1S - UNIT 3 Flashcards
RA 4688
Clinical Laboratory Law of 1966
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
Clinical Laboratory Law of 1966
Who is exempt from securing a license to operate?
government hospital laboratories doing routine/minimum laboratory examinations
When is the license to operate renewed?
annually
Who is professionally in-charge of a registered clinical laboratory?
Licensed physician
Section 3
The ____, through ____ shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules & regulations
Secretary of Health
Bureau of Research and Laboratories
Section 4
How long would the imprisonment period be for anyone who violates any provisions of the Act?
not less than 1 month, but not more than 1 yr
Section 4
How much would the fine be for anyone who violates any provisions of the Act?
not less than P1,000 nor more than P5,000
Section 5
Separability Clause
Section 6
How much is the funding for this Act and where does it come from?
P50,000
out of any funds in the National Treasure not otherwise appropriated
Section 7
Repealing Clause
Section 8
When does this Act take effect?
upon its approval
June 18, 1966
Enumerate the implementing guidelines for RA 4688
AO No. 201, S. of 1973
AO No. 290, S. of 1976
AO No. 52, S. of 1983
AO No. 49-B, S. of 1988
EO No. 102, S. of 1999
AO No. 59, S. of 2001
AO No. 2007-0027
AO No. 2007-0027A
AO No. 2008-0002
AO No. 2008-007
AO No. 2021-0037
What executive order redirects the functions & operations of DOH?
EO No. 102, S. of 1999
what was the original administrative order for the rules & regulations governing the establishment, operation & maintenance of Clinical Laboratories in the PH
AO No. 59 , Series of 2001
Revised Rules & regulations governing the Licensure and Regulation of Clinical Laboratories in the PH
AO No. 2007-0027
Amendment to Administrative ORder No. 2007-0027
AO No. 2007-0027-A
Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities
AO No. 2008-0002
Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories
AO No. 2008-0007
NEW rules and regulations governing the regulation of Clinical Laboratories in the PH
AO No. 2021-0037
specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories
Health Facilities & Services Regulatory Bureau
What was the former name of HFSRB?
BHFS (Bureau of Health Facilities & Services)
in charge of all clinical laboratory licensing and related concerns
HSFRB (Health Facilities & Service Regulatory Bureau)
The License to Operate is the responsibility of the ____
Pathologist or chief Medtech (if pathologist is not in the country)
Who signed AO No. 2021-0037
DOH Sec. Francisco Duque
The necessity to review the current AO …. is aligned with the main objective of ____ or the ____
RA 11223 or Universal Health Care Act
guarantee access to quality and affordable health products, devices, facilities and services
RA 11223 or Universal Health Care Act
natural or juridical person who intends to operate a clinical laboratory
Applicant
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 “life-threatening” unless something is done promptly and for which some corrective action could be undertaken
Critical Values
program where participating laboratories are given unknown samples for analysis
EQAP (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:
Assessment tool for licensing a General Clinical Laboratory
AO 2021-0037 Annex B1
Assessment Tool:
Equipment/Instruments/Glassware/Supplies/Reagents per area of Activity/Service Capability of General Clinical Laboratory
AO 2021-0037 Annex B2
Assessment Tool:
Prohibited Acts in the Operations of Clinical Laboratories
AO 2021-0037 Annex C
Assessment Tool:
Planning and Design Guidelines for General Clinical Laboratory
AO 2021-0037 Annex D1
Assessment Tool:
Checklist for review of floor plans General Clinical Laboratories
AO 2021-0037 Annex D2
Assessment Tool:
Guidelines in securing for remote collection permit for Clinical Laboratories
AO 2021-0037 Annex E
Assessment Tool:
Application form for COR for Research and Teaching Clinical Laboratory
AO 2021-0037 Annex F
corporate body or establishment organized for 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
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
T or F:
Mobile Clinical Laboratories shall have a base laboratory
T
tests done in series on patients as a guide for treatment or follow-up of their condition
Monitoring Examinations
laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas
NRL (National Reference Laboratory)
related to Internal Quality Assessment Program
NRL (National Reference Laboratory)
NRL for Hematology, Immunohematology, Urinalysis
NKTI (National Kidney & Transplant Institute)
NRL for Serology
SACCL (STD/AIDS Central Cooperative Laboratory)
NRL for Clinical Chemistry
LCP (Lung Center of the Philippines)
NRL for Drug Testing, Water Microbiology, Micronutrient Assay
EAMC (East Avenue Medical Center)
NRL for Microbiology and Parasitology
RITM (Research Institute of Tropical Medicine)
individual doctor’s office/clinic wherein laboratory examinations are performed
POL (Physician’s Office Laboratory)
Diagnostic testing at or near the site of patient care rather than in clinical laboratory; includes bedside testing, outpatient and home care
POCT (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 hr after the procedure
STAT Tests
STAT is an abbreviation for ____ which means ____
sta’tim
immediately
Enumerate the Classification of Laboratories by Ownership
- Government
- Private
Enumerate the Classification of Laboratoires by Function
- Clinical Pathology
- Anatomical Pathology
Enumerate the Classification of Laboratories by Institutional Character
- Institution Based
- Free-Standing
Enumerate the Classification of Laboratories by Service Capability
- General Clinical Laboratory
- Special Clinical Laboratory
Classification of Laboratories by function:
includes Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring and other similar disciplines
Clinical Pathology
Classification of Laboratories by function:
includes Surgical pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology & Molecular Pathology
Anatomic Pathology
Identify what type of Laboratory by Service Capability:
Limited Service Capability
General Clinical Laboratory
Identify what type of Laboratory by Service Capability:
TB culture lab
Special Clinical Laboratory
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
a laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory
Special Clinical Laboratory
What are the service capabilities of a Primary Laboratory?
Routine Hematology
Qualitative Platelet Determination
Routine Urinalysis
Routine Fecalysis
Blood Typing (for hospital-based)
What are the service capabilities of a Secondary Laboratory?
Primary Laboratory services +
- Routine Clin Chem
- Quantitative Platelet Determination
- Cross Matching (for hospital-based)
- Gram Staining (for hospital-based)
- KOH (for hospital-based)
What are the service capabilities of a Tertiary Laboratory?
Secondary Laboratory services +
- Special Chemistry
- Special Hematology (including coagulation procedures)
- Immunology
- Microbiology
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 or F:
Dialysis Centers with their own laboratories do not need to have LTO
F; need
Which laboratories are exempted from the licensing requirement but required to register?
Research Laboratories
Teaching Laboratories
Forensic Laboratories
Assisted Reproduction Technology Lab
Molecular & Cellular Technology Lab
Molecular Biology Lab
Anatomic Pathology
T or F:
NRL is covered by the license of clinical laboratory of the hospital
T
When are POLs required to secure an LTO?
- Issue official laboratory results
- Perform more than monitoring examinations
- Cater not only to the physician’s own patients
Minimum Technical Working Area for Primary lab
10 sq m
Minimum Technical Working Area for Secondary lab
20 sq m
Minimum Technical Working Area for Tertiary lab
60 sq m
What is the criteria for the renewal of LTO?
Satisfactory performance rating in EQAS
What is the minimum number staff required for a primary laboratory in an 8 hr shift
4
What is the minimum number staff required for a primary laboratory in a 12 hr shift
3
What is the minimum number staff required for a secondary laboratory in an 8 hr shift
6
What is the minimum number staff required for a secondary laboratory in a 12 hr shift
5
What is the minimum number staff required for a tertiary laboratory in an 8 hr shift
14
What is the minimum number staff required for a tertiary laboratory in a 12 hr shift
11
What is the minimum working hrs?
8 hrs
What is the maximum working hrs?
12 hrs
How many tests per RMT for Manual Testing for an 8 hr shift?
50 tests
How many tests per RMT for Manual Testing for a 12 hr shift?
75 tests
How many tests per RMT for Automated Testing for an 8 hr shift?
100 tests
How many tests per RMT for Automated Testing for a 12 hr shift?
150 tests
T or F:
For tertiary laboratory, only three sections (namely Microscopy, Hematology, and Clinical Chemistry), function during AM and night shifts
F; PM and night shifts
In reporting a laboratory result, it must bear the ____
name & signature of Pathologist & RMT
T or F:
Results can be orally reported (via the phone) from the operating room
T
Results can be orally reported in emergency cases such as:
- Operating Room
- Emergency Room
- NICU
T or F:
Results can be orally reported (via the phone) for outpatients
F; only for emergency cases
T or F:
Anatomic & Forensic pathology reports are kept permanently
T
All requests and reports of all specimens submitted and examined are kept in file for at least ___
1 yr
T or F:
One-Stop-Shop Licensure System is for non-hospital based laboratories
F; Hospital-based laboratory
When should non-hospital based laboratories start renewing their LTO to receive a discount?
first day of October to last day of November
T or F:
LTO is automatically cancelled with prior notice when failure to submit a duly accomplished application form before the expiration date stated in license
F; WITHOUT prior notice
shall conduct announced inspections at any reasonable time
CHD (Center for Health Development)
Identify if there is a violation in this statement, and what (if there is):
Transferring results of tests done in an outside lab to the result form of the referring laboratory
Violation; No attached name of the outside lab
who shall investigate charges or complaints?
HSFRB / 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
HFSRB / CHD Director or representative
For a Clinical Laboratory part of hospitals & other facilities, sanctions shall be governed by ____
AO No. 2007-0022
Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals
For a non-institution-based Clinical Laboratory not under the One-Stop-Shop Licensing System (OSSOLS), what is the 1st offense?
stern warning
For a non-institution-based Clinical Laboratory not under the One-Stop-Shop Licensing System (OSSOLS), what is the 2nd offense?
Php 30,000
For a non-institution-based Clinical Laboratory not under the One-Stop-Shop Licensing System (OSSOLS), what is the 3rd offense?
Php 50,000
For a non-institution-based Clinical Laboratory not under the One-Stop-Shop Licensing System (OSSOLS), what is the 4th offense?
Revocation of DOH-LTO
What will happen if a pathologist in charge of a Clinical Laboratory does not secure the necessary DOH-PTC & corresponding DOH-LTO?
issued a CDO (Cease-and-Desist Order) and fined Php 50,000
guidelines in securing a license to operate a COVID-19 Testing Laboratory in the PH
AO No. 2020-0014
amendment to AO No. 2020-0014
AO No. 2020-0014-A
amendment to AO No. 2020-0014-A
AO No. 2020-0014-B
a government COVID-19 Laboratory may be under?
- National Government
- DOH
- Local Government Unit (LGU)
- Department of National Defense (DND)
- PNP
- DOJ
- State Universities and Colleges (SUCs)
- Government Owned and Controlled Corporations (GOCCs)
a private COVID-19 Laboratory may be under?
- Single proprietorship
- Partnership
- Corporation
- Cooperative
- Foundation
- Religious
- NGO
What is the minimum no. of personnel in a COVID-19 Laboratory? Who are they?
7
- 1 Pathologist
- 3 Analyst
- 1 Laboratory Aide
- 1 Receptionist
- 1 Encoder
COVID-19 Laboratory Personnel must be trained in?
- Biosafety & Biosecurity
- Molecular Diagnostic Techniques
T or F:
COVID-19 Laboratory Personnel require an annual medical exam w/ Influenza Vaccination
T
COVID-19 Laboratory Personnel must use a respirator with ___ efficiency
95% efficiency
What are the required equipment & supplies for reagent preparation in a COVID-19 Laboratory
- PCR cabinet/laminar flow
- 4°C ref for reagents
- -20°C freezer for reagents
- Microcentrifuge
- Vortex mixer
- Minifuge
- Cold rack for PCR tube
- Set of four-adjustable volume micropipettes with rack
- Micropipette tips
- Gloves
In reagent preparation and specimen preparation under a COVID-19 Laboratory, what is the measure of the four adjustable-volume micropipettes used?
100-1000 uL
20-200 uL
2-20 uL
0.5-10 uL
What are the required equipment & supplies for specimen preparation in a COVID-19 Laboratory
- Biological Safety Cabinet Class II type A2
- 4°C ref with -20°C for specimens
- 4°C ref with -20°C for nucleic acid extracts
- Microcentrifuge
- Vortex mixer
- Minifuge
- Computer & printer for accessioning
- Cold rack for PCR tube
- Set of four-adjustable volume micropipettes with rack
- Micropipette tips
- Gloves
What are the required equipment & supplies for amplification/PCR in a COVID-19 Laboratory
- real-time PCR machine
- conventional PCR machine
- Minifuge
- Computer & printer
- -20°C or -40°C freezer for storage of PCR products
