COOPERATIVE AGREEMENT GUIDANCE FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS

Public Health Laboratory Capabilities and Outcomes

Key Outcomes

Chemical, radiological, and biological agents causing or having the potential to cause widespread illness or death are rapidly detected and accurately identified by the public health laboratory within the jurisdiction or through a network collaboration with other appropriate federal, state, and local laboratories. The public health laboratory, working in close partnership with public health epidemiology, environmental health, law enforcement, agriculture, and veterinary officials, hospitals, and other appropriate agencies, produces timely and accurate data to support ongoing public health investigations and the implementation of appropriate preventive or curative countermeasures.

Capabilities

For all public health laboratories:

• Prepare/update/maintain a lab continuity of operations plan (COOP) consistent with chemical, radiological, and select agent requirements.
  
  
• Develop, maintain, and evaluate a plan to rapidly identify radiological, chemical, and biological agents which may be involved in a terrorist event.

For biological laboratories:

• Evaluate your capabilities and capacity for identification of biological agents in clinical (human and animal) specimens and environmental samples by ensuring the jurisdiction can:
  1. Ensure availability of at least one operational Biosafety Level 3 (BSL-3) laboratory in the jurisdiction (or have formal arrangements in place for this capacity to be acquired).
  2. Identify all biological sentinel labs in the jurisdiction and coordinate for training and logistics in specimen packaging and shipping.
  3. Maintain and test the competencies of the bioterrorism laboratory coordinator to advise on proper collection, packaging, labeling, shipping, and chain of custody procedures for biological samples.
  4. Test the competency of biological sentinel laboratories to properly send samples to a Laboratory Resource Network (LRN) Reference Laboratory in their region.
  5. Develop and disseminate operational plans and protocols for:
     • Specimen collection, transport, handling, and storage
     • Laboratory safety, to include emergency response operations
     • Training of laboratory personnel in biosafety
     • Compliance with federal biosecurity and biosafety regulations
     • Training of laboratory personnel in LRN-deployed rapid testing methods
     • Triaging samples
     • Maintaining supply levels and equipment necessary for bioterrorism response efforts
     • Addressing gaps identified in surge capacity for biological incidents
  6. When a Homeland Security Exercise and Evaluation Program (HSEEP)-compliant, operations-based exercise(s) that public health personnel participate in or conduct includes a laboratory element, ensure that the exercise includes the conduct and evaluation of critical laboratory functions including sample and/or specimen collection, triage, accessioning, testing, and data messaging of results to the sending entity.
  7. Coordinate and/or collaborate with local law enforcement and regional Federal Bureau of Investigation for screening and triage procedures for mixed environmental samples (to include chemical, biological, radiological, and explosive materials).
  8. Maintain supply levels and equipment necessary for bioterrorism response efforts and high throughput considerations for pandemic influenza.
  9. Have the capacity to test for or rule out for variola virus in both human and environmental samples.
  10. Participate in the LRN proficiency testing program.
  11. Ensure proper and timely reporting of proficiency testing results to the CDC Director’s Emergency Operations Center (DEOC) when required and when significant results warrant, as well as participate in LRN-sponsored exercises.

For laboratories testing for chemical threat agents:

Level 3 Laboratories:

• Conduct outreach to hospitals and conduct clinical chemical specimen collection, packaging, and shipping training.
• Demonstrate competence in sample collection, packaging, and shipping by successfully participating in at least one LRN-C sample collection, packaging, and shipping (SCPaS) exercise.
• Establish a working relationship with poison control centers who can act as sentinel resources for obscure chemical exposure incidents, such as food poisoning.
• Stock sample collection and shipping supplies for a minimum of 500 patient samples.

Level 2 Laboratories:

• Meet all Level 3 requirements.
• Successfully complete at least one Emergency Response Exercise (Pop PT).
• Conduct outreach activities to first responders, such as hazardous materials teams and civil support teams (CSTs), to establish a technical link between them and the public health chemistry lab with respect to field analysis of unknown samples.
• Stock materials and supplies for the analysis of at least 500 patient samples for each qualified analysis method.
• Attain/maintain LRN-C PT Program Qualified status for:
  • Cyanide in blood by GC-MS
  • Nerve agent metabolites in urine by GC-MS (or LC-MS/MS)
  • VOCs in blood by GC-MS
  • Multi-element urine by ICP-MS
  • As/Se in urine by DRC-ICP-MS
  • Blood Cd/Hg/PB by ICP-MS
  • At least one additional LC-MS/MS analysis

Level 1 Laboratories:

• Meet all Level 2 and 3 requirements.
• Maintain LRN-C PT Program Qualified status for all Level 1 and Level 2 analysis methods.
• Attain LRN-C PT for each new analysis method transferred by CDC.
• Maintain an adequate supply of materials and supplies for the analysis of 1,000 patient samples for each analysis method.
• Successfully participate in all surge capacity exercises.
• Send at least two representatives to each Level 1 Surge Capacity Laboratory meeting

For laboratories testing for radiological threats:

• Evaluate, maintain, or increase as needed the capability and capacity for identification of radioactive material in clinical (human and animal) and environmental samples.
  1. Maintain and test the competency of the radioanalytical laboratory coordinator to advise on proper collection, packaging, labeling, shipping, storage and chain-of-custody of clinical (blood, urine, etc.) and environmental samples.
  2. Develop and execute plans and protocols to properly collect, store, package, label, ship, coordinate routing, and maintain chain-of-custody of clinical and environmental samples to laboratories that can test for radioactive materials.
  3. Develop a system to triage samples.
  4. Maintain supply levels and equipment necessary for response to radiological incidents.
  5. Identify and address gaps in surge capacity for radiological incidents.
• Maintain compliance with federal and/or state regulations regarding use of radioactive materials and laboratory and worker safety.
• Coordinate and/or collaborate with local law enforcement and regional Federal Bureau of Investigation for screening and triage procedures for mixed environmental samples (to include chemical, biological, radiological, and explosive materials).