Dear Editor,
Pre-release visual inspection of platelet products is one of the important steps not only to check the quality but also to identify bacterial contamination of the platelet units. We present root cause analysis of an interesting case of bacterial contamination in platelet component.
One of our technical staff noted multiple white clots in a pooled platelet concentrate during visual inspection just before release of the unit as per our standard operative procedure (SOP) (Fig. 1a, b). He also noted that the unit lacked swirling and performed pH of the unit which was found to be 6.10 suggestive of bacterial contamination of the unit. A bacterial culture of the platelet unit was ordered from the microbiology department and a root cause analysis of the unit was initiated to find the potential source of contamination. Sample for bacterial culture was taken after proper sanitization and disinfection of the place.
Fig. 1.
Multiple white clots in a pool platelet and a root cause analysis to find the potential source
All the processes from the donor selection to processing and storage of the platelet units were analysed using a fish bone diagram (Fig. 1c). As it was a pool of four individual whole blood derived platelet concentrate, process related to all the four units were analysed. We could rule out any deviations in donor selection and material used for collection. Similarly, issues related to equipment failure, storage and pooling were also ruled out. Platelet pooling was done using sterile connecting device. However, it was found that one of the implicated units was collected by a recently joined trainee. The trainee had not followed the SOP for donor arm disinfection as well as failed to clamp the diversion pouch resulting in flow of initial blood from diversion pouch to the primary blood bag. As expected, the culture report confirmed the presence of Staphylococcus aureus, a skin commensal in the unit. We retrained our phlebotomy staff in arm disinfection techniques and reemphasized that SOP is followed for every process. It was also decided to allow the trainees to perform blood collection only after competency assessment and under supervision for the initial period.
Bacterial contamination remains a significant problem in platelet transfusion. There are many practical problems associated with bacterial testing of blood product as compared to viral testing. These may include the ideal time to test the platelet concentrates as the storage time is only 5 days. Bacterial inoculum at collection may also be too low for detection and a late testing may not yield results on time before issue.
Blood and blood components being a biologic drug carry certain inherent risks. With the realisation of the risks and advancements in technology these risks have been reduced to a minimum. For example, the risk of viral transmission of HIV, HBV and HCV through blood transfusion has been brought down to 0.047, 0.134, and 0.079 per million donations [1]. Bacterial contamination of blood components has lately been recognised as one of the more common problems associated with transfusion of blood components. The risk of transmission of bacterial infection through blood transfusion has been estimated in the range of 1:1000 to 1:3000 units [2, 3].
A number of pathogens have been implicated to cause contamination of blood components. Skin microflora such as S. aureus are implicated in some of the instances and majority of these can be prevented by the use of proper donor arm disinfection techniques and use of diversion pouch in blood bags [3]. An estimated 20% to 30% of individuals are long-term carriers of S. aureus which can be found as part of the normal skin flora and in the upper respiratory tract [4, 5].
A system to identify the problem, do the root cause analysis and implement the improvements is what may be the need of the hour in our set-up.
Acknowledgment
All persons who meet authorship criteria are listed as authors, and all authors certify that they have participated sufficiently in the work to take public responsibility for the content, including participation in the concept, design, analysis, writing, or revision of the manuscript. Here we indicate the specific contributions made by each author.Conceptualization/Methodology: Romesh Jain, Rakesh Kumar, Poonam CoshicAnalysis: Hem Chandra Pandey, Rakesh Kumar, Romesh Jain. Writing: Original Draft Preparation: Romesh Jain, Rakesh Kumar. Writing: Review & Editing: Hem Chandra Pandey, Poonam Coshic. Final approval of the version to be published: Hem Chandra Pandey, Poonam Coshic, Rakesh. Kumar, Romesh Jain. Supervision: Poonam Coshic, Hem Chandra Pandey
Compliance with Ethical Standards
Conflict of interest
There are no conflicts of interest.
Footnotes
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