Mercy Fitzgerald Hospital, a member of the Mercy Health System serving Southeastern Pennsylvania, is among the first facilities to use RALS®-Plus version 1.0, integrating their management of glucose and coagulation, with blood gases and urinalysis to follow. Recently, MAS sat down with Dr. Bette Seamonds, PhD, DABCC, Clinical Chemist, and the hospital’s Director of Point-of-Care Services, and Bhupen Desai, Point-of-Care Testing Coordinator, to get their impressions of RALS-Plus and the direction of point-of-care testing.

MAS:

We do a lot of point-of-care testing at Mercy Fitzgerald and use a number of different devices from different vendors. Therefore, it was very important to us to have a solution which could handle our testing environment. We knew RALS-Plus, as a vendor-independent product, was the only system out there that could satisfy our needs. And being a modular system, we knew that we could easily change existing analyzers and add devices for new tests without adding information management software packages.  In essence, the feeling here is that if you’re not RALS friendly, then you’re not Mercy friendly.

There is going to be a need for products that provide for connectivity and lockout features to ensure that the results being generated are valid and accurate. This will require a change in instrument design to allow connectivity, QC lockout and user lockout features. We are realizing that if we are conducting tests at the point of care, checks and balances are necessary to monitor the validity of results. This helps with our emphasis to reduce medical errors.

The RALS-Plus system will provide connectivity and accountability in my facility for a variety of analyzers. In addition, there are certain lockout or exception processing features within RALS, which greatly increase our confidence in the validity of results being generated at the point of care.

Absolutely. But it requires the movement toward devices that are able to provide real time monitoring and collection of data and QC lockout in order to ensure the result generated is valid and accurate. We were able to achieve this through the implementation of RALS-Plus through the "dialogue" between system and the device. This provides useful data and demonstrates whose performance testing accounts to regulatory requirements and whose is not.

Since point of care tests are out of the direct supervision and control of the laboratory, there is no one to oversee that test procedures and regulations are being followed. Because you’re getting data live, you can act on it right away.  RALS-Plus makes sure that operator accounts and certifications are verified before users are able to perform tests.

The only way to efficiently gather test result data from point of care devices is through real-time connectivity. RALS-Plus helps us to meet regulatory demands with real-time data collection and monitoring. The ability to review QC daily, print user-defined reports, Levy Jennings reports, keep track of operator certifications and prevent uncertified users from using the system are key components to meeting regulatory requirements. If users are not complying with procedures, you can print the reports and show who’s doing things right and who’s not. Once the inspectors realize what my RALS system can do, like operator and QC lockout, they are usually more interested in the system than the inspection.

It went very well, nice and smooth; I think the installers were only here a couple of days. I had RALS-G already so the training went very well; it was very easy to learn. The reporting function is easier to use and provides all the reports I need.

I have four hospitals to oversee, and I don’t know how I could possibly manage all that and meet regulations without a data management program like RALS. The system makes my life a lot easier. It tells you right away on the screen where the problems are, so you can deal with them right away while people remember what they did. I know some friends who don’t have it yet and can only do monthly what I do daily. I am getting data live and I can act on it right away. I think that if you want to have a proper point of care program, then you need automation.

The point of care market is growing and evolving to meet the needs of patients and physicians, and we must realize that if we are going to be using something at the point of care there are checks and balances that are absolutely necessary. With RALS-Plus, we’ve taken something that has been a nightmare to manage and made it basically a pleasure. Now one Point of Care Coordinator can efficiently monitor multiple hospitals and outside clinics for all their POCT

I don’t know how one person could possibly manage a point-of-care program without RALS.