Reference 2019-166

REF:           2019-166

Subject:       Laboratory Information Management System (LIMS)

 

Request:

Under the freedom of information act please could you answer the following questions around your Trust’s LIMS (Laboratory Information Management System)

  • Do you have a full User Requirement Specification (URS) within your LIMS service?
  • Do you have a full (requirements) traceability matrix (RTM) to drive validation for LIMS
  • Do you have full validation evidence ready for review and fully referenced on your local QMS for LIMS?
  • Which LIMS is in use?
  • When was it last upgraded?
  • When was the URS last reviewed?
  • When did the MHRA last inspect the lab?
  • How much notice did MHRA provide before this inspection?
  • Would you benefit from a review of evidence to assess the transfusion labs “readiness for inspection”?

 

 

Response:

Do you have a full User Requirement Specification (URS) within your LIMS service? No
Do you have a full (requirements) traceability matrix (RTM) to drive validation for LIMS? No
Do you have full validation evidence ready for review and fully referenced on your local QMS for LIMS? Individual departments document their validation of new versions of the software. All in adherence with UKAS
Which LIMS is in use? LabCentre
When was it last upgraded? January 2018
When was the URS last reviewed? N/A
When did the MHRA last inspect the lab? The blood transfusion laboratory has never been inspected by the MHRA. We submit a compliance report annually in April; the analysis of the report by the MHRA would then trigger an inspection under the regulations. To date, our compliance report has always been deemed satisfactory, with no requirement for an inspection.
How much notice did MHRA provide before this inspection? N/A
Would you benefit from a review of evidence to assess the transfusion labs “readiness for inspection”? Our LIMS validation was inspected by UKAS last year & deemed to be acceptable at that point. We therefore do not require a review currently.