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