An audit by the MHRA had found serious deficiencies in the validation of the BT element of the Pathology Lab Information Management System (LIMS) at West Suffolk Hospital.
THC was asked to provide the facility for acceptance of validation by the MHRA
The MHRA were deciding whether or not to implement an immediate "Cease and Desist" order on Blood Transfusion in West Suffolk Hospital.
This would have prevented the issue of blood products at the site, with its attendant knock-on impacts on ED, Maternity, and routine procedures. The potential for closure of the complete hospital was identified as a very real and pressing risk.
As it was, the MHRA produced a remedial action plan, with stringent requirements on actions and timescales. The "Cease and Desist" would be imposed if the action plan was not adhered to.
An immediate gap analysis was completed, comparing what was available with what the MHRA required. This meant becoming very familiar in pressing timescales with the MHRA requirements and reconciling that with how they had been interpreted by West Suffolk.
A presentation was made to the stakeholders detailing the new requirements, a plan for delivery, and some alternative resourcing solutions. A Validation Master Plan (VMP) was designed and implemented. This provided the basis of the work to construct a User Requirement Specification (URS) document. This was reviewed and the build documentation compared.
A risk-based approach to the validation requirements was performed and a well-defined scope of validation and testing presented to the BT Lab and Trust board.
West Suffolk initially tried to resource delivery themselves, and THC managed this until the failings inherent in that approach, exacerbated by the shortage of staff became evident. At that point THC supplied resource to complete the work. This included completing new system tests (1,100hrs), collating the results and ultimately presenting them in the Validation Summary Report (VSR) to the MHRA and Trust Board.
The Value Added by Trans Health Co
West Suffolk passed the MHRA audit with no defects.
THC left West Suffolk with a cadre of trained staff so that as their system is maintained, updated and improved, the validation requirements should be continued.
The Lessons Learned
i) Always keep the User Requirement Specification (URS) Document, up to date.
ii) Store all validation evidence collected through testing on the local Quality Management
iii) Follow latest guidance from MHRA and use GaMP5 recommended process for validation (use V-Model)
iv) Resource the requirement internally, with discipline specific Subject Matter Experts (SME)