MODERATOR
:
SPEAKER
(S):
Patricia Cappelli, BS, CQA(ASQ), Qualtiy Assurance Director, South Texas Blood and Tissue Center
Data Driven Quality Improvement: It's Time to Take it to the Next Step!
Sharon O'Callaghan, MT(ASCP), Consumer Safety Officer, FDA/CBER
Ruth Sylvester, MS, MT(ASCP)SBB, Director, Regulatory Services, Americas Blood Centers
Description
The 1980s and 1990s were a tumultuous time for blood banks with the recognition that HIV was transmitted by blood. This led to an ever increasing number of donor screening questions, infectious disease tests, and regulatory oversight. It was also accompanied by an explosion in the number of errors being made. Implementation of the FDA quality systems in 1995 and the requirement to identify, correct and report errors lead to a substantial increase in the number of reportable errors, now called Blood Product Deviations (BPDs), reaching a peak in 2003. The number of reports has reached a plateau and remained constant over the past several years. New approaches can transform the current system, based on detection and correction of errors, to a data-driven system focused on error prevention. This workshop will review some of the available approaches and their future impact in blood banking.
LEARNER OUTCOMES:
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Discuss the reasons why the number of reportable deviations has remained flat over the past several years.
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Perform a critical evaluation of the types of deviation reports required by the FDA and their contribution to blood safety.
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Propose new data driven approaches such as data warehouses and data mining that can help identify root causes and hidden components not detected by current quality sytems.
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Provide a review of the history of Blood Product Deviation Reports to the FDA.
CE Category | CE Value |
---|
California Clinical Laboratory Personnel |
1.5 |
California Nurse |
1.8 |
Florida Laboratory Personnel |
1.8 |
General Attendee |
1.5 |
Physician |
1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.