Bridging the Gap:Bridging the Gap:Connecting Local, State, Federal Connecting Local, State, Federal

Laboratory ResourcesLaboratory Resources

Clay HughesClay HughesLaboratory Medical SpecialistLaboratory Medical Specialist

NC Regional Response Lab NC Regional Response Lab –– Mecklenburg CountyMecklenburg County

Why Regional Laboratories?Why Regional Laboratories?New Reality in Protecting the PublicNew Reality in Protecting the Public’’s Healths Health

““Environmental EventsEnvironmental Events””October 7 October 7 –– December 31, 2001: SLPH received 667 pieces December 31, 2001: SLPH received 667 pieces of evidence to analyzeof evidence to analyzePrevious 2 years 4 suspected BT samplesPrevious 2 years 4 suspected BT samplesCompetition with other core activitiesCompetition with other core activitiesEnhance routine core activitiesEnhance routine core activitiesNatural OccurrencesNatural Occurrences

Water Testing (Hurricanes)Water Testing (Hurricanes)

““Natural OccurrencesNatural Occurrences””Confirmation testing on suspect isolatesConfirmation testing on suspect isolatesCoordinates with CDC on new & emerging disease testing Coordinates with CDC on new & emerging disease testing such as Avian Influenza and other resuch as Avian Influenza and other re--emerging diseasesemerging diseases

Definitive need for increased Lab CapacityDefinitive need for increased Lab Capacity

The Regional Lab MissionThe Regional Lab MissionThe primary mission of the NC Public Health Regional The primary mission of the NC Public Health Regional

Response Laboratories is to provide accurate testing Response Laboratories is to provide accurate testing using Laboratory Response Network protocols in using Laboratory Response Network protocols in rapid response to biological terrorism and emerging rapid response to biological terrorism and emerging infectious diseases. infectious diseases.

The secondary mission is to provide surge capacity in The secondary mission is to provide surge capacity in the event of other public health emergencies. the event of other public health emergencies.

These laboratories, in service to their regions, will also These laboratories, in service to their regions, will also establish and maintain a communication network of establish and maintain a communication network of sentinel and local health department labs and work sentinel and local health department labs and work with regional emergency response agencies to share with regional emergency response agencies to share essential public health laboratory information.essential public health laboratory information.

BTEP Coordinator

Regional LabPitt

1 Specialist 1 Tech

Medical Lab Specialists

X2

Med Lab Tech X2

BTEP Lab Consultant

Public Health Scientist

NCSLPHDirector

Regional LabBuncombe

1 Specialist 1 Tech

Regional LabMecklenburg1 Specialist

1 Tech

Administrative Asst.

The mission of the NCSLPH is to provide certain medical and enviThe mission of the NCSLPH is to provide certain medical and environmental laboratory services (testing, consultation, ronmental laboratory services (testing, consultation, and training) to public and private provider organizations respoand training) to public and private provider organizations responsible for the promotion, protection, and assurance of nsible for the promotion, protection, and assurance of health of North Carolina citizens. health of North Carolina citizens.

The mission of the BTEP Unit is to maintain laboratory capacity The mission of the BTEP Unit is to maintain laboratory capacity for the detection of biological weapons and emerging for the detection of biological weapons and emerging infectious diseases and to act in a manner that strengthens crisinfectious diseases and to act in a manner that strengthens crisis response within the Division of Public Health.is response within the Division of Public Health.

Bioterrorism and Bioterrorism and Emerging Pathogens UnitEmerging Pathogens Unit

Laboratory for rapid identification and Laboratory for rapid identification and confirmation of agents. Suitable for work confirmation of agents. Suitable for work with infectious agents which may cause with infectious agents which may cause serious or potentially lethal disease as a serious or potentially lethal disease as a result of exposure by the inhalation route.result of exposure by the inhalation route.

Implementation of RealImplementation of Real--time Polymerase time Polymerase Chain Reaction (PCR) assays and TimeChain Reaction (PCR) assays and Time--Resolved Fluorescence (TRF) testing for Resolved Fluorescence (TRF) testing for potential BT agents.potential BT agents.

BioBio--safety Level 3safety Level 3

ABSL-1

B BSL-2

CBSL-3

A - Rule-out and forward organisms

B - Limited confirmation and Transport

C - Molecular assays, reference capacity

D - Highest level characterization (Federal)D BSL-4

Critical Biological AgentsCritical Biological AgentsBacillus anthracisBacillus anthracisYersinia pestisYersinia pestisFrancisella tularensisFrancisella tularensisHemorrhagic Fever VirusesHemorrhagic Fever VirusesSmallpoxSmallpox

Pan Orthopox Pan Orthopox Clostridium botulinum toxinClostridium botulinum toxin

Brucella Brucella sp.sp.Coxiella burnettiCoxiella burnettiBurkholderia malleiBurkholderia malleiRicin toxinRicin toxinStaphylococcus Staphylococcus enterotoxin Benterotoxin BAlpha virusesAlpha viruses

EEEEEEWEEWEE

Food or waterborne Food or waterborne pathogens:pathogens:

Salmonella Salmonella sp.sp.Shigella dysenteriaeShigella dysenteriaeE. coli E. coli O157:H7O157:H7Vibrio choleraeVibrio choleraeCryptosporidium parvumCryptosporidium parvum

BackgroundBackground

Laboratory Response NetworkLaboratory Response Network

Provided to Each LRN LabProvided to Each LRN Lab

Standardized Reagents & ControlsStandardized Reagents & ControlsAgentAgent--Specific ProtocolsSpecific ProtocolsLab Referral DirectoryLab Referral DirectorySecure Communications Secure Communications Electronic Laboratory ReportingElectronic Laboratory ReportingTraining & Technology TransferTraining & Technology TransferProficiency TestingProficiency TestingAppropriate Vaccinations for Lab WorkersAppropriate Vaccinations for Lab Workers

Information Technology Information Technology SupportSupport

Provides secure access for Provides secure access for more than 1,700 LRN Lab more than 1,700 LRN Lab workersworkersSecure communications on Secure communications on emerging and emergency emerging and emergency issuesissuesOrder reagentsOrder reagentsView protocols for PCR and View protocols for PCR and TRF assaysTRF assaysReport and review Report and review proficiency testsproficiency testsReceive periodic updates Receive periodic updates regarding reagent regarding reagent availability, etc. availability, etc.

LRN Formula for SuccessLRN Formula for Success

Unified operational planUnified operational planStandardized protocols and testsStandardized protocols and testsSecure communicationsSecure communicationsMolecular diagnosticsMolecular diagnosticsRapid response and reportingRapid response and reportingSafe, secure laboratoriesSafe, secure laboratoriesTrained laboratoriansTrained laboratoriansCoverage for human, animal, food, Coverage for human, animal, food, environmental specimensenvironmental specimensCDC coordinated support and oversightCDC coordinated support and oversightQuality laboratory resultsQuality laboratory results

LocationsLocations

What We Have Accomplished What We Have Accomplished So FarSo Far……

CertificationsCertifications

CDC: Select AgentCDC: Select AgentUSDAUSDADepartment of JusticeDepartment of JusticeWorld BioHazTecWorld BioHazTecCLIACLIA

TrainingTrainingCDC & Virginia SLPHCDC & Virginia SLPHEagleson Institute & Georgia SLPHEagleson Institute & Georgia SLPHNC State Lab of Public Health (central lab)NC State Lab of Public Health (central lab)ASM WorkshopsASM WorkshopsOnsite and OnOnsite and On--line Proficiencyline ProficiencyWeapons of Mass DestructionWeapons of Mass DestructionCounter Terrorism Counter Terrorism Emergency Response to Biological Emergency Response to Biological IncidentsIncidentsPH response for Meth LabsPH response for Meth LabsResponse Planning for Public Water Response Planning for Public Water Facilities Facilities PH Incident Command SystemPH Incident Command System

Guidelines for Sentinel (Hospital) Guidelines for Sentinel (Hospital) LabsLabs

Develop and maintain capability of Develop and maintain capability of Sentinel LaboratoriesSentinel Laboratories

Perform rulePerform rule--out testing on critical Bioterrorism out testing on critical Bioterrorism (BT) agents(BT) agentsSafely package and handle specimensSafely package and handle specimensRefer to LRN (Reference) Lab for further testingRefer to LRN (Reference) Lab for further testingContact informationContact information

Communication NetworkCommunication NetworkDatabase of key personnel in Region 7 Database of key personnel in Region 7 hospitals and HD for the Lab Response hospitals and HD for the Lab Response NetworkNetwork

Receive and send information rapidly during Receive and send information rapidly during infectious disease outbreaks and BT drills / infectious disease outbreaks and BT drills / eventsevents

Federal Federal ⇒⇒ State State ⇒⇒ LocalLocal

Continuing educationContinuing educationPublic health updatesPublic health updatesCommunicable disease reportingCommunicable disease reportingReagent/equipment recallsReagent/equipment recallsLaboratory operationsLaboratory operations

CAPCAP--CLIACLIA--JCAHO inspectionJCAHO inspectionCertificate required for PackagingCertificate required for Packaging--Ship Ship trainingtraining

Surge Capacity HSurge Capacity H22O Testing O Testing (hurricanes, floods)(hurricanes, floods)

43 private well water samples from two 43 private well water samples from two WNC counties during fall 2004 floodsWNC counties during fall 2004 floodsusing Colilertusing Colilert®® and Colisureand Colisure™™ test kitstest kits

Surge Capacity Surge Capacity FoodFood--borne outbreaksborne outbreaks

>1000 samples during Meck County >1000 samples during Meck County ShigellaShigellaoutbreakoutbreak

~195 samples during Wilkes County ~195 samples during Wilkes County ShigellaShigellaoutbreakoutbreak

Testing CapabilitiesTesting CapabilitiesMolecular (presumptive) and Classical Molecular (presumptive) and Classical Microbiology (confirmatory) for reporting of Microbiology (confirmatory) for reporting of BT agents and other emerging infectious BT agents and other emerging infectious agents agents

EnvironmentalEnvironmentalClinicalClinicalPostal Service (BDS)Postal Service (BDS)FoodFood

Testing CapabilitiesTesting CapabilitiesDPDx System for diagnosis of foodDPDx System for diagnosis of food--borne and parasitic diseasesborne and parasitic diseases

Website developed and maintained by CDCWebsite developed and maintained by CDC’’s s Division of Parasitic DiseasesDivision of Parasitic DiseasesDPDx system: digital camera, microscope and DPDx system: digital camera, microscope and imaging software using imaging software using ““telediagnosistelediagnosis”” to to exchange images from diagnostic specimens exchange images from diagnostic specimens via the internetvia the internetThrough DPDx, images transmitted to CDC Through DPDx, images transmitted to CDC receive answers to inquiries in minutes to receive answers to inquiries in minutes to hourshours

Response PlanningResponse PlanningLocal county and regional Local county and regional responseresponseSmallpox vaccination clinicsSmallpox vaccination clinics

HepatitisHepatitis--A A MRSAMRSALegionella Legionella

Group A StrepGroup A StrepE. coli 0157 Outbreaks E. coli 0157 Outbreaks SARS Surveillance SARS Surveillance Influenza Vaccine shortageInfluenza Vaccine shortageRegional Flood ResponseRegional Flood Response

Laboratory ImprovementLaboratory Improvement

BT workshops for Hospital and HD labsBT workshops for Hospital and HD labs

BT Preparedness updatesBT Preparedness updates

InspectionsInspections

Biosafety and Quality AssuranceBiosafety and Quality Assurance

Capabilities of all Mecklenburg County Capabilities of all Mecklenburg County Governmental Lab AgenciesGovernmental Lab Agencies

Assist PHRSTeamsAssist PHRSTeams

Clinical Sample Submission and Clinical Sample Submission and Environmental Sampling during BT Environmental Sampling during BT EventsEvents

Information Sessions with Police, Information Sessions with Police, Fire and HazMat on BT agents and Fire and HazMat on BT agents and sample package and delivery sample package and delivery

Assist First RespondersAssist First Responders

Communication with law Communication with law enforcement and emergency enforcement and emergency services to ensure chain of custody services to ensure chain of custody concerning specimen transferconcerning specimen transfer

Forensic Epidemiology Forensic Epidemiology presentationspresentations

Packaging/ShippingPackaging/ShippingLow suspicion Low suspicion ––Hospital/HD Hospital/HD courier system/FedExcourier system/FedEx

Packaging/ShippingPackaging/ShippingHigh suspicion High suspicion –– hand delivered by hand delivered by law enforcementlaw enforcement

Bioterrorism Agents of Concern - Main

Agents of Concern

Bacillus anthracis

Yersinia pestis

Smallpox

Brucella spp

Francis. tularensis

Ricin

Submission Criteria

Submission Form

Environmental Form

Clinical Form

Shipping Guidelines

FAQ

Contact Numbers

Relevant Links

NC Epidemiology

NC EPI PHPR

CDC Bioterrorism

FDA Bioterrorism

CDC

http://slph.state.nc.us

Contact InformationContact Information

NC Regional Response LabNC Regional Response Lab--Mecklenburg:Mecklenburg:Clay Hughes: (704) 432Clay Hughes: (704) 432--17351735

Justin Edwards: (704) 432Justin Edwards: (704) 432--15141514

BTEP:BTEP:Duty Phone 24/7: (919) 807Duty Phone 24/7: (919) 807--86008600Duty Pager 24/7: (919) 310Duty Pager 24/7: (919) 310--42434243

Questions?Questions?