Statewide Rollout of Continuous Temperature Monitoring in Massachusetts Pejman Talebian, Director Immunization Program Massachusetts Department of Public Health

National Immunization Conference September 29, 2014

In Search for the Perfect Data Logger

 There

are plenty of data loggers available.  How to evaluate which loggers to pilot.  Survey of providers indicated that software installation would be an issue.  Lack of resources to do on-site set up requires a device with simple set up.  Recalibration and Recertification on a scheduled basis would be an issue. MDPH Sept. 2014

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Pilot Tested Products in House  Obtained

several products from multiple manufacturers and vendors.  Interviewed vendors concerning procurement and customer support.  Discussed calibration and battery life.

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Fridge-tag2® Selected as Logger  NIST

certified  No software required  Easy to install and use 

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simple set up instructions including cartoon graphics short YouTube videos to enhance set up and assist with troubleshooting

 Extended

state pricing (through VWR Scientific) to provider sites wanting to purchase additional loggers.

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Fridge-tag2® by Berlinger

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Small Initial Pilot Program  Sent

loggers to selected familiar sites.  Solicited feedback on how the set up process could be improved.  Shared feedback with manufacturer’s General Manager.  Modifications and enhancements prior to full roll out 

Included marking of AM/PM temp readings on data chart

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Additional Training Materials  Bullet    

lists developed for:

Start up Daily monitoring Monthly reporting with vaccine orders Data retention options

 MDPH

Vaccine Unit staff available by phone to assist, if necessary.

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Controlled Roll Out  Notify

selected provider sites that one refrigerator and one freezer logger would be mailed to them with instructions for set up.  Provider could notify us before mailing if they did not want to participate.  Short survey sent one week after mailing seeking feedback on ease of installation and operation of the loggers. MDPH Sept. 2014

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Roll Out Complete  Refrigerator

and freezer loggers have been sent to 494 sites who use over 80% of the pediatric vaccine supply.  Small percentage of equipment problems.  More feedback on setup problems.  Suggestions on alarm configuration (longer delays for warmer temperatures).  Review issues with General Manager to further improve the product and the process. MDPH Sept. 2014

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Lessons Learned Fridge-tag2® data logger with 5 ml vial of glycol is more sensitive to temperature changes than thermometer in 30 ml bottle of glycol.  Thermometer in 30 ml bottle of glycol will never get as cold or as warm as data logger probe in 5 ml vial of glycol.  Significantly more temperature excursions detected using the Fridge-tag2® data logger.

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More Lessons Learned  Most

temperature excursions occur in household model combination refrigerator/freezers.  Significant temperature variations occur within the refrigerator compartment. 

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Colder at the top of refrigerator compartment where freezing cold air input is located. Colder at rear of refrigerator compartment where coils are located.

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A Better Tool Has Its Consequences  Because

more temperature excursions are being detected, more vaccine is lost due to damage.  Children who received a dose of damaged vaccine need to be revaccinated. 

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After 6 months, 84 letters have been sent to providers recommending revaccination. For all of 2013, there were only 6 letters recommending revaccination.

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Time to Educate Providers Massachusetts has been requiring providers to submit their temperature logs with each vaccine order since 2008.  All providers with data loggers are required to submit their information with each vaccine order.  Logs are being reviewed by Vaccine Unit staff, and often times follow up by the Vaccine Manager or VFC Coordinator is necessary. 

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Time to Educate Providers, cont. At least 50% of the Vaccine Manager’s and VFC Coordinator’s time over the last 4-5 months has been spent speaking with providers on the merits of data loggers and addressing temperature excursion issues.  The data loggers record the temperature every minute of every day versus the “looks” in morning and afternoon  The pdf report provides tremendous detail on the operation of the refrigerator and freezer. 

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Time To Educate Providers, cont. 

Some of the topics discussed with providers include: 

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The merits of using pharmaceutical grade stand-alone refrigerators and freezers versus a household combination model. Pharmaceutical grade units have an internal fan to disperse the cold air evenly throughout the unit. Measure the temperature using a probe in 5 ml glycol solution much more closely mimics the temperature of a 0.5 ml vial or syringe of vaccine.

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Time to Educate Providers, cont.  Other 

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Topics:

Fridge-tag2® report lets you see the operating range and efficiency of the refrigerator or freezer. Sometimes a refrigerator only needs to be “warmed up” to avoid freezing temperatures. Location of the Fridge-tag2® vial in the household style refrigerator is critical when trying to measure the temperature of the vaccine.

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Slow Painful Process But Providers are Accepting  Education

process is one provider at a

time.  Providers understand the advantages of data loggers and do what is necessary to ensure the effectiveness of the vaccines.  Although CDC recommends stand alone refrigerators and freezers, MDPH is recommending pharmaceutical grade units for vaccine storage. MDPH Sept. 2014

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How Do We Proceed? Data loggers are a great tool!  Significant variations in temperature when using a 5ml glycol solution versus 30 ml glycol solution  CDC and NIST need to determine what volume of glycol solution would be best to determine the temperature of the vaccines.  Consider eventual requirements for pharmaceutical grade vaccine storage units. 

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Questions?

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