Announcement
Date: May 9, 2016
To:
MnVFC Providers
From: MnVFC Program
Re:
Updated certificate of calibration requirements for temperature
monitoring devices and discontinuation of semi-annual reports
Please route to:
• Clinical supervisor
• Medical director
• Clinic manager
• Clinic staff
• Pharmacy
• Vaccine staff
Updated certificate of calibration requirements
All storage units that contain MnVFC vaccine must have a temperature monitoring device with a current and valid
certificate of calibration. CDC recently updated what items are required on these certificates making it easier for sites to
demonstrate their certificates of calibration are valid.
Required elements:
• Model/Device Name or Number
• Serial Number
• Date of Calibration (Report or Issue Date)
• Instrument Passed Testing (Instrument in
Tolerance)
Recommended element:
• Recommended Uncertainty = ± 0.5° C / ± 1.0° F
Starting now, certificates of calibration that meet these requirements will be considered valid. We are updating our
resources to reflect these new requirements.
To determine if a certificate of calibration testing was issued by an appropriate entity, check to see if the certificate
indicates one or more of these items:
• Conforms to ISO 17025.
• Performed by an ILAC/MRA Signatory body accredited laboratory. You can review this list of the ILAC MRA and
Signatories (http://ilac.org/ilac-mra-and-signatories/).
• Traceable to the standards maintained by NIST.
• Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard
E2877 tolerance Class F (≤ 0.5 °C) or better.
• Includes reference to another acceptable accuracy validation method, such as comparison to other traceable
reference standards or tests at thermometric fixed points.
Note: The CDC recommends that certifications be issued for the entire monitoring unit (detachable probe, data logger,
etc.) and not individual certificates for each component.
If you have questions, call the MnVFC program at 651-201-5522 or 1-800-657-3970 or email [email protected].
Discontinuation of semi-annual reports for MnVFC
The semi-annual report of doses administered is no longer a requirement for MnVFC sites that practice the replacement
method of vaccine management because doses administered are now being reported to MIIC.
MnVFC Program
651-201-5522, 800-657-3970
www.health.state.mn.us/vfc