John C. Staley
Content Type
Store
Profiles
Forums
Blogs
Events
Frequently Asked Questions
Gallery
Downloads
Glossary
Links Directory
Questions
Jobs
Vendors
Everything posted by John C. Staley
-
If I remember correctly most of my FDA inspectors carried around the CFR Title 21 and did most of their inspection while constantly referring to it, primarily those sections referring to blood bank but sometimes they were looking at other sections as well. It's been too long for me to remember the specific sections. I went through CFR21 and highlighted the areas I thought were most important and prepared for them. I actually had one FDA inspector who was a SBB and knew what they were talking about. She did our inspection so we could get a license to ship blood products interstate. That was the best inspection I ever had in 30 years of supervising blood banks.
-
Is a signed consent required for RhIG administration?
John C. Staley replied to knelson's topic in Transfusion Services
This is the way it should be, if at all. The blood bank / transfusion service has better things to be doing than worrying about consents being explained and signed. Just my 2 cents worth. -
That's good news. So far sounds like an interesting academic exercise without a lot of urgency. My experience with NICU babies is if they need transfusion it is generally do to blood loss from testing. Keep us posted and hopefully someone here can come up with more ideas as to what you are seeing in the blood bank.
-
I'm curious, aside from being born at 28 weeks, how is the baby doing clinically?
-
Most assuredly!! She's a nurse and would not allow such activity unless performed with the upmost professionalism!
-
Not many have my option. My wife has an Anti-D, an Anti-K and for a short time a detectible Anti-s. I would just draw some of her blood every so often.
-
Just a thought but you may want to check the AABB Standards instead of the Technical Manual. Your question is more of a standards question than a technical one. Since I no longer have access to the Standards this is the best I can do.
-
Temperature mapping in small refrigerator required?
John C. Staley replied to Mabel Adams's topic in Transfusion Services
I have no supporting references but for me, common sense dictates that in a space that small you could not get the probes far enough apart to get any significant temperature variations. Having said that, regulations, requirements or other such problems seldom involve anything resembling common sense. Much like common courtesy, common sense is seldom common.- 1 reply
-
- 2
-
-
Thanks Cliff, that is some interesting data. When I was working in Utah there was a push for licensing Clinical Laboratory Scientists every couple of years in the state legislature. What I found most interesting, surprising and some what alarming was that the most strident lobbying opposition came from physician groups. My assumption was that they did not want to have to pay for qualified people to do the testing in their office and clinic labs.
-
Cliff, I've been glancing at the birthday list and it got me thinking (dangerous, I know), how hard would it be to run an algorithm that could calculate either the average age or the median age of group members. It might give us some perspective on the need to recruit more people into the profession. Just a random thought.
-
I'm not sure if this is still the case but the IS step was intended to confirm ABO compatibility.
-
First question, is the patient actively bleeding? If not and they just want to "top them off" then A neg is the choice. If they are and your A negs are very limited then stay with the A pos blood. As far as RhIG goes, as mentioned above, forget about it. All it will do at this point is cause more problems. That's what I would do.
-
I'm curious, what is the motivation for moving from Solid Phase to Gel?
-
So, is this then not a real and current situation but instead an exercise in, what if? Why would pre-warming be out of the question if you are already convinced that the antibody screen is negative and all you want to do is confirm ABO compatibility?
-
My next step would be to pull another unit off the shelf and see if it is IS compatible. The problem may be with the unit and not the patient.
-
Urine Collection for a Transfusion Reaction
John C. Staley replied to butlermom's topic in Transfusion Services
Why are you even asking for a urine for an allergic rxn to platelets? -
As much as I hate to ask it but having been out of world of blood banking for a few years, would you mind telling us boomers what the acronyms LTOWB and TXA stand for. Maybe in all his spare time Cliff can include a list of current acronyms for us.
-
How not to miss a weak reaction
John C. Staley replied to mommymini1's topic in Transfusion Services
My motto was "when in doubt, shake it out". Seemed to work for me. -
I've always used the C1 x V1 = C2 x V2 formula for such calculations. My question is why do you want a Hct of 35%??
-
Malcolm, you appear to have know all the greats. I had the honor of meeting a few of them over the years and it's sad to witness the passing of an era of such amazing discoveries.
-
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?
-
Meditech BB module and antibody screen reference range
John C. Staley replied to frenchie's topic in Transfusion Services
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.
-
Supervisor competency assessment
John C. Staley replied to Tympanista's topic in Accrediting Agencies
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.
