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Joint statement by UKAS and ARHAI on the use of unaccredited microbiological test results

Statement by Antimicrobial Resistance and Healthcare Associated Infection (ARHAI) Scotland

We are aware of concerns in relation to the use of non-UKAS accredited test methods for water testing and environmental swabbing to detect target organisms of interest which are outwith a laboratory’s scope of accreditation. Hesitancy to use non-accredited test methods has hindered investigation of incidents and outbreaks.

There will always be new and emerging organisms causing outbreaks, for which there will not yet be established or accredited methods but where microbiology testing laboratories play a vital role in elucidating the source of infection.

The lack of UKAS accreditation for a specific test does not preclude laboratories from processing these samples. There is significant risk to patients if sources during outbreaks are not detected and mitigated against. Such specimens can be processed provided the laboratory states on the report that the test is not UKAS accredited.

Scottish diagnostic laboratories who do not undertake water testing should continue to send such samples to an external laboratory with capabilities to do so and discuss their specific requirements.

For diagnostic laboratories undertaking environmental swabbing, samples may be processed using methodology similar to clinical isolates and reports can be issued highlighting that the test is not UKAS accredited.

 

Statement by UKAS

UKAS is the National Accreditation Body for the United Kingdom. We are appointed by government, to assess and accredit organisations that provide services including certification, testing, inspection and calibration.

Our aim is that everything that should be underpinned by accreditation, is. To this end, UKAS has a strong focus on developing assessment approaches for new areas of accreditation in response to our stakeholders’ requirements.

A laboratory’s scope of accreditation is defined in its schedule of accreditation, published on the UKAS website. It is common, however, for laboratories to also provide testing outside their scopes of accreditation; this may be because testing of the sample type or the organism of interest is rarely requested, or because the customer request requires a novel method to be used.  It is recommended that appropriate proficiency testing and internal quality control processes be employed for all testing methods to provide a level of assurance about the competence of the laboratory and the accuracy of the results in the absence of accreditation for specific tests.

Non-accredited testing must be reported as such, in line with UKAS publication GEN 6. Should requests for an unaccredited test method or sample type become frequent, incorporation into the UKAS scope of accreditation is often the natural next step.

UKAS supports innovation and upholds technical excellence through accreditation, however the need to use unaccredited methods to respond in a timely way to specific customer requests is recognised, and the lack of accreditation for required methods should not stifle the laboratory’s overall capability to respond to customer needs.

 

Download this Technical Bulletin as a pdf here