Temperature Monitoring and Excursions Tennessee Immunization Program

What Is A Temperature Excursion (TE)? When the temperature in a vaccine refrigerator is: above 8⁰C (46⁰F) below 2⁰C (36⁰F) When the temperature in a vaccine freezer is: above -15⁰C (+5⁰F) below -58⁰C (-50⁰F)

Read and Record Twice a Day Upon arrival to clinic Current temperature Minimum/Maximum temperature Check for alarms 1 hour before leaving clinic Current temperature Check for alarms

Digital Data Logger For Temperature Monitoring Records current, minimum and maximum temperatures Records that user checked temperatures AM and PM Visual and/or audible alarms for out-of-range temps Low battery indicator Data are easily downloadable to computer for review

Checking Temperatures Twice a Day when Clinic is Open Presentation examples use a common Berlinger Fridge Tag 2™ model data logger; other types of loggers are acceptable and may have different instructions. Use of this example should not be construed as an endorsement or preferential recommendation. Checking Temperatures Twice a Day when Clinic is Open

Be Familiar With Your Data Logger Read the data logger manual. Know how to: locate and read the CURRENT, MINIMUM, & MAXIMUM temperature download the temperature data files and read the report recognize that a temperature alarm is indicated audible sound? alarm symbols on main digital display? email or text message alerts? how to clear an alarm once addressed

Indicates Temperatures Within Range Example of Fridge Tag2 (FT2)Digital Data Logger

1ST Press of READ – READ the Display Today’s MAXIMUM temperature is displayed in the lower right corner of the display. TRIANGLE POINTING UP WILL FLASH

2nd Press of READ – READ the Display Today’s MINIMUM temperature is displayed in the lower right corner. TRIANGLE POINTING DOWN WILL FLASH 3.2ºC

3rd Press of READ – RECORD Records (in the memory of the data logger), when the temperatures were checked. Recorded on data logger report as “am” or “pm”. If using a FT2L, the exact time the temperature was checked will be recorded in the Events Column.

Know Your Alarm Symbols

Example FT2 - The Giant “X” Alarm Symbol Temperature has been or is OUT-OF-RANGE DO NOT USE VACCINE CALL TIP 800-404-3006

Multiple OUT-OF-RANGE temperatures. The Alarm Symbol Multiple OUT-OF-RANGE temperatures. DO NOT USE VACCINE CALL TIP 800-404-3006

Triangle (Pointing UP or DOWN) Alarm Symbol OUT-OF-RANGE temperature alarm occurred on this day. The triangle will stay for 30 days.

Example – Fridge Tag2 (FT2) Yellow & Black “Piano Keys” A visual “picture” of alarms that occurred within past 30 days TODAY = far right YESTERDAY = next key -2d = 2 days ago, etc UP & DOWN Triangles Up = too warm alarm occurred Down = too cold alarm occurred Place = day the alarm occurred

Know How To Handle An Alarm Presentation examples use a common Berlinger Fridge Tag 2™ model data logger; other types of loggers are acceptable and may have different instructions. Use of this example should not be construed as an endorsement or preferential recommendation. Know How To Handle An Alarm

1 2 3 Follow These Steps DO NOT USE THE VACCINE Unit failures cannot always be prevented. Revaccination is 100% preventable. 2 Restore proper storage conditions (if current temperature is out of range) Label “Do Not Use until approved by TIP” 3 CALL TIP IMMEDIATELY during business hours (8-430 Central Time) at 800-404-3006 Answer questions from TIP Email or fax data logger report to 615-401-6829 Note edits to steps on this slide - klm

Standard TIP Questions for Excursion What is the current temperature? Is the MMR kept in the refrigerator or freezer? Have any vaccines been given since the excursion? Have the vaccines been involved in any previous excursions? Do you have any open multi-dose vials (e.g., IPOL)? Is this a stand-alone or combination R/F storage unit? How high or low did the temperature go outside of the recommended range and for how long? Are privately-purchased vaccines also in this unit?

What’s next? TIP contacts vaccine manufacturers for guidance If private vaccines were inside the unit, TIP also will obtain manufacturer recommendations for them Provide a list of private vaccine by brand Merck vaccines require lot numbers & expiration dates TIP calls the clinic and shares recommendations Vaccine usability Storage and handling recommendations to prevent future problems

Vaccine Transport (if required) Use Emergency Vaccine Storage and Handling Plan. Follow emergency “pack out” instructions found at www.cdc.gov/vaccines/SandH Any back-up unit used to store vaccines must meet VFC requirements Remember, do not use the freezer portion of a combination refrigerator/freezer unit to store frozen vaccine. You must monitor any back-up units used to store vaccine a minimum of twice a day with a VFC-approved thermometer with a current certificate of calibration, just as with the primary storage unit. No out of range temperatures.

Power Outage Contact your utility company; ask an approximate time the power may be restored. 2. If power is expected to be restored in <4 hours: DO NOT MOVE THE VACCINE. Keep the doors shut. Monitor the temperature inside the units Prepared to transport vaccine to Emergency Vaccine Storage location, or hold in a properly packed temporary transport box if necessary. If a temperature alarm occurs, notify TIP IMMEDIATELY during business hours: 800-404-3006.

Power Outage continued If the utility is unsure when power will be restored and the clinic is closing: Use Emergency Vaccine Storage & Handling Plan. Notify TIP immediately (if after hours, call next business morning) 800-404-3006. If restoration of power will be more than 4 hours: Notify TIP immediately (if after hours, call next business morning) at 800-404-3006. Why notify TIP immediately? The emergency plan is to be followed after hours: immediate notification is ONLY during business hours.

Presentation examples use a common Berlinger Fridge Tag 2™ model data logger; other types of loggers are acceptable and may have different instructions. Use of this example should not be construed as an endorsement or preferential recommendation. Reviewing the Alarm

Indicates “too warm” alarm 1st Press of READ If “too warm alarm” (triangle points UP), it will show the MAXIMUM temperature reached. If “too cold alarm” (triangle points DOWN), it will show the MINIMUM temperature reached. Indicates “too warm” alarm 10.2 C Warmest Temperature Reached was 10.2C

2nd Press of READ-date & time alarm occurred. Alarm occurred on September 16, 2012 at 1:47PM

3RD Press of READ - duration of alarm Alarm lasted 3 hours and 47 minutes

4th Press of READ Clears the Alarms To clear the X, press read 4 times on EACH day a triangle is pointing either up or down until a √ appears.

Reading The Data Logger Report Presentation examples use a common Berlinger Fridge Tag 2™ model data logger; other types of loggers are acceptable and may have different instructions. Use of this example should not be construed as an endorsement or preferential recommendation. Reading The Data Logger Report

Example of a FT2 Data Logger Report

Reading the Report Indicates temperature has been checked once in the morning (am) & once in the afternoon (pm). Target is 5⁰C or 40⁰F

Reading the Report – Lower Alarm Limit The coldest temperature reached in a 24 hour period was 0⁰C . The alarm lasted 3 hours 17 min. The alarm occurred at 12:22PM.

Reading the Report – Upper Alarm Limit “In Progress” indicates a temperature reading is still occurring at this time. *The temperature reached 11.3⁰C for 36 minutes within a 24 hour period. *The time above recommended range was not long enough to trigger an alarm.

Reading the Report – External Sensor Connection “OK” = secure connection; temperature is being measured. “In progress” = disconnected ; hasn’t reached 10 min or >. “ALARM!” = not connected for > 10 min.