In multisite healthcare organizations, a patient might present for testing at different laboratory sites during a single healthcare episode or between healthcare visits, healthcare providers might practice at multiple locations, and individual laboratory sites might require operational backup. For each of these scenarios, laboratory results are expected to be sufficiently comparable to ensure optimal care. Multi-analyzer, multisite validation to ensure comparable patient results is not only a good laboratory practice, but also a regulatory requirement.
Thorough planning, well-documented validation protocols, a multidisciplinary team effort, and detailed communications to all stakeholders will keep a complex multisite multi-analyzer validation on track. Here, we describe the approach we took in planning the validation of three automated platforms across five Ontario sites at LifeLabs, the largest community laboratory in Canada. Our validation at two large central sites each with 15,000 to 20,000 daily test volume and three regional sites each with 1,000 to 6,000 daily test volume included 23 analyzers covering 45 assays from a single chemistry platform, and 28 analyzers covering 27 assays across two immunoassay platforms. We also validated two automation lines at two central laboratories.
The Protocol
A documented validation protocol outlines the planned validation studies, and we advise having a single validation protocol for each platform that is to be validated. The protocol should be comprehensive and specific, including detailed step-by-step procedures for each study. This eliminates variability in how the studies are performed and allows for adequate comparisons across the sites. The protocol should include defined acceptance criteria for each study, as decided by the lab director. We also recommend that each protocol be discussed and formally approved by internal stakeholders at each site, since large scope validation studies come with a significant resource commitment and substantial cost. In our experience it also helps to share validation protocols with vendors to make them aware if the validation acceptance criteria are different from vendor-stated ones and to ensure easier, faster troubleshooting.
As part of our validation protocol, we also decided which assays to validate at which sites and on which analyzers—this is sometimes referred to as “assay mapping.” Some important considerations for assay mapping include testing volume and required turnaround time for the test, specimen stability, and potential for sample and reagent carryover.
The Team
Our core validation team members included staff who perform the studies, and those who manage the data, review, and approve results. We gained from the knowledge and experience of some team members who work at a single site and others who perform duties at several sites, such as clinical biochemists and IT specialists. The complexity of implementing many analyzers at multiple sites also requires significant involvement from other teams, like facilities, procurement, automation specialists, and vendors. We found it particularly helpful to designate a project manager who had insights into the operations at all locations and who knew our validation and implementation requirements. This individual planned the project timelines, ensured team communications and the pace of validation and, in a way, kept the whole team accountable throughout the validation.
Using a staggered validation approach, in which one site performs valid ation prior to another site, reduces the number of staff required for validation at any one time and puts less stress on laboratory operations overall. This strategy also enabled us to promptly discover and mitigate issues before we moved on to validations at other sites. To ensure the entire project has adequate resources, we suggest identifying key operators for each platform and group of analyzers. The in-depth training they receive from vendors can be leveraged for internal training of the remaining operators at all sites.
Validation Samples and Data Management
We advise labs to start collecting validation samples early—including patient samples, proficiency testing materials, reference materials, and spiking materials—that will be needed based on each validation protocol. Plan sufficient sample volumes for the number of analyzers to be validated and studies to be completed. Sample concentrations should cover the analytical measurement range. Aliquots might need to be prepared, stored, and transported between sites while preserving sample stability. Since there could be several dozen assays and several analyzers validated simultaneously, we recommend using inventory spreadsheets to log available samples and concentrations for each assay.
Data management can be a big validation bottleneck. In multi-analyzer validations, there could be thousands of data points from a single validation study, so labs should plan to automate data management as much as possible. For example, data can be exported from analyzers into validation spreadsheets in .csv files. We also recommend that labs take advantage of statistical software packages like Excel with Analyse-it, EP Evaluator, and R.
Communication
Communication matters with any validation, but even more so when multiple sites are involved. In addition to daily or weekly touch-point meetings, we used validation progress spreadsheets to show visually where sites were in process, assigning colors to validation steps—for example, study in progress (yellow); study completed (green); follow-up needed (red); etc. In addition, we sent automatic emails to inform all team members each time a validation stage changed. This enabled prompt engagement of the accountable team members at each validation stage.
These activities, although requiring considerable time and effort, allow for a well-coordinated and successful multisite multi-analyzer validation. This enables adequate assessment of test result comparability, ensuring standardized, high-quality patient care across all sites of the organization.
Danijela Konforte, PhD, FCACB, and Kika Veljkovic, PhD, FCACB, are clinical biochemists at LifeLabs Medical Laboratory Services in Toronto, Ontario, Canada. +Email: [email protected]; [email protected]