Quality Monitoring Statistical Process Control software

This Prior Information Notice (PIN) is separate to any tender opportunity and not related in any form whatsoever to any subsequent activity that NHSBT may wish to pursue. The purpose of this PIN is to consult the market to improve NHSBT’s knowledge on the status of manufacturer(s) or economic operator(s) that can supply a Statistical Process Control (SPC) Data Management Software System for the recording, statistical analysis, interpretation, and reporting of NHSBT data.<br/>NHSBT needs to gauge market interest in a new provision of this service. It is the intention of NHSBT to further consult and engage with only those manufacturer(s) and economic operator(s) who meet the outline requirements.<br/>he objective of NHS Blood and Transplant (NHSBT) is to save and improve lives with the aim of being the best organisation of our type in the world. A Procurement of a Statistical Process Control (SPC) Data Management Software System is required towards meeting these objectives by maintaining and improving the services provided by NHSBT to patients, donors and customers through improved regulatory compliance, safety, quality, data integrity, data security and workflow efficiency.<br/><br/>We require a Statistical Process Control (SPC) Data Management Software System for the recording, statistical analysis, interpretation, and reporting of NHSBT data.<br/><br/>NHSBT operations are based at a number of locations and the System software and its functionality must be operational on NHSBT servers.<br/><br/>Current NHSBT SPC activities to monitor process specification conformance and trend, and improve, production process capabilities include:<br/>

• blood components and their production methods<br/>
• defect data e.g. number of defects in blood bags<br/>
• laboratory test assays and QC results<br/>
• environmental monitoring e.g. colony counting on agar plates.<br/><br/>NHSBT SPC datasets include a wide range of process data to support process review and root cause analysis:<br/>
• unique process identifiers e.g. donation barcode numbers and test assay barcode numbers<br/>
• process description fields e.g. component type, production centre, equipment serial number, process date, test date<br/>
• process measure fields e.g. volume, pH, haematocrit, colony count, test assay result<br/>
• process calculation fields e.g. calculated fields derived from other fields i.e. Unit Volume x Count per L to calculate Count per Unit<br/><br/>The SPC Data Management Software System must support data entry and reporting to allow both single datum point review and periodic data review. The System must be capable of supporting full automation of data handling including data transfer to and from other NHSBT IT systems.<br/>The Supplier will be validated against the specification criteria prior to the software being accepted for use by NHSBT.<br/><br/>It is NHSBTs’ intention to engage with the market to gather detailed information about the market capabilities. The format for this will be communicated to those that respond to this PIN. Expressions of interest should be e-mailed to [email protected] by no later than 12:00 hours on 19th Oct 2023.