Recalibrating Devices
Because data loggers experience a drift over time that affects their accuracy, providers must recalibrate all primary and backup data loggers (device and probe together) every two to three years or according to manufacturer’s suggested timeline. A new device might be less expensive than calibration testing.
What is Calibration Testing?
A calibrated device is one that has been professionally tested to determine its accuracy by comparing its readings to a reference thermometer that is traceable to national standards. Such testing confirms that devices are accurately recording temperatures in vaccine storage units.
Key Points
- Calibrate primary and backup devices on different schedules to ensure storage units storing publicly supplied vaccines are always equipped with data loggers.
- 2-point testing/calibration (tests high and low extremes for intended environment) meets program requirements.
- Calibration cost for a basic device should be similar to a thermometer; cost for more advanced devices might vary depending on enhanced functions and number of probes.
- Vaccine orders will not be processed if calibration certificates have expired and provider fails to calibrate on time or replace with a new device.
Testing Laboratories
Calibration testing might be performed on-site or shipped to a laboratory that meets program requirements, ideally to a laboratory with accreditation from an International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body. Certificates issued by non-accredited laboratories must meet requirements for certificates of calibration (PDF).
Sample accredited laboratories:
| Lab | Address | Phone | Accreditor |
|---|---|---|---|
| Control Solutions | 35851 Industrial Way, Suite D St. Helens, OR 97051 | 503-410-5996 | PJLA |
| Merit Calibrations | 7923 Warner Avenue. Suite K Huntington Beach, CA 92647 | 657-259-0597 | ISA |
| MDQ Calibration | 879 Maple Street Contoocook, NH 03229 | 603-746-5524 | PJLA |
| Onset Computer Corporation | 470 MacArthur Blvd. Bourne MA, 02532 | 800-564-4377 | ANAB |
Search for accredited laboratories on these sites:
- American Association for Laboratory Accreditation (A2LA)
- ANSI National Accreditation Board (ANAB)
- International Accreditation Service (IAS)
- Perry Johnson Laboratory Accreditation, Inc. (PJLA)
- National Voluntary Laboratory Accreditation Program (NVLAP)
How to Calibrate
Follow this guidance to comply with program requirements and best practices.
| Step | Description |
|---|---|
| 1. | Confirm that data loggers still meet program requirements. |
| 2. | Find a calibration laboratory that can provide a compliant Certificate of Calibration (PDF). a. Calibrate primary and backup devices on different schedules. |
| 3. | Prepare devices then ship. a. Stop the device. b. Download and save any existing temperature data files. c. Place probe in bubble wrap or other protective material to prevent leakage then place in a sealed plastic bag. d. Wrap device in protective material and seal in a plastic bag. e. Place data logger and probe in a padded envelope or box, label and include forms requested by calibration laboratory. |
| 4. | Follow up to ensure laboratory has received the device and ask when to expect the updated certificate of calibration and device. |
| 5. | When results come back, review findings to confirm results as pass or in tolerance. Replace any devices that fail calibration testing. |
| 6. | Keep certificates of calibration on file for three years. |
