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Biosafety in the Clinical
Laboratory
A SMILE Presentation
Patient Safety Monitoring in International
Laboratories (SMILE)
1
Responsibility
Safety is Everyone’s Responsibility!
Patient Safety Monitoring in International
Laboratories (SMILE)
2
Laboratory Responsibility
• To develop biosafety policies and
procedures
• To advise personnel of special hazards
• To provide Personal Protective
Equipment (PPE)
• To maintain safety equipment: fire
extinguishers, blankets, eye wash
stations
• To train employees to recognize
potential hazards and proper handling
procedures
Patient Safety Monitoring in International
Laboratories (SMILE)
3
Staff Members
When working with infectious agents or
potentially infected materials:
• Must be aware of potential hazards;
• must read and follow required procedures;
• must be trained and proficient in practices and
techniques required;
• must report unsafe conditions or incidents to the
Laboratory Director.
Patient Safety Monitoring in International
Laboratories (SMILE)
4
The Laboratory Director is
responsible for selecting
additional safety practices in
keeping with the hazards
associated with the agents and
procedures.
Patient Safety Monitoring in International
Laboratories (SMILE)
5
Biosafety Program
Objective: The containment of potentially
harmful biological agents.
Purpose: To reduce or eliminate exposure of
laboratory workers, other persons, and the
outside environment to potentially hazardous
agents.
Patient Safety Monitoring in International
Laboratories (SMILE)
6
BioSafety
Containment = methods for managing
infectious agents in the laboratory
environment where they are being
maintained or handled
Patient Safety Monitoring in International
Laboratories (SMILE)
7
The most important element of
containment is:
Strict adherence to
standard microbiological
practices and technique
Patient Safety Monitoring in International
Laboratories (SMILE)
8
Biosafety
Elements of containment:
• Laboratory practices and techniques
• Safety equipment
• Facility design
Patient Safety Monitoring in International
Laboratories (SMILE)
9
Standard Microbiological Practices
• Policies must be enforced
• Handwashing
• No eating, drinking, chewing gum, smoking, or
storing of food in laboratory areas
• No mouth pipetting
• Sharps handling policy
• Procedures to minimize splashes and aerosols
Patient Safety Monitoring in International
Laboratories (SMILE)
10
Standard Microbiological Practices
• Decontamination of work surfaces
• Decontamination of cultures, stocks and
infectious materials
• Sign posted with Universal Biohazard symbol
when infectious agents are present
• Effective pest management program
• Appropriate training regarding duties
Patient Safety Monitoring in International
Laboratories (SMILE)
11
Hand Washing
•
•
•
•
•
When to wash?
What to use?
Where to wash?
How long?
Why wash?
Patient Safety Monitoring in International
Laboratories (SMILE)
Decontamination
• When cleaning up surfaces use 5% freshly diluted
bleach or another approved disinfectant
• Do an initial wipe up
• Spray and allow it to stand for ten minutes then
wipe up
• Dispose of all wipes in biohazard containers
• PPE should be removed and
disposed of in biohazard containers
Patient Safety Monitoring in International
Laboratories (SMILE)
Biosafety
Primary containment
The protection of personnel and the
immediate laboratory environment from
exposure to infectious agents, is provided
by good technique and the use of
appropriate safety equipment.
Patient Safety Monitoring in International
Laboratories (SMILE)
14
Personal Protective Equipment
(PPE)
Anything that is used to
protect a person from
exposure
Patient Safety Monitoring in International
Laboratories (SMILE)
Biosafety
Personal Protective Equipment (PPE)
Gloves/shoe covers/boots
Safety glasses/Goggles/face shields/respirators
Lab coats/gowns (should be fluid resistant)
Clothing should provide protection to skin
Closed toe shoes
Patient Safety Monitoring in International
Laboratories (SMILE)
16
Biosafety
How much PPE should you use?
Wear as much or as little as you will need to prevent blood and
other infectious materials from contact with your skin,
mucus membranes and clothing.
Used in combination with BSCs and other devices that contain
the agent being handled.
Patient Safety Monitoring in International
Laboratories (SMILE)
17
PPE Rules to Remember
• Always check PPE for defects or tears before
using
• If PPE becomes torn or defective, remove and
get new
• Remove PPE before leaving a contaminated
area
• Do not reuse disposable PPE
Patient Safety Monitoring in International
Laboratories (SMILE)
Biosafety
Safety equipment:
BSCs
Enclosed containers
Other engineering controls
Patient Safety Monitoring in International
Laboratories (SMILE)
19
Biosafety
Biological Safety Cabinet (BSC)
The principle device used to provide
containment of infectious splashes or
aerosols generated by microbiological
procedures
Patient Safety Monitoring in International
Laboratories (SMILE)
20
Biosafety
Safety Centrifuge Cup
An enclosed container designed to
prevent aerosols from being released
during centrifugation.
Patient Safety Monitoring in International
Laboratories (SMILE)
21
Biosafety
Secondary containment
The protection of the external laboratory
environment from exposure to infectious
materials, is provided by a combination of
facility design and operational practices.
Patient Safety Monitoring in International
Laboratories (SMILE)
22
Biosafety
Secondary Barriers:
• Doors for access control
• A sink for handwashing
• Laboratory design for easy cleaning- no carpets
or rugs
• Furniture for laboratory use
• Windows fitted with screens
Patient Safety Monitoring in International
Laboratories (SMILE)
23
Biosafety
When the risk of infection by exposure to an
infectious aerosol is present, higher levels
of primary containment and multiple
secondary barriers may be necessary to
prevent infectious agents to escape into the
environment.
Patient Safety Monitoring in International
Laboratories (SMILE)
24
Biosafety
These guidelines specify four biosafety
levels (BSL) based on the potential
hazard of the infectious microorganisms
Patient Safety Monitoring in International
Laboratories (SMILE)
25
Biosafety
•
•
•
•
BSL-1
Agents- not known to consistently cause
disease in healthy adults
Practices- Standard Microbiological practices
Primary Barriers- Labcoats or gowns, gloves
worn if broken skin or rash on hands,
protective eyewear for possible splashes
Secondary Barriers- Open bench top sink
required
Patient Safety Monitoring in International
Laboratories (SMILE)
26
Biosafety
•
•
•
•
BSL-2
Agents- associated with human disease, hazard=
percutaneous injury, ingestion, mucus membrane
exposure
Practices- BSL-1 plus limited access; hazard
warning signs; sharps precautions; Biosafety
manual
Primary Barriers- Biological safety cabinet (BSC),
PPE’s: labcoats, gloves, face protection is needed.
Secondary Barriers- BSL-1 plus: Autoclave
available
Patient Safety Monitoring in International
Laboratories (SMILE)
27
Biosafety
•
•
•
•
BSL-3
Agents- indigenous or exotic agents with potential for
aerosol transmission; disease may have serious or lethal
consequences. Hazard- autoinoculation, ingestion, and
exposure to aerosols.
Practices- BSL-2 plus controlled access; decontamination of
all waste; decontamination of lab clothing before
laundering; baseline serum
Primary Barriers- Biological safety cabinet (BSC), PPE’s:
protective lab clothing, gloves, respiratory protection as
needed.
Secondary Barriers- BSL-2 plus: Physical separation from
access corridors; self closing double door access; exhausted
air not re-circulated; negative airflow into lab
Patient Safety Monitoring in International
Laboratories (SMILE)
28
Biosafety
BSL-4- is applicable to working with dangerous
and exotic agents which pose a high individual
risk of life-threatening disease.
This level is not applicable to the diagnostic
laboratory.
Patient Safety Monitoring in International
Laboratories (SMILE)
29
Biosafety
Biological Safety Cabinets (BSC) used for
Biosafety Levels 1,2,3 and 4 depending on the
tasks are divided into 3 classes.
Patient Safety Monitoring in International
Laboratories (SMILE)
30
Biosafety
Class I BSC
• negative pressure with minimum face velocity of
75 linear feet per minute
• all of the air from the cabinet is exhausted
through a HEPA filter either into the laboratory,
or to the outside.
• provides protection of personnel and
environmental but not product
• Class I BSCs are no longer being manufactured on
a regular basis
Patient Safety Monitoring in International
Laboratories (SMILE)
31
Biosafety
Class II BSC
• Provides a face velocity of 75 – 100 linear feet
per minute,
• HEPA-filtered vertical laminar airflow provides
personnel, product and environmental
protection
• All Class II cabinets are designed for work with
BSL-1,2,and 3.
• not for use with volatile or toxic chemicals.
Patient Safety Monitoring in International
Laboratories (SMILE)
32
Biosafety
Class III BSC
• Is totally enclosed, ventilated cabinet of gas-tight
construction
• highest degree of personnel and environmental
protection from infectious aerosols, as well as
protection of research materials from
microbiological contamination.
• for work with hazardous agents that require
Biosafety level 4 containment.
Patient Safety Monitoring in International
Laboratories (SMILE)
33
Biosafety
General suggestions:
Effectiveness of the BSC is a function of
directional air flow (Inward and downward)
through a “high efficiency particulate air”
(HEPA) filter. Anything such as rapidly moving
your arms in and out of the BSC, doors
opening, and people walking rapidly behind
you, can disrupt the air flow which will reduce
the cabinet’s effectiveness.
Patient Safety Monitoring in International
Laboratories (SMILE)
34
Biosafety
Operational suggestions:
• Do not place objects on or over front or rear air intake grilles
• Arrange materials to segregate contaminated and clean items
• Work should be performed at least six inches back from front
grille
• Inside the BSC, always use discard pans containing
appropriate disinfectant
• Clean up spills immediately. Wait 5 minutes before resuming
work
• Do not use the BSC for storage
Patient Safety Monitoring in International
Laboratories (SMILE)
35
Biosafety
Questions and Comments
Patient Safety Monitoring in International
Laboratories (SMILE)
36
Biosafety
Reference:
Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, US
Government Printing Office found at
http://www.cdc.gov/OD/ohs/pdffiles/bsl123.pdf
Patient Safety Monitoring in International
Laboratories (SMILE)
37