Accreditation Amendments

Microbiology

Microbiology department UHND are now testing COVID-19 swabs.

However this is not currently part of the department's UKAS scope of accreditation (9341) at this time the test will remain unaccredited but this will not affect the quality or standards of the results produced.

Microbiology in July 2019 voluntarily suspended part of the scope of accredited tests while work is carried out to rebuild the containment level 3 laboratory at UHND. During this time work will be process at the Darlington Pathology site.

During this period, certain tests will not be included in the laboratory's UKAS scope of accreditation (9341). This does not affect the quality or standards of the results produced; it is a temporary state while the department awaits re-assessment at the end of summer.

The accreditation will be reinstated once all UKAS requirements have been demonstrated after the rebuild has been completed. the following test are now off scope for Microbiology:

• Sputum, Broncho-alveolar lavages, Pleural fluids and any other respiratory secretions for C&S.
• RSV testing by lateral flow Immunoassay

Transfusion

The Transfusion Department in October 2019 has voluntarily suspended part of the scope of accredited tests whilst awaiting an Extension to Scope visit from UKAS. This is following the introduction of the new Bio-Rad IH-1000 analysers, Blood Transfusion.

 During this period, certain tests will not be included in the laboratory's UKAS scope of accreditation (8770). This does not affect the quality or standards of the results produced; it is a temporary state while the department awaits re-assessment in May 2020.

 The accreditation will be reinstated once all UKAS requirements have been demonstrated following introduction of the new analysers.

The following tests are now off scope for Blood Transfusion:

• Group and Screens

for further information please contact the Pathology Quality Manager rebecca.sedman@nhs.net