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A policy informing qualitative study to improve the process of blood product recalls and withdrawals
Author(s) -
Heddle Nancy M.,
Eyles John,
Webert Kathryn E.,
Arnold Emmie,
McCurdy Bronwen R.
Publication year - 2008
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2008.01909.x
Subject(s) - blood product , process (computing) , product (mathematics) , process management , medicine , business , operations management , intensive care medicine , computer science , surgery , engineering , operating system , geometry , mathematics
BACKGROUND: Challenges associated with blood product recalls and/or withdrawals in Canada identified a need to understand the process and identify ways in which it could be improved. With the use of qualitative techniques and a modified grounded theory approach, the current process was mapped, issues were identified, and recommendations to improve the system were developed. STUDY DESIGN AND METHODS: Potential participants were identified using a sampling strategy that included key stakeholder groups. After consenting, participants were interviewed using a semistructured interview guide. Interviews were audiotaped, transcribed, and coded using a coding scheme developed from the content of the interviews. A team approach to analysis identified relevant emergent themes and led to the development of recommendations. Draft recommendations were presented at a consensus meeting, and feedback was incorporated into the final set of recommendations. RESULTS: Forty‐five interviews were conducted. Major themes arising from the data were communication, timeliness of follow‐up information, and challenges related to patient notification. The current recall and/or withdrawal process was described and a new model for the recall and/or withdrawal process was developed. Nineteen recommendations were formulated: 12 general and 7 hospital‐specific. CONCLUSION: Large‐scale recalls and/or withdrawals involving unknown or uncertain risks can be challenging both for hospitals and for the blood supplier. However, using a qualitative research approach, recommendations and a model for improving the system were developed. Key recommendations include the development of national guidelines for notification and the use of a group of resource experts to assess risk and assist with notification decision making.