1. Capability Cliff Notes Series PHEP Capability 12—Public Health Laboratory Testing What Is It And How Will We Measure It?

2. Glossary of Terms Rapid and conventional detection—Tests that detect the presence of an illness- causing agent in a quick way, which is less specific, or by a longer more specifically targeted method Confirmatory testing—Pathogens such as those that cause Hepatitis have levels of testing. An initial or presumptive test may determine if there has been exposure, or if there might be the presence of a range of agents. Confirmatory testing either identifies the actual presence of an agent or can identify a particular agent out of a range. IATA/DOT—International Air Transport Association/Department of Transportation, the organizations that issue protocol for how items such as lab samples are to be moved. LRN-B—Laboratory Response Network, the network of laboratories throughout the nation that detect and characterize biological, chemical, and radiological agents, and communicate through the CDC. They are divided into national labs, reference labs, and sentinel labs for biological threats, and Level 1, 2, and 3 for chemical threats. More information can be found at this link: http://www.bt.cdc.gov/lrn/ http://www.bt.cdc.gov/lrn/

3. Glossary of Terms LRN-C Testing Methods—Methods set up to detect chemical threats. LRN-R Testing Methods—Methods set up to detect radiological threats. National labs have the largest capacity and the most specific biological testing, such as for specific strains of highly infectious agents. Reference labs, such as the CDPHE Lab, can do confirmatory biological testing. Sentinel labs, such as some hospital labs, are usually the first to see an biological agent, and refer to reference or national labs for more specific results. Level 1 Laboratory—These laboratories are large labs that can detect exposure to most toxic agents, such as including mustard agents, nerve agents, and other toxic industrial chemicals, and can handle a lot of samples including surge samples from the other laboratories. Level 2 Laboratory—These laboratories are smaller with less capacity, that can detect exposure to a number of toxic chemical agents, such as cyanide, nerve agents, and toxic metals in human tissue. Level 3 Laboratory—These laboratories are the smallest or least capacity that are usually the first to detect the presence of a chemical agent.

4. Glossary of Terms Forensic chain of custody—The tracking of a sample through different people handling it in a forensic, or a criminal investigation. Clinical sample—A sample sent to a laboratory that comes through medical/laboratory channels. Nonclinical sample—A sample that comes from outside a clinical setting, a community setting, such as from a first responder/EMT, or other source. Biomarker—A substance found in a sample that can be measured and indicates a biological process, exposure, or disease. PulseNet—A system and database that uses DNA from biological agents to track strains of the agents in different locations. This can be used to identify or connect cases of illness in different places, or identify when a strain of bacteria has changed. http://www.cdc.gov/pulsenet/about/faq.htmlhttp://www.cdc.gov/pulsenet/about/faq.html Pulsed field gel electrophoresis (PFGE)—A test using electricity and gel to identify the DNA of different biological agents. Results from these tests are stored in the PulseNet database for comparison.

5. Public Health Laboratory Testing Public health laboratory testing is the ability to conduct rapid and conventional detection, characterization, confirmatory testing, data reporting, investigative support, and laboratory networking to address actual or potential exposure to all- hazards. Hazards include chemical, radiological, and biological agents. This capability supports routine surveillance, in addition to pre-event or pre-incident and post-exposure activities. How can health public health laboratories ensure their ability to test for harmful agents?

6. Public Health Laboratory Testing Functions: How Should Public Health Laboratories Ensure Testing and Surveillance Abilities? Manage laboratory activities Perform sample management Conduct testing and analysis for routine and surge capacity Support public health investigations Report results

7. Capabilities and Measures Resources The presentation will be an overview of what the functions and tasks mean, linked to the performance measures. The following performance measures are required for this capability: Time to complete notification between CDC, on-call laboratorian, and on-call epidemiologist; or time to complete notification between CDC, on-call epidemiologist and on-call laboratorian – depending on drill direction Start Time: Date and time that CDC EOC staff first dialed the contact number for the on-call laboratorian or epidemiologist, depending on drill direction. Stop Time: Date and time that on-call laboratorian or epidemiologist (depending on drill direction) contacted CDC EOC to complete the drill cycle. Performance Target: 45 minutes Percentage of biomarkers of chemical agents successfully detected by Level 1 and/or Level 2 laboratories during the LRN-C Emergency Response Exercise Numerator: Number of biomarkers of chemical agents successfully detected by Level 1 and/or Level 2 laboratories Denominator: Number of biomarkers of chemical agents included in the exercise Measures cont’d next slide:

8. Capabilities and Measures Resources Proportion proficiency tests (additional methods) successfully passed by PHEP-funded laboratories of LRN-C Numerator: Number of LRN-C additional methods successfully proficiency tested by the PHEP-funded laboratory Denominator: Total number of LRN-C additional methods for which the PHEP-funded laboratory is qualified to test Proportion proficiency tests (core methods) successfully passed by PHEP-funded laboratories of LRN-C Numerator: Number of LRN-C core methods successfully proficiency tested by the PHEP-funded laboratory Denominator: Total number of LRN-C core methods for which the PHEP-funded laboratory is qualified to test Ability of PHEP-funded LRN-C laboratories to package and ship specimens properly during an LRN exercise Specimen packaging and shipping exercise (SPaSE) results, per laboratory: Passed/Did not pass/Did not participate Proportion of LRN-B proficiency tests successfully passed by PHEP-funded laboratories Numerator: Number of LRN-B proficiency tests successfully passed by PHEP-funded laboratory Denominator: Total number of LRN-B proficiency tests participated in by PHEP-funded laboratory Percentage of pulsed field gel electrophoresis (PFGE) sub-typing data results for E. coli O157:H7 submitted to the PulseNet (PN) national database within four working days of receiving isolate at the PFGE laboratory Numerator: Number of results from PFGE sub-typing of E. coli O157:H7 human isolates that were submitted to the PulseNet (PN) database within four working days of receipt at the PFGE laboratory. Denominator: Total number of E. coli O157:H7 human isolates for which the state performed PFGE subtyping Performance Target: 90%. Measures cont’d next slide:

9. Capabilities and Measures Resources Percentage of pulsed field gel electrophoresis (PFGE) sub-typing data results for Listeria monocytogenes submitted to the PulseNet (PN) national database within four working days of receiving isolate at the PFGE laboratory Numerator: Number of results from PFGE sub-typing of Listeria monocytogenes human isolates that were submitted to the PulseNet (PN) database within four working days of receipt at the PFGE laboratory. Denominator: Total number of Listeria monocytogenes human isolates for which the state performed PFGE subtyping Performance Target: 90%. The BP3 Performance Measures Specifications and Implementation Guidance can be found at the following link: https://www.colorado.gov/pacific/cdphe/hpp-and-phep-performance-measures-and-capabilities

10. Function 1: Manage laboratory activities How can public health laboratories manage their activities to make sure they can respond as needed? Exchange information and data with laboratories and laboratory networks within the jurisdiction.

11. Task Elements There are elements that health departments should keep in mind to address different aspects of the tasks: Identification of laboratories and laboratory networks Procedures for contacting sentinel laboratories and standard response guidelines Lab COOP Awareness of current laboratory national policy and practice Personnel safety and laboratory methods trainings Database of contact information for laboratory networks

12. Function 2: Perform sample management Tasks: What can public health laboratories do to make sure that samples are shipped and maintained correctly for testing? Handle, package, and transport samples following established IATA/DOT and laboratory-specific protocols. Maintain forensic chain-of-custody throughout the sample- management process.

13. Task Elements There are elements that health departments should keep in mind to address different aspects of the tasks: Procedures and protocols for sample collection Protocol for transportation security for laboratory materials Protocol for chain of custody Procedures in place to maintain sampling and/or shipping supplies stock Maintain certification of laboratory personnel in a shipping and packaging program Document forensic chain of custody procedures training Shipping and packaging training Document training on practices for personnel safety while managing samples Maintain appropriate regulatory requirements Chain of custody procedure recommendations Access to sampling and shipping supplies

14. Function 3: Conduct testing and analysis for routine and surge capacity Tasks: What steps will ensure that public health laboratories can successfully test and analyze samples, in a normal situation, and also when many samples come in at the same time? Provide LRN-B reference-level testing on clinical, food, and environmental samples for both rapid and conventional methods. Conduct chemical laboratory testing that follows LRN-C testing methods. Conduct radiological and nuclear laboratory testing that follow LRN-R testing methods (if program funds become available).

15. Task Elements There are elements that health departments should keep in mind to address different aspects of the tasks: Laboratory surge capacity Preventative maintenance contracts and service agreements Guidance for referring suspicious samples Reagent and supply accessibility Protocols to operate at expanded laboratory capacity for surge events LRN-R Proficiency Testing Program Qualified status Competency for LRN-B testing methods LRN proficiency tests Attain LRN-C Proficiency Testing Program Qualified status LRN methods training documentation Meetings focused on technical competencies Level 1 surge laboratory LRN-C Level 1 meeting Safety training documentation Accreditation for LRN-C clinical testing Accreditation for LRN-B clinical testing Accreditation for LRN-R clinical testing Access to a biosafety level 3 laboratory Rapid nucleic acid testing instrument Instrument for detection of LRN-C agents Maintain additional support equipment and supplies Instrument for detection of LRN-R agents Maintain inventory or reliable sources of testing material Equipment necessary for performing LRN assays

16. Function 4: Support public health investigations Tasks: What should public health laboratories do to support public health investigations? Provide analytical support for investigations with first responders and other investigation partners. Provide consultation and technical assistance to health departments, first responders, and other investigation partners for sample collection, management, and safety.

17. Task Elements There are elements that health departments should keep in mind to address different aspects of the tasks: Coordinate activities, gain assistance from, and/or share data Processes to disseminate and receive information from partner agencies Trained on the CDC Public Health Law Program 101, Forensic Epidemiology 3.0

18. Function 5: Report Results Tasks: What should public health laboratories do to report their results and ensure everyone who needs the results has them? Notify appropriate public health, public safety, and law enforcement officials of presumptive or confirmed laboratory results from clinical, food, or environmental samples that involve a chemical, radiological, or biological threat. Send presumptive and confirmed chemical, radiological, or biological laboratory results to CDC and all submitters.

19. Task Elements There are elements that health departments should keep in mind to address different aspects of the tasks: Security and maintenance of records management system Data-exchange processes Notification procedures with health investigation partners utilizing secure contact methods LRN data messaging and laboratory-specific policies Jurisdictional Laboratory Information Management System Digital certificate for access to electronic results-reporting systems Computer for access to LRN and partner electronic reporting systems Mechanism for reporting to LRN-B, LRN-C and LRN-R

20. Questions? Please contact: Rachel Coles Program Evaluator--CDPHE 303-692-2764 rachel.coles@state.co.us