Beginning January 1, 2012 all Vaccines for Children (VFC) providers in Oklahoma will be required to use certified calibrated thermometers in all refrigerators and freezers used for storage of VFC vaccines. Correct vaccine storage temperatures are a high priority for the VFC program to ensure that the vaccines are effective when they are administered to patients and to prevent the unnecessary loss of expensive vaccines. To ensure temperatures are correct, accurate thermometers must be used.
This guide explains how VFC providers can meet federal and Oklahoma requirements for vaccine storage unit thermometers. It also includes examples of thermometers that meet these requirements.
Thermometer Requirements Clinics storing VFC-supplied vaccine must: Use a calibrated thermometer with a current Certificate of Traceability and Calibration in each refrigerator and freezer compartment. A Certificate of Traceability and Calibration guarantees that the thermometers accuracy has been measured against a National Institute of Standards and Technology (NIST) or another internationally recognized standards agency. o The National Institute of Standards and Technology (NIST) is an agency of the U.S. Department of Commerce Use the calibrated thermometer to read and record refrigerator and freezer temperatures at least twice each workday in the morning and before the end of the workday. Keep the current certificate of calibration on file with the temperature logs for a period of at least three years. Follow the manufacturers recommendations for recalibration of the thermometers.
Thermometer Recommendations The Immunization Service strongly recommends the use of a continuous recording thermometer. Continuous recording thermometers provide valuable information when there is a problem with vaccine storage units. The continuous recording of temperatures allows the user to determine when and for how long refrigerator and/or freezer temperatures were too hot or too cold for vaccines. Ask your vendor if the thermometer comes with a certificate of calibration. Have a back-up thermometer with a current certificate of calibration in each refrigerator and freezer. Contact the Immunization Service if you have questions about which thermometer brands and models meet the requirements.
What is a Certificate of Calibration? A certificate of calibration guarantees that the thermometer is accurate as measured against a National Institute of Standards and Technology (NIST) or American Society for Testing and Materials standard. When you buy a thermometer, the certificate will ensure the accuracy of the thermometer for a certain period of time. After that time, the thermometer will need to be recalibrated. Some vendors charge for a certificate of calibration and most charge for recalibration.
What is Recalibration? Recalibration refers to testing and adjustment of the instrument to maintain accuracy after purchase. Most manufacturers recommend recalibration every one to two years. All Instruments lose accuracy over time due to normal usage and the environmental conditions to which they are exposed. Periodic NIST certified calibrations maintain the accuracy of your instrument throughout its life. In some cases it is more cost effective to buy a new thermometer rather than pay for recalibration. OSDH Immunization Service Section 2 - Page 13 Provider Resource Guide April 2012
11/15/2011 Vaccine Storage Thermometer Types and Examples
The following list is provided for you information. All thermometers in this list correctly record vaccine storage unit temperatures and meet the requirements for storing VFC vaccines. The list includes the names and web pages of manufacturers and products to show the range of types, options, and prices. You can purchase other thermometers not on this list, as long as the thermometer has a certificate of calibration. Most manufacturers offer a variety of thermometers over a wide price range. We do not endorse specific products or manufacturers. Continuous reading thermometers are the most effective tool to track the refrigerator/freezer temperature over time and are strongly recommended by CDC and the Immunization Service.
Type Model/Features Manufacturer/ Vendor Continuous Recording of the temperatures inside the unit at all times (24 hours a day, 7 days a week or longer). Mechanical Data Logger Records temperatures on paper, usually a circular graph. You must change the graph paper at the appropriate interval.
Model VFC70 for refrigerator and freezer. Cost: $260 Dickson Co. www.dicksondata.com/ Wireless Monitoring Includes reports and alarm notification system SensoScientific Vaccine Monitoring Module Automated and continuous (24/7) temperature monitoring and logging to insure the temperature in the refrigerator is maintained at 35-46F (2-8C) and the freezer as low as -13F (-25C) The system provides comprehensive reporting detail on a monthly basis in an easy to read layout. Corrective action history will also be kept. Reports can be set up to list your VFC Provider #, Location Name, and Lead Contact. The system maintains and keeps track of temperature history even during power outages or in the event of a refrigerator/freezer failure. You will receive immediate alerts via email, pager, or cell phone text message or a call center during work hours or when the office is closed if temperatures are out of limits. SensoScientific provides a NIST and NPL traceable Calibration Certificate for its temperature sensors. SensoScientific, Inc. www.sensoscientific.com/sol utions/vaccine.html
Digital Data Logger Records temperatures in the units memory. You must download the data to a computer or other device to view or print past data.
USB data logger for refrigerator and freezer. Model VFC 6000 LCD Click here for more information. Approximately $79.00 Model VFC5000-TC has LCD display and remote sensor. Approximately $100.00 Other models available. Available through Control Solutions, inc. www.vfcdataloggers.com/. Other vendors also sell USB data loggers.
Model SP425 for refrigerator and freezer. Data logger with LCD display. Cost: $159.00 Dickson Co. www.dicksondata.com/ OSDH Immunization Service Section 2 - Page 14 Provider Resource Guide April 2012
11/15/2011 Minimum / Maximum record the highest and lowest temperatures and may be digital or fluid filled. Digital Easy to read. Some have alarms and remote temperature probes.
Control Company Min/Max Traceable Refrigerator/Freezer Digital Alarm Thermometer, 58 to 158F / 50 to 70C with a NIST Traceable Calibration Certificate Cost: $51.98 Control Company thermometers available from Novatech USA http://www.novatech- usa.com/Products/Digital- Traceable-Thermometers
Models MM120 (one-probe) and MM125 (two-probe) for refrigerator and freezer. Digital display and remote sensors. These models do not track detailed temperature history but the min/max display does inform you of temperature highs and lows. Cost: $49.00 and $59.00
Dickson Co. www.dicksondata.com/
Model 12213 Certified Refrigerator/ Freezer Alarm Thermometer System. Digital display and remote sensor. This thermometer features an enclosed temperature-buffered sensor which ensures accurate temperature measurements that are not impacted by rapid temperature fluctuations caused by frequent refrigerator/freezer door opening. It also mimics temperature readings in a medium similar to the common fluids stored in refrigerators and freezers, in labs. Cost: $54.50 Delta TRAK Inc. www.deltatrak.com/
Streck Temp-Chex digital Thermometer Model 240056 for refrigerator and freezer. Digital display and remote sensor. Cost: $47.00 Streck www.streck.com/
Fluid Filled
Exact-Temp thermometers Model T210-11T for refrigerator (5 to 15 C) and Model T120-22 for freezers (-30 to 0 C) Biodegradable Liquid and Dye - Easy to Read Each thermometer is mounted in a square shaped shatter proof plastic bottle filled with ethylene glycol to insure accurate readings despite the opening and closing of the refrigerator or freezer doors. The thermometers have engraved stems and are thoroughly annealed for lasting accuracy. Each one has its own unique serial number and has been tested against a standard calibrated at the National Institute of Standards and Technology (NIST). A certificate of accuracy is supplied with the thermometer making its indications traceable to NISAT Cost: $44.00 MG Scientific www.mgscientific.com/
Streck Temp-Chex Models for refrigerators (-5 to +15 C) and freezers (-30 to +1C) Enviro-Safe and Red Spirit Temp-Chex thermometers monitor refrigerators, freezers, incubators, and room temperatures. Each Temp-Chex thermometer is engraved with a serial number traceable to NIST/DKD with scales in 1/2 increments*, allowing the laboratory to meet CAP and CLIA standards. Contained in a vial of propylene glycol, Temp-Chex thermometers attach to your refrigerator or freezer wall magnetically or adhesively. The Temp-Chex thermometer and vial are enclosed in a plastic tube to protect the thermometer and to contain contents in case of breakage. All Temp-Chex thermometers are mercury-free, and Enviro-Safe thermometers utilize only biodegradable, nontoxic, and nonflammable components. Cost: $47.00 Streck www.streck.com/
Digital Built-In Come as standard or optional accessory on commercial lab or medical-grade refrigerators/freezers. Before you purchase one, you may want to ask if the built-in thermometer has a certificate of calibration. If not, you must use another thermometer with a certificate as the primary thermometer.
Other Possible Sources Traceable Hi-Accuracy Thermometers at http://www.healthcarelogistics.com/about Fisher Scientific at www.fishersci.com/ OSDH Immunization Service Section 2 - Page 15 Provider Resource Guide April 2012