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Knowledge of food and drug administration reportable deviations
Rebecca Lam1, Barbara J Bryant
1Scottsdale Healthcare, Thompson Peak Hospital, Laboratory Department, Blood Bank Division, Arizona, USA.
Transfusion
|July 9, 2011
Summary
Blood bankers lack understanding of FDA reportable deviations, with few correctly identifying all required occurrences. Knowledge gaps persist regardless of establishment size or job title, impacting blood product safety reporting.
Area of Science:
- Blood banking and transfusion medicine
- Regulatory compliance in healthcare
- Quality management systems
Background:
- The Food and Drug Administration (FDA) mandated reporting of blood product deviations affecting safety, purity, or potency in 2001.
- Hospitals reported an average of only 8.6% of blood product deviations between 2004 and 2009.
Purpose of the Study:
- To assess the understanding of FDA reportable deviations among blood bank professionals.
- To identify factors influencing knowledge of regulatory reporting requirements.
Main Methods:
- Case scenarios were developed to evaluate knowledge of FDA reportable deviations.
- A web-based survey was administered to 176 blood bank medical technologists.
- Data on job title, responsibilities, and establishment size were collected.
Main Results:
- Only 5.7% of respondents answered all questions correctly, indicating a significant knowledge gap.
- No correlation was found between job title/establishment size and the number of correct responses.
- Deviations in quality control and identification were prioritized over administrative errors.
Conclusions:
- Blood bankers demonstrate a lack of clear understanding regarding FDA reportable occurrences.
- Establishment size and individual job title do not correlate with improved knowledge of FDA reportable deviations.
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