The pathology department at Heartlands Hospital is part of University Hospitals Birmingham and serves Heartlands, Good Hope and Solihull Hospitals and in addition to providing services for GPs in and around Birmingham and Solihull
Website update for CLL MRD
Minimal residual disease for CLL is performed by flow cytometry within the Cell Markers Lab in Haematology. The procedure for measurement has been reviewed and updated in line with current recommendations1. The new panel provides clearer delineation of CLL populations and is able to exclude other minor B cell populations such as haematogones and plasma cells.
Sample requirements remain the same: either 1-2mls of Bone marrow or 4-5 mls PB in EDTA (although additional sample may be advisable in patients who are leucopenic).
Samples should be received and tested within 48 hours to ensure meaningful results (note that the laboratory is not open at weekends).
Reporting of CLL MRD has also been updated to provide additional information and will include:
A summary statement
A quantitation (%) ONLY if the level is at or above the limit of quantitation
Limit of detection (LOD) The percentage above which CLL cells can be recognised but there are too few to be reliably quantified.
Limit of quantitation (LOQ) The minimum percentage at which CLL cells may be quantified.
LOD and LOQ are calculated for each patient sample.
The procedure has been optimised to achieve an LOD of 0.004% and an LOQ of 0.01%, but this is dependent upon the cellularity of the sample and may therefore be higher (and thus less sensitive).
Rawstron et al
Leukaemia2016 Apr;30(4):929-36. doi: 10.1038/leu.2015.313. Epub 2015 Dec 7
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.
On the 1st October 2018, the current UKAS accredited Blood Group and Antibody screen offered by HGS laboratories will no longer be performed on the Biorad blood grouping analysers. We are currently in the process of validating the replacement Grifols blood grouping analysers. An extension to scope has been submitted for this test to be accredited at our UKAS assessment in October 2018.
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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