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Notification of change: Upgrade of analyser for Serum free light chains, Immunoglobulin subclasses and C1 inhibitor

In order to improve the service to our users we have upgraded the analyser used to run the following assays, Serum free light chains, Immunoglobulin subclasses and C1 esterase inhibitor. These were previously run on the Binding Site SPA analyser, which we have replaced with the Binding Site OPTILITE analyser, A full verification of the change has been performed. There are no changes to the reference ranges used for these analytes and the analysers both utilise the same methodology. 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 analyser as an extension to scope of our accreditation at our next inspection in October 2018. This is normal procedure when changing analyser 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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