DOH Immunization Program Op...

This document provides a comprehensive vaccine management plan for the protection and maintenance of your practice's vaccine supply. The plan consists of two sections: (1) the Routine (daily) Storage & Handling Plan, which covers all aspects of routine vaccine management and (2) the Emergency Plan, which is used in the event of an emergency situation that may affect the storage and potential viability of your vaccines.

Ensure that all staff (current and new), including those persons who may be required to transport vaccine in an emergency situation, read the plan and understand it. The completed plan must be posted on or near the vaccine storage equipment.

One staff member must be designated as the primary vaccine coordinator, providing oversight for all vaccine management within the office. At least one back-up vaccine coordinator should be trained to perform the same responsibilities as the primary vaccine coordinator in the event the primary person is unavailable. We strongly recommend that the primary and back-up coordinators perform vaccine management activities together from time to time so that procedures and protocols are fully standardized, understood, and implemented by both persons.

NOTE: The District of Columbia VFC program requries each practice to develop and maintain an Emergency Vaccine Retrieval and Storage plan, and a Routine (daily) Vaccine Storage and Handling plan. VFC provider form must review and update this plan annually or more frequently if there are any changes in procedures, vaccine coordinators, and/or equipment. The most current Vaccine Management plan will be reviewed during the VFC Compliance Site Visits and Unannounced Storage & Handling Visits.

A copy of this plan must be posted on or near any refrigerator or freezer used to store all vaccines (government-funded, as well as privately-funded vaccine).

Routine Vaccine Storage & Handling Plan

Name of Medical Director *

Practice Name *

Effective Date *

Routine Vaccine S&H Plan Updated by:

Name *

Title *

Signature *

Date last reviewed *

NOTE: A copy of this plan, along with the Emergency Vaccine Storage and Handling plan, must be posted or or near any refrigerator or freezer used to store vaccines.

Vaccine Coordinators

Primary Coordinator Telephone Number *

ext.

Primary Coordinator Email *

Resource Contact List

Local Health Department Name

Local Health Department Telephone

ext.

Local Health Department Email

VFC Immunization Program Name

VFC Immunization Program Phone

ext.

VFC Immunization Program Email

Electric Power Company Name

Electric Power Company Phone

ext.

Electric Power Company Email

Generator Repair Company Name

Generator Repair Company Phone

ext.

Generator Repair Company Email

Refrigerator Repair Company Name

Refrigerator Repair Company Phone

ext.

Refrigerator Repair Company Email

Freezer Repair Company Name

Freezer Repair Company Phone

ext.

Freezer Repair Company Email

Building Manager Name

Building Manager Phone

ext.

Building Manager Email

Alarm Company Name

Alarm Company Phone

ext.

Alarm Company Email

Proper Storage & Handling Procedures

Vaccine Storage/Temperature Monitoring:

-Provider form are required to have appropriate equipment that can store vaccine and maintain proper conditions.

-Refrigerator and freezer units must be large enough to hold the year's largest inventory without crowding.

-Only stand-alone units are acceptable for vaccine storage.

-Dormitory-style refrigerators are never allowed for the storage of vaccines.

-Maintenance information (contact, serial numbers, etc.) for all VFC vaccine storage units will be kept/posted next to the units.

-Combination refrigerator/freezer units outfitted with a single external door or separate external doors, and dormitory-style refrigerators are never allowed for the storage of VFC vaccine.

-The refrigerator must maintain temperatures between 36 deg F and 46 deg F (2 deg C and 8 deg C) for vaccine viability.

-The freezer must maintain temperatures between -58 deg F and 5 deg F (-50 deg C and -15 deg C).

-Temperatures must be checked and documented twice daily.

-Temperature logs must be kept for a minimum of 3 years.

-The temperature readings/documentation must include the date, time, minimum and maximum, and the initials of the person completing them.

-Place water bottles (labeled "Not for consumption") on the top shelf by the cold air vent, floor, and in door racks of the refrigerator.

-Plug each unit directly into the wall outlet.

-The unit MUST NOT be controlled by a light switch, power strip or surge protector with an on/off switch.

-Post "DO NOT UNPLUG" signs at each outlet and circuit breakers.

-Diluents that are not packaged with vaccine may be stored in the door of the refrigerator and can provide extra insulation much like bottles of water.

Main Inventory Form

Inventory Management/ Ordering:
Ordering Frequency (monthly, bimonthly, quarterly, etc.):
   Provider must make a list of vaccines they need to order. CDC recommends provider form have a four to six week supply of vaccine available.

   Provider must conduct a physical vaccine inventory before making a vaccine order and submit the inventory count to the VFC

   Inventory must be separated based on funding sources and population.

   Clinic staff is able to distinguish VFC vaccine from private vaccine.

   Provider must maintain an accurate report of all VFC vaccine doses administered for each vaccine by lot number

   Clinic staff is trained to screen for VFC eligibility at each clinic visit and document in Electronic Health Record (EHR) or Vaccine Administration Record (VAR).

   Provider must rotated vaccines weekly so the vaccines with the closest expiration dates are used first.

   Provider will train staff involved in receiving vaccine deliveries to be familiar with procedures for handling vaccine shipments

   When vaccines are delivered:
   Staff will inspect package to make sure that it wasn t tampered with.
   Staff will determine the length of time the vaccine was in transit by looking at the packing list.
   Staff will check the temperature indicator readings to determine if the vaccines were exposed to out of range temperatures.
   Staff will confirm lot numbers, expiration dates, and number of doses.
   Staff will check that the correct amount of diluent is included
   Staff will check vaccines for expiration dates to verify that vaccines are not short- dated.
   Staff will immediately store the vaccines at the appropriate temperature.
   Never reject vaccine shipments, even if you did not request/order vaccines.
   Contact the VFC within 2 hours of receiving the vaccine shipment if any discrepancy is noticed.
Vaccine Loss (Expired and Wasted Vaccine)

   Provider will follow the procedures listed below when vaccine loss occurs:
   will complete and submit the Vaccine Loss Report.

   Remove expired/spoiled vaccine from the vaccine storage unit immediately and quarantine.
   Provider will report every dose of vaccine that is lost to the VFC program on a Vaccine Loss Report no later than four days after the loss.
   The completed Vaccine Loss Report must be signed by the medical director who signs the provider agreement.
   Provider will follow the procedures listed below for returning nonviable vaccine;
   is responsible for returning nonviable vaccine.
   Provider will submit a complete Vaccine Loss Report.
   Once the Vaccine Loss Report is approved, the provider will receive a vaccine return label through VTrcks.
   Provider will ensure that all the vaccines listed on the Vaccine Loss Report are included in the box for return.
   Print and include a copy of VTrckS return request form in the box.
   Never include broken vials/syringes or exposed syringe needles in the box for return.

Staff Training and Education

   The primary and backup vaccine coordinators must complete and document annual training by completing one of the following;
   Immunization 101: a 4 hour course offered by the DOH immunization program.
   Two web based training modules. CDC s �You Call the Shots� module 10 and 16. http://www2a.cdc.gov/nip/isd/ycts/mod1/courses/sh/ce.asp http://www2a.cdc.gov/nip/isd/ycts/mod1/courses/vfc/ce.asp
   Staff must be trained on how to properly screen patients and select vaccines based on insurance type.
   The Vaccine storage and handling plan should be posted on or near vaccine storage units.
   Annual immunization-related training should be documented for all staff who administer or manage immunizations.

   Every new staff should be trained on topics covered in this plan at the time of hire/orientation.
   The vaccine storage and handling plan should be reviewed with all staff annually.
   Vaccine administration protocols and recommended immunization schedules should be posted near preparation areas.
   Staff should have immediate access to resources about vaccines, such as CDC s Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book) and the CDC s Vaccine Storage and Handling Toolkit. http://www.cdc.gov/vaccines/recs/storage/toolkit/

Staff Training Documentation

Clinic/Facility Name

PIN #

Emergency Retrieval & Storage Plan

Signature2

Date last reviewed2

This plan should be followed any time the usual vaccine storage is not maintaining proper temperatures, such as during a power outage, vaccine storage unit malfunction, or other emergency.
Mishaps with the vaccines must be reported to the VFC Program immediately
All mishaps that compromise vaccine integrity such as improper storage conditions due to equipment failure, power outage, and/or natural disaster MUST BE reported to Jacob Mbafor VFC Program Coordinator at (202) 576-9317 or (202) 573-2421 and in writing to jacob.mbafor@dc.gov immediately after you have discovered that the vaccine has been compromised.
During an emergency;
   Assess the situation. Do not open the unit.

   Determine the cause of the power failure or equipment malfunction and estimate the time it will take to restore power or have unit repaired.

   Notify the key staff listed on the Emergency Plan.

   If the power outage is expected to be short term, usually restored within 2 hours or repair will take less than 2 hours,

   Record the time the outage started, the unit temperatures (Current, Min, and Max) and room temperature.

   Place a �DO NOT OPEN� sign on the storage unit to conserve cold air mass.
   Monitor the temperature until the power is restored.

Note: Temperatures in commercial, pharmacy, and lab grade units tend to increase faster during power failures. As a result, clinics using these units need to monitor temperatures more frequently and may need to transport vaccines to an alternate location sooner.

Emergency Contacts (in order of listing)

Role

Name2

Title2

Phone

ext.

Role 2

Name 2

Title 2

Phone 2

ext.

Role 3

Name 3

Title 3

Phone 3

ext.

Role 4

Name 4

Title 4

Phone 4

ext.

If the outage is expected to be long term, or maintenance will take longer than 2 hours, consider moving vaccines to an alternative unit or facility.

Temporary Vaccine Transfer Location

Temp Location Name

POC Name

Temp Location Address

Temp Location Phone

ext.

Generator on-site

Date of Agreement

Vaccine Transport Supply Location

Please indicate a list of packing supplies and where someone can obtain them at your site.

Cooler Location

Calibrated Thermometer

Ice Packs/Water Bottles

Extra insulation materials

Packing refrigerated vaccines:
Pack the refrigerated vaccines first, using enough conditioned frozen water bottles to maintain the cold chain. The number and placement of conditioned frozen water bottles inside the container will depend on container size and outside temperature.

   Be sure to place an insulated barrier (e.g., bubble wrap, Crumpled brown packing paper, and Styrofoam peanuts) between the conditioned frozen water bottles and the vaccines to prevent freezing. The vaccines can also be stored in plastic sandwich bags. Layer as follows: conditioned frozen water bottles, barrier, vaccine, thermometer or temperature monitor, another layer of barrier and additional conditioned frozen water bottles.

   DO NOT USE SOFT-SIDE COLLAPSIBLE COOLERS.

   Place thermometers near the vaccine to monitor the temperature. They should not come in contact with the conditioned frozen water bottles.

   Attach labels or write on the container: VALUABLE AND FRAGILE

   Record vaccine type(s), quantity, date, time, and destination on the label or on the outside of the container.

   Record the temperature reading on the label or outside of the container.

   Secure the lid with tape.

   Document the following information:

o Time/temperature of refrigerator storage unit at the time the vaccine is removed for transport.
o Time/temperature of insulated container at end of transport.
o Time/temperature of refrigerator storage unit at alternate vaccine storage facility upon receipt of vaccine(s).

Packing frozen vaccines:

   Dry ice cannot be used for transport or storage of varicella-containing vaccine.

   If frozen vaccines must be transported, the CDC recommends transport with a portable freezer that maintains a temperature between -58�F and +5�F (-50�C and -15�C).

   A VaxiPac may also be used to transport frozen vaccine. Pack the frozen vaccines (varicella, MMRV and zoster) last, using the VaxiPac portable carriers and 3 or 4 remaining VaxiSafe cold packs.
   Place specialized cooler pack then vaccines then cooler pack.
   The VaxiPac carrier must be latched and closed before transport.
   If varicella-containing vaccine must be transported and a portable freezer unit or VaxiPac is not available, the vaccine may be transported under refrigerated conditions for up to 72 continuous hours prior to reconstitution. Immediately upon arrival at the alternate storage facility, place the varicella-containing vaccine in the freezer between -58�F and +5�F (-50�C and -15�C). Contact the manufacturer (Merck) for guidance regarding vaccine use and stability. If transporting frozen vaccine under refrigerated conditions, the following information must be documented:
o Time/temperature of refrigerator storage unit at the time the vaccine is removed for transport.
o Time/temperature of insulated container at end of transport.
o Time/temperature of refrigerator storage unit at alternate vaccine storage facility upon receipt of vaccine(s).
o Recommendation from Merck on stability and use of the vaccine after the transport.
Note: Transport vaccines in the passenger seat; not in the trunk because temperatures cannot be controlled inside the trunk. Transport immediately to the alternate storage site and use the shortest driving route.
   Upon arrival at the alternate facility, check the temperature of the unit in which the vaccine will be stored. The freezer temperature should be at 5� degrees F� (-15 degrees C) or colder. The refrigerator temperature should be between 36� degrees to 46� degrees (2� degrees to 8� degrees). Make sure there is no food stored in the unit.

   Once at the alternate storage facility, check temperature of unit.

   Ensure temperatures are within range for both refrigerator and freezer.

   Unpack refrigerated vaccines first.

   Unpack freezer vaccines last.

   Do not store vaccines in the door. (Diluent can be stored in the door.)

   Vaccines shouldn t touch the sides of the refrigerator.

   Do not pack tightly. Ensure that adequate cold air can circulate around the vaccines.

   Put the MMR, MMRV, Zostavax and Varicella in the freezer ONLY.

   Label vaccines DO NOT USE and store appropriately until a determination on their viability can be made.

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