Blood Regulations - Error or Accident Investigation Preliminary Report Form (FRM-0337)

Introduction

As per section 107 of the Blood Regulations, establishments conducting an investigation must file a preliminary error or accident report with Health Canada within 24 hours after the start of the investigation, if all of the following criteria are met:

• the error or accident is thought to have occurred during an activity they conducted;
• the error or accident is identified after the blood is distributed or transfused; and
• there is a reasonable probability that the error or accident could lead to a serious adverse reaction.

Health Canada has developed FRM-0337 to facilitate the submission of these reports. Although the use of this form is encouraged, other formats will be accepted.