jeanne.wall

Cliff - I'm easy - any night -any food, just want to see everyone. Jeanne

Kate - I'm a couple of days behind reading my CAP Today but noticed the CAP ad about their Commpetency Assessment program (www.cap.gor/competency). It covers competency assessment, safety and compliance training, and continuing education credits. Don't know anything else about it, beyond what the ad said (and I don't trust ads on face value) but thought I'd point it out. Jeanne

jerriemc - It has been a while since I was running an active transfusion service but we offered physicians the 'oportunity' to order a pre-op antibody screen with the patient's other PAT work. Our approach was that if the antibody screen was negative we'd have some appropriate blood for the patient and the physician could have more confidence accepting 'uncrossmatche' blood if it was necessary. If the antibody screen was positive, we had the opportunity to work through what was going on and discuss issues with the physician. We didn't convert all the physicians but if someone did get 'caught' it didn't happen again. Jeanne

Ravi, I'm so glad you found this site - it will help. There is always something more to learn and this is the place to do it. Jeanne

Kate, You might want to check out www.cms.gov they have a list of proficiency testing providers that is all inclusive. If you are just looking for competency testing/ training samples, Quotient does sell a package of 'human antibody' samples and Immucor also offers a competency kit as well. Jeanne

What a great group of nerds! I'm proud to be counted!:cool:

I’ll try to help phan,binh. You can check out the actual CFR reference yourself, 21 CFR 606.171, but in brief, you report any deviation from cGMP, regulations, standards, established specification or unexpected event that may affect the safety, purity or potency of the product, and involves a distributed product, when the deviation has occurred in your facility or under your facility’s control. 1/ This one is dependent on what your procedures say, if you violated your standard operating procedures and you issued product to the patient then it would be reportable. In general, whether the test was ordered or not, once you know the result, it is considered known and should be managed, so I’d have worked it up. The discussion with your reference laboratory has no impact on whether the situation is FDA reportable or not. 2/ Since QC was not performed correctly (incorrect cell suspension used) it could be reportable if the antigen type was done as part of pre-transfusion testing (manufacturing according to the FDA definitions) and the product was issued to the patient.

I agree - it becomes reportable as soon as you violate the procedure, it doesn't matter if patient safety was actually at risk or not.

Glad you found us - we range from newbies to more seasoned folk! We all learn from each other, and I'd have to say learn lots. Read, learn, enjoy and don't be afraid to participate either.

Hi Jen - Welcome to the site, and know that you will learn lots here. Pay attention, even when you are lost. When you find your way, it all will make sense. Jeanne

Someone has to say it so it might as well be me - whose on first?????

I keep cheering for you at every chance :hooray:

I'd say yes Cliff - sounds great!

I'll be there - looking forward to seeing you all. It is nice to have the meeting in my own back yard, or maybe it is really my front yard. I'll have to think about that. I enjoyed our gathering last year, even though it was small. Jeanne

Scott - it looks like the CLIA requirements "spruced up" into Joint Commission talk. Jeanne

lacs - You might want to check the package inserts. In the past, the only Quotient/ Alba product that requires unbuffered saline is their monoclonal Anti-M, which is very pH specific. The other antisera just requires saline (buffered or unbuffered), I doubt that requirements has chanced since I was "in the know". I know that confusion has caught more than one person. Jeanne

Oh Malcolm, I'm afraid my "tongue in cheek" humor didn't come across well. I hate to say it but we've both been around long enough to know that "there, but for the grace of God, go I". I've certainly had my share of moments when half way through a question or comment I realize I'm sawing off the limb I'm sitting on! Jeanne

Malcolm - Maybe your rant colored your perspective! I feel a little foolish correcting the "great one" but I think bbanker2 was shaking his head about someone thinking that performing a compatibility test with a sample that wasn't demonstrating the antibody, actually had any importance in selecting the units for transfusion. He knew you needed to select antigen negative units for the reason you stated, and using the patient's current sample wasn't going to help anyone select appropriate units. They sent him the "two units" to confirm they had selected the right ones and he was left not only having to find units for them to transfusion, he needed to explain to the facility that they had gone down the wrong path - of course, without offending! I never liked telling someone they were so far off the mark when it was so obvious that they had missed the point completely. Just my thought - Jeanne

As painful as it is - a one day use daily worksheet. No one likes it, most of all me but if you are using paper the easiest way to avoid copying is making it easier to write the lot number and expiration date off the bottle, rather than having to get up and find yesterday's form. I switched to computerized reporting ASAP and had the information recorded there. I hate to say people are lazy but they often look for the easy way - maybe it was just that I added a reminder. I solved a problem of staff opening a new lot without finishing the in-use lot by putting a rubber band around the new lot. Magic, solved that one.

Laura, I'm not sure which PeG you were using but if it was one where the PeG is suspended in LISS (Immucor for sure) you might be able to use that factoid. The fact may help make staff a little more confident in using the LISS as well. Jeanne

Q Juli - I too wish you the best - I'm impressed with your ethics and I know from personal experience how difficult the decisions in front of you are to make. Not easy no matter how you look at it. Jeanne

Q Juli I share your belief that this is wrong and that you need to step up and speak out. If your facility is AABB accredited you have the option of anonymously communicating concerns about quality or safety (the standard is listed below). The contact information is +1.301.215.6492 or accreditation@aabb.org. CAP has a similar program, and while I don’t know about other laboratory accrediting groups I’d expect that you will find a similar program. Good luck! 1.5 Communication of Concerns The blood bank or transfusion service shall have a process for personnel to anonymously communicate concerns about quality or safety. Personnel shall be given the option to communicate such concerns either to their facility’s executive management, AABB or both. AABB’s contact information shall be readily available to all personnel. Standards 6.1.5 Standard 9.1 apply.

But with more and more color copiers it won't be long until that doesn't matter either! Time moves on and we keep having to find new ways to "win"

There is no requirement about ink color, but many folks have a record completion or documentation procedure that limits the ink color that can be used. The requirement to use blue or black ink goes back to the ability of other color ink to be copied or filmed. When documents used to be filmed for microfilm or microfiche colors like red just didn’t film well and so it was a big problem – heck I’m old enough to remember when photo copiers didn’t do a good job unless you used black and some dark blues! Now that we have moved to digital scanning the issue is less important. There is an AABB Standard (6.2.1.1) that requires if you are creating copies that you do need to verified your copy is completely represents the original, other than that, as long as you don’t violate your facilities requirements on ink color you can use whatever color is allowed. Jeanne

You are so right - and on a recent AABB assessment I actually got to explain the difference!