GQ5-Governance and quality system standards

HTA standard         

 Examples of best practice standards

a)   Staff are instructed in how to use incident reporting systems.

• Evidence of training documented.

• The Adverse Effects (AE)/incident form can be found here. This should be emailed to the HT Act DI who will advise further, following an investigation.

b)   Effective corrective and preventive actions (CAPA) are taken where necessary and improvements in practice are made.

• These should be documented in the CAPA form supplied by the DI. Note: examples of AE include specimen loss; missing or incorrect documentation; security breach; abnormalities in storage temperature readings; inappropriate disposal.