SusieQ132

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."

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!   
Thanks,
Susan

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.

reply to SusieQ132: yes we our satisfied with the label. Sorry for the delay in my response

We had a Terumo SCD 312 a few years back that never gave us any problems until one day it just flat stopped working and couldn't be fixed.  I had been talking to Fresenius about the ComboDock but we have limited space and it was too big for our area.  We ended up with the Terumo TSCDII because they were the only ones to get us a same day quote and had the equipment to us in 2 days plus they let us return the 6 boxes of wafers we had from the previous version and gave us out money back (minus 25% stocking fee).  Working at a children's hospital we have to have a sterile docker so for us fast was what we needed. 
With the Terumo TSCD you have a clear catch bin for the used wafers so it's easy to tell when you need to empty it.  I was watching a youtube video on the Genesis TCD and it looks more complicated than the Terumo.  You have to load a wafer every time and your tubing has to be longer.  Here's the link to the video: 
 
 The only problem we've had is during a emergency generator load test one night it revered back to the LED screen being in German instead of English but the user's guide has a really good troubleshooting guide and I was able to fix it in about 5 minutes.  I don't like the way you change cassettes though.  It's not as easy to change them as the older SCD 312 model.  Here's a video on the Terumo: 
Hope this helps!

There is no required number of samples to use for method comparison.   I would suggest 1 pos, 1 neg for Rh and antibody screen and pick your samples wisely - a nice strong K or anti D to eliminate those pesky (expected) discrepancies between different methodologies and required corrective action.     

I just answered this question.


My Score PASS  

From what I have been told by accrediting agencies here, different tests can only be combined into one test system if there are no unique aspects in testing or in problem solving when something goes wrong.  I interpret that as meaning the antibody ID, DAT, and elution are all separate test systems because the testing method is very different.  Different treatments, however, I could see being grouped into 1 test system (EGA, DTT, ficin) if you can "sell" them as being similar enough.  Same goes for the adsorptions, in my opinion.  I would rotate which treatment and which type of adsorption you do each year, but group them each into a test system (RBC Treatments as 1 test system and Adsorptions as a separate test system).   If you group multiple tests into a test system, only one of the tests in that system need to have the 6 elements of competency assessed each year.  However, you have to watch what you group into a test system!
It seems crazy, but by the letter of the "law," we should be doing all 6 elements of competency for every test we perform if the procedure is not exactly the same.  (I have read that even if the amount of a reagent is different, it would be a different test system.  Crazy! )  In practice, this doesn't work for our site; we would spend more time assessing competency than doing real work!  We decided to live on the edge and combine a few things into test systems, even though they are pretty different test procedures. 

From what I have been told by accrediting agencies here, different tests can only be combined into one test system if there are no unique aspects in testing or in problem solving when something goes wrong.  I interpret that as meaning the antibody ID, DAT, and elution are all separate test systems because the testing method is very different.  Different treatments, however, I could see being grouped into 1 test system (EGA, DTT, ficin) if you can "sell" them as being similar enough.  Same goes for the adsorptions, in my opinion.  I would rotate which treatment and which type of adsorption you do each year, but group them each into a test system (RBC Treatments as 1 test system and Adsorptions as a separate test system).   If you group multiple tests into a test system, only one of the tests in that system need to have the 6 elements of competency assessed each year.  However, you have to watch what you group into a test system!
It seems crazy, but by the letter of the "law," we should be doing all 6 elements of competency for every test we perform if the procedure is not exactly the same.  (I have read that even if the amount of a reagent is different, it would be a different test system.  Crazy! )  In practice, this doesn't work for our site; we would spend more time assessing competency than doing real work!  We decided to live on the edge and combine a few things into test systems, even though they are pretty different test procedures. 

Remember that you can combine the 6 elements into 1 competency exercise. You may observe the tech while they are performing testing on an unknown (2 elements covered) and ask questions related to the exercise for problem solving (another element). Have them document the unknown as they would a patient (4th element) and ask them to perform the appropriate QC for the tests they are using. Once you've reviewed any intermediate worksheets/other paperwork (5th element). They will use equipment while they work (6th element or at least part of it). Cover as much ground as possible with each observation.

Thank you for the input!   So I'm thinking that for anything that is not a test, we can put "N/A" for the other items that do not apply.  That makes more sense now. 

That's what I think, too!  It is a crazy task for our 40 staff members, so I really hope this goes okay.  It is daunting to look at right now!

New information: 
The patient's post-RXN plasma reacts 1+ with the patient's pre-RXN red cells.  (So whatever it is, it is in the plasma, too!) We performed an antibody screen on the plasma from the platelet unit, and that was negative.  We have ruled out Anti-Jsa, -Kpa, -V, -Cw, and -Lua in the eluate. The eluate was performed using the Elu-Kit (acid elution).  I know this isn't the best for picking up Anti-A, but we have picked it up using this kit in the past, so it was surprising not to see it this time. 
At this point, the patient doesn't show any signs of hemolysis, and the significance of this positive DAT is unclear.  We are going to crossmatch at AHG for future RBC needs as a precaution, but we aren't going to pursue it further.
 
My wild theory: 
The patient had received Zosyn (Tazobactam-Piperacillin) and Vancomycin, which have both been reported to cause drug-induced hemolytic anemia.  These were given a few weeks prior to the transfusion reaction, and theoretically, the patient could have formed Anti-Piperacillin (or another drug antibody) that only reacts in the presence of the drug.  Then, the platelet or RBC donor took the medication, and it was passively administered to the patient with the blood component.  Then, the drug was introduced back into the patient's system and caused a positive DAT.  Or maybe the donor has Anti-Piperacillin (or another drug antibody).     
Not very likely.  But you never know!

That's what I think, too!  It is a crazy task for our 40 staff members, so I really hope this goes okay.  It is daunting to look at right now!

Thanks for that SusieQ132, which just serves to confirm my thoughts that some accreditation organisations are their to massage their own egos, rather than to help either the laboratories or their clientele (those being patients or clinicians).

You may assess tasks (those things that are not tests) as you choose. Only 'tests' require the 6 elements. Splitting a platelet unit would definitely be a task. If you use a tube welder for sterile docking when preparing platelet doses, the only elements you might not use would be #5, unless you choose to make a dummy unit for splitting and involve some kind of QC on the unit and #2 if you do no testing on the products. Simply observing the entire process would cover elements 1, 3 and 4. Problem solving skills could be addressed by asking 'what if' and 'what would you do if' questions while you are observing the process. Alternatively, the 'if' questions could be in the form of a written quiz.
My question would be, who informed you that competency had to be assessed at each site? If it was a CLIA inspector, can you request a review of that ruling based on what you've told us?

Different CLIA numbers, must do the competency at each site, despite everything being the same.  I sent this specific question to CAP after a webinar they ran.  It is silly and it seems our community and licensing agencies should be fighting to have this changed.  There are not many hospitals that are not part of a system and need to share staff.  Things need to keep up with our reality to make them feasible.

Just HOW ridiculous is that?
In the UK, even UKAS, which appears to be an accreditation service set up to serve its own ends, rather than that of the laboratory or the patient, allows Biomedical Scientists and Laboratory Aides to "transfer" their competencies from one laboratory to another, if the tests are the same.
This ruling from CLIA seems to me set up to justify THEIR existence, rather than help either the laboratory or the patients, but will end up creating more and more (unjustified) work for all concerned, for no benefit - and they wonder why they get a bad reputation for making such stupid rulings.

I just joined the site, and have some questions about competency assessments.  We have staff that rotate between two different campuses of the same hospital, but the labs have different CLIA numbers.  So we were recently informed that we have to demonstrate competency at each site where our staff works.  (Even though we use the same procedures, follow the same standard work, and have standardized things completely.)  So I am trying to put this into practice without overwhelming our staff, but I still want to make sure we are doing a thorough check.  We have a high percentage of new staff right now, so I don't want to half-a$$ it.
Question 1:  Competency must be assessed for every "test system," but what are the Blood Bank test systems you assess?  Do we need to assess competency for every method of testing we use every year?  Or would I be able to assess IAT as a test system and rotate yearly on what method we use?  I cannot seem to find any Blood Bank-specific listing of test systems that require annual competencies!  It seems pretty clear for other areas, but I am getting a bit stressed out trying to make sure we are fulfilling the requirements for CAP/AABB.  And I also don't want to overwhelm our staff with 17 yearly competencies.  
In my lab, we perform the following tests:
ABO/Rh - automated gel and tube testing Antibody screens - automated gel, manual gel, and tube testing DATs - manual gel and tube testing Antibody titration - manual gel and tube testing Antibody identification Antigen typing Elutions Fetal bleed screens Question 2:  How do you handle items that you want to do a competency assessment on that are not tests?  For example, we do quite a bit of component preparation, so we generally try to do an annual competency assessment and direct observation of our staff splitting a platelet into a pediatric dose.  I am familiar with the 6 elements of competency assessment (show below), but I struggle with how to apply these to processes.
"The following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing:
Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observations of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills."  
Thank you in advance!  
Susan

I just joined the site, and have some questions about competency assessments.  We have staff that rotate between two different campuses of the same hospital, but the labs have different CLIA numbers.  So we were recently informed that we have to demonstrate competency at each site where our staff works.  (Even though we use the same procedures, follow the same standard work, and have standardized things completely.)  So I am trying to put this into practice without overwhelming our staff, but I still want to make sure we are doing a thorough check.  We have a high percentage of new staff right now, so I don't want to half-a$$ it.
Question 1:  Competency must be assessed for every "test system," but what are the Blood Bank test systems you assess?  Do we need to assess competency for every method of testing we use every year?  Or would I be able to assess IAT as a test system and rotate yearly on what method we use?  I cannot seem to find any Blood Bank-specific listing of test systems that require annual competencies!  It seems pretty clear for other areas, but I am getting a bit stressed out trying to make sure we are fulfilling the requirements for CAP/AABB.  And I also don't want to overwhelm our staff with 17 yearly competencies.  
In my lab, we perform the following tests:
ABO/Rh - automated gel and tube testing Antibody screens - automated gel, manual gel, and tube testing DATs - manual gel and tube testing Antibody titration - manual gel and tube testing Antibody identification Antigen typing Elutions Fetal bleed screens Question 2:  How do you handle items that you want to do a competency assessment on that are not tests?  For example, we do quite a bit of component preparation, so we generally try to do an annual competency assessment and direct observation of our staff splitting a platelet into a pediatric dose.  I am familiar with the 6 elements of competency assessment (show below), but I struggle with how to apply these to processes.
"The following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing:
Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observations of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills."  
Thank you in advance!  
Susan