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Annex 1, Appendix 5 STRATEGIC NATIONAL STOCKPILE COUNTERMEASURE DISTRIBUTION & DISPENSING STANDARD OPERATING PROCEDURES (SOP) 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; State Law Enforcement Division; 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 Baptist Association; SC Hospital Association; SC Medical Association; SC Nursing Association; SC Pharmacy Association I. INTRODUCTION A. The Strategic National Stockpile (SNS) 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,(chemical, biological, radiological or explosive) or a major natural or technological disaster. This plan provides 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. B. Purpose: This SOP implements S.C. Strategic National Stockpile Emergency Operations Plan Standard Operating Procedure which is incorporated into Annex 1, Appendix 5 “Mass Casualty Plan” of the South Carolina Emergency Operations Plans (EOP). This SOP provides operational guidance to those who are assigned to work in ESF-8 at the State Emergency Operations Center, the DHEC Emergency Operations Center, DHEC Health Region Emergency Operations Center and in all phases of SNS or other countermeasure distribution and dispensing operations. SNS SOP Rev Jan 2013 ANNEX 1-Appendix5-1-1 SNS SOP C. Authorities and References: 1. 2. 3. 4. 5. 6. 7. 8. 9. SC Emergency Operations Plan (SCEOP) SC Emergency Operations Center (SEOC) Plan SC DHEC Emergency Operations Plan SCDHEC, Office of Public Health Preparedness, Emergency Notification Plan SC Mass Casualty Response Plan, Appendix 5 of the SCEOP Title V, Emergency Preparedness and Response, section 502 of the “Homeland Security Act of 2002”. SC Emergency Health Powers Act amendment to SC Homeland Security Act of 2002, rule R. 61-112 Implementation of the Emergency Health Powers Act Receiving, Distributing, and Dispensing the Strategic National Stockpile, A Guide for Planners, Version 10.02, August 2006. PB1 (2012-2013) Public Health Emergency Preparedness Cooperative Agreement D. Organization: The DHEC Director of Emergency Management, Office of Public Health Preparedness, assisted by the DHEC Emergency Management Coordinator and other support staff will serve as the lead of ESF-8 response and recovery efforts, which includes all state and region Strategic National Stockpile, or other countermeasure distribution and dispensing activities, and upon activation will be located at the State Emergency Operations Center (SEOC), 1100 Hatchery Road, West Columbia, SC 29172. All SNS response staff that has leadership roles is 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 January 2011. These ESF-8 representatives will coordinate Strategic National Stockpile efforts through each DHEC Regional Health Director and/or the Regional Director of Public Health Preparedness or their designee. In support of ESF-8, the Office of Public Health Preparedness will coordinate among DHEC deputyships, program areas, named support agencies and participating private sector resources to support SNS preparedness plans and response in accordance with this SOP and in conjunction with the South Carolina Emergency Management Division and the South Carolina Emergency Operations plan. At the determination of the DHEC Director, the DHEC Emergency Operations Center (DHEC EOC) may be activated to help coordinate other department responsibilities associated with a SNS countermeasure deployment to South Carolina. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-2 SNS SOP The SEOC ESF-8 representative will coordinate and monitor SNS response and recovery efforts through the DHEC EOC. This information will be monitored and executed through WEBEOC at the South Carolina Emergency Operations Center. These SNS activities will be monitored by the DHEC EOC and further managed using the DHEC copy of WEBEOC. SNS response information will be provided to ESF-5 (Information & Planning) by ESF-8 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 (JIC) located at the SEOC. E. Plan Hierarchy: The SNS Emergency Operations Plan is written to be functional as incorporated as Annex 1, into Appendix 5 “South Carolina Mass Casualty Emergency Operations Plan” of the South Carolina Emergency Operations Plan. DHEC Health Regions and the Columbia Metropolitan Statistical Areas (MSA) Cities Readiness Initiative (CRI) are also required to have an SNS plans to function as extensions of the State SNS plan and in coordination with the Regional Mass Casualty plans. Operations in this plan are to be coordinated by ESF-8 and the ESF-8 SOP. II. MISSION The mission of the Strategic National Stockpile 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 South Carolina 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 of “health and medical” and as such serves as the plan for all medical material acquisition and distribution. III. SITUATION AND ASSUMPTION A. B. Situation: 1. 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. 2. 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. Assumptions: SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-3 SNS SOP 1. The State Emergency Operations Plan will be activated. 2. The State Emergency Operations Center will be activated at Operating Condition 1 (OPCON 1) or the appropriate Operating Condition as well as responding county EOC’s. 3. The South Carolina Emergency Management Division will activate the Statewide Mutual Aid Agreement and the Emergency Management Assistance Compact. 4. All infrastructures including communications are intact. 5. The appropriate state and federal declarations have been made by the Governor of South Carolina, the President of the Unites States and the Secretary of the Department of Human Services. 6. The arrival of the Strategic National Stockpile 12-Hour Push Package from the federal stockpile to the state receiving, staging and storage site (RSS) 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 DSNS guidance. Delivery to the Health Regions will not occur until 12 hours after the first receipt of federal medical materials. 7. South Carolina has a centralized public health system under the South Carolina Department of Health and Environmental Control (DHEC). All county health departments are staffed and managed by DHEC and respond to emergencies as one agency. Planning and daily management are done utilizing the 8 DHEC Health Regions as the administrative unit. Each of these Regions geographically contains four to ten counties and has in round numbers between 250,000 to 1,000,000 residents. IV. CONCEPT OF OPERATIONS A. Rev Jan 2013 South Carolina Department of Health and Environmental Control, lead agency for ESF-8, 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 SC Emergency Operations Plan in conjunction with SC Emergency Management Division. DHEC is responsible for the coordination of all SNS administrative, management, planning, training, preparedness/mitigation, response, and recovery activities to include developing, coordinating, and maintaining the SNS SOP. All ESF-8 supporting agencies will assist DHEC in the planning SNS SOP ANNEX 1_Appendix 5-1-4 SNS SOP 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, to represent ESF-8 and the SNS at the SEOC, who, on the behalf of, or in the Director's absence from the SEOC, shall act to meet the health and medical responsibilities as described in the SCEOP. This person will be the point of contact and SNS lead for ESF-8 and SNS Operations at the SEOC. Additional public health personnel to coordinate the state level response will be housed at the DHEC Emergency Operations Center located on the second floor of the Sims/Aycock building, 2600 Bull Street, Columbia, SC 29201. D. In coordination with the Office of Public Health Preparedness and the SNS Pharmacist, the DHEC Public Health Regions assess the situation (both preand post-event), and in coordination with local county emergency management officials and response agencies, develop strategies to respond to the emergency. E. Requesting the SNS: The decision to deploy the SNS 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 Region Health Director will contact the Office of Public Health Preparedness Director of Emergency Management. The initial recognition of this event may occur at the state level by DHEC and as such the notifications will be made at that point. A strategic policy group comprised of the Governor, the SC EMD Director, and the DHEC Director will be convened to determine if the SNS should be requested. If the Federal assets are required, the DHEC Director on behalf of the governor will request the deployment of the SNS in SC in one of two manners. 1) In federally declared disasters it will be necessary to prepare the Action Request Form (FEMA form 90-136) and process this form through the SC Emergency Management Division request process for federal assistance through DHS/FEMA. Upon submission of the request form and approval, DHS/FEMA will direct HHS to provide the appropriate assistance. 2) In the absence of a federally declared disaster the DHEC Director will initiate the process in one of 4 ways. Contact the HHS regional emergency coordinator (REC). SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-5 SNS SOP Reach out to the SNS program services consultant (PSC). Call the CDC emergency operations center (EOC) at 770-488-7100 Call the HHS secretary’s operations center (SOC) at 202-619-7800 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 material before a public health emergency declaration; a federal Stafford Act disaster declaration or receipt of requests for DSNS assets. The US Marshall’s service no longer routinely deploys with the SSAG. South Carolina may receive the 12-Hour push package or may receive palletized material (4 X 4 X 4 pallet) from managed inventory or a combination of the two. How the SNS material is deployed and signed for will be coordinated as part of the request for assistance between the state and DSNS. The SNS Services Advance Group (SSAG) who will determine the type of technical assistance required in response to the State’s request. “Technical assistance requirements, including specific objectives and timeframes, will be coordinated as part of the request for assistance from the project area”. This request will be made by calling the CDC Director’s Emergency Operations Center (DEOC) 770-488-7100. . F. In response to the event, the Secretary of HHS 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 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 pharmacist or designee will transfer the State of South Carolina owned drugs from the pharmaceutical cache located at the PHP Pharmacy, 8229 Parklane Road, Columbia, SC 29223 to the SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-6 SNS SOP predetermined RSS site for distribution per this plan. If the magnitude of the event does not warrant utilization of the predetermined RSS site, distribution operations will be run out of the PHP pharmacy which has been surveyed by the DSNS program consultant and the US Marshall’s service. H. Receipt: Once the deployment of SNS assets have been ordered the State Emergency Operations Center 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. The responding county EOC’s will also be activated at the appropriate Operating Condition. A draft South Carolina Emergency Health Powers declaration has been written by the DHEC Office of General Counsel and is available in the event it is needed. DHEC will request the following resources to support this plan through the State Emergency Operations Center (SEOC): warehouse, warehouse management and inventory tracking, 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 Receiving, Staging and Storage (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 services consultant and the US Marshall’s service. The SC SNS Pharmacist or designee will notify the Receiving, Staging, and Storage site of the deployment of the SNS assets by the DSNS. Previously when the SNS “12- Hour Push-Package” or “Managed Inventory” arrived at the SNS RSS site the CDC liaison for the SNS will immediately transfer custody of the SNS assets to the State of South Carolina using the “CDC Strategic National Stockpile Program Medical Material Transfer Form” and the DEA Form 222. As of 10/6/2009 “How SNS materiel is deployed and signed for will be based on numerous factors and will be coordinated as part of the request for assistance between the project area and DSNS”. The SC SNS Pharmacist or designee is designated by the DHEC Director to officially accept the custody of the SNS assets from the CDC for the State of South Carolina at the SNS RSS site. In addition to the SNS Pharmacist the following pharmacists may sign for the SNS, the Director of Pharmacy DHEC Health Services, the Director of the DHEC Bureau of Drug Control, the back-up SNS Director or the Assistant Director DHEC Bureau of Drug Control. The Region Distribution sites will be notified of the arrival of the SNS assets at the RSS site. South Carolina may accept all or part of the “12-Hour Push-Package”. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-7 SNS SOP In the absence of an emergency declaration by the Governor of South Carolina 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). Vaccines shipped to the RSS site or PHP Pharmacy will be stored in the Division of Immunization walk-in refrigerator (8 feet X 12 feet) at the DHEC Hayne Building SC Board of Pharmacy, non-dispensing drug outlet permit # 10385, 8231 Parklane Road if the quantity shipped exceeds the capacity of the PHP Pharmacy refrigerator. All vaccine storage and handling will follow the DHEC Division of Immunization Vaccine Storage and Handling policy rev. 02/09/12.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 refrigerators by ESF-2 or by the DHEC Bureau of Business Management depending upon the size of the event. I. Staging: Once custody of the SNS assets have been signed for by the Director of the Strategic National Stockpile and transferred to the State of South Carolina at the RSS site or PHP pharmacy, these assets will be off loaded and staged. The SNS shipping containers will be arranged in a color-coded schematic 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 assets are being staged at the RSS site, the DHEC Region Director 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 Region Distribution site for transfer to the designated hospitals or directly to the designated hospitals as specified in the DHEC Health Region SNS plan. Transportation assets to perform this will be requested through ESF-2 at the South Carolina Emergency Operations Center (SEOC). SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-8 SNS SOP All Control Drugs will be transferred to the designated treatment center’s Drug Enforcement Agency (DEA) registrant employing DEA form 222 where applicable. All Control substances will be packaged separately from other legend drugs and will be transferred utilizing the “Control Substances in 12Hour Push Pack” form revised 9/2011. All Control substances not transferred to designated treatment center’s DEA registrant will be transferred to the PHP pharmacy which is a SC Drug Control/DEA as well as SC Board of Pharmacy permitted location. Post exposure prophylaxis packages, initial 10 day supply, will be delivered to the Region Distribution sites. 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 on 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 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 Region Distribution site will distribute these initial regimens to the identified first responder site, 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. Hospitals will request any needed SNS medical material other than initial prophylaxis supplies from the State RSS site through the ESF-8 liaison at their county Emergency Operations Center or through the Region unified medical command. These requests will be forwarded to the RSS site by the ESF-8 leads at the State Emergency Operations Center. The Region Distribution sites will meet the same specifications as the RSS site. 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 each DHEC Health Region and can serve as an alternate RSS site in a more localized event. The DHEC Health Region plan will provide for necessary support to off load the shipment, manage and track the inventory, and on-site security at the Region Distribution site. Transport and transport security, and traffic control of the medical supplies from the Region Distribution site to the predetermined receiving hospital or to the predetermined dispensing site will be specified in the Region SNS/CRI plan. The Region SNS/CRI plan will specify an individual from the predetermined treatment center/hospital to be available to accept custody of the SNS control drugs from the DHEC Drug Control Pharmacists. Unless stated otherwise the SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-9 SNS SOP control substances will be delivered to the main pharmacy within the hospital and received by the Director of Pharmacy or his designee. The DHEC Region Director (or designee) will be the lead official at the Region Distribution site and will specify an individual to accept custody of the shipment of the SNS assets from the RSS site and will assure that the Region Distribution Site is made ready to receive countermeasures from the RSS site. The SNS Operations lead or designee will notify the Region Distribution Site of the deployment of the SNS from the RSS site to the Region Distribution site. The Region SNS and CRI plans will arrange for transportation and security of post exposure prophylaxis packages to the local points of dispensing for dispensing to the entire Region population within the prescribed time frame. 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 Region Distribution Site, the DHEC Region Director 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 event is a declared national disaster and the National Response Framework has been activated the Department of Homeland Security would establish a Joint Operations Center (JOC) 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 ESF-8 at the JOC. A FEMA Action Request Form (ARF) for the additional assets may be required. The same process will be followed as in the initial request phase of the response. The Managed Inventory pharmaceuticals may arrive in bulk or repackaged regimens and will be shipped directly to the RSS site from their points of origin. Additional pharmaceuticals and/or medical supplies not available through the Strategic National Stockpile Managed Inventory program may be procured through the State of South Carolina emergency procurement procedures. These procedures may utilize national resources such as RX Response. In an event when the causative factors have been identified and the DHEC Region Health Director in conjunction with local/county emergency management officials and the CDC Director can determine the specific supplies that are needed, the first shipment received may be from the Managed Inventory and not from the multi-hazard “12-Hour Push Package.” The Region Distribution Sites will report continually to the RSS site the number and type of prophylactic regimens dispensed, the number and types of SNS assets transferred to the treatment centers and the projected number of additional assets that will be needed. Requests for additional assets for the SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-10 SNS SOP RDS site from the RSS site will be received at a minimum of daily in conjunction with the reports. The frequency of these reports will be determined by the specific incident. The points of dispensing will request additional post exposure prophylaxis antibiotics from the Region Distribution Site. The process for this request procedure will be specified in the Region SNS plan and will mirror the RDS to RSS request process. Inventory Control at the RSS site and the Region Distribution site will follow the procedures below. The DHEC Bureau of Finance will be the lead for inventory control at the RSS site. The Region/ CRI plan will identify the inventory lead at the Region Distribution site. The initial packing slips will be given to the inventory clerks for entry into the manual inventory system. All items received and distributed will be listed one product per page on DHEC form 1285 SNS Perpetual Inventory. The following information will be recorded per item: (1) Item description found on the inventory list provided by DSNS (2) Lot Number and expiration date (3) NDC number found on the inventory list provided by DSNS (4) Unit of measure found on the inventory list provided by DSNS (5) Unit pack (number per case or box) found on the inventory list provided by DSNS All items will be recorded as each and distributed by box or case. There will be a running decreasing balance (similar to a checkbook) inventory sheet for every item contained in the shipment. Each entry into the “checkbook” will list the following: (1) Which container the item came from or (2) Where the item is going to (3) Number received or shipped Currently the inventory tracking system for the state level response is transitioning to the secure federal Inventory Management and Tracking System (IMATS). This system will track all SNS assets which can be preloaded by the DSNS. The Region Distribution site will continue to use the paper system or an excel spreadsheet since the RDS in most instances will handle only oral medications or vaccines. The initial shipment of SNS materials will be apportioned and shipped to the affected Region Distribution site, treatment facilities or point of dispensing based on population if the threat has been identified. DHEC form 1286 or 1287 will be used to record the following information concerning the shipment: (1) Region or Point of Dispensing (2) Treatment center (if applicable) (3) Date (4) Time SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-11 SNS SOP (5) Lot Number & Expiration date (6) NDC Number (7) Quantity (8) Requested by (if applicable) (9) Filled by (10)Time Filled (11)Delivered by (12) Time delivery left All Control substances will be packaged separately from other legend drugs and will be transferred utilizing the “Control Substances in 12-Hour Push Pack” form revised 9/2011. This form will be completed by the individual who signs for the control substances and will be given directly to the DHEC Drug Control pharmacist who will make the delivery to the hospital on the delivery slip. All drugs control, legend, or other countermeasure will be tracked in the same manner. The original slip will go to the perpetual inventory clerk and a copy will be given to the fulfillment area to be filled. Once the order is filled and all names are recorded two copies of the filled order form will then go with the shipment as the packing slip and delivery slip. The packing slip will be inside the order and the delivery slip will be signed and returned to the inventory clerk at the RSS site or Region Distribution site. This slip may be returned via the truck driver in hard copy or by fax. The original will return to the inventory clerk to match the filled order with the requested order. The contents of the shipment will then be subtracted from the perpetual inventory. These processed orders will then be set aside awaiting verification of receipt of the order from the Health Region. The fulfillment area will be manned by 4 teams of 4 people each. The DHEC forms 1285, 1286, and 1287, 1288 can be found on the DHEC intranet site and can be accessed as follows: http://dhecnet --Technologies Tab –RIMS –PDF Forms “Control Substances in 12-Hour Push Pack” form revised 9/2011 will be provided at the time it is required by the SNS Pharmacist or designee. Once the agency EOC is activated and WebEOC is being used to track the incidence all forms related to the response will be posted in WebEOC. L. Rev Jan 2013 Dispensing Sites: The Region Health Director or his designee in conjunction with local/ county emergency management agencies will develop the Health Region Strategic National Stockpile and City of Columbia Metropolitan Statistical Area (MSA) Cities Readiness Initiative (CRI) plans which identify adequate public/ private points of dispensing to provide initial ten day prophylaxis for the entire population within 48 hours of the federal decision to ship medical countermeasures into South Carolina in response to a disease SNS SOP ANNEX 1_Appendix 5-1-12 SNS SOP outbreak or other emergency event. First responder dispensing sites separate from the public points of dispensing will be identified in each Region plan. If the emergency event is a disease outbreak and laboratory confirmation of the infecting organism has been made additional prophylaxis up to 60 days may be required for those exposed to the infecting agent. The DHEC Region Health Director (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 report adverse reactions to the countermeasure. In the event that the drug is being dispensed to the public on a Food & Drug Administration Emergency Use Authorization ( EUA), the DHEC Region Health Director will ensure that all terms of the EUA are followed prior to dispensing including providing adequate dispensing information as provided by the manufacturer or the DSNS to all public and private points of dispensing. Adults 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 over, 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 SC 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 Region SNS plan to accommodate citizens with a variety of special needs such as language, vision and mobility barriers at the dispensing sites. The DHEC Region Health Director (or designee) will be the lead official at the public points of dispensing. Large employers, that meet the requirements to serve as a point of dispensing for their employees and employee’s family will identify the lead official at the employer’s closed dispensing site and that person will be listed in the Region SNS or CRI plan. Facilities with confined populations and established medication dispensing procedures will provide to the Region distribution site the number of needed SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-13 SNS SOP regimens and will follow their usual and customary medication dispensing procedures for patients/ residents, staff and staff’s family following CDC and DHEC guidelines and recommendations. Examples of these affected institutional populations 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 will receive their medication will be identified and defined in the DHEC Region or CRI SNS SOP. The DHEC Region SNS and CRI plans will also identify 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 870(Volunteer Health Care Provider Agreement). The DHEC Region/CRI plans will identify how traffic control and security will be provided at the large employer closed point of dispensing. Each mass public/closed dispensing site will need to provide for the following characteristics, while allowing differences to accommodate the various facilities hosting the dispensing site and the security requirements of local law enforcement. Adequate signage needs to be in place to ensure a smooth patient flow. (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 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. Rev Jan 2013 A memorandum of agreement currently is 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 Gubernatorial 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 the public health, safety and welfare in a mass casualty event that SNS SOP ANNEX 1_Appendix 5-1-14 SNS SOP would require federal or other medical countermeasures being sent to South Carolina. All necessary forms including the standing orders will be posted to WEBEOC under file library once most current CDC event driven updates are available. 1. Protocols/ standing orders to provide current guidelines for the assessment, prophylaxis and/or treatment and follow-up 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. To access these orders go to dhecnet – program areas-health services manuals & reports- Health services standing orders manual – BT tab. Copies of these orders will be printed by the Region Health director or his 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 treatments for all citizens of South Carolina. These protocols include the CDC treatment and post exposure prophylaxis guidelines. 2. The Clinical Evaluation Form for Dispensing Mass PostExposure Prophylaxis Therapy ( DHEC 1288) form for patients exposed to a biologic agent will serve as the (1) exposure screening form, (2) dispensing record, (3) refill record, (4) medical chart and (5) acknowledgement of receiving treatment. To access this form go to dhecnet – program areas- technologies – RIMS – PDF forms. This form will be filled out for every person who receives prophylaxis. This record is to be maintained in the Health Region pharmacy in lieu of a written prescription document for 3 years after the last date of service. After 3 years the record is to be transferred to archives where it will be maintained in accordance with DHEC policy A.932. The 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. Each prepackaged 10-day regimen from the CDC comes labeled with two perforated labels identifying drug, quantity, expiration 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, (the Deputy Director of Health Services), will be handwritten on the dispensing label. To SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-15 SNS SOP 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-FDA-1088.” Each patient will be counseled on the proper use of the drug and any drug- drug and drug- medical condition 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 his/her physician. General patient drug information is available to DHEC through internet based drug information at www.factsandcomparisons.com. The log-in is located on the left side of the page. Click on “e answers log-in” and on the left side of the page is medfacts patient information. Click on that and scroll through until you find the drug. Each Region with a pharmacy should have an IP address set up with access to this site. If not login with SCDOHAEC and SCDOHAEC1. Each drug information sheet 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-FDA-1088.” 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 available 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 Centers for Disease Control and Prevention (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 SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-16 SNS SOP 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 forms that patients must read and sign to give informed consent at the time of the event. 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 appropriate paperwork will be distributed with the countermeasure to the DHEC Public Health Region Distribution site 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 are 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 The DHEC Region 3 and City of Columbia Cities Readiness Initiative (CRI) plans will coordinate planning with the Charlotte/Mecklenburg county North Carolina CRI to insure adequate coverage of York County South Carolina and the Catawba Indian Nation whose population is included under the Charlotte, NC metropolitan statistical area and is funded as part of the Charlotte CRI by the Centers for Disease Control and Prevention. The Office of Tribal government will have its members receive prophylactic medication through this process in a declared emergency. The ultimate responsibility for York County South Carolina falls under the DHEC Region 3 plan. N. 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 SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-17 SNS SOP 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 purposes. Also, per the terms of the 2010 memorandum of agreement between the CDC and DHEC, at the conclusion of a public health emergency response, CDC will assess 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. Other unused medical materiel including pharmaceutical items will be returned to the RDS. Once all materiel is returned to the RDS site, these materiels will be returned to the RSS, with any durable assets, for final disposition. O. Communication: 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 3 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. DHEC is the lead agency for all ESF-8, health and medical, response which includes primary responsibility for all messaging which affects the public’s health. 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 medicine, cost of the medicine, medicine for pets, medication safety. SNS specific messages will include but not limited to where to pick up your medication, how to pick up your medication, why you need to pick up the medicine for you and your family, why you need to take the medicine, what medical information is needed to receive medication, what is needed for identification, how to take your 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 your are currently symptomatic. Templates for these messages have been written and when needed will be incident specific and SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-18 SNS SOP distributed through local public information channels such as television, radio, newspaper and at the local dispensing sites by the 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. DHEC, ESF-8, will provide the prescripted 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 Types of information to be included 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 assets needed by treatment centers. These numbers will be reported on a regular basis as determined by the incident by the Region Distribution site lead to the RSS site and to ESF-8 at the State Emergency Operations Center. The DHEC EOC will monitor all response and recovery activities through the state and agency copies of WebEOC. The DHEC EOC will maintain communications with ESF-8, RSS Site, Region Distribution sites by email, fax, telephone, cell phone, 800 MHZ radio. Requests from the county emergency operations center for SNS distributed medical countermeasures or other health and medical services will be either called into the SEOC by telephone, transmitted via WebEOC or by radio. The State Emergency Operations Center (SEOC) Operations Tasking Group (OTG) will task any such requests for health and medical services to ESF-8. DHEC representatives 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 the OTG at the SEOC. Completion of all tasks will be reported to the DHEC representatives in ESF-8 at the SEOC for inclusion in the periodic situation reports. This procedure is consistent with the request procedures found in the ESF-8 SOP. 3. Equipment SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-19 SNS SOP Cell phones, land lines, fax lines and DHEC internet services will electronically tether all SNS 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 Emergency Operations Center, the RSS site, the Region Distribution Sites, the Region Dispensing Sites will be in communication by 800 MHz 2-way radio, which are linked by a wide area communications systems that covers the entire state. These radios are currently available within the agency through the Bureau of Information Services. Additional communications for RSS and other SNS operations will be requested through the State Emergency Operations Center ESF-2 (Division of State Information Technology). Maintenance of the emergency response radios held by the Division of State Information Technology is the responsibility of the Division of State Information Technology as described in the ESF-2 annex of the SC Emergency Operations plan. These include providing additional telephone lines to the RSS, handheld radios, HAM radios, cellular phones, satellite phones, computer terminals, internet access, teleconferences and telephone bridge requirements. DHEC State and Region communication systems that are not utilized in day to day operations will be tested quarterly to ensure readiness. SCDHEC response activities will be tracked through the SCDHEC State and Region copies of WebEOC. Access and functionality of this system will be tested and recorded the first month of each calendar quarter. P. Security and Transport: The security and transport functions will be coordinated through the State Emergency Operations Center Operations Group and will be provided by ESF-1, ESF-8, ESF-13 and ESF-15. Transportation to the Region Distribution Sites 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 assets during 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 of the SC Emergency Operations Plan (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 an 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 of SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-20 SNS SOP 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. The SC Emergency Management Division (SCEMD) is responsible for the SC Logistics Plan. SCEMD in support of the logistics plan maintains transportation services on a contingency contract and will activate those contracts in support of SNS logistical activity when required. Security will be provided for all personnel, material, and equipment involved in the management and distribution of the SNS countermeasures in accordance with the South Carolina Law Enforcement Division (SLED) SNS 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. SLED coordinates with support agencies including the SC Department of Public Safety (DPS) (ESF-16) to ensure operational readiness during and post disaster. In accordance with SC Code of Laws Section 23-315 (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 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 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. 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 State Emergency Operations Center if needed. The South Carolina Air and/or Army National Guard have been tasked with providing security for the SNS assets at the RSS site and will follow the base’s usual and customary use of force guidelines in maintaining the RSS site integrity. The RSS site will provide security for all operations within its fence line. 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. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-21 SNS SOP All persons working in or with the DHEC SNS 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 Region plans will specify credentialing procedures for all Region dispensing sites and distribution sites. Anyone entering the facility where the RSS site is housed will have to present a government issued picture identification to the armed security guard at the guard gate prior to admission. No one will be admitted unless their name appears on the roster provided by ESF-8/SCDHEC. The SC Law Enforcement Division (ESF-13) has been tasked with traffic control, security and escort in transport to the Region Distribution Sites and with coordinating security with local law enforcement at the Region Distribution Site. ESF-2 will notify the RSS site of the size of the truck, a description of the truck and of 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 insure delivery of the medications to the Region distribution sites. The South Carolina Law Enforcement Strategic National Stockpile Standard Operations Plan will support ESF-13’s mission to the SC Mass Casualty Plan, (Annex 1 – Strategic National Stockpile), of the SC Emergency Operations Plan (SCEOP). This SOP provides operational guidance to those who are assigned to work in ESF-13 in all phases of SNS operations The Department of Health and Environmental Control Drug Control Pharmacists are tasked with providing security and transportation of any controlled substances from the RSS site to the designated DEA registrant facility usually a hospital pharmacy in each Region. The Region/CRI SNS plan will provide for security at the Region Distribution site, security and transport to the points of dispensing and at the mass public points of dispensing/vaccination. Provision of security at the large employer closed dispensing/vaccination sites will be identified in the Region/CRI SNS plans. If repackaging is necessary prior to distribution from the Receiving, Staging and Storage (RSS) site, SLED will provide security in transport from the RSS site to the repackager and back to the RSS site. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-22 SNS SOP The US Marshall’s service are not considered part of the SNS Services Advance Group (SSAG) and will not provide routine security for SNS assets and personnel unless threat analysis of the event indicate federal security is necessary. Q. V. Repackaging In the event that the prophylactic medication required to treat the biologic agent is not available in the unit of dispensing packaging, in the 12-Hour push package or the state receives bulk medication from the DSNS Managed Inventory the bulk medication will be transported to the Consolidated Mail Order Pharmacy in Charleston, SC or to the Moncrief Community Hospital for repackaging into packages of 10-day or other appropriate dosage regimens. ESF ACTIONS The emergency operations necessary for the performance of this Attachment I to Appendix 5 of the SCEOP include but are not limited to the following: A. Rev Jan 2013 Preparedness 1. Develop, coordinate and maintain written plans, which reflect latest CDC/DSNS requirements, to implement SNS 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 assets and other approved countermeasures in support of ESF-8 responsibilities. 4. Identify and establish state and regional locations for receiving, staging, storing and distributing SNS and other medical materials. 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. Identify and coordinate with other health care providers other sources of pharmaceuticals and medical equipment/supplies. SNS SOP ANNEX 1_Appendix 5-1-23 SNS SOP B. Rev Jan 2013 7. Develop and maintain dosing and dispensing guidelines and procedures for the prophylactic drugs contained in the SNS and for other medical countermeasures designed for mass distribution or dispensing. 8. Assure that DHEC Health Regions develop SNS and/or CRI plans for the management of the 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 maintain training and training exercises for related areas of SNS management. Response 1. Assess the situation and determine if 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. Request the SNS 12-Hour Push package 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 call 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 Plan and upon receipt of the SC SNS Plan, the CDC Director will order the deployment of the SNS. 5. Request deployment of the SNS materiels 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” allowing for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. 7. Notify the DHEC Regions Health Directors, the Public Health Preparedness Director and the CRI Coordinator of the deployment of SNS SOP ANNEX 1_Appendix 5-1-24 SNS SOP the SNS medical assets to the SC RSS site by the CDC and request the implementation of the Region/CRI SNS plans. Rev Jan 2013 8. Notify SEOC of the deployment of SNS by the CDC to the SC RSS site. 9. Notify SNS RSS location of expected arrival of the SNS. 10. Notify and coordinate the agencies and organizations involved in the staging of the SNS. 11. Notify and coordinate the agencies and organizations involved in the support of the individuals involved in the staging of the SNS. 12. Notify and coordinate the agencies and organizations involved in the transport of the SNS. 13. Notify Region Distribution sites and/or Region Health or Public Health Preparedness Directors of the arrival of the SNS at the SC RSS site. Notify the Region Distribution Sites and/or Region Directors of the deployment of the SNS to the Region Distribution Site. Request that the Region points of dispensing are notified of the deployment by the DHEC Region Health Director. 14. Coordinate with ESF-1 transport of SNS asset from the RSS site to the Region Distribution sites for distribution to the points of dispensing/vaccination or designated hospital. 15. Coordinate with DHEC Health Region distribution of SNS medical assets to designated hospitals. 16. Coordinate with DHEC Health Regions dispensing initial 10 days of antibiotics or other approved countermeasures to the entire Region population within the prescribed time frame of 48 hours and follow up prophylaxis of 50 days if needed. 17 Coordinate with ESF-13 security for SNS assets in transport from the RSS site to the Region Site, treatment center or repackaging center. 18. Coordinate with ESF-2, Budget and Control Board, the use of additional 800 MHz radios and the 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 assets in South Carolina and of the gubernatorial declarations. SNS SOP ANNEX 1_Appendix 5-1-25 SNS SOP C. Recovery 1. Determine the need for additional medical supplies in conjunction with the SC DHEC Region Director 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 Health Regions follow up of individuals receiving prophylaxis to insure completion of therapy in individuals actually exposed to the biologic agent. 4. Coordinate retrieval of all unused assets of the SNS program from the distribution and dispensing sites to the RSS site. 5. 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. 6. 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. . D. VI. Mitigation 1. Support, plan and implement mitigation measures. 2. Support requests and directives resulting 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. RESPONSIBILITIES SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-26 SNS SOP A. Department of Health and Environmental Control (ESF-8) Rev Jan 2013 1. Develop, coordinate and maintain written plans to implement the Strategic National Stockpile response operations in South Carolina on both State and Regional level. 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 assets and other approved countermeasures to meet ESF-8 responsibilities 4. Identify and establish state and regional locations for receiving, repackaging, staging, storing, distributing SNS and other medical materiels. 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. 8. Assure that Department of Health and Environmental Control Health Regions develop Strategic National Stockpile and/or Cities Readiness Initiative plans 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 plan. 10. Notify all Strategic National Stockpile supporting agencies upon implementation of the Strategic National Stockpile plan. 11. Develop mutual support relationships with professional associations SNS SOP ANNEX 1_Appendix 5-1-27 SNS SOP and other private services and volunteer organizations that may assist during emergencies or disasters. Rev Jan 2013 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 eight 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 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 with supporting agencies in assessing the situation to 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 with the Centers for Disease Control and Prevention Division of Strategic National Stockpile among state and federal response officials. 17. Insure that required information is available for the consultation phase 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 plan, 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 a plan to receive, repackage prophylactic oral antibiotics. 18. Coordinate need for initiating 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. SNS SOP ANNEX 1_Appendix 5-1-28 SNS SOP 20. Insure all state and federal documentation available and in order to accept and distribute the Strategic National Stockpile 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 assets. 22. Provide all inventory control records and distribution records of Strategic National Stockpile assets as required by Centers for Disease Control and Prevention. 23. Maintain all expense records associated with deployment of the Strategic National Stockpile 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. Request Strategic National Stockpile assets by the Department of Health and Environmental Control Director with the consent of the Governor, when it is determined by state and local officials that Federal assets are required. 26. Accept custody of the Strategic National Stockpile assets from the Centers for Disease Control and Prevention. 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 Plan. Upon receipt of the SC Strategic National Stockpile Plan, 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 SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-29 SNS SOP 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” allowing for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. 29. Notify the Department of Health and Environmental Control Region Health Directors, the Public Health Preparedness Directors, the CRI Coordinator of the deployment of the Strategic National Stockpile 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 plan(s). 30. Notify SEOC of the deployment of Strategic National Stockpile 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 assets. 32. Notify and coordinate the agencies and organizations involved in the staging of the Strategic National Stockpile assets. 33. Notify and coordinate 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 assets. 34. Notify and coordinate the agencies and organizations involved in the transport and security of the Strategic National Stockpile assets from the RSS site to the Region distribution sites. 35. Notify Region Distribution sites and/or Region Directors or his designee of the arrival of the Strategic National Stockpile at the South Carolina Receiving, Staging and Storage site. Notify the Region Distribution sites and/or Region Directors or his designee of the deployment of the Strategic National Stockpile to the Region Distribution sites. Insure that the Region points of dispensing are notified of the deployment by the Department of Health and Environmental Control Region Director. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-30 SNS SOP 36. Coordinate with ESF-1 (Transportation Services) transport of Strategic National Stockpile assets to the Region 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 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 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 assets in transport to the Receiving, Staging and Storage site, from the Receiving, Staging and Storage site to the Region Distribution site, designated hospitals, and repackaging facility and back to Receiving, Staging and Storage site. 40. Provide transport 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 transport of bulk pharmaceuticals to repackaging facilities. 42. Determine the need for additional medical supplies in conjunction with the South Carolina Department of Health and Environmental Control Region Health Director and the county/local emergency management officials. 43. Request additional supplies of specific items through the Centers for Disease Control and Prevention Managed Inventory portion of the Strategic National Stockpile program and/or through other commercial sources if available 44. Coordinate with ESF-2, Budget and Control Board, 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. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-31 SNS SOP B. 45. Coordinate with the Department of Health and Environmental Control Health Regions follow up of individuals receiving prophylaxis to insure completion of therapy in individuals actually exposed to the biologic agent. 46. Coordinate retrieval of all unused assets of the Strategic National Stockpile 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 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. Office of the Governor 1. Rev Jan 2013 Coordinate with the Department of Health and Environmental Control Director, South Carolina Emergency Management Director, the Department of Health and Environmental Control Deputy Director of Health Services, the Department of Health and Environmental Control District Health Director and the Department of Health and Environmental Control Director of Public Health Preparedness SNS SOP ANNEX 1_Appendix 5-1-32 SNS SOP requesting federal assistance in the form of medical assets from the Strategic National Stockpile. C. 2. Authorize the Department of Health and Environmental Control Director to request Strategic National Stockpile assets. 3. 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. 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 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 perform security at the Receiving, Staging and Storage site for the Strategic National Stockpile 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. f. Provide backup transportation for the SNS assets to the Region Distribution sites. . 2. SC Emergency Management Division(ESF-5) SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-33 SNS SOP D. a. In accordance with the SNS Guidance version 11, State Emergency Management Officials will confer with the Governor and the Department of Health and Environmental Control Director to determine the need to request federal support in the form of the Strategic National Stockpile assets. b. In accordance with the SNS Guidance version 11 the Governor or State Emergency Management officials will participate in the consultation phase of the Strategic National Stockpile with the Centers for Disease Control and Prevention. c. Activation of the State Emergency Operations plan and the State emergency Operation Center (Center) will occur 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. 2. F. Rev Jan 2013 USC School of Pharmacy: Provide pharmacy students to assist in the repackaging of bulk quantity antibiotics into individual patient regimens. MUSC School of Pharmacy: Provide pharmacy students to assist in the repackaging of bulk quantity antibiotics into individual patient regimens. SC Hospital Association: Identify hospitals to receive SNS 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. SNS SOP ANNEX 1_Appendix 5-1-34 SNS SOP G. SC Medical Association: Assist with recruitment of physicians for SNS 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 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 Region Dispensing sites. J. SC Baptist Convention: Provide 4 meals per day, snacks and personnel to distribute these meals/snacks for workers staffing the RSS site. 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 Region points of dispensing. M. South Carolina Law Enforcement Division: (ESF-13 & 16) 1. Provide security in transport and escort during transport to the Receiving Staging and Storage site. 2. Provide security in transport and escort during transport to the Region Distribution site. Coordinate security at the Region Distribution Site with local law enforcement. 3. Provide security in transport to the repackaging facility and back to the Receiving Staging and Storage site. N. South Carolina Department of Transportation: (ESF-1) SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-35 SNS SOP 1. Provide transportation and/or coordinate provision of transportation with local carriers if state assets are not adequate of the Strategic National Stockpile materials from the Receiving, Staging and Storage site (RSS) to the Region Distribution sites. 2. Provide transportation and/or coordinate provision of transportation with local carriers if state assets are not adequate of the Strategic National Stockpile materials to the designated treatment centers. 3. Provide transportation and/or coordinate provision of transportation with local carriers if state assets are not adequate of Strategic National Stockpile materials to the repackaging facility and back to the Receiving Staging and Storage site. 4. Provide transportation and/or coordinate provision of transportation with local carriers if state assets are not adequate of the return of any unused Strategic National Stockpile assets from the Region Distribution site to the Receiving, Staging, Storage site for return to the Centers for Disease Control and Prevention. O. P. Budget and Control Board (ESF-2) 1 Provide additional communications devices if needed for Strategic National Stockpile operations. 2. Provide for additional radios, voice and data lines at the Receiving Staging and Storage site. South Carolina Society of Health System Pharmacists: 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 or the Veterans Administration Consolidated Mail Order Pharmacy. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-36 SNS SOP 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 Health Region Director, county emergency management officials will determine if local medical supplies will be exhausted and if federal assets in the form of the SNS will be needed to manage the WMD, or major natural or technological event. The DHEC Region Health Director after consultation with the county emergency management officials will request the initial SNS “12Hour Push Package” and any additional specific SNS 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 Health Region, county governments will provide Emergency Medical Technicians and security at local Dispensing Sites and security at Region Distribution Sites. In conjunction with the DHEC Health Regions, county emergency management officials will report to ESF-8 at the state emergency operations center 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 number of people still requiring treatment. 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. IX ADMINISTRATION AND LOGISTICS 1. General Reporting Requirements a. 2. Personnel hours will be recorded as the individuals normal program and location code and will use the disaster (999) activity code. General Support Requirements a. Meals at the RSS site will be supplied by the facility caterer. SNS SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-37 SNS SOP 3. 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 SOP Rev Jan 2013 ANNEX 1_Appendix 5-1-38