NCIP Storage and Handling Procedures 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 breakage

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.

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 pocket)

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 unreliable.

7 Most Common Storage and Handling Errors.

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” person. 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 vaccine. 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 compromised 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) This information can be found on “North Carolina Immunization Program Minimum Required Vaccine, Ordering, Handling and storage Procedures” Posting this information with Disaster Recovery Plan or in a nearby, central location will suffice during site visit.

Minimum Required Ordering Handling and Storage Procedures

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)

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…

False!! 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 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)

Temperature Monitoring Freezer temperature (requirement) -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 DAYS before vaccine can be stored in 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 reading. 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 Crystal style 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 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.

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… 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

3. Discarding Temperature logs at the end of the month

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

Examples of Temperature Logs

4. Refrigerating vaccine in a manner that could jeopardize its quality…

True or False It helps to put vials directly on glass shelves to maintain temperature...

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

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 If unit is unable to keep stable temperatures, you may need to replace your unit

Vaccine Vial Storage Methods and Locations DUAL ZONE PHARMACEUTICAL FREEZERLESS 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. 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

5.Inadvertently leaving the refrigerator or freezer door open or having inadequate seals…

Preventative Measures Use a plug guard or safety-lock plug Do not disconnect stickers on breaker and plug Digital Thermometers with Alarms 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 Refrigerator/Freezer Lock Continuous read temperature monitor 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 adjusted

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

6. Storing Vaccine in an inappropriate unit

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

True!! 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. Acceptable: Stand-alone refrigerator-only (no freezer compartment) Upright freezer (no refrigerator compartment) Household-style (full size or compact) Under counter refrigerator-only Under counter freezer-only Commercial-style

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

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

Water Bottles may solve your problem- Add or subtract them!! 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

FAQ 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

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

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 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.

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.

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.

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 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

NCIP Storage and Handling Consultant 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