Analytical tests which are not in the accredited scope of ISO 15189:2022
The Clinical Biochemistry Department is a UKAS accredited medical laboratory (8202).
Please see below the tests which are not accredited.
All other tests are under the accredited scope of ISO 15189:2022 which can be found on the UKAS website. Please use the following link to take you directly to our scope:
www.ukas.com/download-schedule/8202/Medical/
The tests that are non-accredited have undergone rigorous in-house verification testing and clinical oversight to ensure they are safe to be offered as a test.
Due to changes of the Core Automation equipment, all tests performed on these analysers are currently out of scope.
An assessment has taken place in June to place these tests back on scope. We are waiting for UKAS to formally agree and add the methods/analysers onto our scope.
Other tests in the department that have gone for Extension to scope are:
Screening: Newborn screening by Mass Spec (due to the recent nationwide change)
Screening JR Immunosuppressants (Cyclosporin A, Tacrolimus, Sirolimus) (due to analyser change)
Manual JR Urine 5HIAA
Manual JR Urine Metadrenalines
Tests currently not accredited:
Core Laboratory All sites
Manual JR Urine dipstick for bilirubin and urobilinogen
Manual JR Calprotectin
Screening JR Citrulline
Point of Care All sites All Point of Care
Screening: Newborn screening by Mass Spec (due to the recent nationwide change)
Screening JR Immunosuppressants (Cyclosporin A, Tacrolimus, Sirolimus) (due to analyser change)
Manual JR Urine 5HIAA
Manual JR Urine Metadrenalines
