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Do you have to be a certified CLS , ASCP or MT to work as LIS Coordinator? If a non -licensed built the system dictionaries and has a licensed CLS validate the system, is that compliant ? I do not have a full understanding of CFR 21 part 11. Since a new LIS is considered a medical device, does it require a licensed personnel to perform the test build?

Does anyone know if a CLS license is required to work as a QI Coordinator in the state of CA? If a QI Coordinator is non-CLS, can he/she by law and standards can make recommendations regarding quality for both the General Lab , Blood Bank and Pathology? I need to find out if there is a standard out there that mention the requirements and certification?

Just had our AABB inspection last week and our facility's minor deficiency was not having a detailed internal disaster plan. The assessor was curious what our policy says as to how we are going to respond to the event of an internal disaster and our blood bank is inaccessible. I'm curious how would everyone will answer the question.

Thank you cswikard. Definitely a long year ahead of me. Great idea to start the parallel testing as my staff is a little nervous about the solid phase. I don't want to overwhelm them. Our team went to Meditech training for s week and the trainor seems to have a good grip of BB but I wish its a little more in-depth. We'll see how it goes.

Hardware installation is almost complete and our next phase is dictionary building. This is a one man project the way I see it. I have to build the dictionary and validate the system at the same time .As far as Echo, I'm all there is to it as well. There will be another key operator but she's not part of any of the projects . We're so limited with staffing but I'm not far from complaining . Call it crazy but I'm very excited about the whole thing.

We are almost out of RH control and I'm still thinking whether we will switch to Monoclonal control. Since we are switching to Echo can we switch temporarily to 6% Albumin as Rh control? This will give me enough time to finish my validation study. We use Anti D series monoclonal.

Our lab is upgrading our old system to Meditech 5.6. This is going to be interesting. In addition, they also purchase Immucor Echo. Our current method is tube and manual gel. I dont know where to start. In 2 weeks, Meditech's hardware installation is schedule to complete. I'm thinking its probably better to finish the LIS upgrade first before ECHO instalation. Has anyone experience upgrading to a new system and methodology/equipment at the same time? I'm a little nervous about the whole thing. How are we building our BBK dictionary ? can we have our method validated as BOTH (automated and manual?)

A type and cross for 2 units was ordered from the ED the other night for a 31 yr old female with no prior BB history. She was typed O Pos and a positive screen. She expired before antibody workup was completed. Doc called BB to cancel the order. Do we still have to complete the workup eventhough the patient expired already? Your feedback is greatly appreciated.