The Dako Autostainer Link 48 System at the University of Rochester

Transcription

1 Improving Workflow and Efficiency Case Study Series The Dako Autostainer Link 48 System at the University of Rochester Institution Strong Memorial Hospital University of Rochester Rochester, NY Contacts David Hicks, M.D. Director of Surgical Pathology Strong Memorial Hospital Loralee McMahon, HTL (ASCP) Immunohistochemistry Supervisor Department of Surgical Pathology Strong Memorial Hospital 11-DAK-105_Dako_Rochester Case Study_r6.indd 1 12/9/ :46:51 AM

2 Based on our experience with the new Dako Autostainer Link 48, we are convinced this system gives us the affordability, speed and ease-of-use we need. David Hicks, M.D., Director of Surgical Pathology 11-DAK-105_Dako_Rochester Case Study_r6.indd 2 12/9/ :47:47 AM

3 Improving IHC Workflow and Turnaround Introduction The Immunohistochemistry Laboratory at the University of Rochester is a highly sophisticated facility that processes a broad range of specialized samples for research as well as a full gamut of conventional samples. In addition, the laboratory staff has hands-on experience with competitive autostaining systems as well as Dako autostaining systems. These factors made the University of Rochester laboratory an ideal site for an initial phase I alpha test of the new Dako Autostainer Link 48 system. Following the alpha study, a phase II beta test of new software developed specifically to enhance efficiency was evaluated. Key Findings The Dako Autostainer Link 48 system with upgraded software outperformed the previous Dako systems. Run time was reduced by 35%. Secondary run rate was reduced by 64%. Hands-on time associated with reagent loading was reduced by 75%. And overtime was reduced by 89%. The accuracy and efficiency of sample tracking and data retrieval were significantly improved. And the quality and consistency of slides produced on the system were at a high level. Background The Immunohistochemistry Laboratory at the University of Rochester processes approximately 3,000 slides each month for research and clinical assays. On a day-to-day basis, the laboratory serves the needs of Strong Memorial Hospital, Golisano Children s Hospital, Highland Hospital, and a variety of research programs. As a result, the laboratory is frequently required to accommodate both STAT cases with real-time patient consequences and novel slide preparations with unique chemistry. On the administrative side, the laboratory is also challenged with increasing volume and the need to work more efficiently with existing staff. Prior experience of laboratory staff reported the limitations of closed protocol systems in accommodating chemistry beyond conventional preparations, particularly in research. Additionally, the staff indicated a need for faster turnaroundtime to better accommodate STAT requests and laboratory volume demands. The Dako Autostainer Link 48 system was chosen for evaluation because of the capacity (48 slides per run), the potential for turnaround improvement, protocol flexibility and prior experience with the high quality and consistency of Dako Autostainer slides. The initial three units of the Dako Autostainer Link 48 system were introduced into the laboratory as an alpha test on June 30, 2009 and an additional unit was added on March 10, Installation of the initial three Autostainer units was performed in one day. In June 2010, a major software upgrade was performed in less than one hour. Four primary users of the system were initially trained over the course of one week and received one day of additional training after the software upgrade. A beta test evaluating the software upgrade was conducted between June 14, 2010 and June 22, Objectives The primary objectives the University of Rochester laboratory sought to achieve with the Dako Autostainer Link 48 system and upgraded software included the following: Improved workflow Improved turnaround-time Increased process standardization Increased productivity of laboratory staff Reduced overtime Methodology The test of the Dako Autostainer Link 48 system consisted of two phases. Phase I was comprised of the formal alpha test in Phase II consisted of a retrospective analysis of system performance in day-to-day operation in the laboratory with the upgraded software.

4 Phase I Results Concordance A variety of slides with substantial complexity were run on the system and compared with control slides to assess the quality of output, expressed as concordance with the associated control slides. The results of this test are as follows: Total number of slides stained: 129 Total number of concordant slides: 125 Percentage of concordant slides: 96.9% Run Time Several runs were performed with a full set of slides (48) comparing run times with the original software running on the new system and run times with the upgraded software running on the new system. The original software running on the new system provided run times approximately equivalent to the previous Dako Autostainer system. The new software significantly improved run times. Specific results are demonstrated in Table 1 below. Note: Non-concordant slides were designated as such because the staining intensity was too weak. Table 1. Run Times: Original Software Compared With Upgraded Software (minutes) Run No Average DL 3.0 a Run Time 5:29:28 4:44:14 5:20:45 5:50:12, 6:40:00 5:27:53 4:29:45 3:35:07 5:06:45 DL A8 b Run Time 3:11:25 4:01:34 3:29:22 2:27:50, 3:59:57 2:47:19 3:00:24 2:55:20 3:20:46 Difference -2:18:03-0:42:40-1:51:23 Average Run Time Savings: 35% -3:22:22, -2:40:03-2:40:34-1:29:21-0:39:47 1:45:59 a Original software b Upgraded software DL = Dako Link Software Notes: Each slide run was based on 48 slides. Runs 1, 2 and 7 were excluded because they did not meet run size criteria. Double run times in run 6 were due to chromogen addition. The Dako Autostainer has made us all more productive. Everything is easy, fast, and very efficient. Loralee McMahon, Immunohistochemistry Supervisor

5 Phase II Results Secondary Runs When slides cannot be completed with the initial run, they must be put on a later run. This can be due to a number of factors, including insufficient reagent(s) required for that slide, and repeats and/or last minute slides added to the workload. Because reagents can be added at the beginning of runs and zero-out reagent bottles can be replenished mid-run, the Autostainer Link 48 system substantially reduces the need to repeat slides. The zeroout function in combination with the shorter run times reduces the secondary run rate substantially. Table 2 shows actual performance comparing secondary run rates in 2008, before the new Dako system was installed, and those run in 2010, when the new system with updated software was in full operation in the laboratory. Table 2. Secondary Run Rates for 2008 and 2010 Month Monthly Repeats by Year Jan Feb Mar Apr May Jun Jul Aug Sep 61 8 Oct Nov Dec Total Total Secondary Run Rate Reduction: 64% Reagent Mapping Original Software With the original software, after the laboratory technician loaded the barcoded samples, the system would analyze the samples and provide a reagent map indicating the precise position each reagent needed to occupy in the rack. The reagents would then be loaded by hand in the exact position indicated by the printed map. To allow runs to begin promptly the next morning, laboratory technicians would typically prepare the racks the previous afternoon. When last-minute samples were added to the run, a new reagent map would have to be generated, reagents rearranged, and new ones added in the new positions indicated on the map. The frequent addition of last-minute samples combined with the time-consuming reagent mapping process often triggered the need for overtime to complete the racks. Upgraded Software With the new software, mapping is no longer necessary. The barcoded samples are loaded on the Autostainer system, the system prints out a list of required reagents, and the laboratory technician loads those reagents on the rack in any order. Since both the samples and the reagents are barcoded, the system will automatically select the proper reagent(s) for each sample no matter where it is in the rack. This not only saves time, it also removes an opportunity for human error. In addition, it allows the laboratory technicians to load the basic reagents onto the rack the day before and store the partially loaded rack in the refrigerator. A final reagent list can be generated in the morning when all of the samples have been loaded and the remaining reagents can quickly be added to the rack. Table 3 indicates that eliminating reagent mapping reduced the time to assemble reagent racks by 75%. Table 3. Time Savings Associated With the Elimination of Reagent Mapping Software Version DL 3.0 w/ Reagent Mapping DL A8 w/o Reagent Mapping Approximate Time to Assemble Reagent Racks Per Instrument All Four Instruments 10 min. 40 min. 2.5 min. 10 min. Difference 7.5 min 30 min. Total Time Savings: 75% * Note: This example assumes that each reagent rack would be loaded only once. As discussed above, in day-to-day operation, each rack would typically be remapped and reloaded multiple times, with a corresponding greater time differential.

6 Overtime As a result of the substantially reduced run time and the elimination of reagent mapping, the laboratory is better equipped to manage special slides and last-minute STAT requests. For example, with run time reduced from a little over five hours to approximately three hours, the laboratory is able to perform two full runs with each Autostainer every day rather than a single run. This essentially establishes two cut-off times per day rather than one. This means that STAT requests that come in after the morning cut-off time can still be accommodated the same day on the second run. This allows the laboratory staff to substantially increase throughput while eliminating a significant amount of overtime as reported in Table 4. On this system, we can successfully run novel antibodies that have not previously been used. The Dako system gives us excellent flexibility. David Hicks, M.D., Director of Surgical Pathology Table 4. Overtime Savings Associated with Upgraded Software 5 Month Comparison* Software Version Total Overtime Hours 2010 Feb-Jun Original (3.0) Feb-Jun Upgraded (3.1.1) 10.4 Difference 85.1 Total Overtime Savings: 85.1 hours Reduction in Overtime: 89%** *Comparison from installation to data collection in June. **Over same time period from previous year. Flexibility Laboratory personnel found that the new Dako Autostainer Link 48 system with upgraded software gave them virtually unlimited freedom to run unusual samples with novel reagents and antibodies from any source and to modify parameters as necessary. Those who had worked with the previous Dako systems reported that the new Dako Autostainer Link 48 system provided a high level of flexibility. Conclusions The new Dako Autostainer Link 48 system with the original software was compared with the same system after a major software upgrade. The new system with upgraded software outperformed the same system with the original software on every criterion measured, including run time, secondary run rates, hands-on time, and overtime. The system met or exceeded every objective set by the University of Rochester and delivered benefits beyond those that were expected. In addition, the system demonstrated a degree of flexibility, affordability and ease-of-use.

7 With the Dako Autostainer Link 48, we can be sure that every sample will be run in exactly the same way with exactly the same reagents every time. And we can go back at any time and find out exactly how each sample was treated from initial capture to final report. That s huge. Loralee McMahon, Immunohistochemistry Supervisor

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