Nilam Patel, MT (ASCP) SH, is senior product manager, Automation Solutions, Sysmex America Inc, Lincolnshire, Ill. She helps labs of all sizes across North America find lab automation solutions that meet current needs and accommodate expected future needs.

       Every day, hematology laboratories across the United States are ramping up automation levels and implementing results using autovalidation. But despite the benefits—including savings in personnel hours and expense, and speeding the process—according to some estimates, resistance to automation means that as many as 50% of labs still haven’t automated.

       Automation offers big gains to clinical laboratories, because using it means technicians don’t have to touch every sample, creating more efficiency and freeing up techs for other tasks.
       At Mercy Medical Center, Canton, Ohio, automation in the form of integrated lavender top management was warmly embraced. Mary Ann Burich-Boccia, MBA, MT (ASCP) SBB, administrative director, Mercy Laboratory Services, and Barbara Carter, MT (ASCP), laboratory manager, have been advancing the efficiency and value of their department for the past 6 years.

                               Meet Mercy

       Mercy Medical Center, a JCAHO fully-accredited 476-bed hospital operated by the Sisters of Charity Health System, provides centers of excellence in cardiology, emergency services and trauma, cancer, stroke, and vascular care.
       The hospital processes approximately 450 samples/day on the XN-9000 line.
       Its Department of Pathology and Laboratory Medicine achieved ISO 15189? accreditation through the College of American Pathologists based on quality standards outlined by the International Organization for Standardization. Accreditation focuses on improved patient safety and risk reduction, outlining standards for quality and competence particular to medical laboratories.

First line to integrate diabetes testing
       After going LEAN in 2004, Mercy’s lab, in conjunction with its medical director and administration, was looking for opportunities to achieve greater efficiencies. In 2007, the first lavender top management solution was introduced by Sysmex, allowing Mercy to optimize a number of the efficiencies it gained from the LEAN process. This new line would introduce hemoglobin A1c (HbA1c) testing to the hematology lab for the first time and would result in >95% of HbA1c being autovalidated for immediate reporting. Turnaround time for complete blood count (CBC) results improved significantly. Since then, Burich-Boccia says that all lavender top tubes go directly to the hematology line, and that system has been in place for the last 5 years. “When our contract expired and our health system was looking at instrumentation, we could not find a comparable substitute for the line,” she says.

Upgrade keeps up with community demands
       Mercy Medical Center’s laboratory strives to be responsive to the needs of its community, which led it to implement advanced clinical lab diagnostics for conducting on-demand, HbA1c diabetes testing, as well as analysis of important red blood cell, white blood cell, and platelet indices.
       Its newly upgraded line uses two next-generation hematology analyzers, an integrated slide maker/stainer, a new HbA1c analyzer, an integrated tube sorter, and archiver. The new line also has a smaller footprint, fully 29% smaller than the former line. Results’ reporting includes a fluorescent nucleated RBC count with every CBC, and quantitative information on advanced clinical parameters such as immature granulocytes. Parameters to help assess erythropoiesis and thrombopoiesis are also reported. The smaller footprint allows the lab to review placement of other analyzers and relocate other instrumentation for even more efficiencies.

Mercy2Paula Bentley, a medical lab technician at Mercy, performs CBCs using the new system.A Critical Role in Determining Diabetes Control
       The HbA1c unit will continue to provide results 24/7. The latest system uses HPLC (high-performance liquid chromatography) technology—the gold standard for HbA1c testing—to perform HbA1c analysis, which measures the amount of glucose attached to the hemoglobin in the red blood cell and estimates blood glucose control during the previous 3 to 4 months.
       “This platform allows us to offer faster on-demand diabetes testing, improving treatment decisions that impact patient care,” Carter says. “We know that we have a reliable automated hematology solution that has the potential to impact treatment guidelines, care pathways, and patient flow.”   
        It takes Mercy approximately 7 minutes to turn around a CBC on a normal sample that can be autovalidated. “Getting these results out in this time, especially in an emergency room setting, is phenomenal,” Carter says. “With the new instrumentation, the technologists can really focus on the abnormal without delaying the reporting of the normal results. That adds up to better patient care.”

Advanced Parameters:
       In addition, with its new XN 9000 system, Mercy can now perform:

  • NRBCs (fluorescent nucleated red blood cell count) with every CBC
  • IG (Immature granulocyte enumeration) with every differential
  • RET-He (Reticulocyte hemoglobin) as a parameter in the reticulocyte profile
  • IPF (Immature platelet fraction) to aid clinicians in the assessment of thrombocytopenia

       Mercy is working with the vendor’s clinical specialist team to provide education programs for its medical staff and other clinicians. The programs are planned for the fall.

Upgrading to new hematology middleware
       Mercy Medical Center’s middleware system is newly upgraded and is specific for hematology. Carter considers the new rules for manual differentials to be a significant facilitator in managing workflow. Well-defined rules provide maximum results in autovalidation.

IMG 0119Lab technician Paula Bentley processes on-demand, hemoglobin A1c tests using the medical center’s newly upgraded line, which includes two next-generation hematology analyzers.Implementation without interruption
       With all of its experience, Mercy Medical Center’s lab was fortunate to be able to free up space in the lab close to hematology. The line was set up in that area so that validation and training could be performed without interfering with the current processes. Once validations were completed, a coordinated effort was planned to quickly move the new line in place of the old. The lab was able to turn the old analyzers off and begin testing on the new hematology line without disrupting patient testing and turnaround time.
       Like other labs that have been successful with automation and autovalidation, Mercy stresses the need for planning, and having a designated member of the staff to manage this process is the first priority. The lab formed a committed team that included dedicated members from the automation and middleware supplier, along with a project manager who coordinated the entire process from install to go-live. Mercy’s provider was in touch daily and weekly to provide wrap-up reports on what had been learned in the last week. On-site help involved rewriting rules.
       “You need to ensure that you have the resources available and timelines that are realistic,” Carter says. “We found the vendor’s project manager helped to keep everyone accountable and kept the project on track.”
       Another key piece of advice is to include the staff in the process. At Mercy, lab management attributes much of the success of the transition to following that strategy. “If you get them on board early, you are able to achieve great successes,” Burich-Boccia says. At Mercy, technologists ran more than 150 correlation studies and daily QC so they became familiar with the new instruments. Body fluid analysis is still in the validation process for Mercy. This includes comparisons with manual testing and automated testing on both the old and new line. Technologists also helped with writing and testing out the new rule package.
       Medical technologists are dedicated professionals who value very highly the quality of the reports they issue, which is why autovalidation can be uncomfortable for some. Labs need to enable technologists to concentrate on the larger challenges facing the lab, not every single normal result that they get. By proper validation both pre- and post-live, Mercy was able to gain the confidence in the instrument and the autovalidation rules, Burich-Boccia says.

       It’s not hard to imagine what autovalidating 85% of its workload might do for a lab. Mercy Medical Center Laboratory can address well-known challenges such as increasing productivity and efficiency, reducing costs, and improving turnaround time, even though the number of samples it processes has increased.
       In addition, the higher level of integration Mercy achieved preserves its investment while offering future flexibility to scale up. Its software application will remain the same as it grows; only the server changed. The single-source solution has increased efficiency and provided instrumentation and software that were designed to work together, eliminating workarounds and multiple-vendor interface/accountability. A single-source solution also meant a single, accountable support team to help Mercy get up and running at full speed, achieving more productivity gains in months instead of years.
Also, integrated data and standardized differential results are dramatically reducing turnaround times and impacting clinical outcomes, because rules can be configured to automatically validate >80% of hematology tests and >90% of A1 c tests without operator intervention.
       Upgrading and standardizing the lab means the hospital can continue to stay ahead of testing complexities and provide quality HbA1c testing and results on a 24/7 basis, Burich-Boccia says. “This powerful new platform will greatly benefit patients in our community, many of whom suffer from diabetes, and it will contribute to positive patient outcomes,” she says.

Nilam Patel, MT (ASCP) SH, wrote this article on behalf of Mercy Medical Center.