Eman

We have the same BUT we decided to use production as what if!...
It is very easy to block billing by just creating a code at interface level.
We also use teo patient to stock in ER and OR and again we hav eit blocked at interface so it does not generate any transactions.

@John C. Staley, this may be true, but the FDA does actually review each file.  They notify us a couple fo times a year that an event is not reportable.  

Thanks so much Eman that is just what I needed. I just couldn't find it.
 

Nice work, congrats!
When I was doing my SBB training our reference lab manager/educator had an running bet, she'd buy dinner for any student that took an SBB exam and didn't get a question about anti-D,C and G.  Don't think she has bought anyone dinner yet  

There's an annual BPDR summary for BB/TS from the FDA, looks like 2016 is the most recent available at: https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129757.htm
1,956 BPDRs from Transfusion Services in 2016, a majority being QC and distribution related, not documenting issue in the computer system is typically the #1 reason.

We use production as we wanted to mimic real patient. Only difference...the order is not coming from EPIC. we record specimen in safetrace.
We use same last name all the time and we have it blocked at interface level so billing is not generated.

Irradiation does not "kill" T lymphocytes per se, which are the cells that cause TA-GvHD, but what it does is disrupt the DNA within the nucleus, and this disruption prevents them from cloning.  As a result, they are unable to "reproduce" (for want of a better way of putting it) and so, instead of being able to form a clone within the recipient, will be removed from the circulation by natural apoptosis.  Prior to this apoptosis, once they have been irradiated, the T lymphocytes are relatively benign.

Doesn't seem extreme to us at all, we also enter PT specimens into our LIS, although we use the validation environment to keep fake patients out of the live side, which also means we don't get billing issues with these. By managing the PT specimens in the LIS we are truly treating them like real patient specimens.

I did mine FT while also working FT.  It was brutal, but it was the fastest 12 months of my life.  Takes a lot of discipline, at least 3 hours every night. You can't skip more than 2 days or you reach the point of no return.  As soon as I started to feel overwhelmed, I would take a day off from work to catch up. You have NO social life during this time. However, you have a MUCH better chance of passing the test if you do it FT and then commit to take the test within 2 months of ending. Private message me if you want more info.

I believe it would need to be reported. The unit was issued with an error. It also doesn't hurt to just submit it since the FDA will let you know if it didn't need to be reported. 

If you're registered with FDA you ought to update your address with them, since your address is part of the registration record.

I thought I was lucky not to have a criminal background check and drug screen prior to being retired, let alone rehired!!!!!!!!!!!!!!!!!!  

Yes.
You could give the red cells and the plasma to your NICU and let them transfuse as they wish.

Yes you do! In accordance with 21 CFR 607.21, you must register and list the blood products you manufacture ( when you reconstitute, you are manufacturing a new product = whole blood ( new ISBT #) for commercial distribution every year between October 1 and December 31 and you must update your blood product listing every June and December. I hope that helps.
Simret
 

Back story is there was a travelling OR tech at another hospital - he turned out to be a drug diverter and managed to infect a number of patients with Hep C.  I volunteered to help the State of NH test exposed people for Hep C and spent a day in a local school cafeteria doing that testing along with my medical student daughter.  Well, the legislature decided to somehow attempt to regulate these "Lab Technicians" and thus this kangaroo board of 3 people in the state who meet monthly and determine if people are worth of "Lab Tech" designation or not.  2 physicians (1 a gastroenterologist from the affected hospital) and a nurse.  And they are going to determine if I, a medical technologist registered by ASCP is deemed worthy of being a "lab technician"?  I think not! We are going to fight this.

I think that this is very possible.  We have seen some thawed plasma look like egg drop soup after several hours in the refrigerator.  If you place it back in the water bath for about 5 minutes, cryoprecipitate will go back in solution and should be fine to transfuse.  If it still looks the same after warming, then you shouldn't use it.

I suspect there will be some regional bias after mentioning AABB
That said, I'm in the Midwest and have been impressed by the Wisconsin Association of Blood Banks annual meeting (disclosure: I used to chair their Education Committee and since leaving WI have been back as a presenter twice in the past 6 years). There's is a 2 day conference with a fairly large vendor area/participation.  www.wabb.org

From my understanding, liquid plasma is plasma that has never been frozen and has a much longer outdate.  We order it specifically from our supplier.

Awesome details. Thanks for all the information. I worked at couple of facilities that switched to 5 day plasma and I do not remember them doing any factor studies. They did a lots of validation with the ISBT labels. I do not remember the exact details. My supervisor said that since it has been approved by FDA, we do not need to repeat the factor studies but, has to make sure that the thawed labels match the product code for the frozen product. Is that right ? 

I had hoped that the validation mania had subsided.  It's good to see that there is still some common sense out there.  I never did understand why so many of us felt the need to continually reinvent the square wheel when all the work on the round one had already been completed.   

Both the Technical Manual and Circular of Information include a table from a paper published a while back (2009) showing how the various factor and proteins C and S and anti-thrombin persist (or not) over 5 days.
It's really not pretty but here is a copy/paste from the circular of information, which is also available from AABB (direct link, go to page 14 for easier reading of the table)
I do QA and software support now, so read your question as about validating the computer/labeling process. Our facility skips the 24 hour FFP step, so when we thaw a plasma it is immediately re-labeled as 5 day Thawed Plasma
[looks like our study results might not have passed at Kate's place, only about 70% of FVII remained after 5 days at 1-6 in FFP, but the FP24 would pass (it started lower but retained 86% of activity).]
Table 3a. Coagulation Factor Activity in FFP and PF24 (whole blood) at the Time of Thaw and after 120 Hours of 1 to 6 C Storage
(adapted from Table 1. Scott EA, et al. Transfusion 2009;49:1584-91)
Thaw, mean ± SD (range) by product
120 hr, mean (range) by product
%Change after 120 hr at 1 to 6 C
Analyte
FFP (n=20)
PF24 (n=14)*
FFP (n=20)
PF24 (n=14)*
FFP
PF24
FII (IU/dL)
97 ± 10 (83-125)
97 ± 8 (80-113)
95 ± 10 (82-126)
96 ± 11 (74-120)
3‡
1
FV (U/dL)
85 ± 13 (63-104)
86 ± 16 (54-124)
67 ± 19 (17-92)
59 ± 22 (15-109)
21‡
31‡
FVII (IU/dL)
105 ± 25 (50-163)
89 ± 22 (54-145)
70 ± 18 (34-102)
77 ± 27 (50-159)
33‡
14‡
FVIII (IU/dL)§
81 ± 19 (47-117)
66 ± 17 (30-100)†
43 ± 10 (27-60)
48 ± 12 (26-73)
47‡
28‡
F IX (IU/dL)
82 ± 13 (62-108)
88 ± 13 (70-105)
80 ± 12 (64-107)
84 ± 12 (65-99)
2
4‡
FX (IU/dL)
94 ± 10 (71-112)
94 ± 11 (72-112)
87 ± 11 (65-111)
91 ± 12 (67-114)
7‡
3‡
vWF:Ag (IU/dL)§
98 ± 27 (57-156)
132 ± 41 (78-211)
97 ± 30 (48-150)
127 ± 40 (79-224)
1
4
vWF:RCo (IU/dL)§
101 ± 26 (61-152)
123 ± 47 (58-238)
93 ± 30 (48-149)
102 ± 38 (50-191)
8‡
17‡
Fibrinogen (mg/dL)
280 ± 52 (223-455)
309 ± 70 (211-500)
278 ± 50 (223-455)
303 ± 50 (205-490)
1
2‡
Anti-thrombin (IU/dL)
97 ± 9 (85-118)
97 ± 11 (77-110)
100 ± 10 (85-131)
101 ± 14 (73-116)
3
4‡
Protein C (IU/dL)
107 ± 20 (74-148)
88 ± 16 (65-120)†
107 ± 19 (77-148)
89 ± 17 (65-115)†
0
2
Protein S (IU/dL)
97 ± 18 (61-123)
92 ± 18 (54-121)
90 ± 22 (52-134)
78 ± 19 (46-114)†
7‡
15‡
*N = 25 for FII, FV, FVIII, Fibrinogen, vWF:RCo, and Protein S.
†p < 0.05 compared with mean activity in FFP of the same age.
‡p < 0.05 when comparing mean activity at thaw to mean activity after 120 hours of 1 to 6 C storage.
§Only results from group O products were used for statistical comparisons of factor VIII, vWF:Ag, and vWF:RCo activities.
 

Both the Technical Manual and Circular of Information include a table from a paper published a while back (2009) showing how the various factor and proteins C and S and anti-thrombin persist (or not) over 5 days.
It's really not pretty but here is a copy/paste from the circular of information, which is also available from AABB (direct link, go to page 14 for easier reading of the table)
I do QA and software support now, so read your question as about validating the computer/labeling process. Our facility skips the 24 hour FFP step, so when we thaw a plasma it is immediately re-labeled as 5 day Thawed Plasma
[looks like our study results might not have passed at Kate's place, only about 70% of FVII remained after 5 days at 1-6 in FFP, but the FP24 would pass (it started lower but retained 86% of activity).]
Table 3a. Coagulation Factor Activity in FFP and PF24 (whole blood) at the Time of Thaw and after 120 Hours of 1 to 6 C Storage
(adapted from Table 1. Scott EA, et al. Transfusion 2009;49:1584-91)
Thaw, mean ± SD (range) by product
120 hr, mean (range) by product
%Change after 120 hr at 1 to 6 C
Analyte
FFP (n=20)
PF24 (n=14)*
FFP (n=20)
PF24 (n=14)*
FFP
PF24
FII (IU/dL)
97 ± 10 (83-125)
97 ± 8 (80-113)
95 ± 10 (82-126)
96 ± 11 (74-120)
3‡
1
FV (U/dL)
85 ± 13 (63-104)
86 ± 16 (54-124)
67 ± 19 (17-92)
59 ± 22 (15-109)
21‡
31‡
FVII (IU/dL)
105 ± 25 (50-163)
89 ± 22 (54-145)
70 ± 18 (34-102)
77 ± 27 (50-159)
33‡
14‡
FVIII (IU/dL)§
81 ± 19 (47-117)
66 ± 17 (30-100)†
43 ± 10 (27-60)
48 ± 12 (26-73)
47‡
28‡
F IX (IU/dL)
82 ± 13 (62-108)
88 ± 13 (70-105)
80 ± 12 (64-107)
84 ± 12 (65-99)
2
4‡
FX (IU/dL)
94 ± 10 (71-112)
94 ± 11 (72-112)
87 ± 11 (65-111)
91 ± 12 (67-114)
7‡
3‡
vWF:Ag (IU/dL)§
98 ± 27 (57-156)
132 ± 41 (78-211)
97 ± 30 (48-150)
127 ± 40 (79-224)
1
4
vWF:RCo (IU/dL)§
101 ± 26 (61-152)
123 ± 47 (58-238)
93 ± 30 (48-149)
102 ± 38 (50-191)
8‡
17‡
Fibrinogen (mg/dL)
280 ± 52 (223-455)
309 ± 70 (211-500)
278 ± 50 (223-455)
303 ± 50 (205-490)
1
2‡
Anti-thrombin (IU/dL)
97 ± 9 (85-118)
97 ± 11 (77-110)
100 ± 10 (85-131)
101 ± 14 (73-116)
3
4‡
Protein C (IU/dL)
107 ± 20 (74-148)
88 ± 16 (65-120)†
107 ± 19 (77-148)
89 ± 17 (65-115)†
0
2
Protein S (IU/dL)
97 ± 18 (61-123)
92 ± 18 (54-121)
90 ± 22 (52-134)
78 ± 19 (46-114)†
7‡
15‡
*N = 25 for FII, FV, FVIII, Fibrinogen, vWF:RCo, and Protein S.
†p < 0.05 compared with mean activity in FFP of the same age.
‡p < 0.05 when comparing mean activity at thaw to mean activity after 120 hours of 1 to 6 C storage.
§Only results from group O products were used for statistical comparisons of factor VIII, vWF:Ag, and vWF:RCo activities.
 

All of my books say O>A2>B>A2B>A1>A1B.
The only impact this may have on your routine work is either if you come across a patient who has auto-anti-H or auto-anti-HI in their plasma (in which case, cross-match ABO compatible units and ignore the results of the panel - because the panel will be group O and so give very strong results with such auto-antibodies), or if you are taking an examination, and the examiner is particularly sadistic or trying to show just how much they know, rather than trying to find out what the candidate knows.
Do, however, watch out for a genuine Oh individual, with an allo-anti-H (which you could come across at any time - if you are unlucky), but such an anti-H is usually, but not always, pretty damn strong!

Another important difference, at least in the US, is that INTERCEPT is approved/licensed for use with platelets and plasma but approval to use Mirasol in the U.S. is still pending (The Terumo website says Mirasol is "available in select markets". We went live with INTERCEPT for platelets earlier this year, been a generally positive experience. Downsides have been mostly related to collection targets (there are somewhat strict acceptance parameters for volume, platelet concentration and platelet content that required us to tweak our collection targets a fair bit) and the system isn't licensed for triple products, so we can only collect and process single and double collections.  We had previously irradiated all of our platelets, so it was a nice benefit to no longer have to irradiate once we implemented INTERCEPT.

Another important difference, at least in the US, is that INTERCEPT is approved/licensed for use with platelets and plasma but approval to use Mirasol in the U.S. is still pending (The Terumo website says Mirasol is "available in select markets". We went live with INTERCEPT for platelets earlier this year, been a generally positive experience. Downsides have been mostly related to collection targets (there are somewhat strict acceptance parameters for volume, platelet concentration and platelet content that required us to tweak our collection targets a fair bit) and the system isn't licensed for triple products, so we can only collect and process single and double collections.  We had previously irradiated all of our platelets, so it was a nice benefit to no longer have to irradiate once we implemented INTERCEPT.