Any facility that is considering a move to wireless temperature monitoring must involve clinical engineering representatives from the onset. Instead of worrying about running wires throughout the complex, signal strength and viability needs to be determined for all areas that will use the system. This process, often done by trial and error, will dictate the number of transmitters needed, as well as their physical placement and frequency of placement. Depending on the layout and construction materials used in certain areas of the hospital, the number and placement of transmitters will need to be customized. Once the system is in place, it is helpful to keep a supply of extra transmitters, monitors, and probes in stock, as these can and will fail at some point, and having replacements on hand will make maintenance much easier.
Establishing Monitoring Responsibilities
Roles should be defined early on in the process. Specifically, you should establish who will be responsible for monitoring the data from the wireless system, and how that data will be used and acted upon. Due to the nature of real-time data, you quickly will be made aware of the number and variety of alerts relayed by the system. Everything from a malfunctioning unit to a door being left open will be reported, so you need to have a system in place to determine the proper action for every kind of alert. In addition, as a wireless monitoring system may be used for applications other than pharmacy (e.g., food and nutrition, lab, etc), the responsibilities of data reporting must be clearly delineated.
One great benefit of wireless data transmission is the multiple capabilities available from certain vendors. Some systems allow for additional measurements, including humidity and air pressure. All of these variables should be taken into account if you are seeking USP compliance.
Accurate and easy access to data is particularly important when dealing with investigational drug research and vaccine storage. For investigational drugs, there is often a data stream that must be maintained over a period of time, and a Web-based wireless system will allow for easy and consistent data availability. Likewise, vaccines require multiple temperature reviews daily, so having the data available 24/7 is important.
Be sure to review any accompanying software that comes with the system, as not only will you need to determine whether it will be compatible with your current system, but you also want to gauge the ease-of-use of the system. Are the monitoring mechanisms clear? Is the data accruing in an intuitive way? These are issues you want to resolve before making a purchase.
Temperature Monitoring and TJC
One of the most important issues for The Joint Commission (TJC) is consistency. They will want to know if the same temperature monitoring protocols are being used not just for drugs but also for other operations, including lab and nutrition services. This will really bring to light the scope of a facility-wide temperature monitoring system, as it has the potential to include 100+ individual units. It is important to note that this includes any devices used on a temperature dependent basis; so not just refrigerators and freezers, but warmers also. These devices tend to be overlooked, and during an inspection, the surveyor will note that the OR is storing IV bags in a warmer, and will want to know who is monitoring that temperature data, and that best practices are in place. As a final point of consideration, TJC’s transplant standards indicate that temperature monitoring data for tissues, organs, etc, must be retained for 10 years. Keeping 10 years of paper data, or any other type of manual record system, would be very difficult, and is yet another reason to consider a wireless, Web-based system going forward.
Rosario (Russ) Lazzaro, MS, RPh, is the director of pharmacy services at Holy Name Hospital in Teaneck, New Jersey. Russ received his BS in Pharmacy, and his MS in Pharmacology from St. John’s University.
Holy Name Hospital’s policies and procedures for temperature monitoring:
Holy Name Medical Center
Teaneck, New Jersey
PHARMACY POLICIES AND PROCEDURES
SUBJECT: Temperature Monitoring
DATE EFFECTIVE: 5/2010
The following accrediting federal and state agencies require biologicals, contrast media, solutions, and pharmaceuticals are kept within approved temperature ranges and that the freezers, refrigerators, and warmers where these products are stored are monitored:
Of note, the manufacturer’s expiration date for solution containers is generally based on a constant temperature of 25°C/ 77°F
(room temperature). Prolonged storage at higher temperatures may accelerate concentration and pH changes.
The USP approved temperature range for freezers is as follows:
The USP approved temperature range for refrigerators is as follows:
Maximum temperature monitoring is set to just below 100°F for bags and bottles, although bags and bottles can be
warmed up to 150°F.
Retention limits for bags, bottles, and contrast media are as follows:
Wireless, 24/7 temperature monitoring sensors have been installed in all freezers, refrigerators, and warmers where biologicals,
contrast media, drugs (i.e., Mannitol), IV bags, irrigation bottles, and vaccines are stored until use. These sensors continuously track
and record pre-determined temperature data for all units in the facility.
Should a unit’s temperature exceed the set limits, high or low, the director of pharmacy receives an e-mail alert and a page alert indicating a breach of temperature range. In the director’s absence, e-mails and pages are sent to the director of clinical engineering or the director of maintenance for action and/or correction, if needed. Pharmacy can review and/or print out reports hourly, daily, weekly, monthly, and yearly for every single recording device. The pharmacy retains all temperature records for a period of two to five years.
Hospital staff operating in areas where warmers reside must label all bags and/or bottles placed in a warmer with a beyond use date (BUD) or expiration date. Bags contained in over-wrap bags can be stored up to 14 days, and irrigation pour bottles can be stored for up to 72 hours.
In the case of contrast media stored by the radiology and/or nuclear medicine departments, the time period is 30 days of storage in a warmer, during which the contrast must not exceed a temperature of 37°C (98.6°F).
Nursing and radiology personnel in these areas must rotate stock and remove any bags and/or bottles that have reached their BUD date. Pharmacy personnel will also monitor these temperature-regulated storage areas during routine unit inspections every 60 days.
Occasionally alarms are triggered during the course of cleaning the units, or when searching for or stocking items in the units. If a unit door remains open for an inordinate time period, the temporary drop in temperature will usually activate an alarm. When this occurs during a known cleaning or stocking period, wait to see if there are any subsequent alarms, which should be set to occur within 30 to 60 minutes. If no other alarms are triggered, the temperature has returned to normal. If a subsequent alarm is triggered in the same unit, the director should take appropriate action.
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