(M) Lec 4: Setting Up and Managing a Clinical Laboratory Flashcards by Martin Andrei Loyola

Main role as a Medical Technologist

Generate accurate,
timely results

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Refers to generating results based on the limited resources
that you have.

Quality

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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

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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

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Refers to tme you receive your sample and request up to the time that the results are available

TAT

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EQAP is given every when?

Annually

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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

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Specific requirement

● Counter/Tray
● Space for patient seating
● Hand-washing stations (dedicated cubicle/designated toilet
for specimen collection).

Collection areas

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Specific requirement

● Not within a high volume traffic.
● Hand-washing area (dressing area) at entry and exit points

Exits/Entrance/Traffic

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Specific requirements

● Stainless steel sink; depth at least 8” and a gooseneck faucet.

Sink

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Specific requirements

● Each sections

Properly identified/labeled

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Specific requirements

● Preferably outside of the working area and it should be
adjacent to the laboratory.
● Separate for patients and for staff.

Toilets/Amenities

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Specific requirements

● Fluctuations in air supply and exhaust or the operations of equipment do not alter the performance standard of the cabinet/food

BSC

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Specific requirements

● No more than 23 meters of travel distance to any exit door
from any point of the clinical working area.

Fire safety

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Specific requirements

Minimum width shall be at least but not limited to 1.20 meters or four (4) feet.

Corridors

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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

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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

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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

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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

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Specific requirements

● Continuous and sufficient supply of water.
● Piping systems shall be kept conceals, yet easily accessible
for service and

Plumbing

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Specific requirements

● Artificial AC provided in the clinical working area to attain required HVAC.

Ventilation - directional airflow

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Specific requirements

● ADEQUATE for staff, activity, equipment, and utility.

Space

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Minimum working area for primary lab

10 sq

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Minimum working area for secondary

20 sq

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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

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.

BSL ● Infectious agents associated with human disease. ● Ability to infect through autoinoculation, ingestion, and mucous membrane exposure.

BSL ● Infectious agents with potential for aerosol transmission. ● Effects may be serious or lethal

BSL ● Infectious agents which pose high risk of life-threatening disease, aerosol transmitted lab infectious, or agents with unknown risk of transmission.

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?