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)
Who is the current director of the Research Institute of Tropical
Medicine?
Celia Carlos
POL stands for…
Physician’s Office Laboratory
Individual doctor’s office/clinic wherein laboratory examinations
are performed
Physician’s Office Laboratory
POCT stands for…
Point of Care Testing
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
Basic, commonly requested tests in the laboratory, the results of
which are not required to be released immediately upon completion
Routine Tests
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
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 immediately.
Statim
What are the two classification of laboratories by ownership?
Government
Private
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
Government Laboratory
Owned, established and operated by any individual, corporation,
association or organization Private
Owned Laboratory
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, lmmunohistopathology, Cytology,
Autopsy, Forensic Pathology and Molecular Pathology
Anatomical Pathology
What are the two types of laboratory according to function?
Clinical Pathology
Anatomical Pathology
What are the two types of laboratory according to 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
A laboratory that does not form part of any other institution
Free-Standing Laboratory
What are the four types of laboratory according to service capability?
Primary
Secondary
Tertiary
Limited Service Capability
What type of laboratory is referred to below:
- Routine Hematology
Ë Complete Blood Count
Hemoglobin
Hematocrit
WBC Count
WBC Differential Count
Ï Qualitative Platelet Determination Ï Routine Urinalysis
Ï Routine Fecalysis
Ï Blood Typing - for hospital based
Primary Laboratory
What type of laboratory is referred to below:
- Routine Clinical Chemistry
Ë Glucose
Ë Blood Urea Nitrogen
Ë Uric Acid
Ë Creatinine
Ë Total Cholesterol
Ï Quantitative Platelet Determination Ï Cross Matching - for hospital
based
Ï Gram Staining - for hospital based Ï KOH - for hospital based
Secondary Laboratory
True or False: You may perform cross-matching, gram staining,
and potassium hydroxide test in a hospital-based secondary laboratory
True
What are the tests may a hospital-based secondary laboratory
perform?
Cross-matching
Gram Staining
Potassium Hydroxide Test
Only prioritize the training of interns into those that are really
important. Cross-matching, gram-staining, and KOH procedures
were one of those priority areas that were identified
Joint Memorandum Circular No. 1, s. 2021
What type of laboratory is referred to below:
Ï Special Chemistry
Ï Special Hematology, including coagulation procedures
Ï Immunology
Ï Microbiology
Ë Culture and Sensitivity aerobic and anaerobic (for hospital based) aerobic or anaerobic (for non-hospital based)
Tertiary Laboratory
Under DOH, who is in charge of inspection for clinical laboratories
internship per region?
Regional Quality Assurance Team
True or False: In the region, if you are planning to admit interns for
internship, you have to apply for CHED recognition.
True
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
A laboratory that offers highly specialized laboratory services that
are usually not provided by a general clinical laboratory
Special Clinical Laboratory
True or False: LTO may be issued to clinical laboratories that do
not comply with the standards and technical requirements.
False
True or False: Clinical laboratories exclusive for research and
teaching purposes shall be exempted from the licensing requirement but shall be required to register
True
Enumerate the special laboratories required to register but not
licensed. (6)
- Assisted Reproduction Technology
- Molecular and Cellular Technology
- Molecular Biology
- Molecular Pathology
- Forensic Pathology
- Anatomic Pathology
True or False: NRL shall be covered by license of clinical laboratory of the hospital.
True
POL required to secure a LTO when it undertakes any or all of the
following activities: (2)
- Issues official laboratory results
- Cater not only to the physician’s own patients
True or False: POCT (in hospital) required under management of
an anatomical laboratory.
False
(Clinical Laboratory)
Who is the head of laboratory?
Pathologist
A pathologist is certified by __________.
Philippine Board of Pathology
They shall have administrative and technical supervision of the
activities in the laboratory.
Pathologist
The specific guideline that states that there must be adequate
number of RMTs & other health professionals with documented
training and experience to conduct the laboratory procedures.
Human Resources
The number of staff shall depend on: (2)
Workload
Services
Human Resources shall have ________________ and
_________ at all levels of the organization
staff development and CPE
For primary and secondary category clinical laboratories, there is
a need for __________ registered medtech in every section.
one
What is the minimum working hours in a laboratory?
8 hours
How many shifts are there in a laboratory?
3 shifts
True or False: Interns must not do graveyard shifts.
False
What is the specific guideline focusing on the working area, glasswares, reagents, supplies, and wastes of the laboratory?
Physical Resources
True or False: A laboratory must be Well-ventilated, adequately
lighted, clean and safe.
True
What is the minimum technical working area for a primary laboratory?
10 sq. meters
What is the minimum technical working area for a secondary
laboratory?
20 sq. meters
What is the minimum technical working area for a tertiary laboratory?
60 sq. meters
What are the two quality control programs?
Internal QC
External QC
Quality Control Program is a part of what guideline?
Physical Resources
What form of quality control program is referred to below:
A designated NRL gives a certain sample which the NRL has
already tested and there is actually a value already determined
and then they give this sample to the laboratory. The laboratory
should run and get the exact value. If not, they will fail the EQAS.
External QC
What is the criteria for renewal of license?
Satisfactory performance rating
What is the basis for suspension/revocation of license?
Refusal to participate in EQAS-NRL
For reporting, the report must bear the name and signature of: (2)
Pathologist
RMT
True or False: An oral or written report without directive from the
pathologist or associate may be given for emergency cases.
True
What files must be recorded?
All requests and reports of all specimens submitted and examined
How long must the records be kept in file? =
At least a year
How long must the records be kept in file (for anatomic and
forensic reports)?
Permanent
True or False: Laboratory Fees should conform with the current
standards.
True
When is the renewal of LTO for Non-hospital based?
First day of October to Last day of November
Renewal of LTO is processed not later than _______ working days
after expiration date of LTO.
5
True or False: LTO automatically cancels with notice when failed
to submit a duly accomplished application form and to pay proper
fee on or before the expiration date stated in license
False
(without notice)
All organizations will have to apply under the _________ in order
to join the benefits and privileges of being an accredited professional organization (APO).
PRC
Licensee shall ensure the following (2) for inspection of CHD
Director or authorized representative(s) at any reasonable time.
- accessibility of premises and facilities
- availability of all pertinent records for checking/review
With any violation in the operation of a clinical laboratory, there
are sanctions in the form of ___________. (3)
fine
imprisonment
both
Yes or No.
Refusal on any clinical lab to participate in external quality assurance project or program (EQAP) is a form of violation.
Yes
Yes or No.
Issuance of a report, orally or in writing (in whole or part thereof)
which is in accordance with documented procedures is a form of violation.
No
Yes or No.
Permitting unauthorized persons to perform technical procedures
is a form of violation.
Yes
Licenses are __________________ (from one clinical laboratory
to another) and _______________ (not for sharing).
non-transferable & inalienable
Violations will always depend on __________________.
Written Complaint
Who shall investigate the complaint?
HFSRB/CHD/BHFS Director or representative
True or False: HFSRB/CHD Director or representative shall suspend, cancel or revoke and may seek any law enforcement agency
to execute the closure of any erring lab when necessary.
True
Penalties for clinical laboratories in a hospital will be governed by
__________________.
=
AO No. 2007-0022
What administrative order is pertained to below:
“Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals”
=
AO 2007 - 0022
For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the first offense?
Stern Warning
When was AO No. 2007 - 0022 implemented?
June 6, 2007
For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the second offense?
30,000
For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the third offense?
50,000
For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the fourth offense?
Revocation of DOH-LTO
If offender is a firm or corporation, who 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); Fifty thousand pesos (Php
50,000.00).
Guidelines in Securing a License to Operate a COVID-19 Testing
Laboratory in the Philippines
Administrative Order No. 2020-0014
Amendment to the Administrative Order No. 2020-0014
Administrative Order No. 2020-0014-A
Amendment to the Administrative Order No. 2020-0014-A
Administrative Order No. 2020-0014-B
What are the two classification of COVID-19 laboratories according to ownership?
Government
Private
This is owned, established and operated with funds through donation, principal, investment or other means by any individual
corporation, association or organization.
Private
What are the two classification of COVID-19 laboratories according to institutional character?
Hospital Based
Non-hospital Based
True or False: A COVID-19 Laboratory may be part of a general
clinical laboratory but with a designated room distinct from the
main laboratory.
True
What is the minimum number of personnel for the COVID-19
laboratory?
7
Enumerate the 7 personnel of a COVID-19 laboratory.
1 Pathologist
3 Analysts (3 MTs; 2 MTs & 1 Allied Health with Training)
1 Laboratory Aide
1 Receptionist
1 Encoder
The personnel for COVID-19 laboratories must be trained in what
fields?
Biosafety and Biosecurity
Molecular Diagnostic Techniques
Fit testing of respirator has ______% efficacy.
95%
True or False: Performing a seal check when donning an N95
mask is optional.
False
What is the temperature for refrigerator of reagents?
4 degrees Celsius
What is the temperature for freezer of reagents?
-20 degrees Celsius
