David Saikin

I had a patient who had anti-K. He was transfused fairly regularly (2-4u/month) for years. Always K neg rbcs. Always had a +DAT. Only anti-K in the eluate.

I've experienced remote alarms that were monitored by facilities crew. Even though the lab was 24/7. Facilities even did the alarm checks. Seemed to work pretty well though I had to tweak that system while I was their temp manager. Alarm probe in freezer in the air - they wanted it to be sensitive, well it was. The chart looked like a supernova explosion. I told the medical director if I was inspecting they would be tossing everything out. Once we put the probe in 50% glycerol the system worked pretty well. I still did weekly checks on the documented temps for both refriges and freezer. Otherwise, I agree, if you are 24/7 there is no need for a remote alarm.

How can you prove anyone did anything? Unless you watch. Inspectors cannot impune your work is bogus based on your process, unless something seems amiss. I would immediately contact their regulatory agency and ask for the official stance on such and/or a replacement inspector.

I've never heard of that practice though I understand the concept.

My audits are on line and remain available indefinitely. I'm assuming you are auditing your transfusions.

We have the same for MTP and Emergent Release (we use 50 as the cutoff age). For routine transfusions we still require Path approval.

My Medical Director still has to approve this switch.

Get a disclaimer from your administration that you are not responsible for cell saver operations. Your Medical Director should offer advice on what is acceptable practice even if you get the disclaimer. You don't want to be responsible if you are not the responsible party operating the device(s).

Usually you don't have to revalidate after a scheduled downtime unless you had some changes made, especially if it involves any automation you are using. However, if you have an unscheduled downtime you will need a validation plan - to make certain your truth tables are still intact. I've had these in the past but I no longer have a BBIS .

Unless you are going to change the FFP to thawed plasma (5 day outdate), the original code should suffice. It does for routine FFP and FP24.

I've never had a problem w BB reagents not working (except when I set them up to fail). I have seen problems with reactivity not on par with usual results. Contacting vendor discovered a change in the formula at production.

I QC reagents before I put them into use; usually not upon receipt.

When gel was our primary testing method a reaction w anti-D of 1+ or less was called Rh negative. I know of folks who call 3+ rxs or weaker Rh negative. This was determined by the Medical Director.

I just answered this question. My Score FAIL  

When you say assay, that is, to me, a test, like Type and Screen. Yes, we are using the same reagents but they are being used differently (automation vs manual). Your QC in this instance validates the entire test system.

We QC the reagents. The assay gets the QA treatment during its implementation.

Here is my response from CAP today, 4/28/2022: Good afternoon David; Thank you for contacting the CAP. Each test platform/system must have QC performed each day of testing. Regardless of the lots of reagents, the two systems you mentioned are separate. When I worked in the Blood Banks, we used the same Immucor reagents for the Echo instrument and the bench. We still performed the QC for each system. If you have any further questions, please feel free to reach out. Happy Lab Week! Linda Whaley, MLS (ASCP) Take a tour of our accreditation resources!

JCAHO in California. I agree with this only because the manual QC not only qcs you gel cards but your manual pipets, manual pipetting and your mts centrifuge. It is a different system. However, if CAP says what you are doing is fine you should have that documented because if I was inspecting you I would cite.

Anti-M comes to mind most often, esp w Ortho gel cards. It is possible to work up cold abs. I've used the buffered gel cards to do so. I've also used 2 stage papain pretreatment of panel cells (in gel).

Yes you need to qc both as they are separate testing systems. I fought this battle in the past and had to contact my regulatory agency to get confirmation that both are necessary. As I told my boss, that's why you pay me - to know stuff like this.

We have to sign a statement that the product was maintained appropriately. It is part of the transfer process.

no

Decades ago that's how we used to store plts. Good for 3 days at that time. My understanding of such is that refrigerated plts are able to function upon transfusion whereas the current room temp plts require an "adjustment" period before they are clinically functional. I'd like to hear the current feelings on such (just so I'm not laboring under a delusion).

Me too. My patients were/are rather unhappy w the Nursing approach to TP. I'm not JC so I've never had that scrutiny.