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Vaccine Management Plan V.I. DEPARTMENT OF HEALTH – IMMUNIZATION VACCINES FOR CHILDREN PROGRAM V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 1 Table of Contents VACCINES FOR CHILDREN (VFC) 2022 Vaccine Management Plan ................................................. 2 Vaccine Coordinator Information.............................................................................................................. 2 VACCINE MANAGEMENT PERSONNEL ............................................................................................ 3 Provider of Record (Enrollee) ................................................................................................................... 3 VACCINE COORDINATOR ROLES AND RESPONSIBILITIES ................................................................ 4 Vaccine Storage and Handling ........................................................................................................ 6 Vaccine Storage Units ................................................................................................................................ 6 REFRIGERATOR ROUTINE MANAGEMENT ...................................................................................... 7 FREEZER ROUTINE MANAGEMENT ................................................................................................. 8 POWER SUPPLY ROUTINE MANAGEMENT ..................................................................................... 9 VACCINE STORAGE UNIT/LOCATIONS AND MAINTENANCE ......................................................... 11 Temperature Monitoring Device List and Maintenance ............................................................... 11 Temperature Monitoring .............................................................................................................. 12 Data Loggers ............................................................................................................................................ 12 Safeguarding Vaccines, Handling and Reporting Out-of-Range Temperatures ...................................... 12 Temperature Monitoring and Documentation ....................................................................................... 13 Inventory Management ................................................................................................................ 14 Vaccine Stock ........................................................................................................................................... 14 Stock Rotation, Returns, and Transfers ................................................................................................... 14 Vaccine Ordering ..................................................................................................................................... 14 Receiving and Inspecting Vaccine Shipments ......................................................................................... 15 Transporting Vaccines ................................................................................................................... 15 VARICELLA-CONTAINING VACCINES.............................................................................................. 15 Procedure for Packing Vaccines .............................................................................................................. 16 SUPPLIES FOR TRANSPORT............................................................................................................ 17 PACKING THE VACCINE ................................................................................................................. 18 Staff Training on Vaccine Management and VFC Program Requirements .................................. 18 Signature Log ................................................................................................................................ 19 V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 2 VACCINES FOR CHILDREN (VFC) 2022 VACCINE MANAGEMENT PLAN Vaccine Coordinator Information This plan must be reviewed and updated annually (every 12 months) or when key staff change (primary/back-up coordinators and/or signatory). This plan must be dated and signed by the person responsible for the VMP content. Office/Practice Name VFC PIN (6 Digits e.g. M00L00) Physical Address Phone Number Fax Number Medical Director/Signatory Name: Email: Contact Number: Primary Vaccine Coordinator Name: Email: Contact Number: Back-Up Coordinator Name: Email: Contact Number: Person(s) with 24-hour access to building, in case of emergency Name: Contact Number: Reviewed on ____________________________ by __________________________________________ Date Signature V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 3 VACCINE MANAGEMENT PERSONNEL This section highlights key duties of designated vaccine management staff. However, all personnel working with vaccines should be familiar with VFC Program requirements and guidelines. Provider of Record (Enrollee)  Complies with all federal vaccine management requirements, including key areas outlined in this plan.  Designates one employee as the practice’s Vaccine Coordinator, responsible for vaccine management.  Designates one employee as the Back-up Vaccine Coordinator responsible for vaccine management when the primary Vaccine Coordinator is not available.  Reports staffing changes regarding the Vaccine Coordinator, Back-up Vaccine Coordinator, and enrollee to the VFC Program.  Meets and documents required orientation and annual training for the practice’s vaccine management personnel.  Ensures that vaccine management personnel are skilled and knowledgeable regarding VFC Program requirements for temperature monitoring and storage equipment.  Ensures that the practice’s vaccine inventory management is consistent with VFC Program requirements.  Ensures that the practice’s vaccine storage units meet VFC Program requirements.  Updates and revises vaccine management plans at least annually and when necessary.  Reviews VFC Program requirements and management plans with staff at least annually and when necessary. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 4 VACCINE COORDINATOR ROLES AND RESPONSIBILITIES Summary The Vaccine Coordinator’s responsibilities vary depending on the amount of vaccine the practice gives and practice protocols. The Vaccine Coordinator is responsible for all vaccine management activities, completing required VFC Program trainings, including training other (especially new) staff. In other practices, a different person may have one or more vaccine management responsibilities, such as ordering vaccines. Below is a list of essential responsibilities. Receiving vaccines • Be present when vaccine is delivered and immediately process it into inventory. • Ensures acceptable temperature ranges have been maintained. Storing vaccines • Rotates the vaccine inventory so that vaccines with shorter expiration dates are used first. • Ensures there are no expired vaccines in the refrigerator or freezer. • Keep VFC Program vaccine separate from private vaccine stock. • Perform routine cleaning on vaccine storage units. Monitoring vaccine temperatures • Use a certified calibrated continuous temperature monitoring device (data logger) to review refrigerator and freezer temperatures. • Take immediate action if temperatures are outside acceptable ranges. • Implement the Emergency Vaccine Management Plan, if necessary. • Temperature logs must be maintained for three years. If you upload temperature data to VTrakS, your data will be kept for three years. Ordering vaccines • Perform a physical inventory monthly of all vaccines in stock. • Account for doses of returned or transferred vaccines since the last order. • Complete and submit the VFC Program vaccine order in VTrakS. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 5 Back-Up Vaccine Coordinator • Complete required VFC Program trainings. • Meet responsibilities described above when the primary Vaccine Coordinator is not available. Notify the DOH Vaccines for Children Program Coordinator immediately of any changes in the medical director, primary vaccine coordinator, or back-up vaccine coordinators via the email or phone number listed below. VI Department of Health VFC Program Coordinator Cherise Thomas, MSW Email: Cherise.thomas@doh@vi.gov Contact Number: 340-776-1113 ext. 2225 V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 6 VACCINE STORAGE AND HANDLING All vaccine storage and handling requirements and recommendations are in place to ensure the vaccine cold chain is maintained. The cold chain begins at the manufacturing plant, includes delivery to and storage at the provider facility, and ends with the administration of vaccine to the patient. Too much exposure to heat, cold, or light at any step in the cold chain can result in a loss of vaccine potency. Once potency is lost, it cannot be restored. Vaccine storage and handling plans follow the “Vaccine Management Guidelines” found in the VFC Program Manual and the Centers for Disease Control and Prevention's (CDC) Vaccine Storage and Handling Toolkit found at http://www.cdc.gov/vaccines/recs/storage/toolkit/storage- handling-toolkit.pdf. Vaccine Storage Units Equipment • The practice uses VFC Program compliant vaccine storage refrigerator(s) and freezer(s) and maintains recommended temperature ranges: o Refrigerator: between 36°F-46°F (2°C-8°C) o Freezer: between -58°F and -5°F (-15°to -50°C) • Storage units have adequate capacity to store vaccine supply at all times, including during peak back-to-school and flu season. • Storage units are routinely cleaned inside, kept dust-free outside, and doors have proper seals. • Keep maintenance and repair records on file and make them available to review upon request. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 7 REFRIGERATOR ROUTINE MANAGEMENT V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 8 FREEZER ROUTINE MANAGEMENT V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 9 POWER SUPPLY ROUTINE MANAGEMENT V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 10 Power Supply • Each unit is plugged directly into a wall outlet and is not controlled by a light switch, power strips, or surge protectors with an on/off switch. • Extension cords are never used to connect storage units to an outlet. • “DO NOT UNPLUG” signs are posted at each outlet and circuit breakers. Set-up • Storage units are set up according to VFC Program requirements. • Units are kept away from direct sunlight and away from walls to allow air circulation. • Vaccine is never stored in the door, drawers, or bins. Unit drawers/deli crispers are removed. • To stabilize temperatures, water bottles are kept in the refrigerator where vaccines cannot be stored. Frozen cold packs are kept in the freezer for similar purpose. • VFC Program and private vaccine storage areas/shelves are marked “VFC” and “Private” to clearly identify vaccine supplies. • The glycol-encased data logger probe is placed in the center of the unit, near the vaccines. • The data logger’s display is securely attached to the outside of the storage unit. • Vaccines are stored in their original packaging until administered; vaccine supply is 2-3 inches away from walls, air vents, and floor to allow space for air circulation. • Food, beverages, and laboratory specimens are not stored in the units at any time. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 11 VACCINE STORAGE UNIT/LOCATIONS AND MAINTENANCE Maintenance/Repair Company ____________________________ Phone __________________ Unit Type Unit/Location Brand Model Dates of Repair Refrigerator Refrigerator Refrigerator Refrigerator Refrigerator Freezer Freezer Freezer Freezer Freezer Location of completed temperature logs _____________________________________________ TEMPERATURE MONITORING DEVICE LIST AND MAINTENANCE Calibration Company/Laboratory __________________________________________________ Contact _____________________________________ Phone ____________________________ Refrigerator Refrigerator Digital Data Logger or Continuous Monitoring Systems Device Model/Serial Number Primary? Backup? Calibration Expiration Date Alarm Setting Low Alarm Setting High V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 12 TEMPERATURE MONITORING Data Loggers • Each storage unit has a VFC Program compliant continuous temperature monitoring device or data logger accurate within +/-1°F (+/- 0.5°C). • Each data logger has a current and valid Certificate of Calibration (also known as a Report of Calibration). • Each data logger has a biosafe glycol-encased probe placed in the center of the storage unit in close proximity to the vaccine. • Each data logger has a digital display of current, minimum, and maximum temperatures. • The practice has a minimum of one back-up data logger, meeting VFC Program requirements, for use when primary data loggers fail or are being recalibrated. • Probes are NEVER placed in the unit’s doors, near or against unit’s walls, underneath air vents, or on the unit floor. Safeguarding Vaccines, Handling and Reporting Out-of-Range Temperatures • When an out-of-range temperature is identified, immediate action is taken to assess the situation and to prevent vaccine spoilage. • If you find that vaccines have been “potentially spoiled”/exposed to out-of-range temperatures or to light, Providers may not under any circumstance determine if vaccine are viable or non-viable. 1. Label vaccine “DO NOT USE.” 2. Keep vaccine stored in the recommended temperature range until viability is determined by the manufacturer. 3. If necessary, relocate vaccines according to your emergency relocation plan. 4. Call the vaccine manufacturers and their responses concerning viability must be emailed to you. 5. Notify the VFC Program Coordinator at 340-776-1113 ext. 2225 or 2226. • The practice has an Emergency Vaccine Management Plan to follow in the case of power outage, appliance malfunction, weather conditions, or human error that may affect vaccine viability. • When necessary to transport vaccine to another storage unit or to a predetermined site, the practice always follows VFC Program guidelines. • Actions are documented on the VFC Program temperature log and other VFC Program forms, as appropriate. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 13 Temperature Monitoring and Documentation • Read and record refrigerator and freezer temperatures twice a day, when the clinic opens and before it closes. o Record current temperatures on a VFC Program supplied temperature log twice a day. If available, record minimum and maximum temperatures once a day, preferably in the morning. o Record a.m. temperatures before opening storage units. o Record p.m. temperatures at the end of the day. o Reset MIN and MAX after each reading by pressing the memory clear button (in most data loggers). • The person documenting the storage unit temperature initials the temperature log. • Document temperatures on VFC Program temperature log even if the practice uses a continuously recording/graphing data logger, data logger, or remote monitoring system. • Temperature logs are posted on the storage unit door or nearby in an accessible location. • The practice maintains completed temperature logs for three years and makes them available for review upon request to VFC Program representatives. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 14 INVENTORY MANAGEMENT Vaccine Stock • The practice conducts a physical vaccine inventory at least once a month and before ordering vaccine. • The practice has enough vaccine supply to meet the needs of its VFC Program eligible patients. • The practice must keep up to four weeks' additional supply to mitigate shortages in the event of shipment delays. • Vaccine drawn up and not used is disposed of and accounted for properly VTrakS. • Diluents can be refrigerated or stored at room temperature, but never frozen. Stock Rotation, Returns, and Transfers • The practice organizes vaccines so those with the shortest expiration dates are used first. • The practice returns expired and/or spoiled vaccine to McKesson for excise tax credit within six months of expiration/spoilage. • If the practice has vaccine due to expire within three months and it will not be used: • Notify the VFC Program about the vaccine. • Request a transfer approval from the VFC Program. • Identify VFC Program providers in the area to contact and inquire if they may be able to use the soon-to-expire vaccines. • If a practice transfers or transports vaccine, it follows VFC Program guidelines, and completes the appropriate transaction in VTrakS. • If vaccine becomes spoiled or expires, staff removes it immediately from the storage unit, reports it to the VFC Program, and adjusts it out of their inventory in Florida VTrakS. • Vaccine that is spoiled or expired must be reported to the VFC Program before a new order can be submitted. Vaccine Ordering • Orders are submitted in VTrakS and placed according to assigned order frequency, vaccine usage, and take into account the inventory in stock. Orders are placed with sufficient inventory on hand to allow time for order processing and vaccine delivery • The practice does a physical inventory before placing a vaccine order. • Any changes to the practice’s hours are reported to the VFC Program to avoid receiving vaccine shipments when the clinic is closed, or the staff is not available. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 15 Receiving and Inspecting Vaccine Shipments • Staff accepting deliveries must be trained. • The practice assumes responsibility for all VFC Program vaccine shipped to its site. • Vaccine shipments are inspected immediately upon arrival to verify that the temperature during transport was within range, length of time the vaccine was in transit, and that the vaccines being delivered match those listed on the packing slip and order confirmation. If there are any discrepancies or a question of viability, call McKesson (1-877-822-7746) and the VFC Program within 2 hours of receipt. • Vaccines are immediately stored according to VFC Program requirements. TRANSPORTING VACCINES • When transporting vaccines in ordinary vehicles, use the passenger compartment, not the trunk. • Consult the VFC Program for permission to transfer VFC vaccines between providers. • It is critical to maintain the cold chain at all times during transport. • Stay with vaccines at all times during transport and promptly unpack and place in appropriate storage units upon arrival. • FDA requires that opened multi dose cannot be transported/transferred to other providers. VARICELLA-CONTAINING VACCINES The vaccine manufacturer does not recommend transporting varicella-containing vaccines (MMR/V,VAR). If these vaccines must be transported in an emergency situation: • They should be packed and transported in a portable freezer unit that maintains the temperature between -58°F and +5°F (-50°C and -15°C). • Dry ice is never allowed. • If a portable freezer unit is not available and the vaccines cannot be packed in a unit that maintains +5°F or colder: o Varicella-containing vaccines may be transported and stored at refrigerator temperatures between 36°F and 46°F (2°C to 8°C). o Refrigerated varicella-containing vaccines must be used within 72 hours. o Remaining refrigerated varicella-containing vaccine must be discarded if it is not used within 72 hours. Refreezing varicella-containing vaccines that are stored at refrigerated temperatures is prohibited. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 16 Procedure for Packing Vaccines 1. Use properly insulated container, (i.e. hard sided plastic insulated containers with at least 2-inch thick walls) 2. Validate the containers beforehand to ensure they are capable of maintaining recommended temperatures. 3. Diluents MUST travel with its corresponding vaccine at all times. 4. Pack enough refrigerated/frozen packs to maintain the cold chain. Do not use loose or bagged ice. 5. Place an insulating barrier (e.g. bubble wrap, crumpled brown packing paper, Styrofoam peanuts) between the refrigerated/frozen packs and the vaccines to prevent accidental freezing. 6. Do not remove vials from the original packaging and do not draw up vaccine in advance. 7. Attached labels to the outside of the container to identify the contents as valuable and fragile vaccines. o Place the following documentation in an envelope placed on the outside container: o Date and time packed o Originating facility o Vaccine types o Number of doses o Lot numbers o Signature of person who packed the vaccines If vaccines must be kept in transport containers during an off-site clinic: • The containers should remain closed as much as possible. • Only the amount of vaccine needed at one time should be removed for administration. • Certified thermometers should be placed in the center of the vaccines. • The temperatures inside the containers should be read and documented at least hourly. The contents of the container should be layered as follows: 1. Refrigerated/frozen packs 2. Insulating barrier 3. Vaccines 4. Certified thermometer in the center of vaccines 5. Insulating barrier 6. Refrigerated/frozen packs V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 17 SUPPLIES FOR TRANSPORT V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 18 PACKING THE VACCINE STAFF TRAINING ON VACCINE MANAGEMENT AND VFC PROGRAM REQUIREMENTS All office staff that handle or administer vaccines should receive annual training to ensure they are familiar with the Vaccine Management Plan and the VFC Program requirements. V.I. Department of Health – Immunization Program | Vaccines for Children Program | 2022 Vaccine Management Plan Rev: 8/2022 19 SIGNATURE LOG Staff assigned vaccine management responsibilities are to review and sign the signature page at the end of this document annually and when the plan is updated. This Plan may be reviewed by VFC Program representatives during routine and drop-in site visits. By signing, I acknowledge I have reviewed and am familiar with the information in this document. Review Date: Provider of Record Name: Signature: Vaccine Coordinator Name: Signature: Back-Up Coordinator Name: Signature: Review Date: Provider of Record Name: Signature: Vaccine Coordinator Name: Signature: Back-Up Coordinator Name: Signature: