But, as you know, there’s so much more that goes into maintaining the highest quality of care — even down to the seemingly smallest detail, like keeping medications within the ideal temperature range.
There are a variety of standards that EMS organizations can use to make sure they are up-to-date with industry best practices where safe temperatures are concerned. However, most accreditation agencies rely heavily on US Pharmacopeia (USP) for best practices on shipping and storing pharmaceuticals. And while not required, many EMS providers seek accreditation as a point of differentiation and illustration of best practices from one or both the Commission on Accreditation of Ambulance Services (CAAS) or the Commission on Accreditation of Medical Transport Systems (CAMTS).
If you are considering working toward accreditation — understanding USP guidelines from the outset could help the process go a bit more smoothly for you. That’s because both require procedures be in place for monitoring the temperature of medication in storage and vehicles, and both also base their standards on USP guidelines.
The Story Behind USP
USP has had standards in place for many years around the best practices for shipping and storing pharmaceuticals. “USP Chapter 659 Packaging and Storage Requirements,” for instance, provides definitions for appropriate and various packing materials as well as storage conditions. This includes temperature definitions for frozen, refrigerated, cold, cool, room temperature and controlled room temperature. There is also information related to allowable temperature excursions and how best to measure and track temperature, all to protect the integrity of drugs as well as ensure patient safety.
More recently, as the industry has been working toward Good Distribution Practices, the USP updated their guidelines to include “Chapter 1079 Good Storage and Distribution Practices for Drug Products.” This informational chapter builds on the definitions provided in the earlier Chapter 659 and is used as guidance for all organizations and individuals involved in any aspect of the storage and distribution of all drug products, including Emergency Medical Services.
The Commission on Accreditation of Ambulance Services
In Version 3.0 of CAAS standards, released in October of 2009, section 203.03.04 covers temperature extremes saying:
“The agency shall have a policy/procedure for the storage of medications and IV fluids that allows for protection from extreme temperature changes. The policy shall also include a procedure for what to do if medications or IV fluids do get exposed to extreme temperatures.”
Commission on Accreditation of Medical Transport Systems
As noted, CAMTS includes air transportation in its standards in addition to ambulances, vans and other ground EMS vehicles. In the tenth edition of their accreditation standards, updated in October of 2015, the CAMTS states in Section 03.06.00, Page 3.27 and 3.28:
“Storage of medications allows for protection from extreme temperature changes if environment deems it necessary. If there is a refrigerator on the vehicle for medications, a temperature monitoring and tracking policy is required, and the refrigerator is used and labeled ‘for med use only.’”
Then on Page 3.29 regarding blood products:
“Determination of when the blood product was released from the Blood Bank. Blood must be maintained at a controlled temperature of 2-8 degrees C during transport and must be infused within 4 hours of removal from therÂ¬mal control. The temperature of the cooling mechanism is monitored and recorded.”
A Case in Point: Walton County Fire Rescue
Walton County Fire Rescue is a 130-member department providing fire suppression and prevention as well as emergency medical services in Walton County, Florida. Working out of 11 stations, the highly trained crews serve people living in a 760 square mile area north of the Choctawhatchee Bay.
In 2019, Walton County Fire Rescue began working toward earning certification from CAAS. Among the requirements for certification is the ability to verify that medication and devices stored in stations and carried in emergency vehicles are kept within compliant temperatures, as outlined by the manufacturer and referenced in USP Guidelines, explains Tim Turner, Division Chief of EMS Training, Walton County Fire Rescue.
For much of the medication the Fire Rescue crews carry, this means either refrigerated temperature (36â°F to 46â°F) or controlled room temperature (68°F to 77°F). “While our medications were all kept in a climate-controlled environment, we had no formal process in place for monitoring and recording temperature data,” Chief Turner says. When he and Kayleigh Sanders, the organization’s Accreditation Clerk, began talking to other EMS providers about what they were doing to monitor and record temperatures — they found that many were doing it manually. Overall, says Chief Turner, the results did not seem to be meeting CAAS standards. That’s when Walton Fire Rescue decided to look for a more automated, reliable process.
The Benefits of Automated, Wireless Temperature Monitoring
The team settled on a comprehensive solution that includes 60 wireless, Bluetooth®-enabled sensors to monitor medication in storage areas on rescue vehicles, in drug bags and in supply rooms. That includes supply closets and refrigerators at each of their 11 stations as well as on their six primary ambulances where they have a sensor in each StatPack™ and cooler.
Fifteen corresponding wireless gateways were also installed, which collect data when vehicles return to the station and store it in the cloud where it can be easily accessed or downloaded for generating reports. A gateway is also installed directly on the two EMS vehicles. With gateways in these ambulances, the fire rescue team can get alerts in real-time while crews are in the field. If that happens, they can quickly log in to the free mobile app or web-based system to see exact temperature exposures as they are happening.
Since everything is automated and cloud-based, they don’t need to rely on crews to log correct temperatures. “It just takes stress away from crews, which is important so they can concentrate on saving lives and putting out fires,” says Chief Turner. In addition to using the temperature monitoring system to earn accreditation, Chief Turner says the sensors are invaluable also because they give him and his crews a new level of confidence in the efficacy of the medications they administer.
Technology Streamlines Compliance Reporting
Wireless sensors can be programmed from a smartphone or tablet using a mobile app. This allows users to set preferences such as alarms, datalogging intervals and startup options as well as time and temperature units. Mobile apps also make it easy to access temperatures, locations and other information captured by the wireless sensor.
A web application with a sophisticated dashboard gives users a consolidated snapshot of data uploaded from sensors to the cloud. This allows users to view and manage all information, including temperatures, the location where sensors were read and any alarms that might have occurred. Data can easily be exported to PDF or CSV files to generate detailed reports of sensor readings, events and settings for internal tracking as well as to meet CAAS and CAMTS requirements. According to Shaun Curtis, Support Services Manager for Medstar Mobile Healthcare in Texas, reports are detailed enough that compliance with temperature monitoring has been the easiest part of their CAAS audits — which take place every three years.
You can access the full set of standards at www.caas.org and www.camts.org, and the USP Guidelines at www.usp.org/.
Katie Kraverath is a Senior Business Development Manager for Temptime Corporation. She began her career working specifically with pharmacies, and today Kraverath uses that experience to help EMS providers and others develop solutions for monitoring temperature-sensitive medications. This includes providing guidance on the regulatory and accreditation requirements around cold chain temperature monitoring.