(M) Lec 4: Setting Up and Managing a Clinical Laboratory Flashcards

1
Q

Main role as a Medical Technologist

A

Generate accurate,
timely results

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2
Q

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

A

Quality

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3
Q

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

A

Internal Quality Assurance Program

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4
Q

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

A

Continuous Quality Improvement Systems

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5
Q

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

A

TAT

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6
Q

EQAP is given every when?

A

Annually

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7
Q

Familiarize factors needed to be assessed by top management

A

● Location (Geography)
● Privacy
● Conformance with Building Laws (PTC)
➔ Mandatory
● Ventilation
● Spaces Required
● Functional and Planning Considerations

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8
Q

Specific requirement

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

A

Collection areas

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9
Q

Specific requirement

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

A

Exits/Entrance/Traffic

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10
Q

Specific requirements

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

A

Sink

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11
Q

Specific requirements

● Each sections

A

Properly identified/labeled

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12
Q

Specific requirements

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

A

Toilets/Amenities

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13
Q

Specific requirements

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

A

BSC

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14
Q

Specific requirements

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

A

Fire safety

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15
Q

Specific requirements

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

A

Corridors

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16
Q

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

A

Clearances

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17
Q

Specific requirements

● Within 30 meters of work access, a hands-free eyewash unit with a hand wash unit is preferred.
● Pressure is required

A

Emergency eyewash/shower

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18
Q

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

A

Lighting

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19
Q

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.

A

Ceiling height

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20
Q

Specific requirements

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

A

Plumbing

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21
Q

Specific requirements

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

A

Ventilation - directional airflow

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22
Q

Specific requirements

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

A

Space

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23
Q

Minimum working area for primary lab

A

10 sq

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24
Q

Minimum working area for secondary

A

20 sq

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25
Q

Minimum working area for tertiary lab

A

60 sq

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26
Q

Optional section for secondary lab

A

Immunology sero and histopath

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27
Q

Optional section for primary lab

A

Histopath

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28
Q

These sections in a tertiary lab is room type

A

Microbio ad histopath

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29
Q

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

A

AO: 2021-0037

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30
Q

Aralin niyo yung space and area requirement under AO

A

Dali na ‘di ko ma-copy paste eh

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31
Q

The project team

Expert on lab design

A

Archi

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32
Q

The project team

● Communicator
● Consensus Builder
● Expeditor

A

Project manager

33
Q

The project team

Expert on lab systems

A

Engineer

34
Q

The project team

Expert on the Institution’s Needs

A

Administration

35
Q

The project team

Expert on the Laboratory’s Needs

A

User group

36
Q

The project team

Expert on the Building’s Needs

A

Facilities rep

37
Q

Select the technology that you want and define the ___________

A

Text menu

38
Q

Enumerate the project phases - architecture

A
  • Charrette
  • Schematic
  • Design development
  • Construction drawings
  • Construction administration
  • Closeout
39
Q

Project design phases

A

● Programming
● Schematic Design
● Design Development
● Construction Documents
● Bidding and Negotiation
● Construction

40
Q

Project design phase

● All issues that will affect the lab and the facilities will be
presented and evaluated.
● Equipment, personnel, existing conditions and finances.

A

Programming

40
Q

SMART as project goals is under what project design phase

A

Programming

41
Q

Meaning of SMART

A

➔ Specific
➔ Measurable
➔ Achievable
➔ Relevant
➔ Time-Bound

42
Q

Refers to:

Increasing complexity of test, increased
automation, genetic testing and personalized medicine, the
need to reconfigure the lab in the future

A

Drivers of Transition

43
Q

Looking up/looking down?

● Traditional Service Column
● Ceiling Panel
● Ceiling Structure

A

Up

44
Q

Looking up/looking down?

● Services & Utilities

A

Down

45
Q

Refers to

● Manufacturer/model
● dimension/ clearance required
● Electrical
● Data information - LIS (Laboratory Information System)
● Plumbing
● HVAC

A

Equipment - Info generated

46
Q

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.

A

Schematic design plan

47
Q

Graphic illustration of a laboratory block plan that shows
how samples, staff, waste, supplies, and visitors may move
through the space.

A

Movement diagram

48
Q

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.

A

Construction documents

49
Q

In this phase, construction documents are sent to the contractors who will review documents and estimate cost of construction

A

Bidding and negotiation

50
Q

Evaluate all the potential costs and revenues that a company might generate from the project.

A

Cost-benefit analysis

51
Q

In many models, this will also factor the opportunity cost into the decision-making process.

A

Cost-benefit analysis

52
Q

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.

A

Lab managers

53
Q

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.

A

Engineering and design phase

54
Q

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.

A

Moving in

55
Q

Applicable for remodeling of existing laboratories wherein,
construction activity is done by phases to assure continuous
laboratory activity/service.

A

Phasing

56
Q

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.

A

Phasing

57
Q

Lab classification in relation to hazards

● High hazard
● 10 to 20 gal. of various flammable or combustible liquids
allowed.

A

Class A

58
Q

Lab classification in relation to hazards

● Intermediate Hazard
● 5 to 10 gal. of various flammable or combustible liquids
allowed.

A

Class B

59
Q

Lab classification in relation to hazards

● Low Hazard
● 2 to 4 gal. of various flammable or combustible liquids
allowed.

A

Class C

60
Q

BSL

Infectious agents not known to cause disease in healthy adults.

A

1

61
Q

BSL

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

A

2

62
Q

BSL

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

A

3

63
Q

BSL

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

A

4

64
Q

Refers to the CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability.

A

Referral tests

65
Q

T or F: The referral laboratory must be a NIH -licensed CL.

A

False (DOH)

66
Q

There must be what kind of agreement with the DOH CL?

A

Memorandum of Agreement

67
Q

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.

A

True

68
Q

Familiarize the LTO requirements

A

● 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

69
Q

Where will you submit the LTO application?

A

HFSRB-CHD-RLED

70
Q

Days of processing application

A

20 days

71
Q

T or F: There is no need for DOH to visit the lab after application of LTO

A

False (Issuance of LTO and post-licensing visit)

72
Q

Validity of LTO

A

1 year

73
Q

What kind of suspension is implied under monitoring compliance?

A

Preventive

74
Q

T or F: CL that are operated and maintained exclusively for research and teaching purposes can issue official results for diagnostic purposes.

A

False (shall not)

75
Q

What will be issued against those who operate a CL without securing the necessary rqs?

A

Cease-and-Desist Order (CDO) and shall pay the administrative penalty of Fifty thousand pesos (P 50,000)

76
Q

How many days is the preventive suspension that may be given?

A

60 days

77
Q

CL with revoked licenses can only reapply after after how many years?

A

1