6313 RA 4688 Flashcards
REPUBLIC ACT 4688 is also known as?
Clinical Laboratory Law
How many sections?
8
What does RA 4688 state?
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
When was RA 4688 approved?
June 18, 1966
What does section 2 state?
unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician
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
What should the licensed physician be qualified in in order to be uncharge of a registered clinical lab?
Laboratory medicine
How often should the head of the lab renew the authorization from the secretary of health?
annually
What does section 5 state?
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.
According to section 3, who 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?
Secretary of Health (through the Bureau of Research and Laboratories)
What does section 1 state?
Any person, firm or corporation, operating and maintaining a clinical laboratory shall register and secure a license annually at the office of
the Secretary of Health
Who is the exception stated in section 1?
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.
According top section 6, how much and from whom is the money needed to enforce this act?
50,000 from National Treasury
What section is the repealing clause?
7
What section: 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.
5
Based on section 4, how much is the fine and imprisonment of violation?
Imprisonment: 1 month - 1 year
Fine: 1,000 - 5,000 pesos
What section is the effectivity clause?
8
What are the implementing guidelines (old and amended)?
AO No. 201, Series of 1973
AO No. 290, Series of 1976
AO No. 52, Series of 1983
AO No. 49-B, Series of 1988
EO No. 102, Series of 1999
AO No. 59, Series of 2001
What is the Redirecting Functions and Operations of DOH?
EO No. 102, Series of 1999
What is AO #59, s. 2001
Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines
What are other implementing guidelines?
Administrative Order No. 2007-0027
Administrative Order No. 2007-0027-A
Administrative Order No. 2008-0002
Administrative Order No. 2008-0007
Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories
Administrative Order No. 2008-0007
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
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
Administrative Order No. 2007-0027
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 labs
Health Facilities & Services Regulatory Bureau
HFSBR fka?
BHFS (Bureau of Health Facilities & Services)
A.O. 2021-0037 signed by?
then DOH Sec. Francisco Duque
What does A.O. 2021-0037 state?
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 Republic Act No. 11223 or the Universal Health Care Act which is to guarantee access to quality and affordable health products, devices, facilities and services.
natural or juridical person who intends to operate a
clinical laboratory
Applicant
What is CHD?
Center for Health Development
What is a clinical laboratory?
where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment
What is HFSRB?
Health Facilities and Services Regulatory Bureau
What are critical values?
panic values
Critical values were described by Lundberg as?
“life- threatening” unless something is
done promptly and for which some corrective action could be undertaken
What is EQAP?
External Quality Assessment Program; program where participating laboratories are given unknown samples for analysis
What is an assessment tool?
checklist used by regulatory officers during inspection visits to evaluate compliance of
clinical laboratory to minimum standards and technical requirements
AO 2021-0037 Annex B2
EQUIPMENT/INSTRUMENTS/GLASSWARE/SUPPLIES/REAGENTS PER AREA OF ACTIVITY/SERVICE
CAPABILITY OF GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex E
GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT FOR CLINICAL LABORATORIES
AO 2021-0037 Annex D1
PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex C
PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL LABORATORIES
AO 2021-0037 Annex F:
APPLICATION FORM FOR CERTIFICATE OF REGISTRATION FOR RESEARCH AND TEACHING CLINICAL LABORATORY
AO 2021-0037 Annex B1
ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex D2:
CHECKLIST FOR REVIEW OF FLOOR PLANS GENERAL CLINICAL LABORATORY
What is considered a corporate body or establishment organized for an educational, medical, charitable or similar purpose
Institution
individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance
Licensee
What is LTO?
License to Operate aka license
Who is the license issued by?
DOH
laboratory testing unit that moves from
testing site to another testing site, or has a temporary testing location; shall have a base laboratory
Mobile Clinical Laboratory
tests done in series on patients as a guide
for treatment or follow-up of their condition
Monitor Examinations
What is NRL?
National Reference Laboratory
T or F: NRLs are privately owned
F, government hospitals designated by DOH for special functions and services for specific diseases
NRL for serology
STD/AIDS Central Cooperative Laboratory (SACCL)
EAMC NRL for?
Micronutrient Assay, Water Microbiology, Drug Testing
RITM NRL for?
Parasitology and Microbiology
NRL for hematology, immunohematology, and urinalysis
NKTI National Kidney and Transplant Institute
NRL for Clinical Chemistry?
LCP Lung Center of the Philippines
What is POL?
Physician’s Office Laboratory; individual doctor’s office/clinic wherein laboratory examinations are performed
What is POCT?
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
T or F: Routine tests need not be released immediately.
T
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
How long should STAT tests be released after the procedure?
1 hour
STAT is short for?
sta’tim meaning immediately
Classification fo Labs based on ownership?
Government
Private
Classification of Labs based on function?
Clinical Pathology
Anatomic Pathology
Anatomic Pathology includes?
Surgical pathology
Forensic pathology
Cytology
Autopsy
Molecular pathology
Immunohistopathology
Classification of labs based on institutional character?
Institution based
Non institution based
Classification based on service capability?
General Clinical Lab:
Primary
Secondary
Tertiary
Limited Service Capability (institution based)
Special Clinical Lab
Services of Primary lab?
Routine Hematology
*Complete Blood Count
* Hemoglobin
* Hematocrit
* WBC Count
* WBC Differential Count
Qualitative Platelet Determination
Routine Urinalysis
Routine Fecalysis
Blood Typing – for hospital based
Services of Tertiary Labs?
Special Chemistry
Special Hematology, including coagulation procedures
Immunology
Microbiology
*Culture and Sensitivity
* aerobic and anaerobic (for hospital based)
* aerobic or anaerobic (for non-hospital based)
Services of Secondary labs?
Routine Clinical Chemistry
* Glucose
* Blood Urea Nitrogen
* Uric Acid
* Creatinine
* Total Cholesterol
Quantitative Platelet Determination
Cross Matching – for hospital based
Gram Staining – for hospital based
KOH – for hospital based
What do limited service capability labs provide?
laboratory tests required for a particular service in
institutions such as but not limited to dialysis centers and social hygiene clinics
What kind of labs are exempted from requiring a license to operate but are required to register?
Clinical labs for research and teaching purposes
*Assisted Reproduction Technology
* Molecular & Cellular Technology
* Molecular Biology
* Molecular Pathology
* Forensic Pathology
* Anatomic Pathology (independent from a clinical laboratory)
When is a LTO required in a POL?
*Issue official laboratory results
* Perform more than monitoring examinations
* Cater not only to the physician’s own patients
T or F: POCT (in hospital) required under management of clinical laboratory
T
What kind of pathologist heads the lab?
Clinical or anatomical, certified by Philippine Board of Pathology
What should the staff have at all levels of the organization?
Staff development and CPE
Minimum Technical Working Area is what law/decree? What are the measurements for each type of lab?
DM #148, s. 2003
Primary - 10 sq m
Secondary - 20 sq m
Tertiary - 60 sq m
Requirements of physical facility?
Well-ventilated, adequately lighted, clean and safe
Specific Guidelines include?
*Glasswares/Reagents/Supplies
* Waste Management
* Quality Control Program (Internal and External)
What rating should be given to have grounds for license renewal?
Satisfactory
What is the basis for revocation/suspension of license?
Refusal to participate in the EQAS-NRL
What are the guidelines for reporting?
Bear the name and signature of Pathologist & RMT
No report orally or in writing without directive from pathologist or associate except in emergency cases
How long are records of requests and reports kept in file for?
1 yr
T or F: Anatomic and Clinical pathology reports are kept in file for 1 year
Anatomic and forensic pathology are kept permanently
How do hospital labs renew their license?
under One-Stop-Shop Licensure System
How do non-hospital based labs renew their LTO?
first day of October to last day of November
(discount on renewal fee if application completed during this period)
Guidelines for renewal?
processed not later than 5 working days after expiration date of LTO
LTO automatically cancelled without notice when failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in license
How are the inspections conducted? Who conducts them?
CHD director conducts them announced and at reasonable time
Make all facilities and premises available
Pertinent records should be made available for review
Inspection tool is used to see if the lab upholds standards, criteria and technical requirements for LTO issuance
Who investigates on the charges or complaints?
HFSRB or CHD director can cancel, suspend, and revoke licenses and seek a law enforcing agency to close any erring lab
Penalties as per AO 2021-0037 is governed by?
AO 2007-0022 dates June 6, 2007, Violations under the One Stop Shop Licensure System for Hospitals
For non-institution based labs, the punishments for violations are what?
1 offense: stern warning
2 offenses: 30,000
3 offenses: 50,000
4 offenses: Revocation of DOH-LTO
If offender is a firm or corporation, the _______shall be liable to the penalty imposed
managing head and/or owner(s)
Any person who operates a CL without securing the necessary _______ shall be issued a _________ and shall pay the administrative penalty of _______
DOH-PTC and corresponding DOH-LTO; Cease-and-Desist Order (CDO); 50k
What are the implementing guidelines for licensing a COVID-19 Testing lab?
Administrative Order No. 2020-0014
Administrative Order No. 2020-0014-A
Administrative Order No. 2020-0014-B
What is Administrative Order No. 2020-0014 entitled?
Guidelines in Securing a License to Operate a COVID-19 Testing
Laboratory in the Philippines
Classification of COVID-19 labs according to ownership?
Government, Private
Classification of COVID-19 labs according to institutional character?
Hospital based
Non hospital based
Minimum number of COVID-19 Lab personnel and who are these?
Minimum number of staff: 7
1 – Pathologist (with training in Infectious Disease & Molecular
Diagnostics)
3 – Analyst (3 MTs; or 2 MTs & 1 Allied Health with training)
1 – Laboratory Aide
1 – Receptionist
1 – Encoder
Personnel requirements?
Must be trained:
* Biosafety and Biosecurity
* Molecular Diagnostic Techniques
* Fit Testing of Respirator (95% Efficiency)
* Performing a Seal Check When Donning an N95 Mask
* N95 Fit Testing
* Annual Medical Exam w/ Influenza Vaccination
* Updated trainings
What kind of biosafety cabinet should be used in COVID-19 labs?
Biological Safety Cabinet Class II Type A2
