What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE...

69
What’s In the Field? a Leveraging Partnerships for Public Health Preparedness & Response Monday, September 9, 2013 2:00 pm ET Association of Public Health Laboratories

Transcript of What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE...

Page 1: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

What’s'In'the'Field?'a'Leveraging'Partnerships'for'Public'Health'Preparedness'&'Response'

Monday, September 9, 2013 2:00 pm ET Association of Public Health Laboratories

Page 2: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Agenda'•  Tod Companion, PhD

o  Standards for State and Local CBRNE Response

•  Christina Egan, PhD, CBSP o  Linking Field Screening and Public Health Laboratory Testing

•  Cindy Bruckner-Lea, PhD Ann Lesperance, MPH o  PNNL Activities in Support of Field Biodetection and First

Responders

•  Stefan Saravia, MPH, CIH, CHMM Moe Sullivan, MPH o  Sample Collection and Hazard Screening

Training Program •  Q&A

Page 3: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

'

'

Tod'Companion,'Program'Manager'

''DHS$S&T$$Acquisi-on$Support$and$Opera-ons$Analysis$Group''Office'of'Standards'''Standards'for'State'&'Local'CBRNE'Response''September'9'2013''

Page 4: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Coordination'of'CBRNE'Standards''''

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•  Federal, State, Local and Tribal Communities •  Tight budgets create collaboration opportunities

•  Many agencies are funding RDT&E for CBRNE equipment (DHS, DOD, NIST and EPA)

•  Other federal stakeholders provide input on standards (CDC, FBI, DOJ, USPS and USDA)

•  U.S. system of standards provides for private sector & public sector input

Page 5: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

'''''''''Standards'Development'by'DHS'•  The'Homeland'Security'Act'of'2002'(Public'Law'

107U296)'directs'DHS'to'conduct'all'standards'acXviXes'in'accordance'with'the'NaXonal'Technology'Transfer'and'Advancement'Act'of'1995'(Public'Law'104U113)'and'OMB'Circular'AU119'

•  OMB'AU119;'Federal'ParXcipaXon'in'the'Development'and'Use'of'Voluntary'Consensus'Standards'and'in'Conformity'Assessment'AcXviXes'–  Directs'Federal'agencies'to'develop'and'use'

voluntary'consensus'standards'in'lieu'of'governmentUunique'standards'

–  Two'caveats:'•  When'pracXcable'•  Use'in'whole'or'in'part'

5'

Page 6: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Goals'of'the'NaXonal'Strategy'•  Establish'an'interagency$group$for$CBRNE$standards'

to'promote'the'coordinaXon'of'such'standards'among'Federal,'state,'local,'and'tribal'communiXes''

•  Coordinate'and'facilitate'the'development'and'adopXon'of'CBRNE$equipment$performance$standards''

•  Coordinate'and'facilitate'the'development'and'adopXon'of'CBRNE'equipment$interoperability$standards$$

•  Promote'enduring'CBRNE'standard$opera-ng$procedures''

•  Establish'voluntary'CBRNE'training$and$cer-fica-on$standards'and'promote'policies'that'foster'their'adopXon''

•  Establish'a'comprehensive'CBRNE'equipment$tes-ng$and$evalua-on$(T&E)$infrastructure$and'capability'to'support'conformity'assessment'standards''

6'http://www.whitehouse.gov/blog/2011/08/30/path-emergency-reponse-standards

Page 7: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

•  Guide procurement decisions of end-users (e.g., First Responders, private-sector end-users, government)

•  Provide First Responders with independently-validated tools for incident management

•  Provide commercial sector with guidance for developing tools that meet the needs of Public Health and First Responders

Impacts

7'

Page 8: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Standards$Capability$Model$

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!  'Performance'Standards'

!  'Test'Methods'

!  'Conformity'Assessment'

!  'Procure'validated'tech'

!  'Standards'for'Training''Programs'

!  'CONOPS'

!  'Guides'for'standard''operaXons'

Page 9: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

The$Case$for$Standards$

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Does this work? (Performance Standards)

How do I test this? (Test Methods)

Does this solve the right problem? (CONOPS/ standard operations guides)

How do I use this?

(Training)

Should I buy this?

How do I comparison

shop? (Conformity Assessment)

Will this work with my other devices?

(Test Methods)

NOW AVAILABLE! Radiation/Multi-Toxin

Detection Meter $299.99*

•  Advanced Radiation and Bio-Chemical Agent Protection!

•  Industry Leading Working Duration

•  Completely Self-Contained

•  Compact and Innovative Design

* Special GSA rates on request

Standards enable effective capability delivery

Page 10: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Use'Cases'

•  Rather'than'drive'a'product/process/technique'into'operaXons,'how'do'we'develop'a'capability?'

•  …it'depends'– Who?'When?'How?'

•  Rather'than'develop'50'or'100'separate'cases,'there'must'be'some'starXng'point'

10'

Page 11: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Service'Oriented'Architecture'

–  Principles'and'methodologies'for'designing'and'developing'interoperable'services''

•  Defined'by'funcXon,'built'as'components,'with'replicable'elements'already'in'use'by'customers…'

– What'are'our'services?'What'are'communiXes'already'doing?'

– HAZMAT'– EMS'– LRN'– CST/CBRF'

11'

Page 12: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Mission'Capability'

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• ConOps1

• Training • Proficiency Testing • Sampling & Sample Handling2

• Assay " Performance Specifications3

" Testing and Certification3

1.  ASTM E2270-10 Standard Guide for Operational Guidelines for Initial Response to a Suspected Biothreat Agent 2.  ASTM E2458-10 Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being

Biothreat Agents from Nonporous Surfaces 3.  Dr. Mathew Davenport, DHS Science and Technology, CBD, PSAA Project

An assay, method, or detector must be operated by a trained and proficient user and integrated into a response plan

Page 13: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Framework'for'a'Biothreat'Field'Response'Mission'Capability'

Develop$guidance$to$first$responders$for$the$biological$assessment$of$suspicious$powders$•  Interagency'effort'involving'DHS,'CDC,'FBI,'and'

EPA'•  Defines'a'Mission'Capability'(a.k.a.,'an'

AcXonable'Assay'–'the'Onion)'•  Outlines'the'accomplishments'and'remaining'

gaps'

13'

https://www.rkb.us/contentdetail.cfm?content_id=270212&query=270212&overridesubtype=950

Page 14: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Timeline'of'BiodetecXon'Standards'and'T&E'Methods'Development'

14'

Attempts at coordination of assay performance metrics

and T&E between DoD and CDC

BioMonitoring MOU between

DHS, CDC, DoD, DoJ, USPS

National BioMonitoring

Architecture (calls for PHAA standards)

DHS S&T PHAA

program established

PHAA Standards

development begins with

AOAC contract & SPADA

Original PHAA split into PSAA (stds for 1st responders and private

sector) and PHAA (stds for federal biodetection systems)

Establishment of NSTC/

CHNS/SoS

BioMonitoring MOU expires

Publication of A National Strategy on

CBRNE Standards

Establishment of NSTC/CHNS/SoS-

CBRNE

Publication of first SPADA Standards

Publication of Framework for a Biothreat Field

Response Mission Capability

Page 15: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Public'Safety'and'Public'Health'AcXonable'Assay'Architecture'

15'

PHAA Sample goes to LRN

PSAA

• Evacuate(• Close(building(• Decon(exposed(•  Incident(Management(• Transport(Sample(to(LRN(

•  Ini>ate(Public(Health(Inves>ga>on(• Determine(need(for(supplementary(tes>ng(• Conduct(risk(assessment(for(need(of(PEP(• Risk(communica>on(

Users First Responders Private Sector

Users LRN/CDC Fed owned & operated

Public Health Action

Public Safety Action

Page 16: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

PSAA'ObjecXves'&'History'

16'

!  Original$Objec-ves$in$2007$–$PSAA$Pilot$Project$-  Establish'standards'to'validate'Polymerase'Chain'ReacXon'(PCR)Ubased'

technologies'that'detect'aerosolized'Bacillus(anthracis,'Yersinia(Pes0s,'or'Francisella(tularensis(

-  Pilot'the'validaXon'process'with'an'assay'that'detects'B.(anthracis((

!  Objec-ves$added$in$2009'-  Develop'standards'to'validate'immunoassayUbased'HandUHeld'Assays'(HHAs)'

that'detect'B.(anthracis(or'Ricin'in'suspicious'powders'-  Test'commerciallyUavailable'HHAs''

!  Objec-ves$added$in$2010$-  Develop'standards'to'validate'PCRUbased'technologies'that'detect'aerosolized'

Burkholderia(psuedomallei(and'Burkholderia(mallei'-  Develop'standards'to'validate'PCRUbased'technologies'that'detect'B.(anthracis(

in'suspicious'powders''

!  Objec-ves$added$in$2011 -  Develop'recommendaXons'on'controls'needed'for'fieldUbased'assays'

Page 17: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

SPADA'Sets'the'Standards'

•  A'voluntary'consensus'standards'body'established'via'a'DHS'S&T'contract'with'AOAC'InternaXonal'

•  Includes'representaXon'from'DHS,'CDC,'DoD,'DoJ,'FDA,'EPA,'USPS,'NIST,'State'&'Local'Public'Health,'First'Responders,'Industry,'and'Academia'

•  Establishes'method'performance'requirements'and'panels'of'reference'materials'(and'validaXon'protocols)'

17'

The$Stakeholders$Panel$on$Agent$Detec-on$Assays$(SPADA)$

*The SPADA PHAAWG did not develop strain panels and method performance requirements; rather, the WG discussed necessary elements of an actionable assay (e.g., performance standards, user training, ConOps)

#  All SPADA members volunteer their time and expertise

B.(anthracis(Working(Group((PCR)(

Y.(Pes>s(Working(Group((PCR)(

F.(tularensis(Working(Group((PCR)(

Environmental(Factors(Working(Group((PCR)(

Public(Health(Ac>onable(Assay(Working(Group*((

B.(anthracis(HHA(Working(Group((

Ricin(HHA(Working(Group((

Burkholderia(Working(Group((PCR)(

Assay(Control(Working(Group((PCR)(

SPADA(

Page 18: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

SPADA'Established'Standards'

SPADA$has$established$detec-on$performance$standards$for$eight$detec-on$missions;$standards$include$panels$of$reference$materials$and$performance$requirements'

18'

!  DetecXon'of'B.(anthracis(in'visible'powders'with'an'HHA*'!  DetecXon'of'ricin(in'visible'powders'with'an'HHA*'!  Detection of B. anthracis in visible powders by PCR* !  DetecXon'of'B.(anthracis'in'aerosol'collecXon'samples'by'PCR(!  DetecXon'of'Y.(pes0s(in aerosol collection samples by PCR(!  DetecXon'of'F.(tularensis(in aerosol collection samples by PCR(!  Detection of B. psuedomallei in aerosol collection samples by PCR !  Detection of B. mallei in aerosol collection samples by PCR'

* Standards are focused on testing of tools used in the field by first responders

Page 19: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Concept(of(Opera>ons(

How'does'tesXng'become'an'acXonable'Mission'Capability?'

19'

(((((((((((

Tes>ng(against(SPADA(Detec>on(Standards(

Method$Developer$Valida-on$

Independent$Lab$Valida-on$

Opera-onal$Spec$Tes-ng$

Laboratory(Tes>ng(

Collabora-ve$Study$

Opera-onal$$T&E$ + SOPs$

Competency$Assessment$

Training$and$Exercises$

Proficiency$Tes-ng$

Page 20: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

SupporXng'a'Field'DetecXon'Capability'

A$mission$capability$integrates$a$number$of$essen-al$elements$

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• Performance'SpecificaXons'(AOAC'SPADA)'• TesXng'&'CerXficaXon'of'Tools'(AOAC'SPADA)'• Sampling'&'Sample'Handling'(ASTM'E2458U10)'• Training'&'Exercises'(OVS,'TESSB)'• Proficiency'TesXng'(NGB?'NFPA?)'• ConOps'(ASTM'E2770U10)'

Performance$Specifica-ons:'for'HHA'(BA'and'Ricin),'PCR'(on'a'filter),'PCR'(on'a'powder)'AOAC'SPADA'Stakeholders''Panel'on'Agent'DetecXng'Assays,'chaired'by'Maphew'Davenport,'PhD,''

Page 21: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Working'with'ASTM'and'AOAC'standards'development'organizaXons,'the'federal'community'including'CDC,'FBI,'DOD,'DHS,'EPA,'OSHA,'state'and'local'stakeholder'community'to'develop'and'coordinate'an'ASTM'standards'for'response'to'and'the'collecXon'and'transport'of'suspicious'powders'to'the'LRN'laboratory'by'the'first'responders.'''

Sample'CollecXon'

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Page 22: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Working'with'the'Department'of'Homeland'Security'to'develop'standards'for'measurement'assurance'of'detecXon'assays'in'the'hands'of'first'responders.'Working'with'a'consorXum'of'technology'developers,'federal'agencies'and'state'and'local'members'of'the'first'responder'community,'to'idenXfy'standards'and'materials'for'rouXne'measurement'assurance'in'the'field.'

Biothreat'DetecXon'Standards''

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Page 23: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Operation Vigilant Sample

$  Clandestine Terrorist Lab $  RV modified for BT agent production

$  Environmental and Clinical PH LRN Response $  Biological powders $  Cutaneous anthrax specimen

$  Army National Guard 4th WMD CST $  Sample collection $  On-scene testing $  Air-mobile

$  Live Players and Props $  Recreation vehicle “biological production facility” $  Incident Command, triage, collection, transport $  On-scene and LRN analysis

$  Performed in “Real-Time”

FLETC, Glynn County GA 8/7-9/06

Full-Scale GPHL LRN-CST Exercise Brunswick, GA

Page 24: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

GA PH Labs CDP DHS-FLETC Coastal Health District 9-1 Glynn Co. FD/HazMat FBI GEMA GA State Patrol National Guard Bureau Responders Resource Technologies Dugway Proving Ground CPT Bryon Marsh 4th CST-WMD 404-660-8917 [email protected]

Page 25: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Next'Steps?'''Focus$on$the$needs$of$first$responders$•  IdenXfy'technology'needs'of,'and'technologies'purchased'by,'the'first'

response'community'•  Categorize'those'needs'and'technologies'

•  Establish'addiXonal'Standards'where'necessary'•  Provide'CONOPS'and'training'

–  ONLY'in'context'of'their'local/state'operaXons'•  Cost'share'tesXng'of'3U5'products'in'each'technology'type'

25'

Technology$Type$ Sensi-vity$ Specificity$ Cost$

Advanced$(e.g.,$PCR)$ ++++$ ++++$ $$$$$$

Intermediate$(e.g.,$HHAs)$ ++$ ++$ $$$

Low$(e.g.,$protein$screen)$ +$ +$ $$

To(make(available(a(series(of(validated(tools(that(jurisdic>ons(can(choose(from(based(on(their(resources(

Page 26: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Linking'Field'Screening'and'Public'Health'Laboratory'TesXng'

Christina)Egan,)Ph.D.)

New)York)State)Department)of)Health)

Wadsworth)Center)

Page 27: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Field'Screening''''''''''''PHL'TesXng'! Rapid)screening)of)samples)to)generally)characterize)the)potential)threat,)without)consuming)large)quantities)of)sample,)with)appropriate)safety)considerations))

! Ensures:)1.  Sufficient)sample)remains)for)confirmatory)testing)

2.  Sample)can)be)safely)transferred)to)appropriate)laboratory)

!  Bomb)disposal)unit)

!  Radiation)laboratory)

!  Chemical)analysis)laboratory)

!  Biodefense)laboratory)

3.  Safety)of)staff)and)laboratory)are)not)compromised)

Page 28: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Rethinking'“White”'Powders'!  Environmental)threat)samples)

!  Traditionally)screened)for)biological)agents)based)on)our)2001)experiences)

)

!  Majority)of)“white)powders”)are:)

!  Illicit)drug)compounds)

!  Explosive)compounds)

!  Crystalline)powders)may)present)extremely)hazardous)explosive)

conditions)

!  Little)consideration)given)to:)!  Chemical)Warfare)Agents)(CWA))

!  Explosives)

!  Radiological)threats)

)

!  Laboratory)staff,)lab)infrastructure)and)emergency)response)are)at)risk)if)samples)are)only)tested)for)Biological)Agents)

Page 29: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

All'Hazards'A)comprehensive)approach)to)screening)environmental)

threat)samples)for)the)presence)of:)

))

! ! !Chemical)warfare)agents)

! ! !Biological)agents)

! ! !Radiation)sources)

! ! !Explosive)compounds)

Some tools and screening protocols were available to Public Health Laboratories Many different protocols and screening tests being performed nationally

Page 30: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

''All'Hazards'Screening'Laboratory'

Page 31: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

ARHF'Training'for'Lab'Staff'

Page 32: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

APHL'TesXng'Algorithm'for'Unknown'Environmental'Samples'Task'Force'

! Taskforce)established)in))))))October)2009)

! To)develop)and)issue)guidance))))))to)public)health)laboratories))

))))on)how)to)process)unknown))

))))environmental)samples.)

! Members)consisted)of)State))

)))representatives)from)both))

)))LRN\B)and)LRN\C)

Page 33: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Page 34: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Page 35: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Guidelines'for'the'Unknown'Algorithm'

http://www.aphl.org/AboutAPHL/publications/Documents/PHPR_2011June_ Algorithm-and-Guidelines-for-Responding-to-an-Incident-Involving-a- Suspicious-Non-Clinical-Sample.pdf

Page 36: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Unknown'Algorithm'GuidelinesU'Minimal'Recommended'Chemical'Tests'

Page 37: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

Many'Efforts'related'to'Threat'Screening'and'Laboratory'TesXng'

!  FBI,)HHS,)CDC,)DHS.)Guidance)on)Initial)Responses)to)a)Suspicious)Letter/Container)With)a)Potential)Biological)Threat<)2004.))

! DHS)published)the)Framework)for)Biothreat)Field)

Response)Mission)Capability\2011)

! ASTM)E2270\10)Standard)Guide)for)Operational)Guideline)for)Initial)Response)to)a)Suspected)Biothreat)Agent\2010))

! EPA)All)Hazards)Screening)Protocol\2008)

Page 38: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

New York State Department of Health

Wadsworth Center

ConXnued'APHL'Efforts….FiRST'Subcommipee'

Page 39: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

PNNL Activities in Support of Field Biodetection and First Responders

CINDY BRUCKNER-LEA, PH.D. [email protected]

ANN LESPERANCE, M.P.H. [email protected]

SEPTEMBER 2013

1

Page 40: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

PNNL Outline

Northwest Regional Technology Center Overview of Ground-Up Approach to Assess and Address Biodetection Needs End-User Technology and Info Needs: Identification and Assessment PNNL Biodetection Testing Plan – Modified AOAC Approach Biodetection Instrument and Assay Testing at PNNL Testing Outcomes Path Forward

Page 41: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

NW Regional Technology Center for Homeland Security

Identify critical technology needs and requirements to influence the Federal R&D agenda Enable testing and evaluation of technologies by regional Federal agencies, State, local, and tribal users Provide unbiased information/support on S&T to support acquisition and/or implementation Accelerate technology development and deployment

Mission: Lead collaborative efforts between technology developers and Federal, State, local, and tribal users to:

Page 42: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Define performance requirements with stakeholder and end-user input

Conduct interviews with end users Bring together end users and key agency reps (FBI, PH/LRN, CST, DHS, etc.) in workshops to fully understand and define key needs and gaps

Perform technology foraging (collect, validate, compile info) Establish technology test plans Conduct 3rd party independent testing

and evaluation; support and facilitate end-user testing Publish and disseminate instrument and assay testing results and summaries for instrument use, limitations, cost/benefit Facilitate adoption of approved equipment lists

Ground-Up Approach: Biodetection Technology ID, Assessment and Transition

Page 43: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Statistical Methodology for COTS Testing

Existing AOAC test guidance (SPADA) is extremely burdensome due to the large number of samples that must be analyzed Because biodetection technology and assays are rapidly evolving, with new versions appearing almost annually, a more efficient, but still statistically based testing approach is needed PNNL Test Plan follows AOAC inclusivity, exclusivity and 95% confidence Probability of Detection (POD) guidelines

PNNL Test Plan approach • 34 samples must be tested without

a single failed result, • 53 samples must be tested with no

more than a single failed result, or • 86 samples must be tested with no

more than two failed results.

Calculated using a one-sided confidence interval and the normal approximation to the binomial distribution

Page 44: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Testing of PCR-Based Instruments Using PNNL Test Plan Test Plan for PCR Hand Portable Instruments

Test plan follows AOAC/SPADA statistical guidance 5 PCR-based biodetection platforms:

FilmArray RAZOR Bio-Seeq PLUS T-COR4 POCKIT

Bacillus species only Inclusivity panel DNAs (SPADA) (n=13)

Starting test concentration: 2,000 copies/mL Each strain analyzed in triplicate Strains not containing pXO2 were omitted from inclusivity panel

Exclusivity panel DNAs (SPADA) (n=18) Starting test concentration: 20,000 copies/mL Each strain analyzed in duplicate Strains with pXO2 homologous genes were omitted from exclusivity panel

Follow on testing with Bacillus spores and environmental hoax powders (n=21) Final results will be published/disseminated

Page 45: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Initial Screening of A Wide Range of Biodetection Technologies for Bacillus and Ricin detection

Goal: understanding instrument performance, limitations, and cost/benefit Test samples

Bacillus anthracis spores (BSL-2 and BSL-3) Ricin toxin (4 preparations of varying purity) Environmental material and potentially interfering common powders

Screening Assays: General Protein: BioCheck and Indipro strips Biochemical: ATP/luminometer test: New Horizons and Clean-Trace tests General DNA: Prime Alert Chemical/Spectroscopic: HazMat ID 360 Immunoassays: RAID 8 and Pro Strips PCR Assays: Razor, FilmArray, T-COR4, POCKIT, and Bio-Seeq PLUS

Outcome of these tests will help to formulate additional testing, including LOD studies with white powder + Ba and ricin mixtures

Page 46: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Testing Outcomes and Info Dissemination

PNNL laboratory testing Establish LOD, dynamic range, potential for false positive/negative results, and impact of other substances such as common hoax powders ID technology deficiencies/limitations prior to high cost/effort field testing Develop objective information and guidance for selection and use of biodetection technology

Publish and disseminate information COTS biodetection instrument summary reports Peer-reviewed publications of COTS instrument testing Dissemination of PNNL Test Plan for future instrument testing and transition

Summaries of instrument use, limitations, cost/benefit

Evaluation of the FilmArray® system for detection of Bacillus anthracis, Francisella tularensis and Yersinia pestis

Volume 114, Issue 4, pages 992–1000, April 2013

Biodetection Technology First Responder Report: http://1.usa.gov/17RHdt8

Page 47: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Path Forward

Continue technology foraging and instrument testing Provide information to end-users to assist in making more informed decisions on equipment selection, improving training and better understanding of equipment use and limitations In partnership with Public Health and other Agencies (APHL, LRN, CST, FBI, NIST, Others), support first responder field biodetection exercises

Support DHS and other agencies in the implementation of key elements of the Biothreat Field Response Mission Capability Conduct additional Working Meeting with first responders in 2014 to report testing results, present instrument use/guidelines and solicit stakeholder feedback

Page 48: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Acknowledgments

Principle Investigator: Cindy Bruckner-Lea

Project Manager: Rachel Bartholomew

Project Team: Cheryl Baird

Heather Colburn

Janine Hutchison

Ann Lesperance

Richard Ozanich

Jessica Sandusky

Timothy Straub

Kristin Victry

Pamela Kinsey

This effort is funded by the Department of Homeland Security Science and Technology Directorate under Contract HSHQDC-08-X-00843. DHS Program Manager: Anne Hultgren, Ph.D.

Page 49: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

SAMPLE COLLECTION AND HAZARD SCREENING TRAINING PROGRAM Stefan Saravia, MPH, CIH, CHMM Chemical Threat Preparedness Coordinator Minnesota Department of Health Public Health Laboratory Division

Page 50: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Overview • Minnesota response to suspicious substances

• Developing and implementing our training programs

• Lessons learned and outcomes

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Page 51: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Chemical Assessment Teams

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• Eleven teams strategically located around the state

• Responsible for responding within region

• Crew of at least 1 specialist and 2 techs

• Deployed through state Duty Officer

Page 52: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Chemical Assessment Teams

• Each team has specialized equipment for: •  Air monitoring •  Material identification •  Sample collection •  Decontamination

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Page 53: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

55th Civil Support Team

• CST provides advanced capabilities for WMD events •  Mobile laboratory •  Sample collection •  Communications

•  Takes longer to deploy than CATs

• Not required for every incident

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Page 54: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

MN Laboratory Testing • Accept samples from:

•  Law (local/FBI) • Hazmat • Other gov. agencies

• Have an “all hazards” approach – not just bio

• Require: • Rad and explosives

screen • Proper packaging

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Page 55: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Practice Sample Program • Began in 2009 • 3 samples/quarter • Scenario driven exercise

• We have stressed “characterization” over “identification”

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Page 56: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Practice Sample Program • Heavy reliance on field spectroscopy

• Suggest an orthogonal approach

• Great excuse to interact with teams

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Page 57: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Areas for Improvement

• Teams had moved away from basic “characterization” techniques

•  If no match on IR or Raman we would often get no information

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Pre-screening

Page 58: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Areas for Improvement

• Sample too big •  55-gallon drum

• No sample to test • Powder letter w/ no

powder •  Inappropriate matrix

• Dead mice

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Inappropriate sample volumes/types

Page 59: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Areas for Improvement

• Samples not sealed • Samples delivered in grocery store bag

• Samples not decontaminated

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Improper Packaging

Page 60: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Training Goals • Hands-on training • Standardized approach • Work with individual responders

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Page 61: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Sample Collection

• Provided teams with kits and procedures

• Had hands-on exercise practicing using kits

• Covered chain-of-custody procedures

• Practiced using our submission forms

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Page 62: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Hazard Screening

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• Based on DOT hazard classes

• Emphasized “assessment” not identification

• Focused on need for proper lab analysis for toxins and infectious substances

Page 63: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Field Spectroscopy • Explained how field spectroscopy works

• Discussed strengths and limitations

• Ensured that they could recognize the FTIR spectra for water!

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Page 64: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Screening Exercise

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• Groups had kits with chemicals and instruments

• Demonstrated MDH approach

• Minimal screening •  Explosives •  Radiation

• Additional screening •  VOCs/CGI •  FTIR/Raman •  Reactives •  Corrosivity (pH) •  Oxidizers

Page 65: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Challenges

• Wide geographic area • Scheduling

•  Time restrictions •  Multiple shifts

• Equipment •  Expensive •  Large amount of supplies •  Hazardous chemicals

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Page 66: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Outcomes

• Some stats: •  trained 15 hazmat teams

around the state •  trained 303 individuals •  provided 25 half day classes •  driven 2,872 miles

•  Teams wanted the training to be longer!

• Higher participation rate in practice sample program

• More individual interaction with members from teams

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Page 67: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

First Responder Standards and Technologies Subcommittee • Under guidance of APHL Public Health

Preparedness and Response Committee • Why do we need this subcommittee?

•  better define the roles and responsibilities of state/local PHLs and First Responders

• Who are the First Responders? •  Police •  Fire •  Hazmat Teams •  Civil Support Teams

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Page 68: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Goal of subcommittee

•  To provide guidance and to establish, enhance and maintain partnerships with first responders

•  Initially focus on the lab-first responder partnership and will expand to include federal partners

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Page 69: What’s'In'the'Field?' · Agenda' • Tod Companion, PhD o Standards for State and Local CBRNE Response • Christina Egan, PhD, CBSP o Linking Field Screening and Public Health

Proposed Activities

•  Identify best training practices • Oversee APHL’s Algorithm and Guidance for

Responding to an Incident Involving a Suspicious Non-Clinical Sample

• Develop a database template for PHL’s to collect information on the first responders in their jurisdiction

• Compile and synthesize existing national standards

• Review Existing first responder technologies

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