The ultimate goal of temperature monitoring is to ensure the preservation of safe and effective medications. Given the high cost of many temperature-dependent medications, investing in an effective temperature monitoring system has the potential to deliver significant financial benefits by identifying temperature excursions at the outset, and thus averting product loss.
The CDC’s Vaccine Storage & Handling Toolkit is a comprehensive document that provides detailed guidance on best practices for temperature monitoring of vaccines (see www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf). Once these guidelines are put in place to manage vaccine storage, it makes sense to apply them to all medications in refrigerated storage.
The CDC recommends that vaccine storage practices include policies and procedures (P&Ps) for temperature monitoring. At a minimum, temperatures are to be reviewed and recorded twice per workday. Reviewing the temperatures at least once at the outset of the day and again at the end of the day allows for quick corrective action should a temperature excursion occur.
Further, best practice is to utilize a digital data logger to record and store temperature information at regular intervals over a 24-hour period. This continuous monitoring creates a thorough record of temperature control. The data logger’s digital display should be located outside of the refrigerator or freezer to allow for easy temperature review without having to open the unit or manipulate the probe. Even when alarms are used to indicate out-of-range temperatures, at least two temperature recordings must be recorded daily.
Should a regular temperature recording be missed, the record for that day should be left blank. Anytime a temperature excursion occurs, the event and any actions taken in response should be documented, along with the ultimate outcome. In addition, any mechanical problems, power outages, or repairs performed (with or without an impact on the temperature range) also should be documented.
To facilitate ongoing equipment maintenance and satisfy regulatory requirements, temperature monitoring data must be reviewed weekly. This task should be assigned to the primary or alternate vaccine coordinator. Unless your state has more stringent requirements, temperature data records should be retained for 3 years. Regular review of this data will demonstrate any developing patterns in temperature excursions and indicate when equipment may be in need of repair or reaching the end of its life cycle. Likewise, regulatory inspections will be smoother when the temperature data for a given unit can be quickly accessed to demonstrate system control.
- Purchase refrigerators and freezers with self-closing doors, and utilize an open door alarm.
- Check the door seal on each storage unit by closing the door on a thin paper slip. If the slip falls or moves easily when pulled, consider replacing the door’s rubber seal. Perform this check all around the door, paying particular attention to the corners.
- If temperature readings never vary within a unit, check the temperature probe to be sure it is functioning properly.
- A buffered probe is the most accurate tool for measuring temperature; temperatures measured in air may be misleading.