BankerGirl

We do the same.  We have a few docs who still think we need to crossmatch units ahead, but we educate them at the time of order.  We keep it mostly for those times when a patient with special needs is scheduled for a procedure.

We do the same.  We have a few docs who still think we need to crossmatch units ahead, but we educate them at the time of order.  We keep it mostly for those times when a patient with special needs is scheduled for a procedure.

And WHEN are we going to get freeze dried plasma?!?!?  
Spray-dried plasma: A post-traumatic blood “bridge” for life-saving resuscitation
Mark A. Popovsky1 | Nathan White
Transfusion. 2021;61:S294–S300.
 

I attended a webinar presentation on this and the presenter stated specifically that NOTHING has been grandfathered.  There are some items that the FDA has said it would still use enforcement discretion, but was very much above my understanding.
 

I believe internal QC or non-patient testing is not covered by the FDA regs.  Only tests used to report patient results.

"the presenter stated specifically that NOTHING has been grandfathered. "
I think the presenter is mistaken.  The FDA specifically noted that the area of rare reagents and cells, and similar testing would not be subject to LDT enforcement.  Of course, all the opinions in the world matter not a bit until the FDA actually acts or does not act.  I cannot imagine they want to be inspecting every tertiary care hospital and blood center reference laboratory for this purpose.  And most of the things we are discussing in the transfusion service and immunohematology lab are not used to provide diagnostic results to practitioners,  but rather used for internal resolution of therapeutic decisions. Quite different from your average laboratory test which provides quantitative or semi-quantitative result to physicians and other practitioners who make decisions based upon lab results.  Perhaps a nuance, but a real difference.  If the FDA insists we validate the use of a potent anti-HPA1 anti-platelet antibody in our decision making, we're out of luck :).  Ain't happening.
Interestingly, much of what we do in clinical medicine has not been "validated" or subjected to FDA-like regulation.  Such as using autologous or allogeneic stem cell transplants, liver transplants, using a stethoscope or looking at a patient's retina with an ophthalmoscope.  No validation.  No data to speak of at all.

Same here.

We use MediaLab also and scan the package inserts in a job aids.  You can revise them the same as you can your policies.

We use MediaLab also and scan the package inserts in a job aids.  You can revise them the same as you can your policies.

This is what we have from CAP for proficiency:

I just answered this question.

My Score PASS  

I'm all for the concept of quality and the strive to provide the safest blood products to patients, but I won't deny that sometimes many of our current practices in blood banking in terms of achieving that "quality" seems excessive, unnecessary, and sometimes it feels like a mere quality charade for inspectors and regulators. Considering the hight cost that blood banks have to incur to meet all quality regulations, it may be worth studying the financial impact of the many quality measures that regulate the practice of blood banking and to what extent these measures are actually contributing to achieving the quality needed to provide the best blood products to patients.

We have had HFAP until they were purchased by ACHC, and both of those have cited me for the lack of correlations:  one for not performing them at all, although I pointed out that we do that on every specimen without previous records, and just last year because I didn't include crossmatch tests with my Type and Screen correlations.  I contested the citation again, stating that it was the exact same methodology as the antibody screen, but was unsuccessful as their standards say "the same test using different methodologies ".  I gave up and added XM as well.  No concept of what we do and no common sense! 

We have had HFAP until they were purchased by ACHC, and both of those have cited me for the lack of correlations:  one for not performing them at all, although I pointed out that we do that on every specimen without previous records, and just last year because I didn't include crossmatch tests with my Type and Screen correlations.  I contested the citation again, stating that it was the exact same methodology as the antibody screen, but was unsuccessful as their standards say "the same test using different methodologies ".  I gave up and added XM as well.  No concept of what we do and no common sense! 

We have had HFAP until they were purchased by ACHC, and both of those have cited me for the lack of correlations:  one for not performing them at all, although I pointed out that we do that on every specimen without previous records, and just last year because I didn't include crossmatch tests with my Type and Screen correlations.  I contested the citation again, stating that it was the exact same methodology as the antibody screen, but was unsuccessful as their standards say "the same test using different methodologies ".  I gave up and added XM as well.  No concept of what we do and no common sense! 

We print ours on a 4x4 adhesive label and place the label on the back of the unit at issue.

All, I am about to blow your mind....
Our plasma freezer is down and so is our backup. The freezer will not get colder than -18 C. I was preparing to move all the products into boxes with dry ice until I had a conversation with my 87 year old dad, a retired blood banker from University of Chicago. He said to me, do not take the plasma out of the freezer and put it in boxes, PUT THE DRY ICE IN THE FREEZER, IT IS THE BEST STORAGE BOX YOU HAVE!!!!
MIND=BLOWN!!!!
I did that. Our freezer is currently reading -25.1C and getting colder. Furthermore, the probes in the freezer continually monitor the temp in the freezer so you don't have to record temps every 4 hours, the chart is doing that for you!!!
Isn't that cool? That perfectly illustrates the difference between wisdom and knowledge there. I wish we could hire my dad.
I just had to share this here.
PS. Freezer is now at -26.4C.
 

We have the compatibility question on the pre-transfusion checklist in Meditech TAR.  We were also cited for this several years ago and have not had a problem with this since.  Whether the RN understands is another question though.

We have the compatibility question on the pre-transfusion checklist in Meditech TAR.  We were also cited for this several years ago and have not had a problem with this since.  Whether the RN understands is another question though.

We do the same.  We have a test that simply asks how many antigens were tested and the technologist enters a number.  This is how many charges will go to the billing module.

Have your LIS person set up the History Backup Client.  This will backup all files and then automatically backup any new or edited files every hour.  We have ours backed up to our network and a portable hard drive that we can access if the network is also down.

Have your LIS person set up the History Backup Client.  This will backup all files and then automatically backup any new or edited files every hour.  We have ours backed up to our network and a portable hard drive that we can access if the network is also down.

We have been used HFAP (now part of ACHC--Accreditation Commission for Health Care) for at least the past 20 years.  I have no experience with any other accreditation organization so can't really compare to CAP, but they are another option.

I just answered this question.


My Score PASS  

I agree with David and his comments above.  We transfuse neonates very rarely as well.  Considering you are a small rural health center and will not be doing this routinely, you just have to do the best you can in an emergent situation.  We do keep neonatal syringe sets and most of them outdate.