The South East Scotland Genetics service recently submitted an Extension to Scope moving areas of the Genetics Laboratory to Flexible Scope; this decision was based on a the June 2023 Technical Bulletin from UKAS: https://www.ukas.com/resources/technical-bulletins/genomic-testing-services-flexible-scope/
Due to the size of the information stored in our Flexible Scope documentation, we are unable to share it on the website. Information on the current list of tests accredited under Flexible Scope can be shared with our Service Users, if requested. If you have any questions about the Flexible Scope, please contact us using the information above.
Accreditation is the independent evaluation of conformity assessment bodies against recognised standards to carry out specific activities to ensure their impartiality and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in the calibration and test results, inspection reports and certifications provided. United Kingdom Accreditation Service (UKAS) is the National Accreditation Body for the United Kingdom. UKAS is appointed by government, to assess and accredit organisations that provide services including certification, testing, inspection and calibration.
When applying for Accreditation, Organisations can request “Fixed” or “Flexible” Scopes. A Fixed Scope would be more applicable for Medical Laboratories whose Test Repertoire (known as a Schedule of Accreditation) does not change that often. While a Flexible Scope would be more applicable for Medical Laboratories whose Test Repertoire is frequently updated. To be granted a Flexible Scope, there are additional, specific processes and competencies to be implemented by the laboratory and these are assessed by UKAS. But it must be stated that one type of Accreditation is not superior to the other (i.e. Flexible is not superior, or inferior, to Fixed Scope).
NHS Lothian do not state on Reports that a Result comes from a Fixed Scope or a Flexible Scope; we simple comment if it is not an accredited test (as per UKAS Policy GEN 6). Our Boundaries for our Flexible Scopes are documented on our UKAS Schedule of Accreditation, which can be found on the UKAS Website:
- Genetic (UKAS no. 8413) Flexible Scope boundary:
- ETS Submitted and UKAS assessment of Flexible Scope on-going (assessment due to end 28th of June 2024)