[3] RA 4688 Flashcards
Clinical Laboratory Law of 1966
RA 4688
RA 4688 is composed of how many sections?
8 sections
RA 4688 was approved on] ______________________
18-Jun-66
An Act regulating the operation and mainte nance of clinical labora tories and requiring the registration of the same with the Department of Health, providing penal ty for the violation there of, and for other purpos es
RA 4688
Covers regulation and operation of all clinical laboratories nationwide, which focuses on for malizing the operations of clinical laboratories nationwide
RA 4688
Any person, form 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 __________________ at the office of the Secretary of Health
Annually
Exemption for the annual securing of license for clinical labs
Government hospital laboratories doing routine or minimum laboratory examinations (e.g. gov ernment satellite laboratories)
T/F 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 un der the administration, direction, and supervision of an authorized physician.
TRUE
T/F It shall be unlawful for any person to be pro fessionally in charge of a registered clinical lab oratory unless he is a licensed physician duly qualified in laboratory medicine and autho rized by the Secretary of Health, such authorization to
TRUE
The ____________________________, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of RA 4688t and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.
Secretary of Health
In the 1960s, they were in charge of inspecting the operations of clinical laboratories
Bureau of Research and Laboratories (BRL)
In the present time, they are the ones in charge of inspecting the opera tions of clinical laborato ries
Health Facilities and Services Regulatory Bureau (HFSRB)
Imprisonment for not less than one month but not more than one year. A fine of not less than one thousand pesos nor more than five thousand pesos. Or both such fine and imprisonment
Repercussions of violating RA 4688
Any violation of the provisions of the act shall be punished with Imprisonment: Fine:
Imprisonment: not less than one month but not more than one year Fine: not less than one thousand pesos but not more than five thousand pesos
T/F Section 5 of RA 4688 is the separability clause of the law
TRUE
The budget appropriation of the enforcement of RA 4688 is ______________________
50,000 pesos
T/F Section 7 of RA 4688 is the repealing clause of the law
TRUE
Directive necessary to administer properly current affairs but not consistent with the constitu tion or the court, which revised rules and reg ulations governing the registration operations and maintenance of clinical laboratories
Administrative Order No. 201, Series of 1973
Discussed the work force requirement of clinical laboratory
Administrative Order No. 290, Series of 1976
Reengineered the services of Department of Health followed by the devolution of services rendered by the DOH to the local government unit
Executive Order No. 102, Series of 1999
Rules & Regulations Governing The Establishment, Operation & Maintenance of Clini cal Laboratories in the Philippines
Administrative Order No. 2001-0059
Prescribed minimum standard of clinical lab oratory to ensure accuracy and precision in lab examination- AO No. 2007-0027- AO No. 2008-0002- AO No. 2008-0007
Administrative Order No. 2007-0027
Exempted the National Tuberculosis Reference Laboratory (NTRL) and its regional TB refer ence laboratory per forming TB culture from securing a license to co operate a clinical labo ratory
Administrative Order No. 2007-0027-A
The cost of laboratory test should be posted publicly to standardize the pricing of lab tests to protect the consumers from overpricing- AO No. 2007-0027- aO No. 2008-002- AO 2021-0037
Administrative Order No. 2008-0002
Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Labora tories- No. 2008-0002- No. 2008-0007
Administrative Order No. 2008-0007
By 2008, the cost of registration of clinical laboratories was ______________________
1200 - 2500 pesos
Universal Health Care Act
RA 11223
In charge of all clinical laboratory licensing and related concerns
Health Facilities and Service Regulatory Bureau (HFSRB)
The Health Facilities and Service Regulatory Bureau (HFSRB) was formerly known as ______________________
Bureau of Health Facilities & Services (BHFS)
A bureau of the DOH which sets minimum standards for the regulation of health facilities and services, disseminate regulatory policy and standards, information and compliance and most importantly issues permit to construct, license to operate, and certificate of accreditation of labs
Health Facilities and Service Regulatory Bureau (HFSRB)
Administrative order No. 2021-0037 was signed by ______________________
DOH Secretary Franscisco Duque III
New Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines
Administrative order No. 2021-0037
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” un less 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
External Quality Assessment Program (EQAP)
Issued by DOH to an individual, agency, part nership or corporation that operates a clinical laboratory upon compliance with the requirements set forth
License to Operate (LTO)
Individual, agency, part nership or corporation to whom the license is issued and upon whom rests compliance
Licensee
Laboratory testing unit that moves from testing site to another test ing 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
Monitoring Examinations
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)
Individual doctor’s office/clinic wherein laboratory examinations are performed
Physician’s Office Laboratory (POL)
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)
Basic, commonly requested tests in the lab oratory, the results of which are not required to be released immedi ately upon completion
Routine Tests
Examples of Routine Tests
CBC, Urinalysis, Fecalysis
Tests designated as STAT are to be processed immediately within ______ of the procedure
1 hour
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
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 Laboratories
Owned, established and operated by any individual, corporation, association or organiza tion
Private Laboratories
Includes Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molec ular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring and other similar disciplines
Clinical Pathology
Includes Surgical Pathology, immuno histopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology
Anatomic Pathology
Focus of specimens in Clinical Pathology Labs vs Anatomic Pathology Labs
Clinical Pathology - body fluids Anatomic Pathology - tissues
A laboratory that operates within the premises and as part of an insti tution, 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 laboratories
A laboratory that does not form part of any other institution
Free-standing laboratories
Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas
National Reference Laboratory (NRL)
Routine Hematology Complete Blood Count (Hemoglobin,Hemat ocrit, WBC Count, WBC Differential Count) Qualitative Platelet Determination Routine Urinalysis Routine Fecalysis Blood Typing - for hospital based
Service capabilities of primary laboratories
All Primary Laboratory services plus: Routine Clinical Chemistry (Glucose, Blood Urea Nitrogen, Uric Acid, Creatinine, Total Cho lesterol) Quantitative Platelet Determination Cross Matching - For hospital based Gram Staining - for hospital based KOH - for hospital based
Service capabilities of secondary laboratories
All Secondary Laboratory plus: Special Chemistry Special Hematology, including coagulation pro cedures Immunology Microbiology (Culture and Sensitivity, Aerobic and anaerobic (for hospital based and non-hospital based)
Service capabilities of tertiary laboratories
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
Sanctions imposed on clinical laboratories not under the One Stop Shop Licensing System (OSSOLS)
1st offense: Stern warning 2nd offense: 30,000 pesos 3rd offense: 50,000 pesos 4th offense: revocation of DOH-LTO
Any person who operates a CL without securing the necessary DOH-PTC and cor responding DOH-LTO shall be issued a Cease-and-Desist Or der (CDO) and shall pay the adminis trative penalty of ______________
50,000 pesos
COVID laboratories that are created by law; and may be under organi zations such as DOH, LGUs, DND, PNP, DOJ, SUCs, and GOCs.
Government Labs
COVID laboratories that are owned, established and operated with funds through donation, prin cipal, investment or oth er means by any individual corporation, association or organization
Private Labs
COVID laboratories within the premises or compound of the hospital
Hospital based
COVID laboratories located outside the premises or compound of a hospital and in dependently function ing on its own
Non hospital based
Personnel for COVID 19 Labs
1 Pathologist 3 Analysts (3 MTs, or 2MTs and 1 Allied Health) 1 Lab Aide 1 Receptionist 1 Encoder
Minimum respirator efficiency used for COVID 19 Labs
95% efficiency (N95 masks)
Biological safety cabi net used in a COVID 19 Lab
Class II, Type A2 BioSafety Cabinet
T/F Clinical laboratories exclusive for research and teaching purpos es shall be exempted from the licensing re quirement but shall be required to register
TRUE
POLs are required to secure a LTO when it undertakes any or all of the following activities
Issue official laboratory results Perform more than monitoring examinations Cater not only to the physician’s own patients
Special Laboratories that are also required to register but not licensed
Assisted Reproduction Technology Molecular & Cellular Technology Molecular Biology Molecular Pathology Forensic Pathology Anatomic Pathology
Head of Laboratory
Pathologist
Minimum number of medtechs in a primary lab
8hr shifts - 4 RMTs 12 hr shifts - 3 RMTS
Minimum number of medtechs in a sec ondary lab
8hr shifts - 6 RMTs 12 hr shifts - 5 RMTS
Minimum number of medtechs in a tertiary lab
8hr shifts - 14 RMTs 12 hr shifts - 11 RMTS
Minimum working area for a primary laboratory
10 sqm
Minimum working area for a secondary labora tory
20 sqm
Minimum working area for a tertiary laboratory
60 sqm
Done everyday to ensure reliability
Internal quality control
All laboratory shall par ticipate in an Exter nal Quality Assessment Services (EQAS) given by designated NRL
External quality control
T/F Oral reports or in writing without directive from pathologist or associate is permitted even with out an emergency case
FALSE
Duration of recording of files in a laboratory
1 year; Permanent if anatomic and forensic pathology reports
Renewal of LTO for non-hospital based labs
First day of October to last day of November
Deadline of renewal of LTO
Not later than 5 days after expiration of LTO
T/F LTO automatically can celed without notice when failure to submit a duly accomplished ap plication form and to pay proper fee on or be fore the expiration date stated in license
TRUE
T/F Centers for Health De velopment(CHD) shall conduct announced in spections at any rea sonable time
TRUE
Refusal on any clinical lab to participate in EQAP- Issuance of a report, orally or in writing (in whole or part thereof) which is not in accordance with docu mented procedures- Permitting unauthorized persons to perform technical procedures- ncompetence - Deviations from standard test procedures- Lending or using the name of licensed labora tory or head or RMT to an unlicensed laboratory- Unauthorized use of the name and signature of Pathologist and RMT to secure LTO- Reporting a test result for clinical specimens even if the test was not actually done- Transferring results of tests done in an outside lab to the result form of the referring laboratory- Performing and reporting tests in a specialty or subspecialty in which the laboratory is not licensed- Giving and receiving any commission, bonus or kickback or rebate or engaging in any split-fee for referral to clinical laboratory licensed by DOH
Possible violations of any clinical lab
They shall investigate the complaint and sus pend, cancel or revoke and may seek any law enforcement agency to execute the closure of any erring lab when necessary
FSRB/CHD Director or representative
New rules and regulations for governing of clinical laboratories- AO No. 2007-0027- AO No. 2008-0002- AO 2021-0037
AO 2021-0037
Guidelines in securing a license to operate COVID 19 Testing Laboratory
AO No. 2020-0014
Amendment to AO 2020-0014
AO 2020-0014-A
Amendment to AO 2020-0014-1
AO 2020-0014-B
Minimum personnel of COVID19 Lab
7
Commonly gives biosafety and biosecurity training
BioRisk Association of the Philippines
Temperature of freezer for COVID 19 reagents
-20 degrees
Temperature for refrigerator for reagents
4 degrees
Commonly used micropipettes
0.5-10 uL
Blue micropipette tip
100-1000uL
Yellow to clear micropipette tip
lower than 100uL
