RA 4688 Flashcards
Implementing Guidelines (Old & Amended)
● Administrative Order No. 201, Series of 1973
● Administrative Order No. 290, Series of 1976
● Administrative Order No. 52, Series of 1983
● Administrative Order No. 49-B, Series of 1988
● Executive Order No. 102, Series of 1999
● Administrative Order No. 59, Series of 2001
Redirecting the Functions & Operations of DOH
Executive Order No. 102, Series of 1999
Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines
Administrative Order No. 59, Series of 2001
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
Administrative Order No. 2007-0027
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
Specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories
Health Facilities & Services Regulatory Bureau
Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories
Administrative Order No. 2008-0007
is in charge all clinical laboratory
licensing and related concerns
Health Facilities & Services Regulatory Bureau
Formerly BHFS (Bureau of Health Facilities & Services)
Health Facilities & Services Regulatory Bureau
Signed by then DOH Secretary Francisco Duque
AO 2021-0037
The 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
New Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines / AO 2021-0037
Natural or juridical person who intends to operate a clinical laboratory
Applicant
HFSRB
Health Facilities & Services Regulatory Bureau
CHD
Center for Health Development
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 describe by Lunderberg as “life-threatening” unless something is done promptly and for which some corrective action could be undertaken
Critical Values
DOH
Department of Health
EQAP
External Quality Assessment Program
Program where participating laboratories are given unknown samples for analysis
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 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 D2
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
Corporate body or establishment organized for an 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
Also refers to the license
License to Operate (LTO)
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 Testing 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 for Clinical Chemistry
Lung Center of the Philippines (LCP)
NRL for Hematology, Immunohematology, Urinalysis
National Kidney and Transplant Institute (NKTI)
NRL for Drug Testing, Water Microbiology, Micronutrient Assay
East Avenue Medical Center (EAMC)
NRL for Serology
STD / AIDS Central Cooperative Laboratory (SACCL)
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 laboratory, the results of which are not required to be released immediately after 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 (1) hour after the procedure
STAT Tests
STAT is an abbreviation for ______ which means immediately
sta’tim
Classification of Laboratories
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
Classification of Laboratories
Owned, established and operated by any individual, cooperation, association or organization
Private
T/F: Private and Government clinical laboratories have different functions in the clinical lab.
F; they have the same function
Clinical Pathology includes
- Clinical Chem
- Hematology
- Immunohema
- Microbio
- Immunology
- Clin Microscopy
- Endocrinology
- Mol Bio
- Cytogenetics
- Toxicology & Therapeutic Drug Monitoring
- Oth. similar disciplines
A laboratory that does not form part of any other institution
Free-Standing
Anatomic Pathology includes
- Surgical Pathology
- Immunohistopathology
- Cytology
- Autopsy
- Forensic Pathology
- Molecular Pathology
SICAFM
A laboratory that operates within premises and as part of an institution, such a but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatry facility, drug rehabilitation center
Institution-based
Specific services only
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
Primary Lab service capabilities
Routine Hema (CBC - Hemog, Hemato, WBC count, WBC diff count)
Qualitative Platelet Determination
Routine Urina
Routine Feca
Blood Typing (hosp-based)
Secondary service capabilities
+ primary
Routine Clin Chem (Glucose, Blood Urea Nitro, Uric Acid, Creatinine, Total Cholesterol)
Quanti Platelet Determination
Cross Matching (hosp)
Gram Staining (hosp)
KOH (hosp)
What labs are exempted from the licensing requirement but shall register?
- Clinical laboratories exclusive for research and teaching purposes
- Special 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 Lavoratory
Tertiary service capabilities
+ secondary
Special Chem
Special Hema
Immunology
Microbiology (Culture Sensi - Aero & Anaero [hosp] Aero/Anaero [non-hosp])
Special labs exempted
○ Assisted Reproduction Technology
○ Molecular & Cellular Technology
○ Molecular Biology
○ Molecular Pathology
○ Forensic Pathology
○ Anatomic Pathology (independent from a
clinical laboratory)
(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
POL / Physician’s Office Laboratory
(in hospital) required under management of clinical laboratory
POCT
Shall have administrative and technical supervision of the activities in the laboratory
Pathologist (Head)
Clinical / Anatomic is certified by
Philippine Board of Pathology
New Requirement for Staffing from AO 2021-0037
8 RMTs in the primary lab
Minimum Technical Working Area (DM No. 148 s. 2003)
Primary
10 sqm
Minimum Technical Working Area (DM No. 148 s. 2003)
Secondary
20 sqm
Minimum Technical Working Area (DM No. 148 s. 2003)
Tertiary
60 sqm
Well-ventilated, adequately lighted, clean and safe
Physical Facilities
T/F: In External QC, all laboratory shall participate in EQAS given by designated NRL
T
Basis for suspension / revocation of license
EQAS-NRL
In reporting, bear the name ad signature of?
Pathologist & RMT
T/F: When reporting, there should be no report orally or in writing without directive from pathologist or associate except in emergency cases
T
Records are kept in a file for at least?
1 year
T/F: Anatomic & clinical pathology reports are kept permanently.
F; anato & forensic
Under One-Stop-Shop Licensure System for Hospitals
Renewal of LTO
Renewal of LTO date for non-hospital based
First day of October to last day of November
Renewal of LTO is processed not later than _____________ after
expiration date of LTO
5 working days
shall conduct announced inspections at any reasonable time
CHD
shall ensure accessibility of premises and facilities for inspection of CHD Director or authorized representative(s) at any reasonable time
shall ensure availability of all pertinent records for checking/review of CHD Director or his authorized representative(s)
Licensee
prescribes the standards,
criteria and technical requirements for the issuance of LTO, shall be utilized
Inspection Tool
T/F: Inspection is not announced for old (after 1 yr) labs
T
T/F: Inspection for new (1st time) labs are announced
T
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/Rep
Who investigates the complaint?
HFSRB/CHD Director/Rep
Penalties for clinical laboratories in a hospital will be
governed by ________, dated _____,
titled ______________
AO No. 2007- 0022
June 6, 2007
“Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals”
Owned, established and operated with funds through donation, principal, investment or other means by any individual corporation, association or organization
Private
Within the premises or compound of the hospital
May be part of general clinical laboratory but with designate
Hospital-based
Located outside the premises or compound of a hospital and independently functioning on its own
Non-hospital based
Minimum number of personnel
7
1 Patho
3 Analysts (3 RMTs / 2 MTs & 1 Allied Health w/ training)
1 Lab Aide
1 Receptionist
1 Encoder
With training in Infectious
Disease and Molecular
Diagnostics / Infectious
Disease Specialist
Pathologist
Reagent Preparation
● PCR cabinet / laminar flow
● 4°C refrigerator for reagents
● -20°C freezer for reagents
● Microcentrifuge
● Vortex mixer
● Minifuge
● Cold rack for PCR tube
● Set of four adjustable-volume micropipettes with rack
○ 100-1000 uL
○ 20-200 uL
○ 2-20 uL
○ 0.5-10 uL
● Micropipette tips
● Gloves in different sizes (S, M, L)
Specimen Preparation
Biological Safety Cabinet Class II Type A2
used to protect personnel,
products and the environment from exposure to biohazards and cross contamination during routine procedures.
Biological Safety Cabinets
provide a partial barrier for the safe manipulation of low, moderate and high-risk microorganisms.
most frequently used in research and clinical laboratories, are divided into four types (Types A1, A2, B1 and B2).
Class II BSCs
1st Offense
Stern Warning
3rd Offense
P50,000
2nd Offense
P30,000
4 Offenses
Revocation of DOH-LTO
If offender is a firm or corporation, the ________ and/or owner(s) shall be liable to the penalty imposed
managing head
Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall
pay the administrative penalty of
P50,000
Amplification / PCR
● Real-time PCR machine
● Conventional PCR machine
● Minifuge
● Computer and printer (associated with the real-time
PCR machine)
● -20°C or -40°C freezer for storage of PCR products
● Real-time PCR machine
● Conventional PCR machine
Guidelines in Securing a License to Operate a COVID-19 Testing
Laboratory in the Philippines
Administrative Order No. 2020-0014
