NCIP Storage and NCIP Storage and Handling ProceduresHandling Procedures

Presented by:

Shirelle Everett

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It is better to It is better to NOT NOT VACCINATE VACCINATE than to than to

administer a dose of administer a dose of vaccine that has been vaccine that has been

mishandled, has expired, mishandled, has expired, or is the wrong vaccine...or is the wrong vaccine...

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Objectives for this sessionObjectives for this session

Basic Storage and Handling Basic Storage and Handling ProceduresProcedures

Understanding how to Understanding how to handle cold chain breakagehandle cold chain breakage

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What is a “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

Procedures

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

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It is important to maintain the cold chain because…

……vaccines are very fragile and can lose vaccines are very fragile and can lose potency following excessive heat or coldpotency following excessive heat or cold

……once potency is lost, its gone for goodonce potency is lost, its gone for good … … if discovered, it could cost your office if discovered, it could cost your office

thousands of dollars, and/or cause you to thousands of dollars, and/or cause you to have to revaccinate (average infant visit have to revaccinate (average infant visit cost between $181 -$281, maintaining the cost between $181 -$281, maintaining the cold chain keeps that money in your cold chain keeps that money in your pocket)pocket)

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It is important to maintain the cold chain because…

……your vaccine can be your vaccine can be exposed to out of exposed to out of range temperatures range temperatures and look normal- and look normal- visual inspections are visual inspections are unreliableunreliable..

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7 Most Common

Storage and Handling Errors.

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11. . Designating only Designating only one person to be one person to be responsible for responsible for

storage and storage and handling of vaccineshandling of vaccines

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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” person.

Educate all staff on vaccine storage and handling- TEAM EFFORTTEAM EFFORT to make sure vaccine moves properly through cold chain.

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Vaccine Coordinator should be in charge of…

Receiving vaccines-Receiving vaccines- Be present when shipments are delivered and process

the shipment into inventory and ensuring the cold change has been maintained.

Storing Vaccines- 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

vaccine. Perform routine cleaning of vaccine storage units.

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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

compromised Ensuring that temperature logs are retained for at least

three years

Ordering VaccinesOrdering 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

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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)

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Minimum Required Ordering Handling and Storage Procedures

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Disaster Recovery Plan Should be posted near

refrigerator including the following information: Designated responsible

vaccine person and backup

Alternate Storage Facility Electrical company Refrigerator/ Freezer

repair company Locations of key items

needed during power outage (i.e.: Keys, Packing Material, Flash lights)

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2.Recording Temperatures only

once per day or using one unit temperature for multiple units…

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True or False

When your office is closed, temperatures should be checked at

least once a day…

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False!!False!!

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

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Temperature MonitoringTemperature Monitoring

Refrigerator temperature

2 ° C to 8 ° C (36° F to 46° F)

Optimum of 5 ° C (40 ° F)

Report/document out of range 0 ° C (out of range) 1 ° C (out of range) 8.1 ° C (out of range)

2 C to 8 °C(36° F to 46°F)

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Temperature Monitoring

Freezer temperature (requirement)

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

Optimum of -20 °C (-4 ° F) Report/document out of

range -14 ° C (out of range) -13 ° C (out of range)

New units must be monitored and in range for FIVE DAYSFIVE DAYS before vaccine can be stored in it.

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Thermometer Placement Thermometers should be placed in the

center of the unit, away from coils, walls floors and fans to get the most accurate reading. When temperatures seem to be out of range,

check the placement first. Is it too far back?

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Vaccine Storage EquipmentNational Institute of Standards and Technology (NIST)

certified and calibrated thermometers (requirement)

Liquid or Crystal style

Liquid or Crystal style

Examples of certificates showing thermometer was certified in accordance with NIST standards

Examples of certificates showing thermometer was certified in accordance with NIST standards

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It is a requirement to check temperatures on both refrigerator and freezer twice a day. 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.

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If temperatures are out of range… Notify

Primary or back up Vaccine Coordinator

Isolate- Mark vaccine DO NOT USE 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

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If temperatures are out of range… NEVER NEVER

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

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3. Discarding 3. Discarding Temperature logs at the Temperature logs at the

end of the monthend of the month

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Temperature logs should be kept for 3 years 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

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Examples of Temperature Logs

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4. Refrigerating vaccine in a manner that could jeopardize

its quality…

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True or FalseTrue or False

It helps to put vials It helps to put vials directly on glass directly on glass

shelves to maintain shelves to maintain temperature...temperature...

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FALSE!!FALSE!!

Glass in refrigerator could negatively effect the vials by

making them 2-5 degrees colder than the rest of the refrigerator.

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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

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Vaccine Vial Storage Methods and LocationsDUAL ZONE FREEZERLESSPHARMACEUTICAL

No storage in vegetable crisper: thermally isolated + floor level runs cold

Manufacturer recommends no floor storage, but vial TC maintained at 2 – 8 °C throughout testing

1 – 2 °C colder than main fridge space

Never place vials directly on glass shelf = 2 - 5 °C colder

Avoid storing on top shelf – near cooling vent. First location to exceed max allowed temp during outages.

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5.Inadvertently leaving the

refrigerator or freezer door open or having inadequate

seals…

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Preventative Measures

Use a plug guard or Use a plug guard or safety-lock plugsafety-lock plug

Do not disconnect stickers Do not disconnect stickers on breaker and plugon breaker and plug

Digital Thermometers with Digital Thermometers with AlarmsAlarms

Sound when temperatures reach above or below certain temperatures.

Combo units with separate Combo units with separate controls for refrigerator controls for refrigerator and freezerand freezer

Door LocksDoor LocksLocks whenever door is Locks whenever door is

closed, button releaseclosed, button release Educate maintenance and Educate maintenance and

custodial staff custodial staff

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Preventative MeasuresRefrigerator/Freezer Refrigerator/Freezer

LockLock

Clock/plug styleClock/plug style

Penny in a cupPenny in a cup

Continuous read temperature monitorContinuous read temperature monitor

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Inadequate Door SealsInadequate 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 adjusted

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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 dates

Notify NCIP if you have vaccine that you will not use before it expires- at least four months in advance

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6. Storing Vaccine in 6. Storing Vaccine in an inappropriate an inappropriate

unitunit

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True or FalseTrue or False

Dorm styled refrigerators with Dorm styled refrigerators with two external doors are two external doors are

acceptable for long term acceptable for long term vaccine use...vaccine use...

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True!!True!!

This type of unit is This type of unit is acceptable as long as it is acceptable as long as it is

large enough to hold large enough to hold facility’s state supplied facility’s state supplied

vaccine inventoryvaccine inventory

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Dorm Styled Units… …with single external door are acceptable for day storage

ONLY 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 NEVER acceptable for frozen vaccines

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Unacceptable UnitsNOT Acceptable:

Units with a Single External Door, but have interior freezer and refrigerator compartments

Units used routinely to Store Food

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Equipment Requirements for Vaccine StorageEquipment Requirements for Vaccine StorageRefrigerator 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.

Acceptable:

Household-style(full size or compact)

Stand-alone refrigerator-only (no freezer compartment)

Under counter refrigerator-only

Under counter freezer-only

Upright freezer (no refrigerator compartment)

Commercial-style

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7. Documenting out of 7. Documenting out of range temperatures range temperatures on vaccine logs but on vaccine logs but

not taking actionnot taking action

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The NCIP requires each provider to call the

Immunization Branch when temperatures have gone

out of range.

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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.

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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

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If your unit is too WARM

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If your unit is too WARM cont’d

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If your unit is too COLD

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If your unit has STOPPED

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FAQFAQ

Is there anything specific I need to know about

transporting vaccine to a clinic or to another

facility?

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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

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FAQFAQ

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

at my facility?at my facility?

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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 NOTDO 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.

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Restitution and Restitution and Appeal PolicyAppeal Policy

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Restitution Policy and Appeal

Wasted- Any Vaccine that cannot be used

Expired- any vaccine with an expiration date that has passed

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.

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Situations that DO require Financial Restitution

Failure to Rotate

Failure to act according to Disaster Recovery Plan

Doors left open by staff, contractors, or guest

Expired Pre-drawn vaccine.

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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

transit.

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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 BranchAttention: Vaccine Manger1917 Mail Service CenterRaleigh, NC 27699-1917

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Any Questions?

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Educational Tools Immunization Branch web page

www.immunizenc.com

National Immunization Program http://www.cdc.gov/vaccines/ Epidemiology and Prevention

of Vaccine Preventable Diseases (The Pink Book)

Vaccine Storage and Handling Toolkit

Vaccine Management - Recommendations for Handling and Storage of Selected Bilogicals

North Carolina Immunization Branch Customer Service staff

1-877-873-6247

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Contact InformationContact InformationShirelle EverettShirelle Everett

NCIP Storage and Handling ConsultantNCIP Storage and Handling Consultant

1917 Mail Service Center1917 Mail Service Center

Raleigh, NC 27699-1917Raleigh, NC 27699-1917

Phone: 1-877-873-6247Phone: 1-877-873-6247

Fax 919-870-4826Fax 919-870-4826