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Notification of Change: upgrade of instrumentation For Virology Real-Time PCR testing

on Thursday, 24 May 2018.

In order to improve the service to our users we have upgraded the instrumentation used to perform the testing and detection of Viral and Bacterial nucleic acids by real time PCR. A full validation of the change has been performed and users will be informed of any change in performance characteristics.
However, these assays now lie outside our scope of accreditation as assessed by UKAS. UKAS have been informed and will assess the assays on the new instrumentation as an extension to scope of our accreditation at our next inspection. This is normal procedure when changing platforms.

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HTA licence number is 12366

Protection of Personal Information – Laboratory Medicine comply with the Trust Data Protection Policy and have procedures in place to allow the Directorate and it’s employees to comply with the Data Protection Act 1998 and associated best practice and guidance.

The Trust Laboratories at Heartlands Hospital, Good Hope Hospital and Solihull Hospital were awarded UKAS (United Kingdom Accreditation Service) accreditation to the internationally recognised ISO 15189 standard in May 2015. For a list of accredited tests and other information please visit the test database http://www.heftpathology.com/frontpage/test-database.html.
Tests not appearing on this scope are either under consideration or in the process of accreditation and so currently remain outside of our scope of accreditation. However, these tests have been validated to the same high standard as accredited tests and are performed by the same trained and competent staff.

For further information contact Louise Fallon, Quality Manager, 0121 424 1235

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