Jane12 Posted October 30, 2017 Share Posted October 30, 2017 My facility wants to move from 24 hrs to 5 day thawed plasma. I was wondering if someone would like to share the validation plan and any other requirements for the process. I really appreciate your time and attention. Thank you. Link to comment Share on other sites More sharing options...
kate murphy Posted November 3, 2017 Share Posted November 3, 2017 We did this a few years ago. Our medical director is conservative, and we sacrificed several FFP - thawed them and took samples for factor assays. Then repeated factor assays at 24 hrs, 48, 72... What you really just want to show is that x% of factors are still present at 5 days. So you just need to set what x% is acceptable. I think we set 80% of FVII and fibrinogen. Link to comment Share on other sites More sharing options...
Eman Posted November 3, 2017 Share Posted November 3, 2017 (edited) 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. Edited November 3, 2017 by Eman remove comment about adamts13 John C. Staley and JasonS 1 1 Link to comment Share on other sites More sharing options...
Eman Posted November 3, 2017 Share Posted November 3, 2017 Here's another useful paper, it was the model for the study reported above (and they had a bit better FVII retention). http://onlinelibrary.wiley.com/doi/10.1046/j.1537-2995.2001.41040570.x/full Serial measurement of clotting factors in thawed plasma stored for 5 days Authors Katharine A. Downes MD, Erica Wilson MD, Roslyn Yomtovian MD, Ravindra Sarode MD First published: April 2001 able 1. Mean coagulation factor levels at 24-hour intervals by blood group Level* Coagulation factor Day 1 Day 2 Day 3 Day 4 Day 5 Mean change from Day 1 to Day 5 (%) p values * Mean ± SD. † Comparison of FVIII activity at Day 1 and that at Day 3 was statistically significant. FVIII (%) Blood group A 107 ± 26 76 ± 19 66 ± 18 65 ± 17 63 ± 16 41 <0.004† Blood group B 103 ± 44 74 ± 37 71 ± 35 67 ± 36 67 ± 33 35 <0.02† Blood group O 70 ± 16 51 ± 10 43 ± 10 43 ± 7 41 ± 8 41 <0.001† Factor II (%) 81 ± 9 81 ± 9 81 ± 9 80 ± 10 80 ± 10 1 NS Factor V (%) 79 ± 7 75 ± 8 71 ± 9 68 ± 9 66 ± 9 16 NS Factor VII (%) 90 ± 18 81 ± 15 76 ± 15 72 ± 14 72 ± 15 20 NS Factor X 85 ± 13 84 ± 13 84 ± 15 82 ± 11 80 ± 11 6 NS Fibrinogen (mg/dL) 225 ± 12 224 ± 13 224 ± 13 224 ± 17 225 ± 12 0 NS Link to comment Share on other sites More sharing options...
Jane12 Posted November 4, 2017 Author Share Posted November 4, 2017 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 ? John C. Staley and Eman 2 Link to comment Share on other sites More sharing options...
mollyredone Posted November 4, 2017 Share Posted November 4, 2017 9 hours ago, Jane12 said: 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 ? That's my understanding. We did label validation when we got plasma frozen < 24 hours, since it is labeled as thawed plasma. John C. Staley 1 Link to comment Share on other sites More sharing options...
John C. Staley Posted November 4, 2017 Share Posted November 4, 2017 10 hours ago, Jane12 said: 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. AuntiS, Malcolm Needs, exlimey and 1 other 4 Link to comment Share on other sites More sharing options...
Jane12 Posted November 4, 2017 Author Share Posted November 4, 2017 So where do I start with this process? Do we still need to request variance from FDA ? I am a new lead and trying to figure out how to initiate and implement this process. Link to comment Share on other sites More sharing options...
Neil Blumberg Posted November 6, 2017 Share Posted November 6, 2017 Don't believe you need a variance or validation. Just relabel the product before 24 hours is up. The product is liquid plasma, not FFP after 24 hours. John C. Staley 1 Link to comment Share on other sites More sharing options...
Eman Posted November 6, 2017 Share Posted November 6, 2017 Neil is correct, there was some kind of regulatory change around 5-10 years ago so 5 day Thawed Plasma is legal now, no variances required. [I think the change was officially recognizing the 5 day product.] Also agree that validation of the plasma contents is not required, just validate your computer/label processes. Our frozen product is immediately relabeled as E2720 (Plasma, thawed, CP2D) upon thawing, given the 5 day expiration right away. Link to comment Share on other sites More sharing options...
mollyredone Posted November 7, 2017 Share Posted November 7, 2017 On 11/6/2017 at 4:59 AM, Neil Blumberg said: Don't believe you need a variance or validation. Just relabel the product before 24 hours is up. The product is liquid plasma, not FFP after 24 hours. 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. Eman 1 Link to comment Share on other sites More sharing options...
Carrie Easley Posted November 8, 2017 Share Posted November 8, 2017 On 11/7/2017 at 8:12 AM, mollyredone said: 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. This is correct...two different products. The liquid plasma we use has a 26-day outdate, and was never frozen. tricore 1 Link to comment Share on other sites More sharing options...
Jane12 Posted November 9, 2017 Author Share Posted November 9, 2017 Thanks for all your time and advice. I will ask our blood supplier to provide us with some labels for validation process. Link to comment Share on other sites More sharing options...
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