CLIN LAB LAW Flashcards
CLINICAL LABORATORY LAW
RA 4688
Current AO that we are using.
ADMINISTRATIVE ORDER 2021-0037
Date of Approval:
JUNE 18, 1966
All laboratories should be licensed and regulated by the____ (except______ laboratories doing minimum lab exams).
DOH
government
________ should be in-charge of the laboratories.
Licensed Physicians
_________is the one in-charge with the implementation of this act and to issue rules and regulations
DOH-BRL
Punishment for violators
(1 month - 1 year imprisonment // 1,000 - 5,000 pesos fine)
Php______ from National Treasury are appropriated to carry out this act
50,000
New Rules and Regulation governing the regulation of Clinical Laboratories in the Philippines
ADMINISTRATIVE ORDER 2021-0037
a facility that is involved in the pre-analytical, analytical, and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases.
CLINICAL LABORATORY
RA 4688 also known as
Clinical Laboratory Law of 1966
services play an important roles in diagnosis, treatment, prevention, and control of disease
Clinical Laboratory
CLs must generate (3) results.
accurate, precise, and reliable
Revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines.
AO 2007-0027
This is a laboratory law prior to RA 4688 and is ALREADY AMENDED.
AO 2007-0027
(HFSRB)
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU
Set standards for the regulation of clinical laboratories.
Strictly enforce the provisions of this Order.
HFSRB
Disseminate regulatory policies, standards and forms.
Respond promptly to complaints.
HFSRB
(CHD-RLED)
CENTER FOR HEALTH DEVELOPMENT - REGULATORY LICENSING, AND ENFORCEMENT DIVISION
Strictly enforce the provision of this Order.
Submit quarterly report on Suspension/Revocation/Cease and Desist Order issued on CL.
Respond promptly to complaints.
CENTER FOR HEALTH DEVELOPMENT - REGULATORY LICENSING, AND ENFORCEMENT DIVISION (CHD-RLED)
(NRL)
NATIONAL REFERENCE LABORATORY
Provide laboratory reference/referral services for confirmatory testing.
Train laboratory personnel and recognize other training institutions.
NATIONAL REFERENCE LABORATORY (NRL)
Perform technical evaluation of reagents and diagnostic kits.
NATIONAL REFERENCE LABORATORY (NRL)
Maintain the National External Quality Assessment Scheme (NEQAS).
NATIONAL REFERENCE LABORATORY (NRL)
are the ones creating the NEQAS.
NRL
An external quality assessment program (EQAP) activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories
NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEMES (NEQAS)
Participating CLs are given unknown samples for analysis.
Quality of performance shall be assessed through the closeness of results to the predetermined value or reference value generated by the participating CL through peer group analysis
NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEMES (NEQAS)
(DOH-LTO)
DEPARTMENT OF HEALTH - LICENSE TO OPERATE
A formal authorization issued by DOH to an individual, partnership, corporation, association or any government agency/unit seeking to perform laboratory tests in compliance with the requirements prescribed in this Order.
DEPARTMENT OF HEALTH - LICENSE TO OPERATE
A permit issued by DOH through HFSRB or CHD-RLED to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents prior to the actual construction of the said facility.
DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT
required for substantial alteration, expansion, renovation, increase in the number of beds, transfer of site, or for additional services (add-ons) beyond their service capability
DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT
Prerequisite for LTO.
DEPARTMENT OF HEALTH-PERMIT TO CONSTRUCT
A laboratory testing unit capable of performing limited CL diagnostic procedure and collection of specimens
MOBILE CLINICAL LABORATORY
MCL Diagnostic procedure are:
Urinalysis
Fecalysis
Pregnancy test
Basic Serologic rapid tests
Moves from one testing site to another (needs MOA).
Within the same region, at a maximum of (____) kilometers radius, from the address of the DOH-Licensed CL
100km
MOBILE CLINICAL LABORATORY
MCL
Has a DOH-Licensed____ as its main laboratory.
CL
An extension of the main CL located within the facility’s compound or premises.
Shall have the same service capability as the main laboratory.
SATELLITE CLINICAL LABORATORY
Doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only.
PHYSICIAN’S OFFICE LABORATORY
NO official results shall be issued.
POL within the premises of a DOH-regulated facility shall be under the supervision of the CL.
PHYSICIAN’S OFFICE LABORATORY
Diagnostic testing done at or near the site of patient care rather than the CL.
POINT OF CARE TESTING
May be in the emergency room, operating suites, wards and ambulances.
Does not need to secure a license from RLED or BHFS.
POINT OF CARE TESTING
CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability (needs_____)
REFERRAL TESTS
MOA
All CL shall secure______ prior to operation.
DOH-LTO
CLs for teaching and research: Register with_____
HFSRB
NRLs
: license is part of the hospital where it is affiliated
: secure LTO from HFSRB
Institution-based
Independent
All laboratory prices must be accessible (as mandated by the_______)
Universal Health Care Law
XI. CLASSIFICATION OF CLINICAL LABORATORIES
FISO
Function
Institutional character
Service capability
Ownership
Ownership
Government
Private
Institutional Character
Institution-based
(attached to hospitals, schools, etc.)
Non-institution based
(independent, e.g Lab ng Bayan)
Function
Clinical Pathology
Anatomic Pathology
Molecular Pathology
Service Capability
Primary
Secondary
Tertiary
Special
XIV. SANCTIONS
1st violation:
2nd violation:
3rd violation:
4th violation:
written warning
Php 30, 000 fine
Php 50, 000 fine
Suspension or revocation of LTO
PROCEDURAL GUIDELINES
• On-site assessment
If not fully compliant, lab must comply with the deficiencies within____ days (if not, application will be denied)
• If fully compliant, LTO will be issued.
License to Operate
30
______ or _______
must be notified in writing in cases of change in management name, ownership, headship or lab personnel
Failure to notify within____ days shall be a bias for suspension/revocation of license.
HFSRB or CHD-RLED
15
Different branches of a clinical laboratory even if owned by the same entity shall secure separate____
LTOs
LTO must be placed in an area readily seen by the public
Validity:
1 year
Certificate of Registration (COR) is required for research and teaching laboratories
Renewed every____
3 years
Any person who operated a CL w/o DOH-PTC and DOH-LTO shall be issued a______ and shall pay the administrative penalty of _______
Cease-and-Desist Order (CDO)
Fifty thousand pesos (Php 50, 000)
Due process during investigation:____ days preventive suspension may be given to the CL
60
Appeal:
File a notice of appeal to the Head of the _______ within 10 days after receipt of the decision
___ Head’s decision is appealable to the________ whose decision shall be final and executor
Health Regulation Team (HRT)
DOH Secretary
CL with revoked licenses can only re-apply after_______ from the date of LTO revocation
one year
NRLs in QC
• Lung Center of the Philippines (QC)
• East Avenue Medical Center (QC)
• National Kidney and Transplant Institute (QC)
• Philippine Heart Center (QC)
NRL in muntinlupa
Research Institute for Tropical Medicine (Muntinlupa)
NRL in Manila
San Lazaro Hospital/ STD AIDS Central Cooperative Laboratory
Clinical Laboratory for Anatomic Pathology only
Provides services for any of the following, but not limited to:
cytology
histopathology
Clinical Laboratory for Molecular Pathology only
Provides services for (3)
genetics
immuno/hematopathology
infectious disease
COVID-19 testing laboratories shall be covered by another Order.
