(1) UNIT 2: RA 4688 Flashcards
RA 4688 is otherwise known as ___
Clinical Laboratory Law
RA6488 is comprised of how many sections?
8
RA4688 is approved on ___
June 18, 1966
An Act Regulating the Operation and Maintenance of Clinical Laboratories of 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
Identify the Section of RA4688:
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
Identify the Section of RA4688:
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
Identify the Section of RA4688:
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
Identify the Section of RA4688:
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
Identify the Section of RA4688:
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
Identify the Section of RA4688:
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
Identify the Section of RA4688:
The sum of fifty thousand pesos, or so much 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
Identify the Section of RA4688:
All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.
Section 7
Identify the Section of RA4688:
This Act shall take effect upon its approval.
Section 8
Amendment of RA4688 that redirects the functions and operations of DOH
EO no. 102, s. 1999
Amendment of RA4688 which states the rule and regulations governing the establishment, operation, and maintenance of clinical laboratories in the Philippines
AO no. 59, s. 2001
Implementing guideline of RA4688 that provides the revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines
AO no. 27, s. 2007
AO No. 2007-0027
Implementing guideline of RA4688 that amends AO 2007-0027
AO No. 2007-0027-A
Implementing guidelines of RA4688 that mandates the posting of schedule of fees for laboratory and other diagnostic services of hospitals and other health facilities
AO No. 2008-0002
Implementing guidelines of RA4688 that mandates the posting of schedule of fees for the licensure of general clinical laboratories and the registration of special clinical laboratories
AO No. 2008-0007
New rules and regulation governing the regulation of clinical laboratories in the Philippines that is used at present and is updated related to COVID-19
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
Health Facilities & Services Regulatory Bureau is formerly known as ___
Bureau of Health Facilities & Services (BHFS)
In charge of all clinical laboratory licensing and related concerns
Health Facilities and Service Regulatory Bureau (HFSRB)
Region-based licensing and regulation division of HFSRB
Regulatory Licensing Enforcement Division (RLED)
AO 2021-0037 is signed by ___
Former DOH Sec. Francisco Duque
Provides the necessity to revies the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned to RA11223 which is to guarantee access to quality and affordable health products, devices, facilities, and services
AO 2021-0037
Identify the term:
Natural or judicial person who intends to operate a clinical laboratory
Applicant
What does HFSRB mean?
Health Facilities and Services Regulatory Bureau
What does CHD mean?
Center for Health Development
Identify the term:
Facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis, and treatment of disease
Clinical Laboratory
Identify the term:
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
What does DOH mean?
Department of Health
What does EQAP mean?
External Quality Assessment Program
Program where participating laboratories are given unknown samples for analysis
External Quality Assessment Program (EQAP)
Identify the term:
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
Identify the term:
Corporate body or establishment organized for an educational, medical, charitable or similar purpose
Institution
Identify the term:
Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the requirements set forth
License
Identify the term:
Individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance
Licensee
Identify the term:
Also refers to the license
License to Operate (LTO)
Identify the term:
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
Identify the term:
Tests done in series of patients as a guide for treatment or follow-up of their condition
Monitoring Examinations
T/F: mobile clinical laboratories do not need base laboratories as they are already equipped enough
F
Identify the term:
Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas
National Reference Laboratory (NRL)
NRL for hematology, immunohematology, urinalysis
National Kidney and Transplant Institute (NKTI)
NRL for serology
STD/AIDS Central Cooperative Laboratory (SACCL)
NRL 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)
Identify the term:
Individual doctor’s office/clinic wherein laboratory examinations are performed
Physician’s Office Laboratory (POL)
Identify the term:
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 (POCT)
Identify the term:
Basic, commonly requested tests in the laboratory, the result of which are not required to be released immediately upon completion
Routine Tests
Identify the term:
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
Identify the term:
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 immediateley
sta’tim
Meaning of STAT
Short turn around time
Two classifications of laboratories based on ownership
Government
Private
Operated and maintained, partially or wholly, by the national government, a local government unit, any other political unit or any department, division, board or agency thereof
Government Laboratories
Owned, established, and operated by any individual, corporation, association, or organization
Private Laboratories
Classification of laboratories based on function
Clinical Pathology
Anatomic Pathology
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, immunohistopathology, cytology, autopsy, forensic pathology, and molecular pathology
Anatomic Pathology
Classifications of laboratories based on 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 laboratory
A laboratory that does not form part of any other institution
Free-standing
Types of general clinical laboratory
Primary
Secondary
Tertiary
Limited Service Capability (institution-based)
A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory
Special Clinical Laboratory
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/F: clinical laboratories exclusive for research and teaching purposes shall be exempted from the licensing requirement but shall be required to register
T
T/F: NRLs have different licensing process aside from the clinical laboratory of the hospital
F (it is already covered by the license of the hospital)
POL is required to secure a LTO when it undertakes any or all of which activities?
- issue official laboratory results
- perform more than monitoring examinations
- cater not only to the physician’s own patients
T/F: POCT (in hospital) required of licensing under management of clinical laboratory
T
Head of laboratory
Pathologist
Minimum duty in laboratories
4 MTs for 8 hours (3 for each 8 hours + 1 reliever)
3 MTs for 12 hours (2 for each 12 hours + 1 reliever)
Minimum technical working area for physical facilities according to AO 2007-0027
Primary: 10 sq m
Secondary: 20 sq m
Tertiary: 60 sq m
Criteria for renewal of license
Satisfactory performance rating
Basis for suspension/revocation of license
Refusal to participate in EQAS-NRL
Recordings should be kept in file for at least ___
1 year
Anatomic and forensic pathology reports are kept for ___
Permanently kept
Schedule of renewal of LTO
First day of October to last day of November
Renewal of LTO should be processed not later than ___ after expiration date of LTO
5 working days
T/F: LTO is automatically cancelled without notice when there is a failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in the license
T
Shall conduct announced inspections at any reasonable time
Center for Health Development (CHD)
Prescribes the standards, criteria, and technical requirements for the issuance of LTO
Inspection tool/Self assessment tool
___ shall investigate the complaint
HFSRB/CHD Director
1st offense penalty as per AO 2021-0037
Stern warning
2nd offense penalty as per AO 2021-0037d
P30 000
3rd offense penalty as per AO 2021-0037
P50 000
4th offense penalty as per AO 2021-0037
Revocation of DOH-LTO
If offender is 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 DOH-PTC and corresponding DOH-LTO shall be issued a ___ and shall pay the administrative penalty of ___
Cease-and-desist order (CDO)
P50 000
Implementing guideline of RA4688 which provides the guidelines in securing a license to operate a COVID-19 testing laboratory in the Philippines
AO 2020-0014
Implementing guideline which amends to the AO 2020-0014
AO 2020-0014-A
Implementing guidelines which amends to the AO 2020-0014-A
AO 2020-0014-B
Minimum number of personnel in COVID-19 labs
7
Minimum number of pathologist in COVID-19 labs
1
Minimum number of analyst in COVID-19 labs
3 (3 or 2 MTs & 1 allied health)
Minimum number of lab aide in COVID-19 labs
1
Minimum number of receptionist in COVID-19 labs
1
Minimum number of encoder in COVID-19 labs
1
Each personnel in COVID-19 lab must be trained for ___
Biosafety and biosecurity
Molecular diagnostic techniques
Fit testing or respirator should have ___ efficacy
95%
Personnel of COVID-19 lab should have annual ___
Medical exam w/ influenza vaccination
Biosafety cabinet class and type required for specimen preparation
Biological safety cabinet class II type A2
