(P-BC-51) Process Improvement for the Electronic Documentation of LVDS Platelets that Test Positive for Bacterial Detection

With the implementation large volume delayed sampling (LVDS) at a community blood center, the positivity rate increased from 4.6 per year to 23.6 per year. From January 2022 to January 2024, 29.5% of the platelets with positive blood cultures that were reported in the Quality Management System (QMS) were missing documentation and had to be sent back to the applicable department to obtain the data. As a result, in January 2024, Quality Assurance (QA) implemented a streamlined electronic process in the QMS that prevents the omission of data required for the documentation of LVDS platelet collections that test positive for bacterial detection (BD).

Study

Design/Methods:

Upon initial creation of the product corrections form (PCF) in the QMS by the Quality Control Laboratory (QCL) to electronically control components from a positive BD case, additional forms within the PCF are reflexively launched to the Chief Medical Officer (CMO), Donor Services Lot Release (DSLR), Component Manufacturing Lab (CML), and the QCL. Each form requests critical information related to the positive BD case and has required fields to prevent omission of this data. The CMO documents notification to the hospital transfusion service for final component disposition of involved products, as well as providing them with the final interpretation of the positive BD case (false positive, true positive, etc.). DSLR provides the donor identification information, the phlebotomist(s) involved in the collection of the suspect platelet, and the lot numbers of the critical supplies used during the collection of the platelet. CML documents the final disposition of the platelet and the consignee notification. QCL provides the technologist involved in the sampling of the platelet component, the lot numbers of the culture bottles, whether that lot has been involved in previous cases, and the gram stain and blood culture results of the contaminated platelet.

Results/Findings:

Due to the required fields in department specific forms, no omission of data has been observed since implementation. The information provided by the aforementioned departments is consolidated into one electronic record for review prior to case closure and/or notification to the FDA of the biological product deviation (BPD). Additionally, the accumulation of all relevant data in one electronic record simplifies the investigation process for root cause analysis and effective corrective action.

 

Conclusions:

The implementation of LVDS platelet manufacturing, and the resulting five-fold increase in positive BD cases, required an improved process for the collection of relevant data in the QMS. The enhancement of the electronic forms for use by all involved departments ensures an efficient approach to the blood center’s practices for a thorough investigation for each positive BD case.