Laboratories accredited to ISO 15189:2012 or ISO/IEC 17025:2017 can apply to include COVID-19 testing in their accreditation, using the AC COV form. It is acknowledged that to increase the national testing capacity, it may be necessary for non-clinical laboratories accredited to ISO/IEC 17025:2017 to be utilised. UKAS believes that there are certain circumstances where this may be entirely appropriate to do and this position is confirmed by the UKAS MedLabs Technical Advisory Committee (TAC). The TAC provides technical advice to UKAS on matters relating to the development and operation of the accreditation process. This position statement is to clarify the circumstances under which ISO/IEC 17025:2017 accreditation would be appropriate.
It is crucial for a laboratory not to apply for accreditation to a standard that is clearly not applicable to them. Broadly, for a laboratory to be considered for ISO 15189:2012 accreditation, both of the following statements would be true for the service they provide:
- The testing performed is for the purpose of clinical diagnosis
- Clinical opinion and interpretation on the testing is provided by the laboratory
Where both statements do not apply, accreditation to ISO/IEC 17025:2017 is almost certain to be the most appropriate route. In such instances, it is important for laboratories to be able to consider the clinical governance and how the right service is delivered to the right patients. For instance, following production of the result by an ISO/IEC 17025:2017 testing laboratory, there still needs to be consideration for where this is reported to for clinical interpretation and by whom. It is acknowledged that there are many different testing scenarios and an applicant laboratory should speak to their Assessment Manager or the other contacts listed at the end of this document for guidance.
Granting of accreditation
The assessment will naturally focus on fitness for purpose of the assay but also what happens with the reporting of the test results and how they are handled. This is particularly important for applications that fall under ISO/IEC 17025:2017, as referred to above. To reflect the service provided, it may be necessary for UKAS to be very clear on the schedule of accreditation regarding what the limitations of the testing service are and the specific purpose of the testing.
As with any assessment, laboratories will be provided with an Assessment Report and Improvement Action Report after the assessment and be provided with timescales for clearance of the findings. UKAS will have dedicated resource available to review evidence submitted to clear findings to progress the extension to scope further as quickly as possible.