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Cliff

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Posts posted by Cliff

    It's mislabeled, so yes, it's reportable.

    We are pretty big, and send in a lot of reports.  The FDA is really easy to work with.  I've had a couple of phone calls (they called me) and many emails regarding our reports.  Again, always helpful.

    @SMILLER, we have always been able to determine who received our products, including all emergency release products.  We have a form the physician signs that lists the units.  The blood bank issues those products (when they have time) to that patient and we can track where every product goes.

    What I take exception to is the inspector insisting that we also put the patients name and MRN on the product.  They again insisted this made the process safer.  It does not in any way make it safer, especially if it's a system assigned name / MRN and more importantly, when it takes a modest amount of time to generate these labels.

    We have done a tremendous amount of planning to ensure we can give out emergency release coolers, almost on demand.  It takes us very little time to give the requester their products, these labeled units have put a significant delay on that, and in my opinion, has deceased patient safety.

    7 hours ago, Malcolm Needs said:

    I agree entirely Cliff, but, in the UK, largely as a result of The Blood Safety and Quality Regulations (BSQR), originally introduced in 2005 by the European Union (EU), we have to have an audit trail from vein to vein for all units of blood, blood components and blood products, and this is seen by the inspectors as MUCH more important than the mere life of a patient.  Woe betide anyone who does not have a full audit trail and proof of cold chain, as they will have their finger nails ripped out without anaesthetic, then chucked into jail and the cell key thrown away.  In other words, while I agree that there should be audit trails and cold chain proof, the attitude is totally over the top.

    Yup, that was about how our inspection went.  We were made to feel like we were murdering patients by not having a fake name, attached to a universally "safe" product, being infused into a exsanguinating, unidentified patient.

    I understand the need for rules, but saving the patient comes first.  We do have a trail of who got what.  The idea that having a fake name on a product makes is safer is very frustrating. 

    As I mentioned, we need to go to a separate system just to print the labels to stick on to generic emergency release forms.  All of this adds time.  We are a large level 1 trauma center with a very active labor center.  We have many emergency release situations.  Some with dozens of products.  This adds no safety at all and adds time; therefore in my humble opinion, decreases patient safety.

    If I give an o neg RBC to the wrong patient (both of whom were going to get emergency released products), did I harm anyone?

    We were cited last year for not labeling emergency release products.  It was deemed an unsafe practice.  Now we ask for the patients names and medical record number.  If they don't have one, a temporary one is to be assigned and that info is provided to us.  We then need to use a different system to print these stickers to place on the emergency release tags that we attach to the units.  This can take a fair amount of time, but somehow is felt to be safer.  Very frustrating.

    3 hours ago, Malcolm Needs said:

    I should point out, nice as it is for Cliff to absolve me from all guilt, that nobody - and in particular me - is perfect, and so any mistakes could well be mine, and nothing whatsoever to do with the administration team!

    All I heard was blah blah blah.  :P  I have that as a disclaimer for all of the questions you provided.

    Malcolm did an insane amount of work for us, I am forever grateful for all that he does for this site.

    On 10/16/2017 at 6:35 AM, sherif said:

    thanks and for me i want to know the effect of mixing donor blood with anticoagulant(ACD-CPD-CPDA-1) on viral marker testing results .

    I can imagine at least two negative effects, first you will dilute out the marker you are testing for, second, the anticoagulant will interfere with the test.  It's critical that you follow the manufacturer's specimen requirements.

    7 hours ago, John C. Staley said:

    Cliff, I know I've been out of the donor side of the business a long time but, unless I'm mistaken, the moment you take the cover off the needle prior to inserting it into the donor it becomes an "open" system.  Granted, there is no other way to accomplish this and most blood bag contamination comes from the skin plug that is made on insertion, rare as that is.  When the needle is inserted into the tube the blood flows from the bag into the tube then the line is sealed.  The odds of contamination occurring in this process is actually much less than the act of drawing the blood from the donor.  

    Having said all this I imagine that some one has, in fact, come up with a better method of obtaining blood for infectious disease testing of the donor.   Just trying to justify how we did it in the olden days.  :rolleyes:

    I agree.  What I remember from older bags is a sampling port being attached to the line.  You'd collect your samples first, then clamp that off, then divert the blood to the collection bad.  I believe most modern bags have a diversion pouch where you collect the blood for the samples to that pouch (40 or 50 mls - not sure), then again, divert to the collection bag.

    In both of those scenarios, the initial collection of the blood, including a skin plug if present, go to the diversion bag first.  This helps reduce the risk of contamination.

    11 hours ago, sherif said:

    thanks and what about my first question as pic. is this an open system ? and why ? and what sample requirements(especially anticoagulants)  for viral testing by FDA ,AABB?

    These are regulated tests, AABB is not a regulator.  FDA mandates the testing in the US.  Here is the list of approved tests and their specimen requirements: https://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/blooddonorscreening/infectiousdisease/ucm080466.htm

    As for the pic of the blood bag, that is an open system.  You have an open needle, and while I understand the philosophy that it will be placed under a vacuum, the bag itself is still open.  All collection bags have a mechanism to collect the specimens in a closed system, there is no need to ever enter a bag like you show.  If this is a one off thing that you need to do, you can steriley dock on a satellite bag and enter that bag.  I still advise against this for your infectious disease specimens as it's not allowed.

    On 10/13/2017 at 6:52 PM, sherif said:

    whole blood with CPDA-1 is not suitable for viral marker testing ?

    Again, it appears you are not in the US, so I am not familiar.  You'll need to check what the sample requirements are for your infectious disease testing.  That's a lot of anticoagulant diluting the specimen and it's not likely acceptable.

    1 hour ago, Maureen R said:

    Sorry it has taken me awhile to get back to you. I will go through my questions and submit some by the end of the week.

    Thank you!

    53 minutes ago, Malcolm Needs said:

    Cliff, can I just check that the ones that I have sent you already do not need to be re-submitted on this form please?

    I will enter them for you, I saved them, but have not had a chance to look through them yet.  Thank you!

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