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TJUHBB

Temperature Monitoring & Alarms

Standard Operating Procedure (SOP 04.006)

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PURPOSE

Temperature monitoring is instrumental in ensuring biospecimen quality and longevity. Biospecimens are subject to degradation at the tissue, cell, and molecular levels unless temperatures are kept sufficiently low. Furthermore, large deviations in operating temperatures and repeated freeze-thaw cycles can also negatively affect biospecimen integrity. Therefore, it is important to monitor the temperature of biospecimen storage units and have adequate reporting and recovery procedures if temperature deviations occur.

SCOPE

This standard operating procedure (SOP) describes how the temperature of biospecimen storage units should be monitored. Furthermore, this document describes the procedures required if a temperature deviation is encountered.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

None.

ROLES AND RESPONSIBILITIES

This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in recruiting patients and the acquisition of informed and voluntary consent. This may include the following personnel:

Tumor Biobank PersonnelResponsibility
Biobank TechnologistMaintaining temperature logs; Testing and validating alarm systems

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials & EquipmentQuantity
Temperature Probes1 per storage unit
Temperature Transmitters1 per storage unit
Temperature Receiver (gateway)Managed by Jefferson Facilities

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

Temperature Monitoring

  • Temperature monitoring is conducted autonomously through the Jefferson Facilities. Temperature probes are placed within the freezer at the same location as the internal temperature probe (Panasonic NTCPBUNIV) via the freezer port.
  • The probe is connected is to the transmitter (Panasonic NTCUNIVZBPS) which relays the temperature of the probe over an independent wireless connection at 15 minute intervals.
  • The temperature readout from the transmitter is received by the gateway (Panasonic NTCGATEWAYT) which is connected to the local area network and relays all of the temperature information to Jefferson servers.
  • Daily reports are summarized on a monthly basis and printed out in hardcopy.

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Receiver or Probe Malfunction

If a temperature probe or transmitter malfunctions and gateway does not receive a signal for greater than 15 minutes, an alert will be sent through SMS message and email to the biobank manager.

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Gateway Malfunction

If the Jefferson servers do not receive a signal from the gateway for greater than 15 minutes, an alert will be sent through SMS message and email to the biobank manager.

Alarms

  • If temperature deviations occur outside the specified range, a warning will be issued initially. This warning is received by the biobank manager through SMS message and email.

  • If the temperature deviation continues past the alarm threshold, the biobank manager will be alerted via SMS message and email.

  • Simultaneously, a ticket will be created on the monthly report that will require documentation regarding the cause of the alarm as well as any actions taken.

  • If a ticket is created, the technologist should double-click on the ticket to document and close the ticket. This can be seen in the Figure 4 below.

  • The following fields are required documentation for any ticket created.

    • Ticket Cause - Document the underlying cause of the alarm
    • Ticket Action - Document any actions that were required to either stop the alarm and/or prevent future alarms of a similar type from occurring.
    • Acknowledge - Document that the alarm was acknowledged by the manger.

  • If any report costs are incurred or if the equipment being monitored is still in warranty, these can be optionally documented as well.

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Alarms

The alarms must be attended to promptly as to ensure the viability of all biospecimens. If an alarm is received, a manager is required to physically evaluate the alarm within 1 hour of receiving the alarm. The manager must document the alarm report, the cause of the alarm, and any actions taken.

Freezer Malfunction

In the event the main freezer ceases to work and the back-up liquid nitrogen is not sufficient to compensate, the biobank manager is alerted via SMS or email. The manager must respond promptly and move all samples into the back-up freezer to prevent degradation of samples.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

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