ASSOCIATION OF PUBLIC HEALTH LABORATORIES MODEL PRACTICE: Algorithm and Guidelines for Responding to an Incident Involving a Suspicious ...
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ASSOCIATION OF Algorithm and Guidelines for Responding to an Incident PUBLIC HEALTH Involving a Suspicious LABORATORIES Non-Clinical Sample MODEL PRACTICE: VERSION 3.0, MARCH 2018
THE ASSOCIATION OF PUBLIC HEALTH LABORATORIES (APHL) IS A NATIONAL NON- PROFIT ORGANIZATION DEDICATED TO WORKING WITH MEMBERS TO STRENGTHEN GOVERNMENTAL LABORATORIES THAT PERFORM TESTING OF PUBLIC HEALTH SIGNIFICANCE. BY PROMOTING EFFECTIVE PROGRAMS AND PUBLIC POLICY, APHL STRIVES TO PROVIDE MEMBER LABORATORIES WITH THE RESOURCES AND INFRASTRUCTURE NEEDED TO PROTECT THE HEALTH OF US RESIDENTS AND TO PREVENT AND CONTROL DISEASE GLOBALLY. This APHL Report was 100% supported by Cooperative Agreement #NU060OE00103 funded by the US Centers for Disease Control and Prevention. Its contents are solely the responsi- bility of the authors and do not necessarily represent the official views of CDC. Copyright © 2018, Association of Public Health Laboratories. All Rights Reserved.
TABLE OF CONTENTS USING THE APHL MODEL PRACTICE .....................................................................................................................1 First Responder Algorithm................................................................................................................................................. 2 LRN-B Reference and LRN-C Laboratory Testing Algorithm............................................................................................. 3 GUIDELINES ON HOW TO USE THE ALGORITHMS...................................................................................................6 1.0 Incident involving a Suspicious Non-Clinical Sample Occurs............................................................................ 7 2.0 First Responders Perform a Risk Assessment................................................................................................... 7 3.0 No Apparent Risk (continue to box 4.0)............................................................................................................. 7 3.1 Risk Low or High (continue to box 4.1)......................................................................................................... 7 4.0 No Testing Necessary ......................................................................................................................................... 7 4.1 Threat Assessment........................................................................................................................................ 8 5.0-5.2 No Apparent Threat, Potential or Credible Threat........................................................................................ 8 6.0 No Testing............................................................................................................................................................ 9 6.1 Field Screening (Explosives and Radiation at a minimum).......................................................................... 9 7.0 Field Screening is Negative................................................................................................................................. 9 8.0 Sample Arrives at the State or Local Public Health LRN Member Laboratory................................................ 10 9.0 Perform Recommended Preliminary Screening and Split Sample for Biological, Radiological and Chemical Testing Groups for Future Testing ........................................................................ 11 10.0 Sample is sent to the LRN-B Reference Laboratory and tested for Biological Threat Agents......................13 11.0 Preliminary Positive Laboratory Result...........................................................................................................13 11.1 Preliminary Negative Laboratory Result.........................................................................................................13 12.0 Agent Specific Confirmatory Testing...............................................................................................................13 13.0 Report Confirmatory Testing Results..............................................................................................................13 14.0 Sample sent for Chemistry Analysis...............................................................................................................13 15.0 General Chemical Compound Classification.................................................................................................. 14 16.0 Determine if further classification of the material is needed. ...................................................................... 15 17.0 Perform chemical class or agent specific confirmatory testing using SAM or other methods. ................... 15 APPENDIX A: CHAIN-OF-CUSTODY GUIDANCE.....................................................................................................18 APPENDIX B: DESCRIPTION OF THE LABORATORY RESPONSE NETWORK (LRN).................................................21 APPENDIX C: HIGH PRIORITY CHEMICALS FOR CHEMICAL THREAT ASSESSMENT..............................................23 REFERENCES......................................................................................................................................................24
1 Association of Public Health Laboratories Model Practice ALGORITHM AND GUIDELINES FOR RESPONDING TO AN INCIDENT INVOLVING A SUSPICIOUS NON-CLINICAL SAMPLE The purpose of the response and testing algorithms is to provide guidance to state and local public health Laboratory Response Network (LRN) member laboratories working with multiple organizations and agencies to respond to an USING incident involving a suspicious non-clinical sample. This guidance should be a starting point for communication between the laboratory and response com- THE APHL munities and should supplement other guidance documents currently available in the field. It is critically important for laboratories to understand the roles of all MODEL partners involved in a suspicious incident event to ensure a timely and effective response. The algorithms should be followed step by step until a resolution point has been reached. The accompanying guidelines in this document should be PRACTICE: used for further clarification on how to follow the algorithm. These are minimal guidelines, and APHL anticipates that state and local public health LRN member laboratories will adapt these algorithms to best fit their needs and protocols. These practices are not meant as a standalone protocol, and it is strongly rec- ommended that laboratorians work closely with their first responder communi- ties to provide additional guidance. This document is available online at http://www.aphl.org/ AboutAPHL/publications/Documents/PHPR_2015June_ AlgorithmandGuidelinesWhitepaper.pdf.
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 2 FIRST RESPONDER ALGORITHM [1.0] Incident with a Non-clinical Sample (See FBI/DHS/HHS-CDC Guidance on Initial Responses to a Suspicious Letter/Container with a Biological Threat for more information on response scenarios, if a biothreat.) [2.0] 1st Responders Perform Risk Assessment (See ASTM 2770-17 and NFPA 1600 for more information on performing a risk assessment.) [3.0] No Apparent Risk [3.1] Risk [4.1] Threat Assessment is performed in [4.0] No Testing consultation with FBI Weapons of Mass Destruction Coordinator and /or local law enforcement: notify appropriate state or local public health LRN laboratory. [5.1] Potential Threat [5.2] Credible Threat [5.0] No Apparent Threat [6.1] Field Screening for Explosives, Radiation, and Specific Chemical Compounds. NO FIELD SCREENING FOR BIOLOGICAL THREAT [6.0] No Testing AGENTS SHOULD OCCUR. (See ASTM 2458-17 for more information on sample collection for field screening and transfer to LRN laboratories) Samples not screened are accepted at the lab director’s discretion and may be rejected for submission to the LRN reference laboratory. [7.0] Negative: follow proper decontamina- tion and appropriate packaging require- ments. Consult with appropriate state or local public health LRN staff and send sample immediately to appropriate LRN [7.1] Positive: follow first responder guidelines. laboratory, following Chain of Custody Consult with appropriate state or local public procedures. health LRN laboratory in order to send sample to appropriate testing agency. Follow Chain of Custo- dy procedures at all times.
3 Association of Public Health Laboratories Model Practice LRN-B REFERENCE AND LRN-C LABORATORY TESTING ALGORITHM [8.0] Non-clinical Sample arrives at the state or local public health LRN laboratory. Perform gamma radiation screening on the exterior of packaging. [9.0] Perform recommended preliminary screening and Split Sample for Bio, Chem or other testing - For credible threat samples submitted by the FBI, they request that no chemical threat testing should be conducted. Be sure to consult with your FBI WMD Coordinator regarding the testing being requested. - Perform alpha and beta radiation screening before the sample is split. Follow the LRN-B Refer- ence Level Protocol for Processing an Unknown [10.0] Test for Biological Threat Agents Non-Clinical Sample for Bioterrorism Agents [11.1] Negative: Report preliminary results using LRN Notification and Data Messaging Policies and consult with the [11.0] Positive: Report preliminary LRN-C laboratory to determine capability results using LRN Notification and Data for Chemical Threat Agent Analysis. Messaging Policies. [12.0] Perform agent specific confirmatory testing using LRN Reference Level Protocols. [13.0] Report confirmatory testing results using LRN Notification and Data Messag- ing Policies. [14.0] Sample sent for Analysis for Chemical Threat Agents
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 4 LRN-B REFERENCE AND LRN-C LABORATORY TESTING ALGORITHM (CONT'D) [15.1] Microscope/ IR/ Raman [15.2] Solubility Tests [15.0] General Chemical - [15.3] Compound Colorimetric Classification Tests [15.4] XRF (Solids Only) [15.5] Other Techniques (NMR, GC/MS, etc.)
5 Association of Public Health Laboratories Model Practice LRN-B REFERENCE AND LRN-C LABORATORY TESTING ALGORITHM (CONT'D) [17.1] Explosives FTIR, IMS, (Explosives) Calorimetry [17.2] Non-Volatile, LC/MS/MS, Organic, Com- UV/VIS, pounds (Gases) Fluorescence [16.1] No: Report [17.3] VOCs/SVOCs GC/MS, [16.0] Further using LRN Notifica- (Flammable, Com- SPME-GC/MS Classifcation tion and Data bustable Liquids) Needed? Messaging Policies [17.4] Metals and Elemental ICP/MS, Compounds LC-ICP/MS (Flammable Solids) [16.2] Yes: Identify [17.0] Perform [17.5] Inorganic likely analytical chemical class or compounds IC-FTIR, Other targets based on agent specific (Oxidizers) (NMR, XRF, Raman) preliminary and confirmatory first responder testing using results available methods [17.6] Toxic GC/MS, GC-FID, Gases (Toxic GC-NPD Substances) [17.7] Radio- Gammas Spec., chemicals Alpha Spec., LSC (Radioactive) [18.0] Positive or Negative results: [17.8] Report using LRN Acids/Bases Titration indicators, Notification and (Corrosives) pH, FTIR Data Messaging Policies [17.9] Pesticides GC/MS, GC-FID, (Misc.) GC-ECD, GC-NPD [17.10] Chemical Variable Warfare Agents
GUIDELINES THESE ARE MINIMAL GUIDELINES, AND APHL ANTICIPATES THAT STATE ON HOW TO AND LOCAL PUBLIC HEALTH LRN USE THE MEMBER LABORATORIES WILL ADAPT THESE ALGORITHMS TO ALGORITHMS BEST FIT THEIR NEEDS.
7 Association of Public Health Laboratories Model Practice Business Continuity Programs, available FIRST RESPONDERS ALGORITHM at: https://www.nfpa.org/assets/files/ FOR RESPONDING TO AN INCIDENT AboutTheCodes/1600/1600-13-PDF.pdf.ii INVOLVING A SUSPICIOUS NON- 3.0 CLINICAL SAMPLE HOW TO USE THE ALGORITHMS GUIDELINES ON NO APPARENT RISK (CONTINUE 1.0 TO BOX 4.0) INCIDENT INVOLVING A SUSPICIOUS NON- 3.0.1 If the sample/situation is deemed to CLINICAL SAMPLE OCCURS have no apparent risk, no testing is neces- 1.0.1 An incident here is defined as an sary and the algorithm ends. An example event that initiates a call to public safety of a sample/situation with no apparent risk (e.g., 911) and activates first responders, is an unknown powder found next to a box such as hazardous materials (HAZMAT) of powdered donuts in a kitchen area or a personnel, local law enforcement and fire mailing from a company with a free sample department personnel. Such incidents of their new and improved detergent. involve environmental samples, defined Essentially, the potential sample (liquid, par- here as non-clinical samples (e.g., powders, ticulate matter, solid) is expected to be there liquids, mixtures, pastes and solids). and there is no articulated threat. 2.0 3.1 FIRST RESPONDERS PERFORM A RISK RISK LOW OR HIGH (CONTINUE TO BOX 4.1) ASSESSMENT 3.1.1 First responders determine there 2.0.1 Risk is defined as the probability of is a risk which may require the assistance suffering a harm, trauma or peril. The risk of public health agencies. A sample/situa- assessment is defined here as an assess- tion that has risk may be the presence of ment that indicates the potential for suf- powder, particulate matter, or liquid with fering harm or peril. Factors that influence no obvious explanation, with or without an explicit threat or prior intelligence. Examples the level of risk include the nature of the of risk may include a suspicious liquid hazardous material, amount of material, found in a hallway of an office building or a type of containment device and the level powder found with a threat letter. Risk can of available resources. The risk assess- be broken down into categories such as low ment is a fluid process that should be or high, but for the purposes of this model performed in coordination with local or and to simplify the equation, any risk (low federal law enforcement. More detailed or high) proceeds through the algorithm. An explanations are outlined in the American example of a risk assessment plan can be Society for Testing and Materials found in the ASTM Standard E2770-17. (ASTM) E2770-17, Standard Guide for Operational Guidelines for Initial Response 4.0 to a Suspected Biological Agents and NO TESTING NECESSARY Toxins, available at: https://www.astm. 4.0.1 If a sample/situation is deemed org/Standards/E2770.htm.i Information to have no apparent risk, no laboratory for performing a risk assessment can testing is needed, the state or local public be found in the National Fire Protection health LRN member laboratory is not Agency (NFPA) Guidance 1600, Standard involved and the appropriate first responder on Disaster/Emergency Management and agency protocols should be followed to
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 8 resolve the incident. for first responders to restrict access to the area for public safety pending confirma- 4.1 tion from the state or local public health THREAT ASSESSMENT LRN member laboratory.i 4.1.1 A critical aspect of characterizing HOW TO USE THE ALGORITHMS GUIDELINES ON the unknown non-clinical sample includes 5.0-5.2 an evaluation of the threat, which provides NO APPARENT THREAT, POTENTIAL OR CREDIBLE THREAT an indication of potential violence, harm or danger, and may include an indication After performing the threat assessment, of intent and capability. The credibility of a the incident is categorized as follows: threat is determined by evaluating all avail- 5.0 able information, including that derived from No Apparent Threat law enforcement interviews, intelligence The assessment determines that no threat information, hazard assessment results and exists and as such no testing is required. communication with public health, including Note: In some situations, further analysis the state and local public health LRN may be requested due to ongoing public member laboratory. safety concerns and samples could At the incident scene, the threat assess- continue through the algorithm. First ment is coordinated by the local FBI Field responders on scene will proceed as Office WMD Coordinator and on-scene directed by supervising officials. personnel. The state and local public health LRN member laboratory may be asked to 5.1 Potential Threat (low risk) participate by phone during the FBI-led The assessment determines that a threat threat assessment so they are aware that exists and there is no readily available public health testing and referral support information that explains the presence of may be needed. On-scene responders, the unidentified substance. In these situ- public health representatives, local law ations, communication between the first enforcement and FBI representatives responders on scene and the jurisdictional should work together to determine state or local public health LRN member the threat level. laboratory determines if the sample should Following the initial threat assessment, fac- be sent to the laboratory. tors such as technical feasibility, operational practicability and behavioral resolve com- 5.2 Credible Threat (high risk) bined with examination of pertinent intelli- The assessment determines that a threat gence will inform the credibility level exists and that it is credible. On-scene infor- of the threat. mation leads law enforcement officials to If the initial threat assessment determines have a reasonable belief that an event has that there is a potential threat, the FBI will occurred. All credible threats should imme- perform their credibility threat procedure, diately be sent to the jurisdictional state or which is conducted by the local FBI WMD local public health LRN member laboratory Coordinator with guidance from the FBI for confirmatory testing. Headquarters. Based on the risk and threat assessments, it may be necessary
9 Association of Public Health Laboratories Model Practice 6.0 The purpose of the field screen is to rule NO TESTING out explosive materials and devices, limited Since there is no apparent threat, no chemical agents, radiological substances further testing is necessary. First responders and materials that may pose significant on scene will proceed as directed risks to transport personnel, state and local HOW TO USE THE ALGORITHMS GUIDELINES ON by supervising officials. public health LRN member laboratories and laboratorians. 6.1 FIELD SCREENING (EXPLOSIVES AND In some instances and at the Governor’s RADIATION AT A MINIMUM) discretion, the National Guard Bureau Weapons of Mass Destruction (WMD) Civil 6.1.1 Field screening is defined as testing Support Teams (CSTs) will be deployed to performed by first responders prior to the an incident. During these events, the CSTs sample being taken to the appropriate state or local public health LRN member labora- may be called upon to provide onsite safety tory. Such testing should include, at a min- screening characterization of potentially imum, radiation and explosives screening hazardous environmental samples. The and other basic analyses that do not CSTs are equipped with mobile laborato- consume the sample. To perform the field ries, referred to as an Analytical Laboratory screen, the sample should be collected as System (ALS), which is a standardized stated in the ASTM Standard, ASTM E2458- mobile laboratory system accessible in every 17, Standard Practices for Bulk Sample state and territory of the United States. The Collection and Swab Collection of Visible ALS is designed to apply standardized anal- Powders Suspected of Being Biological ysis to screen potentially hazardous samples Agents from Nonporous Surfaces, see: and prepare them for safe transport, by the http://www.astm.org/Standards/E2458.htm. iii appropriate law enforcement entity, to the appropriate LRN reference laboratory for Guidance on performing field screening confirmatory testing and definitive analysis. can be found in the FBI, Department of State and local public health laboratories Homeland Security (DHS), Health and are encouraged to develop relationships Human Services (HHS)/CDC Coordinated with their CSTs prior to an incident. More Document, Guidance on Initial Response information on the capabilities of the CSTs to a Suspicious Letter/Container with a is available in the document, The Role Potential Biological Threat, available at: of Civil Support Teams in Support of the https://emergency.cdc.gov/planning/pdf/ Laboratory Response Network.vi suspicious-package-biothreat.pdf.iv 6.1.2 Samples not properly screened are The field screen should be performed by accepted at the lab director’s discretion and trained HAZMAT personnel and other trained first responder teams. Responder training may be rejected for submission to the LRN guidance can be found in National Fire reference laboratory. It is up to the indi- Protection Agency (NFPA) Guidance 472: vidual state lab director to determine if Standard for Competence of Responders they will accept incomplete screens. to Hazardous Materials/Weapons of Mass 7.0 Destruction Incidents, available at: https:// FIELD SCREENING IS NEGATIVE www.nfpa.org/codes-and-standards/all-codes- and-standards/list-of-codes-and-standards/ 7.0.1 If the field screen is negative, com- detail?code=472.v plete proper decontamination, appropriately
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 10 package and transport sample along with the proper Sample Submission and Chain- of-Custody Form to the appropriate state or STATE AND LOCAL PUBLIC HEALTH local public health LRN member laboratory. LRN MEMBER LABORATORY See Appendix A for Chain-of-Custody Form TESTING ALGORITHM FOR HOW TO USE THE ALGORITHMS GUIDELINES ON or use forms which are consistent with law PROCESSING A SUSPICIOUS enforcement requirements. All samples UNKNOWN NON-CLINICAL SAMPLE transported to the laboratory should be 8.0 triple sealed in leak-proof containers. Each SAMPLE ARRIVES AT THE STATE OR LOCAL container should be sprayed with 10% PUBLIC HEALTH LRN MEMBER LABORATORY bleach solution to decontaminate it with a 8.0.1 Prior to accepting the sample, minimum of 20 minutes contact time for the the receiving laboratory must check the outermost container. Further sample trans- incoming sample to ensure that proper port requirements and instructions can be packaging occurred, that all accompanying found in ASTM 2770. Note: Ensure you con- documentation is included and correct, sult with your state or local public health and that it comprises any field screening LRN member laboratory. See Appendix B results to ensure that explosive, radiological for acceptable sample requirements. It and volatile organic compound (VOC) field is at the state or local public health LRN screening was performed, at minimum. member laboratory director’s discretion to accept a sample that arrives without 8.0.2 Sample Preservation proper documentation or packaging Photos of the materials should be taken; according to national sampling standards minimize handling of evidence (e.g. enve- such as ASTM 2458 Method A. lopes), and store some of the original sample. The recommendation is to remove 7.1 materials from the outside packaging, such FIELD SCREENING IS POSITIVE as an envelope, and store the contents in 7.1.1 If the field screening is positive for the appropriate conditions according to your radiation or explosives, immediately consult laboratory protocol. The outside packaging with the state or local emergency response should be minimally handled and stored or public health LRN member laboratory to in the best possible conditions to preserve send the sample without delay to an appro- traditional forensic evidence. Secondary priate testing agency capable of handling evidence such as growth plates can be such a sample. It is expected that both destroyed after final testing conclusions laboratory and first responders be familiar have been made and adhering to the LRN-B with US Department of Transportation Reference level protocols. The important Hazardous Materials Transportation Act material to save is the primary evidence, and Hazardous Materials Safety Act as which is the original sample, so that further mentioned in the All Hazards Receipt testing can occur if requested. The general Facility (AHRF) Screening Protocol, rule of thumb is to preserve the original available at: https://www.aphlweb.org/cmt/ sample until all legal matters have been phprcmt/First%20Responder%20Outreach/ resolved. All%20Hazards%20Receipt%20Facility%20 Screening%20Protocol.pdf.
11 Association of Public Health Laboratories Model Practice 9.0 screening process. If the laboratory has an PERFORM RECOMMENDED PRELIMINARY AHRF, then the AHRF and AHRF Screening SCREENING AND SPLIT SAMPLE FOR Protocolviii should be used for this prelimi- BIOLOGICAL, RADIOLOGICAL AND CHEMICAL nary screen. TESTING GROUPS FOR FUTURE TESTING HOW TO USE THE ALGORITHMS GUIDELINES ON The following is the minimal recommended 9.0.1 Preliminary Laboratory Screening: If testing that should be performed if appro- sufficient sample is available, it is highly rec- priate instrumentation and supplies are ommended, for the safety of the laborato- available. Note: Before preliminary testing rians, that state and local public health LRN is performed, laboratories must have pro- member laboratories perform a preliminary tocols in place to triage potential positive laboratory screen to confirm field tests prior samples. to further manipulation of the sample. Two trained laboratorians should perform a joint The following list is not comprehensive initial assessment of the sample in at least and any appropriate instrumentation should a Biosafety Level 3 (BSL-3) suite in a Class be used to test the sample. II biological safety cabinet or a BSL-2 suite with a Class III Biological Safety Cabinet (glove box) in a facility capable of filtering and protecting against chemical, radiolog- ical and biological agents. If LRN Biological and Chemical member laboratories are co-located and staff are cross-trained in basic practices, both a biologist and a chemist should work together to perform this screening process. If the laboratory has radiological capability, then a radiochemist should also be engaged in this preliminary EQUIPMENT/TEST HAZARD CLASS/COMPOUNDS Geiger Counter with a Geiger Mueller Probe (β/γ) and Pancake Probe (α) -Gamma radiation screening should be con- Radiation ducted on the exterior of the package. -Alpha/beta radiation screening should be con- ducted on the sample before it is split. Explosives Kit Explosives and Oxidizers E.L.I.T.E Tickets Explosives DropEx Plus Explosive Detection System Explosives M8, M9 Paper Chemical Warfare Agents Volatile Organic Compounds/ Gas Meter Lower Explosive Limit Oxidizer Test Kit/Strip Oxidizers Litmus Paper pH, Corrosives, Water Reactivity Additional Chemical Classifications via FTIR/Raman Spectroscopy Water Reactivity Test Water reactive chemicals
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 12 If preliminary positive results are obtained that a separate chain-of-custody form from these screening assays, the state or should be started for derivative samples. local public health LRN member laboratory An example of documentation is to note should follow existing protocols for subsequent that 10 plates, such as 5 chocolate agar testing or referral. If all screening assays and 5 sheep blood agar, were created HOW TO USE THE ALGORITHMS GUIDELINES ON performed are negative for both radiation and from sample 1 and were delivered by explosives, accession the sample into the Person A and received by Person B at X LRN-B Reference laboratory for further testing. time. Derivative or secondary evidence Take into consideration results for all tests to can often be properly decontaminated and ensure proper PPE, air filters, fume hoods or destroyed after testing is complete (see other protection equipment is used. Sample Preservation 8.0.2). 9.1.1 Prior to performing any labora- It is critical to maintain chain-of-custody tory analyses, the sample may be split to on each sample. If chain-of-custody is not allow for biological, chemical and other maintained, this may severely jeopardize testing. To maintain chain-of-custody for a law enforcement prosecution of suspected split sample, a laboratory should create a perpetrators. Note: If chemical, biological, new chain-of-custody form and document on and radiological laboratory facilities are the new form the creation of an additional not co-located and biological testing is sample identification number on the original negative and the need exists for chemical form. For example, if a powder comes into testing or it is requested, the sample the laboratory (sample 1) and is immedi- should be appropriately packaged and ately split for biological and chemical testing transported to a laboratory capable of then the new samples would be 1.0 and 1.1. such testing. Each additional split must also be noted and Note: For credible threat samples sub- given a unique identification. If the sample mitted by the FBI, be sure to consult 1.1 is split again, the resulting samples with the WMD Coordinator regarding the would be identified as 1.1 and 1.2. This type testing being requested. Per FBI policy, no of splitting identifies each sample individu- chemical testing should be performed on ally and avoids the issue of disappearing credible threats by LRN laboratories. identifiers such as splitting 1 into 1.1 and 1.2, where item 1 seems to disappear. As • Minimum Sample Size Requirements long as records are kept and a logical iden- for Biological Analysis: tification is used, chain-of-custody is main- If there is bulk liquid or solid, save 1 tained. Each time any portion of the sample milliliter of liquid or a swab of solid changes hands or is transferred chain-of- material. Acceptable sample types for custody must be completed and maintained. biological testing include swab, wipe, liquid, powder, HEPA sock and filters. For derivative or secondary evidence such First responders should consult with as plates, slants and cultures, a similar their LRN-B Reference level laboratory system can be employed. The general rule of to determine additional acceptable thumb still holds that as long as records are sample types. kept in a logical system and documented at • Minimum Sample Size Requirements each step, then chain-of-custody is main- for Chemical Analysis: tained. Guidance from the FBI (see Appendix Save 1-2 milliliters or 1-2 grams (pea- A for an example form) laboratory suggests
13 Association of Public Health Laboratories Model Practice size) of remaining, unprocessed sample policies. Consult with the LRN-C laboratory in a sealable glass container. First to determine capability for chemical threat responders and state or local public agent analysis. health LRN-B Reference level labora- tories should consult with the state or 12.0 AGENT SPECIFIC CONFIRMATORY TESTING HOW TO USE THE ALGORITHMS GUIDELINES ON local public health (LRN-C) or state radi- ological laboratory to verify testing capa- 12.0.1 LRN-B Reference level laboratories bility and sample size requirements. will perform agent specific confirmatory testing per existing protocols. 10.0 SAMPLE IS SENT TO THE LRN-B 13.0 REFERENCE LABORATORY AND TESTED FOR REPORT CONFIRMATORY TESTING RESULTS BIOLOGICAL THREAT AGENTS 13.0.1 Report positive and negative 10.0.1 Perform the LRN-B Reference results using LRN-B Reference level level protocol for Environmental Sample notification and data messaging policies Processing for Bioterrorism Agents Panel, as well as your laboratory specific communi- PCR Screening and Ricin Toxin TRF Testing cation policies. and begin culturing for microorganisms. • Sample Disposal 11.0 Biological: Upon completion of all PRELIMINARY POSITIVE LABORATORY tests and depending on the needs RESULT of the requestor, sample may be 11.0.1 Report preliminary positive returned to submitter, referred to results using LRN-B Reference level another laboratory or destroyed using notification and data messaging policies an autoclave. All sample disposal as well as your laboratory-specific procedures should comply with federal communication policies. guidancex and the select agent regula- tion.xi Note: The original sample should 11.0.2 Consult with your laboratory be kept for evidence unless specified by director and biological, chemical and/or an appropriate source. radiological terrorism coordinators terrorism coordinators to determine if there is a need 14.0 for chemical or radiological threat agent SAMPLE SENT FOR CHEMISTRY ANALYSIS analysis. If testing is determined necessary, Additional federal guidance is needed to deter- the sample should be prepared for chemical mine what chemical analyses should testing using appropriate personal protec- be performed. APHL developed this algorithm tive equipment (PPE) and biological safety to assist laboratories with analyzing these hoods/rooms. suspicious non-clinical samples for chemical threat agents. 11.1 PRELIMINARY NEGATIVE Sample submitters should consult with the LABORATORY RESULT LRN-C laboratory to determine testing capa 11.1.1 Report preliminary negative bilities. Upon receiving a request, the LRN-C results using LRN-B Reference level notifica- laboratory should ensure the Laboratory tion and data messaging policies as well Director, LRN-B Coordinator, and FBI WMD as your laboratory specific communication Coordinator are contacted and consulted.
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 14 LRN laboratories have different capabilities 15.1 for chemical testing and may not be able to Microscope / IR/ Raman. perform certain methods. Laboratories should Fourier-Transform Infrared (FTIR) techniques, not accept any sample that is beyond their either FTIR-Microscopy or FTIR coupled with analytical capability or ability to accept, store, Raman will allow library screening, which HOW TO USE THE ALGORITHMS GUIDELINES ON and analyze the sample safely. If this situation may provide compound specific or mixture occurs, they should contact another LRN lab specific classification. This technique is not that has the ability to perform the requested effective on most metal/metalloid com- testing method or the CDC LRN- C through pounds and dilute and/or complex mixtures. the LRN Help Desk or DEOC. The labora- Few LRN-C laboratories have this capability tory must have trained personnel available and instrumentation. to perform the requested testing and these laboratorians should have competency assess- 15.2 Solubility Tests. More traditional ments for the methods in place before any wet chemistry techniques will provide gen- samples are tested. If the LRN lab can per- eral classification of materials (liquid or form chemical testing, the sample is sent to solid). Coupled with FTIR results, potential the LRN-C laboratory for analysis for chemical structure elucidation is possible. Most threat agents. The sample initially is classi- LRN-C laboratories have this capability, but fied according to general chemical class. If may not have a standard written protocol or additional analysis is needed to either confirm reagents available. the identity of the material or classification, it is completed after the initial classification. 15.3 All results are reported using the appropriate Colorimetric Tests. laboratory and network reporting mechanisms. Wet chemistry colorimetric techniques, such Note: EPA has a program with National as a hazard classification test, can be used Homeland Security Research Center called to determine chemical class and/or provide Standardized Analytical Methods (SAM) hazard recommendation. Most LRN-C labo- for Environmental Restoration Following ratories have this capability, but may not Homeland Security Events. These analytical xii have a standard written protocol or reagents methods may be used to determine the available. chemical involved in the event or to confirm field screening results. 15.4 XRF (solids only). 15.0 X-ray fluorescence (XRF) is widely used GENERAL CHEMICAL COMPOUND for elemental analysis, particularly in the CLASSIFICATION investigation of metals, glass, ceramics and This first level of testing provides a general building materials. Detector types vary, and chemical classification, such as acidic inor- can include gas flow proportional counters, ganic compound, volatile organic compound, sealed gas detectors, scintillation counters carbonate salt, cyanide or fluoride compound, and semi-conductor detectors. Most LRN-C etc. Depending on the instrumentation and laboratories do not have this capability or material in question, a specific chemical or instrumentation. class may be identified. If the capability exists, chemical identification should be performed.
15 Association of Public Health Laboratories Model Practice 15.5 17.0 Other Techniques (NMR, GC/MS, etc.) – PERFORM CHEMICAL CLASS dependent on availability. OR AGENT SPECIFIC CONFIRMATORY These techniques will be dependent on the TESTING USING SAM OR OTHER METHODS. availability of instrumentation, expertise and This is broken down into 10 general high HOW TO USE THE ALGORITHMS GUIDELINES ON material available for testing. Many LRN-C priority categories of materials. See also laboratories do not have this capability Appendix C. or may not have a written protocol or reagents available. 17.1 Explosives – (corresponds to US DOT 16.0 Class 1 – Explosives). DETERMINE IF FURTHER CLASSIFICATION This includes materials, such as Diazonium OF THE MATERIAL IS NEEDED. salts, Nitro compounds, Perchlorates, 16.1 Peroxides, RDX, etc. Recommended No further classification is needed instrumentation for this category is FTIR Consult with your laboratory director and FBI Spectroscopy, Ion Mobility Spectroscopy WMD Coordinator (if applicable) to deter- (IMS) and calorimetry. At present, mine how to report results. Note: A central- most LRN-C laboratories do not have ized mechanism, LIMS or other electronic instrumentation. data reporting capability, is still needed to report non-clinical chemical test results. Report results using LRN Notification and 17.2 Non-Volatile Organic Compounds – (this does Data Messaging Policies if clinical speci- NOT correspond to US DOT Class 2 – Gases) mens are tested. This category includes materials such 16.2 as pharmaceutical and environmental Additional Classification is needed contaminates or toxins. Recommended Identify likely analytical targets based upon instrumentation for this category includes preliminary and first responder results. Liquid Chromatography Tandem Mass Select the appropriate methods available to Spectrometry (LC/MS/MS), Ultraviolet- the laboratory. Consult with your laboratory Visible Spectroscopy (UV/Vis) or director and FBI WMD Coordinator (if appli- Fluorescence spectroscopy. At present, cable) to determine how to report results. some LRN-C laboratories have LC/MS/MS; Note: A centralized mechanism, LIMS or most laboratories do not have Fluorescence other electronic data reporting capability, or UV/VIS spectroscopy. is still needed to report non-clinical chem- 17.3 ical test results. Report results using LRN VOCs/SVOCs – (corresponds to US Notification and Data Messaging Policies DOT Class 3 – Flammable Liquids and if clinical specimens are tested. Determine Combustible Liquids). if analysis can be completed within the This category includes volatile and semi- selected laboratory or requires referral to volatile materials. Recommended instru- another laboratory. mentation for this category includes Gas Chromatograph-Mass Spectrometry
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 16 (GC/MS), Solid Phase Micro Extraction Fluorine, Hydrogen cyanide, Hydrogen (SPME)-GC/MS, and purge and trap GC/MS. sulfide, Methane, Ozone, Phosphine, At present, LRN-C laboratories have GC/MS Phosgene, Radon, etc. Recommended instrumentation; however, not all laborato- instrumentation varies for this category, but ries have purge and trap GC/MS capability. in general is calorimetric, GC/MS, GC-FID HOW TO USE THE ALGORITHMS GUIDELINES ON or GC-NPD. LRN-C laboratories have GC/MS 17.4 capabilities; however, most do not have the Metals and Element Compounds – appropriate autosampler, such as a SUMA (corresponds to US DOT Class 4 – Flammable Solids). canister or Tedlar bag introduction system. This category includes metals (Arsenic, 17.7 lead, cadmium, mercury, chromium, other Radiochemicals – (corresponds to US DOT heavy metals, etc.) and elemental com- Class 7 – Radioactive Materials). pounds (non-metals, transition elements, This category includes a variety of radio- etc.). Recommended instrumentation for chemicals, such as Polonium-210, Radon, this category includes Inductively Coupled Uranium, etc. Recommended instrumenta- Plasma Mass Spectrometry (ICP/MS), Liquid tion includes Gamma Spectroscopy, Alpha Chromatography Inductively Coupled Plasma Spectroscopy and Liquid Scintillation Mass Spectrometry (LC-ICP/MS), as well as Counting techniques. At present, few LRN-C older techniques such as graphite furnace laboratories have basic capabilities and atomic absorption (GFAA) spectroscopy. At limited capacity. The state Conference present, LRN-C laboratories have ICP/MS for Radiation Control Program Directors instrumentation, but not all laboratories (CRCPD) group may have the capability or have LC-ICP/MS or GFAA capability. instrumentation necessary for this testing. 17.5 17.8 Inorganic Compounds – (generally corre- Acid/Bases – (corresponds sponds to US DOT Class 5 – Oxidizers and to US DOT Class 8 – Corrosives). US DOT Class 9 – Miscellaneous). This category includes corrosive materials, This category includes ionic compounds such as acids (either single or mixed) and (such as cyanides, sulfides, phosphates, bases (either single or mixed) and can etc.). The recommended instrumentation for be either organic or inorganic corrosive this category includes Ion Chromatography materials. Recommended instrumentation (IC), Ion Chromatography Mass Spectrometry includes FTIR and wet chemical techniques (IC-MS), FTIR and other techniques, such (such as pH, indicators, titrations, etc.). At as XRF, Raman or MP. At present, most present, most LRN-C laboratories do not LRN-C laboratories do not have this have FTIR capabilities or instrumentation. instrumentation. 17.9 17.6 Pesticides – (does not correspond to US Toxic Gases – (corresponds to US DOT DOT Class 9 – Miscellaneous). Class 6 – Toxic Substances, specifically This category includes pesticides, herbi- Division 6.1 Toxic or Poisons). cides, fungicides, insecticides, etc., such as This category includes toxic asphyxiant, Carbamates, Organo-phosphates, haloacetic explosive, acute or chronic effects, or gases, acids, etc. Recommended instrumentation such as Ammonia, Chlorine, Carbon mon- varies, but primarily includes GC, GC/MS oxide, Cyanogen chloride, Diazomethane,
17 Association of Public Health Laboratories Model Practice and LC/MS/MS. At present, LRN-C labo- Radiological: Consult the Integrated ratories have GC/MS capabilities, but not Consortium of Laboratory Networks (ICLN) all laboratories have GC and LC/MS/MS Laboratory Logistics Limiting Issues Report capabilities. for potential solutions to waste disposition. Training Requirements HOW TO USE THE ALGORITHMS GUIDELINES ON 17.10 Chemical Warfare Agents – (this is a sepa- To ensure consistent implementation of this rate category and does not directly corre- guidance, it is strongly recommended that spond to any US DOT Hazard Class). the following training courses be conducted This category is broad and includes known on an annual basis or more frequently as and suspected Chemical Warfare Agents, needed by the local jurisdiction: such as Vesicants, Mustards, Blister Agents, 1. First Responder Outreach and Organophosphate Nerve Agents, cho- Cross-Training in Laboratory and linesterase inhibitors, choking agents, etc. Field Environments. It is important Recommended instrumentation includes to develop and implement national GC/MS and LC/MS/MS. At present, LRN-C training and competency assessment laboratories have GC/MS capabilities, but programs (e.g., proficiency testing, not all laboratories have GC and LC/MS/MS certification) for first responders involved in responding to all-hazard capabilities. threats. Cross-training should 18.0 include ASTM Standards E2770-17 REPORT RESULTS. and ASTM E2458-17. All results (positive or negative) should be 2. Preliminary Laboratory Screening – reported to the appropriate network and/or chemists and other laboratorians may not be familiar with the stringent organizations utilizing your laboratory specific requirements for working in a BSL-3 communication policies. At present, LRN-C or Class III BSC. As such, joint training does not have a reporting mechanism for for biologists and chemists is essential non-clinical samples. All results should be to ensure employee safety and adher- reported up the proper chain of command ence to laboratory protocols. Laboratories and to the local WMD Coordinator and local are encouraged to cross-train on the law enforcement as deemed necessary. The All-Hazards Receipt Facility Protocol. Currently, training is offered through the Environmental Response Laboratory Network Wadsworth Center in Albany, New York, (ERLN) is still expanding laboratory partici- http://www.wadsworth.org/programs/ pation and developing the Electronic Data ed/biodefense/training.html. Deliverable (EDD) for reporting. ERLN requires 3. Class III Biological Safety Cabinet Training a Basic Ordering Agreement (BOA) to be in – many laboratorians do not work in a place prior to utilization of the laboratory and/ Class III BSC on a routine basis. Annual or method. training on the Class III BSC is vital to ensure proper use of this equipment. Sample Disposal Chemical: Upon completion of tests, follow 4. Radiation detection equipment training Material Safety Data Sheet (MSDS) guide- – many laboratories may not be trained on the proper equipment and procedures lines and consult safety officer for guidance for testing samples for radiation. Annual to dispose of remaining sample. training and refresher courses should be conducted for this function.
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 18 I. GENERAL: GUIDANCE FOR PROPER USE II. RECEIPT OF PROPERTY FORM: OF CHAIN-OF-CUSTODY FORM A. This form must be completed, signed, A. The custodian is responsible to maintain providing date and time, upon the receipt and collect additional chain-of-custody of evidence. Both the laboratory and the documentation generated at the law enforcement official will retain a copy CHAIN-OF-CUSTODY GUIDANCE APPENDIX A laboratory. of the completed form. B. The laboratory will maintain originals B. This form must be completed, signed and (copies if necessary) of all chain-of- dated upon the release of evidence to a custody documentation and provide law enforcement official. Both the labo originals to law enforcement officials upon ratory and the law enforcement official will transfer of evidence. Copies should be retain a copy of the completed form. maintained by the laboratory for its C. Description information should include records. the following information for each C. In the event that custodianship of the and every item: evidence is split, due to sampling of a 1. Unique identifier for each item specimen or the transfer of one or more 2. Number/quantity items, the chain-of-custody forms must 3. Type/description be initiated, maintained and transferred with that portion of evidence; the D. If multiple items are received, all items custodians receiving and releasing must be listed on the form or attached. the sample or item will keep a copy of the Each item should be assigned a unique Receipt of Property form. identifier (e.g., number). The original identifier should be maintained on the D. The chain-of-custody documentation chain-of-custody records for any sample/ should be considered confidential/classi- portion of that item. fied information; it should be maintained in a secure location. E. The name of the carrier/courier and the shipping/reference number should be recorded if item(s) are delivered by a carrier/courier. F. Additional information may be attached as appropriate (e.g., original source/ submitter, collected by, emergency contacts, situational information).
19 Association of Public Health Laboratories Model Practice III. CHAIN-OF-CUSTODY FORM: This form must be signed and dated when transferring custody within the laboratory, from the initial receipt of the evidence, through the processing, storage, and release of the evidence to a law enforcement official. CHAIN-OF-CUSTODY GUIDANCE APPENDIX A RECEIPT FOR PROPERTY RECEIVED/RETURNED Case ID:________________________________________________________________________ Collection/Sampling Date:_____________________________ Time:______________________ Collected/Sample Taken By: ______________________________________________________ Organization: ___________________________________________________________________ Address: _______________________________________________________________________ ______________________________________________________________________________ City, State:______________________________________________________________________ Phone:_________________________________________________________________________ Description of Sample/Evidence:___________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ This Chain-of-Custody form remains with the sample/evidence at all times. By signing this form, all parties verify the sample/evidence is attended at all times. Received from: _________________________________________________________________ (sign/date/time) Received by: __________________________________________________________________ _ (sign/date/time)
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 20 CHAIN-OF-CUSTODY FORM Case ID #:_________________________ Date:_______________________________________________ Time:______________________ CHAIN-OF-CUSTODY GUIDANCE APPENDIX A Transfer From (print/sign):________________________________________________________ Transferred To (print/sign):________________________________________________________ Security Method while held:_______________________________________________________ Date:_______________________________________________ Time:______________________ Transfer From (print/sign):________________________________________________________ Transferred To (print/sign):________________________________________________________ Security Method while held:_______________________________________________________ Date:_______________________________________________ Time:______________________ Transfer From (print/sign):________________________________________________________ Transferred To (print/sign):________________________________________________________ Security Method while held:_______________________________________________________ Date:_______________________________________________ Time:______________________ Transfer From (print/sign):________________________________________________________ Transferred To (print/sign):________________________________________________________ Security Method while held:_______________________________________________________ Date:_______________________________________________ Time:______________________ Transfer From (print/sign):________________________________________________________ Transferred To (print/sign):________________________________________________________ Security Method while held:_______________________________________________________ Additional Comments or Instructions:_______________________________________________
21 Association of Public Health Laboratories Model Practice (LRN) FOR BIOLOGICAL (LRN-B) AND pathogens. When sentinel clinical laboratories CHEMICAL (LRN-C) TERRORISM cannot rule out the presence of a biological PREPAREDNESS terrorism agent, they refer specimens and The Laboratory Response Network (LRN), isolates to an LRN-B Reference laboratory. the nation’s premier laboratory system The Reference laboratories, made up of over RESPONSE NETWORK (LRN) DESCRIPTION OF THE LABORATORY APPENDIX B for identifying, testing and characterizing 170 state and local public health, military, potential agents of biological and chemical international, veterinary, agriculture, food and terrorism, was founded in 1999 by the water testing laboratories, are responsible for Centers for Disease Control and Prevention performing complex analyses and providing (CDC), the Association of Public Health support to law enforcement for threat inves- Laboratories (APHL) and the Federal Bureau tigations. In the years since its inception, of Investigation (FBI). This integrated network the LRN-B has played an instrumental role in of laboratories is a unique asset in responding improving public health infrastructure (e.g., to all-hazard threats, providing immediate and staffing, laboratory equipment) by helping to sustained laboratory testing and communica- boost laboratory capability and capacity, and tion to respond quickly to acts of chemical by responding to real threats in a timely and or biological terrorism, emerging infectious efficient manner. At the apex of the pyramid diseases and other public health threats and are national laboratories, such as those at the emergencies. CDC and the Department of Defense. These laboratories test and characterize samples LRN FOR BIOLOGICAL TERRORISM that pose challenges beyond the capabilities PREPAREDNESS (LRN-B) of Reference laboratories, and provide support The LRN-B is comprised of National, Reference for other LRN members during a serious out- and Sentinel laboratories forming a tiered break or terrorist event. network (see Fig. 1). At the foundation are thousands of sentinel clinical laboratories, which perform initial screening for potential Figure 1: LRN Structure for Biological Threats Preparedness
Algorithm and Guidelines for Responding to an Incident Involving a Suspicious Non-Clinical Sample Version 3.0 • March 2018 22 THE LABORATORY RESPONSE LEVEL 3 LABORATORIES NETWORK FOR CHEMICAL TERRORISM Although every network member participates PREPAREDNESS (LRN-C) in Level 3 activities, only nine laboratories The LRN-C was established in 1999, and are designated as Level 3 laboratories. These comprised CDC and four public health labora- seven laboratories work with hospitals and RESPONSE NETWORK (LRN) DESCRIPTION OF THE LABORATORY APPENDIX B tories (New York State Department of Health, other first responders within their jurisdiction Wadsworth Center; CA State Public Health to maintain competency in clinical specimen Laboratory; VA Division of Consolidated collection, storage and shipment. Laboratory Services and Michigan Public Health Laboratory). In 2000, New Mexico LEVEL 2 LABORATORIES Department of Health, Scientific Laboratory Thirty-five laboratories are designated as Level Division joined the network. These labora- 2 laboratories within the LRN. These laborato- tories use methods that are based on mass ries can detect exposure to a limited number spectrometry and are quantitative, detecting of toxic chemicals—such as cyanide or toxic the actual chemical agent, or more common, a metals—in human specimens, such as blood metabolite of the agent, in urine or blood. or urine. Today there are 55 LRN-C members (CDC and LEVEL 1 LABORATORIES 54 public health laboratories). All labs are qualified to package and ship clinical samples. Ten laboratories in the nation are Level 1 Thirty-five laboratories have the capability laboratories. These laboratories can detect to test for exposure to nine different threat an expanded number of chemical agents agents. Ten laboratories have expanded capa- in human specimens, including all Level 2 bility to test for exposure to an additional four laboratory analyses plus analysis for mustard threat agents, and have expanded capacity to agents, nerve agents and other toxicants that provide 24/7 analytical analyses in the case of could be used in chemical warfare. These a large scale event. (See Fig. 2). laboratories are intended to provide the CDC with much needed surge capacity during a large scale event. 9 9 5 Figure 2: LRN Structure for Chemical Terrorism Preparedness
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