Clinical laboratories are challenged to meet greater testing demands, improve efficiency, and deliver reliable, high-quality results, while facing an increasing shortage of skilled employees1 and growing budget constraints. Recognizing that technology can play a critical role in addressing each of these challenges, Siemens Healthineers brought to market the Atellica® Solution2 immunoassay and clinical chemistry analyzers for in vitro diagnostic testing. Six early adopters of the Atellica Solution recently reported their respective workflow and performance studies, each of which validate the solution’s ambitious commitments to transform operational efficiency and enhance clinical performance.3 Their results, in each instance, exceeded key performance indicators that affect workflow—including turnaround time, throughput, operator hands-on time with system maintenance and quality control, as well as assay performance.
Significantly Reduced Time for System Maintenance and Quality Control Protocols
The Atellica Solution addresses staffing challenges with innovative features such as automated quality control and calibration, a sophisticated vision system, and intelligent sample management and test scheduling. Tied together by a unique bidirectional magnetic sample transport technology, the features work together and condense the workload for highly skilled operators to help refocus their attention elsewhere in the lab. Less hands-on time for routine tasks maximizes existing resources and reduces the need for additional operators as laboratory operations grow.
Utilizing the onboard maintenance and quality control capabilities, Hospital Clinic Barcelona and LBM Bioesterel of France delivered their typical high-volume throughputs with 60 percent and 73 percent less hands-on time respectively, and staff productivity improvements of 13 percent and 21 percent respectively. Access Medical Labs in Florida, USA experienced similar results, reducing hands-on time from an average of one hour to less than 10 minutes per day.
“The time a technologist needs to keep a system working is very important, and it consumes many hours per day. Tasks such as maintenance, QC and calibration, and reagent loading require a lot of time,” said Dr. José Luis Bedini, Head of the Core Lab Operative Area at Hospital Clínic de Barcelona. “We are always facing challenges to design and develop new tests that we can offer to our patients and to our clinicians. The only way to do this is to relocate resources from the routine lab to the specialist lab, which we are expecting to achieve with the Atellica Solution.”
Shorter Turnaround Times for Improved Patient Care
In a study with more than 300 physicians and lab directors, more than 60 percent of respondents reported that fast turnaround time for IVD testing results has high value to physicians4, as the results aid in more than 70 percent of clinical decisions—decisions that can better guide treatments and interventions, reduce the length of hospital stays, and improve patient care.
Institutional protocols contribute to turnaround time, but ultimately the speed at which labs deliver results is determined by the time it takes to process a test. There are times when some assays need to have longer incubation times for optimized performance. Prior to the Atellica Solution, the type of test and mix of tests could impact an analyzer’s entire throughput and capacity to produce results in a given time.
To address this challenge, some laboratories designate analyzers and staff to accommodate those assays that require extended analytical times, or STAT assays that need to be processed as quickly as possible. The Atellica Solution eliminates the need for dedicated specialty analyzers making the entire process—including workflow—more efficient.
“With the management of STAT and routine tubes on the Atellica Solution … the turnaround times for an emergency greatly exceed our expectations. The management of routine samples is not impacted, with a turnaround time that is very much lower than what we provide currently,” reported Dr. Malik Jlaiel, Associate Director of LBM Bioesterel in France.
Independent sample management capabilities, bi-directional Atellica Magline® Transport technology, and dual-ring incubation are helping laboratories to achieve turnaround times from 22 to 53 percent quicker.5
“Atellica Solution is able to provide significantly shorter turnaround times, and this facilitates the treatment and appropriate care of patients, compared with the previous situation,” said Dr. Antonio Buño Soto, Head of Laboratory Medicine Department at Hospital Universitario La Paz, one of the largest in Madrid.
Modernizing Workflow with Sample Integration to Transform Care Delivery
About half of physicians and internists surveyed agreed that investments in lab technology would be very impactful on improving patient outcomes.4 The ability to load STAT samples on the Atellica Solution alongside routine samples—without affecting turnaround time of either test—is a paradigm shift for laboratories that currently operate with dedicated analyzers or dedicated STAT labs adjacent to the emergency rooms.
Such is the case at Hospital La Paz Laboratory. “With the Atellica Solution we have a solution that permits the true prioritization of urgent samples, even when one is processing and analyzing routine samples, and this will facilitate new forms of organization in labs. We could do away with the need to have independent equipment for STAT tests,” Dr. Buño Soto added. Eliminating STAT labs means freeing valuable staff time and floor space for other specialized testing or greater testing capacity.
Similar results were achieved at Hospital Clinic de Barcelona. “Now we have dedicated analyzers for STATs, but in the future we will just have the Atellica Solution,” said Dr. Bedini. “The whole organization of the lab will change as we’ll be using the same systems for both routine and STAT at the same time. The clinicians need results as soon as possible to care for patients, especially those that have very critical conditions.”
The number of analyzers required to achieve the same throughput and turnaround time as current systems was reduced by 33 percent with the Atellica Solution.5 This reduction means acquisition and operational costs of additional analyzers are eliminated and fewer technicians are needed to maintain the instruments.
Strong Assay Performance to Improve Precision Medicine
As laboratories continue to consolidate and utilize both new and existing instruments across their healthcare systems, laboratories must take care that patient results are precise, accurate, and concordant anywhere within the system. These three elements help avoid the need to retest samples.
The six customers’ Atellica Solution studies were conducted using Clinical and Laboratory Standards Institute guidelines to assess the concordance, precision, linearity, and detection capability compared to those reported in the assay’s Instructions for Use. Among the assays assessed for performance at LBM Bioesterel was the Atellica® IM TSH3-Ultra™ Assay for thyroid function, versus the ADVIA Centaur TSH3-UL and Roche ELECSYS TSH assays. The TSH3 assay was selected because it is one of the most common test requests. Biotin interference also was studied.
The Atellica® IM TSH3-Ultra Assay demonstrated a coefficient of variation at or below 6 percent—below those reported in the Instructions for Use—at three control levels. The analytical time-to-result, when compared to the predicate system, decreased by 22 percent. The assay had greater than 99 percent correlation to corresponding ADVIA Centaur® and Roche ELECSYS TSH assays. Further, there was no interference of biotin at up to 500 ng/mL—whereas the competitor assay was significantly impacted by biotin at 500 ng/mL.
“Assuring that our methods have no interferences is absolutely helpful for patient care because we can avoid drawing a second sample, which impacts the time it takes to have a definite or conclusive result in order to assure the correct patient care,” said Dr. Buño Soto.
As labs focus on reducing cost burdens while meeting increasing testing demands, they need solutions that are flexible to adapt as their needs change. The Atellica Solution can address both current challenges and evolve as the laboratory grows. No matter which key performance indicators were of importance, the Atellica Solution delivered.
“I think the results are really excellent from both sides—from the technical evaluations and from the workflow organizational studies. But the most important thing to me has been to see how much my technologists have reacted to the Atellica Solution,” added Dr. Bedini. “Seeing people experience the system for the first time and how they react—this for me also is an excellent result because that means we are going the right direction and that everybody is happy with the new system in the lab.”
The results highlighted in this announcement will be presented during poster presentations at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago, Ill. from July 31 to August 2.
American Society for Clinical Pathology’s 2016-2017 Vacancy Survey of Medical Laboratories
Product availability varies by country.
The outcomes obtained by the Siemens Healthineers customers described here were realized in the customers’ unique settings. Since there is no typical laboratory, and many variables exist, there can be no guarantee that others will achieve the same results.
The Diagnostic Lab: The Hidden Jewel in the Health System https://www.healthcare.siemens.com/magazine/mso-whitepaper-diagnostic-lab.html
Compared to Siemens Healthineers legacy systems.
Siemens Healthineers supported these studies by providing systems, reagents, and protocols and contributed to data analysis.