John C. Staley

If you will be getting any of those units back then a FDA inspector may want to see their storage records. Some will, some won't, depends on the inspector. Better to be prepared for the one that wants to see them. In this case a little paranoia may be a good thing.

I'm curious, years ago we were looking into printing stickers to apply directly to the bag but there was some concern about applying an adhesive to the bag that may not have been FDA approved for such use. Is this still an issue or was our QA department going off the deep end?

Personally, if push comes to shove, (which it often does when dealing with closet dwelling bureaucrats) my reference range would be POSITIVE (POS, +) - NEGATIVE (NEG, -). I don't think I would want to confuse them with indeterminant.

My guess is they want to know when they will be asked for money to replace them. Apparently everything must have an "expiration or best by" date.

Personally, I think you should respond to CAP exactly as you did in your post. You make a logical and compelling argument. I could say more but I think I'll stop for now and see what other responses you get.

One of the highlights of my career was getting to meet with and talk to Peter. I am saddened to learn of the passing of another great in the world of blood banking. Please share my condolences with Marilyn. Malcolm, thanks for for keeping us informed.

My guess is the very hard part is getting the provider (I very much dislike that term) to document the informed consent with a patient's signature. How accessible is the form when the physician is actually with the patient? If someone isn't there to hand the form to them they won't go looking for it. On a side note, whose responsibility is it to make sure the form is signed and in the chart? I certainly hope it's not the transfusion service's.

Thanks Cliff. Just noticed I didn't have to sign in. To be honest, I was surprised I even remembered my password!!

Cliff has any thing changed recently. For the past few days I've had to sign in every day? Not sure how I managed but I do remember my password.

The USA is considerably larger, we do not have a national healthcare system (which I personally hope we never have), and there is not a central data base that is accessible to all. I'm afraid the cost / benefit analysis of establishing such would not favor attempting one. Just my opinion.

I've never heard of that. While I can understand the rationale, I'm afraid that if there was enough of a fetal bleed to impact antigen testing mom there are bigger problems than just getting the antigen type right. Just my thoughts.

Just curious, do they want the documents sent electronically or hard copy? Either way, especially since you referred to the request as a "big list" I would probably, respectfully decline. I would indicate that the listed documents would be readily available upon their arrival. But that just me and I never had an inspector request anything like this. I'm sure things have changed since my last CAP inspection.

Most blood bankers I know have a pain tolerance only slightly less than their resistance to change!!

Malcolm, my questions were directed specifically to applejw and the several examples mentioned. I was assuming they were fairly recent, at least in the last couple of decades and that info might be available. In 1967 I was in Jr. High and did not even know there was such a thing as blood banks!

Just curious but how long did those passively acquired antibodies remain detectable? We're they ever responsible for a transfusion reaction? Did they ever cause anything more serious than an inconvenience for the staff? I really am just curious what the ramifications were, if any.

I've been thinking about this question and I don't remember if our SOP specified what type of cell to use (I've slept a couple of times since last performing a titer). What I do remember was that we wanted to use the same type with every repeat during the pregnancy. In other words if the initial titer was done using an R1R1 cell for anti-D then every subsequent titer was performed with an R1R1 cell. At the time, the change in titer was considered the most important finding. Also, again I'm trying to awaken long dormant memories, we used a tube/saline or tube/albumin technique ( can't remember which) because that was how the original studies were done for anti-D and how the values utilized by the OB docs were derived. I know this is ancient history for many of you but thought I would throw it out there. I seem to remember that titers were going out of vogue about the time I retired and there were much more accurate methods of determining the effect on the fetus from maternal antibodies coming into use.

Best story/advice I've heard in a long time!!! Thanks for sharing it.

You may not "mean to offend" but that does not make it any less offensive. If you have nothing helpful to contribute it's best not to. I have worked in level 2 trauma centers with 24 / 7 coverage in the blood bank. I have also worked in a rural clinic in a Wyoming county the size of most states east of the Mississippi and there was not hospital in the county. The closest hospital was 2 hours by ground and if we needed a trauma center it was at least 3 hours to get a helicopter or airplane in and out. You do the best you can with what you have. The people of the county realized that one of the prices they had to pay for living in one of the most beautiful areas in the world was limited access to health care. They understood, accepted it and were actually grateful for the level we could provide! They neither wanted nor needed .......... I best stop now.

It's never safe to assume that everyone, or for that matter, anyone knows what you are talking about when providing one short sentence. Especially us old, retired guys. Both Malcolm and I thought you were looking for some philosophical discussion. Hope you find the key you are looking for.

I have to agree with Malcolm. In the 35+ years I spent in blood banks and transfusions services I saw and trained many Clinical Laboratory Scientists. I have to say that there were a noticeable few who just did not have the talent for it. No matter how knowledgeable they were in the science they just could not see it. I might even argue with Malcolm's 75% science. I'm leaning more to a 60-40 ratio.

As I've said many times, "Inertia is the most powerful force in the universe and blood bankers prove it everyday!" Sadly, "that's how we have always done it!" is often our mantra and no amount of data or lack of it can change many minds.

Malcolm, I meant that statement not as a criticism of them but just a recognition of reality. Frankly I was excited to get the forms back most of the time and fully understood the pressure they were under. When I was in school I worked in the emergency room on night shift so I was very familiar with trauma situations and fully understood the, "do it now and worry about the paperwork later" mentality. Cheers

What I noticed over the years was that many times when faced with signing for uncrossmatched blood the physician would take a second to reevaluate the situation. Often they would then respond with something like, I want it crossmatched so hurry. Not always but it was not uncommon or rare. When they did sign the form it was most often when the crisis had resolved and the dust settled.

It's not uncommon for inspectors/assessors etc to come up with their own interpretations. Before I would bother making any changes I would certainly do as Neil suggested and go up the food chain for clarification. Actually, my first inclination would be to ignore this on the chance you never see that inspection person/team again. If you do need to respond in some manner then "we're looking into it" should buy some time for confirmation. Best of luck.

Mollymotos, sorry I don't remember! That was 16 years, 2 jobs and retirement since 2015 ago. If I were to guess we probably would have reported as positive or negative for fetal cells or possibly as no fetal cells seen or fetal cells seen. We were really into waffle words when making such determinations.