Ebola First described in 1976 in DRC 2014-2016 largest outbreak - - PDF document

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Ebola First described in 1976 in DRC 2014-2016 largest outbreak - - PDF document

Nov 06, 2022 473 likes •722 views

6/27/2019 Laboratory Management in a Crisis: Experiences with Ebola Vicki Herrera, MS Research Coordinator University of Nebraska Medical Center, Nebraska Public Health Laboratory Ebola First described in 1976 in DRC 2014-2016

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Laboratory Management in a Crisis: Experiences with Ebola

Vicki Herrera, MS – Research Coordinator University of Nebraska Medical Center, Nebraska Public Health Laboratory

Ebola

  • First described in 1976 in DRC
  • 2014-2016 largest outbreak in

history with over 28,600 cases and over 11,000 deaths

  • 11 treated in United States
  • Nebraska Medicine/NPHL cared

for 3 patients and several individuals with exposures

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Objectives

  • Lab Management
  • Lessons Learned
  • Moving Forward

Background

  • 1997 Public Health Laboratory moves to Omaha
  • 2005 Nebraska Biocontainment Unit Opens
  • July 2014 – State Department visited to assess

readiness

  • August 2014 Emory receives 2 patients infected with

Ebola virus to their Biocontainment Unit

  • September 4, 2014 Nebraska receives first patient

infected with Ebola virus

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Why Nebraska Public Health Lab (NPHL)?

  • NPHL was designated as the lab to

test specimens for the NBU

  • Integrated into UNMC/Nebraska Medicine
  • Proximity to NBU
  • BSL-3 lab
  • Contact with CDC
  • Part of LRN
  • Tests initially provided
  • iSTAT (electrolytes)
  • Malaria smears

Challenges

  • Expand the test menu
  • Train staff
  • Comply with regulatory requirement
  • Short time frame
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Lines of communication

NPHL Hospital Admin Critical Care Physicians NBU Nursing Staff Industrial Hygienists Infectious Disease Personnel Environ. Services Hospital Lab Staff Shipping Couriers Pharmacy / IRB State HHS CDC Federal

  • Depart. HHS

DSAT Pharm. Companies

Expand Test Menu

  • Define essential list of test
  • Liver function
  • Coagulation
  • Define where testing could safely be

performed

  • Define who could safely perform

testing

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Performing a Risk Assessment

  • Is there a potential for aerosol generation?
  • Vortexing
  • Pipetting
  • Centrifugation
  • Opening and closing tubes
  • Are sharps used?
  • Are appropriate PPE available?
  • Face shields, gowns, gloves, respiratory

protection, booties, bonnet

  • Are staff trained in the utilization of the PPE?
  • Doffing and donning
  • Is a protocol for waste disposal available?

Results of Our Risk Assessment

  • Chemistry automated analyzer
  • Initial centrifugation did not use sealed rotors
  • centrifuge in BSL-3 with sealed rotor
  • Coagulation automated analyzer
  • Required open tube testing
  • POC Instrumentation (Hemochron analyzer) in

BSL-3

  • Blood Bank
  • Cross matching required open tube centrifugation
  • Perform blood type by slide agglutination in

BSL-3

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Test menu before Risk Assessment Test menu after Risk Assessment

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Staff Training Requirements

Trained in PPE Trained on POC analyzers Trained in BSL-3 practices NPHL Staff = 3 ½ Plus Director

PPE

N95 Mask Double Glove Impermeable Gown Hair Bonnet Shoe Covers Face Shield

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Lab Safety

Buddy System

Lab Safety

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Lab Safety Lessons Learned after 1st patient

  • Needed more trained staff
  • Needed a laboratory within the NBU
  • Communication is key
  • Shipping was challenging
  • Support for Laboratory staff
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Benefits of Moving Lab to NBU

  • Reduced TAT for Tests
  • Increased Communication between

departments establishing a Team atmosphere

  • Better patient management for

physicians/nurses

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Successes

  • Increased POC testing options
  • Increased staffing
  • Laboratory integrated into the NBU
  • Successful care of patients

Challenges

  • Shipping specimens
  • Training
  • Sustainability
  • Funding
  • Staffing
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Moving Forward

  • Increased testing options
  • Increased our staff training program
  • Participate in local, state and national drills
  • Building a successful program to train other

laboratorians within the State and the Nation

  • Members of national committees addressing

different areas of concern

  • Be Flexible!!

Laboratory Management During a Crisis:

Experiences with Zika

Andrew Cannons, Ph.D., HCLD(ABB) Laboratory Director Bureau of Public Health Laboratories (BPHL) Tampa 6/27/2019

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Outline

  • Zika Testing –The Process Broken

Down

  • Managing the Zika Response
  • What, Where, When
  • Identification of Successes and

Challenges at Each Step

  • Moving Forward, experiences in 2017
  • Final Thoughts

Zika Sample Collection/Testing/Reporting ‐ The Simplistic View!

1: Case Identification Symptomatic Travel History Asymptomatic pregnant with/without travel 2: Samples to Lab Serum, urine 3: Testing PCR/ELISA Diagnosis 4: Reporting to Submitters

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Zika Sample Collection/Testing/Reporting ‐Where the Challenges Were!

1: Case Identification Symptomatic Travel History Asymptomatic pregnant with/without travel 2: Samples to Lab Serum, urine 3: Testing PCR/ELISA Diagnosis 4: Reporting to Submitters

1. Case Identification and Review: Epidemiology Surveillance and Local Response Challenges

  • Guidance documents produced for partners:
  • Need a more efficient process to circulate quicker
  • Better use of surveillance tools
  • Case review process
  • Complicated, changing algorithm
  • Better use of surge staff
  • Communications
  • Particularly with laboratories about incoming samples/priority testing

1: Case Identification Symptomatic Travel History Asymptomatic pregnant with/without travel

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2. Samples to Laboratory Successes

  • Initially able to deal with increased volume of samples:
  • Samples received mainly from usual submitters
  • Receiving and accessioning area set up in laboratories
  • Used testing algorithm to determine where samples went for testing
  • With local case identification:
  • Large increase in submitted samples
  • Mobilized staff to help with increase load
  • BPHL‐Miami set up triage area to re‐route samples to Jacksonville and Miami
  • Able to continue receiving and accession all non‐Zika samples

2: Samples to Lab Serum, urine

2. Samples to Laboratory Challenges

  • Sample delivery:
  • Boxes delivered from new submitters
  • Laboratory/department not always identified
  • Large increase in numbers
  • Specimen Integrity:
  • Some poor samples delivered
  • Leaking, broken tubes
  • Criteria for satisfactory vs. unsatisfactory not established
  • Accessioning:
  • Testing algorithm changed
  • Testing algorithm required interpretation and slowed down accessioning

2: Samples to Lab Serum, urine

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2. Samples to Laboratory Challenges

  • Sample Submission form:
  • Initially our sample submission form did not work for Zika testing
  • Not always complete information provided
  • Incomplete information held up data entry into Labware ‐initially
  • High Priority:
  • Determining high priority samples was difficult early on
  • Development of an Excel file helped with this
  • Blood Bank samples:
  • Always ended up with two sets of samples and two sets of submission forms that

were confusing to link up

  • Difficult to confirm
  • Commercial Lab Samples:
  • Confirming positives added to high sample burden

2: Samples to Lab Serum, urine

2. Samples to Laboratory Challenges to Successes

Guidance documents developed for those submitting samples:

  • Developed guidance documents for sample

submission

  • Help with what sample types, how to package, how

and where to ship

  • Developed FAQ documents for those submitting

samples

  • Answered the commonly asked questions

Updated sample submission form to work for Zika testing

2: Samples to Lab Serum, urine

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3. Laboratory Testing Successes

  • Both BPHL‐Jacksonville and BPHL‐Tampa had PCR

and ELISA test (set up in 2015)

  • BPHL‐Miami brought on board in July 2016 with

CDC Trioplex assay:

  • Urine surveys, serum/urine testing later on
  • Initially able to maintain testing of approximately

250 PCR and 250 ELISA per week

  • Maintained testing of all non‐Zika samples in

laboratory

3: Testing PCR/ELISA

3. Laboratory Testing Successes

  • Utilized Surge Plan:
  • Internal Surge: mobilized staff in laboratory to help out

with accessioning, processing, testing

  • External Surge: Epidemiology and CDC staff deployed on

short term basis to help with paperwork, and non licensed testing

  • Shipped surge samples to CDC (over 1500 during 6 weeks)
  • Communications:
  • Overall worked well
  • Daily calls between the three laboratories
  • Input on Incident Management Team calls, via Operations

3: Testing PCR/ELISA

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3. Laboratory Testing Challenges

  • Testing Platform:
  • Urged to switch to FDA approved PCR assay (Trioplex)

during the outbreak

  • Brought challenges including approved sample types, reporting

to CDC, licensing issues

  • Huge increase in sample load:
  • Equipment in place not designed for high throughput
  • Not enough staff for high throughput (initially staff doing

accessioning were same staff doing testing)

  • Staff needing to work extra hours –fatigue, low moral

3: Testing PCR/ELISA

3. Laboratory Testing Challenges to Successes

Instrumentation:

  • At the beginning of 2016 BPHL was not geared for

Zika surge testing

  • Equipment not designed for high throughput
  • Added later in the year:
  • PCR extraction capacity increased – added

MagnaPure 96 robots in each laboratory

  • ELISA testing increased – added additional

plate washers and readers in each laboratory

3: Testing PCR/ELISA

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3. Laboratory Testing Challenges to Successes

  • Maintaining A Happy Workforce,

even though working long hours:

  • Maintaining a Zika–free zone
  • Food, drink, puzzles, games
  • T‐shirt competition
  • Constant awareness of how staff are

doing

3: Testing PCR/ELISA

3. Laboratory Testing Challenge Resolved Quickly

  • August 2016:
  • Free Zika testing at county health

departments for all pregnant women in Florida

  • Approximately 200,000 births per year in

Florida

  • Would overwhelm testing in BPHL very

quickly

  • Contracted with LabCorp to help with testing

asymptomatic pregnant women for Zika IgM

3: Testing PCR/ELISA

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4. Reporting to Submitters Successes

  • Turn around time:
  • Maintained, initially, required turnaround times for

reporting results

  • LIMS (LabWare):
  • Able to make changes to LabWare when needed
  • Staff mobilized to help with data entry and

reporting

  • Developed a faxing program to report out to reduce

mailing costs and improve reporting times

4: Reporting to Submitters

4. Reporting to Submitters Challenges

  • Data Entry:
  • Incomplete submission forms resulted in reporting delays
  • Large increase in samples resulted in increase in data entry

requirements

  • Who to report to?
  • Originally all reports went to EPI (as submitter)
  • Later on, providers wanted results, and multiple providers for same

set of results

  • New submitters:
  • Receiving samples from non traditional submitters (blood banks,

directly from hospitals, commercial labs)

  • How to report back?
  • Surge Samples to CDC:
  • Brought its own challenges for shipping
  • Results sent back via email, 1 result per email

4: Reporting to Submitters

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4. Laboratory Testing Challenges to Successes

Sending Samples to CDC:

  • Utilized additional staff with accessioning and

repackaging to CDC

  • Utilized dedicated personnel for data input

and generation of data file for CDC

  • Developed macro for downloading email

results from CDC

4: Reporting to Submitters

Zika Testing Continued in 2017

100 200 300 400 500 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43

2017

200 400 600 800 1000 1 3 5 7 9 1113151719212325272931333537394143

2016

IgM Tests PCR Tests

2016: 1,115 cases reported in Florida (218 local) 2017: 110 cases reported in Florida (2 local)

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Challenges to Successes in 2017

  • Staff:
  • Increased staffing in all three BPHLs for Zika testing
  • Equipment:
  • Better equipped than 2016
  • Equipment for high throughput (PCR & ELISA)
  • Testing Capability:
  • Able to manage testing numbers in all three BPHLS
  • PCR at Jacksonville, Miami, Tampa
  • IgM ELISA at Jacksonville, Tampa
  • PRNT at Tampa
  • Reporting:
  • Improvements in LIMS

Final Thoughts

  • 2016 was a very busy year for BPHL:
  • Zika testing involved all three laboratories
  • Just about all staff in all three laboratories were involved!
  • Keys to managing the crisis included:
  • Preparedness, Communication, Flexibility, Troubleshoot often!
  • 2017:
  • BPHL better prepared for managing Zika testing
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Contact Information

Andrew Cannons Laboratory Director BPHL‐Tampa (813) 233‐2277 Andrew.cannons@flhealth.gov