Cliff

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So many questions... Is it for read only? Regardless, can you do a regular download of the data that is exported to a separate database? Have you talked to the vendor to see what options they offer?

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There are FDA requirements for labels that are directly adhered to a blood product. If you are applying a label on top of an approved label, those rules do not apply. I always had good luck with Shamrock labels. https://www.shamrocklabels.com/

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Here is where we landed.

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Has the baby had any infusions / transfusion? Plasma, platelets, IVIG?

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Hi @Emmanuel Akomanin Asiamah, You can create a new post about histotechnology or cytotechnology. Maybe a new efficiency you come up with in testing, equipment issues, trouble finding qualified staff...

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What are RTTIs? This information in this question / answer was generously provided by AABB. Any errors are those of the site admin, not AABB. Mention of specific products or equipment in this AABB publication does not represent an endorsement of such products by the AABB nor does it necessarily indicate a preference for those products over similar competitive products. Efforts are made to have publications of the AABB consistent in regard to acceptable practices. However, they may not be. As new developments in the field of relationship testing occur, changes may be recommended to the AABB Standards for Blood Banks and Transfusion Services. It is not possible, however, to revise each publication at the time such a change is adopted. Thus, it is essential that the most recent edition of the Standards be consulted as a reference in regard to current acceptable practices. Copyright © 2018 by AABB. Permission to republish on PathLabTalk has been granted by AABB. If you would like to purchase the source material this was quoted from, please visit here. Submitter Cliff Category BloodBankTalk Submitted 05/02/2022  

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Once it's in place, I suggest taking the internal temp with an independent device for 24 hours. If it held temp, I'd be satisfied. Are you using the on-device data recorder? We used a Rees system, so we never validated the temp display, nor the recorder. That would be a whole separate validation.

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Lies, damned lies, and statistics. You've asked the question that has plagued my small brain for almost three decades. How many is enough - the question cannot be answered to everyone's satisfaction. Some will tell you to do more, others will tell you your plan is overkill. Everything is a risk; you need to use sound judgment and work with your CLIA director to make sure they are satisfied with your plan. When we moved to a new computer system, we had millions of records. I chose to use statistics. We fully validated 384 randomly selected records - lots of sites to determine this number. This took a tremendous effort to complete. As the years went on and we "simply" upgraded to a newer version, we had a solid history of working with, and validating, the software so we eased up a bit on our plan. These are brand new instruments, albeit with the same methodology. You need to perform a validation that will ensure each new device performs as expected. I always started with the vendor; they almost always offer a suggested plan.

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That's a tough one. As a patient I like to see my results in a graph over time. If I've been coming to you for my cancer treatment for the past two years and there is a two-month gap, that would be disappointing. As a black and white person living in a grey world, the OCD person in me would want the results entered. Maybe hire temps to enter and verify by a tech?

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