The Yellow Card Scheme for laboratory medicine in vitro diagnostics

Background: The Yellow Card Scheme was introduced in the UK in 1964 with an aim to address adverse drug reactions patient safety concerns. Medical devices are now included within the scope of reportable events. Aim: We report here what we believe is the first survey of the Yellow Card Scheme in relation to medical devices in the clinical laboratory. Materials & methods: A Microsoft Forms descriptive, cross-sectional survey was made available by the Patient Focused Laboratory Medicine Group to anyone working within the discipline of laboratory medicine in the UK; however, dissemination was limited through primarily clinical biochemistry channels. The survey was open for 32 days. Questions were structured that respondents could only continue, firstly if they were aware of the Yellow Card Scheme and a secondly, if they had ever made a submission. We know from external quality assessment post-market surveillance that over the last year there have been multiple assays with significant changes in analytical performance to cause a change in patient management, therefore it would be expected that a notable number of Yellow Cards should be reported. Results: Responses were received from 321 individuals. Out of the 207 respondents who were aware of the Yellow Card Scheme, 140 (68%) have not raised a Yellow Card. Of the Yellow Cards that had been raised, only 23% of respondents who have raised a Yellow Card use the Scheme regularly, this equates to only 5% of the total respondents to the survey. Free text comments were allowed to some questions, a few responses are included in full in the paper, some of which are alarming. Conclusion: Lack of awareness of the overall process shows that there is an educational issue and concerns about completion of the form, lack of feedback and consequential disengagement with the process potentially means it is not fit for purpose, which could explain why people are not using it. We believe that this is a potentially huge patient safety issue.