Technical Adverse Incident (TAIs)
A laboratory based technical adverse incident (TAI) is an event giving rise to, or having the potential to produce, unexpected or unwanted effects involving the safety of patients, users or other persons. TAIs can vary from very minor to extremely serious but by rapid communication to the MHRA (Medicines and Healthcare products Regulatory Agency) other users can be warned of problems with products.
Examples of TAIs are malfunction of equipment such as serology analysers, tests failing QC, false positive or false negative reactions and cross-contamination problems.
TAI and Possible TAI Reporting
All laboratories should identify their obligations to their NHS Trust by liaising with the Trust MHRA Liaison Officer and ensure that they report all TAIs directly to the MHRA.
In addition, we ask that HPA laboratories and those NHS laboratories who partake in the HPA scheme, to report TAIs and possible TAIs to the Standards Unit by copying the MHRA form to standards@hpa.org.uk so that other users can be alerted to potential faults with products. Simply copy and paste the email address (standards@hpa.org.uk) onto the email part of the MHRA form.
We will send out an email to participant laboratories requesting further information about similar incidents.
We ask that laboratories who send us information about a possible TAIs check that they have undertaken the test according to the manufacturer's instructions, that the result is outside that specified in the manufacturer's instructions, and that the laboratory has checked its internal quality controls results.
HPA and other participating laboratories may tell us about TAIs / possible TAIs using the HPA TAI Report Form.
Non-HPA laboratories are welcome to join the HPA scheme,
by emailing us at standards@hpa.org.uk