Transcript Real Life Experiences in Responding to the Ebola Epidemic

Real-Life Experiences in
Responding to the
Ebola Epidemic:
Are Laboratorians in the US
Prepared for the Next Event?
Peter C. Iwen, PhD, D(ABMM)
Director, Nebraska Public Health Laboratory
Professor, UNMC College of Medicine
[email protected]
No Disclosures to Reveal
Ebola Today: What about tomorrow?
Objectives
Historical perspective
 Caring for patient’s with EVD
 Laboratory response and challenges
Preparing the laboratory for the next
event
Experiences in the
Management of Patients
with EVD
Ebola Patients in Nebraska
 Patient #1
– Admit Dt
9/5/14
– Discharge Dt 9/25/14
– Cured
 Patient #2
– Admit Dt
10/6/14
– Discharge Dt 10/21/14
– Cured
 Patient #3
– Admit Dt
11/15/14
– Discharge Dt 11/17/14
– Died
 PUI Patients (7)
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Admit Dt
1/4/15
Discharge Dt 3/20/14
All high-risk PUIs
Two admitted to the unit
None had EVD
Laboratory Response
Historical
 NE Public Health Laboratory provided lab
support for the NBU
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BSL-3 lab
CDC connection
Laboratory Response Network-B partnership
 MOU in place
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iSTAT
Malaria smears
Specimen transport
Monitor electrolytes
Rule out malaria
CDC support
Prior to 1st Patient’s Arrival
Discussions with US State Dept
 About 1 month before
Expanded lab test menu
 Additional POC testing
 Liver function
 Coagulation
 Expanded panel types
 Molecular testing capabilities
Increase trained work force
 24/7 coverage
Timeline of Patient #1
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7/20 Began ordering
- POC instruments/reagents
8/1 Began validations
- New instrument/assay panel
8/1 Began staff training/competency
9/3 Contacted LRN
- EZ-1 rRT-PCR assay
9/4 Shipped
- EZ-1 assay kit
9/5 Patient #1 admitted, drug study protocol development
9/6 Received
- EZ-1 assay kit
9/9 Received
- EZ-1 validation panel
9/10 Sent - 3 EV-infected plasmas to CDC (Wed)
9/12 Completed
- EZ-1 validation assay
9/12 CDC results
– ct 25.6, 27.5, 31.7
9/17 Sent - 3 EV-infected plasmas to CDC (Wed)
9/18 Passed
- EZ-1 competency panel
9/19 CDC results
– ct 33.2, 37.6, 38.9
9/19 Finalized list of essential lab tests
9/23 Sent- 3 EV-infected plasmas to CDC (Mon)
9/24 CDC results
-ct undetected
9/25 Patient #1 discharged
9/26 Completed on-site laboratory
During 1st Patient
• Defined an essential test menu
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Specimen collection protocols
• Developed an on-site laboratory
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Decreased TAT
Decreased specimen handling
Provided interaction with care team
Lab became operational with 2nd patient
• Opened communication lines
Be flexible!
Iwen, PC, et al. 2015, Amer J Clin Path, 143: 4-5
Specimen Collection Guidance
Created On-Site Laboratory
Open Lines of Communication
Infectious
Disease
Personnel
Critical Care
Physicians
NBU
Nursing
Staff
Hospital
Admin
Hospital
Lab Staff
Pharmacy /
IRB
Environ.
Services
NPHL
Pharm.
Companies
Industrial
Hygienists
Shipping
Couriers
Federal
Depart. HHS
CDC
State HHS
DSAT
What level of risk were we willing
to accept?
Knew that specimens contained Ebola virus
Our “line in the sand”
• No open-tubed processing or centrifugation
outside BSL-3 containment.
• NBU laboratory
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Centrifugation
POC testing
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Molecular assay
Microbiology testing e.g. blood cultures
Archive specimens
• NPHL BSL-3 laboratory
• Hospital Core laboratory
• Closed tubed testing
• Chemistry analyzer
• CBC diff
• Malaria smears (after fixation)
Laboratory Challenges
OSHA
General Duty Clause
U.S.C. 654(a)(1), requires that employers furnish every
employee a workplace that is free from recognized
hazards that can cause or are likely to cause death or
serious physical harm
Risk to Handle EV-Infected Specimens
• High viral loads in symptomatic patient
• >100,000,000 pfu/ml
• Infectious dose
• <10 viable viral particles
• Blood micro-droplets
• Could easily contain enough virus to cause infection
CDC document, Review of
Human-to-Human
Transmission of Ebola Virus
Safety
Risk Mitigation
Based on the biological risk assessment
• Engineering Controls
• Biosafety cabinet
• Sealed centrifuge rotors or safety cups
• Sharps containers
• Laboratory ventilation/Negative
• Anterooms
• Administrative/work practice controls
• Training
•
SOPs
• Institutional policies
• Medical surveillance
• Appropriate PPE
Safety
Risk Mitigation
Other strategies
• Use point-of-care instruments
• Limit laboratory staff
• Segregate equipment
• Test in dedicated space
Core Laboratory
Automated Chemistry Analyzer
Beckman Coulter
DxC880i
On-Site Risk Assessment Results
 Chemistry automated analyzer
 Initial centrifugation – no sealed rotors
 Coagulation automated analyzer
 Required open tube testing
 Blood Bank
 Cross match required open tube centrifugation
 Biosafety cabinets not universally available
Not all laboratory sections were able to safely
handle specimens from a patient with the
potential to have EVD.
Safety
PPE
Proper donning and doffing
• Laboratory staff must be trained
• Strict adherence to protocols essential
PPE use dependent on work performed
• More PPE
• Direct contact with patient
• Less PPE
• Specimen transport within facility
• Laboratory testing
• Protect bare skin and mucous membranes (eyes, nose, mouth)
Safety
PPE
More NOT always necessary
• Reduced visibility, dexterity, sensory perception and mobility
• Heat stress and fatigue
• Discomfort causes distraction
N-95 respirator
• Annual fit testing and medical clearance required
• Some cannot wear N-95 respirators
• Facial hair may compromise seal
• Changes in facial structure can compromise seal
Safety
PPE
Specimen Transport
In-House
Before removal from site-of-care
• Decontaminate outside of specimen transport
container
• Use an approved disinfectant
Hand carry packaged specimen to lab
• DO NOT use pneumatic tube system
• Consider using a buddy system
Specimen Transport
Off-Site
• DOT classifies EV as a Category A infectious substance
• Package and transport in accordance with….
• …DOT Hazardous Materials Regulations and
• …International Air Transport Association (IATA) Dangerous Goods
Regulations
• Trained and certified individuals to package and ship
• DOT - every three years
• IATA - every two years
• Requires specific UN-certified packaging, labels, marking, and
documentation
Specimen Transport
Off-Site
Off-Site Transport
Define Courier
Select Agent Issue
Rules Changed?
Specimens become select agents
when no longer used for diagnostic
purposes?
Ebola Virus as a Select Agent
Rules are changing as to how infected specimens can be stored and shipped
All serially collected specimens were retained and shipped to USAMRIID
42 CFR Part 73
POC Instruments
Utilization Issues
Clinical laboratory director
• Ensure compliance with CLIA regulations
• Waived vs non-waived testing
• Meets intended use as approved by the FDA
Intended use excludes testing of critical patient
• Considered off-label use
• Must establish performance specifications and validate before use
Clinical Chemistry
Manufacturer
Device
Beckman-Coulter
DxC880i
Abbott Laboratories
iSTAT
Abaxis
Piccolo Xpress
Hematology
Manufacturer
Device
Sysmex
XN 9000
Sysmex
pocH 100i
Listing for information only and not intended as an endorsement of these
instruments or practices, nor should this be considered a complete list of all test
instruments that may be acceptable.
Coagulation
Manufacturer
Device
ITC
Hemochron Signature
Elite
F. Hoffman-La Roche
CoaguChek
Microbiology
Test
Method
Blood Culture
Plastic bottle/manual
monitoring method
Malaria
Smear fixed in methanol
for 30 mins
Alere BinaxNOW
Ebola virus testing
Biofire FilmArray*
Listing for information only and not intended as an endorsement of these instruments
or practices, nor should this be considered a complete list of all test instruments that
may be acceptable
If testing is done on the BioFire, also send a sample to the LRN laboratory for testing.
Ebola Virus Screen
Consult with jurisdictional public health official
• CDC assays required to confirm a negative and positive
result
• Obtain blood specimen when patient meets criteria
Elevated body temperature or subjective fever
OR
• Any Ebola-compatible symptoms , including severe
headache, fatigue, muscle pain, vomiting, diarrhea,
abdominal pain, or unexplained hemorrhage
AND
• An epidemiological risk factor within the 21 days
preceding onset of symptoms
Ebola Virus Screen
Ebola virus screening
• >55 Laboratory Response Network (LRN) labs
• Can confirm negative result
• Minimal 3 hr assay once specimen received in lab
Use a commercial Ebola virus test
• Also submit paired specimen to an LRN-approved lab
or CDC
Ebola virus confirmation of positive screen
• At the CDC
• Jurisdictional PHL
EZ1 Real-Time RT-PCR
ABI 7500 Fast, Emergency Use Authorization
Are Laboratorians
Prepared for the
Next Event?
Low-Incidence,
High-Consequence
Pathogens
Communicability
o High
o
o
o
o
o
o
Ebola virus
MERS virus
SARS virus
Pandemic influenza virus (Avian)
Rabies virus
Smallpox virus
o Moderate
o Lassa fever virus
o Yersinia pestis (bubonic form)
o Low
o Bacillus anthracis
o Francisella tularensis
Emerging Infectious Diseases
Bioterrorism
Bioterrorism
Anthrax vaccine
Smallpox vaccine
**All hospitals**
Prepared to perform
basic laboratory
testing
State Treatment Centers
How can your laboratory be
prepared?
 Define laboratory location
 Low traffic area
 Negative pressurization
 Available equipment
 Biological safety cabinet
 Centrifuge with safety caps/sealed rotors
 Define test menu
 Develop protocols
 PPE requirements
 Personnel training
 QA for POC instruments
 Specimen
 Collection
 Transport
 Disposal
Sustainability??
http://netec.org/
Scenario: Responding to a PUI for
MERS admitted to your ED
#1. Is there a defined area where the patient will be housed?
#2. Are protocols in place for PPE and training?
#3. Do you have a menu of laboratory tests that can be performed safely?
-Stabilize the patent
-Provide on-going care
#4. Are specimen collection protocols established?
#5 Have you consulted with your jurisdictional PHL for specimen transport?
#5. Do you have a methods in place to transport patient if MERS is diagnosed?
#6. Are protocols in place for room and transport vehicle decontamination?
Major Learning Lessons
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On-site laboratory optimized specimen testing
Laboratory test menu needed to be flexible
Not all tests could be performed safely
Communication was essential

Physicians
 Critical care
 Infectious diseases
 Other medical staff
 Laboratorians
 CDC, LRN
 Lab policies/procedures needed to be fluid
 Expanded pool of trained laboratorians
Final Thought
“Be prepared to provide optimal patient
management in an environment that is
safe for employees.”
Acknowledgements
NPHL
Tony Sambol
Vicki Herrera
Amy Kerby
Andi Brockman
Kidney
Lung
Sarah Trotter
Karen Stiles
Sue Peters
David Moran
Caitlin Murphy
Robbie Southern
Steve Hinrichs
Bin Li
Hepatocytes
(TEM)
SR Zaki/C Goldsmith (CDC); SH Hinrichs/PC Iwen (UNMC)
Questions