Consolidation has been the name of the game in recent years in U.S. hospitals and health systems, with healthcare networks becoming ever larger and geographically dispersed. As health systems grow, standardizing laboratory practice across all sites is not merely a matter of efficiency, but also holds significance for patient satisfaction, quality of care, and overall clinical operations. As system director of chemistry, toxicology, and point-of-care testing overseeing these functions in seven hospitals and 80 clinics for the Geisinger Health System in central Pennsylvania, I deal every day with the triumphs and challenges of standardization.
In healthcare networks, patients typically receive care across the network and expect uniform laboratory services throughout. Any differences in testing requirements or process based on location (registration, billing, patient preparation, collection process) create confusion for patients and for providers who may instruct their patients on what to expect.
As an example, glucose tolerance testing should require fasting the same number of hours and consuming the same amount of glucose drink, and samples should be monitored and collected the same way regardless of testing location.
Common Instruments, Methods
Providers absolutely need testing standardization to interpret results properly and to adopt clinical protocols. To illustrate, the reference intervals for free T4 and thyroid stimulating hormone (TSH) tests—the bedrocks of thyroid disease monitoring—will vary if different laboratories within the healthcare enterprise use different methodologies. Seeing different results can be very confusing to providers who don’t always pay attention to small differences in reference intervals or who may be trending results numerically from one methodology to another. This confusion potentially results in misinterpreted lab results.
We have faced this issue at Geisinger and are in the process of standardizing our instrumentation for TSH and free T4 testing as leases expire or analyzers near the end of their lifecycles. This year, I am overseeing the installation of standardized instruments at two sites. So when it comes to testing these two analytes, I see light at the end of the tunnel (until another new site comes along).
As another example of methodology-induced confusion, cardiac troponin (cTn) cutoffs (99th percentile) are method-dependent. There also are multiple types of cTn assays: I versus T and new high-sensitivity versus contemporary. When hospital labs offer different cTn assays misdiagnosis is a distinct possibility, especially in crowded emergency departments (ED) with providers who practice at multiple hospitals in the same system. Patient transfers among facilities add to test interpretation challenges.
At Geisinger, cTn results can’t be trended together in our electronic health record (EHR) unless they have been measured by the same method, but this still sometimes confuses providers, especially those who cover multiple sites. We are in the process of implementing the same high-sensitivity¬ cTn assay throughout the system.
Standardization also benefits labs through improved quality and efficiency and reduced redundancy and errors. When all sites use the same methodology and instrumentation to perform testing, they are able to share the same testing policies, procedures, and best practices. Cross-lab standardization also streamlines the EHR-laboratory information system electronic build for each test, where interface, test code, procedure name, reference interval, critical values, results, comments, etc., all are set up the same way, regardless of performing location.
Similarly, quality management, including quality control (QC) management, quality matrix dashboard, middleware rules for autofiling results, and result flags management, can be applied across the enterprise, streamlining operating efficiency and ensuring consistent system-wide quality and service.
Unifying Lab Operations
Although implementing uniform testing platforms is an important aspect of standardization, unifying clinical laboratory operations sometimes is much more complex. While we strive for standardization across our laboratories at Geisinger, the differences in testing volumes, hospital and clinic sizes, level of services, site-specific clinical needs, and provider mix may mandate site-specific workflow and needs.
As an example, a location with a low volume of tests is unlikely to require the same frequency of QC monitoring as high-volume sites. Likewise, an ED physically close to the lab and with few critically ill patients may not need point-of-care testing for basic chemistry or blood gas measurements.
As health systems continue to grow, lab standardization will remain a work in progress through phases of developing and sharing best practices and learning and working together as one unified laboratory. For example, a newly acquired hospital may not immediately (or always) adopt practices in place throughout the healthcare system.
The long road to standardization also provides opportunities along the way to reengineer processes to make them better. A virtue of combining knowledge from different practices and experiences at all hospitals and clinics is that together a better process can be developed to enhance patient service. Accomplishing this unified lab model depends on a realigned management structure, with buy-in from local laboratory directors and managers.
In our experiences, system laboratory directors who specialize in different laboratory areas (e.g., chemistry, blood bank, microbiology) are essential in providing unified direction and ensuring that all local management teams align with the standardized approach.
Labs have the opportunity to lead by example in system-wide standardization, but the concept has to be embraced in other clinical departments as well. Otherwise, a standardized laboratory approach will only go so far in ensuring all patients have the same access and care at all locations.
Elsie Yu, PhD, DABCC, FACB, is system director of chemistry, toxicology, and point-of-care testing at Geisinger Health System in Danville, Pennsylvania. Email: [email protected]