Marianne

I agree that looking into software programs to build in rules and help would be good for a lab without a dedicated blood banker. AntigenPlus is another good option

We are reviewing all our dashboard thresholds. I could not find much in a web search and am wondering if anyone would be willing to share what values they use as a threshold for disposed (wasted/expired) red blood cells and apheresis platelets. Thanks!

You may need to keep your patient population in mind. Our hospitals are in cities with very global populations and we do see women who appear D Pos, but have developed an Anti-D. So we see value in having this testing performed.

Kate- one of our hospital Transfusion Services is about to move forward with a trial to extend to day 6 and 7 as well. Anything you can share that might be helpful before they begin?

Too bad you live across the pond or we might need to validate your statement by taste testing that lasagna!

or interpretations as appropriate the back half is what would apply for Transfusion. You have interps, Pos, Neg, A, B........................as applicable.

I would also suggest you ask to be involved in review of any proposed contracts for change. Often upper leadership is not knowledgeable enough to look beyond the cost of a rbc. Often that cost may appear lower, but then there are more "hidden" costs (higher reference test cosst) or perhaps extra fees for: trips, restocking or moving stock, premium on certain group products and such. So you need to look at the full picture when comparing any options. Also, customer service provided is very important. I would imagine a community blood center would be more vested in your needs.

Does anyone know if any of the reagent vendors has a commercial DTT product that can be purchased and used to eliminate the dilution prep?

Hi Kate- we have had disucssions regarding whether to only use the day 6/7 pheresis only if no"in-date" platelets are available or to use these up first to prevent waste. Would you mind sharing your protocol?

Fun!

I would have called the AABB office to challenge that non-conformance. It is not about what the assessor "likes" or "wants", it is about meeting the intent of the standards and no where does it specify you need to have those details in your SOPs.

I have also always used the "current edition" phrase in my references to prevent constant changes. I have never had an issue with FDA, AABB or CAP. What you do need to have is some type of change management process and documentation that shows that when applicable regs change, that you reviewed and updated as needed.

We are working with Pharmacy as well to receive a heads up fax in the Transfusion service when the Dara is ordered. We are also trying to get a flag in our HIS for a sample to be ordered and sent prior to start of this med.

Hope this helps. Preparation of Phosphate Buffered Saline Solutions.pdf

So true, but now that they put that out there for the world to hear, you know it will be on some inspectors "radar". Doesn't mean you can't contest it though. Never a dull moment in our field!

They presented 4 webinars on10-7-16. They did say they would eventually get posted to Success. The one that had this topic was "Ask The Expers: Quesiton and Answer with Blood Bank Inspector"s. They had resp from CLIA, CAP and AABB. The CLIA person stated this and cited CLIA interpretive guideline 42 CFR 494.1271(a)(1), saying that using expired reagents is not following manufacturer's instructions and thus an LDT.

I was listening to that same webinar. They stated that anything past expiration, is off manufacturers approved FDA usage and therefore requires the disclaimer and would be considered an LTD.

It is "Say what you do and do what your say". You must define in your SOP what you will accept and then monitor that, as well as have a plan for what you will do if the products are not within your definition. Make sure you make clear in your SOPs what is "storage" and what you consider "transport" as well. Might be good to ask what others on this website consider an acceptable range. Is it +/- 1 degree, or 2 degrees etc. See if there is a consensus and then use that as best practice.

Our system just chose to lower to 50 as well.

Thanks for sharing the origin of the article.

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.

it interfaces with cerne millenium as well

If there is anyone up and running on the Infinity, I would love to have an off-line conversation about your implementation experience and differences bewteen the Optimo and Infinity.

Having managed many different teams and mentored new leaders for years, I suspect from the posts that your team does not feel that you respect them or their experience. Despite their behavior (and I agree with David about accountability and documenting unacceptable behavior or practices) you need to make them feel heard and valued. Try and include them by discussing the need for change and soliciting their opinions. When they are involved they then have ownership. Then perhaps (no guarantees) the behavior will start to change. Being "the boss" is not for wimps!

For those receiving the Babesia tested products, what do you do about product modification and ISBT labeling? Or are they so few, you can avoid using them? Our LIS will not print any of the new testing results. I also received the same blood supplier notice and would like to hear how others will be approaching the patient consent issure. We did not require consent for WNV back in the day either, so this is new territory.