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Beaker for Kleihauer-Betke Resulting - Rhogam dosing comments/calculations?

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Quick summary of my question

Our organization is transitioning to Epic/Beaker for the main LIS and SafeTrace TX for the Blood Bank module.  I understand that Beaker does not have FDA 510K clearance as a Blood Bank LIS, so we can't do "Blood Bank tests" there.  However, does anyone have any resources on what is defined as "Blood Bank" when evaluating what can go into Beaker?  In specific terms, do you think having Beaker built to automatically calculate the volume of a fetal bleed based on a Kleihauer-Betke stain is acceptable?  What about automatically calculating the dose of Rh Immune Globulin (RhIg) should the patient be Rh negative?  


Longer version of the story:

In our lab, Hematology / Manual Bench does the Kleihauer-Betke (KLEI) testing, and it has historically been resulted as a % / ML result only.  Then, it gets handed off to Blood Bank where we answered a separate test code with the RhIg dosing comments with EVERY SINGLE KLEI, even when there is no RhIg ordered or when the mom is Rh positive.  It's always felt a bit unnecessary to have Blood Bank result a separate test every single time, and the idea was proposed to have Beaker automatically calculate the RhIg dose based on calculations built into Result Entry.  Then, the KLEI would go out with the mL of the bleed, and a comment:

  • "If patient is Rh negative and Rh Immune Globulin is needed, then a ___ ug dose is recommended.  Enter a Transfuse Rh Immune Globulin order if Rh Immune Globulin is to be administered."

In this workflow, if a RhIg order is received after the fact (or before), Blood Bank staff would verify the appropriateness of the request, and review the KLEI for dosing requirements, then send the order to Pharmacy for fulfillment.  I'm wondering if this is acceptable practice.  I could reach out to the FDA as well if no one has a resource here, but hoping someone else has had the same idea!   



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You can only put interpretations in as Beaker has no "control' functions/truth tables that have been submitted and approved by the FDA.  Make certain you validate the time it takes for Beaker to update the BBIS information.  I went live w Beaker and another vendors BBIS (as a temp manager).  It took over 30 minutes for the interface to interact.  I was not privy to that validation, though I was told it was done, I was kept from being able to verify that.

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Thank you, David!  We have been able to watch the results go across from the BBIS into Beaker and vice versa, and it has been quite fast so far!  I'll keep an eye out for it as we move forward.  

For this inquiry, we did reach out to the FDA.  In case it's ever helpful for anyone else, here's what they sent back:   :)


"Thank you for your inquiry.  Your request was forwarded to the FDA Devices Review Branch (DRB) and they provided the following response:

According to 21 CFR 864.9165 Blood Establishment Computer Software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. A FDA cleared BECS device is required for performing the functions that meet the definition above. According to the information you provided below, Kleihauer-Betke testing doesn’t fall under the definition of BECS.  We are unable to comment on products that do not meet the definition of BECS, thus this decision falls under your discretion."

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