Clinical Specimens BT agents may not be initially suspected. Exposed/ill patients will be seen in ER’s, clinics, offices. Collect appropriate specimens based on patient symptoms.
Nasal Cultures? NOT recommended for asymptomatic patients with no known exposure. Sensitivity and specificity unknown A positive or negative nasal swab does not predict infection. Collected for epidemiology purposes ONLY after consult with MDCH.
Specimen Handling Clinical Follow storage guidelines established by laboratory processing specimens Universal precautions Proper packaging and shipping
Specimen Collection, Processing & Shipping Exposure to Chemical Agents
Specimens Required by CTLN Urine-25 ml, screw capped container, no preservative, frozen Whole blood, two 5 or 7 ml EDTA(purple), unopened, 4 C. Whole blood, one 5 or 7 ml gray or green, 4 C, plus an empty tube for each lot used as a blank. Whole blood, two 10 ml red (not SST or gel), DO NOT centrifuge, 4 C.
Recommended Times of Specimen Collection Blood should be collected as soon as possible after exposure Urine should be collected 7-8 hrs after exposure Testing is largely used to rule out exposure (worried well) or document exposure, cause of death
Processing & Shipping (per the CDC for chemical agents) Before shipping specimens contact MDCH or CDC. Specimens should be labeled with identification #, collector’s initials, date & time (patient names should not be included). “De-identify”. Sample identification # & patient names should be maintained by the submitter. Results will be reported with identification # Use chain of custody form and forensic tape to seal tubes and packages
Processing & Shipping (continued) Use cool packs for blood and dry ice for urine Package urine and blood separately Include a shipping list of specimens with ID #s Include a contact name and phone # Label outside of box with: Non-infectious, diagnostic specimens, packed in compliance with IATA, packing instructions 650
Contact Information MDCH Bureau of Laboratories 517-335-8063 Division of Chemistry and Toxicology 517-335-9490 Shipping address: PO Box 30035, 3350 North Martin Luther King Jr. Blvd, Lansing, MI 48909 After hours emergencies, 517-335-9030
Rapid Toxic Screen: Groups of Chemical Agents Nerve Agents (metabolites of parent agent) Sulfur mustards (metabolite) Nitrogen Mustards (metabolite) Lewisite Agents Hydrogen Cyanide Volatile Agents (Phosgene, Vinyl Chloride) Heavy Metals (lead, arsenic, cadmium, uranium)
Rapid Handheld Equipment for Chemical Agents Several vendors are now marketing products that may meet this need. One high profile example is Airport Security instrumentation for explosives, illicit drugs and chemical warfare agents. Mobile labs for biological and chemical agents are being designed. Rapid testing is needed to make decisions but confirmation will be required This area of laboratory testing is unregulated & performed by non-lab personnel
What about other Specimens to be Tested for Chemical Agents? Laboratory expertise and testing capabilities can vary greatly with the specimen type In human specimens, testing may target metabolites and not the parent compound In non-clinical testing( unknowns, liquids, solids) testing will likely target parent compound Foods and veterinary specimens need also be included in the preparedness plan Funding is needed to develop all of these testing programs
Michigan Emergency Management Plan & Laboratory Office of Public Health Preparedness: provides interdepartmental coordination of preparedness MI Department of Environmental Quality: environmental, pesticides, chemical, nuclear, water. MI Department of Agriculture: food safety, 51st WMD Civil Support Team via MSP (explosives,nuclear, biological, chemical) MI Poison Centers: Detroit & Grand Rapids, 800-222-1222
Michigan Emergency Management Plan & Lab (continued) MI Dept Labor & Economic Growth MSU Diagnostic Center for Population & Animal Health Laboratory: veterinary specimens
Safety – Chemical & Infectious Agents Mixing of infectious and chemical agents is a real possibility in a BT incident Best solution is still under development Gamma irradiation of specimens prior to chemical analysis is being evaluated by the CDC
Safety-Clinical Specimens BSL-2 Processing specimens BSL – 3 Culture manipulations that might produce aerosols
Safety – Clinical Specimens Standard Infection Control Practices: Wash hands Wear PPE- as appropriate Process contaminated supplies Clean and disinfect environmental surfaces Follow occupational health/blood-borne pathogen procedures
Environmental Testing for BT Agents What do you do if you have a suspicious item? Notify law enforcement What will they do? Threat assessment, package and transport sample. Compile a list of contacts to the item
Sample Submission All testing is approved by the FBI after a threat assessment has been performed Each sample must be certified risk-free before the lab will accept it for testing Chain of Custody is initiated at delivery of the sample to the laboratory Priority of testing is determined by the FBI and the Bureau’s of Epidemiology and Laboratories at MDCH
Environmental Samples for BT Agents Rapid field testing may be done by law enforcement, HazMat or 1st responders CDC has not yet endorsed any of the rapid field tests for BT agents Samples must always also be tested at Public Health Laboratories for definitive result MDCH will test environmental samples including packages, liquids, letters, swabs and food.
Packaging Environmental Samples All samples will be triple bagged as evidence by law enforcement or HazMat All samples will be transported by the FBI WMD Coordinator or another law enforcement agency Transported using only one vehicle Transporting officer stays with sample at all times
Environmental Laboratory Testing Samples obtained in an investigation will go to the MDCH laboratory for testing Samples submitted will be preserved as evidence Samples will be retained at MDCH until a final negative report is issued Samples are released to the FBI If part of a law enforcement investigation, samples are sent to the MSP Forensic Laboratory or an FBI facility If no law enforcement action is to be taken, samples are returned to the submitter or destroyed
Lab Results Reports on environmental specimens submitted to MDCH go to: FBI Local Public Health Department MDCH Bureau of Epidemiology
Specimens Submitted to MDCH White powder hoaxes received from October 2001until 12/31/03 265 environmental specimens 128 Postal Service specimens All were cleared by local law enforcement and the FBI None were positive for B. anthracis
Rapid Hand-Held Assays for Biological Specimens HHS – does not recommend use False positives False negatives Sensitivity/specificity Requires confirmation
Chain of Custody Chronological written record Acquisition until final disposition Assures continuous accountability Considered confidential/classified Maintained in a secure location
Chain of Custody Each chain of custody form is agency specific If a sample is transferred to a second agency that agency will start another chain of custody form for the time that the sample remains in its custody Each agency is responsible for retaining records regarding sample
Chain of Custody Each person signing the form is responsible for the care and preservation of that sample while in their possession Form will account for all persons handling the sample Who obtained Who delivered Who tested Who disposed Those signing may be called on to testify in a criminal proceeding
Chain of Custody Form will include: Sample information Source Condition Collecting/Submitting agency information Contact information Internal and external transfer information Transferred to whom, for what purpose Destruction of sample information