title: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Departments of Medicine and the School of Geography, and Earth Science, McMaster University, Hamilton, Ontario, Canada. heddlen@mcmaster.ca
authors.forename: Nancy M
authors.initials: NM
authors.lastname: Heddle
authors.forename: John
authors.initials: J
authors.lastname: Eyles
authors.forename: Kathryn E
authors.initials: KE
authors.lastname: Webert
authors.forename: Emmie
authors.initials: E
authors.lastname: Arnold
authors.forename: Bronwen R
authors.initials: BR
authors.lastname: McCurdy