Nonpharmaceutical Interventions^[1]

Definition: Nonpharmaceutical interventions are actions that people and communities can take to help slow the spread of illness or reduce the adverse impact of public health emergencies. This capability focuses on communities, community partners, and stakeholders recommending and

implementing nonpharmaceutical interventions in response to the needs of an incident, event, or threat. Nonpharmaceutical interventions may include

•        Isolation

•        Quarantine

•        Restrictions on movement and travel advisories or warnings

•        Social distancing

•        External decontamination

•        Hygiene

•        Precautionary protective behaviors

Functions: This capability consists of the ability to perform the functions listed below.

•        Function 1: Engage partners and identify factors that impact nonpharmaceutical interventions

•        Function 2: Determine nonpharmaceutical interventions

•        Function 3: Implement nonpharmaceutical interventions

•        Function 4: Monitor nonpharmaceutical interventions

Summary of Changes: The updates align content with new national standards, updated science, and current public health priorities and strategies. Listed below are specific changes made to this capability.

•        Focuses on collaboration by expanding suggested partners for implementing nonpharmaceutical interventions (NPIs)

•        Supports establishment of community reception center processes to enhance ability to respond to radiological and nuclear threats

•        Highlights management of mass gatherings (delay and cancel) based on all-hazards scenarios

For the purposes of Capability 11, partners and stakeholders may include the following:

•        agriculture departments

•        businesses

•        community and faith-based organizations

•        environmental health agency

•        government agencies

•        groups representing and serving populations with access and functional needs

•        health care organizations

•        jurisdictional emergency management agency

•       law enforcement

•       legal authorities

•       mental/behavioral health agencies

•       public health agencies

•       school districts

•       social services

•       state radiation control programs

•       travel and transportation agencies

•       tribes and native-serving organizations

Function 1: Engage partners and identify factors that impact nonpharmaceutical interventions

Function Definition: Engage with partners and stakeholders to identify authorities, policies, and community factors that guide decision-making about NPIs and to determine jurisdictional roles and responsibilities for NPIs.

Tasks

Task 1: Identify authorities, policies, and other factors that impact NPIs . Identify jurisdictional, legal, and regulatory authorities and policies as well as other community factors that enable or limit the ability to recommend and implement NPIs.

Task 2: Determine jurisdictional roles and responsibilities related to NPIs . Determine jurisdictional lead and support roles for implementing NPIs, and confirm roles and responsibilities among partners and stakeholders.

Preparedness Resource Elements

P1: (Priority) Documentation of applicable jurisdictional, legal, and regulatory authorities and policies for recommending and implementing NPIs in incident-specific situations. Develop and incorporate guidance to address existing legal and policy gaps with assistance from legal counsel or academic partners as necessary. Policies and guidance may include

•      Written agreements, such as contracts or memoranda of understanding (MOUs), with law enforcement that describe how NPIs would be implemented

•      Procedures for how decision-making processes are used to identify the most effective NPIs while imposing the least amount of restrictions on individual rights

•      Criteria for initiating and ceasing use of NPIs

•      Written agreements with community partners outlining roles, responsibilities, and access to necessary resources to implement NPIs

•      Contact information for representatives from partner agencies and organizations

•      Written agreements with health care providers to establish a common operating picture, including

·  Procedures to communicate case definitions to health care providers, as determined from epidemiological surveillance

·  Procedures for health care providers to rapidly report suspected and confirmed cases to the public health agency

•      Assessment of the access and functional needs of at-risk individuals who may be disproportionately impacted by the incident and plans to address identified access and functional needs

(See Capability 1: Community Preparedness, Capability 6: Information Sharing, and Capability 13: Public Health Surveillance  and Epidemiological Investigation)

P2: (Priority) Identification and documentation of local conditions or incident characteristics that are relevant to the NPI decision-making process. These factors may include

•      Individuals and groups, such as active monitoring and restriction of movement

•      Facilities, such as health care facilities, safe housing, and shelters

•      Animals, such as service animals, ill animals, animals exposed to infectious diseases, and animals exposed to environmental, chemical, and radiological hazards

•      Food safety, such as contaminated consumer food products•      Imported items that fall under federal regulations, such as human remains, human tissues or products, animal meat, trophy shipments, and non-human primate shipments

•      Public works and utilities, such as water supply

•      Travel through ports of entry

Function 2: Determine nonpharmaceutical interventions

Function Definition: Collaborate with subject matter experts and community representatives to make recommendations for NPIs based on incident characteristics and subject matter expertise in applicable specialties, such as epidemiology, laboratory, surveillance, health care, chemistry, biology, radiology, social service, emergency management, and law enforcement.

Tasks

Task 1: Engage subject matter experts to assess exposure or transmission . Assemble subject matter experts to assess the severity of exposure or transmission at the jurisdictional level and the need for NPIs.

Task 2: Develop recommendations for NPIs . Identify NPI recommendations based on science, risks, resource availability, and legal authorities.

Preparedness Resource Elements

P1: Decision matrix indicating questions for public health leadership and recommendation options based on existing community risk assessments and incident severity.

P2: (Priority) Procedures in place to develop NPI recommendations specific to the incident and based on science, risks, resource availability, and legal authorities. Categories of NPIs may include

•      Separation of individuals with a contagious disease from individuals who are not sick (isolation)

•      Separation or restricted movement of healthy, but exposed individuals to determine if they are ill (quarantine)

•      Restrictions on movement and travel advisories and warnings, such as screening at port of entry, limiting public transportation, and issuing travel precautions

•      Social distancing

·  School and childcare closures

·  Postponement or cancellation of mass gatherings

·  Closures and modifications of workplace or community events

•      External decontamination

•      Hygiene and sanitation

•      Precautionary protective behaviors, such as personal decontamination, shelter in place, and face mask in special situations during severe pandemics

NPI recommendations may include

•      Personnel and subject matter expert roles and responsibilities

•      Intervention actions and their associated legal and public health authorities

•      Pre-identified locations with specific equipment or easily adaptable locations

•      Contact information and notification plans for community partners involved in intervention, meaning those providing services or equipment

•      Impact of any secondary effects of implementing measures, such as needs for additional security or provision of essential goods and services to isolated or quarantined persons

•      Intervention-specific methods for disseminating information to the public, such as methods to distribute information at ports of entry during public health events

•      Processes for the phase down of interventions when they are no longer needed

•      Processes to supplement existing resources for surge capacity

•      Guidance for health educators about NPIs

•      Guidance for individuals about NPIs

•      Identification of considerations that can inform decision making about starting or stopping use of NPIs (See Capability 1: Community Preparedness, Capability 4: Emergency Public Information and Warning, Capability 13: Public  Health Surveillance and Epidemiological Investigation, and Capability 14: Responder Safety and Health)

Skills and Training Resource Elements

S/T1: Personnel trained to understand jurisdictional risks, legal authorities, and options for implementing NPIs based on the best available science.

S/T2: Personnel trained to understand and implement their respective agency role(s) and responsibilities as they relate to NPIs.

Function 3: Implement nonpharmaceutical interventions

Function Definition: Coordinate with jurisdictional partners and stakeholders to implement and, if necessary, enforce the recommended NPI(s).

Tasks

Task 1: Implement NPIs in designated locations . Coordinate with jurisdictional officials to implement NPIs in priority locations, such as community settings where disease is circulating, isolation sites, or quarantine sites.

Task 2: Coordinate support services for NPIs . Assist community partners with coordinating support services, such as medical care, mental health services, and the provision of food and water, for individuals and communities targeted for NPI(s).

Task 3: Close locations and cancel events with mass gatherings . Implement voluntary or mandatory closure of specific locations or cancel large events in coordination with appropriate jurisdictional officials and other stakeholders.

Task 4: Restrict movement . Implement voluntary or mandatory restrictions on movement, as needed, in coordination with relevant jurisdictional officials, partners, and stakeholders.

Task 5: Manage and detain passengers at ports of entry . Coordinate with CDC’s Division of Global Migration and Quarantine (quarantine station), port authorities, and jurisdictional officials to manage and detain passengers at ports of entry, as applicable to the incident, including security and law enforcement support, notification of family, and provision of food, shelter, water, and communication channels.

Task 6: Ensure external decontamination of individuals . Screen, register, and conduct external decontamination of potentially exposed or contaminated individuals.

Task 7:  Inform the public, responder agencies, and other partners of recommendations for NPIs .

Provide education and appropriate messaging to the public, responder agencies, and other partners regarding the recommended NPIs.

Preparedness Resource Elements

P1: (Priority) Written agreements, such as contracts or MOUs, with partners to implement appropriate plans for NPIs, including provisions of support services, such as care for dependent children, notification of family, and provision of food, shelter, water, and communication channels, to individuals during isolation or quarantine scenarios.

(See Capability 1: Community Preparedness and Capability 10: Medical Surge)

P2: (Priority) Written agreements, such as contracts or MOUs, to provide mental/behavioral health services to individuals affected by NPIs, including services to address the access and functional needs of at-risk individuals who may be disproportionately impacted by a public health incident or event.

Agreements may be established for services, which may include

•      Mental/behavioral health services for specific populations when monitoring restriction of movement, such as isolation or quarantine, or other NPIs , such as social distancing and implementation of specialized hygiene requirements

•      Mental/behavioral health services for families and dependents of those placed under mandatory restrictions

•      Systems to provide mental/behavioral health services in person or via alternate communication methods, including phone, Internet, social media, teleconference, or other means

P3: (Priority) Procedures in place to separate and monitor cohorts of potentially exposed travelers from the general population at ports of entry.

Legal and regulatory considerations that apply to ports of entry may include

•      State or local legal authorities for detention, quarantine, and conditional release of potentially exposed persons and isolation of ill persons

•      Triggers for transfer of authority, such as from federal to state or local levels or vice versa

•      Local and state port of entry Communicable Disease Response Plans, as described in the Code for Federal Regulations, 42 CFR, Parts 70 and 71

•      Information sharing between CDC and state, local, tribal, and territorial public health authorities, including protection of sensitive information, such as protected health information

Resource and planning considerations may include

•      Identification of personnel and other resources, including facilities and equipment, at or near ports of entry to be used for separation of cohorts

•      Resources to address the needs of individuals for food, water, shelter, communications, and other resources

•      Processes to supplement or surge resources

•      Scalable plans to accommodate cohorts of various sizes in facilities

•      Processes for transportation of cohorts to and security at pre-identified sites

(See Capability 13: Public Health Surveillance and Epidemiological Investigation)

 P4: Procedures in place to implement isolation or quarantine measures at designated locations. Procedures may include

•      Time frame for establishing supporting operations at designated locations

•      MOUs or similar agreements with site owners for use of sites

•      Written agreements for equipment needed at designated sites

•      Triggers for transfer of authority, such as from federal to state or local levels or vice versa

•      Pre-identified sites for housing cohorts to be isolated or placed under quarantine

•      Environmental conversion of sites needed for intervention, such as converting rooms to negative pressure and establishing isolation rooms, dedicated patient care equipment, and separate areas for donning and doffing personal protective equipment (PPE)

•      Processes to supplement and surge resources, such as reallocating resources or obtaining additional resources through mutual aid or other agreements

•      Documentation of expenses for potential reimbursement at either the jurisdictional or federal level

•      Returning the site to normal operation, including decontamination, managing medical waste, or sanitization, if needed

•      Advance consideration of family or child care issues that may have an impact on the implementation of a quarantine order

P5: Procedures in place to support coordination of population monitoring and external decontamination of individuals. Procedures may include

•      Screening based on incident-specific criteria determined by relevant radiological or chemical subject matter experts

•      Registration of exposed or possibly exposed individuals, including name, address, contact information, and location at the time of the incident. Include responders and volunteers in this registration process, as needed

•      Processes to coordinate with organizations trained in decontamination to establish external decontamination stations at designated sites and removing or storing contaminated materials

•      Facilitating referrals or transfers of individuals to emergency housing (accessible housing as needed) and to immediate or follow-up medical care

(See Capability 14: Responder Safety and Health and Capability 15: Volunteer Management)

P6: Procedures in place to support evacuation or relocation of populations because of a nuclear emergency, as appropriate, based on the jurisdictional public health role.

P7: Templates and intervention-specific public educational materials that are modifiable at the time of the incident. Public education content may include

•      How the public can access reliable information and sources for obtaining official information, such as hotlines, websites, radio station or public service announcements, social media, and television

•      Populations recommended to seek medical care

•      When and where the public should or should not seek medical care, if applicable

•      How to prevent infection or exposure, including hand washing and other protective behaviors applicable to an incident

(See Capability 1: Community Preparedness, Capability 4: Emergency Public Information and Warning, Capability 7: Mass  Care, and Capability 10: Medical Surge)

Skills and Training Resource Elements

S/T1: Personnel trained in supporting operations at an emergency community reception center (CRC). This training focuses on

•      Locating CRCs based on the amount of space needed, the anticipated magnitude of the incident, and population needs of the community

•      Establishing crowd management operations, including the development of process flow or triage procedures and the distribution of patient information sheets during population monitoring

•      Using on-site equipment to monitor external contamination

•      Planning for and addressing the access and functional needs of at-risk individuals who may be disproportionately impacted by a public health incident or event to allow them to access and move through the CRC

•      Facilitating referrals of individuals experiencing psychological trauma to mental/behavioral health services

•      Establishing and maintaining contacts with federal agencies for equipment, personnel, and expertise

S/T2: Personnel or agencies with legal expertise authorized to advise individuals on legal or regulatory aspects of NPIs. Ensure the appropriate legal guidance needed for interventions, such as quarantine, isolation, and mandatory orders to close events or order evacuations.

S/T3: Relevant personnel trained to understand decontamination procedures.

Function 4: Monitor nonpharmaceutical interventions

Function Definition: Monitor the implementation and effectiveness of interventions, adjust intervention methods and scope as the incident evolves, and determine the level or point at which interventions are no longer needed.

Tasks

Task 1: Assess implementation and effectiveness NPIs . Assess the effectiveness and uptake of NPIs using relevant data about the disease or exposure, such as the degree of transmission,

contamination, infection, and severity of exposure, and monitor potential unintended or adverse effects of interventions.

Task 2: Provide updated information to partners related to the use of NPIs . Provide reports about the use of NPIs, as needed, to relevant agencies, partners, and stakeholders to inform continuous and timely decision making.

Task 3: Revise recommendations for NPIs . Update recommendations for NPIs as indicated by the incident, including increasing or decreasing frequency or implementing new interventions.

Task 4: Conduct after-action reviews of NPIs . Identify lessons learned related to NPI implementation within after-action reports (AARs) and develop and implement corresponding improvement plans (IPs).

Preparedness Resource Elements

P1: (Priority) Procedures in place, developed in consultation with appropriate public health officials, to monitor the effectiveness of NPIs based on surveillance data and other information. Procedures may include

•      Methods for evaluating public understanding of information messages about NPIs

•      Indicators of compliance with interventions, such as findings from on-site inspections and participation in active monitoring

•      Tracking of environmental changes, such as wind direction, that may impact the need for or effectiveness of interventions

•      Surveillance methods to monitor ongoing rates of transmission, contamination, or infection and severity of exposure, including

·  Case definitions

·  Contact investigations

·  Surveys

·  Epidemic curves

·  Reproductive ratios

•      Systems to be used for electronic laboratory reporting (ELR), electronic case reporting (eCR), environmental monitoring, and other epidemiological reporting

(See Capability 4: Emergency Public Health Information and Warning and Capability 13: Public Health Surveillance and  Epidemiological Investigation)

P2: Procedures in place to describe how the public health agency will monitor cases or exposed persons with assistance from community partners. Procedures may include

•      Sharing surveillance information between community partners and jurisdictional public health agencies

•      Establishing a common operating picture between the jurisdictional public health agency and the health care system

•      Following up with persons or households participating in NPI(s), which may involve registries, call lines, or periodic follow-up observations

•      Protecting confidential information or personal identifiers, including secure receipt and storage of sensitive information

(See Capability 3: Emergency Operations Coordination, Capability 6: Information Sharing, and Capability 13: Public Health  Surveillance and Epidemiological Investigation)

P3: Documented feedback related to intervention actions taken by local jurisdictions and community partners as part of the incident AAR and IP.

(See Capability 3: Emergency Operations Coordination)

P4: (Priority) Triggers and time frames for ceasing NPIs.

(See Capability 3: Emergency Operations Coordination and Capability 13: Public Health Surveillance and Epidemiological  Investigation)

Equipment and Technology Resource Elements

E/T1: Equipment to support collection and compilation of incident data, such as electronic communications and data storage equipment.

(See Capability 6: Information Sharing)

Capability 12: Public Health Laboratory Testing^[2]

Definition: Public health laboratory testing is the ability to implement and perform methods to detect, characterize, and confirm public health threats. It also includes the ability to report timely data, provide investigative support, and use partnerships to address actual or potential exposure to threat agents in multiple matrices, including clinical specimens and food, water, and other environmental samples. This capability supports passive and active surveillance when preparing for, responding to, and recovering from biological, chemical, and radiological (if a Radiological Laboratory Response Network is established) public health threats and emergencies.

Functions: This capability consists of the ability to perform the functions listed below.

•        Function 1: Conduct laboratory testing and report results

•        Function 2: Enhance laboratory communications and coordination

•        Function 3: Support training and outreach

Summary of Changes: The updates align content with new national standards, updated science, and current public health priorities and strategies. Listed below are specific changes made to this capability.

•        Updates Laboratory Response Network (LRN) requirements

•        Incorporates LRN-chemical requirements

•        Prioritizes cooperation, coordination, and information sharing with LRN laboratories, other public laboratories, and jurisdictional sentinel laboratories

For the purposes of Capability 12, partners and stakeholders may include the following:

•        civil support teams

•        clinical laboratories

•        emergency management agencies

•        environmental health

•        epidemiologists

•        federal laboratory networks and member laboratories11

•        first responders

•        food safety

•        health care providers

•        jurisdictional sentinel laboratories11

•        law enforcement

•        LRNs

•        non-laboratory response health care providers

•        non-LRN public health

•        poison control centers

11 For example, the Food Emergency Response Network, National Animal Health Laboratory Network, and the Environmental Response Laboratory Network

Function 1: Conduct laboratory testing and report results

Function Definition: Perform or coordinate laboratory testing to detect, characterize, confirm, and report biological, chemical, radiological, and public health threats using established protocols and procedures. Testing may include clinical specimens and food, water, and other environmental samples.

Tasks

Task 1: Check in samples for specimen testing . Receive, record, and route specimen samples to ensure that the samples are received by the appropriate laboratory for testing and that the specimen information is populated in the laboratory information system.

Task 2: Conduct specimen sample testing . Test clinical specimens and food, water, and other environmental samples according to designated laboratory type and level in order to identify biological, chemical, or radiological threat agents.

Task 3: Report presumptive or confirmed laboratory results . Notify appropriate public health, public safety, and law enforcement officials of results using electronic messaging in appropriate formats with the ability to notify 24/7.

Task 4: Maintain plans for surge and continuity of operations . Establish and maintain the ability to implement continuity of operations (COOP) plans and surge plans for both the short term (days) and long term (weeks to months).

Preparedness Resource Elements

P1: (Priority) LRN for Biological Threats Preparedness (LRN-B) Reference laboratories with proficiency in LRN-B testing methods and the ability to accurately test for agents as defined in the LRN-B Standard Laboratory Checklist.

P2: (Priority) LRN for Chemical Threats Preparedness (LRN-C) member laboratories with LRN-C Quality Assurance Program ”Qualified” status achieved through the successful participation in proficiency testing challenges. LRN-C core and additional methods are identified on the restricted access LRN website and updated annually.

P3: (Priority) LRN for Radiological Threats Preparedness (LRN-R) participating laboratories with

LRN-R Quality Assurance Program ”Qualified” status achieved through the successful participation in performance testing challenges, if LRN-R is established.

P4: Procedures in place for referring suspicious samples, such as samples from sentinel laboratories or first responders, to the laboratory jurisdictionally designated to receive them. Recommended procedures include those to safely package, document, and ship suspicious samples.

P5: (Priority) Procedures in place to test and report high-consequence samples from designated areas. If a jurisdiction has a high priority area (HPA), the associated LRN-B Reference laboratory must maintain the ability to ensure testing and results reporting of high-consequence samples from these designated areas within 24 hours of notification that testing is required.

P6: Procedures in place to ensure proper security and maintenance of records management systems.

(See Capability 6: Information Sharing)

 P7: (Priority) Procedures in place for data exchange with law enforcement, public safety, and other agencies with roles in responding to public health threats, as permitted by applicable laws, rules, and regulations. Procedures should address data security and prevent inappropriate or unauthorized

disclosure of secure information. Procedures should detail the acceptable data exchange processes and list the order of priority for using each process.

(See Capability 6: Information Sharing)

P8: (Priority) Procedures in place for laboratory surge capacity based on best practices and models available through LRN programs. Recommended procedures may include

•      Procedures to secure and deploy surge personnel, equipment, and facility resources for short-term (days) and long-term (weeks to months) response efforts

•      Procedures for triage and management of surge testing, which may include

·  Referral of samples to other LRN laboratories within or outside the jurisdiction using mechanisms and guidance made available by the LRN

·  Prioritization of testing based upon sample type

·  Prioritization of testing based upon risk or threat assessment

(See Capability 10: Medical Surge)

P9: (Priority) Procedures in place for a laboratory COOP plan to ensure the ability to conduct ongoing testing on routine and emerging public health threats. COOP plans should include

•      Procedures for regular maintenance of redundant testing supplies

•      Processes to designate alternate testing facilities for short-term duration in case of localized infrastructure failure

•      Agreements with other agencies to take over critical testing, as appropriate

•      Procedures to address personnel shortages

•      Procedures to address equipment failures

•      Procedures to address operational loss of laboratory facilities

P10: Notification procedures to detail how laboratory results suggestive of an outbreak or exposure will be reported or messaged to appropriate health investigation partners using secure contact methods per LRN notification policies or laboratory-specific policies. Notification procedures should include appropriate messaging timeframes per LRN data messaging and other laboratory-specific policies.

(See LRN Notification and Data Messaging Policies, Capability 3: Emergency Operations Coordination, and Capability 6:  Information Sharing)

Skills and Training Resource Elements

S/T1: (Priority) LRN-B Standard and Advanced Reference laboratories must meet all requirements of the LRN-B Standard Reference laboratories as listed in the Checklist of Laboratory Requirements for LRN-B Member Standard Level Reference Laboratories located on the restricted access LRN website. In addition, Advanced Reference laboratories must support CDC’s LRN-B program office and the network in activities that may include

•      Deployment of new technologies and specialized methods

•      Evaluation of new technologies

12 LRN Notification and Data Messaging Policies are located on the restricted access LRN website.

•      Engagement in multicenter validation studies•      Participation in priority partnership exercises

•      Provision of high throughput surge testing capacity

•      Assistance with quality initiatives, including network training programs and proficiency testing remediation

•      Maintenance of registration with Federal Select Agent Program

•      Provision of resources to ship isolates to CDC for further clarification

S/T2: (Priority) All LRN-B, LRN-C, and LRN-R (if LRN-R is established) laboratories able to pass LRN proficiency testing, as required by the respective LRN program.

S/T3: LRN-B Advanced Reference laboratories and other Reference laboratories capable of performing LRN-B approved assays and participate in technical meetings, as necessary.

S/T4: Personnel who perform LRN protocols trained in LRN methods and able to demonstrate proficiency and competency in compliance with applicable regulations, such as Clinical Laboratory Improvement Amendments (CLIA) from regulatory agencies, such as the Centers for Medicare and Medicaid Services (CMS), College of American Pathologists (CAP), or other regulatory equivalent.

Documentation should include training date(s) and manner of training delivery, such as formal or “train the trainer.”

S/T5: Personnel from LRN-C laboratories who participate in the LRN-C biannual technical meeting, formerly known as Level 1 surge capacity meeting.

S/T6: Personnel who regularly perform LRN testing, including those identified for surge capacity, trained annually in appropriate safety procedures. Documentation should include training date(s) and manner of delivery, such as formal training or “train the trainer.”

S/T7: Personnel trained on emergency operations and incident management system.

S/T8: (Priority) All laboratories accredited by an appropriate accreditation body, such as CAP, CMS, or the International Organization for Standardization.

Equipment and Technology Resource Elements

E/T1: (Priority) At least one LRN-B approved instrument for rapid nucleic-acid detection and one LRN-B approved instrument for antigen-based detection owned and maintained by each LRN-B Reference laboratory. Instruments are listed in the current equipment list, which is updated annually on the restricted access LRN website. Preventative maintenance and service agreements must be provided for all equipment listed on the LRN-B equipment list.

E/T2: (Priority) Laboratory equipment and instruments serviced, inspected, and certified. The following should be established and maintained in coordination with public health emergency management

•      Preventative maintenance contracts and service agreements for equipment and instruments described within applicable LRN protocols, procedures, and methods

•      Inspection and certification of equipment and instruments used by the LRN-B and LRN-C according to manufacturers’ specifications

E/T3: (Priority) LRN-C Level 2 laboratories that own and maintain at least one instrument listed on the LRN-C equipment list. LRN-C Level 1 laboratories that own and maintain at least two instruments each listed on the LRN-C equipment list. Preventative maintenance and service agreements must be provided for all equipment listed on the LRN-C equipment list.

E/T4: (Priority) Reagent inventory and laboratory supplies maintained to levels adequate to perform routine testing, with plans for obtaining additional reagents or supplies during a surge event, establish priority access rights with suppliers, if possible.

E/T5: (Priority) Laboratory Information Management System (LIMS) that is routinely updated and maintained in order to send testing data to CDC according to CDC-defined standards. Procedures and resources needed to use and maintain the LIMS may include

•      Protocols, including timelines, to send and receive data from local LIMS to CDC and other partners

•      Local codes mapped to federal standards, such as Data Integration Requirements for LRN-B and LRN-C

•      Dedicated information technology (IT) support personnel to maintain and update LIMS or contractual agreements with LIMS vendors that are familiar with national standards, such as LIMS integration, Public Health Laboratory Interoperability Project, and industry standards, such as logical observation identities, names, and codes; systematized nomenclature of medicine; Health Level 7 (HL7), to configure the LIMS

•      Periodic validation of LIMS functionality and message structure

•      Alternate data sharing strategies in the event of a failure in the LIMS or CDC-provided systems for LRN data exchange

E/T6: Representative(s) from both the LRN-B and LRN-C laboratories in the jurisdiction with current Secure Access Management Services (SAMS) access to electronic data exchange systems.

E/T7: At least one working computer able to access LRN and partner electronic data exchange systems.

E/T8: Access to a mechanism (automated, electronic, or paper-based) for messaging results to LRN-B, LRN-C, and LRN-R (if LRN-R is established).

E/T9: Access to an operational and biosafety level 3 (BSL-3) laboratory either on site or through a memorandum of understanding (MOU) or other formalized agreement.

Function 2: Enhance laboratory communications and coordination

Function Definition: Ensure timely laboratory results reporting to stakeholders to support determination of the cause or origin, definitively characterize the threat, and inform deployment of appropriate countermeasures.

Tasks

Task 1: Ensure effective information exchange . Ensure timely exchange of laboratory information and data with laboratories, laboratory network partners, and other stakeholders. Provide unique identifiers that support linking laboratory data to epidemiologic data.

Task 2: Coordinate with preparedness partners to support public health investigations . Use laboratory testing to coordinate public health investigations with preparedness and response partners, as required by the incident.

Task 3: Provide investigative consultation and technical assistance . Support jurisdictional public health agencies, first responders, law enforcement, and other health investigation partners with sample collection, management, and safety.

Preparedness Resource Elements

P1: (Priority) Procedures in place to facilitate cooperation, coordination, and information sharing with and among stakeholders, which may include

•      LRN-B, LRN-C, and LRN-R (if LRN-R is established) member laboratories within the jurisdiction, including jurisdictional sentinel laboratories, and non-LRN public health laboratories, such as those identified in COOP planning for example, environmental, agricultural, veterinary, and local public health

•      Federal laboratory networks and member laboratories for example, the Food Emergency Response Network, National Animal Health Laboratory Network, and the Environmental Response Laboratory Network

•      Poison control centers that can serve as supporting resources for exposure incidents

•      Health care providers or clinical laboratories that may be packaging and shipping samples and, subsequently, receiving sample results during a response

•      Epidemiologists who interface with hospitals, public health agencies, and laboratories

(See Capability 6: Information Sharing, Capability 7: Mass Care, Capability 10: Medical Surge, and Capability 13: Public  Health Surveillance and Epidemiological Investigation)

P2: (Priority) Procedures or guidelines in place to coordinate with relevant stakeholders in specific incidents. Procedures may include

•      Procedures for communicating with sentinel laboratories in the event of a public health incident

•      Policies developed in coordination with jurisdictional stakeholders for handling biological, chemical, radiological, nuclear, and explosive incidents

•      Coordination with first responders who may initially identify overt exposure incidents

•      Coordination with Civil Support Teams (CSTs) to establish partnerships between CSTs and the public health laboratories with respect to field analysis of unknown samples

•      Coordination with local law enforcement and Federal Bureau of Investigation (FBI) field offices for screening and triage procedures for environmental samples, such as biological, chemical, radiological, and explosive materials

•      Coordination with emergency management officials and other relevant entities, such as fusion centers supporting an emergency response, including incidents when the Emergency Management Assistance Compact (EMAC) is activated

•      Updated contact list for state, local, tribal, and territorial law enforcement and first responder units, such as HazMat and poison control center, who are approved to perform screening and triage procedures on unknown samples

(See Capability 3: Emergency Operations Coordination and Capability 14: Responder Safety and Health)

P3: Designated individual(s) responsible for coordinating emergency response activities, such as personnel safety, sample collection, methods training, plans, guidance, and outreach to sentinel laboratories and first responder communities.

(For additional guidance on chain of custody procedures, see the restricted access LRN website)

P4: Updated contact list for LRN-B laboratories (sentinel and public health laboratories), LRN-C laboratories, and LRN-R laboratories (if LRN-R is established) in the jurisdiction as well as other jurisdictional laboratories that collaborate with the public health agency.

(See Capability 6: Information Sharing)

Skills and Training Resource Elements

S/T1: Personnel with awareness of current national policy and leading practices for biological, chemical, and radiological (if LRN-R is established) threat preparedness attained through regular participation in LRN national meetings, if available.

S/T2: Public health laboratory managers and directors, meaning those responsible for overseeing laboratory activities, who have completed the CDC/FBI Joint Criminal Epidemiology Investigations workshop, as needed. Coordinate with FBI field office to complete this workshop.

Function 3: Support training and outreach

Function Definition: Perform outreach, facilitate access to training, and maintain applicable protocols for sample collection, handling, packaging, processing, shipping, transport, receipt, storage, retrieval, and disposal.

Tasks

Task 1: Facilitate access to training for handling, packaging, and shipping samples . Ensure established International Air Transport Association (IATA), U.S. Department of Transportation (DOT), and other laboratory-specific protocols are followed when managing laboratory samples.

Task 2: Maintain chain of custody procedures . Ensure chain of custody requirements are maintained throughout the sample management process.

Task 3: Support training, exercising, and laboratory participation in preparedness and response operations . Provide or facilitate access to training and exercises for relevant stakeholders.

Preparedness Resource Elements

P1: (Priority) Procedures in place for sample collection, triage, labeling, packaging, shipping, transport, handling, storage, and disposal. Sample collection procedures should include 24/7 contact information and submission criteria in accordance with applicable requirements, such as requirements from the IATA, DOT, and Federal Select Agent Program.

P2: (Priority) Transportation security procedures in place that may include

•      Select agent and toxin regulations (if applicable)

•      Biosafety or biosecurity plan (applicable even if laboratory is not select agent registered)

•      Chemical hygiene plan

•      LRN-R: Radiation Safety and Security Plan (if LRN-R is established)

•      Other protocols, as needed, to ensure adherence to applicable federal, state, local, tribal, and territorial regulations related to transport of clinical specimens and hazardous and radiological materials