A policy informing qualitative study to improve the process of blood product recalls and withdrawals

Abstract

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.

Cite this work

No public copy is stored for this record, so only the metadata is cited.

Stored only when both papers are in the corpus — 6 citations exist upstream.

Papers that cite the same references — the relational fallback while embeddings are still backfilling.