NIST & Temperature Monitoring in Healthcare

Learn more about our NIST certification and how it ensures the highest standards of accuracy and compliance.

Why NIST Matters for Hospitals:

  • Medicines and vaccines must be stored at precise temperatures (often 2–8 °C for refrigerated vaccines, or below −20 °C for frozen).

  • Regulators like the CDC, FDA, and WHO require calibrated monitoring equipment to ensure accuracy.

  • NIST provides the traceability standards for calibration — this ensures that the thermometer or data logger used in a hospital has a documented, unbroken chain of comparisons back to a national reference standard.

NIST-Traceable Calibration:

  • Hospitals typically use digital data loggers (DDLs) or specialized medical-grade thermometers.

  • These must be NIST-traceable, meaning:

    • The device has been calibrated by an accredited laboratory.

    • The calibration is documented with a certificate.

    • The accuracy is traceable back to NIST’s national measurement standards.

  • Certificates usually specify the date of calibration, test results, and next due date for recalibration.

The Certification / Compliance Process for Hospitals:

Step 1 – Select Equipment

  • Hospitals must use NIST-traceable thermometers or data loggers.

  • CDC’s Vaccine Storage and Handling Toolkit requires continuous monitoring with buffered probes (to simulate vaccine conditions).

Step 2 – Calibration by an Accredited Lab

  • Devices are sent to a calibration laboratory that is ISO/IEC 17025 accredited.

  • These labs follow NIST standards and issue a Calibration Certificate that states NIST traceability.

Step 3 – Documentation & Recordkeeping

  • Hospitals must maintain:

    • Calibration certificates.

    • Logs of continuous temperature monitoring.

    • Records of corrective actions if excursions occur.

Step 4 – Regular Recalibration

  • Typically every 1–2 years, depending on manufacturer and CDC/FDA requirements.

  • Some facilities rotate devices so one can be recalibrated while another is in use.

Step 5 – Compliance Verification

  • During inspections (e.g., CDC Vaccines for Children program or Joint Commission audits), hospitals must show:

    • Proof that devices are NIST-traceable.

    • Temperature logs (usually 24/7 with backup systems).

    • Evidence of corrective actions for out-of-range events.

Related Standards & Regulations:

  • NIST Handbook 150 – sets calibration lab accreditation requirements.

  • CDC Vaccine Storage & Handling Toolkit – mandates NIST-traceable calibrated thermometers.

  • FDA 21 CFR Part 11 – governs electronic records/logging systems.

  • WHO PQS Standards – for international vaccine storage compliance.

Summary for Hospitals:

  • Hospitals don’t get “NIST certified.” Instead, their temperature monitoring devices must be NIST-traceable.

  • Compliance involves:

    • Using calibrated, NIST-traceable data loggers.

    • Keeping calibration certificates.

    • Maintaining temperature logs.

    • Recalibrating on schedule.

  • This process ensures patient safety, regulatory compliance, and eligibility for federal vaccine programs.