‘Biologic Product Deviation Reporting in the Blood Bank’

Sept. 2015
MedicalLab Management
(Cover story)
“Biologic Product Deviation Reporting in the Blood Bank”
By Randy German, MT(ASCP)SBB

“. . . In 2006, following an FDA citation related to BPD reporting, Hoag management decided the blood bank’s paper system was inadequate and acquired a BPD software program [OTIS by Nouvation]. In 2011, the general laboratory was added to this system. The program provides for paperless reporting, helps ensure completeness of reports, guides the RCA and corrective action process, allows for custom coding and risk stratification, provides data for our key indicators of quality, and helps ensure reportable errors are submitted within the allowable time frame using a 45-day countdown clock. The software also can be programmed to require documentation of specific corrective actions linked to the root cause. For example, if competency is determined to be the root cause, the system requires documentation of employee retraining. Other helpful features to look for when contemplating a system include electronic signature capability, the ability to electronically attach and store supporting documentation, and a means for employees to record their recollections of the incident.

Whatever software is chosen, ensure that it has the ability to provide trending data. Hoag’s system has intuitive, click-view report building, allowing trending using virtually any data field or free text term within the report. Trending reports can be run by location of occurrence, SOP number, employee, BPD code, etc. A paper system can be tedious and time-consuming and result in low reporting compliance. Additionally, obtaining meaningful trending data is challenging at best. During our two previous FDA inspections, the investigator asked to review the last 10 reportable and non-reportable BPDs, which staff members were able to quickly and easily pull from a computer terminal. . . .”

Read the full article here.


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