Adult Vaccine Program User Manual
USER MANUALFor clinics participating in the Washington State Adult Vaccine ProgramDOH 348-640. March 2021Questions? Contact the Department of Health at 360-236-2829 orWAAdultVaccines@doh.wa.govTo request this document in another format, call 1-800-525-0127. Deaf or hard of hearing customers,please call 711 (Washington Relay) or email civil.rights@doh.wa.gov.
ContentsDEFINITIONS . 4ADULT VACCINE PROGRAM (AVP). 5ADULT VACCINE PROGRAM UPDATES NEWSLETTER . 5PROGRAM ENROLLMENT . 6VACCINE ORDERING . 6HOW ADULT VACCINE PROGRAM ORDERING WORKS. 7PACKING SLIPS FOR DELIVERED VACCINE . 8VACCINE STORAGE AND HANDLING . 9RECEIVING A VACCINE DELIVERY . 9SHIPMENTS-ALLOCATIONS . 10VACCINE DEPOT . 10STORAGE UNITS . 10DETERMINING STORAGE UNIT SIZE . 11LABELING VACCINE . 12TEMPERATURE MONITORING . 13OUT OF RANGE TEMPERATURES. 14OUT OF RANGE TEMPERATURES-STILL VIABLE . 15OUT OF RANGE TEMPERATURES-NOT VIABLE. 15QUICK CHECKLIST FOR VACCINE STORAGE AND HANDLING . 15OFF-SITE CLINIC GUIDELINES . 16VACCINE LOSS POLICY . 17MANAGING ADULT VACCINES IN THE IIS . 20ADULT VACCINES AND DECREMENTING . 20ADDING ADULT VACCINES IN IIS INVENTORY . 21REQUIRED REPORTING . 22QUARTERLY REPORT . 22SUBMITTING A FINAL REPORT . 23TRANSFERRING VACCINE . 23PROGRAM DISENROLLMENT . 24VACCINE LOSS . 25RETURNING EXPIRED OR SPOILED VACCINE . 25FREQUENTLY ASKED QUESTIONS . 25EMERGENCY PLANNING . 28WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 2 of 32
ELIGIBILITY AND BILLING FOR PUBLICLY FUNDED VACCINES . 30SCREENING . 31OUTBREAK RESPONSE . 32APPENDIX A – PROVIDER AGREEMENT . 33APPENDIX B – VACCINE TRANSFER FORM . 41APPENDIX C – VACCINE LOSS FORM . 43APPENDIX D – TEMPERATURE LOG . 45APPENDIX E – TALLY SHEET . 50APPENDIX F – OFF-SITE TEMPERATURE LOGS . 52WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 3 of 32
DefinitionsAdministration FeeThe amount that can be charged for theadministration of an adult vaccine. Theadministrative fee cap is 23.44.Physical InventoryThe total amount of vaccine that is physicallylocated within a storage unit at the timeinventory is taken.Adult Vaccine Program (AVP)The Washington State Adult Vaccine Program(AVP) provides vaccine for adults 19 years of ageand older who are uninsured or underinsured.The program is funded using 317 federal funding.Vaccine is available for providers to order duringa limited time once a year (usually JuneSeptember).Quarterly ReportThe Adult Vaccine Program quarterly report isdue January, April, July, and October. Submissionis through the quarterly report survey. It providesthe quantity of adult vaccine administered duringthe previous three (3) months.Immunization Information System (IIS)The Washington State Immunization InformationSystem (IIS) is a statewide, lifetime immunizationregistry that tracks immunization records forpeople of all ages. The IIS is a secure, web-basedtool for healthcare providers that provides a freeand user-friendly way to keep immunizationrecords up-to-date and to know which vaccinespatients need.InsuredA person with insurance that covers the cost ofvaccine, even if the insurance includes a highdeductible or co-pay, or if a claim for the cost ofthe vaccine and its administration would bedenied for payment by the insurance carrierbecause the plan’s deductible had not been met.– Centers for Disease Control and Prevention(CDC)WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALUnderinsuredA person who has health insurance, but thecoverage does not include vaccines or a personwhose insurance covers only selected vaccines.– CDCUninsuredA person that does not have health insurance.Vaccine OrderThe number of vaccine doses requested,approved by the program, and delivered to thefacility.Vaccine ReturnAny adult vaccine that is returnable. Returnablevaccines require a completed Vaccine Loss Form(Appendix C) in order to receive a return shippinglabel.Page 4 of 32
Adult Vaccine Program (AVP)The Washington State Adult Vaccine Program (AVP) provides vaccine to participating provider locationsfor adults 19 years of age and older who are uninsured or underinsured. The program is funded using317 federal funding and allows participating providers to receive vaccine at no cost to administeraccording to program requirements. Section 317 vaccine is a precious national resource that will be usedto fill critical public health needs, such as providing routine vaccination for those with no insurance andresponding to outbreaks of vaccine-preventable diseases.Providers may request available vaccine during a limited time once a year (usually June-July). Thevaccines offered may change from year to year.Funding is received in October and prioritized for outbreak response throughout the year. The AdultVaccine Program Updates newsletter will send out information regarding request opportunities typicallymid-June through mid-July. Providers that submit a survey request for doses will receive an emailregarding their enrollment status and if any required documentation is needed. Requireddocumentation will be due before the end of August in order to create an allocation. Eligible providerswill receive an allocation of doses based off remaining 317 funds. In September all remaining fundingwill be allocated for the Adult Vaccine Program and orders will be placed for providers.Adult Vaccine Program Updates NewsletterProvider locations are notified of program initiation, changes, requirements and deadlines through theAdult Vaccine Program Updates newsletter. If interested in receiving the newsletter, please email us atWAAdultVaccines@doh.wa.gov. It is the facility locations responsibility to ensure contact emailaddresses are updated for distribution in order to ensure communication is received. Having multiplecontact email addresses added to the distribution list will help ensure coverage when updates are sent.WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 5 of 32
Program EnrollmentProgram enrollment occurs annually. To enroll in the Adult Vaccine Program:1. Sign and submit a completed Provider Agreement2. Obtain an appropriate thermometer (see page 11 of this manual)3. Complete You Call the Shots: Vaccine Storage and Handling Training4. Ensure all reports are complete and submitted (if previously enrolled)5. Submit Adult Vaccine Program order request when availableProviders who miss the opportunity to request adult vaccine doses can contact the program regardingsurplus dose availability. Once enrollment is approved, you will be add to the distribution list andinformed of any available surplus doses.Providers are only eligible for vaccine if their provider agreement is approved, all reports are complete,and a completed vaccine request is received when the request is available.Vaccine OrderingAdult Vaccine Program orders are not placed in the Immunization Information System. This program isavailable based on a limited funding amount, that typically occurs only once each year. A survey is sentin the Adult Vaccine Program (AVP) Updates newsletter, with a link to submit your vaccine request(typically June-July).Based on any remaining funding a vaccine allocation is created. You will be notified of the vaccine andnumber of doses that are allocated to you (typically in September). We will process your allocated orderand you will receive all doses in one shipment (typically in September). The allocation may not matchthe number of doses you requested. You must have all required enrollment documents submitted inorder to receive an allocation.ReceiveCompleteSubmitAllocationOrder Adult Vaccine Program Updates newsletter Request survey provided in the newsletter (typically June-July) Provider Agreement Reports Any responses required regarding the order request Number of doses provider will receive based on availablefunding is created (that met all program requirements) Placed for providers based on allocationWASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 6 of 32
How Adult Vaccine Program Ordering WorksProgram interest iscollected through theAdult Vaccine ProgramUpdates newsletter surveywhen availableVaccine orders areshipped and delivered toparticipating providersOrder requests aregathered, providers arecontacted regarding anymissing requireddocumentationOrders are processed onparticipating providersbehalf, based onallocation emailA deadline for all requireddocumentation isprovided incommunication forproviders with missingdocumentationProviders with completedrequired documentationreceive an allocationemail. Allocations arebased on how manydoses were requestedand how much fundingremainsWASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 7 of 32
Packing Slips for Delivered VaccineInspect the vaccine delivery when it arrives. Information regarding receiving your delivery can be locatedunder the receiving a vaccine delivery section.Review the packing slip to ensure delivered items are for the correct number of doses and ensureexpiration dates. The packing slip for Adult Vaccine Program doses will indicate ADULT or 317. Theprogram is funded using 317 federal funding.Examples of packing slips are shown below.Make sure to retain all program related materials forthree years, this includes the packing slipExample AExample BWASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 8 of 32
Vaccine Storage and HandlingReceiving a vaccine deliveryAccept all AVP shipmentsDo not reject a vaccine packageRefusing a vaccine delivery can compromise the viability of the vaccine and result in wastage.When vaccine deliveries arrive – unpack vaccines immediately1. Contact the vaccine coordinator, back-up coordinator, or other staff member to immediatelyreceive and store the vaccine shipment appropriately.When receiving a vaccine shipment2. Examine container and contents for physical damage. If the package and contents:o ARE NOT damaged – continue unpacking.o ARE damaged – immediately contact the vaccine distributor, McKesson, at 1-877-836-7123.McKesson must be contacted the same day vaccine arrived from the carrier. Also, notify theprogram at 360-236-2829 or WAAdultVaccines@doh.wa.gov.3. Check the packing list or package insert to determine how long the vaccine was in transit, andthe cold chain temperature monitors to ensure temperatures are within the recommendedrange. If the temperature monitors:o ARE within range – continue unpacking.o ARE NOT within range – immediately note the date, time and temperature monitorreading, label the vaccine Do Not Use and store under proper conditions. Contact thevaccine distributor, McKesson, at 1-877-836-7123. McKesson must be contacted the sameday vaccine arrived from the carrier. Also, notify the program at 360-236-2829 orWAAdultVaccines@doh.wa.gov.4. Store the vaccine at the appropriate temperatures and contact the program the same day atWAAdultVaccines@doh.wa.gov, if you find any discrepancies with vaccine quantities received.o Place vaccines in trays or containers for proper air flowo Put vaccines that are first to expire in fronto Keep vaccines in original boxes with lids closed to prevent exposure to lighto Separate and label by vaccine type and Adult Vaccine Program supplied vaccine5. Crosscheck contents and expiration dates with the packing slip.6. Receive vaccine using the Washington Immunization Information System if applicable.RememberNever RejectInspect/CheckWASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALStorePage 9 of 32
Shipments-AllocationsVaccine allocations will be received in one order; vaccine will not be received at a later date. Theprogram’s funding is limited and prioritized for outbreak response, if vaccine is compromised in anywayand is no longer viable there are no replacement doses.Your entire allocationwill be placed for youStore vaccine correctlybased on packing insert.There are noreplacement doses.Vaccine DepotEnrolled facilities cannot function as a vaccine depot for other facilities. Federal policy does not allowone provider to order vaccine with the intent to disperse vaccine to multiple clinic sites. Each clinic siterequesting vaccine must enroll and obtain a unique Provider Identification Number (PIN).Storage UnitsVaccine storage units must maintain recommended vaccine temperatures at all times. Storage units arerequired to have the capacity to store the largest inventory a provider might have at the busiest point inthe year without crowding. If the storage unit is new or repaired, temperatures must be monitored andmaintain stable temperatures for three to five (3-5) days prior to receipt of vaccine.The use of dormitory or bar-style units is prohibited. A dorm style unit is a small combinationrefrigerator/freezer unit that is outfitted with one exterior door and an evaporator plate (cooling coil),which is usually located inside an icemaker compartment (freezer) within the refrigerator.Vaccine Storage Equipement mustmaintain recommended temperaturesat all timesWASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 10 of 32
Types of vaccine storage units Pharmaceutical-grade units: A storage unit that is specifically designed to store vaccines. Stand-alone storage units: A storage unit that operates independently of any other device orsystem for its desired function. Refrigerator that only functions as a refrigerator. Or freezer thatonly functions as a freezer. Household-grade units: A storage unit that is primarily sold for home use. The freezercompartment of this type of unit is not recommended to store vaccines and there may be otherareas of the refrigerated compartment that should be avoided as well. If the facility providesfrozen vaccine, a separate freezer unit is necessary.Storage Unit PlacementIt is important for good air circulation to be around the outside and inside of the storage unit. Placestorage units in well-ventilated rooms, leaving space around the unit. Nothing should be blocking thestorage unit.Determining Storage Unit SizeTo determine the ideal storage unit size:1. Estimate the maximum number of doses of publicly supplied vaccine and privately purchasedvaccine (if applicable) to be stored in the unit.2. Match the maximum doses with the minimum cubic feet needed to safely store vaccine in thetable below. Purchase a storage unit that is properly sized for your clinics needs and meets allAdult Vaccine Program and if enrolled, Childhood Vaccine Program requirements. Wheneverpossible, choose purpose built pharmaceutical grade units.Maximum Doses100 - 399400 – 700701 – 800801 – 900901 – 10001001 – 20002000 WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALMinimum Cubic Feet4.9 – 6.1 cu. ft.11 – 16.7 cu. ft.17 – 19.5 cu. ft.21 – 23 cu. ft.36 cu. ft.40 cu. ft.May need more than one unitPage 11 of 32
Labeling VaccineLabel Adult Vaccine Program vaccine in your storage unit to distinguish vaccine from childhood vaccineor privately purchased vaccine. The image below provides an example of labeling the contents of thestorage unit to identify different vaccine programs. For example, labeling Adult Vaccine Program doses,“AVP 19 Uninsured/Underinsured.”WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 12 of 32
Temperature MonitoringMonitor the storage unit’s temperature with an appropriate thermometer. Vaccine viability depends onan approved and currently calibrated thermometer.A primary and back-up digital data logger or continuous temperature monitoring system with adetachable probe in a bottle filled with a thermal buffer is required for each unit storing vaccine. Thethermometers must have current certificates of calibration in accordance with National Institute ofStandards and Technology (NIST) or the American Society for Testing and Materials (ASTM) standards.Thermometers must be re-certified every year or every other year depending on manufacturerrequirements.An ongoing file of temperature logs is required. Temperature monitoring log is located in Appendix D.Review digital data logger data weekly to confirm temperatures remained within range.Use anapprovedthermometerEnsure yourthermometeris calibratedMonitor thestorage unit'stemperatureKeep anongoing file oftemperaturelogsThermometer RegulationsRequirements- A detachable, buffered probe- An active temperature display that can be easily read from the outside of unit- Capacity for continuous monitoring and recording capabilities where the data can be routinelydownloaded- Low battery indicator- Reset feature- Current temperature display, as well as minimum and maximum temperatures- Must use as primary thermometer for daily temperatures and minimum and maximumreadings, cannot use backup device- Backup thermometers must also be digital data loggers- All storage units used to store Adult Vaccine Program Vaccine must have a thermometer with acurrent certificate of calibration- Alarm for out-of-range temperatures- Accuracy of /- 1 F (0.5 C)- Memory storage of at least 4,000 readings- User programmable logging interval (or reading rate) to measure and record temperatures atleast every 30 minutesWASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 13 of 32
Out of Range TemperaturesAny temperature reading outside recommended ranges listed in the manufacturers’ package insert isconsidered a temperature excursion. Identify temperature excursions quickly and take immediateaction.NotifyDocumentNotify the primaryand backup vaccinecoordinatorimmediately if youdiscover atemperatureexcursionDocument details of thetemperature excursionincluding: Date and time Storage unittemperature Minimum andmaximumBag the affectedtemperatures duringvaccines and place athe time of the eventlabel on them saying, Room temperature"DO NOT USE." Description of theeventDo not discard the Inventory affectedvaccines or removevaccinesthem from the storage Name of the personunitcompleting the reportContactContact thevaccinemanufacturer(s)for guidanceBe prepared toprovide themanufacturer withdocumentationand digital datalogger dataCorrectDo not disconnect the alarmuntil you determined andaddressed the causeCheck the basics, including: Power Supply Unit door(s) Thermostat SettingsIf you believe the storageunit failed, implement youremergency vaccine planIf the thermometer failed,use your back-upthermometerNever allow vaccines toremain in a nonfunctioningunitComplete the Vaccine LossForm if applicableManufacturer contacts for excursionsMerck: 1-800-672-6372GlaxoSmithKline: 1-888-825-5249Seqirus: 1-855-358-8966WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALSanofi Pasteur: 1-800-822-2463Pfizer: 1-800-438-1985Massachusetts Biological Labs: 1-617-474-3000Page 14 of 32
Out of Range Temperatures-Still ViableIf the vaccines are determined still viable after contacting the manufacturers regarding out of rangetemperatures: Retain all information regarding the temperature excursion Keep a record of the lot numbers impacted Mark the vaccine boxes that experienced out of range temperatures For Example: All information regarding previous excursions will need to be provided to the manufacturer if thevaccine experiences out of range temperatures again.Out of Range Temperatures-Not ViableIf the doses are determined not viable after contacting the manufacturers regarding out of rangetemperatures: Keep the vaccines in the storage unit labeled “do not use” Determine if there was any issue with the digital data logger readingsIf the doses are determined not viable and there is no issue with the digital data logger after contactingthe manufacturers regarding out of range temperatures: Remove the non-viable vaccines from the storage unit Keep them labeled, “do not use” and away from the storage unit Complete the Adult Vaccine Program Loss Form located in the Adult Vaccine Program UserManual Appendix C to start the vaccine return processQuick Checklist for Vaccine Storage and HandlingQuick Checklist for Vaccine Storage and Handling Vaccines are stored accordingly to manufacturer’s packing insert. Vaccine Storage Temperatures are:o Refrigerator: Temperatures are between 36 F and 46 F (2 C and 8 C)o Freezer: Temperatures are between -58 F and 5 F (-50 C and -15 C) Vaccines are stored in a storage unit that is not a dorm style unit. Dorm Style units are a smallcombination refrigerator/freezer unit that is outfitted with one exterior door and an evaporatorplate (cooling coil), which is usually located inside an icemaker compartment (freezer) within therefrigerator. Vaccines are stored in a storage unit with a digital data logger or temperature monitoring systemwith current calibration certificates. If temperatures go out of range, label the vaccine “do not use,” keep under correct temperatureranges and contact manufacturers to determine viability. If temperatures are out of range and cannot be corrected, the emergency response plan isactivated.WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 15 of 32
Off-Site Clinic guidelinesAn off-site clinic is a temporary location to administer vaccines. Vaccines may be properly transported toanother location for administration with the intent to return vaccines to the original location where theywere received.Off-site clinic checklist Ensure you have a working digital data logger with a current certification of calibration for use atyour clinic. This digital data logger must be in addition to the digital data logger that is recordingyour storage unit temperatures. Use a digital data logger that meets state and CDC guidelines for public vaccine. Ensure you have all necessary materials to pack and transport the vaccines for the off-site clinic. Use a portable storage unit or certified pack-out. Follow the vaccine transport guidelines for packing vaccines. Keep record of the temperatures during transport along with the quantity of doses and the lotnumber transferred. An off-site clinic cannot exceed eight hours, including transport time. Ensure the cold chain is always maintained during transport and throughout the clinic. Providers may pre-draw up to 10 doses of vaccine at a time during an off-site clinic.o All remaining pre-drawn doses must be discarded and logged as waste at the end of theclinic. Monitor digital data logger(s) and record temperatures on paper temperature logs hourly,located in Appendix F. After the clinic, download and review digital data logger temperature data. If the vaccine went out of temperature range during the off-site clinic, call the manufacturer toaccess viability of the vaccine and notify the Adult Vaccine Program atWAAdultVaccines@doh.wa.gov. Complete a Vaccine Loss Form for any wasted vaccine doses and submit the loss form toWAAdultVaccines@doh.wa.gov.WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 16 of 32
Transport System RecommendationsType of UnitPortable Vaccine Refrigerator or FreezerQualified Container and Pack outConditioned Water Bottle TransportSystemManufacturer’s Original ShippingContainerFood/Beverage coolersPre-approval required with the AdultProgramEmergencyTransportTransfer to anotherenrolled es (lastresort only)NoNoNoNoNoYesNoNoVaccine Loss PolicyIntroductionProper vaccine storage, handling, and accountability are vital components to the success of theWashington State Department of Health’s Adult Vaccine Program. This policy outlines processes andrepercussions if a vaccine incident or loss were to occur. These may include requiring a provider tocomplete additional training and/or purchase updated equipment to reduce the risk for future vaccineloss.ScopeThis policy applies to all Washington providers who receive publicly supplied adult vaccine.Definitions Provider: An individual, partnership, private organization, or public organization enrolled in theAdult Vaccine Program.Incident/Vaccine Loss: Expired, spoiled, wasted, or lost/unaccounted for vaccine.Negligence: Failure to take reasonable action to prevent vaccine loss.Expectations of Providers Providers agree to maintain proper storage and handling practices to avoid vaccine loss.Providers agree to review vaccine storage temperatures manually during clinic hours based onprogram requirements.Providers agree to take action immediately for temperature excursions or inappropriatestorage conditions for any vaccine. Any temperature reading outside the recommended rangesas outlined in the manufacturers’ package inserts is considered a temperature excursion.WASHINGTON STATE ADULT VACCINE PROGRAM USER MANUALPage 17 of 32
Providers agree to report all vaccine loss by completing an Adult Vaccine Program Vaccine LossForm located in the Adult Vaccine Program User Manual.Providers agree to retain Adult Vaccine Program documentation for three years.Reasons of negligence include but are not limited to the following: Failure to open vaccine shipments immediately, resulting in damaged and non-viable vaccine. Failure to rotate vaccine s
System (IIS) is a statewide, lifetime immunization registry that tracks immunization records for people of all ages. The IIS is a secure, web-based tool for healthcare providers that provides a free and user-friendly way to keep immunization records up-to-date and to know which vaccines patients need. approved by the program
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3 Types of refrigerators for vaccine storage 17 3.1 Purpose-built vaccine refrigerators 18 3.2 Portable purpose-built vaccine refrigerators 19 . The 'cold chain' is the system of transporting and storing vaccines within the safe temperature range of 2 C to 8 C. The cold chain begins from the time the vaccine is manufactured, continues
