Upgrading Middleware Validations Plan (RALS)

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What type of validation plan does everyone's healthcare system follow regarding a middleware upgrade?  For example, we use RALS and EPIC.  We are upgrading to RALS Version 8.6.1 from version 7.1.2 and interested in seeing what other systems have done for validations.  I understand ultimately that the CLIA director has final approval but I would like to provide ideas to him on what other systems are doing.   Thanks so much in advance!

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We also have RALS and Epic.  When we're just upgrading within the same system (one version of RALS to another) we do screen shots for every test from both RALS and Epic to verify that all results are crossing as expected.  This is usually a combination of actual and fake patients to cover everything.  We then have our director sign a cover sheet describing the upgrade and results.  Here is an example of the language we use:

On May 20, 2025 the RALS interface was upgraded from version 8.1.1 to version 8.5.2.  This new version involved minor changes to the user interface but did not change the way data was stored or transmitted.
Results were monitored in real time on the day of the upgrade to ensure that patient test results were received from each device type and were transmitted accurately to the patient’s electronic health record (Epic).  Devices which did not perform tests on 5/20 were monitored on subsequent days until transmission could be verified.
The new version performed as expected and is acceptable for continued use in the management of patient results.


Thanks for sharing this information. I am also seeing an increase in the interest of looking at complete cloud-based middleware, (no more on-site servers needed, minimal I.T. support needed, and access to AI tools for results and compliance metrics reporting.) Definitely what the future will be bringing. 

Hi Kristy, we also have RALS and Epic. We typically perform a test patient on each type of device we have connected in RALS. We will take screenshots from both RALS and Epic and submit that to our medical director for approval.

Hi Kristy
We have RALS and Meditech.  We perform test patients on the analyzers making sure the critical values and comments (specific age/sex results have the correct ranges and hard stop comments perform correctly) cross by grabbing screen shots.

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Kristy Saunders
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