A-361 Developing a Process for Preparation and Validation of Point of Care Middleware Upgrades
Authors: Simpson R , Doe B , Dumaraog S , Eagle N , Gant Kanegusuku A , Maggiore J A 
Published: October 2024

Background

Middleware systems for point of care (POC) testing have become essential connectivity tools for accurate data transmission between POC instruments, laboratory information systems (LIS) and electronic medical record (EMR) systems. Reliance upon these middleware systems among POC coordinators has continued to grow, as quality management system (QMS) services include management of user competency assessment, quality control data, and to ensure lock out capability of end users when compliance is not met. However, industry guidance is lacking for how to prepare for and validate POC middleware upgrades.

Methods

Our POC team mapped the current processes where the services of our POC middleware system, Abbott RALS®, have been integrated into our operations. A listing of all interfaced POC instruments by location helped to identify where to focus post-upgrade validation testing. A memorandum was sent to all POC users one week ahead of the anticipated downtime, which provided directions how test during the downtime and outlined the steps of recovery. To assist the POC coordinators in evaluating the accuracy of result transmission, each location performing testing was instructed to perform quality control testing of the normal and abnormal commercial control material run as simulated test patients for each test that employs an interfaced instrument system at the POC. Data transmission between Abbott i-STAT Data Exchange (DE) for all current i-STAT cartridges RALS was evaluated after the middleware upgrade to demonstrate accurate data transmission, including patient demographics and instrument flags. Similar data tracings were evaluated between our other primary POC instrument systems - Abbott IDNow®, NOVA StatStrip® Glucometer, Radiometer ABL-90®, Siemens Clinitek® Status, Werfen GEM Premier® 4000, Abbott Piccolo® Xpress, Roche Coaguchek® - and RALS, and between RALS and our Sunquest Laboratory Information System.

Results

We compared the instrument printouts to the middleware screen shots for each POC instrument offering at each facility. The screen shots from each of the systems proved that the results were accurately crossing, and the appropriate result flags were applied to any abnormal results. This documentation was captured and summarized for our evidence of compliance. Further, the quality control management and user lock-out functionality of the RALS system was confirmed to be intact by using a badge ID of an end user no longer in our employment.

Conclusions

Two of the quality system essentials (QSE) of quality management systems (QMS) are Process Management and Document and Records Management, and both QSE hinge upon accurate result transmission. Quality Management Systems for POC need to include an assurance that any upgrades in middleware be adequately tested to ensure the middleware retains its functionality, provides accurate data transmission, and that workflows are acceptable to the process mapping. The processes outlined above are designed to prepare POC coordinators for managing these middleware upgrades and demonstrate the increased likelihood of successful outcomes.