Open Data

AUGMENT MEDICAL COUNTERMEASURE DISPENSING OPERATIONS

PURPOSE:

Medical countermeasure dispensing is the ability to provide medical countermeasures (including vaccines, antiviral drugs, antibiotics, antitoxin, etc.) in support of treatment or prophylaxis (oral, injection or vaccination) to the identified population in accordance with public health guidelines and/or recommendations. Most common are air borne, food borne, and contact borne infectious disease illnesses and events, whereby control is an essential component of public health services, and there are many scenarios whereby an outbreak, or man-made-threat might result in the requirement of mass public prophylaxis and/or treatment. This topic was created in compliance with FEMA, CDC, and RAND standards, discusses an overview of POD medical countermeasure dispensing operations, and injects some best practices into the topic. Public Prophylaxis operations are a course of action that may be required to protect U.S. citizens and to prevent the development and spread of disease among those who are exposed (or potentially exposed) to communicable diseases, or other human health hazards.

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INTRODUCTION:

At present time the CDC has identified 1,407 recognized species of human pathogen, 58% of which are zoonotic (transmitted by animals). Of all pathogen species, 208 are viruses or prions, including 77 (37%) regarded as emerging or reemerging. For bacteria, the counts were 538 and 54 (10%), respectively; for fungi, 317 and 22 (7%), respectively; for protozoa, 57 and 14 (25%), respectively; and for helminths, 287 and 10 (3%), respectively and others not specified. I note here that "Emerging disease" is defined as infectious disease that is increasing in incidents in the last 20 years. We can also say that in the modern era, people need their “standard U.S. vaccinations,” and they may need vaccinations for their specialty such as Rabies for Veterinarians and Hep-B for medical staff, Military specific vaccinations, people may require vaccinations or other types of prophylaxis against people who travel to the U.S. carrying disease (e.g. such as the current Romanian Measles outbreak, Zika, and illegal alien issues), or we might need prophylaxis prior to traveling abroad. Prophylaxis consists of countermeasures taken toward disease prevention including "preventive healthcare," (as opposed to pre-existing disease treatment), however, there are cases whereby this line is blurred (as in Malaria whereby the prophylactic drug in some cases can treat/kill the pathogen). Also, many topics tie together including epidemiology of Global outbreaks, surveillance, analysis and risk assessments related to microbiology, virology, parasitology, fungus, prions, chemicals and toxicology, attack vectors, idiopathic disease states, population health, WHAT TO DO AT DIFFERENT PHASES, exposure modelling, and anticipated prevention, protection, mitigation, and recovery activities related to the scope of the problem. Mass population Medical Countermeasures were developed as well via “City Readiness Initiatives” and other research endeavors, and standards were developed through broad collaboration to manage a variety of incident scenarios. Mass Prophylaxis as a countermeasure falls under the FEMA core Capability of Public Health and Medical Services, and is supported by (or a component of) the additional services of Emergency Triage and Pre-Hospital Treatment, Epidemiological Surveillance and Investigation of emerging diseases, Isolation and Quarantine of suspected infectious vectors, Laboratory Testing to identify the causes of an outbreak, capacity building related to Medical Supplies Management and Distribution, and Medical Surge rapid expansion of the existing healthcare system capabilities, all interplay as we will discuss below. We also see the use of other general and specific capabilities such as Information Gathering and Recognition of Indicators and Warnings, Situation assessment, Planning, Screening, Access Control, Information Sharing and Dissemination or other communications such as Emergency Public Information and Warning, risk management, Responder Safety and Health, Long-term Vulnerability Reduction, Public and Private service utilization, Mass Care Services, Security and protection operations, and fatality management, that are all stakeholders and thus planning needs to be coordinated with them.

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---------------------------------------EXAMPLE POTENTIAL EVENTS------------------------------------------

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POTENTIAL ANTHRAX EVENT, CDC YOUTUBE VIDEO (CLOSED POD):

 

In the case of mass (Aerosolize-Inhaled Anthrax exposure), the infected will present with flu-like symptoms that progress to severe breathing problems. The treatment (Doxycycline, Cipro, or other antibiotics [in the event of allergy or ineffective coverage], are given as pills) and must be delivered to the public within 48 hours to prevent 95 percent or more anthrax cases. Thus STANDARDS ARE ALIGNED WITH THE CITIES “48 HOUR” READINESS INITIATIVE GOAL. Local health and emergency officials, and responder staff must rapidly take Cipro that they have stockpiled, mobilize and deliver it to POD sites that can give this free medication to the public to prevent sickness, collect data, and manage the incident in a controlled manor. In this particular case, POD staff must also understand disease and drug specific information (e.g. that they cannot give Doxycycline if the individual has severe allergy to doxycycline, tetracycline, or minocycline, pregnant or breastfeeding, less than 9 years old. Ciprofloxacin cannot be given to anyone with severe allergy to ciprofloxacin or fluoroquinolones, severe kidney disease and/or on kidney dialysis.)

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Here are a few examples we manage every day:

STD's, E. coli O157:H7 Salmonella and Listeria food contamination, let us not forget that human age is a factor, considering Zika, "Primal prevention" aka prophylactic measures to prevent the baby from contracting the disease, or elderly as in varicella vaccination now to prevent shingles later, or immunocompromised (as in HIV) prevention as perpetual carriers of other communicable disease conditions, or Gardasil HPV-cervical cancer prevention, or Hep-B vaccination for liver cancer prevention. We must also consider Illegal Immigrants and Bordetella Pertussis which causes a highly contagious respiratory disease called Whooping Cough (they likely caused the 2010 California Whooping Cough outbreak). In the case of Whooping Cough, the U.S. population is vaccinated (so no one should get it), but the California Sanctuary City issue likely resulted in the 10,000 cases and a reported 10 dead babies in California. Other events may require vaccination (e.g. due to pandemic influenza, or after a smallpox bioterrorist attack), see further pathogen and event information in the Appendix section.

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LAWS AND REGULATIONS PERTAINING TO POD OPERATIONS:

1. Public Readiness and Emergency Preparedness Act

2. Volunteer protection statutes (Hodge, Pepe & Henning, 2007)

3. Sovereign immunity doctrine

4. Good Samaritan statutes

5. Emergency response laws

6. Mutual aid laws

7. Memoranda of understanding (Hodge, Pepe & Henning, 2007)

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LEGAL ISSUES RELEVANT TO POD OPERATIONS:

1. Standard of care can be temporarily relaxed if necessary to reduce total processing time and increase POD throughput.

2. Documentation of care standards can be temporarily relaxed to increase POD throughput.

3. Licensing requirements can be temporarily waived to allow non-medically trained personnel to carry out essential POD functions.

4. Scope of practice requirements can be temporarily relaxed in order to provide more flexibility in the use of available medically-trained personnel.

5. Labeling requirements can be temporarily relaxed or waived support efforts to reduce processing times.

6. Liability can be temporarily waived or reassigned to reduce barriers to use of volunteer staff and organizational entities working under the direction of and coordination with health officials.

7. Workers Compensation requirements can be changed temporarily to reduce government staff and volunteers barriers to full and effective use of medical and non-medical

8. Property and facilities can be appropriated where needed to support dispensing operations.

9. Health authorities can compel treatment and isolation and quarantine of individuals where necessary to protect public health.

10. Laws are clear about who has the authority to waive requirements, under what conditions, and for what period of time.

11. Responsible officials can temporarily waive other laws, regulations, and other requirements that might create barriers to mass prophylaxis operations.

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U.S. HUMAN HEALTH SERVICES BASIC POD OPERATION STANDARDS:

1. The jurisdiction shall estimate the number of people who will likely come to PODs to pick up medication, along with their geographic distribution.

2. The number of PODs shall be greater than or equal to (a) the number of persons needing to receive prophylaxis at PODs divided by (b) per POD throughput multiplied by 24 hours (48 hours minus 12 hours for initial CDC delivery to warehouse and 12 hours to get materiel from warehouse to PODs).

3. All POD locations shall meet relevant SNS site guidelines and security criteria.

4. Jurisdictions shall have at least one viable and exercised rapid dispensing protocol that addresses the following minimal functions: (a) directing clients through the POD, (b) deciding which medication to dispense, (c) dispensing medication, and (d) disseminating information about the medication. Note that this standard does not mandate that these functions be provided by medically licensed personnel, and does not mandate that all of these functions be provided in-person or on-site at the POD.

5. Jurisdictions shall ensure that legal and liability barriers to rapid dispensing are identified, assessed, prioritized, and communicated to those with the authority to address such issues. Such issues include standards of care, licensing, documentation of care, civil liability for volunteers, compensation for health department staff, rules governing the switch between dispensing protocols, and appropriation of property needed for dispensing medications.

6. Jurisdictions shall have viable and exercised procedures for selecting an appropriate dispensing protocol (e.g., medical model vs. rapid dispensing).

7. Jurisdictions shall estimate the number of individuals who are likely to visit each POD location and determine the required hourly throughput at each POD.

8. Using a combination of exercises and/or computer models, jurisdictions shall determine and verify the number of staff required to administer prophylaxis to the population identified pursuant to Standard 1.1.

9. Jurisdictions shall recruit sufficient command staff, and provide plans for recruiting and training of spontaneous unaffiliated volunteers, in sufficient numbers to operate all the planned PODs in the jurisdiction at the levels of throughput required to meet the CRI timeline.

10. Jurisdictions shall assess the availability of the command staff on their call-down rosters on a quarterly basis, via a no-notice call-down drill.

11. Site security assessments shall be conducted on every POD location in coordination with the agency (ies) responsible for security functions at the PODs.

12. The agency (ies) responsible for security functions at PODs shall be consulted on the security aspects of the overall mass prophylaxis plan.

13. Law enforcement in the form of sworn uniformed officers shall maintain a physical presence at each POD location. This requirement may be waived with a written attestation from the parties responsible for POD security. The attestation shall include evidence that compliance with the standard as written is infeasible and that alternate measures designed to ensure adequate security are in place at each POD site.

14. Directing clients through the POD’s, collect and/or track Copies of relevant signage from PODs, Public messages, Floor plans for PODs, Protocols for dealing with ill, upset clients, those refusing medication, those with contraindications, unaccompanied minors, non-English speakers, Job action sheets, Training materials, and Training logs.

15. Deciding which medication is appropriate, and clearly designate Protocols for guiding decisions about which medications to dispense Protocol/guidance on number of regimens that may be dispensed to each client, Job action sheets, Training materials, and Training logs.

16. Dispensing the medication, ensure dispensing staff are is fully capable and have Job action sheets, Training materials, and Training logs.

17. Disseminate copies of relevant information about medications and the event, post signage from PODs, and conduct public messaging (e.g., handouts) including drug and reaction information.

18. Basic POD documentation standard requirements: Jurisdiction list of all POD locations, Certification that all sites meet appropriate physical characteristics, Certification that all sites meet appropriate security guidelines, POD name or identifier, reason for POD location and facility selection, Demand estimate (Number of people who will visit this POD) Required throughput calculation, Staff required to operate one shift of this POD and the estimated throughput, Method by which the staff estimate was generated (exercise date or model name), Number of shifts of distinct staff (this is the number of shifts per day, assuming staff will return for another shift on subsequent days), and Total number of staff required to operate this POD through entire mass prophylaxis campaign, Number of staff on call-down list, Call down method (manual? automated? calling tree?), Percent confirmed reached, Percent reporting that they would be available to report for duty (had this been a real emergency call-down), Time necessary to perform call-down, Time necessary to receive acknowledgements from those called, Documentation of the members of the team(s) assigned to conduct site security assessments, Description of the site security survey methodology used, Copies of site security assessments (including data) conducted on all selected POD locations, Documentation of review of POD security assessments by the CRI or SNS coordinator and lead security official, Jurisdictions must provide a signed letter from presiding law enforcement with the jurisdictional responsibility of the POD area, estimated Communication efforts undertaken during POD operations, Plans for providing transportation to and from PODs

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POD PLANNING GROUP MEMBERSHIP COULD INCLUDE THE FOLLOWING CONSTITUENCIES:

=>Public health departments

=>Jurisdictional Emergency Management/Office of Homeland Security

=>Law enforcement

=>Private businesses (including pharmacies)

=>Emergency medical services (both public and private)

=>Hospitals and clinics

=>Medical professional organizations

=>Military installations

=>Metropolitan Medical Response System participants

=>Volunteer groups (e.g., Red Cross and Salvation Army)

=>Radiation-specific group, (e.g., Radiation Control Programs, U.S. Environmental Protection Agency, or State Environmental Agency).

=>Private organizations such as retailers with supply chains and package delivery services (e.g., U.S. Postal Service, UPS, FedEx, and DHL)

=>U.S. Department of Health and Human Services Regional Emergency Coordinators

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NUMBER OF POD’S REQUIRED CALCULATION:

Number of POD’s required must be greater than or equal to

(Population visiting POD in Person / (Hourly per POD throughput X 24 hours))

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COMPUTER MODELS FOR ESTIMATING STAFF REQUIREMENTS:

If a jurisdiction has not performed a dispensing drill, or was not able to generate reliable throughput estimates from a drill that was performed an alternative method for estimating the staff required to attain a desired level of throughput would be to use a computer model. Possible computer models include:

1. Bioterrorism and Epidemic Outbreak Response Model BERM (Weill/Cornell Medical College) (Weill, 2005):

http://www.ahrq.gov/research/biomodel.htm

2. Clinic Generator (University of Maryland) (ISR, 2008)

3. RealOPT (Georgia Institute of Technology) (ISYE, 2006)

http://www2.isye.gatech.edu/medicalor/research.htm#realopt

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EXAMPLE MEDICATION PROPHYLAXIS METHODS:

=>Disruptive prophylaxis

=>Suppressive prophylaxis

=>Causal prophylaxis

=>Synergistic multi-Regimens and Adjuvants

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-------------------------MEDICAL COUNTERMEASURE CAPABILITY CREATION-------------------------

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In order to make this course of action an available option, the following is required:

1. ELUCIDATE THE THREAT:

=>Conduct disease surveillance (including in partnership with global partners).

=>Map the geographic distribution of the problem.

=>Identify then create a list of “Emerging Communicable Diseases” (see this list in Appendix-A at the end of this topic).

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2. MITIGATE, DELAY, DENY, LIMIT, MANAGE AND THREAT: Identifying effective ways to prevent and treatments to counter “Emerging Communicable Diseases” and/or other Chemical, Biological, or Radiological attacks, according to a list of priorities, including (e.g. probability, plausibility, feasibility, vector, anticipated magnitude and cost/benefit/risk, etc.).

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3. BUILD CAPACITY TO DEAL WITH THE THREAT:

=>Create a drug prophylaxis and/or vaccination strategy for each potential communicable pathogen.

=>Stockpile treatments and/or vaccinations according to priorities.

=>Strategically (using GIS), make sure the supply chain can distribute them to the stakeholders.

=>Provide risk communication messages to address the concerns of the public.

=>Create a mechanism to follow-up and monitor associated adverse events.

=>Big businesses can assist by creating a “Closed POD,” on site, that services their employees only, and thereby decreasing the time lost waiting at a public POD, and assisting with the overall public mass prophylaxis workload. It is particularly important that businesses that ARE STAKEHOLDERS in the supply chain of a mass prophylaxis event, set-up onsite Closed POD’s so that they can continue to function and servicing the event, while protecting their employees.

=>Open POD’s are sites open to the public and are strategically situated accordingly.

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4. PROGRAM AND ASSOCIATED EMERGENCY OPERATING PROCEDURES:

=>NATIONAL/FEDERAL GUIDANCE: Communities are obligated in many ways to develop their Medical Countermeasures referencing National Standards, and access and utilize federal Develop capabilities, and associated informational material and guidance pertaining to dispensing operations, mechanisms to approve the associated operations, and public communications, and designate when and where to distribute said information content.

=>NATIONAL/FEDERAL TOOLS: The Local Technical Assistance Review (TAR) tool is useful to design your Local Strategic National Stockpile. Use NIMS to create and maintain an inventory and map the potential State Assistance resources that a given outbreak may require, and for general incident management. Designate the Primary, Back-up and Paper Inventory Management System, Inventory Management Staff and Training Documentation, Chain of Custody Forms, DEA Registrants Contact List, according to National standards, also see the SNS MOHSAIC Handbook, and IMATS User Manual for further details.

=>LOCAL AUTHORIZATIONS AND DESIGNATIONS: Identify the chain of authorization (and appropriate orders that may be given) during a mass prophylaxis scenario. Identify individuals authorized by the health board or other agencies to request assistance and associated jurisdictional guidelines, personnel authorized to request Strategic National Stockpile Contact List, SNS Item Order Form, Request Justification Form, SNS Request Flow Charts, and POD to Local Re-supply Request Procedures. Identify the Laws, Policies, and Agreements or Obligations that pertain to a given ESD including (e.g. NIMS Compliancy Documentation, MOU’s and Mutual aid agreements, Head of Household Policy, Unaccompanied Minor Guidance and Laws Related to Rights of a Minor including Parent/Guardian being informed of treatment, and a plan for treating minors without attending parent/guardian, Legal Issues Briefing Paper related to the outbreak, Federal Medical Stations protocols, IND and EUA Protocols.

=>LOCAL LEAD AGENCIES: Local Health Dept. and Emergency Management officials will need to develop an effective model with standing orders for dispensing and administration of vaccine or medications for emergency treatment. Identify planners, subject matter experts create the Command and control and Strategic National Stockpile Coordinators Roster, Functional Planning Lead Staff Roster and Planning Leads Contact List, locate and integrate results from the Functional Lead Staff Quarterly Call-down Drill Results, Local Incident Command Charts, and Volunteer Notification Drill Results. Identify and document the threshold values at which point a given community will need to Request State Assistance.

=>SNS AND LDS/RDS PLANNING: Create the Local Strategic National Stockpile Plan, and designate the associated Regional/Local Distribution Sites. Designating the SNS Training and Exercise Coordinators, SNS Training Calendar, Training and Exercise Planning Workshop (TEPW), evaluating the Local Multi-Year Training and Exercise Plan, HSEEP Compliant After Action Reports, SNS After Action Report (AAR), and SNS Training and Exercise Documentation, then designating the Improvement Plan (IP) Tracker, and consider how the SNS will most effectively supply the Local and Regional Distribution Centers.

=>EDS SITE DESIGNATION: Create the final up-to-date call-down list of potential Emergency Dispensing Site (EDS)/facilities within the jurisdiction, and determine if there are enough people in the database to run each of the EDS sites, and extra people to compensate for absent individuals. Call potential Closed POD business sites to determine their participation status.

=>POD SITE: Create and map the Point of Dispensation locations, structures and functions (including availability of quarantine and personal protective equipment) typically at hospitals, but also the availability of secondary locations. Integrate the general POD Policies and Procedures into the specific site plans and capabilities. Designate the associated Regional/Local Distributer Sites, Plans, Checklists, Written Agreements, Lead Roster Contact List and POD Core Management Teams, Lead Training Documentation, Lead Job Action Sheets, integrate Lead Quarterly Call-Down Drill Results and updated Training, designate the POD Supplies and Material Handling Equipment Inventory, Office Equipment Inventory, Cold Storage and Cold Chain Management for SNS Vaccines plan, and associated Open POD Site Plans, Tiered Approach for Dispensing Guidance, Volunteer/Staff Management Plan, Database and Just-in-Time Training Materials, location of supplies, including medications that will be dispensed, location of first aid kit and restrooms. Large businesses are evaluated for use as Closed POD’s with site specific plans and an Essential Closed POD Personnel designations.

=>STAFFING: Create the final up-to-date call-down lists for mass prophylaxis site staffing. Designate individuals who are authorized to issue standing orders pertinent to their POD location. Review organizational chart for the Closed POD and who will be filling what roles. Designate how long will the Open or Closed POD be running. Designate how many staff are working at the Open or Closed POD. Attempt to anticipate how many people will be coming through the Open or Closed POD. Designate when and where staff will be taking breaks, and if the POD will be providing food and drinks for staff and if not, where staff can go to quickly get food and drinks. In the case of Closed PODS, determine if they will be dispensing to their clients in the community as well.

=>EOP: Create the EOP with purpose policies and plans for how medical emergencies will be handled, Command and Control in mind, Communications capabilities in mind, security requirements, designated Regional/Local Distribution Site (RDS/LDS), Inventory Management method, Supply chain distribution network, dispensing mechanisms, Medical Waste Management System, TTE methodology, Demobilization plan, and Emergency contact information including local police, public safety and Security Support Agencies, SNS Functional Planning Lead Staff, Personnel Authorized to Request SNS, Tactical Communication Support Staff, Public Information Partners & Media Contacts, RDS/LDS Lead Roster, DEA Registrants, and additional Volunteer/Staff NGO Database.

=>COMMUNICATIONS (TACTICAL): Create a communications plan with a Tactical Communication Support Staff Contact List, Communications Support Staff Job Action Guidelines, integrate the Communication Systems Quarterly Test Results, Communication Pathways Quarterly Test Results, Inter-Agency Communication Systems Matrix information, Function Lead Staff Communication Training Matrix and documentation information.

=>COMMUNICATIONS (PUBLIC): Designate a Public Information Officer, to coordinate the Public Information and Communication (PIC) plan, Training Documentation for PIC Personnel, PIC Job Action Sheets, Risk Communication Coordination Guidelines, Media Policy for POD Sites, Public Information Partners and Media Contact List Hotline/Call-Bank Procedures, Messaging Templates including POD Directional Signs, Drug Fact Sheets, designate Translator Service agreements, and Agreements with Organizations Servicing At-Risk Populations. Determine how staff can communicate with family members (e.g. Personal phones, Work phones, others). Initial Staff Briefing should include an Incident Briefing and event information provided from the Local Health Department, the purpose of the POD (to dispense medications safely and efficiently to protect the target population, and in the case of Closed POD’s to dispense to employees, family members and/or clients in response to a declared public health emergency. Also, a review of the POD floor plan including how many tables will be at each station and how many staff at each station, a short walk through of the site. Post the floor plan or layout somewhere that it can easily be seen for future reference. Go over basic Incident Command Systems with your staff including how to communicate (radios, walkie talkies, cell phones, in person, etc.) and who everyone should communicate with.

=>SECURITY: Create the security plan, include the Security Lead Roster, Security Support Agencies Contact List, Security Lead Training, Security Escort Plans, Security Site Plans for Regional and Local Distribution center and PODs, Badging Procedures, Badging Training. Define Security emergencies including theft, threats, and altercations. Review Shelter in Place plans, Evacuation plans, and Fire plans, line control and traffic control. If Law enforcement or Private Security staff will be present have them speak to staff about their security plans and polices. Review all pertinent security procedures with POD staff including when to call 911.

=>TRANSPORTATION (Distributing treatments to POD’s): Designate a Distribution Manager, and create Distribution Manager Training Documentation, create a Distribution Strategy, create the Written Agreement with PRIMARY Distribution Agency and with a Back-up Distribution Agency, create a Local Air Transportation Plan, create the POD Material Handling Equipment (MHE) Inventory, designate a trainer and materials for Distribution Training.

=>Create a COOP plan, including sign-on and sign-out of staff if the POD runs longer than 24 hours, and alternative facilities in the event of major problems, such as a crime taking place.

=>Additional Hospital and Treatment Center Coordination will apply and must be planned for, including

Alternate Dispensing Modalities for Homebound and At-Risk individuals.

=>Create the POD Demobilization Checklist

=>Create an exercise program that will adequately validate all aspects of POD operations, example exercise requirements information is below.

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5. POD EXERCISE EVALUATION AND TESTING REQUIREMENTS:

=>POD AVAILABILITY: We need to know the total number of available sites and percentage of sites that will be functional and operating as a POD within a given amount of time. At any given site, we need to know if it was set up according to the State or locally adjusted EDS plan.

=>COMMAND: We need to know if the POD is a safe environment, and how well personnel are coordinating with Emergency Operations Center, and among themselves, including staff sign-in and sign-out, the degree of volunteer management, tasking and utilization, is the Command Post ready with office and processing areas separate from the public areas, are the security staff in full and confident control of the POD, are all communications up, on-line, and functioning including tactical and public information communications. Command needs a process to ensure response staff and appropriate personnel receive prophylaxis BEFORE the response operation begins. The Incident Command System will be utilized and elements of its structure and function will be conveyed to POD staff including the POD ICS organizational structure used to manage an incident, the direction in which communication flows (up the chain of command) and the method in which decisions are made and executed (by command staff), a staffing diagram showing who reports to whom, (i.e. Staff should be able to identify/name the person/s to whom they report, and the positions/functions that report to them, and only the person above you in the chain of command can ask you to do or change a task), convey the importance of always follow the chain of command. In the closed POD scenario, staff must additionally coordinate with their regular business supervisor as well as their ICS supervisor. Review what will occur in the Screening Area and Dispensing Areas (purpose, assignments, function, role, responsibilities, and flow), and if the Operations and Logistics sections have been activated explain how activities, or span of control, have been divided. Supervisors will need to ensure the EDS Training plan is in place, emphasizing ICS as it relates to the clinical area, as well as the proper dispensing of medications and screening for contraindications (e.g. discuss the screening form and the screening/dispensing process is detail with staff to ensure an effective program, ensure members of the public do not have an allergy to medication that they are dispensed, address confidentiality and that any health information learned is considered confidential). Staff need to be trained how to identify the Signs/symptoms of exposure to the (e.g. biological agent in question), as well as associated Behavioral Health issues, as well as the location of supplies and on-site resources, who to consult and how to summon them if needed. Supervisors may choose to track wait times as a performance metric to make adjustments, and/or to keep stakeholders apprised of their status. Medical resources must be tracked (incoming chain of custody), as well as outgoing in an effort to re-order them prior to POD complete depletion. During demobilization, get totals for resource in’s and out’s, conduct the staff debriefing and health survey, track the percentage of equipment accounted for upon completion of the operation. Determination of who will take possession of all records pertinent to the prophylaxis process, and log all documentation being turned over, then task the packing and transfer of records to the appropriate local or State official. Track the percentage of records successfully returned to the State officials.

=>POD PERFORMANCE ADJUSTMENTS: We need a system/schedule implemented to hold regular briefings to assess POD and staff performance, client processing rate per hour, and ascertain if additional training or POD site reconfiguration is needed. Discuss Job Action Sheets, safety hazards (obstacles, cords, ice, tripping, slipping) and crowd control objectives. We need to know how up-to-date the personnel database was, and how accurately it reflected the availability of expected participants. Staff need to be monitored to ensure they take regular breaks, and be aware of warning signs for stress i.e. moodiness, irritability, feeling overwhelmed, etc. and how to support. Command must account for the number of regimens of medication that can be dispensed to an individual, or medical state, and the minimum data elements that need to be collected for each unit of medication dispensed. Adverse events monitoring must identify and track outcomes and adverse events following mass distribution of prophylaxis. This will likely involve a system in place to track adverse events, and documentation established on each case of adverse reaction, the percentage of client records that are incomplete insufficient, or not collected, the percent of patients given the prescribed countermeasures (i.e. the correct medication). Track the percent of patients who receive instructions for adverse event reaction and informed about follow-up requirements.

=>POD CORE STAFF: Core staff include EDS Manager, Safety Officer, Public Information Officer (PIO), Liaison Officer (LNO), Operations Section Chief, Planning Section Chief, Finance and Administration Section Chief, Logistics Section Chief, Inventory Control, IT/Communications Coordinator, Greeters, Triage Team, Forms/Data Collection Team, Dispensing Team, Runners, possibly Behavioral Health. We need to know the total expected number and percentage of personnel able to respond and be functional within a given amount of time. At check-in, we need to check the identity and that the credentials are up-to-date for all personnel, register them, then ensure their skill sets are effectively used in the response operations, take into account personnel interests when placements are made, then give them a walk-through of the POD facility.

=>POD SUPPORT STAFF: We need to know the total expected number and percentage of POD support staff that are able to respond, and if adequate support services were provided to the POD, including implementation of a care/feed plan for staff and volunteers.

=>VOLUNTEERS: We need to know the percentage of Volunteer Coordination Teams (MRC, CERT, etc.), and volunteer that are able to respond within a given amount of time.

=>JOB AIDS: All staff will need to go over all of the Job Action Sheets. This includes allowing time for each person to read their instructions in their entirety. Supervisors need to evaluate whether the Job Action Sheet meet the needs of the staff, does the Screening Form collect the right information, does the Event information sheet accurately describe the information that Command and Control has planned to disclose to the public, do the Vaccine Information Sheets accurately depict CDC recommendations and match the vaccines, do the Drug Information Sheets match the drugs given, is the facility set up according to the Organizational Chart and Floor plan, are the Contact List and Inventory Sheets being updated in real time. Staff need to know the procedures for reporting adverse events and/or other incidents.

=>ARRIVALS: Is the site accessible to emergency vehicles (e.g., ambulances), disabled populations, and logistical equipment (e.g., supply trucks). We need to monitor the Arrival of medication quantity, quality, time, lot numbers and expiration dates, observe the material handling, record the inventory, and ensure safe storage. Greeters/triage staff must be able to identify clients showing signs/symptoms of exposure to the (e.g. biological agent of interest), as well as Behavioral Health issues, then transfer symptomatic clients to a designated area to accommodate them (possibly as a quarantine), then transfer them to planned outside medical resource groups (transportation, and treatment facilities). Triage procedures must account for how to handle minors, Non-English speakers, disabled, Vision/Hearing Impaired, and Functionally Illiterate. Dispensing procedures must follow appropriate hygiene protocols.

=>PUBLIC FLOW: Staff will receive a Review the Four Simple Steps of dispensing: Entering, Filling out a screening form, Getting medication and Exiting, together with the simple site walk through to ensure nothing was overlooked. We need to ensure that parking is adequate and managed related to the flow of staff and the public, the greeting/entry (Triage) is adequate and monitor for bottlenecks and safety considerations, ensure the supply chain including forms distribution (Orientation/Paperwork) and stocking the stations is being managed, observe the registration and interview of patients (Registration/Forms Review) are completed, the Medication Dispensing is managed well, and the exit (Checkout/Forms Collection) is managed. All incoming clients (while waiting to be seen) will receive an educational materials or briefing, which includes incident and facility specific description of the dispensing site process, discussion of all required forms and instructions and assistance of completing the paperwork, uniform written information about the current situation, disease, recent exposures and cases, agent and vaccine/medication, and a toll-free 24/7 telephone number to call with questions, opportunity to ask questions. FAQs may be provided to individuals in a printed form that is available in multiple languages or in an audio format (in multiple languages) for the functionally illiterate, visually impaired, etc. The Clients clinical forms must be reviewed for contraindications and/or general irregularity before dispensing the appropriate amount of medications, this might include medical history, current symptoms, past allergic reactions and other confidential information as needed. (IF) there is a mental health issue, is a counseling available, (IF) there is a symptomatic patient, is the medical evaluation and/or healthcare-center transport managed. Once wait times are determined, bottlenecks can be managed by pulling staff from non-congested areas and replacement in the busiest areas. In some cases, staff may follows established criteria, authorization and procedures to alter clinical dispensing model to increase client throughput. Upon exit, provide instructions on when client will need to return for more medication, or Inform patients about follow-up requirements if necessary, collect and securely store appropriate documentation (Per Health Insurance Portability and Accountability Act [HIPAA]), address post EDS resource needs, ensure they have access to the 24/7 informational hotline, information about Medical/Public Health resources in local community, and address any possible need to return to the POD or other EDS.

=>MEDICAL EMERGENCIES: In the event of an emergency, keep in mind that during a declared public health emergency where Closed PODs have been activated 911 and emergency medical services may be devoting resources to the response, and unavailable, therefore, what is an alternative option for your location.

=>TEST RUN: Break staff up into two groups, Group A will be in POD Staff Roles First (preferably the role they will be filling in the POD), and Group B will go through the Closed POD and practice getting medications. After all of Group B has had a chance to go through the POD process one time and received their medications, the groups will then switch roles. Once you finish these steps, you will want to answer additional questions about the job action sheets or any other aspect of the POD such as (e.g. information about paperwork, maps and layouts, feedback on the tasks and flow of the POD, address concerns, clarify roles, ambiguities, and responsibilities or issues identified by the staff.

=>POD READINESS DECLARATION: (IF) everything is in good standing, it is time to Communicate to staff that the POD is ready to open, and also to let the local Health Department know that your POD is ready to open (or in the Case of a Closed POD let them know that dispensing operations have begun).

=>EDS DEMOBILIZATION: Upon completion, stand down EDS operations are ordered and the site will return to normal operations. Staff might be released or re-deployed. Left over assets and supplies are accounted for, equipment and resources are restored to original, pre-incident condition and capabilities. Review of expenditures and in-kind costs incurred during the operation. Host facility is safely restored to safe pre-event condition. Disposal of waste, including bio-hazardous waste, appropriate cleaning measures, etc. occur. Review this operation and address the need for adjustments and any staffing related issues, overall organizational readiness to respond to another imminent emergency is assessed, gauge resource (personnel and material) level, identify critical asset needs, identify gaps and problems, recommended changes in emergency response plans, initial lessons learned documentation including issues and accomplishments of the event and mission. Initiate the plan and described to personnel to return to prior readiness state, ensure Critical Incident Stress Management (CISM) resources are identified, as well as symptoms of Critical Incident Stress.

=>RETURN TO READINESS STATE: Begin to reconstitute mass prophylaxis personnel and supplies, conduct inventories and request replacement resources and equipment. Update staffing rosters. Follow-up, tracked information, and add to the appropriate information database.

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Adequate standards and systems have been worked out and allocated by our Federal government to effectively enable Medical countermeasures in the event of an outbreak. This overview helps to consolidate information necessary to ensure all stakeholders are included in the planning process, and all standards, laws, policies, rules, regulations and resources are considered during POD operations. There are UN goals factored in to vaccination activities, such as the Millennium Development Goals that relate to Food outbreaks and Zoonotic disease (that could be imported to the U.S.). We also have Zika concerns, Flu concerns, chemical, and bio-terrorism concerns. Further, we have outbreaks in U.S. "Sanctuary cities” (this is irresponsible gross negligence on the part of their Public Health officials, local leadership and others to intentionally let this happen, when we all know that many illegal aliens do not have proper vaccinations, and no one is demanding to checking them with an antibody titer test). This leads us to contemplate what will we do with Illegal Aliens when we try to register them at a POD? In the case of foreign travelers, they should present their International Certificate of Vaccination or prophylaxis information to authorities according to the International Health Regulations (2005). All other U.S. citizens will present to POD’s at their place of work, or at Open POD’s as described above. In the case of the influenza virus, we might stockpile anti-Flu drugs such as Oseltamivir (trade name Tamiflu) and Zanamivir (trade name Relenza) along with associated adjuvants, and vaccinate anyone who has not been (if available), starting with the most vulnerable populations. The groups involved in Flu Global Medical Countermeasures might include the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), the World Organization for Animal Health (OIE), and 88 foreign Governments to address the situation through planning, greater monitoring, and full transparency in reporting and investigating influenza occurrences. The United States and these international partners have led global efforts to encourage countries to heighten surveillance for outbreaks and to rapidly introduce containment measures. The U.S. Agency for International Development (USAID) and the U.S. Departments of State, Health and Human Services (HHS), and Agriculture (USDA) are coordinating future international response measures on behalf of the White House with departments and agencies across the federal government. Ongoing detailed mutually coordinated onsite surveillance and analysis of human and animal flu outbreaks are being conducted and reported by the USGS National Wildlife Health Center, the CDC, the ECDC, the World Health Organization, the European Commission, the National Influenza Centers, and others. At any given time, priorities could be shifted to focus on other emerging diseases should an outbreak occur. Readiness can be improved by:

=>Elevating the bio-threat issue on national agendas

=>Coordinating efforts among donor and affected regions (and among other nations)

=>More effectively mobilizing and leveraging resources

=>Increasing transparency in disease reporting and surveillance

=>Building further capacity to identify, contain and respond to a pandemic influenza, and other diseases

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Idea No. 265