mtl finalz Flashcards
Clinical Laboratory Law
REPUBLIC ACT 4688
Rules and Regulations Governing the Establishment, Operation, and Maintenance of CL in the Philippines
ADMINISTRATIVE ORDER #27 S. 2007
New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
ADMINISTRATIVE ORDER #37 S. 2021
deals with the chemical and cellular analyses of blood and other body fluids
Clinical Pathology
provides processing and examination of surgical specimens
Anatomical Pathology
Anatomical Pathology
Surgical pathology, Cytopathology, Immunohistochemical techniques, Autopsy, Forensic pathology
analysis of genes, SPECIFIC proteins, and other molecules based on principles, techniques, and tools of molecular biology (Administrative Order #)
Molecular Pathology
AO 37
Classification of laboratory by institutional character
- Hospital Based
- Non-hospital Based
Hospital Based (revised by newer AO as _____)
Institution-Based
Non-hospital Based (revised by newer AO as _____)
Free-Standing / independent lab
Classification of laboratory by ownership
Government
Private
Human resource of Clinical Lab
* Head:
o Visitation:
Recommended:
Option 2 (new AO):
* Main Staff:
* Support Staff:
* Staffing (minimum required staff per section & shift):
Anatomic Pathology –
Molecular Pathology –
- Head: Pathologist
o Visitation:
Recommended: once a week
Option 2 (new AO): at least 1 physical and 2 teleconference/call per month - Main Staff: Registered Medical Technologists (CMT, Section Head, MT staff)
- Support Staff: (sometimes are filled by MT, especially if UNDERSTAFFED)
o Laboratory technician, Laboratory aide, Encoders, Receptionists - Staffing (minimum required staff per section & shift):
Anatomic Pathology – at least 1 RMT per section
Molecular Pathology – will depend on the service/s offered
All laboratory reports shall bear the _______ of the ___ and ____
name and signature, pathologist and medical technologist
Physical Facilities
- Space dimensions:
- Sterilization units:
- Conference rooms:
more specific than the previous A.O.s,
added due to pandemic,
optional and usually found in tertiary institution-based lab
Interior walls or partitions and walls of the clinical working area and its sections shall be constructed from ______
WALL TO CEILING
Structurally sound, safe, and sturdy with a minimum ____ as prescribed by the
fire-resistant rating, Fire code of the Philippines
Floors should be _____ especially high-traffic areas (hallways)
Non-slip surface
Floors should be Tiles/cement, smooth flooring, ______; DO NOT USE _____
rubberized
WOOD
Sink is preferably ____ with ____
stainless steel with gooseneck faucet
The minimum clear opening for the main door/s of the clinical laboratory and the clinical working area and exit doors shall be at least _____ and should not be less than ____.
900mm and should not be less than 800mm.
The floor-to-ceiling height of rooms containing biosafety cabinets and fume hoods shall be at least _____.
2.60 meters
______ in the laboratory is RECOMMENDED
Directional airflow
Ventilation for sections w/machines
Artificial air conditioning
___, ___ ___, and other similar finishes shall be avoided
Carpeting, fabrics, wood,
BSL-3: +______ , BSL-4: + _____
anterooms, positive pressure suit
EQUIPMENT AND INSTRUMENTS FOR PRIMARY CLINICAL LABS
Centrifuge (Clinical and Microhematocrit),
Hemocytometer,
Microscope with OIO,
Hemoglobinometer or its equivalent,
Differential blood cell counter or its equivalent
EQUIPMENT AND INSTRUMENTS FOR SECONDARY CLINICAL LABS
PRIMARY (+):
Refrigerator,
Photometer or its equivalent,
Waterbath or its equivalent,
Timer or its equivalent
EQUIPMENT AND INSTRUMENTS FOR TERTIARY CLINICAL LABS
SECONDARY (+):
Incubator,
Balance (triple beam, analytical),
Rotator,
Serofuge and
its equivalent,
Autoclave and drying oven
BSC or its equivalent
There shall be _____, ____, AND ____ for every equipment/machine/instrument/device in the DOH-licensed CL.
a calibration (QC), preventive maintenance, and repair program
There shall be a ______ in case of equipment/machines/devices breakdown and malfunction
contingency plan (backup plan)
There shall be an ____ control of the reagents, glassware, and supplies
inventory
Validity of License to Operate
1 year validity
Application of LTO
thru DOH or Online Licensing Regulatory Systems (OLRS)
If the applying laboratory is not fully compliant with the LTO requirements, the laboratory shall be given _____ to comply
30 days
Submitted complete applications that are not processed within _____ by the HFSRB (BHFS) /CHD-RLED, in accordance with the current DOH guidelines, due to force majeure, shall automatically be granted the LTO, and a post-licensing visit shall be scheduled
20 days
only those with certification by DOH are allowed to secure a LTO as Rapid HIV Diagnostic Algorithm (rHIVda) Confirmatory Laboratory
A.O. 37 s 2021 addition
old confirmatory for HIV
Western blot
new confirmatory as it is more cost effective (3 rapid kits)
rHIVda
HIV confirmatory is now decentralized thru rHIVda allowing _____ to confirm
non-NRL
LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS
Laboratories for RESEARCH and TEACHING PURPOSES,
National Reference Laboratories (NRL),
Physician’s Office Laboratory,
Government laboratories