Approaches for Safe Vaccine Handling and Management

Ruth Carrico PhD RN FSHEA CICAssociate Professor

Division of Infectious DiseasesUniversity of Louisville

Objectives

• Review specific activities that help ensure that the vaccine administered had been handled to ensure it safety and potency

• Identify steps in the handling and management process that places vaccine at risk

• Explore opportunities to make systems adjustments that ultimately protect the patient (the vaccine recipient)

Resources

• CDC Pink Book• www.Immunize.org • CDC. Vaccine Storage and Handling Guide 2011.

Available at www.cdc.gov/vaccines/recs/storage/default.htm . Will no longer be updated. Refer to Pink Book

CDC Pink Book

• Currently 12th edition• Available in hard copy, pdf or

ipad versions• A “must have” for all

immunization programs

The Vaccine Handbook, 4E“The Purple Book”

Gary S. Marshall, MDProfessor of Pediatrics, University of Louisville School of Medicine

Principles of Vaccine Storage and Handling

• Success against vaccine-preventable diseases is impacted by proper storage and handling of vaccines

• Errors result in reduced potency and effectiveness

• It is better NOT to vaccinate than to administer a dose that has been mishandled

• Why worry about this?

National Survey of Practices

• Survey of APIC Infection Preventionists • IRB approval University of Louisville• Web-based survey 38 questions 93 response items

Aims– Evaluate current healthcare worker immunization practices

in US healthcare facilities– Evaluate current vaccine handling and management

practices in employee/occupational health departments in US healthcare facilities

Minimum “Passing” Score,

70%

Median: 47.6%

Significant Findings:Vaccine Handling

• 51% use a refrigerator type specifically contraindicated by CDC guidance

• 20% use calibrated thermometers• 28% report having to discard vaccine due to unsuitable

storage temperature events• 58% maintain redundant power to the vaccine

refrigerator• 31% use temperature-stabilizing strategies• 2% use a vaccine refrigerator to maintain cold chain

when vaccines administered outside the office (e.g., mobile carts)

Significant Findings:Program Management

• 40.2% CIC• 2.4% COHN/COHN-S• 95% either completely or partially responsible for the

immunization program in their facility• 45.9% indicated they developed vaccine policy with

assistance of others (not physician)• 27.2% develop vaccine policy with assistance of

physician• 86.1% listed CDC/ACIP/Public Health as resources for

their programs

Cold Chain

• From manufacturer to administration• Proper maintenance of vaccines during

transport and storage up to the time of administration

• Vaccines are fragile and subject to damage by exposure to temperature fluctuations

• Cumulative effect of temperature changes

Frozen Vaccines

• Between -58°F and +5°F (-50°C to -15°C) • Varicella MUST be frozen and MMR MAY be frozen• Remove from frozen environment immediately before

reconstituting in preparation for administration• If necessary, non-reconstituted varicella vaccine may be

stored at refrigerated temperatures [35°F and 46°F (-2°C to 8°C)] for up to 72 continuous hours. Must be discarded after that time

• Must use diluent provided by the manufacturer• Diluent does not need to be refrigerated

Refrigerated Vaccines

• Between 35°F and 46°F (-2°C to 8°C) • Desired average temperature of 40°F (5°C)• Proper environment for all inactivated

vaccines as well as some of the live attenuated vaccines– FluMist– Rotavirus– Typhoid (oral and injectable)– Yellow Fever

Storage and Handling Plans

• Ordering and accepting vaccine deliveries• Storing vaccines• Handling vaccines• Managing inventory• Managing potentially compromised vaccines• Emergency retrieval and storage plan with

designated backup location

Personnel Training and Education

• Where and how to order vaccine• How to receive, check, log, and store vaccine• Organizing within the refrigerator/freezer• Temperature monitoring• Daily physical inspection• Stock rotation• Expiration date monitoring• Response to temperature fluctuations• Overseeing proper vaccine transport• Documentation

Refrigerator

• CC strongly recommends stand-alone freezers and refrigerators without freezers

• If a combination unit sold for home use is used, it must have separate exterior doors and thermostat controls for each compartment. This is acceptable but NOT recommended

• Dormitory style units are NOT acceptable• At least 4 inches between unit and a wall• 1-2 inches between bottom of unit and floor• No other use except vaccine storage

Refrigerator

• Do not store vaccine in the door• Remove drawers, bins and shelves as they

impede air circulation• Do not store food in with vaccines• Daily physical inspection– Temperature– Proper placement of vaccines– Opportunity for air circulation

Freezer

• Stand alone unit, or a combination unit designed to house vaccines

• Each refrigerated and frozen compartment must have own temperature monitoring process

• Check door seals and frost regularly. Should be frost-free unit

Thermometers

• Calibrated thermometer• Certificate of Traceability and Calibration from an ISO 17025

accredited testing lab or another recognized standards agency– Digital– Bio-safe liquid– Continuous graphic

• Locate ideal thermometer placement by measuring in various locations to identify cold or hot spots

• Currently, temperatures must be monitored twice a day, but continuous monitoring recommendations are forthcoming

Manual Temperature Log

Compromised Vaccine

• Rapid identification• Sequester in a refrigerated or frozen

environment• Label “Do Not Use”• Contact manufacturers for guidance• If identified after administration, contact

medical oversight and other experts to help determine plan of action. Patient safety first

Error Proofing

• Store vaccines in labeled bins (uncovered)• Allow space between bins for air to circulate• Separate vaccines that may be confused (e.g., Td and

Tdap; Hepatitis vaccines)• Keep vaccines in their packages until ready to use.

May unpackage small numbers of vaccines that are expected to be used regularly.

• May keep diluents with refrigerated vaccines (check label requirements), but do not store diluents in freezer

Error Proofing

• Plug unit directly into wall, not into power strip• Use plug guard• Label wall plug with a “Do Not Unplug” sign• Temperature alarm• Emergency generator/backup power• May keep bottled water in refrigerator and ice

packs in freezer to assist with temperature maintenance

Expiration Dates

• Monitor vaccine and diluents• Rotate stock• Can use through end of day on the expiration

date. If expiration listed by month (e.g., 12/13), can use through end of last day of that month

• Multidose vial can be used until expiration date unless otherwise specified by manufacturer

• Date when opened• Never use expired vaccine or diluent

Vaccine Transport to Off Site Clinics

• Minimize the number of times the vaccine is transported

• Multidose vial must be used by same user (office) as the one who opened it

• Maintenance of cold chain is critical• If in a cooler, monitor temperature hourly• Storage of diluent (room temperature) in cooler will

adversely impact the temperature inside the cooler• Patients should NEVER transport their own (or anyone

else’s) vaccine

Vaccine Preparation

• Filling syringes in advance is discouraged• If done, any unused must be discarded at the

end of the clinic• If filling in advance, limit the number prepared

to prevent error and facilitate rapid use• Any prefilled syringe that has been “activated”

(needle applied) must be used or discarded by the end of the clinic

Vaccine Disposal

• Expired or compromised vaccine may be returnable to the manufacturer

• Open files or activated pre-filled syringes are likely not returnable

• For return questions, contact manufacturer• For disposal, request guidance from pharmacy

partner. Disposal may require placement in accordance with new standards

Performance Improvement

• Know existing processes• Evaluate your team’s understanding of the

policies/procedures• Observe practice• When deviation identified, promptly take

action• Engage others in the process so they can

identify defects in the system and correct

Objectives

• Review specific activities that help ensure that the vaccine administered had been handled to ensure it safety and potency

• Identify steps in the handling and management process that places vaccine at risk

• Explore opportunities to make systems adjustments that ultimately protect the patient (the vaccine recipient)