Temperature Excursion

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TN VFC Provider Temperature Excursion (TE) Evaluation and Reporting Form

Email: Temperature.Health@tn.gov | Phone: 800-342-1813 (Press 5, Then 1)

Please ensure you have reviewed the Temperature Excursion Instructions and have all the information ready before completing this form.

This form is to report vaccine manufacturer viability recommendations to VPDIP for vaccines involved in a temperature excursion. Please note, vaccines should not be evaluated until they have returned to the required temperature range.

Provider Information

Facility Name
Facility PIN Please ensure you have entered your facility's 6-digit PIN.
Primary Point of Contact Name
Primary Point of Contact Phone Number
Primary Point of Contact Email Address Please include a valid email, as a copy of this survey will be sent to this address upon completion.

Would you like to provide a secondary point of contact?

* must provide value

Yes

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Secondary Point of Contact Name

Secondary Point of Contact Phone Number

Secondary Point of Contact Email Address

Please include a valid email, as a copy of this survey will be sent to this address upon completion.

Temperature Data & Incident Description

Please select the reason for the temperature excursion.

* must provide value

Power outage

Door left ajar

Mechanical failure

Failure to store properly - Please Specify

Other - Please Specify

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Vaccine Storage Unit(s) affected (select all that apply)

* must provide value

Refrigerator

Freezer

Ultra Cold Freezer

Transport Container (please specify)

Other - Not in Storage Unit (please specify)

How many Refrigerators do you need to report a current TE for?

(if you need to report more than 5 Refrigerator TEs, please complete an additional survey)

* must provide value

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Please input details for 1st Refrigerator TE:

Date of 1st Refrigerator TE:
Time of 1st Refrigerator TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 2nd Refrigerator TE:

Date of 2nd Refrigerator TE:
Time of 2nd Refrigerator TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 3rd Refrigerator TE:

Date of 3rd Refrigerator TE:
Time of 3rd Refrigerator TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 4th Refrigerator TE:

Date of 4th Refrigerator TE:
Time of 4th Refrigerator TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 5th Refrigerator TE:

Date of 5th Refrigerator TE:
Time of 5th Refrigerator TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

How many Freezers do you need to report a current TE for?

(if you need to report more than 3 Freezer TEs, please complete an additional survey)

* must provide value

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Please input details for 1st Freezer TE:

Date of 1st Freezer TE:
Time of 1st Freezer TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 2nd Freezer TE:

Date of 2nd Freezer TE:
Time of 2nd Freezer TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 3rd Freezer TE:

Date of 3rd Freezer TE:
Time of 3rd Freezer TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

How many Ultra Cold Freezer TEs are you reporting?

(if you need to report more than 2 Ultra Cold Freezer TEs, please complete an additional survey)

* must provide value

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Please input details for 1st Ultra Cold Freezer TE:

Date of 1st Ultra Cold Freezer TE:
Time of 1st Ultra Cold Freezer TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for 2nd Ultra Cold Freezer TE:

Date of 2nd Ultra Cold Freezer TE:
Time of 2nd Ultra Cold Freezer TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for Transport TE:

(if you need to report more than 1 Transport TE, please complete an additional survey)

Date of Transport Container TE:
Time of Transport Container TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Please input details for Other TE:

(if you need to report more than 1 Other TE, please complete an additional survey)

Date of Other Container TE:
Time of Other Container TE:
Highest Temperature if Reporting Too Warm TE (in Celcius):
Lowest Temperature if Reporting Too Cold TE (in Celcius):
Duration Out of Range:	hour(s)	minute(s)

Are there any open multidose vials involved?

* must provide value

Yes

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Opened/punctured multidose vials are evaluated differently than unopened vials. When reporting TE(s) to vaccine manufacturers, ensure that you report this vial is opened/punctured (e.g. with the Sanofi online stability calculator for opened IPOL, you should answer "yes" to, "Was the vaccine product(s) activated/prepared/mixed for administration?").

Is MMR II stored in the refrigerator or freezer?

* must provide value

Refrigerator

Freezer

N/A - Do Not Stock

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As a result of the temperature excursion, were vaccines transported to a different unit or alternate storage location?

* must provide value

Yes

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Please provide the following transport details:

Date transported:
Time transported:
Transported to (specify unit or location):
Describe how vaccines were transported:

Have any of the vaccines been involved in a previous TE?

* must provide value

Yes

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When reaching out to vaccine manufacturers for vaccine stability evaluation, you must provide details for all temperature excursions (current and previous TEs) the vaccines have been involved in.

Please note, some online stability calculators cannot be used when previous temperature excursions are involved (e.g. Merck). Please follow vaccine manufacturer guidance.

Did you include the previous TE details when reporting to vaccine manufacturers for evaluation?

* must provide value

Yes

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Please stop completing this form and contact the vaccine manufacturer(s) for a complete evaluation, including all temperature excursion details.

You can save and return to this survey once you've contacted the vaccine manufacturer(s) to complete the survey.

How many previous TEs have the vaccines been in?

* must provide value

6 or more

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Please provide details of the first previous TE below:

Date:
Highest Temperature if Reported as Too Warm TE (in Celsius):
Lowest Temperature if Reported as Too Cold TE (in Celsius):
Duration Out of Range:	hour(s)	minute(s)
Vaccine Names & Lot Numbers Involved:

Please provide details of the second previous TE below:

Date:
Highest Temperature if Reported as Too Warm TE (in Celsius):
Lowest Temperature if Reported as Too Cold TE (in Celsius):
Duration Out of Range:	hour(s)	minute(s)
Vaccine Names & Lot Numbers Involved:

Please provide details of the third previous TE below:

Date:
Highest Temperature if Reported as Too Warm TE (in Celsius):
Lowest Temperature if Reported as Too Cold TE (in Celsius):
Duration Out of Range:	hour(s)	minute(s)
Vaccine Names & Lot Numbers Involved:

Please provide details of the fourth previous TE below:

Date:
Highest Temperature if Reported as Too Warm TE (in Celsius):
Lowest Temperature if Reported as Too Cold TE (in Celsius):
Duration Out of Range:	hour(s)	minute(s)
Vaccine Names & Lot Numbers Involved:

Please provide details of the fifth previous TE below:

Date:
Highest Temperature if Reported as Too Warm TE (in Celsius):
Lowest Temperature if Reported as Too Cold TE (in Celsius):
Duration Out of Range:	hour(s)	minute(s)
Vaccine Names & Lot Numbers Involved:

If you need to add a sixth or more additional TE, please include the following below for each TE:

Date(s)
High and low temperatures (in Celsius)
Duration Out of Range (in HH:MM)
Vaccine names & lot numbers

* must provide value

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Vaccine boxes involved in the temperature excursion (TE) should be marked with the date of TE, time out of range, and high/low temperature reached. This will help keep track of the total time out of range that each vaccine has been involved in any temperature excursion(s).

Have you marked all vaccine boxes involved with the TE details?

* must provide value

Yes

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Please stop completing this form and mark the affected vaccine boxes with the date of TE, duration out of range, and high/low temperature reached. This will help keep track of the total time out of range that each vaccine has been involved in any temperature excursion(s).

You can save and return to this survey once you've marked your boxes to update and complete the survey.

Reporting

Did you contact the manufacturer(s)?

* must provide value

Yes

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Please stop completing this form and contact the vaccine manufacturer(s) for evaluation. To find the manufacturer's contact information, please review the Temperature Excursion Instructions.

You can save and return to this survey once you've contacted the vaccine manufacturer(s) to complete the survey.

What manufacturer(s) was contacted? (select all that apply)

* must provide value

Astrazeneca

CSL Seqirus

Dynavax

GlaxoSmithKline

Mass Biologics

Merck

Moderna

Novavax

Pfizer

Sanofi Pasteur

Astrazeneca Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.
Astrazeneca Case Number:

CSL Seqirus Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.
CSL Seqirus Case Number:

Dynavax Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.
Dynavax Case Number:

GlaxoSmithKline Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2. 3. 4. 5.	6. 7. 8. 9. 10.

Mass Biologics Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.
Mass Biologics Case Number:

Merck Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2. 3. 4. 5.	6. 7. 8. 9. 10.

Moderna Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.

Novavax Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.
Novavax Case Number:

Pfizer Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2.	3. 4.

Sanofi Pasteur Stability Details

Date stability assessed:
Manufacturer contacted by:
Please upload manufacturer's stability documentation. *must provide value in field 1	1. 2. 3. 4. 5.	6. 7. 8. 9. 10.

Were the affected vaccines deemed viable by the manufacturer(s)?

* must provide value

Yes, all vaccines are viable with NO changes to expiration dates.

No, none of the vaccines are viable.

Vaccines are partially viable.

Vaccines are viable, but some have shortened expiration.

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Was any spoiled vaccine administered to a patient after the temperature excursion?

* must provide value

Yes

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For UNOPENED (safety cap has not removed from vials or syringes) vaccines, complete the following:

Reconcile VFC inventory in TennIIS as "Spoiled"
Initiate a vaccine return
Print a packing slip
Wait for UPS label to arrive
Once the label arrives, send UNOPENED vaccines with the packing slip to McKesson via UPS
- If needed, contact Vaccine Order Management at TennIIS.VOMS@tn.gov for questions regarding reconciliation or returning vaccines

For OPENED (safety cap has been removed from vials or needles attached to syringes) vaccines, complete the following:

Reconcile VFC inventory in TennIIS as "Spoiled"
Discard these vaccines into a biohazard sharps container, as they cannot be sent back/returned

Please list spoiled vaccine(s) name, lot number, and number of doses.

* must provide value

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Was any spoiled vaccine administered to a patient after the temperature excursion?

* must provide value

Yes

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For UNOPENED (safety cap has not removed from vials or syringes) vaccines, complete the following:

Reconcile VFC inventory in TennIIS as "Spoiled"
Initiate a vaccine return
Print a packing slip
Wait for UPS label to arrive
Once the label arrives, send UNOPENED vaccines with the packing slip to McKesson via UPS
- If needed, contact Vaccine Order Management at TennIIS.VOMS@tn.gov for questions regarding reconciliation or returning vaccines

For OPENED (safety cap has been removed from vials or needles attached to syringes) vaccines, complete the following:

Reconcile VFC inventory in TennIIS as "Spoiled"
Discard these vaccines into a biohazard sharps container, as they cannot be sent back/returned

Please list vaccine name(s), lot number(s), and number of doses with shortened expiration, including the new expiration date.

* must provide value

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Uploads

Upload Digital Data Logger (DDL) report(s) showing the full details of the temperature excursion(s).

Please ensure you upload the data logger report(s) showing before, during and after the vaccine incident.

1. (required)	2.
3.	4.

Upload a list of all affected vaccines - include the type of vaccine, the lot numbers, the expiration dates, and the manufacturers.

If using the reconciliation page from TennIIS VOMS to report the affected vaccines, please ensure the inventory in VOMS is current/accurate.

If you are reporting temperature excursions for more than one vaccine storage unit, please note which unit the vaccines were stored in to help distinguish which vaccines were involved in which TE.

1. (required)	2.
3.	4.

Comments/Questions

Please include any additional comments, questions, or concerns you may have here, and someone will respond as soon as possible.

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Date form is submitted

Once you've successfully submitted this survey, a copy will be sent to the email you provided in the Point-of-Contact Email Address field at the top.

* must provide value

M-D-Y

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To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.