The monitoring of temperature sensitive areas, along with the proper maintenance of equipment and facilities, is critical for proper laboratory operation. This is a very important subset of overall lab quality. Even though all labs strive to employ the best staff, the use of automated maintenance tasks and temperature/humidity monitoring ensures the integrity of specimens, reagents, media and equipment used throughout the lab while ensuring compliance. It also avoids loss due to spoilage, potential patient retesting and litigation.
Proactive Vs. Reactive Management
TQM, Lean and six sigma best practices ought to include proactive vs. reactive management. This includes the tracking, monitoring and management of equipment and material used in the lab. Examples of reactive management would include a review of paper logs at the end of a month that indicate temperatures have been creeping up over time, or that a self-inspection reviled that a filter was never changes on schedule, or worse yet, an inspection reveals leas than adequate QA. Proactive management replaces forms, logs and manual processes with email, text messages and dashboard displays from a central location. This allows to you to manage-by-exception, addressing issues the moment they occur and heading off any quality issues and their consequences that may result.
Labs need to function every day around the clock even though there may be no active processing of specimens. To be successful, an automated lab environment ought to include lights-out operation so that you are notified of both temperature and maintenance tasks no matter where the staff is located and no matter when the deviations happen. To lower the cost of monitoring, transmitters should include provisions for Wi-Fi wireless communication or wired LAN connections for probes. Assignment of task alerts should support notification of the proper individuals or groups of individuals through a variety of media, including audio alerts, email notices, text messages and through smartphone or tablet access outside your labs firewall. Alerts need to have levels of redundancy to include the promotion of alerts/tasks for approvals for deviations with the automatic creation of the resolution documentation.
One of the problems with automatic data capture for temperature/humidity is that data is captured on a more frequent basis; this can lead to a number of false alarms. Examples of nuisance alarms may be the defrost cycle of a cryostat or the monitoring of equipment that has been taken out of operation over a weekend. Because you want to minimize nuisance alerts, your system should include user-defined ranges and schedules of operation. An example may be, “don’t alert me over the weekend if the water bath exceeds a tolerance or the system went back to normal after 5 minutes.” Modern systems you consider should offer trends in the form of an electronic strip charts with drill-down or hover details. This can be used to forecast a refrigeration compressor that is short cycling and may fail or a filter that needs to be replaced.
SEE ALSO: Data Analytics in the Laboratory
More Benefits and a Bonus
Ancillary benefits of automaton are that it will reduce or eliminate inventory loss due to equipment failure and help ensure conformance while automating reports for inspections. This includes CAP, AABB, CLSI, OSHA, DOT, CLIA, AAALAC, FDA, GAMP, GxP, HACCP, Joint Commission, USP 797, State Health departments and provincial regulations with their associated inspection reports.
Often, evaluators of systems overlook the needs of maintenance specific alerts, task generation along with self-documentation of conformance or discrepancies. Modern systems should also include predefined equipment, reagent and material templates to help you quickly build up your inventory. They support both scheduled events, like clean the unit every week and inspect in every six months, and unscheduled events, like replace a gasket. Certification and validation of users may be necessary to authorize the equipment be placed back into service. Examples may be calibration and safety inspections. Your system must insure the tasks generated are completed by the properly authorized individuals and documented as such.
Don’t overlook the monitoring of reagents and other lab materials, as they are also critical for quality. Expirations, proper handling and disposal are important for both safety and compliance. Tasks for these items should be automatically scheduled, assigned and include proper documentation and training aids, such as instruction manuals, MSDS and instruction videos.