Capability Cliff Notes Series

PHEP Capability 12—Public Health Laboratory Testing

What Is It And How Will We Measure It?

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/

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.

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.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.

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?

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

Capabilities and Measures ResourcesThe presentation will be an overview of what the functions and tasks mean, linked to

the performance measures.

Please note that since the capabilities PDF document has come out, more performance measures have been developed. If performance measures have come out since the creation of the capabilities document below, they have been included in the tutorials following their function slide, even if the PDF lists that there are no measures for that function. For functions that still have no measures, questions for health departments to begin thinking about measures have been included instead.

For exact lists of the capabilities and performance measures, and data collected for the measures, documents can be found at these links:

For Capabilities, Functions, and Tasks• http://www.cdc.gov/phpr/capabilities/DSLR_capabilities_July.pdf

For Performance Measures• http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

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.

Function 1 MeasurementHow does CDC measure if public health laboratories are ready to

respond to a need?

Proportion of incidents in which laboratorian reported to laboratory (after hours) prior to receipt of specimen or sample

• Numerator: Number of incidents in which an appropriate laboratorian reported (after hours) to the public health laboratory prior to receipt of a specimen or sample.

• Denominator: Number of incidents in which a specimen or sample was shipped to the public health laboratory with an arrival time outside of normal business hours and requiring immediate testing.

Other data elements that are included in calculating this measure can be found in PHEP Performance Measures on pg 63: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

Function 1 Measurement Cont’dHow does CDC measure if public health laboratories are ready to

respond to a need?

Time for sentinel clinical laboratories to acknowledge receipt of an urgent message from PHEP-funded LRN-B laboratory

• Start Time: Date and time PHEP-funded LRN-B laboratory sends urgent message to first sentinel clinical laboratory

• Intermediate stop time 1: Date and time at least 50% of sentinel clinical laboratories acknowledged receipt of urgent message

• Intermediate stop time 2: Date and time at least 90% of sentinel clinical laboratories acknowledged receipt of urgent message

• Stop Time: Date and time last sentinel clinical laboratory acknowledged receipt of urgent message

Other data elements that are included in calculating this measure can be found in PHEP Performance Measures on pgs 73-74: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

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.

Function 2 MeasurementHow does the CDC measure whether public health laboratories manage their

samples efficiently and correctly?

• Did at least one LRN-C laboratory in the jurisdiction participated and pass the specimen packaging and shipping exercise?

Specific data elements that went into forming this measure can be found in PHEP Performance Measures on pg 72: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

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).

Function 3 MeasurementHow does the CDC measure whether public health laboratories are able to

successfully test, and analyze samples they are qualified to test?

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.

Successful detection requires a score of 80% or higher.

Proportion of LRN-C proficiency tests (additional methods) successfully passed by PHEP-funded laboratories

• 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

Specific data elements that went into forming this measure can be found in PHEP Performance Measures on pgs 69-70: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

Measures continued on next slide:

Function 3 Measurement Cont’dHow does the CDC measure whether public health laboratories are able to

successfully test, and analyze samples they are qualified to test?

Proportion of LRN-C proficiency tests (core methods) successfully passed by PHEP-funded laboratories

• Numerator: Number of LRN-C core methods successfully proficiency tested by the PHEP-funded laboratory

• Denominator: Total number of LRN-C core methods (9)

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(s)

• Denominator: Total number of LRN-B proficiency tests participated in by PHEP-funded laboratory(s)

Specific data elements that went into forming this measure can be found in PHEP Performance Measures on pg 75: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

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.

Function 4 MeasurementHow does the CDC measure how well public health laboratories

can respond to a need for support in a public health investigation?

Total Time to complete the notification loop from CDC to on-call laboratorian to on-call epidemiologist, or from CDC to on-call epidemiologist to on-call laboratorian.

• Start Time: Date/time that CDC contacted the on-call laboratorian or epidemiologist.

• Stop Time: Date/time that on-call laboratorian or epidemiologist contacted the CDC to complete the drill cycle.

Specific data elements that went into forming this measure can be found in PHEP Performance Measures on pgs 64-65: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

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.

Function 5 MeasurementHow does the CDC measure how completely public health laboratories report

the results to the people who need them?

(Optional) Time for PHEP-funded laboratory to notify public health partners of significant laboratory results

• Start Time: Date and time laboratory receives a significant laboratory result • Stop Time: Date and time laboratory notifies public health partners of significant

laboratory results (time when last public health partner was notified)

(Mandatory) Percentage of pulsed field gel electrophoresis (PFGE) results for E. coli O157:H7 that were submitted to the PulseNet (PN) national database within four (4) working days of receiving isolate at the laboratory? • Numerator: Number of results submitted to the PulseNet (PN) database within four

working days of receipt. • Denominator: Total number of E. coli O157:H7 isolates for which the state performed

PFGE subtyping

Target is 90%

Measures continued on next slide:

Function 5 Measurement Cont’dHow does the CDC measure how completely public health laboratories report

the results to the people who need them?

(Mandatory) Percentage of pulsed field gel electrophoresis (PFGE) 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 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 isolates for which the state performed PFGE subtyping

Target is 90%

Specific data elements that went into forming this measure can be found in PHEP Performance Measures on pgs 67-68, 76-79: http://www.colorado.gov/cs/Satellite/CDPHE-EPR/CBON/1251643573938

Questions?

Please contact:Rachel ColesProgram Evaluator--CDPHE303-692-2764rachel.coles@state.co.us