Improving turnaround times for trace element screening of hip replacement patients using the CSols Links for LIMS system with a Thermo Scientific X Series ICP-MS Mass Spectrometer linked to a Clinisys WinPath LIMS system
Metal-on-Metal (MoM) hip replacement devices are used extensively to help patients with hip damage caused by arthritis or fracture. Both the ball and socket components can be made of metal. The metal’s durability makes the devices last longer than ones made from other materials while the larger ball is more stable and less likely to dislocate.
However in 2012 following increasing concerns about incidents of pain and inflammation from a small number of patients the UK’s Medical and Healthcare Related Devices Agency (MHRA) issued a Medical Device Alert (MDA/2012/036) advising that screening should be undertaken on all patients with MoM hip replacements. This alert advises clinicians to screen patients to determine whether further investigations are required. This screening step involves the measurement of two of the device’s constituent metals, chromium and cobalt, in whole blood samples. These metal ions are present in wear debris which cause soft tissue necrosis and adversely affect the results of revision surgery. If they are found at concentrations greater than 7 µg/L then further investigations such as imaging are required to determine whether the replacement hip-joint is failing or not.
The Supra-Regional Assay Service laboratories in Guildford routinely carry out a wide range of trace element testing and scaled up their facilities to address the increase in testing resulting from the MHRA alert. Improvements were made not only to the method and equipment used for analysis but also to the result delivery service. CSols Links for LIMS software was used to electronically report results to the WinPath LIMS system to maintain a high service level to all submitting clinicians across the UK. CSols Links for LIMS® software was installed onto a networked laboratory workstation PC that was connected to two Thermo Fisher Scientific X Series ICP-MS instruments running the PlasmaLab® software system.
A uni-directional data connection was used via the Siemens CentraLink™ middleware and associated server which was also supporting clinical analyser connections to the Clinisys WinPath LIS/LIMS system in other parts of Surrey Pathology Services. To enable communication with CentraLink, Links for LIMS was installed with a driver that supported the ASTM 1394 communications protocol and with a software utility that provided a ‘heartbeat’ to maintain an active link with CentraLink at all times.
The Links for LIMS software was configured to read data from a number of elemental assays including the chromium and cobalt assay. The correct LIS/LIMS test codes as well as formatting and rounding settings were stored in the Links for LIMS method. Links for LIMS sample type filtering was used to distinguish unknown samples from IQC (internal quality controls), EQA (external quality assurance control specimens), standards and blanks. Red, Yellow, Green colour flagging was also used to indicate the quality of QC results. In addition to the Links for LIMS configuration, CentraLink was configured to ‘pass through’ all results direct to WinPath and to copy IQC results to the CentraLink Levey-Jennings charting facility. Sample type filtering was also setup in WinPath to correctly reconcile sample results with their correct sample type and laboratory reference ranges for all sample types managed by the laboratory including urine, serum and whole blood.
Data transfer was instigated after importing instrument results into Links for LIMS and both unknown and QC results were transferred to CentraLink and onto Winpath, using a function key in the software. The acquisition and deployment of the CSols software has helped the SAS Trace Element Laboratory to manage a significant increase in sample numbers for cobalt and chromium analysis, which has arisen from the MHRA directive. In 2008/09 the laboratory measured cobalt and chromium in about 100 samples, usually for nutritional reasons, but in 2013/14 the number of requests for this assay had increased to 12,000. The direct transfer of data without time consuming manual transcription has also helped the management of an increase in testing across all of the elements the laboratory routinely measures. It has had the added bonus of reducing the time for analysis , which is one of the key performance indicators used to measure the laboratories efficiency.
About SAS The Guildford SAS laboratory has existed since the foundation of the SAS in 1973 to meet both Health Service and academic needs. Prior to the formation of the SAS the Laboratory was a Regional Centre. The new Guildford Supra-regional Assay Service (SAS) Trace Elements Centre was opened on 30th April 2014. The Centre accommodates the SAS Trace Element Laboratory and the Trace Elements External Quality Assessment Scheme (TEQAS). The SAS Trace Elements Centre is managed as part of Surrey Pathology Services, a collaboration of the Royal Surrey County, Frimley Park and Ashford & St. Peter’s Hospital Trusts.
About CSols Laboratory Informatics Software and Services CSols provide transcription error free software integration solutions for LC MS-MS, GC-MS, ICP-MS, LC or GC instruments and Clinical LIMS systems. CSols powerful laboratory software solutions have been designed to reduce your laboratory costs, turnaround times and transcription errors and to help improve your traceability, analytical performance and ensure quality lab results. We can help guide you ‘Beyond the Technology’ that you are using in your laboratory today to provide you with solutions that will streamline your lab procedures, reduce your analyst’s administration burden and help you meet your improvement goals. CSols software application packages are being used routinely in many laboratories across the world.
Major CSols Hospital Customers Central Manchester NHS Trust (Manchester Royal Infirmary MRI), Falun Hospital, Galway University Hospitals, Heart of England NHS Trust (Heartlands), Homerton University Hospital, Imperial College Healthcare (Charing Cross Hospital), Leeds Teaching Hospitals NHS Trust (St. James Hospital), Lund University Hospital, & Northumbria Healthcare (Wansbeck General Hospital).
Links for LIMS is not limited to running the applications that are described above and can be used for many other LC-MS/MS applications, with other vendor instruments and with a range of different LIMS systems. For a copy of an article describing the solution above, for further information about another instrument application or for a demonstration please ask via our enquiry page or call or email us at: firstname.lastname@example.org.
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