(M) Lec 4: Setting Up and Managing a Clinical Laboratory Flashcards
Main role as a Medical Technologist
Generate accurate,
timely results
Refers to generating results based on the limited resources
that you have.
Quality
Refers to
● Daily routine
● Running quality controls.
● It is important as a Medtech that you are able to submit
such charts because administrators will check on tha
Internal Quality Assurance Program
Refers to
Give your staff new training so that they are knowledgeable about the new trends, etc.
● TAT - Time that you receive your sample and request up to the time that the results are available.
● Overstated underdeliver
Continuous Quality Improvement Systems
Refers to tme you receive your sample and request up to the time that the results are available
TAT
EQAP is given every when?
Annually
Familiarize factors needed to be assessed by top management
● Location (Geography)
● Privacy
● Conformance with Building Laws (PTC)
➔ Mandatory
● Ventilation
● Spaces Required
● Functional and Planning Considerations
Specific requirement
● Counter/Tray
● Space for patient seating
● Hand-washing stations (dedicated cubicle/designated toilet
for specimen collection).
Collection areas
Specific requirement
● Not within a high volume traffic.
● Hand-washing area (dressing area) at entry and exit points
Exits/Entrance/Traffic
Specific requirements
● Stainless steel sink; depth at least 8” and a gooseneck faucet.
Sink
Specific requirements
● Each sections
Properly identified/labeled
Specific requirements
● Preferably outside of the working area and it should be
adjacent to the laboratory.
● Separate for patients and for staff.
Toilets/Amenities
Specific requirements
● Fluctuations in air supply and exhaust or the operations of equipment do not alter the performance standard of the cabinet/food
BSC
Specific requirements
● No more than 23 meters of travel distance to any exit door
from any point of the clinical working area.
Fire safety
Specific requirements
Minimum width shall be at least but not limited to 1.20 meters or four (4) feet.
Corridors
Specific requirements
● Work counter in clinical working area from a wall = at least 1.2 m or (4) ft.
● Work counter to another wok counter = 1.52 meters or five (5) ft.
● Consideration shall also be given for adequate clearances, such as size and type of equipment, activity involved, ergonomics and anthropometrics
Clearances
Specific requirements
● Within 30 meters of work access, a hands-free eyewash unit with a hand wash unit is preferred.
● Pressure is required
Emergency eyewash/shower
Specific requirements
● All areas are well-lighted.
● No exposed or dangling electrical wires and unwanted glare shall be avoided.
● Convenience outlets shall be provided within the facility
Lighting
Specific requirements
● Conform with the National Building Code of the Philippines.
● The floor-to-ceiling height of rooms containing biosafety cabinets and fume hood shall be at least 2.60 meters.
● For rooms containing tall and ceiling-mounted equipment, the ceiling shall be sufficient height in order to accommodate the equipment and/or fixtures.
Ceiling height
Specific requirements
● Continuous and sufficient supply of water.
● Piping systems shall be kept conceals, yet easily accessible
for service and
Plumbing
Specific requirements
● Artificial AC provided in the clinical working area to attain required HVAC.
Ventilation - directional airflow
Specific requirements
● ADEQUATE for staff, activity, equipment, and utility.
Space
Minimum working area for primary lab
10 sq
Minimum working area for secondary
20 sq
Minimum working area for tertiary lab
60 sq
Optional section for secondary lab
Immunology sero and histopath
Optional section for primary lab
Histopath
These sections in a tertiary lab is room type
Microbio ad histopath
Classification of lab under what AO are the ff:
● The spaces/areas of the clinical laboratory shall be zoned into the following area, if applicable, and planned based on
the functionality of the space and the activity workflow of
the laboratory.
● 5.1.1 General Administrative Services and Public Areas;
● 5.1.2 Clinical Working Area;
● 5.1.3 Support Services Area
AO: 2021-0037
Aralin niyo yung space and area requirement under AO
Dali na ‘di ko ma-copy paste eh
The project team
Expert on lab design
Archi
The project team
● Communicator
● Consensus Builder
● Expeditor
Project manager
The project team
Expert on lab systems
Engineer
The project team
Expert on the Institution’s Needs
Administration
The project team
Expert on the Laboratory’s Needs
User group
The project team
Expert on the Building’s Needs
Facilities rep
Select the technology that you want and define the ___________
Text menu
Enumerate the project phases - architecture
- Charrette
- Schematic
- Design development
- Construction drawings
- Construction administration
- Closeout
Project design phases
● Programming
● Schematic Design
● Design Development
● Construction Documents
● Bidding and Negotiation
● Construction
Project design phase
● All issues that will affect the lab and the facilities will be
presented and evaluated.
● Equipment, personnel, existing conditions and finances.
Programming
SMART as project goals is under what project design phase
Programming
Meaning of SMART
➔ Specific
➔ Measurable
➔ Achievable
➔ Relevant
➔ Time-Bound
Refers to:
Increasing complexity of test, increased
automation, genetic testing and personalized medicine, the
need to reconfigure the lab in the future
Drivers of Transition
Looking up/looking down?
● Traditional Service Column
● Ceiling Panel
● Ceiling Structure
Up
Looking up/looking down?
● Services & Utilities
Down
Refers to
● Manufacturer/model
● dimension/ clearance required
● Electrical
● Data information - LIS (Laboratory Information System)
● Plumbing
● HVAC
Equipment - Info generated
Refers to:
● Shows all major equipment whether countertop or floor
mounted.
● Assists in the discussion of specific workflow and staff
movement.
● Illustrates whether sufficient workspace is allowed for each
instrument and procedure.
● Subject to amendments.
Schematic design plan
Graphic illustration of a laboratory block plan that shows
how samples, staff, waste, supplies, and visitors may move
through the space.
Movement diagram
Refers to
● Purely technical
● Intended to convey expectations for a final product rather
than the means and methods to construct said project.
● Correct information acquired in the design phase could
result in substantial savings during construction.
● Outline material qualities and usage.
● The longest phase of the design process.
● No major changes will occur during this phase.
Construction documents
In this phase, construction documents are sent to the contractors who will review documents and estimate cost of construction
Bidding and negotiation
Evaluate all the potential costs and revenues that a company might generate from the project.
Cost-benefit analysis
In many models, this will also factor the opportunity cost into the decision-making process.
Cost-benefit analysis
They often act as the liaison source between
numerous disciplines during construction to ensure the needs of the lab staff are being met, while also keeping the project on track, and on budget.
Lab managers
Strong evidence from research in the construction industry reveals that one of the factors that cause construction projects to fail stems from the decisions made in the _______ and _____ phase.
Engineering and design phase
Refers to:
● Must be well organized.
● Equipment is coded or numbered for easy placement.
● Existing equipment must be recalibrated and
decontaminated before moving.
● Moving analyzers, irradiators and hood must be supervised
by manufacturers.
● Cost of moving will be added to the budget.
Moving in
Applicable for remodeling of existing laboratories wherein,
construction activity is done by phases to assure continuous
laboratory activity/service.
Phasing
Refers to which phase?
When the last piece is fitted in the lab, the power, and water are turned on and work commences, that is not the end of the construction/renovation. It is essential that you review the lab/s impact over the next few months and years to identify whether it was a success.
Phasing
Lab classification in relation to hazards
● High hazard
● 10 to 20 gal. of various flammable or combustible liquids
allowed.
Class A
Lab classification in relation to hazards
● Intermediate Hazard
● 5 to 10 gal. of various flammable or combustible liquids
allowed.
Class B
Lab classification in relation to hazards
● Low Hazard
● 2 to 4 gal. of various flammable or combustible liquids
allowed.
Class C
BSL
Infectious agents not known to cause disease in healthy adults.
1
BSL
● Infectious agents associated with human disease.
● Ability to infect through autoinoculation, ingestion, and mucous membrane exposure.
2
BSL
● Infectious agents with potential for aerosol transmission.
● Effects may be serious or lethal
3
BSL
● Infectious agents which pose high risk of life-threatening disease, aerosol transmitted lab infectious, or agents with unknown risk of transmission.
4
Refers to the CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability.
Referral tests
T or F: The referral laboratory must be a NIH -licensed CL.
False (DOH)
There must be what kind of agreement with the DOH CL?
Memorandum of Agreement
T or F: A separate MOA is required when referred tests are not within the service capability of the CL unless the referral is part of the contingency plan.
True
Familiarize the LTO requirements
● Completely filled out application Form 1 and its
attachments (downloadable at www.hfsrb.doh.gov.ph).
➔ Notarized Acknowledgment
➔ Any of the following proof of ownership and name
of health facility.
➔ DTI/SEC/CDA Registration including Articles of
Incorporation/Cooperation and By-Laws.
➔ Enabling Act/LGU Resolution (for government
health facility)
➔ Accomplished Self-Assessment Tool
➔ Health Facility Geographic Form
● Copy of official receipt payment
Where will you submit the LTO application?
HFSRB-CHD-RLED
Days of processing application
20 days
T or F: There is no need for DOH to visit the lab after application of LTO
False (Issuance of LTO and post-licensing visit)
Validity of LTO
1 year
What kind of suspension is implied under monitoring compliance?
Preventive
T or F: CL that are operated and maintained exclusively for research and teaching purposes can issue official results for diagnostic purposes.
False (shall not)
What will be issued against those who operate a CL without securing the necessary rqs?
Cease-and-Desist Order (CDO) and shall pay the administrative penalty of Fifty thousand pesos (P 50,000)
How many days is the preventive suspension that may be given?
60 days
CL with revoked licenses can only reapply after after how many years?
1
