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Massachusetts Department of Public Health Training Module. Vaccine Management, Storage, and Handling. Presented by: Bob Morrison Vaccine Manager Massachusetts Department of Public Health November 16, 2010. 1. Learning Objectives. Summarize principles of vaccine management

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Massachusetts department of public health training module

Massachusetts Department of Public HealthTraining Module

Vaccine Management, Storage, and Handling

Presented by:

Bob Morrison

Vaccine Manager

Massachusetts Department of Public Health

November 16, 2010

1


Learning objectives
Learning Objectives

  • Summarize principles of vaccine management

  • Describe current vaccine storage and handling recommendations

  • Describe preventative measures to maintain refrigerator and freezer temperatures

  • List steps to protect vaccine in the event of a power outage or emergency

2

LA DPH



Importance of vaccine protection
Importance of Vaccine Protection

  • Vaccines are fragile-keep at recommended temperatures at all times to maintain potency

  • Mishandled vaccines increase the risk that recipients will not be protected

  • Vaccines are expensive

  • Vaccine Restitution Policy, effective 1/1/11

4

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Vaccine management guidelines
Vaccine Management Guidelines

  • Develop and maintain detailed written protocols and emergency plan

    • See www.mass.gov/dph/imm for sample templates

  • Assign responsibilities to one person

  • Designate a back-up person

  • Provide staff training on vaccine management

  • Obtain proper equipment and materials

LA DPH

5


Vaccine manager responsibilities
Vaccine Manager Responsibilities

  • Order vaccine and oversee inventory

  • Receive vaccine and refrigerate/freeze immediately

  • Provide proper storage and handling

  • Handle damaged, wasted and expired vaccine

  • Respond when vaccine is out of required temperature range

    • Contact MDPH Vaccine Unit to determine if vaccine has been damaged (617-983-6828)

LA DPH

6


Vaccine inventory management
Vaccine Inventory Management

Limit access to authorized personnel

Order vaccines regularly, do not stockpile

Organize vaccine with shortest shelf life in front

Conduct and log vaccine inventory monthly

Rotate vaccines and monitor expiration dates

7

LA DPH


Vaccine inventory management1
Vaccine Inventory Management

  • Separate by lot numbers and formulations

  • Keep vaccines in original packaging to protect from light

  • Never use expired vaccine or diluent

  • Report vaccine usage if required

  • Return unused, expired vaccine and diluent if required

8

LA DPH


Receiving vaccine
Receiving Vaccine

  • Examine shipment immediately upon arrival

  • Report problems to MDPH within two hours

  • Check contents against packing slip

  • Check vaccine expiration dates

  • Examine contents for damage

  • Check temperature monitor

  • Immediately place in appropriate storage

  • Keep a shipping box on hand to use when returning any damaged or expired vaccine

9


10

CDC


3 components of the cold chain
3 Components of the Cold Chain

  • Proper transport and storage equipment

  • Trained personnel

  • Current vaccine management policies and procedures

11

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Maintain the cold chain
Maintain the Cold Chain

Transport vaccine from refrigerator to clinic site in cooler with cold packs (not frozen packs) and thermometer

Refrigerate cold packs for at least 24 hours before use in transport

Keep vaccine on cold packs, but provide a barrier to protect from direct contact with cold pack

12


Vaccinator responsibilities at station
Vaccinator Responsibilities at Station

  • Maintain the cold chain at vaccinator station

    • Injectable vaccine: max 30 minutes at room temperature

    • Intranasal vaccine: kept at 2 - 8° C (35 - 46°F)

  • Any vaccine drawn up must be used by end of clinic or be disposed of

  • Protect from exposure to light

  • Label opened unused vials with date and your initials

13



General vaccine storage requirements
General Vaccine Storage Requirements

Have unit large enough to store your maximum vaccine inventory

Dedicate unit to vaccines/medications only

Monitor refrigerator/freezer temps for at least 3 days prior to storing vaccine

Maintain required temperature range year-round

Make arrangements for vaccine storage, monitoring temperatures and receipt of vaccine during vacations or other lengthy absences

15


Vaccine storage units
Vaccine Storage Units

  • CDC recommends separate refrigerator and freezer units for vaccine storage

  • For combination units, make sure there are separate doors and controls for refrigerator and freezer

  • It is recommended that units used to store vaccines be less than 10 years old

  • Have a certified calibrated thermometer inside both the refrigerator and freezer in a central area

16

LA DPH


Maintain proper temperatures
Maintain Proper Temperatures

HANDLE WITH CARE!

Maintain refrigerator

temps between

2°-8°C or 35°-46°F

Maintain freezer

temps at

-15 °C or 5°F or colder

Protect from light

17


Vaccine storage handling tips
Vaccine Storage & Handling Tips

Do not store vaccine on unit doors

Do not store biologics with food or drink

Place thermometer and vaccine in

central area of the unit

Organize and label vaccine in baskets

that allow air circulation

Refer to package insert for specific guidelines regarding the storage and handling of different formulations

9/11/2014

18

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Monitor temperatures
Monitor Temperatures

  • Record temperatures twice daily

    • First thing in the morning

    • End of the work day

    • Temperature logs must be retained for at least 3 years

    • Monitor for out-of-range temperatures

  • Place temperature logs on front of unit

  • Submit temperature logs as required

23

LA DPH


Out of range temperatures
Out of Range Temperatures

  • All out of range temperatures require immediate reporting to MDPH Vaccine Unit

    617-983-6828 or

    617-983-6800 (24 x 7)

    1-888-658-2850

  • Actions and results of these actions must be documented on the temperature logs

LA DPH

24


Emergency plan for loss of power
Emergency Plan for loss of power

  • Develop an emergency plan

  • Share the emergency plan

  • Post the emergency plan

  • Update and practice your plan annually

25

LA DPH


Power failure
Power Failure

  • If you lose power for extended period, follow your emergency plan:

    • pack vaccine

    • transport to prearranged site

    • notify MDPH Vaccine Unit

  • When power returns:

    • do not adjust the temperature control in unit

    • allow unit to return to proper temperature range

    • return vaccine to unit

  • LA DPH

    26



    Temperature adjustment1
    Temperature Adjustment

    • Never adjust the refrigerator temperature control with vaccine in unit

    • Consult with MDPH Vaccine Unit

    • Remove vaccine to another refrigerator/freezer

    • Adjust temperature of unit

    • Wait until you have 3 successive readings one hour apart within range before returning vaccine to the unit

    28

    LA DPH


    Safeguard power supply
    Safeguard Power Supply

    • Use a plug guard or safety-lock plug

    • Place “Do Not Unplug” sign on storage unit, outlet and “Do Not Disconnect” on circuit breakers

    • Consider installing a temperature alarm

    • Do not use extension cords

    29

    LA DPH




    The effect of thermotrauma on vaccines
    The Effect of “Thermotrauma” on Vaccines

    Live vaccine:

    Tolerates freezing (Call MDPH Vaccine Management Unit if this occurs: 617-983-6828)

    Deteriorates rapidly after removal from refrigeration

    Inactivated vaccine:

    Damaged by freezing

    Tolerates short time out of refrigeration

    32


    Vaccine shelf life
    Vaccine Shelf Life

    • Multi-dose vials of vaccine contain a bacteriostatic agent.

      • After opening, can be used until the date of expiration as specified by the manufacturer and package insert, unless visibly contaminated.

      • Date and initial multi-dose vials after opening and use first.

      • In the event the refrigerator/freezer temperatures are out-of-range, this is important in determining the viability of the remaining doses in the vial.

      • Always check the package insert for shelf life guidelines when opening multi-dose vials.

    • Single-dose vials do not contain a bacteriostatic agent.

      • Once opened, they must either be used or discarded at the end of the day.


    Storing diluents
    Storing Diluents

    • Diluents packaged separately from their corresponding vaccines can be stored at room temperature or in the refrigerator.

    • Diluents packaged with their vaccines should be stored in the refrigerator.

    • Once vaccines are reconstituted with a diluent, their shelf life is limited.

    34


    Take home messages
    Take-Home Messages

    Colder is NOT better for inactivated vaccines

    It is estimated that >$100 million worth of vaccine is exposed to freezing temperatures each year in the United States

    Out of range temperature readings require IMMEDIATE action

    Remove expired vaccine from refrigerator

    Report vaccine usage to MDPH Vaccine Unit: 617-983-6828

    35


    Vaccine storage handling questions
    Vaccine Storage & Handling Questions

    MDPH Vaccine Management Unit

    (617) 983-6828

    MDPH Immunization/Epidemiology Division

    (888) 658-2850

    (617) 983-6800 (24x7)

    Always consult with MDPH Immunization Program before removing improperly stored vaccine from the storage unit

    If the temperature of the vaccine goes out of

    range, either too high or too low, call the MDPH

    Vaccine Management Unit immediately!

    36


    Please take a look at the other training modules
    Please take a look at the other training modules!

    Vaccine and Medication Preparation and Administration

    Planning a Clinic/EDS/POD

    All-Staff Briefing & Just-In-Time Training

    Available at: http://sph.bu.edu/otlt/alliance/training_publichealthnursing.php

    9/11/2014

    37


    Online resources
    Online Resources

    MDPH Guidelines for Compliance with Federal and State Vaccine Administration Requirementshttp://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/guidelines_vaccine_compliance.pdf

    MDPH General Protocols for Vaccine Storage, Administration, Standing Orders, and Mass Immunization Clinics, Sept 2009http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/mso_protocols_general.pdf

    MMWR: General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices (ACIP), December 2006

    http://www.cdc.gov/mmwr/pdf/rr/rr5515.pdf

    MDPH Vaccine Management Guidelines for Vaccine Providerhttp://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/vaccine_management_checklist.pdf

    38


    Online resources1
    Online Resources

    MDPH Immunization Programhttp://www.mass.gov/dph/imm

    Immunization Action Coalitionwww.immunize.org

    Epidemiology and Prevention of Vaccine-Preventable Diseases, The Pink Book: Course Textbook (11th Edition), May2009http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm#download

    World Health Organizationhttp://www.who.int/en

    39


    Online resources2
    Online Resources

    MDPH Sample Vaccine Management-Standards Operating Procedures (SOP)http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/vaccine_management_sop_sample.pdf

    Emergency Response Worksheet for vaccine storagehttp://immunize.org/catg.d/p3051.pdf

    Pediatrics “Standards for Child and Adolescent Immunization Practices” National Vaccine Advisory Committee, Pediatrics 2003: 112: 958-963http://www.pediatrics.org/cgi/content/full/112/4/958

    40


    Online resources3
    Online Resources

    • CDC: Vaccine Storage and Handling Toolkit

      http://www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm

    • CDC: Vaccine Management Business Improvement Project (VMBIP);

      New Centralized Vaccine Ordering and Storage Requirementshttp://www.cdc.gov/vaccines/programs/vmbip/default.htm

    • MDPH: Vaccine Management Business Improvement Plan: Basic Guidelineshttp://mass.gov/EOHHS2/docs/dph/cdc/immunization/vmbip_basic_gu idelines.pdf

    • Los Angeles County Immunization Program, Vaccine Storage and Handling presentationhttp://www.lapublichealth.org/ip/trainconf/Vaccine%20Storage%20Handling.pdf

    41


    Questions thank you

    QUESTIONS? Thank You !

    42


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