Transcript One

Vaccine Storage and
Handling
Joni Reynolds
Colorado Department of Public
Health & Environment,
Immunization Program
Presentation Outline
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Introduction
Cold Chain
Storage and Handling Plans
Personnel
Storage Equipment
Storage Practices
Temperature Monitoring
Handling inappropriate storage conditions
Inventory Management
Shipments
Preparation and Disposal
Objectives
• At the end of this presentation, the
participant will:
– Identify steps in the vaccine cold chain
– List the required elements of an
acceptable vaccine storage and handling
plan
– Identify acceptable vaccine storage units
and thermometers
– Identify correct temperature ranges for
inactivated and live virus vaccines
Introduction
• Storing vaccines improperly is a costly
mistake!
– Reduces vaccine potency
• Inadequate immune responses in
recipients
• Inadequate protection against disease
– Loss of millions of dollars worth of vaccine
Introduction
• Vaccine failures 2° reduced vaccine
potency lead to:
– Large recalls for revaccination
– Expense
– Potential liability
– Decreased patient confidence
– Embarrassment
• Vaccine Storage and Handling
Mistakes are AVOIDABLE!
The Cold Chain
Manufacturer
Distributor
Provider’s Office
Patient
Cold Chain
• Vaccine Potency
– Excessive heat or cold damages vaccine
– Once potency is lost, it can never be
regained
– Vaccine becomes ineffective
• Cold chain must be correctly
maintained
Cold Chain
• Visual inspection of
vaccines is an unreliable
method of assuring potency
Viable vaccine
that has been
stored properly
Non-viable vaccine
that has been
frozen
Cold Chain
• Out of range temperatures require immediate
action
– Refrigerator temps often kept too cold
• One study: site-visits found 15% of refrigeration units had
temps 34°F or lower
• When vaccine integrity is questionable,
contact:
– State immunization program
– Manufacturer of vaccines in question
• Mishandled doses should not be counted as
valid doses and must be repeated
– Unless serologic testing indicates
– adequate response
Cold Chain
• Appropriate
temperature
ranges:
– Refrigerator:
• 35°- 46°F (2°8°C)
• Optimal is 40°F
(5°C)
– Freezer:
• 5°F (-15°C) or
Colder
Varicella,
MMR, Zoster,
Ice Packs
Hepatitis A, B,
DTaP, DT,
Tdap, Hib,
IPV, Pneumo,
Rota, Mening.,
inactivated
influenza,
LAIV, HPV,
Yellow Fever,
Water Bottles
Storage and Handling Plans
• Routine Plan should include:
– Designation of primary vaccine coordinator and
at least one back-up staff
– Proper vaccine storage/handling information
– Vaccine shipping (receiving/transport)
information
– Procedures for vaccine relocation in the event of
an emergency situation
– Documentation that plan has been reviewed or
updated annually or since staff change
– Inventory control procedures
– Procedures for responding to vaccine wastage
Vaccine Personnel
Vaccine Personnel
• Each office should designate:
– One assigned primary staff member
responsible for ensuring proper vaccine
management
– One designated back-up staff member
• Training should be provided for both the
primary and backup coordinators
Vaccine Personnel
• Other staff
– Should be familiar with site’s policies and
procedures for S&H
• Training
– All staff handling vaccines should receive
training on policies and protocols
– Policies and procedures should be
reviewed annually to update all staff
Vaccine Storage
Equipment
Storage Units
• Refrigerators without
freezers and standalone freezers tend to
better maintain
required temps
• Household refrigerator
with freezer-type
storage units are
acceptable, provided
they have separate
compartments and
separate external doors
Vaccine
Refrigerators/Freezers
• Dormitory-Style Units
– Single-door combined
refrigerator-freezer should not
be used
– Freezer compartment cannot
maintain required temp for
varicella and zoster vaccines
– May only be used for small
quantities of inactivated
vaccines
– May not be used for long- term
(overnight) vaccine storage
– Must not be overcrowded and
temps must be monitored
closely for unacceptable
fluctuations
Vaccine
Refrigerators/Freezers
• Placement in clinic
– Must have good air circulation around the
unit
– Place in well-ventilated room
Vaccine
Refrigerators/Freezers
• Temperature Adjustments
– Should only be made by the
primary or back-up vaccine
coordinator
– Make only slight adjustments
and re-assess every 30 minutes
until temp stabilizes
• Temps in newly installed or
repaired units may take 2-7
days to stabilize
– Allow one week before utilizing
new units for vaccine storage
Vaccine
Refrigerators/Freezers
• Maintaining stable
temperatures
– Store containers of
water in refrigerator
doors and ice packs
in freezers
– Limit frequency that
doors are opened
– Routinely check that
doors are closed
tightly
Vaccine
Refrigerators/Freezers
• Vegetable bins should not be used
– Do not store vaccine in very bottom of unit
Vegetable bin
drawer
pulled
Thermometers
• Certified and Calibrated – recommended by
the CDC, NIP for all vaccine storage units
– Calibrated = given a temperature scale at time of
manufacturing
– Certified = A second calibration done against a
reference standard from appropriate agency
• Avoid using cheap thermometers.
• VFC enrolled providers are now required to
use certified/calibrated thermometers, currently
available through the VFC program.
• Periodic recertification and recalibration
required
Certified Calibrated
Thermometers
Certified Calibrated
Thermometers
Thermometer Placement
• Center of
compartment
– Away from coils,
walls, floor, and
fan
– Middle shelf
Protect Power Supply
• Avoid outlets with
built-in circuit
switches (red reset
buttons)
• Avoid outlets that
can be activated by
wall switch
Protect Power Supply
• Use a safety-lock
plug or outlet cover
to prevent
inadvertently
unplugging
• Post warning sign at
plug and on unit
• Label fuses and
circuit breakers
• Consider installing
temperature alarms
Vaccine Storage
Practices
Vaccine Storage Conditions
• Live Vaccines
– Very sensitive to heat
– Varicella and zoster vaccines must be in
continuous frozen state
• 5°F or colder
• MMR usually stored in freezer but can be in
refrigerator
• MMRV must be stored in freezer
– HPV, MMR, MMRV, rotavirus, varicella and
zoster vaccines are light-sensitive
• Protect from light at all times
• Store in their boxes with the tops until needed
Vaccine Storage Conditions
• Inactivated Vaccines
– Sensitive to excessive heat and freezing
– Maintain at temps between 35°F to 46°F
– Colder is not better!
– Can tolerate short periods at room
temperature
• Potency at such temperatures is adversely
affected over time
Location and Positioning
• Store vaccines in middle of
compartment
– Away from coils, walls,
floor and cold air vent
• Do NOT store in doors of
storage unit
• Never store in vegetable bins
• Keep refrigerated vaccine
away from cold air venting in
from freezer
– Usually this is top shelf
– Best to keep MMR on top
shelf if placed in
refrigerator
Air vent
from Freezer
Diluent may be stored in
refrigerator doors.
Vaccines may not.
Storage of Non-Vaccine
Products
• Food and Beverages
– Never store with vaccines
– Results in frequent storage unit opening, unstable
temps, unnecessary light exposure
• Medications and other biologicals
– If possible store in separate unit
– If no choice, store in unit below vaccines
Temperature
Monitoring
Check, Correct and Record
• Post temp log sheet on
door of every storage unit
• Read thermometer in all
compartments of every
vaccine storage unit
– Twice daily
– In morning upon arrival to
clinic and evening upon
clinic closure
– Regardless of type of
thermometer, alarm or
recorder
Check, Correct and Record
• Record temperatures on log every time
a reading is taken
• Record the time the thermometers
were read
– Person must initial log at time of readings
• If reading is missed, leave log space
empty
– Do not guess what temperature was
Check, Correct and Record
• TAKE IMMEDIATE ACTION TO PROTECT
VACCINES!
– Temps found out of range need immediate
correction
– Document problem, how vaccines were
protected, action(s) taken to correct problem,
time problem identified and corrected
– Mechanical malfunctions and power outages
must be documented on log sheet
Maintaining Temperature
Logs
• Store completed logs for a minimum of
3 years
• Store continuous recording/graphic
thermometer readings/paper with logs
for 3 years
Handling
Inappropriate
Storage Conditions
Handling Inappropriate
Storage
• Conduct inventory of
affected vaccines
• Isolate affected vaccine
vials and mark them as “DO
NOT USE”
• Store affected vaccines
under appropriate
conditions until integrity
determined
• Contact state immunization
program for further
guidance
Inventory
Management
Inventory Management
• Expiration Dates
– Multi-dose vials may be used until date of
expiration
• Meningococcal polysaccharide must be used
within 35 days of reconstitution
– Single-dose vials without their protective
caps must be used by end of clinic day
– Reconstituted lyophilized vaccines must
be used within a specified time frame or
discarded
• See package insert
Inventory Management
• Stock Rotation
– Place vaccine/diluent supplies according to
expiration dates
• Weekly and upon receipt of new shipments
• Earliest expiration dates placed in front for earliest use
• Never administer expired vaccines
– Remove from storage unit and label “Expired”
– Contact state immunization program; Do not
discard expired/wasted vaccines
• If expired vaccine is mistakenly
administered, the physician in charge
should be notified, the child should be
recalled and revaccinated, and a
VAERS report should be completed.
Inventory Management
• To minimize risk for waste, maintain a
30-60 day inventory supply
• Order vaccines monthly
• Do not over order vaccines
• Keep privately purchased stock
separate or labeled clearly from VFC
(state supplied) stock
Vaccine Shipments
Vaccine Shipments
• Receiving Vaccine Shipments
– Arrange deliveries only for when primary
or backup person is on duty
– All staff must be aware of maintaining cold
chain and to immediately notify assigned
person(s) of vaccine arrival
– For VFC enrolled providers, notify state
immunization program of changes in
provider, primary contact, unexpected or
different office closures, hours of
operation, change of address
Vaccine Shipments
• Upon Receipt:
– Examine container and contents for signs
of physical damage
– Shipment time should not have exceeded
48 hours
– Crosscheck contents with packing slip
– Check expiration dates
– Check lyophilized vaccine to ensure
correct type and quantity of diluent was
also sent
Vaccine Shipments
• Upon Receipt:
– Examine for heat or cold damage
• Check cold chain indicators
• Inactivated vaccines should be cold, not
frozen
• MMR should be cold or frozen
• Dry ice should be present with varicella and
zoster vaccines
– Immediately and appropriately store
vaccines
Vaccine Shipments
• Concerns about shipment?
– Mark vaccine/diluent as “DO NOT USE”
– Store under proper conditions
• Apart from other vaccine supplies e.g., in
brown bag with appropriate marking “DO NOT
USE”.
– Immediately contact state immunization
program for further guidance
Vaccine Preparation
and Disposal
Vaccine Preparation
• Reconstitution = the mixing of lyophilized
(freeze-dried) vaccine with a liquid (diluent)
before it can be administered
– Reconstitute vaccine immediately before use
– Do not allow exposure to warm temps and light
– Use appropriate diluent – use only the diluent that comes
with that vaccine
– Check for expiration dates on vaccine vial and diluent vial
Lyophilized power + Diluent = Reconstituted Vaccine
Pre-filling Syringes
• The CDC, NIP strongly recommends
providers do NOT pre-fill doses before they
are needed because it increases risk for:
WASTAGE!
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Administration errors
Storage under inappropriate conditions
Bacterial contamination and growth
Reduced vaccine potency
Quality control and patient safety issues
• Manufacturer-filled syringes
are an alternative
Questions
• Name/Contact Info