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2015 APHL – ASCLS Webinar Series
A Rational Approach to Emerging Pathogen Biosafety Considerations
4/16/2015
Speaker
Michael Pentella, PhD, Director of the Bureau of Laboratory Sciences at the Hinton State Laboratory
Institute, MA Dept. of Public Health, Boston, MA
Dr. Pentella is the Bureau Director, Massachusetts Bureau of Laboratory Science. He has a Bachelor of
Science degree from The Ohio State University in microbiology, a Master’s of Science Degree from
Thomas Jefferson University in Clinical Microbiology, and a Doctor of Philosophy Degree from the
University of South Florida in Infectious Diseases. He has over thirty years’ experience in the clinical
microbiology laboratory and over twenty years’ experience in hospital infection control and epidemiology.
He is certified as a specialist in microbiology through the American Society for Clinical Pathology, in
infection control through the Association of Professionals in Infection Control and is certified as an
American Board of Medical Microbiology Diplomate. He is a member of several national committees, for
infectious diseases and preparedness, such as APHL’s Infectious Disease Committee.
Objectives
At the conclusion of this program, participants will be able to:

Review the biosafety risk assessment process.

List examples of risk assessments for emerging pathogens.
Continuing Education Credit
The American Society for Clinical Laboratory Science (ASCLS) is approved as a provider of continuing education programs in the
clinical laboratory sciences by the ASCLS P.A.C.E.® Program. Participants who successfully complete each program will be awarded
1.0 contact hours. ASCLS P.A.C.E.® is accepted by the ASCP Board of Certification and all states including Florida and California as
an approved provider of continuing education. ASCLS will submit attendance to CE Broker for Florida licensees. Continuing education
credits are available to individuals who successfully complete the program and evaluation by 10/16/2015.
CPH-recertification credit is not available for this program.
Evaluation/Printing Certificate
C. Evaluation (complete first)
Go to http://ascls.webedcafe.com/registration/999/5/r/Biosafety and complete the evaluation by 10/16/2015, Upon completion of
the evaluation, you will be sent to a page with a unique session code and instructions on how to use CE Organizer. Print out that
page. Record the session code number. You will need this number in CE Organizer to get credit for attending the session.
B. Certificate
a. If you have not used CE Organizer before, I suggest you take a moment to view the tutorial on the ASCLS web site at
http://ceorganizer.ascls.org/. After you have used the program once or twice, you will be quite comfortable with it.
If you do have questions or comments, please call 571-748-3770 or email [email protected].
b. Here is a brief summary describing how to use the ASCLS CE Organizer:
1. Go to http://ceorganizer.ascls.org/.
2. If you already have a CE Organizer account, log in with your email address and password. If you have not used CE
Organizer before, scroll down the page to the Log In instructions. ASCLS members will log in using the same username and
password used to enter the Members Section of the ASCLS website. ASCLS members without a username and password
should click on the link to register. If you are not an ASCLS member, click the “Register Here” link to create a username
and password. If you cannot remember your username or password, send an email request to [email protected]. Do not
create another username and password.
3. Once logged in, click on Certificates.
4. In the list of ASCLS P.A.C.E. ® approved events, click on “APHL-ASCLS Webinar Series.”
5. On the next screen, check the box(es) of the/every webinar you attended and click “Next” at the bottom of the page. If you
cannot see the checkboxes, you may need to use the scroll bar at the bottom of the page.
Archived Program
The archived streaming video will be available within one day after the live program. Anyone from your site can view the Web archived
program and/or complete the evaluation and print the certificate for free. Registration is not necessary for the archive program. For Live
or archived site registrations, the URL will be sent to the site representative who is responsible for distributing the URL.
Comments, opinions, and evaluations expressed in this program do not constitute endorsement by APHL/ASCLS. The APHL/ASCLS does not authorize any program faculty
to express personal opinion or evaluation as the position of APHL/ASCLS. The use of trade names and commercial sources is for identification only and does not imply
endorsement by the program sponsors.
© This program is copyright protected by the speaker(s), ASCLS and APHL. The material is to be used for this APHL/ASCLS program only. It is strictly forbidden
to record the program or use any part of the material without permission from the author, ASCLS or APHL. Any unauthorized use of the written material or
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Biosafety Topics Are In the Forefront
A Rational Approach to
Emerging Pathogen
Biosafety Considerations
A step-by-step approach to
assess the risk and assure
preparedness.
Michael Pentella, PhD, D(ABMM)
[email protected]
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Emerging Pathogens by Decade
Objectives
• Review the biosafety risk assessment
(RA) process
• Provide examples of risk assessments for
emerging pathogens
Legionella pneumophila
Norwalk virus
MRSA
Helicobacter pylori
E. Coli O157
Prions
VRE
Cryptosporidium
Chikungunya
MERS
D68
Ebola
________________________________ _______________________________
HIV
Campylobacter
Toxic Shock Syndrome
Ehrlichia
West Nile virus
SARS
Nipah virus
Novel H1N1
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What do you do when you learn of
an emerging pathogen?
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Assemble a team
of subject matter experts
• Ask questions:
• Potential SME’s: Infectious Disease
Physician, Microbiologist, Infection
Preventionist
• Learn everything you can about the
emerging pathogen
• Monitor CDC website and listservs
• Engage the facility safety committee
– Is it reasonable to expect to see patients with
this pathogen at your facility?
– What patient populations will likely be
infected?
– What is the clinical setting that you may see
this pathogen?
– Based on the differential diagnosis, what tests
may be ordered?
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Treat it as an infection control problem:
Chain of Infection
Risk can be defined as the probability that a health effect will occur after an individual has been exposed to a specified amount of hazard. Agent
Agent
Susceptible Host
Risk is the probability
that a health event will
occur after an
exposure to a specified
amount of hazard
Reservoir
Risk assessment is the process of gathering all available information on a hazardous substance and evaluating it to determine the possible risks associated with exposure. This is followed by determining the mitigation strategies necessary to provide protection. There is no one standard approach to the RA process.
Portal of Exit
The risk can be mitigated but never zero. Goal: Predict, Identify and Mitigate Risk
Means of Spread
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Step 1
Risk Assessment Goals:
Balancing risk and work performance
Step 1
Practices
implemented to
mitigate risk
What should the Risk Assessment
Cover?
• Pre-analytical activities from the time the
specimen is collected, transported,
unpackaged, centrifuged, aliquoted, and
moves through the lab
• Analytical activities
• Post-analytical activities – clean up of
the lab and destruction of the specimen
and lab generated materials
Performance
of work in a
safe, accurate
and efficient
manner.
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Step 1
Step 1
Steps to complete RA
1.a. Identify agent hazards and perform an initial
risk assessment, place the findings in writing
•
•
•
•
•
•
1.b. Identify lab procedure hazards, place the
findings in writing
1.c. Review assessment with staff and
management
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Risk Assessment Information:
Know the Agent
Pathogenicity
Virulence
Infectious dose
Routes of Transmission
Type of specimens needed for detection
Sources for the information: BMB 5th ed.,
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Step 1
Step 1
Risk Assessment Information:
Who is susceptible?
Questions to ask?
‒ What are the likely specimen types you will
receive and will they contain the pathogen?
‒ Who collects the specimens?
‒ Will the lab be notified of the suspect agent?
‒ How will specimens be transported?
‒ Is there a need to track who handles the
specimens in case of exposure?
‒ How will specimens be handled in the lab?
‒ What disinfectant will be used?
‒ How will spills be handled?
‒ How will specimens and waste be discarded?
• Who is at risk?
– Direct workers?
– Employees in general work vicinity?
– Visitors to the lab?
• Individual level Susceptibility?
• Available vaccination or antibiotic
prophylaxis?
• Effective treatment?
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Step 1
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Step 1
Risk Assessment Information:
Review Protocols
RA - Predict and Identify Risk:
Example – working with a bloodborne pathogen
Procedure
• Agent Concentration in specimens
• Suspension Volume
• Generation of Aerosols, Droplets or
Droplet Nuclei
• Protocol Complexity
• Use of Sharps
• Use of Animals
Preparation
of blood
specimen for
testing
Potential Hazards
Control
Breakage/
Aerosolization/
Splash/
Splatter
Comment
-Minimize number
of staff handling
specimen
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Step 1
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Step 1
RA - Predict and Identify Risk:
RA - Predict and Identify Risk:
Example – working with a blood culture bottles
Procedure
Blood
Cultures
Potential
Hazards
Aerosolization/
Splash/Splatter/
Contact with
Blood
Control
Example – Packaging and Shipping Specimens
Comment
Procedure
-Use plastic
bottles if
available.
Packaging &
Shipping of
Specimens
Potential
Hazard
Control
Comment
Breakage and
Aerosolization
1990
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Step 1
Step 1
RA - Predict and Identify Risk:
RA - Predict and Identify Risk:
Example – Stools Specimens
Example – Sputum Specimens
Procedure
Inoculation of
Stool specimen
for culture
Potential Hazard
Control
Comment
Procedure
Leaking
containers,
external
contamination of
container,
Splash and
Splatter
Inoculation of
Sputum
specimen for
culture
Potential Hazard
Control
Comment
Leaking
containers,
external
contamination of
container,
Splash and
Splatter
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Step 2:
Selection of
Mitigation
Tools
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Step 2
Biosafety level
Tasks to select safety practices
Engineering Controls
PPE
Lab Practices
• Review the risk assessment
• Determine the appropriate control for the
identified risk
• Write the control into the procedure
manual
Medical
Waste
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Step 2
Step 2
Predict, Identify, & Mitigate Risk:
Lab Safety Practices
Example – working with a bloodborne pathogen
• Personal Protective
Equipment
• Disinfectant
Procedure
Preparation
of blood
specimen for
testing
– Daily Disinfectant BSC,
Counters and Centrifuge
•
•
•
•
•
•
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Capped Centrifuge tubes
Splash Proof Containers
Use Of UV lights
Use disposable loops
Allow slides to dry in BSC
Spill Clean-up procedure
Potential Hazards
Breakage/
Aerosolization/
Splash/
Splatter
Control
Comment
-Use PPE: fluid resistant
back-closing gown,
double gloves, N95
respirator and goggles,
or full face shield, (eyes
and mucous membranes
covered).
-Perform work in the
BSC.
-No exposed skin
inside the BSC.
Immediately
change gloves if
contamination is
visible or
suspected.
-Bring all necessary
material into the
BSC before starting
to work.
-Do not enter and
re-enter BSC once
specimen
processing begins.
Document annual competency
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Step 2
Step 2
Predict, Identify, & Mitigate Risk:
Predict, Identify, & Mitigate Risk:
Example – working with a blood cultures
Procedure
Blood
Cultures
Potential
Hazards
Control
Aerosolization/
Splash/Splatter/
Contact with
Blood
-Once received in the
laboratory, all specimens
should be opened inside a
BSC.
-Inspect for any signs of
breakage.
-Wipe the outside of the
bottles with hospital
approved disinfectant
-Place the bottles into a
rigid leak proof container
and carry the container to
the blood culture
instrument.
Example – Packaging and Shipping Specimens
Comment
Procedure
-Use plastic
bottles if
available.
Packaging &
Shipping of
Specimens
Potential
Hazard
Breakage and
Aerosolization
Control
Comment
-Specimens should be
packaged and shipped
without attempting to open
collection tubes or aliquot
specimens.
-Specimens must be
packaged based on the
triple packaging system
which consists of a tube in
a sealable specimen bag
with absorbent material
(primary receptacle) placed
in a watertight, leak-proof
container (secondary
receptacle).
Packaging
and shipping
of Infectious
Substances or
Biological
Substances
should only be
performed by
laboratory
personnel who
are trained
and certified
to do so.
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Step 2
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Step 2
RA - Predict and Identify Risk:
RA - Predict and Identify Risk:
Example – Stools Specimens
Example – Sputum Specimens
Procedure
Inoculation of
Stool specimen
for culture
Potential Hazard
Leaking
containers,
external
contamination of
container,
Splash and
Splatter
Control
Comment
Procedure
-Once received in
the laboratory, all
specimens should
be opened inside
a BSC.
-Inspect for any
signs of leakage.
-Wipe the outside
of container with
hospital approved
disinfectant.
Inoculation of
Sputum
specimen for
culture
Potential Hazard
Leaking
containers,
external
contamination of
container,
Splash and
Splatter
Control
Comment
-Once received in
the laboratory, all
specimens should
be opened inside
a BSC.
-Inspect for any
signs of leakage.
-Wipe the outside
of container with
hospital approved
disinfectant.
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Step 2
Step 3: Connect to Biosafety
Competencies
Predict, Identify, & Mitigate Risk:
Example – ebola
Procedure
Potential
Hazards
Centrifuging Aerosolization
Control
-Ensure o-ring
microcentrifuge tube
is tightly sealed.
-Use sealed head
rotor inside the
BSC.
-Must
decontaminate
specimen before
removing from BSC.
Further Needs
• Connect competencies to required skills
Action – Skill Domain I: Potential hazards
– Skill Domain II: Hazard controls
– Skill Domain III: Administrative controls
– Skill Domain IV: Emergency preparedness
and response
-Perform “mock” Supervisor
sample to
practice
technique
• Determine education and training needs
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Step 3
Step 3
Intent of the Guidelines
Competency Domains
• Define essential competencies needed by
laboratory personnel to work safely with
biologic materials and other hazards
commonly found in biologic laboratory
• Reduce the risk of exposures at all levels
• Provide essential base-line information for
a format to develop facility specific
competencies
• Target audience is the laboratorian
•
•
•
•
Skill Domain I: Potential hazards
Skill Domain II: Hazard controls
Skill Domain III: Administrative controls
Skill Domain IV: Emergency
preparedness and response
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Step 3
Step 3
Competencies are Tiered to Three
Professional Levels of Practitioners
Field
Entry Level
Academia or
research
Technician, research Principal investigator,
associate, or
laboratory manager,
specialist
postdoctoral student,
or senior or staff
scientist
Midlevel
Principal
investigator or
branch or division
manager
Clinical
setting
Laboratory scientist
or medical
technologist
Laboratory
manager, chief
technologist, or
hospital or clinic
director
Chief/head scientist
or medical
technologist,
laboratory specialist,
or laboratory manager
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Skill Domain I: Potential hazards
• Focused on competencies involved with
understanding the hazards.
• Recognition is the first step in prevention
• Subdomains:
Senior level
– Biologic Materials
– Research animals
– Chemical materials
– Radiologic materials
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Step 3
Skill Domain II: Hazard controls
• Focuses on use of primary and secondary
barriers to prevent exposure
• Competencies for decontamination and
management of hazardous waste
• Subdomains:
–
–
–
–
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Personal protective equipment
Engineering controls-equipment (primary barriers)
Engineering controls- facility (secondary barriers)
Decontamination and waste control management
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Step 3
Skill Domain III: Administrative Controls
• Focuses on administrative controls to reduce
the duration, frequency and severity of
exposure to hazardous materials or situations
• Subdomains:
–
–
–
–
–
Hazard communication and signage
Guidelines and regulatory compliance
Safety program management
Occupational health – medical surveillance
Risk Management
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Step 3
Skill Domain IV: Emergency
preparedness and response
• Focuses on management of emergencies
• Subdomains:
– Emergencies and incident response
– Exposure prevention and hazard mitigation
– Emergency response –exercises and drills
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Step 3
Tasks to Link to Biosafety
Competencies
• Review the competencies
• Select the competencies from each
domain that are applicable to the lab
based on the risk assessment
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Step 4
Step 4:
Accomplish education and training
Perform Safety Education & Training
• Based on RA and competencies design
the training that is needed.
• Determine what outside training is
available and what site specific training is
needed.
• Consider the best format for the training
• Write materials and exams for in house
training
• Educate staff about the hazards identified
in the risk assessment
• Train staff on use of safety practices:
Engineering controls, PPE, lab practices
• Require staff to review changes to the
procedures
• Determine staff level of knowledge by
observation and testing
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Step 5
Step 5:
Following up on the biosafety plans
Safety Audits
• Exercise the procedures
• Audit the program by self audits, internal
audits, external audits
• Monitor staff and equipment performance
• Mandate Reporting and Follow up on
accidents, incidents, and near misses
• Revise the plans accordingly
• Discuss biosafety at regular meetings
UNSAFE PRACTICES
OBVIOUS:
Food in work area
LESS OBVIOUS: Boxes
blocking air flow in BSC
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Step 5
Step #6:
Use a biosafety checklist
YES NO
Standard
Resources
Comments
Is basic PPE provided for all
personnel working in the
laboratory? (basic PPE includes
gloves, laboratory coats or
gowns, protective eyewear or
face protection, etc.)
http://www.cd
c.gov/HAI/pre
vent/ppe_train
.html
Any
observation
made during
audit
Occupational Health Program
• Post Exposure Management Plan
• Partner with Occupational Health clinician
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Step 6
Tasks to link with Occupational
Health Program
Step #7:
Address concerns from labs not impacted
• Meet with occupational health services to
review the risk assessment
• Review the procedure for staff access to
occupational health services
• Review reports from occupational health
• Train staff on when to connect with
occupational health
• Hold a special meeting about safety and
the emerging pathogen
• Take every safety question/concern
seriously
• Communicate about the testing so that
everything is transparent.
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Step 7
Final thought: Will technology help us
improve biosafety?
Building a culture of safety?
• Need a commitment from administration
and lab leadership
• Have regular communication about safety
issues
http://www.reuters.com/article/2015/01/29/us‐usa‐cdc‐safety‐idUSKBN0L21LL20150129
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Comments/concerns about this program? Email [email protected]
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