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Annex 1, Appendix 5 STRATEGIC NATIONAL STOCKPILE/MEDICAL COUNTERMEASURES EOP Under 42 USC 300hh-12(c), no federal agency shall disclose under section 552, United States Code, any information identifying the location at which SNS Program materials are stored. To the extent permitted by law, the parties agree that neither will disclose the nature of this effort and the terms of this agreement to any person or entity, except as may be necessary to fulfill its mission and statutory and regulatory responsibilities. PRIMARY: Department of Health and Environmental Control (DHEC) SUPPORT: Office of the Governor, Office of The Adjutant General, SC National Guard and Emergency Management Division; South Carolina Law Enforcement Division (SLED); State Department of Public Safety; Department of Transportation; Office of the Attorney General; State Budget and Control Board; State Department of Education; State Commission on Higher Education; Department of Labor, Licensing and Regulation, Division of Professional and Occupational Licensing and Division of Fire and Life Safety; Department of Defense; American Red Cross; SC Hospital Association; SC Medical Association; SC Nursing Association; SC Pharmacy Association I. INTRODUCTION A. The Strategic National Stockpile (SNS)/ Medical Countermeasures (MCM) of the Centers for Disease Control and Prevention (CDC) is a federally owned and managed national repository of antibiotics, antiviral medication, chemical antidotes, antitoxins, life support pharmaceuticals and equipment, vaccines, intravenous administration supplies, airway maintenance supplies, masks, medical/surgical items, pandemic countermeasures and other medical related supplies established by Congress to supplement and re-supply state and local supplies of these critical need medical items in the event of an incident anywhere in the United States involving Weapons of Mass Destruction (WMD) (Chemical, Biological, Radiological, Nuclear and high-yield Explosives) or a major natural or technological disaster. B. Authorities and References: 1. SC Emergency Operations Plan 2. State Emergency Operations Center SOP 3. SC DHEC Emergency Operations Plan 4. SCDHEC Office of Public Health Preparedness (OPHP) Emergency Notification Plan 5. Appendix 5 (SC Mass Casualty Response Plan) to the SCEOP 1 SNS/MCM 6. Title V, Emergency Preparedness and Response, section 502 of the “Homeland Security Act of 2002”. 7. SC Emergency Health Powers Act amendment to SC Homeland Security Act of 2002, rule R. 61-112 Implementation of the Emergency Health Powers Act 8. Receiving, Distributing, and Dispensing the Strategic National Stockpile, A Guide for Planners, Version 11. 9. PB2 (2013-2014) Public Health Emergency Preparedness Cooperative Agreement C. Organization: The DHEC OPHP, assisted by the DHEC Emergency Management Coordinator and other support staff will serve as the lead of ESF-8 (Health and Medical Services) response and recovery efforts, which includes all state and regional SNS, or other countermeasure distribution and dispensing activities, and upon activation will be located at the DHEC EOC. All SNS response staff that have leadership roles are NIMS compliant in accordance with DHEC policy A.1101, the Homeland Security Presidential Directive (HSPD)-5 and the State of South Carolina Office of the Governor Executive Order Number 2011-06 signed 27 Jan 2011. South Carolina has a centralized public health system under the South Carolina DHEC. All County health departments are staffed and managed by DHEC and respond to emergencies as one agency. Planning and daily management is done utilizing the 4 DHEC Public Health Regions. Each of the Regions covers 11 to 12 counties and has approximately 1,000,000 residents per region. In support of ESF-8( Health and Medical Services), the OPHP will coordinate among DHEC directorates, program areas, named support agencies and participating private sector resources to support SNS/MCM Preparedness EOPs and response in accordance with this EOP and in conjunction with South Carolina Emergency Management Division (SCEMD) and the South Carolina Emergency Operations Plan (SCEOP). At the determination of the DHEC Director, the DHEC EOC may be activated to help coordinate other department responsibilities associated with an SNS/MCM deployment to South Carolina. The ESF-8 (Health and Medical Services) representative will coordinate and monitor SNS response and recovery efforts through the DHEC EOC. This information will be monitored and executed through Web EOC at the SNS/MCM EOP Annex 1, Appendix 5-1-2 July 2014 SNS/MCM DHEC EOC. SNS/MCM response information will be provided to SEOC Operations by ESF-8 (Health and Medical Services) as needed for the standard SEOC Situation Reports. All public information related to the event will be released in coordination with the Joint Information Center located at the SEOC. D. Plan Hierarchy: The SNS/MCM Emergency Operations Plan is written to be incorporated as Annex 1 to Appendix 5 (South Carolina Mass Casualty Emergency Operations Plan) of the SCEOP. DHEC Health Regions and the Columbia Metropolitan Statistical Areas (MSA) Cities Readiness Initiative (CRI) are also required to have an SNS plan to function as an extension of the State SNS/MCM EOP and in coordination with the Regional Mass Casualty plans. Operations in this plan are to be coordinated by ESF-8 (Health and Medical Services) in accordance with Annex 8 (Health and Medical Services) of the SCEOP and the ESF-8 SOP. II. MISSION DHEC, as the lead public & environmental health agency for the State of South Carolina, conducts medical operations in response to natural or man-made disasters or events, or acts of terrorism requiring the requisition, utilization and management of the Strategic National Stockpile (SNS) and other medical countermeasures in order to ensure the health and well-being of the citizens and persons within the boundaries of the State. The mission of the SNS/MCM is to rapidly and safely provide antibiotics, antiviral medication, chemical antidotes, antitoxins, life support pharmaceuticals, vaccines, intravenous administration supplies, airway maintenance supplies, masks, pandemic countermeasures and medical/surgical items in a rapid and safe manner to supplement and re-supply any community in the event that state and local capacities are exceeded or are about to be exceeded due to a weapon of mass destruction or a major natural or technological disaster. This plan’s mission is one of response in support of the ESF-8 mission. III. PURPOSE A. Provide for the request, receipt, staging, storage, repackaging, distribution, dispensing, and retrieval and return of any unused assets of this stockpile, pandemic countermeasures or other medical countermeasures depending upon the event. This plan serves as the plan for all medical materiel acquisition, distribution and dispensing. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-3 SNS/MCM B. Implement the S.C. Strategic National Stockpile Emergency/MCM Operations Plan Standard Operating Procedure which is incorporated into Annex 1, Appendix 5 (Mass Casualty Plan) of the South Carolina Emergency Operations Plans (SCEOP). C. Provide SNS/MCM operational guidance to ESF-8 (Health and Medical Services) at the State Emergency Operations Center (SEOC), the DHEC Emergency Operations Center (DHEC EOC), and the DHEC Regional Coordination Centers and in all phases of SNS or other countermeasure distribution and dispensing operations. IV V. ASSUMPTIONS A. The SCEOP will be activated. B. The SEOC will activate at Operating Condition (OPCON) 1 or the appropriate OPCON as well as responding county EOCs. C. SCEMD will activate the Statewide Mutual Aid Agreement and Emergency Management Assistance Compact. D. All infrastructures including communications are intact. E. The appropriate state and federal declarations have been made by the Governor of South Carolina, the President of the United States and the Secretary of the Department of Health and Human Services (DHHS). F. The arrival of the SNS 12-Hour Push Package from the federal stockpile to the State Receiving, Staging and Storage (RSS) site warehouse will occur within 12 hours and the managed inventory palletized material will occur within 24 hours once the CDC decision to deploy has been made per Division of National Strategic Stockpile (DSNS) guidance. Delivery to the Health Regions may not occur until 12 hours after first receipt of federal medical materials. G. Emergency declarations will include provisions for SLED to assure security in the transport of all materiel and authorization or paramedics to aide in dispensing. SITUATION SNS/MCM EOP Annex 1, Appendix 5-1-4 July 2014 SNS/MCM VI. A. A mass casualty event has occurred or is imminent in South Carolina involving a weapon of mass destruction or a major natural or technological disaster has occurred. B. The capacity of South Carolina’s local and state assets to meet the demand for pharmaceuticals, vaccines, medical supplies, or other related countermeasures or medical equipment is inadequate or has been exceeded. CONCEPT OF OPERATIONS A. South Carolina DHEC, the lead agency for ESF-8 (Health and Medical Services), is responsible for developing, coordinating and maintaining procedures to support the SNS plan as contained in Appendix 5 (South Carolina Mass Casualty Emergency Operations Plan) of the SCEOP in conjunction with SCEMD. DHEC is responsible for coordination of all SNS/MCM administrative, management, planning, training, preparedness/mitigation, response, and recovery activities to include developing, coordinating, and maintaining the State SNS/MCM EOP. ESF-8 (Health and Medical Services) supporting agencies will assist DHEC in the planning and execution of the above as specified in the SCEOP by Gubernatorial Executive order 2011-06 signed January 27, 2011. B. Coordination with all supporting and other appropriate departments/agencies and organizations will be performed to ensure operational readiness in time of emergency. C. DHEC shall provide an Emergency Management Coordinator or Alternate, designated by the Director of OPHP, to represent ESF-8 and the SNS/MCM at the DHEC EOC, who, shall act to meet the health and medical responsibilities as described in the SCEOP. This person will be the point of contact and SNS/MCM lead for ESF-8 and SNS/MCM Operations at the SEOC. Additional public health personnel to coordinate the state level response will be housed at the DHEC EOC D. In coordination with the OPHP and the SNS/MCM Pharmacist, the DHEC Regional Public Health Directors assess the situation (both pre- and post-event), and in coordination with local county emergency management officials and response agencies, develop strategies to respond to the emergency. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-5 SNS/MCM E. Requesting the SNS/MCM: The decision to deploy the SNS/MCM will be a collaborative effort between local, state, and federal officials. After the recognition of a potential or actual WMD event or a major natural or technological disaster that may or will exceed local medical capacity, the Regional Public Health Preparedness Directors, who will notify the Director of OPHP of the event. If initial recognition of this event occurs at the state level by DHEC, notifications will be made from that level. A strategic policy group comprised of the Governor, SCEMD Director, and DHEC Director will convene to determine if the SNS/MCM should be requested. If Federal assets are required, the DHEC Director on behalf of the Governor will request deployment of the SNS/MCM in SC in one of two manners. 1. In federally declared disasters it will be necessary to prepare the Resource Request Form (RRF) (FEMA form 010-0-7) (Attachment I) and process this form through SCEMD request process for federal assistance through DHS/FEMA. Upon submission of the request form and approval, DHS/FEMA will direct DHHS to provide the appropriate assistance. 2. In the absence of a federally declared disaster, the DHEC Director will contact the Health and Human Services (HHS) Regional Emergency Coordinator (REC) to initiate the request. The CDC Emergency Operations Centers (EOC) at 770488-7100 will be also informed of the request as well as the SNS Program Services Consultant (PSC). Once a request is received, federal agencies will collaborate with the state officials to evaluate the nature and magnitude of the public health threat and to understand how the use of federal medical supplies will address the public health threat. If a catastrophic incident occurs, credible threats exist or an attack is imminent, the federal government may direct deployment of SNS/MCM material before a public health emergency declaration; a federal Stafford Act disaster declaration or receipt of requests for DSNS assets. F. In response to the event, the Secretary of DHHS has properly issued a public health emergency declaration, justifying the emergency use of certain medical counter measures to diagnose, treat, provide prophylaxis or prevent the identified threat. The FDA Commissioner has properly issued an emergency use authorization for the medical countermeasures shipped to South Carolina, and DHEC has received and made sufficient copies of the fact sheets required by the FDA to be distributed or dispensed with the medical countermeasure. The DHEC Director will request that the SNS/MCM EOP Annex 1, Appendix 5-1-6 July 2014 SNS/MCM Governor declare a “State of Emergency” and a “Public Health Emergency” allowing for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. G. Prior to the arrival of the Federal assets or in the event that Federal assets are not yet available, the SNS/MCM pharmacist or designee will transfer the State of South Carolina owned drugs from the pharmaceutical cache located at the PHP Pharmacy to the predetermined RSS site for distribution. If the magnitude of the event does not warrant utilization of the predetermined RSS site, distribution operations may be conducted from the PHP pharmacy. H. Once deployment of SNS/MCM assets has been ordered, the SEOC will be activated at OPCON 1 or the appropriate Operating Condition and the Governor will declare a state of emergency and a “public health emergency” allowing for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. DHEC will request the following resources to support this plan through the SEOC: warehouse, warehouse management and inventory tracking (IMATS), on site security, transportation and security during transport, communication, law enforcement and traffic control. These resources will be provided by the support agencies as specified in the SCEOP. The DHEC Director has predetermined an SNS/MCM RSS site for the receipt of all DSNS materials, which include pandemic influenza and other countermeasures. This primary RSS location has been validated by the DSNS program service consultant and the US Marshall’s service. The SC SNS/MCM Pharmacist or designee will notify the RSS site of the deployment of the SNS/MCM assets by the DSNS. When the SNS “12-Hour Push-Package” (Attachment 2) or “Managed Inventory”(Attachment 3) arrives at the SNS RSS site, the CDC liaison for the SNS/MCM will immediately transfer custody of the SNS/MCM assets to the State of South Carolina using the “CDC Strategic National Stockpile Program Medical Material Transfer Form” and the DEA Form 222(Attachment 4). The SC SNS/MCM Pharmacist or designee is designated by the DHEC Director to officially accept the custody of the SNS/MCM Assets from the CDC for the State of South Carolina at the SNS RSS site. In addition to the SNS/MCM Pharmacist, the following may sign for the SNS: the Director of Pharmacy, DHEC Health Services Director, the Director of the DHEC Bureau of Drug Control, the back-up SNS/MCM Director or the Assistant Director DHEC Bureau of Drug Control. The Regional Distribution Sites (RDS) will be notified of the arrival of the SNS/MCM assets at the RSS site. South Carolina may accept all or part of the“12-HourPush Package”. In the absence of an emergency declaration by the Governor, operations will be managed at the Public Health Preparedness Pharmacy Warehouse. This facility is licensed by the S.C. Board of Pharmacy and S.C Drug Control and the federal Drug Enforcement Agency (DEA). SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-7 SNS/MCM Vaccines will immediately be transferred to the DHEC Division of Immunization and control substances will be distributed to the, treatment centers/hospitals during an event, escorted by Drug Control Pharmacists to the respective treatment centers/hospitals. All vaccine storage and handling will follow the DHEC Division of Immunization Vaccine Storage and Handling policy (see Attachment 4). Once the determination has been made as to where the vaccines need to be delivered, the vaccines will be transferred to the DHEC Health Region locations with vaccine refrigerator by ESF-1 or by the DHEC Bureau of Business Management, depending upon the size of the event. I. Staging: Once custody of the SNS/MCM assets has been transferred to the State of South Carolina at the RSS site or PHP pharmacy, these assets will be downloaded and staged. The SNS/MCM shipping containers will be arranged in a color-coded scheme by product type and container number: Red- Oral Antibiotics Yellow – Intravenous Drugs and Supplies Blue – Airway Management Green – Chemical Antidotes and Supplies White – Medical/Surgical Supplies Pink – Pediatric Drugs and Supplies Refrigerated items and control substances will be shipped in specialized containers to maintain proper storage and legal requirements. Noncontainerized materials will be arranged in an area separate but adjacent to the containerized materials. Like items will be grouped together. J. Distribution: While the SNS/MCM assets are being staged at the RSS site, the DHEC Regional Coordination Center (RCC) Manager or designee in conjunction with local emergency management officials will request the supplies that are needed to replenish exhausted local inventories thru the DHEC Region’s incident command structure in conjunction with the affected counties’ incident command structure. The intravenous medicines, IV administration supplies, fluids, life support medicines, airway equipment, antidotes and symptomatic treatment material for casualties and medical or surgical items for treating casualties from a WMD or a major national natural event will be transported from the RSS site to the Regional Distribution Sites (RDS) for transfer to the designated Points of Dispensing(PODs). RSS will ship directly to hospitals as specified in the DHEC State SNS EOP. ESF-8 (Health and Medical Services) will coordinate for transportation of assets to be performed through ESF-1 (Transportation) at the SEOC. SNS/MCM EOP Annex 1, Appendix 5-1-8 July 2014 SNS/MCM All Control Drugs will be transferred to the designated treatment center’s Drug Enforcement Agency (DEA) registrant employing DEA form 222 where applicable. Post exposure prophylaxis packages, initial 10 day supply, will be delivered to the RDS. The numbers of regimens needed has been determined based upon the total population of the Health Region. Additional supplies of post exposure prophylaxis will be shipped upon request to the affected Region. Follow up 50 day prophylaxis and/or Anthrax Vaccine Adsorbed as required by an anthrax exposure will be delivered to the Health Region once received from the DSNS. The 50 day follow up on supplies for the completion of prophylaxis and/or vaccine will be dispensed/administered by the Regions to those individuals who were truly exposed as determined by epidemiological investigation. The RDS will distribute these initial regimens to the identified first responders sites (pre-identified), any facility with a confined population with pharmaceutical services for treatment of residents, staff and staff’s family, the closed large employer points of dispensing and to the mass public points of dispensing for distribution to the general public. Critical infrastructure staff located within the Central DHEC Office Staff will receive post exposure prophylaxis in the same manner as the closed large employer points of dispensing. Public health staff responding at the state level will receive prophylaxis through employee health or at their duty location. Family members of critical infrastructure staff and first responders will be given their post exposure prophylaxis at the same time as the responder provided the responder can provide a brief medical history as occurs at the public points of dispensing (Attachment 5). Hospitals will request any needed SNS medical material/MCM, other than initial prophylaxis supplies, through the Regional Coordination Centers or through the Region unified medical command. These requests will be forwarded to the RSS site by ESF-8 (Health and Medical Services) at the SEOC. The RDS will meet the same specifications per Guidance given in Receipt, Staging and Storing, version 11. A memorandum of agreement currently is in place with the Department of Labor, Licensing, and Regulation, Board of Pharmacy, to insure temporary licensing of drug distribution and dispensing locations. These distribution sites are located in all 4 of the DHEC Health Regions and can serve as an alternate RSS site in a more localized event. The Regional SNS/MCM SOP will provide for necessary support to off load the shipment, manage and track the inventory, and on-site security at the Regional Distribution sites. Transportation, transport security, and traffic control of the medical supplies from the RDS to the predetermined receiving hospital or to the predetermined dispensing site will be specified in the Regional plans (including SNS/CRI jurisdictions). SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-9 SNS/MCM The State RSS will specify an individual from the predetermined treatment center/hospital to be available to accept custody of the SNS/MCM control drugs from DHEC Drug Control Pharmacists. Unless stated otherwise, the control substances will be delivered to the main pharmacy within the hospital and received by the Director of Pharmacy or their designee. K. Continuation of Supplies While the initial CDC “12-Hour Push Package” and/or other pharmaceuticals are being distributed from the RSS site to the RDS, the DHEC Regional Public Health Preparedness (PHP) Directors in conjunction with local/county emergency management officials will continually assess the need for additional supplies of specific items. If additional medical materiel is needed, the SC SNS Pharmacist or designee at the RSS site will request these items from the CDC by calling the CDC 24 Hour Hotline, 770-488-7100 or the CDC Switchboard, 404-639-3311. If the PODS or the RDS are in need of more supplies, the request goes to the RCC, who will send that request up the chain so that the RSS can respond by shipping out more supplies. If the event is a declared national disaster and the National Response Framework has been activated, FEMA would establish a Joint Field Office (JFO) with an Emergency Support Function 8 (ESF-8) for Health and Medical Services. ESF-8 at the SEOC would request federal support through the tasking desk at the SEOC to the federal ESF-8 at the JFO. A FEMA Resource Request Form (RFF form 010-0-7) for the additional assets may be required. The same process will be followed as in the initial request phase of the response. L. Dispensing/Vaccination Sites The Regional Public Health Director or their designee, in conjunction with local/county emergency management agencies, will develop the Health Region Strategic National Stockpile and Cities Readiness Initiative (CRI) plans; the Midlands Health Region will also develop the City of Columbia Metropolitan Statistical Area (MSA) plan. All plans will identify an adequate number of public/ closed Points of Dispensing(PODs) to provide an initial ten day prophylaxis for the entire population within 48 hours of the federal decision to ship medical countermeasures to South Carolina in response to a disease outbreak or other emergency event. First responder dispensing sites, separate from the public points of dispensing, will be identified in each Regional SOPs. If the emergency event is a disease outbreak and laboratory confirmation of the infecting organism has been made SNS/MCM EOP Annex 1, Appendix 5-1-10 July 2014 SNS/MCM additional prophylaxis up to 60 days may be required for those exposed to the infecting agent. The DHEC Regional Public Health Directors (or designee) will insure that symptomatic individuals are directed to treatment facilities, guidelines are followed to determine whether an individual needs prophylactic drugs, individuals are counseled on the threat/risk of the drug, potential contraindications in individuals are identified, guidelines for correct dosage based on age and weight are provided, proper documentation is maintained identifying individual that is receiving the drug, lot number, NDC number, expiration date, and amount of drug received, and that the people who receive a drug understand how the drug is to be taken and how and who reports adverse reactions to the countermeasure agent. In the event that the drug is being dispensed to the public on a Food & Drug Administration Emergency Use Authorization (EUA), the DHEC Regional Public Health Director will ensure that all terms of the EUA are followed prior to dispensing information provided by the manufacturer of the DSNS to all public and private points of dispensing. Head of Household (see HOH Dispensing, Section N) may pick up as many medication regimens as needed for children and homebound adults, with government issued identification, if they can provide age, weight, and a brief medical/prescription drug history of the person for whom they are picking up medication. No identification is required for adults, anyone age 16 or older, picking up medication for themselves only. Unaccompanied minors, anyone under 16 years of age as defined by section 63-5-340 SC Code Of Laws, who arrive at a Dispensing site will be escorted to the special needs area by the behavioral health team, where every effort will be made to contact the parent or guardian prior to dispensing any countermeasure. If a parent or guardian cannot be located, the child will be placed with the South Carolina Department of Social Services Child Protective Services, after the proper dosage of medication is dispensed under the authority of SC Code of Laws section 63-5-350. Provisions must be specified in the Regional SOP to accommodate citizens with a variety of special needs such as language, vision and mobility barriers at the dispensing sites. Large employers, that meet the requirements to serve as a point of dispensing for their employees, employee’s family and vendors, contract workers or other identified participants in their plan will provide the lead official name and contact information to the Regional Coordination Center. The DHEC POD Manager (or designee) will be the lead official at the Public Points of Dispensing. Facilities with confined populations and established medication dispensing procedures will provide to the Regional Coordination Center (RCC), the SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-11 SNS/MCM number of needed regimens and will follow their usual and customary medication dispensing procedures for patients/residents, staff and staff’s family following CDC and DHEC guideline and recommendations. Examples of these affected institutions are hospitals, nursing homes, military installations or prisons. These medications may be either unit of dispensing containers or bulk containers. These institutions and how they receive their medications will be identified and defined in the DHEC Regional SOP. The DHEC Regional SOP will also identify planning for large employer closed points of dispensing. These facilities may not have pharmacy permits, but will follow the scope of services as set forth in the DHEC Closed POD agreement. The DHEC Regional SOP will identify how traffic control and security will be provided at the large employer closed point of dispensing. Each public/closed dispensing site will need to develop an efficient flow diagram in their POD Plan. Adequate signage will need to be in place to ensure a smooth patient flow. While allowing differences to accommodate the various facilities hosting the dispensing site and the security requirements of local law enforcement, each POD site should have: (1) One way into the parking lot of the facility and one way out (2) One way into the building and one way out. Be sure that those arriving do not have access to stop and “visit” with those that are leaving. (3) An area to screen for those that are currently symptomatic and/ or awaiting transfer to treatment facility (4) An area to fill out necessary paperwork and receive disease and drug information via video or printed material. (5) An area for medical/pharmaceutical counseling if needed. (6) A drug and patient drug information sheet dispensing area (7) A special needs area (8) A holding area for patients creating a disturbance. Depending upon the nature of the disturbance, this room can be used for counseling by social work or law enforcement. (9) An area to stamp the hand of the person receiving the medication to prevent them from immediately returning to the line. (10) A secure area to store the pharmaceuticals and a delivery access point and route away from public view. M. A Memorandum of Agreement (MOA) is currently in place with the Department of Labor, Licensing, and Regulation, Board of Pharmacy to insure temporary licensing of mass public and large employer closed drug dispensing sites and distribution sites in a Governor’s declared emergency. This waiver is for the duration of the declaration or 30 days, whichever is less. After 30 days a new declaration will be required. The following procedures have been established to ensure safe drug dispensing and adequate record keeping to protect public health, safety SNS/MCM EOP Annex 1, Appendix 5-1-12 July 2014 SNS/MCM and welfare in a mass casualty event that would require federal or other medical countermeasures being sent to South Carolina. All necessary forms, including the standing orders, will be posted on WebEOC under the file library once most current CDC event driven updates are available. 1) Protocols/Standing Orders are available to provide current guidelines for the assessment and prophylaxis along with followup of persons who may be exposed to a biological and/or chemical agent. These protocols can be found in the DHEC Standing Orders Manual that is available on the DHEC Intranet site. (Attachment 5). To access these orders, go to dhecnet – program area – health services manuals and reports – Health Services Standing Orders Manual – BT tab. Copies of these orders will be printed by the Regional PHP Director or their designee and be available for review at the Points of Dispensing. Healthcare workers and others who participate in the response effort will use these protocols to insure uniform treatment for all citizens of South Carolina. These protocols include the CDC treatment and post exposure prophylaxis guidelines. 2) The Clinical Evaluation Form (NAPH form) for dispensing mass post- exposure prophylaxis therapy for patients exposed to a biologic agent will serve as the (1) exposure screening form (2) dispensing record (3) refill record (4) medical chart (5) acknowledgement of receiving treatment. To access this form, go to dhecnet-program areas-technologies- RIMS-PDF forms. This form , or the Head of Household (HOH) NAPH form, will be filled out for every person who receives prophylaxis. This record is to be maintained in the Health Regional pharmacy in lieu of a written prescription document for 3 years after the last date of service. After the 3 years, the record is to be transferred to archives where it will be maintained in accordance with DHEC policy A.932. The Clinical Evaluation NAPH form will serve as the prescription form for any refills, should they be necessary. A copy may be maintained in the County Health Department where services were rendered to insure rapid availability to the affected individual’s private physician, upon request. Each prepackaged 10-day regimen from the CDC comes labeled with two perforated labels identifying drug, quantity, expiration SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-13 SNS/MCM date, NDC number and prescription number. One label will be attached to the NAPH form for the initial dispensing and for any refills that may be needed. The prescription number, quantity of drug, patient name, date and prescribing physician, will be handwritten on the dispensing label. To comply with proper prescription labeling, each Health Region must include the name of the Health Region, the complete address and the phone number on each of the dispensing labels printed at the Region. Each prescription must be labeled as to proper dosing instruction and each prescription will be labeled with the following statement: “Call your doctor for medical advice about side effects. You may report side effects to Food & Drug Administration at 1-800-FDA1088”. Each patient will be counseled on the proper use of the drug and any drug-drug and drug-medical conditions interactions using the “Patient Counseling Information for Selected Antimicrobials Used for Prophylaxis Following Exposure to Potential Bioterrorist Agents”. A notification to the patient’s primary care physician Form DHEC form 1289 will be given to the patient to take to their physician. Any countermeasures dispensed under an Emergency Use Authorization will be dispensed with the patient information prepared by the requesting authority of the EUA. Each dispensing site will also have information on the causative agent, if known, for distribution to the general public. This information will be prepared at the time of the incident initially using the CDC agent information sheets available at www.bt.cdc.gov until the most current information can be incorporated into the SCDHEC agent information. Countermeasures that have not completed the Food and Drug Administration approval process may be dispensed as an investigational new drug (IND) or on an Emergency Use Authorization (EUA). The CDC designated lead center, institute, or office, will obtain approval from the FDA to use specific IND protocols for medical countermeasures. The CDC will provide the latest versions of the protocols, authorizations and instructions for use to be distributed with the countermeasure. In the event that countermeasures are required that have not completed the FDA approval process, and are not being dispensed as an IND, DHEC will ensure that a FDA Emergency Use Authorization has been obtained by the manufacturer or requesting authority and all SNS/MCM EOP Annex 1, Appendix 5-1-14 July 2014 SNS/MCM appropriate paperwork will be distributed with the counter measure to the DHEC Public Health RDS for distributing with the antiviral or other countermeasure to the healthcare provider or public or closed point of dispensing. These healthcare providers or public or closed points of dispensing will be informed of the conditions under which the countermeasures can be dispensed as set forth by the FDA Commissioner at the time that the Emergency Use Authorization is granted such as: (1) Distribute FDA approved information for healthcare providers or authorized dispenser (2) Distribute FDA approved information for recipients (3) Monitoring and reporting adverse events (4) Records maintenance N. Head of Household Plan SUBJECT: Head of Household Dispensing Policy Statement: During a large scale public health emergency (i.e.: bioterrorism, Pandemic Influenza, etc.) in order to expedite the distribution of prophylaxis to the affected population, a designated representative from a household may obtain medications for as many people in their household, related or not without them being present at the mass dispensing site. Standards: 1. The Head of Household dispensing model will be implemented at every mass dispensing site under DHEC’s oversight. 2. A representative from a household is defined as someone 16 years of age or older who is presenting on behalf of a designated group of persons for the purpose of prophylaxis. a. The representative presenting is called the “Head of the Household” for the purposes of prophylaxis and dispensing. 3. Standing orders will be written to allow for Head of Household dispensing, as well as for individual patient dispensing. Procedures: 1. Upon arrival to the mass dispensing site, the Head of Household must provide the following: a. Government issued identification (ID) that includes address SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-15 SNS/MCM i. If they do not have government issued ID, the address will be verified as completely as possible. They will not be turned away from the dispensing site. b. A working phone number; c. List of the family members needing prophylaxis including the following for each: i. Full name ii. Date of Birth iii. Medication allergies iv. Medical conditions v. Current medications vi. Current weight for family members under the age of 12 2. The Head of Household will complete the required paperwork for each family member. 3. Upon review of the information for each family member, appropriate medication will be dispensed per the standing medical orders. The identifying numbers will be the prescription number and lot number assigned to the bottle given to each person. It is located on the SNS label. 4. Instructions will be provided to the Head of Household regarding use of the medication and any needed follow-up. O. Retrieval Per the terms of the 2010 memorandum of agreement between the Centers for Disease Control and Prevention (CDC) and the South Carolina Department of Health and Environmental Control (DHEC), the CDC retains title to the DSNS and Federal Medical Station durable assets. Any durable assets sent to the Region Distribution Sites (RDS) will be returned to the Receiving Staging and Storage (RSS) site utilizing a transportation tasking to ESF-1 at the State Emergency Operations Center (SEOC). The RSS site will arrange for the pick-up of the durable assets from the RDS and returning it to the RSS. Upon CDC request and at CDC expense, the durable assets will be returned to the CDC or when no longer needed for public health emergency response, CDC will assess the return of unused medical materiel to determine if sealed, nonpharmaceutical items stored in accordance with manufacturer recommendations can be returned to federal custody. CDC will not otherwise accept return of any unused medical materiel. Other unused medical materiel, including pharmaceutical items, will be returned to the RDS. Once all materiel is returned to the RDS sites, these materiels will be returned to the RSS, with any durable assets, for final disposition. P. Communication SNS/MCM EOP Annex 1, Appendix 5-1-16 July 2014 SNS/MCM The communications function ensures the timely flow of information used in the decision making process as well as in operational effectiveness. The communications function involves three distinct areas. 1. Public Healthcare Communication All official public healthcare information related to the incident will be coordinated through and released in conjunction with the SC Emergency Management Division and participating agencies through the Joint Information Center (JIC) located at the State Emergency Operations Center as described in Annex 15 (ESF-15) of the South Carolina Emergency Operations Plan and in accordance with the DHEC Public Information Emergency Operations Plan. The types of information released will include information on the event itself, how to protect yourself and your family and any public health orders such as quarantine, shelter in place or evacuation orders. Also included will be messages how to get the medication and medication safety. SNS/MCM specific messages will include, but will not be limited to, where to pick up medication, what medical information is needed to receive the medication, what is needed for identification, how to take medication, who should take the medication, how long to take the medication, what are the expected side effects of the medication, who to call in the event of unexpected side effects and what to do if one is currently symptomatic. Templates for these messages have been written and when needed will be incident specific and distributed through local public information channels such as television, radio, newspaper, and at the local dispensing sites by healthcare professionals. Direct contact with affected individuals will be available through the call-in SC Public Information Phone System (PIPS), South Carolina 211 or the GIS based call-out system, REACH SC (HAN) housed on the DHEC server. DHEC, ESF-8, will provide the pre-scripted messages to the community in a variety of ways to ensure that harder to reach populations, due to economic disadvantage, language, or literacy, medical issues, isolation or age will receive the necessary information. Since South Carolina has a centralized health agency, all DHEC Health Regions and the county health departments within those regions will use the same public health information provided by DHEC Division of Media Relations. 2. Logistical/Tactical Communication Logistical/Tactical Communication include, but not limited to, are as follows: expected number of potential individuals needing treatment, number treated with prophylactic medication and sent home, number transferred to hospitals or other treatment centers, number still requiring treatment, medications and supplies transferred to treatment center, additional SNS/MCM assets needed by treatment centers. These numbers will be reported on a regular basis as SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-17 SNS/MCM determined by the incident, by the RCC to the RSS site and to ESF-8 at the SEOC. The DHEC EOC will monitor all response and recovery activities through the state and agency copies of Web EOC. The DHEC EOC will maintain communications with ESF-8, RSS site, RDS sites by email, fax, telephone, cell phone, 800MHZ radio. Requests from the county emergency operations center for SNS/MCM or other health and medical services will be either called into the SEOC by telephone, transmitted via Web EOC or by radio. The SEOC Operations will task any such requests for health and medical services to ESF-8. DHEC representative in ESF-8 will task either a support agency or the appropriate DHEC program area. This procedure is consistent with the request procedure found in the ESF-8 SOP. Requests from DHEC Health Regions to the DHEC EOC will be tasked by DHEC EOC personnel to the appropriate program areas within DHEC. Requests for support from outside the agency for Health Region response will be requested by the DHEC EOC thru ESF-8 or directly by the Health Region through SEOC Operations Section. Completion of all tasks will be reported to the DHEC representatives in ESF-8 at the SCEOC for inclusion in the periodic situation reports. This procedure is consistent with the request procedures found in the ESF-8 SOP. 3. Equipment Cell phones, land lines, fax lines and DHEC internet services will electronically tether all SNS/MCM function and area leads. These communication services are operational 24 hours/day, 7 days per week and are used daily in the performance of routine agency functions. The State Emergency Operations Center, the DHEC EOC, the RSS site, and the RDS will be in communication by 800 MHZ 2-way radio, which are linked by a wide area communications system that covers the entire state. . Q. Security and Transportation The security and transportation functions will be coordinated through the SEOC and will be provided by ESF-1, ESF-8, ESF-13 and ESF-15 and ESF16. Transportation to the RDS will be tasked through ESF-1. The SC Department of Transportation (SCDOT) is the primary or lead agency for ESF-1 and coordinates with support agencies to provide transportation of assets during SNS/MCM EOP Annex 1, Appendix 5-1-18 July 2014 SNS/MCM and post disaster. The state’s emergency responsibility includes the allocation and prioritization of state transportation assets to include processing all transportation requests from state agencies and local governments. Per Annex 1 (Transportation) of the SCEOP, the SC Department of Transportation is responsible for all ESF-1 administrative, management, planning, training, preparedness, response, mitigation and recovery activities to include developing, coordinating and maintaining the ESF-1 SOP. All ESF-1 supporting agencies, as listed in the SCEOP, will assist SCDOT in the planning and execution of the above. ESF-1 is responsible for the execution of all emergency transportation services necessary to support emergency operations of state agencies, including repair or replacement of disabled vehicles en route. In accordance with Annex 1 (Transportation) of the SCEOP, ESF-1 will maintain current inventories of government transportation facilities, supplies, and equipment by node and will maintain current resource directories of all commercial and industrial transportation assets, facilities, and supplies within the State to include points of contact, their geographic locations, territories and operating areas. SCEMD is responsible for the SC Logistics Plan. SCEMD maintains transportation services on a contingency contract and will activate those contracts in support of SNS/MCM logistical activity when required. Security will be provided for all personnel, material, and equipment involved in the management and distribution of the SNS/Medical countermeasures in accordance with the South Carolina Law Enforcement Division (SLED) SNS/MCM security plan. The SC Law Enforcement Division is the primary or lead agency for ESF-13 (law enforcement) and provides for the coordination of law enforcement personnel and equipment in an emergency or disaster for all law enforcement tasks except for traffic management which is the responsibility of ESF-16. ESF-13 coordinates with support agencies including the SC Department of Public Safety (DPS) to ensure operational readiness during and post disaster. In accordance with SC Code of Laws Section 23-3-15 (A) (8), SLED has specific and exclusive jurisdiction and authority for coordinating the state response in the event of a terrorist threat or actual incident. Since South Carolina is a “Home Rule” state, the sheriff or chief of police is responsible for law enforcement activities within his/her jurisdiction. Per Annex 13 (Law Enforcement) of the SCEOP, when state law enforcement personnel and equipment are committed, a member of SLED will be assigned to coordinate state activities with the local law enforcement officer in charge. Also in accordance with Annex 13 (Law Enforcement) of the SCEOP, no use will be made of private security agencies or volunteers unless they are sworn and trained special deputies, state constables, or auxiliary policy. Such personnel will be the responsibility of the public safety agency which appoints and utilizes them. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-19 SNS/MCM Security to be provided includes but is not limited to access in and out of the RSS facility, security within the RSS compound; traffic control within and to and from the RSS facility. A DHEC driver and vehicle will be available to transport any CDC/DHS/HHS representative to the SEOC if needed. The South Carolina Air and/or Army National Guard have been tasked with providing security for the SNS/MCM assets at the RSS site and will follow the base’s usual and customary use of force guidelines in maintaining the RSS site integrity. This security will be included in the basic facility security plan that includes but is not limited to controlled access in and out of the facility, controlled access to the flight line, controlled access to the RSS warehouse within the facility compound. All entrances to the RSS warehouse, flight access, and compound fence line are under 24-hour manned video surveillance. All persons working in or with the DHEC SNS/MCM program during a disaster whether natural or a terrorist event, will be credentialed as per the attached description of the credentialing system. All persons without exception, will be required to wear a credential holder around their neck and clearly visible at all times. The DHEC Regional SOPs will specify credentialing procedures for all Regional Dispensing sites and Distribution sites. Anyone entering the facility where the RSS site is housed will have to present a government-issued photo identification to the armed security guard at the gate prior to admission. No one will be admitted unless their name appears on the roster provided by ESF-8/SCDHEC. ESF-13 (Law Enforcement) will coordinate with its internal agencies and with ESF-16 (Emergency Traffic Management) for traffic control, security and escort in transport to the RDSs and with coordinating security with local law enforcement at the RDSs. ESF-1 (Transportation) will notify the RSS site of the size of the truck, a description of the truck and the driver’s name. This information will be given to the guard gate and must be verified against the driver’s identification prior to admission to the RSS site. The driver will be informed of where the delivery will be made at the time of loading. The drivers will be escorted between two law enforcement vehicles. Routing will be determined by law enforcement. SLED and DPS will utilize their usual and customary use of force guidelines to ensure delivery of the medications to the Regional Distribution sites. The South Carolina Law Enforcement SNS/MCM Operations Plan will support ESF-13’s mission to the SC Mass Casualty Plan (Annex 1 – SNS/MCM) of the SCEOP. This SOP provides operational guidance to those who are assigned to work in ESF-13 in all phases of SNS/MCM operations. The DHEC Drug Control Pharmacists are tasked with providing security and transportation of any controlled substances from the RSS site to the SNS/MCM EOP Annex 1, Appendix 5-1-20 July 2014 SNS/MCM designated DEA registrant facility, usually a hospital pharmacy in each region. The Regional MCM SOP will provide for security at the Regional Distribution site and transport to the points of dispensing and at the mass public points of dispensing/vaccination. Security for the large employer closed dispensing/vaccination sites will be identified in the Regional/CRI SNS/MCM SOP. If repackaging is necessary prior to distribution from the RSS site, SLED will provide security in transport from the RSS site to the repackager and back to the RSS Site. The US Marshall’s service is not considered part of the SNS/MCM SSAG (Surveillance Science Advisory Group) and will not provide routine security for SNS/MCM assets and personnel unless threat analysis of the event indicates federal security is necessary. R. Repackaging In the event that the prophylactic medication required to treat the biologic agent is not available in the unit of use packaging in the 12-Hour push package or the state receives bulk medication from the Managed Inventory (MI), the bulk medication will be repackaged into unit of use containers by an off-site re-packager prior to distribution from the RSS site. At this time Moncrief Hospital is our re-packaging facility. V. ESF ACTIONS The emergency operations necessary for the performance of this Annex I to Appendix 5 of the SCEOP include, but are not limited to the following: A. Preparedness 1. Develop, coordinate and maintain written plans to implement SNS/MCM state and regional response operations in South Carolina. 2. Develop and maintain mutual support relationships with other governmental entities, professional associations, volunteer organizations and other private services that may assist during a WMD, natural or technological disaster. 3. Identify, coordinate and credential personnel necessary to deploy the SNS/MCM assets and in support of ESF-8 responsibilities. 4. Identify and establish state and regional locations for receiving, staging, storing and distributing SNS/MCM. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-21 SNS/MCM B. 5. Identify and establish adequate regional locations (points of dispensing/vaccination) to provide initial 10 day prophylaxis to the entire DHEC Health Region population within 48 hours and to provide follow up prophylaxis to complete the regimen if needed. 6. With other health care providers, identify and coordinate other sources of pharmaceuticals and medical equipment/supplies. 7. Develop and maintain dosing and dispensing guidelines and procedures for the prophylactic drugs contained in the SNS/MCM designed for mass distribution or dispensing. 8. Assure that DHEC Health Regions develop SOPs for the management of medical supplies and medications in the SNS “12-Hour Push Package”, the SNS Managed Inventory, Pandemic countermeasures and any additional pharmaceutical and/or medical supplies. 9. Develop and implement training and training exercises for related areas of SNS/MCM management. Response 1. Assess the situation and determine if a potential or actual WMD event or a major natural or technological disaster may exceed local medical supplies. 2. Facilitate the collaboration of state, regional and local officials to determine whether to request federal assistance. 3. Coordinate request for the SNS 12-Hour Push package, Managed Inventory, Pandemic countermeasures and other pharmaceutical, vaccine or medical materiel by the DHEC Director with the consent of the Governor, when it is determined by state and local officials that Federal assets are required. 4. Participate in the CDC Director’s conference calls to the DHEC Director and other Federal, State and local officials to determine if an event threatens the public health and exceeds or strains the local capacity to respond. The CDC Director will then request a copy of the SC SNS EOP and upon receipt will order the deployment of the SNS/MCM. SNS/MCM EOP Annex 1, Appendix 5-1-22 July 2014 SNS/MCM 5. Request deployment of a SNS/MCM package, Managed Inventory, Pandemic countermeasures and other pharmaceutical, vaccine or medical materiel adequate to respond to the scope and size of the event. 6. Request the Governor declare a state of emergency and a “public health emergency” to allow the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. 7. Notify the DHEC Regional PHP Directors and the Regional MCM Coordinators, the PHP Director and the CRI Coordinator of the deployment of the SNS/MCM medical assets to the SC RSS site by the CDC and request implementation of Regional SOPs. 8. Notify SEOC of the deployment of SNS/MCM by the CDC to the SC RSS site. 9. Notify SNS location of expected arrival of the SNS/MCM. 10. Notify and coordinate the agencies and organizations involved in the staging of the SNS/MCM. 11. Notify and coordinate with the agencies and organizations involved in the support of the individuals involved in the staging of the SNS/MCM. 12. Notify and coordinate with the agencies and organizations involved in the transport of the SNS/MCM. 13. Notify RDS and/or Regional PHP Directors of the arrival of the SNS/MCM at the SC RSS site. Notify the RDS and SNS/MCM Coordinators in the Regions (including CRI) of the deployment of the SNS to the RDS. Request that the Regional Points of Dispensing are notified of the deployment by the regional DHEC SNS/MCM Coordinators. 14. Coordinate with ESF-1 to transport SNS/MCM assets from the RSS site to the Regional Distribution sites for distribution to the Points of Dispensing/vaccination. 15. Coordinate with DHEC RCC distribution of SNS/MCM medical assets to designated hospitals. 16. Coordinate with DHEC RCC dispensing initial 10 days of antibiotics or other approved countermeasures to the entire Region population SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-23 SNS/MCM within the prescribed time frame of 48 hours and follow up prophylaxis of 50 days if needed. 17 Coordinate with ESF-13 to secure SNS/MCM assets in transport from the RSS site to the Region Site, treatment center or repackaging center. 18. Coordinate with ESF-2, Communication, for use of additional 800 MHZ radios and installation of phone and data lines at the RSS site. 19. Notify the South Carolina Labor, Licensing and Regulation of the pending arrival of SNS/MCM assets in South Carolina and of the gubernatorial declarations. 20. Coordinate all official public health information related to the event with participating agencies through the Joint Information Center at the South Carolina Emergency Operations Center. C. Recovery 1. Determine the need for additional medical supplies in conjunction with the SC DHEC RCC and the county/local emergency management officials. 2. Request additional supplies of specific items through the CDC Managed Inventory of the CDC-SNS program or through the State of South Carolina emergency procurement procedures. 3. Coordinate with the DHEC Regions to ensure follow-up with individuals actually exposed to the biological agent and provide remainder of their medical countermeasure prophylaxis. 4. Coordinate retrieval of all unused assets of the SNS/MCM program from the distribution and dispensing sites to the RSS site. 5. Coordinate with CDC to return unused or reusable Durable Assets to CDC upon request at CDC expense unless the CDC has agreed, in writing, to another disposition of the Durable Assets. 6. Coordinate with CDC at the conclusion of a public health emergency response to return of unused medical materiel to determine if sealed, non-pharmaceutical items stored in accordance with manufacturer recommendations can be returned to federal custody. CDC will not otherwise accept return of any unused Medical Materiel. SNS/MCM EOP Annex 1, Appendix 5-1-24 July 2014 SNS/MCM D. Mitigation 1. Support, plan and implement mitigation measures. 2. Support requests and directives from the Governor and/or CDC concerning mitigation and/or re-development activities. 3. Document matters that may be needed for inclusion in agency or state/federal briefings, situation reports and action plans. VI. RESPONSIBILITIES A. Department of Health and Environmental Control (ESF-8) 1. Develop, coordinate and maintain written plans to implement the Strategic National Stockpile/MCM response operations in South Carolina on both State and Regional levels. 2. Develop and maintain mutual support relationships with other governmental entities, professional associations, volunteer organizations and other private services that may assist during a Weapons Mass Destruction (WMD), natural or technological disaster. 3. Identify, coordinate, train and credential personnel necessary to deploy the Strategic National Stockpile/MCM assets to meet ESF-8 responsibilities. 4. Identify and establish state and regional locations for receiving, repackaging, staging, storing, distributing SNS/MCM and other medical materiel. 5. Identify and establish adequate regional Points of Dispensing to provide initial 10 days of antibiotic prophylaxis to the entire DHEC Health Region population within 48 hours and follow up prophylaxis of 50 days if needed to complete the regimen. 6. Identify and coordinate with other health care providers other sources of pharmaceuticals and medical equipment/supplies. 7. Develop and maintain dosing and dispensing guidelines and procedures for the prophylactic drugs contained in the Strategic National Stockpile and for other medical countermeasures designed for mass dispensing. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-25 SNS/MCM 8. Assure that Department of Health and Environmental Control Health Regions develop Strategic National Stockpile and/or Cities Readiness Initiative SOPs for the management and distribution of the medical supplies and medications in the Strategic National Stockpile “12-Hour Push Package”, Managed Inventory, Pandemic countermeasures and other pharmaceutical, vaccine or medical materiel. 9. Identify, train, and assign Department of Health and Environmental Control personnel to implement Strategic National Stockpile/MCM EOP. 10. Notify all Strategic National Stockpile/MCM supporting agencies upon implementation of the Strategic National Stockpile/MCM EOP. 11. Develop mutual support relationships with professional associations and other private services and volunteer organizations that may assist during emergencies or disasters. 12. Coordinate and direct the activation and deployment of state agencies, volunteer health/medical personnel through SCSERV, the emergency system for advance registration of volunteer health professionals (ESAR-VHP) and the four Regional Medical Reserve Corps, supplies, equipment and provide certain direct resources under the control of the Department of Health and Environmental Control. 13. Develop and conduct training, drills and exercises to coordinate emergency medical care in disaster situations requiring Strategic National Stockpile/MCM assets. 14. Assure that the procedure described in section IV.E is in place for requesting the Strategic National Stockpile “12-Hour Push Package” and “Managed Inventory” from the Centers for Disease Control and Prevention. 15. Facilitate the collaboration of state, regional and local officials from supporting agencies to assess the situation and determine if a potential or actual WMD event or a major natural or technological disaster may exceed state and local medical capacity. 16. Coordinate requesting and consultation phases of the Strategic National Stockpile/MCM with the Centers for Disease Control and Prevention Division of Strategic National Stockpile/MCM among state and federal response officials. 17. Ensure that required information is available for the consultation phase SNS/MCM EOP Annex 1, Appendix 5-1-26 July 2014 SNS/MCM with the Centers for Disease Control and Prevention. This information includes but is not limited to the following: current or projected casualties, projected needs based on population, presence of an Strategic National Stockpile/MCM EOP, hospital capacities at the time of the event including Intensive Care Unit beds and ventilators; other state/local resources such as pharmacy distributors, oxygen suppliers, nearby hospital and alternate care sites, other stockpiles of pharmaceuticals and an EOP to receive, repackage prophylactic oral antibiotics. 18. Determine need to initiate any waiver of rules and regulations regarding licensing of drug distribution or dispensing outlets. 19. Coordinate the verification of volunteer medical personnel through the South Carolina ESAR-VHP program. 20. Ensure all state and federal documentation is available in order to accept and distribute the Strategic National Stockpile/MCM assets and that such documentation complies with state and federal pharmacy and drug control regulations. 21. Maintain lists of points of contact with all agencies and organizations involved with the warehouse management, inventory control, on-site security, transport, transport security, distribution, dispensing, retrieval and return to Centers for Disease Control and Prevention of Strategic National Stockpile/MCM assets. 22. Provide all inventory control records and distribution records of Strategic National Stockpile/MCM assets as required by Centers for Disease Control and Prevention. 23. Maintain all expense records associated with deployment of the Strategic National Stockpile/MCM for possible reimbursement. 24. Assess the situation and determine if a potential or actual WMD event or major natural or technological disaster may/or will exceed local medical capability. 25. With the consent of the Governor and it has been determined by state, local officials, the Department of Health and Environmental Control Director will request Strategic National Stockpile/Assets. 26. Accept custody of the Strategic National Stockpile/MCM assets from the Centers for Disease Control and Prevention. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-27 SNS/MCM 27. Participate in the Centers for Disease Control and Prevention Directors conference call to the Department of Health and Environmental Control Director and other Federal, State and local officials to determine if an event threatens the public health and exceeds or strains the local capacity to respond. If the Secretary of the Department of Health and Human Services or his designee decides that the event threatens the public’s health and that the on-site capacity and resources have or will be strained or exhausted, a request will be made for a copy of the SC Strategic National Stockpile/MCM EOP. Upon receipt of the SC Strategic National Stockpile/MCM EOP, the Secretary of the Department of Health and Human Services or his designee will order the deployment of the Strategic National Stockpile “12-Hour Push Package” and/or other medical materiel to the SC Strategic National Stockpile Receiving, Staging and Storage (RSS) site as designated by the Director of the Department of Health and Environmental Control. . 28. Request the Governor declare a state of emergency and a “public health emergency” to allow the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. 29. Notify the Regional PHP Directors, the Regional SNS/MCM Coordinators and the CRI Coordinator(s) of deployment of the Strategic National Stockpile/MCM medical assets to the SC Receiving, Staging and Storage site by the Centers for Disease Control and Prevention and request the implementation of the Region/CRI Strategic National Stockpile SOP(s). 30. Notify SEOC of deployment of Strategic National Stockpile/MCM assets by the Centers for Disease Control and Prevention to the South Carolina Receiving, Staging and Storage site and request notification of supporting agencies. 31. Notify Receiving, Staging and Storage location of expected arrival of the Strategic National Stockpile/MCM assets. 32. Notify and coordinate with the agencies and organizations involved in the staging of the Strategic National Stockpile/MCM assets. 33. Notify and coordinate with the agencies and organizations involved in the support of the individuals involved in the receipt, staging, storage and on-site security of the Strategic National Stockpile/MCM assets. 34. Notify and coordinate with the agencies and organizations involved in the transportation and security of the Strategic National SNS/MCM EOP Annex 1, Appendix 5-1-28 July 2014 SNS/MCM Stockpile/MCM assets from the RSS site to the Regional distribution sites. 35. Notify Public Health Preparedness Directors or his designee of the arrival of the Strategic National Stockpile/MCM at the South Carolina Receiving, Staging and Storage site. Notify the PHP Director or his designee of the deployment of the Strategic National Stockpile/MCM to the Regional Distribution sites. Ensure that the Regional points of dispensing are notified of the deployment by the DHEC Regional PHP Director. 36. Coordinate with ESF-1 (Transportation Services) transportation of Strategic National Stockpile/MCM assets to the Regional Distribution site(s) for distribution to the local points of dispensing or designated hospitals. 37. Coordinate with Department of Health and Environmental Control Health Regions distribution of Strategic National Stockpile/MCM medical materials to designated hospitals. 38. Coordinate with Department of Health and Environmental Control Health Regions and City of Columbia MSA/CRI dispensing initial 10 days of Strategic National Stockpile/MCM prophylactic antibiotic regimens or other approved countermeasures to the entire health Region population within the prescribed time frame of 48 hours and follow up prophylaxis of 50 days to complete the regimen if needed. 39. Coordinate with ESF-13 (Law Enforcement) and ESF-16 (Emergency Traffic Management) security for Strategic National Stockpile/MCM assets in transport to the Receiving, Staging and Storage site, from the Receiving, Staging and Storage site to the Regional Distribution sites, designated hospitals, and repackaging facility and back to Receiving, Staging and Storage site. 40. Provide transportation and security of control substances to designated treatment centers and provide for the transfer of these control substances to treatment centers that are properly registered to accept these substances by the federal Drug Enforcement Agency (DEA). 41. Provide transportation of bulk pharmaceuticals to repackaging facilities. 42. Determine the need for additional medical supplies in conjunction with the SCDHEC Regional PHP Director and the county/local emergency management officials. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-29 SNS/MCM 43. Request additional supplies of specific items through the Centers for Disease Control and Prevention Managed Inventory portion of the Strategic National Stockpile/MCM program and/or through other commercial sources if available 44. Coordinate with ESF-2, Communication, the use of additional 800 MHZ radios, HAM radios, satellite phones, mobile satellite trailers and the installation of additional telephone and data lines at the RSS site. 45. Coordinate with the DHEC Regions to ensure follow-up with individuals actually exposed to the biological agent and provide remainder of their medical countermeasure prophylaxis. 46. Coordinate retrieval of all unused assets of the Strategic National Stockpile/MCM program from the distribution and dispensing/vaccination sites to the Receiving, Staging and Storage site. 47. Coordinate with CDC the return of unused or reusable Durable Assets to CDC upon request, at CDC expense unless the CDC has agreed, in writing, to another disposition of the Durable Assets. 48. Coordinate with CDC at the conclusion of a public health emergency response, the return of unused medical materiel to determine if sealed, non-pharmaceutical items stored in accordance with manufacturer recommendations can be returned to federal custody. CDC will not otherwise accept return of any unused Medical Materiel. 49. Maintain and provide all inventory control records and distribution records as required by the CDC. 50. Maintain all personnel time and other expense records associated with the deployment of the SNS/MCM in the response for possible reimbursement. 51. Support, plan and implement mitigation measures. 52. Support requests and directives resulting from the Governor and/or Centers for Disease Control and Prevention concerning mitigation and/or re-development activities. 53. Document matters that may be needed for inclusion in agency or state/ federal briefings, situation reports and action plans. SNS/MCM EOP Annex 1, Appendix 5-1-30 July 2014 SNS/MCM B. C. Office of the Governor 1. Coordinate with the Department of Health and Environmental Control Director, South Carolina Emergency Management Director, the Department of Health and Environmental Control Director of Health Services, the Department of Health and Environmental Control Regional Public Health Preparedness Directors and the Department of Health and Environmental Control Director of Public Health Preparedness to request federal assistance in the form of medical assets from the Strategic National Stockpile/MCM. 2. Authorize the DHEC Director to request Strategic National Stockpile/MCM assets. 3. Declare a state of emergency and a “public health emergency” to allow for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. Office of The Adjutant General (ESF-19) 1. SC National Guard a. Identify, train, and assign South Carolina National Guard personnel to maintain contact with and prepare to execute missions in support of Strategic National Stockpile/MCM and Pandemic Influenza Response activities during periods of activation. b. Provide on-site security at the Receiving, Staging and Storage site for Strategic National Stockpile assets and other medical countermeasures. Site security will follow base usual protocol. Additional security will be in place at identified RSS building. c. Provide personnel to assist in the unloading/loading at the Receiving, Staging and Storage site for the Strategic National Stockpile/MCM assets and other medical countermeasures. d. Provide warehouse facilities to receive, stage, store and distribute Strategic National Stockpile assets and other medical countermeasures. e. Provide personnel to assist with receipt, staging, storage of the Strategic National Stockpile assets and other medical countermeasures at the Receiving, Staging and Storage Site. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-31 SNS/MCM f. Provide backup transportation for the SNS/MCM assets to the Regional Distribution sites. . 2. D. SC Emergency Management Division(ESF-5) a. In accordance with the CDC SNS/MCM Guidance version 11, State Emergency Management Officials will confer with the Governor and the DHEC Director to determine the need to request federal support in the form of the Strategic National Stockpile/MCM assets. b. In accordance with the SNS/MCM Guidance version 11 the Governor or State Emergency Management officials will participate in the consultation phase of the Strategic National Stockpile/MCM with the Centers for Disease Control and Prevention. c. The State Emergency Operations Plan and the State Emergency Operation Center (SEOC) at the appropriate Operating Condition (OPCON) to ensure adequate support. Department of Labor, Licensing and Regulation, Division of Professional and Occupational Licensing 1. Assist with the temporary licensure of drug distribution and dispensing facilities. 2. Assist with the verification of volunteer medical personnel through the South Carolina ESAR-VHP program. 3. E. Review and approve policies and procedures employed at points of dispensing are consistent with the purpose of Board of Pharmacy. South Carolina Commission on Higher Education 1. USC School of Pharmacy: Provide pharmacy students to assist in the repackaging of bulk quantity antibiotics into individual patient regimens. SNS/MCM EOP Annex 1, Appendix 5-1-32 July 2014 SNS/MCM 2. MUSC School of Pharmacy: Provide pharmacy students to assist in the repackaging of bulk quantity antibiotics into individual patient regimens. F. SC Hospital Association: Identify hospitals to receive SNS/MCM supplies when local capacities are exceeded. Identify hospitals to participate in regional planning to determine local capacities for response prior to the arrival of the SNS/MCM. G. SC Medical Association: Assist with recruitment of physicians for SNS/MCM operations at the Points of Dispensing. These physicians will assist in determining appropriate treatment in presenting individuals. H. SC Pharmacy Association 1. Assist with recruitment of pharmacists for emergency operations by actively participating in the South Carolina Emergency System for Advance Registration of Healthcare Professionals. 2. Assist with obtaining pharmaceuticals, medical equipment and supplies not found in the Division of Strategic National Stockpile/MCM inventory. 3. Disseminate event and/or health information to community providers through the RX Alert system. I. SC Nursing Association: Assist with recruitment of nurses from the community to assist DHEC nurses at the Points of Dispensing (PODS) J. Two Meals a day will be served to the RSS participants and McEntire Air National Guard personnel assisting in the shipping and receiving of the RSS Assets. This will be accomplished by calling the SEOC and requesting food. K. SC Department of Education: Provide dispensing sites for prophylactic drug distribution to the general public in a biologic exposure. L. American Red Cross: Provide snacks/ liquids at Regional points of dispensing. M. South Carolina Law Enforcement Division: (ESF-13) SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-33 SNS/MCM 1. Provide security escort during transportation from the Georgia/South Carolina border to the Receiving Staging and Storage site. 2. Provide security escort during transportation from the RSS to the RDS. Coordinate security at the RDS with local law enforcement. 3. Provide security escort during transportation to the repackaging facility and back to the Receiving Staging and Storage site. N. South Carolina Department of Transportation: (ESF-1) 1. Provide transportation and/or coordinate provision of transportation with local carriers of the Strategic National Stockpile/MCM materials from the Receiving, Staging and Storage site (RSS) to the RDS if state assets are not adequate . 2. Provide transportation and/or coordinate provision of transportation with local carriers of the Strategic National Stockpile/MCM materials to the designated treatment centers if state assets are not adequate . 3. Provide transportation and/or coordinate provision of transportation with local carriers of Strategic National Stockpile/MCM materials to the repackaging facility and back to the Receiving Staging and Storage site if state assets are not adequate . 4. Provide transportation and/or coordinate provision of transportation with local carriers of the return of any unused Strategic National Stockpile/MCM assets from the RDS to the Receiving, Staging, Storage (RSS) site for return to the Centers for Disease Control and Prevention if state assets are not adequate. . O. P. Budget and Control Board (ESF-2) 1 Provide additional communications devices if needed for Strategic National Stockpile/MCM operations. 2. Provide for additional radios, voice and data lines at the Receiving Staging and Storage site. South Carolina Society of Health System Pharmacists: SNS/MCM EOP Annex 1, Appendix 5-1-34 July 2014 SNS/MCM 1. Identify Directors of Pharmacy at SC Hospital Association identified hospitals. 2. Participate in surge capacity planning within their facility to respond to a mass casualty event. Q. United States Department of Defense: Provide repackaging of bulk pharmaceuticals into 10 or 25-day dosage regimens at Moncrief Community Hospital. VII. VIII. FEDERAL INTERFACE A. This annex has no counterpart in the National Response Framework. B. The formation of this plan is required for receipt of the NPS/SNS by the CDC under Title V, Emergency Preparedness and Response, section 502 of the “Homeland Security Act of 2002.” COUNTY INTERFACE In conjunction with the DHEC PHP Director(s), county emergency management officials will determine if local medical supplies will be exhausted and if federal assets in the form of the SNS/MCM will be needed to manage the WMD, or major natural or technological event. The DHEC PHP Director(s) after consultation with the county emergency management officials will request the initial SNS “12Hour Push Package” and any additional specific SNS/MCM assets that are needed to insure a continual supply of medications and medical supplies to manage casualties until the event has reached the point that the operation may be scaled down. In conjunction with the DHEC Public Health Preparedness Director(s), county governments will provide Emergency Medical Technicians and security at local Dispensing Sites and security at Regional Distribution Sites. In conjunction with the DHEC Health Regions, county emergency management officials will report, to ESF-8 at the SEOC, the number of people treated, given prophylactic medication and sent home, the number of treated and transferred to hospitals or other treatment centers and the number of people given prophylactic medication and sent home. Also to be reported are the projected numbers of people still requiring prophylaxis. These numbers will be reported on a regular basis determined by the particular incident. In conjunction with the DHEC Health Regions the county will maintain and provide lists of county medical resources. SNS/MCM EOP July 2014 Annex 1, Appendix 5-1-35 SNS/MCM IX ADMINISTRATION AND LOGISTICS 1. General Reporting Requirements Personnel hours will be recorded as the individual’s normal program and location code and will use the disaster (999) activity code. 2. 3. General Support Requirements a. Two Meals a day will be provided to the RSS Staff and McEntire personnel assisting in the shipping and receiving of the MCM Assets. A request will be made thru the SCEOC. b. Shift tours c. Security/ badging will be accomplished by roster and verification of identity by DHEC identification badge, response partner support agency identification badge or other government issued identification. Policies on augmenting response staff DHEC Administrative Manual Policy A.514 rev. 08/2007 4. Resource Management may include financial record keeping; reporting procedures; tracking resource needs, sources, use, and cost. SNS/MCM EOP Annex 1, Appendix 5-1-36 July 2014