H&Evolve

Dr. Michael Lynch, Pathologist, Ventana Medical Systems, Inc., over 20 years of clinical pathology experience

Dr. Tom Grogan, MD, Pathologist, Ventana Medical Systems, Inc. Founder

Dr. Tom Grogan, MD, Pathologist, Ventana Medical Systems, Inc. Founder

Goal of Study

This study examines the impact of simple lean workflow improvements and implementation of the VENTANA H&E system on productivity at the University of Oklahoma Health Sciences Center

Study Results (at OU)

• 33% improvement in wait times for specimens between process steps (H&E staining to case assembly).
  • Reduction from 1.5 hours to 1 hour wait time (30 minute improvement).
• Process redesign reduced manual steps from 219 to 182 (17% reduction).
• A total of 106 miles of transport distance saved per year (within H&E work cell).
• With the VENTANA H&E system and lean workflow implementation, the H&E work cell has capacity to grow by 32% before exceeding turn-around time threshold.

Conclusion

• Histology labs are facing significant economic and productivity pressures.
• Changes associated with the VENTANA H&E system implementation have created a more robust process that is less susceptible to workload and work variations.
• A single piece flow stainer can help to increase overall productivity of histotechs and improve time to case readiness.
• From the authors of the study:"Introduction of an automated staining system alone has produced some small but significant improvements in productivity, and our projections indicate that these will have a reasonable payback period due to significant cost avoidances in additional labor, equipment, space and liability".
• Discussion of change management with the lab personnel is an important part of the VENTANA H&E system implementation process.

Goal of Study

To determine if the SYMPHONY instrument can improve the detection of prominent nucleoli in foci of prostate cancer.

Issue

• Two main issues exist in the diagnosis of limited cancer on needle biopsy of the prostate:
  • Recognition of limited carcinoma and prevention of false negative diagnosis.
  • Prevention of false positive diagnosis due to lesions mimicking adenocarcinoma.

Study results

• Out of 120 cases of prostatic carcinoma across 6 institutions, the SYMPHONY instrument showed a statistically significantly higher percentage of prominent nucleoli in the malignant tissue than the linear stained sections.
• SYMPHONY instrument showed no statistically significant increase in the percentage of prominent nucleoli in benign prostate tissue.

Goal of Study

To investigate a quality improvement opportunity for Bone Marrow Biopsies at University of Pittsburgh Medical Center.

Issue

Bone marrow slides stained on the Leica linear stainer showed artifacts of focal areas in which the nuclei exhibited a “waxy” homogenization of the chromatin which gave the appearance of pseudonuclear inclusions. This artifact was viewed as a risk in potentially obscuring diagnosis.

Study Parameters

• Serial sections of 119 cases were stained on both the VENTANA H&E system & Leica linear stainer (Leica ST 5010 Autostainer XL).
• Biopsy cores were evaluated for nuclear morphology and color balance on a scale of (1) poor, (2) fair and (3) good.

Study Results

• 37 cases (31%) showed nuclear artifact on the Leica linear staining process
• 0 cases showed nuclear artifact on the VENTANA H&E system
• 72.5% of specimens showed improved morphology when stained on the VENTANA H&E system (99% were equivalent or better) compared to the Leica linear staining process
• 54% of specimens showed improved color balance when stained on the VENTANA H&E system (100% were equivalent or better) relative to the Leica linear staining process

Conclusion

VENTANA H&E system provides superior staining of H&E slides with fewer staining artifacts, better nuclear morphology, and superior color balance when compared to the linear stainer.

Goal of Study

To develop a multi-institutional reference database of extraneous tissue (contaminants) in surgical pathology

Current Issue

• By identifying the sources of cross-contamination, one can then look to mitigate or eliminate the risk
• 275 laboratories were included in the prospective study (321,757 slides)
• 262 laboratories were included in the retrospective study (57,083 slides)

Class of Extraneous Tissue

Source of Extraneous Tissue

Goal of Study

Study sought to quantify and assess the risk for tissue floaters and contaminants in both the water bath (microtomy) and the linear stainer (H&E staining process).

Issue

• The risk of cross-contamination and thus misdiagnosis is prevalent in the staining process. By identifying the sources of cross-contamination, one can then look to mitigate or eliminate the risk.
• Majority of labs erroneously believe the risk of cross-contamination is greater during the microtomy process than the H&E staining process.

Study Results

• 8% of blank slides run through the linear stainer had “floaters” attached to slide.
  • None of the slides stained on the VENTANA H&E system had contaminants.
• Only 1 tissue fragment was found in the water baths.
  • Spun down 195 liters of fluid (13 microtomy stations, 13 different histotechs, ~1700 total blocks, fluid collected at end of shift)
• 696 tissue fragments were found in the stainer baths.
  • Spun down the 27 reagent baths in the linear stainer, avg. of 25.6 contaminants per stainer bath.
  • Majority of contaminants found in the first containers of xylenes and alcohols of the linear stainer.

Conclusion

• In this study, the prevalence of cross-contamination was much higher in the linear H&E staining instrument used than that of the microtomy water baths. Furthermore, in this study the VENTANA H&E system virtually eliminated the risk of cross-contamination (zero "floaters") due to the stainer with its individual slide staining for H&Es.
• Citing very large sample sizes, the study finds an overall cross-contamination rate of 8% in the dip-and-dunk stainer (Leica), compared with no stainer cross- contamination in the comparative study from the VENTANA H&E system. In this study the vast majority of "floaters" occurred in the dip and dunk staining baths, with particularly high rates occurring in the first containers of xylenes and alcohols of the linear stainer. Contamination rates as high as 25% are found during the latter part of the lab workday shift, after reagents have been used for a high number of slides.