NCIP Storage and Handling Procedures by dffhrtcv3


									NCIP Storage and Handling
       Presented by:

       Shirelle Everett
It is better to NOT VACCINATE
    than to administer a dose of
       vaccine that has been
   mishandled, has expired, or is
        the wrong vaccine...

   Objectives for this session

Basic   Storage and Handling Procedures

Understanding   how to handle cold chain
           What is a “Cold Chain”
   The system used to keep
    and distribute vaccines in
    good condition
       Transport and Storage,
       Trained Personnel
       Efficient Management

   Excess heat or cold
    adversely affect the cold
    chain, increasing the risk
    that patient will not be
    protected against VPD.

    It is important to maintain the cold
              chain because…
 …vaccines are very fragile and can lose
  potency following excessive heat or cold
 …once potency is lost, its gone for good
 … if discovered, it could cost your office
  thousands of dollars, and/or cause you to
  have to revaccinate (average infant visit
  cost between $181 -$281, maintaining the
  cold chain keeps that money in your

     It is important to maintain the cold
               chain because…
   …your vaccine can be
    exposed to out of
    range temperatures
    and look normal-
    visual inspections are

  7 Most Common
Storage and Handling
1   . Designating only one person to
      be responsible for storage and
           handling of vaccines

   One person should be designated as “in charge”
    and should be responsible for ensuring that
    vaccine is properly handled and documented.
    There should be at least one back up “in charge”
   Educate all staff on vaccine storage and handling-
    TEAM EFFORT to make sure vaccine moves
    properly through cold chain.

    Vaccine Coordinator should be in
              charge of…
   Receiving vaccines-
       Be present when shipments are delivered and process
        the shipment into inventory and ensuring the cold
        change has been maintained.
   Storing Vaccines-
       Rotating the vaccine inventory so that vaccine with
        shorter expiration dates are used first.
       Ensuring that there are no expired vaccines in
        refrigerator or freezer.
       Keep VFC vaccine separate from privately purchased
       Perform routine cleaning of vaccine storage units.

    Vaccine Coordinator should be in
              charge of…
   Monitoring Vaccine Temperatures
       Recording fridge and freezer temperatures
       Implementing vaccine emergency plans, if needed
       Calling Immunization Branch when cold chain has been
       Ensuring that temperature logs are retained for at least
        three years

   Ordering Vaccines
       Perform a Physical inventory of all vaccines
            To prevent over ordering and expiration, smaller practices
             should only order once every other month, and larger
             practices may order vaccines once a month.
       Complete the VFC vaccine order form by fax or NCIR
   Vaccine Coordinator should be in
             charge of…
Developing and maintaining storage and
  handling protocol which includes:
 Vaccine Ordering Procedures
 Controlling Inventory
 Storing Vaccine and Monitoring storage
  conditions Minimizing vaccine wastage
 Vaccine shipping (receiving and transport)

Minimum Required Ordering Handling and Storage

              Disaster Recovery Plan
   Should be posted near
    refrigerator including the
    following information:
       Designated responsible
        vaccine person and
       Alternate Storage Facility
       Electrical company
       Refrigerator/ Freezer
        repair company
       Locations of key items
        needed during power
        outage (i.e.: Keys,
        Packing Material, Flash

2.Recording Temperatures only
  once per day or using one unit
 temperature for multiple units…

           True or False

    When your office is closed,
temperatures should be checked at least
             once a day…


It is recommended that your office does
  a thorough check of all units and use
    monitoring methods to determine if
   power outage occurred in absence of
        staff (i.e.: penny in cup)

Temperature Monitoring
   Refrigerator temperature

       2 ° C to 8 ° C   (36° F to 46° F)

       Optimum of 5 ° C (40 ° F)

       Report/document out of range        2 C to 8 °C
            0 ° C (out of range)           (36° F to 46°F)
            1 ° C (out of range)
            8.1 ° C (out of range)

     Temperature Monitoring
   Freezer temperature

        -50 °C (58 °F) to -15 ° C
         (5 ° F)

        Optimum of -20 °C
         (-4 ° F)

        Report/document out of New units must be monitored
         range                  and in range for FIVE DAYS
             -14 ° C (out of range)   before vaccine can be stored in
             -13 ° C (out of range)   it.
              Thermometer Placement
   Thermometers should be placed in the
    center of the unit, away from coils, walls
    floors and fans to get the most accurate
       When temperatures seem to be out of range,
        check the placement first.
            Is it too far back?

Vaccine Storage Equipment
National Institute of Standards and Technology (NIST)
 certified and calibrated thermometers (requirement)

                                                   Liquid or

                    Examples of certificates
                    showing thermometer was
                    certified in accordance with
                    NIST standards
It is a requirement to check temperatures
  on both refrigerator and freezer twice a
     NCIP requires National Institute of Technology
      and Standard (NIST) certified thermometers
          Thermometers costing a little less are not worth the
           risk; there are thousands of dollars worth of vaccines
           in most VFC providers refrigerator and freezer
     Temps should be checked first thing in the am
      and the last thing in pm
     If you have 3 combo units, there should be 1
      temperature log for every unit.
If temperatures are out of range…
   Notify
      Primary or back up Vaccine Coordinator

   Isolate-
      Mark vaccine DO NOT USE (Store appropriately)

   Record
      Collect information including lot numbers, expiration
       dates, length of time vaccine was exposed (always
       worst case scenario) Max/Min temperature, and room
       temperatures in case of unknown unit temps.
      Record actions taken – store near temperature logs

   Transport
      In case of power outage, vaccine will need to be moved
       to secure location. VC or back up will need to use DRP to
       insure vaccine stability

If temperatures are out of range…
       Assume vaccine can not be salvaged

       Administer vaccine that has been effected by
        out of range temperatures

       Improperly store vaccine while waiting for
        results- always return vaccine back to
        appropriate storage temperatures

3. Discarding Temperature logs at the end
               of the month

   Temperature logs should be kept for 3
       This helps to track problems and to identify
        how long a problem has existed.
   If even in doubt, most temperature
    requirement information is stated on the
    temperature log.
       Where to keep certain vaccines
       Optimum temperatures and ranges
       Immunization Branch contact information
Examples of Temperature Logs

 Refrigerating vaccine in a
manner that could jeopardize
       its quality…
      True or False

 It helps to put vials
directly on glass shelves
        to maintain

Glass in refrigerator could negatively
  effect the vials by making them 2-5
  degrees colder than the rest of the

    Vaccine Should NEVER be stored…
                In poor circulation situations
 In Vegetable Bins
 In shipping box-
 Over packed units
 In storage bags
               Extreme temperatures situations

   Outside of acceptable temperature ranges
   On floor of units- Unstable Temperatures
   Near unit Coils- Temperatures are usually colder
   Outside of Original Packaging- Colder temperatures
   Directly on glass shelves- Temps 2-5 degrees colder
   In unit doors- Temperature unstable
   In unit with food/drink- Unstable Temperatures

      Vaccine Vial Storage Methods and Locations
       DUAL ZONE                    PHARMACEUTICAL                          FREEZERLESS
 Never place vials directly   Avoid storing on top shelf – near cooling vent. First location to
 on glass shelf = 2 - 5 °C    exceed max allowed temp during outages.

No storage in vegetable                  Manufacturer recommends          1 – 2 °C colder
crisper: thermally                       no floor storage, but vial       than main
isolated + floor level                   TC maintained at 2 – 8 °C        fridge space
runs cold                                throughout testing

5.Inadvertently leaving the
 refrigerator or freezer door
 open or having inadequate
               Preventative Measures

   Use a plug guard or safety-
    lock plug
   Do not disconnect stickers
    on breaker and plug
   Digital Thermometers with
           Sound when temperatures
            reach above or below
            certain temperatures.

   Combo units with separate
    controls for refrigerator
    and freezer
   Door Locks
        Locks whenever door is
          closed, button release
   Educate maintenance and
    custodial staff

   Preventative Measures

                    Continuous read temperature monito

                    Penny in a cup

Clock/plug style
          Inadequate Door Seals
   Door seals should be checked regularly
   Seals for units usually start around $45 and
    can be found at local hardware stores
   To check
        1. Place paper strip against the cabinet of the unit
        2. Close the Door
        3. Pull the paper strip. If it moves easily or falls away
         by itself, the door and the seals my need to be

Vaccine Rotations
   All providers are REQUIRED to rotate
    vaccine stock monthly
       Always place vaccines with shorter expiration
        dates in front of those with longer expiration
       Notify NCIP if you have vaccine that you will
        not use before it expires- at least four months
        in advance

6. Storing Vaccine in an
    inappropriate unit

         True or False

Dorm styled refrigerators with two
 external doors are acceptable for
      long term vaccine use...


This type of unit is acceptable as
   long as it is large enough to
  hold facility’s state supplied
         vaccine inventory

                Dorm Styled Units…
   …with single external door are acceptable for day storage
    ONLY and temperatures must be checked
       No more than one day of clinic’s refrigerated supply should be
        kept in dorm for day storage
  …are acceptable if there are two
  external doors
 …temperatures aren’t stable
   in any part of single
 door dorm unit-over night
storage is unacceptable
 …single Door dorm units
are NEVER acceptable for
frozen vaccines

 Unacceptable Units
           NOT Acceptable:

Units with a Single External Door, but have interior freezer
and refrigerator compartments
Units used routinely to Store Food
                 Equipment Requirements for Vaccine Storage
Refrigerator and freezer must have externally separate, sealed doors.
Refrigerator compartment must maintain temperatures between 35º and 46ºF (2º and 8ºC).
Freezer compartment must maintain temperatures 5ºF (-15ºC) or colder.
Household-style units should have separate thermostat/temperature controls for the refrigerator and freezer.
Both the refrigerator and freezer compartments must contain an NIST- or ASTM-certified thermometer.


                                             Stand-alone           Upright freezer
                                             refrigerator-only     (no refrigerator
                    (full size or compact)
                                             (no freezer           compartment)

                                             Under counter        Under counter
                     Commercial-style        refrigerator-only    freezer-only

   7. Documenting out of range
temperatures on vaccine logs but not
           taking action

TheNCIP requires each
  provider to call the
 Immunization Branch
when temperatures have
  gone out of range.

        Temperature changes
 Vaccine Coordinator (or back up) should be the
      only person to adjust temperatures (more
              hands, more room for error)
   Temperature should be adjusted ½ ° C or F,
           closed and recheck in 30 minutes.
 If using household unit, and freezer is too cold,
   it will effect refrigerator. If there's no room to
          adjust, a new unit may be needed.
 Water Bottles may solve your problem- Add or
                     subtract them!!
    Opening and closing the door too often will
               cause temperatures to rise.
   If your unit’s temperature have gone out
    of range, and you are unsure why, there
    are many different options.
     While attempting to solve problems, never
      leave vaccine in non functioning unit while you
      attempt to solve your problem.
     Implement Disaster Recovery Plan if you are
      unsure how long storage unit will not be
      functioning properly.
    **Always record the date and time of any
      malfunctions or power outages
If your unit is too WARM

If your unit is too WARM cont’d

If your unit is too COLD

If your unit has STOPPED


Is there anything specific I need to know
 about transporting vaccine to a clinic or
            to another facility?

             Transporting Vaccines
   Vaccine may only be transported in insulated containers
    with ice packs and thermometer
   Never place in trunk, temperatures can not be controlled.
   Never leave vaccine in car when it is parked, especially in
    extreme cold or hot temps
   Refrigerated vaccines should not touch cold packs- may
    cause accidental freezing in short amounts of time. Freezer
    stored vaccines may sit directly on ice packs
   Diluents may travel at room temperature or with
    refrigerated vaccines– Should NOT be in contact with
    icepacks/ cold packs
   Diluents should be refrigerated in advanced so that it does
    not raise the temperature of refrigerated vaccine
   Diluents should never be transported with dry ice


When wasting vaccine, do I send it back to
   you, or can I discard it here at my

   When you have vaccine that has expired
    or spoiled, you are required to complete a
    wasted/expired report (NCIR or Paper)
       syringes and multi-dose vials with safety caps
        in place should be mailed back to NCIP
       Prepaid mailing labels can be mailed to you
        upon request
       DO NOT return drawn, but not administered
        vaccine or open vials. Dispose of them at your
        facility. Wasted/Expired reports will need to be
        completed indicating that vaccine was wasted.
Restitution and Appeal Policy

        Restitution Policy and Appeal
   Wasted- Any Vaccine that cannot be used

   Expired- any vaccine with an expiration date that has

   Soiled- any vaccine that exceeds the limit of approved cold
    chain procedures or is pre-drawn and not used within
    acceptable time frames.

   Lost- Shipping company does not deliver the vaccine or
    does not deliver in timely manner.
   Failure to adhere to the current “North Carolina Immunization Program
    Minimum required vaccine ordering, handling and storage procedures”
    document will likely result in a restitution situation.

Situations that DO require Financial
                   Failure to Rotate

       Failure to act according to Disaster
                   Recovery Plan

   Doors left open by staff, contractors, or

            Expired Pre-drawn vaccine.
       Situations that do NOT require
             Financial Restitution
   Cooling unit equipment problems where proof of repair or
     equipment replacement is provided to the Immunization
    Branch within 30 days from the date you become aware of
                          the situation

   Drawing vaccine after screening, but not administered due
                        to parent refusal.
               Partially used multi-dose vials.

   Package is not delivered to the provider in a timely manner
       or is otherwise damaged or stored improperly during

          Restitution Policy Appeals
   If your office experiences a wastage situation
    which defined as provider negligence, and you
    believe there are circumstances which prove it
    was not, you may appeal restitution charges after
    you receive an invoice.
       Must be on formal letterhead
       Fax to Vaccine Manager at 919-870-4824
       Mail to:
         DHHS/ DPH/Immunization Branch
         Attention: Vaccine Manger
         1917 Mail Service Center
         Raleigh, NC 27699-1917

Any Questions?

               Educational Tools
   Immunization Branch web page

   National Immunization Program
      Epidemiology and Prevention
        of Vaccine Preventable
        Diseases (The Pink Book)
       Vaccine Storage and Handling
       Vaccine Management -
        Recommendations for
        Handling and Storage of
        Selected Bilogicals

   North Carolina Immunization
    Branch Customer Service staff
      Contact Information
           Shirelle Everett
NCIP Storage and Handling Consultant
      1917 Mail Service Center
      Raleigh, NC 27699-1917
      Phone: 1-877-873-6247
         Fax 919-870-4826


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