Quality Control

Tips on Environmental Monitoring in the Cath Lab

Nick Kovacic, Dickson Company, Addison, Illinois
Nick Kovacic, Dickson Company, Addison, Illinois
Whether you are talking about proper handling and storage of drug-eluting stents, plasma supplies, or protecting anticoagulants from humidity-caused deterioration, there is a wide range of drugs and other supplies in the typical cath lab that need to be protected from adverse temperature and/or humidity effects. Documentation is key — both from a regulatory compliance standpoint and for liability considerations, which for all practical purposes are one and the same. If your cath lab’s drug and supply storage practices were ever examined in legal proceedings, how well your lab conformed to any and all relevant regulations during the time period in question will become the basis by which torts are determined in a court of law. The paper trail or electronic equivalent that you have on hand to document that environmental monitoring is “done by the book” is always an issue. There are basically four different instrument types available for monitoring and documenting temperature or temperature and humidity: thermometers, chart recorders, data loggers, and new wireless technology. Where regulations only require a twice-daily manual check of temperatures, use of a thermometer may suffice, as long as the accuracy of the thermometer is validated. There are significant drawbacks to this method, however, which one can visualize easily if you imagine being cross-examined in a court of law. Would an attorney barrage you with questions such as, “What proof do you have that the temperatures were taken at these times and not filled in after the fact?” “Were refrigerators ever unplugged by cleaning crews?” “How did your cath lab monitor storage conditions on the days when you were not open?”, etc. More importantly, when one considers how periodic emergencies can upset routine schedules, the inadequacies of manual monitoring become even more apparent. To the extent that this is a manual process, it is fraught with the possibilities for human error. A variant on manual thermometer monitoring is to employ what is known as an alarm thermometer. In fact, many regulations require that there be an alarm system of some kind. The better alarm thermometers one can find have remote probes for monitoring both refrigerators and freezers, tamper-resistant alarms, and also will indicate MIN/MAX temperatures as well as current readings. The downside of alarm thermometer instruments is that there isn’t an automatic paper trail as with chart recorders or automatic storage of data points, as in data loggers or wireless data logger technology. Chart recorders, data loggers, and wireless monitoring technology are relatively liability-proof when compared to manual logging and use of temperature indicators such as alarm thermometers, precisely because of the vast amount of tamper-proof data that they capture and can provide as evidence of environmental stability. Chart recorders provide either a strip or circular paper record of temperature (or temperature and humidity) conditions. These paper records can be validated with dates and signatures, photocopied, and filed for more than 10 years. Their main advantage is that they make data immediately accessible, even to non-technical users, and do not require any computers or computer skills. Chart recorders also can feature alarms, digital displays of MIN/MAX or current readings, remote probes, and relays for connecting to auto-dialers. Chart data can be viewed in fine granular detail (e.g., over a 24-hour monitoring period) or as relative trend data (e.g., over a 7-day monitoring period). If maximum flexibility is essential to your cath lab’s operations, a data logger is typically the recording instrument of choice. Data loggers are electronic instruments that enable you to store data sample points on the logger’s hard drive for later download to a PC or laptop. Accompanying software makes it possible to view data in graphical or tabular form and export it to whatever data analysis applications are required for an application. Like chart recorders, data loggers monitor a variety of temperature and/or humidity ranges. Their features include alarm options, start/stop buttons for cleaner compliance records, data display options ranging from large flat panels showing detailed graphs at a glance to simple MIN/ MAX or current condition digital readouts, with remote probes, and a variety of options on how data is downloaded, such as by using the same type of removable FLASH memory cards that are now commonplace with digital cameras. A variant of data loggers are the newer, wireless data loggers. The advantage of these wireless systems is that they monitor and display in real time on PCs and eliminate the time ordinarily needed for data downloading. This makes them more practical for most cath lab administrators, who generally log many hours at their PCs and who do not want to have to walk about taking readings from remote instruments. Until recently, wireless technology was not thought to be up to the demands of the hospital environment, but there are now wireless data loggers that automate data backup for more than a week and give ongoing feedback that their wireless network is intact, i.e. the kind of reliability features that are required when proof of system functioning is both a compliance issue and requirement for patient safety. Perhaps the most common mistake made by cath lab managers is in thinking that the task of environmental monitoring is complete once the proper monitoring instrument and procedures are in place. Years go by, and without notice, the monitoring instruments, just like ANY instrument, drift out of their initial calibrations. Re-calibrations are not only necessary, but procedures must be in place to determine how and when to do these recalibrations, and what “level” of calibration is required. “Level of calibration” refers to the accuracy that can be validated. Choosing the wrong calibration type can be troublesome. For example, from a liability standpoint, you could actually be destroying evidence of your cath lab’s compliance if you do not ensure that the “before” data is collected by the metrology service performing the re-calibration such that you can demonstrate in a court of law, if it comes to that, that your monitoring instruments remained within acceptable accuracy ranges before routine re-calibrations were done. For a step-by-step guide on how to determine necessary calibration schedules, summaries of regulations bearing on critical storage for various media, drugs and supplies used in most cath labs, and for more detailed instrument selection guides, download the white paper “Hospital Environmental Monitoring — What You Need to Know About Critical Storage Regulations, Liabilities, Audits, Instrument Selection and Cost Controls,” at: http://www.dicksondata.com/upload/1249418111_Dickson_White_Paper_Finalerrata052209.pdf/ (or) http://tinyurl.com/yzzt3qp About the author. Nick Kovacic is the Hospital and Clinical Application Specialist for Dickson Company (www.dicksondata.com) which offers data loggers, chart recorders, alarm thermometers and wireless monitoring instruments for hospital regulatory compliance. Mr. Kovacic advises cath lab directors and other hospital managers worldwide on best-match environmental monitoring technology to meet regulatory compliance and other application requirements. Inquiries can be directed to: Nick Kovacic, nkovacic@dicksondata.com, (800) 757-3747 or +1-630-543-3747 outside the U.S.