|IMAGE IN HEMATOLOGY
|Year : 2022 | Volume
| Issue : 1 | Page : 68-69
Root cause analysis of a moderately large fibrinous coagulum in a thawed fresh frozen plasma bag: Discussing the lessons learnt
Manish Raturi1, Reshma Nambiyar2, Yashaswi Dhiman1, Adityaveer Sahrawat1
1 Department of Immunohematology and Blood Transfusion, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
2 Department of Pathology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
|Date of Submission||15-Nov-2021|
|Date of Decision||27-Dec-2021|
|Date of Acceptance||12-Jan-2022|
|Date of Web Publication||28-Apr-2022|
Dr. Manish Raturi
Department of Immunohematology and Blood Transfusion, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun - 248 016, Uttarakhand
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Raturi M, Nambiyar R, Dhiman Y, Sahrawat A. Root cause analysis of a moderately large fibrinous coagulum in a thawed fresh frozen plasma bag: Discussing the lessons learnt. J Appl Hematol 2022;13:68-9
|How to cite this URL:|
Raturi M, Nambiyar R, Dhiman Y, Sahrawat A. Root cause analysis of a moderately large fibrinous coagulum in a thawed fresh frozen plasma bag: Discussing the lessons learnt. J Appl Hematol [serial online] 2022 [cited 2022 Jun 25];13:68-9. Available from: https://www.jahjournal.org/text.asp?2022/13/1/68/344258
Technological advancements have happened in the field of blood transfusion at a very high pace. Nevertheless, bacterial contamination continues to be the leading adverse risk associated with it. It is a leading cause of morbidity and mortality seen especially with platelet units because of its optimal storage at room temperatures ranging from 20°C to 24°C supporting the growth of bacteria. We, however, report our observation of a 5 cm × 5 cm moderately large fibrinous coagulum in a thawed fresh frozen plasma (FFP) bag prepared from a double 350 bag (CPDA-1, Terumo Penpol, Trivandrum, India). It warranted the initiation of a root cause analysis (RCA) of the entire event [Figure 1].
|Figure 1: A moderately large fibrinous coagulum of size nearly 5 cm x 5 cm found inside the thawed fresh frozen plasma bag and a closure look of the same inside|
Click here to view
We began by gathering the information from the donor details and then mapping the complete information to identify the actual cause of the problem with the various contributing factors. Once all the team members (led by two faculty members, one junior resident, and the technical supervisor of our blood center) agreed on the cause identified, we made a final report and took corrective action. We also proposed the appropriate recommendations for avoiding the recurrence of such events. A young Indian family donor donated the implicated whole blood unit (WBU). Its blood components were, harvested, within 6 h following the national regulatory recommendations. We also ruled out any inadvertent puncture of the artery (there were no signs of pain/hematoma or the extravasation of blood as enquired telephonically from the donor).
During the literature search for the potential sources of contamination, we found that it could multi-factorial. Few known reasons are: (a) incomplete disinfection of the phlebotomy site, (b) transient bacteraemia in the donors, (c) asymptomatic carrier or subclinical infection missed during the pre-donation screening, (d) contamination during blood bag thawing, (e) contamination during blood component processing and or blood bag manufacturing, (f) and many times, the cause may remain unidentified. Furthermore, the visual inspection showed a moderately large [5 x 5 cm] fibrinous coagulum in the thawed FFP bag. The packed red blood cell (PRBC) bag prepared from the implicated WBU got quarantined, given the possibility of bacterial contamination. While doing RCA, the probability of “asymptomatic bacteremia” was narrowed down by utilizing a look-back strategy. Proper disinfection of the phlebotomy site using antiseptic agents such as 70% isopropyl alcohol, 10% povidone-iodine, or 2% chlorhexidine before pricking reduces the chances of contamination drastically. Repeated and regular training of the phlebotomist/s regarding disinfection of the phlebotomy site was sought after diligently and ensured. In addition, the microbiological culture from the thawed FFP bag detected growth of Pseudomonas aeruginosa (an encapsulated Gram-negative bacillus. This bacterium is also found on medical equipment/s, water baths, and catheters, causing cross-infection within hospitals and blood centers). Interestingly, the PRBC bag prepared from the implicated WBU was sterile as per the culture report.
Further, testing the sterility of the water from the water bath showed contamination with Pseudomonas bacilli. As per the recommendations, the thawed FFP should be kept at 1–6°C and infused within 24 h of thawing. After 24 h, the component must either be discarded or, if collected in a functionally closed system, may be relabeled as thawed plasma. In this case, our blood centre technician had inadvertently extended the storage of the thawed FFP already kept at 1-6° C for nearly 46 h instead of the recommended 24 h. This had most probably led to the development of the bacteria-induced fibrinous coagulum. This bacteria-contaminated unit could have been detrimental if administered to the recipient. Published reports have suggested the occurrence of neonatal infections due to P. aeruginosa associated with a water bath used for thawing the FFP units. As a preventive action, we initiated regular and repeated quality checks of the water bath. We have also updated our standard operating procedure (SOP) regarding the frequent change of the water almost 12-hourly post-thawing of frozen blood products as a corrective action.
To conclude, robust pre-donation screening by the residents while taking history, physical examination of the asymptomatic blood donors and vigilant monitoring of the critical areas such as donor arm cleaning, collection and blood component processing including, the thawing of the frozen blood products all count as cost-effective measures to reduce the recurrence of bacterial contamination/s in the blood products.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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