Achieving Automation in Serology: A New Frontier in Best Practices
provided to Larry H. Bernstein, MD, FCAP by Susan Hayes, Editor, and President of LabSim, Inc.
Achieving Automation in Serology: A New Frontier in Best Practices
Ferdinand Vlaspolder, MD, PhD, and Patricia Glasius, Ing
Laboratory for Medical Microbiology
Medical Center Alkmaar (MCA), Alkmaar (MCA), Netherlands
Published in the Dark Report
Table of Contents
Introduction 3
Chapter 1: Workstation Consolidation 4
Chapter 2: Efficiency 7
Chapter 3: Productivity 10
Chapter 4: Quality 14
Chapter 5: Cost 16
Summary 18
Case Study Background on Serology Lab Automation 19
Appendices
A-1 About The Author 22
A-2 About MCA Alkmaar 23
A-3 About DARK Daily 24
A-4 About The Dark Intelligence Group, Inc., and THE DARK REPORT 25
A-5 About the Executive War College on Laboratory and Pathology Management 26
A-6 About The Editor 27
Terms of Use 28
Introduction
Microbiology, specifically serology, has stubbornly resisted efforts at automation. The reasons are multiple, from lack of space to remote proximity to the main lab, from complexity of procedure to dedicated versus shared FTEs. Serology will always have some level of manual testing involved. The question is how to minimize manual procedures without compromising the quality of results.
The upside is potentially huge; as one of the most labor-intensive areas in the lab, automation offers a way to reduce FTEs that are increasingly in short supply. Concomitantly, it holds the promise of significantly reducing turnaround time and preventing life-threatening errors through sample consolidation; eliminating sample splitting, automating sample handling, and speeding results notification. There is also the advantage of increasing the serology lab’s capacity; as the volume of infectious disease (ID) testing grows, the need to process more samples with reduced resources is becoming acute.
The solution may actually lie within the emerging field of micro-automation, where serology platforms are combined with sophisticated automation systems. It goes beyond front-end sample handling; it requires an elevated level of automation intelligence to merge autonomous characteristics of different platforms into a unified whole.
This white paper will explore the various components of automating a high volume serology lab, detailing a schema for platform consolidation, leading to efficiency, productivity and quality improvements, ultimately driving significant reductions in cost. A specific case study will provide an example of how micro-automation can improve the serology laboratory.
Workstation consolidation is the primary driver behind automation efforts in serology.
1. Workstation Consolidation
The primary impetus behind any automation scenario is the need to consolidate testing platforms. Serology has traditionally been served by Elisa-based micro-titer plate (MTP) manual or semi-automated benchtop systems. With the expansion of ID testing portfolios on mainframe and dedicated immunoassay analyzers, the opportunity to consolidate has improved. The problem is that no one platform has all the requisite tests. In addition, the ability to extend a main lab automation line into serology is often precluded due to lab layout, floor space and proximity considerations. Thus, a piece meal solution has become the norm for most serology labs.
In assessing various platforms for performing ID testing, a side-by-side comparison of menus showed where the opportunities for consolidation are. Among automated immunoanalyzers, the VersaCell® System, which combines the Siemens Centaur® XP and IMMULITE® 2000 XPi, provides the broadest menu, covering 96% of high volume routine serology. The additional 4% of specialty low volume tests are done on MTP platforms such as the Dynex DSX, Biomerieux Vidas. While there are other automated and semi-automated platforms they do not have the same breadth of menu as the VersaCell combo and do not offer the same level of sample handling and results integration.
The VersaCell System is the unique variable. By connecting two high-throughput instruments, the VersaCell System complements the capabilities of each stand-alone system by:
Enhancing efficient sample handling with a single point of entry that minimizes the need for tube sorting and aliquoting
- Automatically prioritizing and managing samples by analyzing the workload and using a robotic arm to intelligently move samples within the system
- Enabling continuous loading and unloading of specimens from a single location through easy-access drawers
- Providing consolidated reports on all the analyzers and samples in the system
- Reporting results directly to the laboratory information system (LIS)
- Using random access technology, with automatic rerun and reflex testing, to help reduce overall turnaround time.
In the specific situation at MCA, traditional platforms including Biomerieux Vidas and the Dynex DSX were offloaded to the Siemens Centaur XP and IMMULITE 2000 XPi with the VersaCell system, essentially merging the two platforms into a single workstation. The Vidas and Dynex remained for specialty low volume tests. In the MCA situation, the consolidation put 96% of all testing on the VersaCell system.
Menu Consolidation:
Improved efficiency is defined as using less input relative to a fixed output Time is one of the key measures of efficiency.
2. Efficiency
Efficiency is driven by reducing the amount of input relative to a fixed output. Therefore, any procedural change that reduces steps taken, whether walking around the lab or setting up a daily run, will directly impact efficiency. The efficiency gains, in turn, reduce the time required to perform the testing, whether it is hands-on time, turnaround time, or time to first result. The implications for MCA were dramatic: The efficiency gains translated to reduced turnaround time and reduced labor.
Turnaround Time (TAT)
Automation reduces the turnaround time required to report results through several areas. In the instance of this study, the TAT decreased to less than 1 day for 96% of the workload. Every request arriving prior to 4:00 PM is now completed same day. Previously, accessions coming in after 1:00 PM would not be done until the following day.
Labor
Automation dramatically reduces labor elements such as sample handling, sample splitting, interventions, and results reporting.
The VersaCell dramatically reduced the labor minutes per reportable. For instance, there was a reduction in hands-on labor from 29 minutes to 13 minutes on the IMMULITE using the VersaCell. Pre-VersaCell daily hands-on labor was 196 minutes for 253 tests. Post-VersaCell daily hands-on labor dropped significantly to 33.2 minutes for 286 tests. This freed up FTEs to focus on other important tasks, such as quality control initiatives and the expansion of capabilities in molecular testing. This can be extrapolated to the Per Reportable level as well, as seen in the following chart, where there is a 43% reduction in the labor minutes per reportable with the VersaCell.
Workflow Mapping
The most obvious impact from automation and workstation consolidation is improved workflow in the serology laboratory. Since serology is often not physically located near the main laboratory, hooking platforms onto the automation line is not practical. However, it is still possible with the VersaCell to automate the workflow within serology.
Workflow mapping can show significant reductions in the number of human steps required to process the workload. This translates to reduced labor and turnaround time (TAT).
Overall, the sum of the parts is less than the whole: While both IMMULITE and Centaur have automation components on their platforms, the VersaCell is more efficient than either of the individual parts working separately. It consolidates front-end sample loading as well as eliminating sample splitting, retrieving samples for add-on/reflex testing, and reporting results.
Improved productivity is defined as increasing output relative to a fixed input, such as labor or resources.
3. Productivity
Technologist Productivity
System productivity is driven by capacity utilization. The greater the available capacity, the greater the ability to increase production.
Laboratory Productivity
Productivity gains are found in increased capacity utilization for testing in the lab. By adding automation, the inherent capacity of each system is able to be maximized both in terms of FTEs and instruments having more capacity. As more tests are able to be processed, a.k.a. produced, overall lab productivity goes up. It is possible for a lab to be more productive without the FTE productivity increasing (i.e. more tests are produced due to increased demand, but the number of techs also increases, so the productivity per tech stays the same). It is also possible for the FTEs to be more productive without the lab productivity increasing (i.e. there are less FTEs but the total volume of testing that the lab produces does not change.)
In the current study, by restructuring the test mix, MCA gained greater testing capacity.
For example, the IMMULITE 2000 XPi system has the potential to accept 65% more work, and the ADVIA Centaur XP platform can do 82% more. With the VersaCell System’s ability to accept up to 200 samples at once on the system, MCA could significantly increase testing capacity. This enables the laboratory to manage anticipated growth in test demand while maintaining existing staff levels
The increased capacity translates to productivity gains which are demonstrated through the 17% increase in billable tests seen post-VersaCell. In addition, the additional capacity is now being translated into increased productivity through the consolidation of serology testing from three other labs which is now being sent to MCA, amounting to 40% increase in lab productivity.
Relative Productivity
The Relative Productivity Index (RPI) is a combination of technologist and laboratory productivity. It is computed as the number of test results divided by the number of technologist hours. The greater the number of tests produced relative to a fixed number of hours, the greater the RPI. In the case of MCA, moving to an automated system translated to a significant gain in the RPI.
Improved quality is driven by reduction in human factors such as sample handling, sample splitting and results notification.
4. Quality
There are many elements that define quality, but several key areas include reproducibility, lack of repeats, and minimized human error rates. The benefits of automation include elimination of repetitive tasks, such as reduced sample splitting and pipetting, and a highly reproducible process, with minimal direct interaction.
Sample Handling
The VersaCell System has a central area for sample processing. Human operators only have to open the sample drawer, load the sample tubes, and close the door. From a LEAN perspective, this has a major impact on non–value added tasks, while significantly reducing the potential for human error. Anyone in the lab can operate the system with no need to dedicate the highest skill level technician for daily routine use. A laboratory supervisor with knowledge of software, adjustment, and troubleshooting is enough to ensure smooth operation of the system.
Sample Splitting
Because the system uses a primary tube, there are fewer errors than with a manual approach. No sample splitting is required eliminating the potential of technicians pipetting a sample into the wrong tube. As a result, there are fewer manual errors with a reduced need to repeat tests; blood draws are kept to a minimum. This minimizes the amount of tubes, labels, and pipettes that need to be purchased.
Turnaround Time
Turnaround time savings also translates into increased quality metrics and physician satisfaction. At MCA, TAT dropped by over 24 hours for over 30% of the tests. The reduced TAT can accelerate patient care pathways, improving patient care.
The VersaCell has the ability to sequester the non-VersaCell samples automatically into a “tailor-made” row in the last drawer. This makes it very easy for the techs to find the 4% of samples that require testing on either the Vidas or DSx.
The ability of the VersaCell to sequester non-VersaCell samples automatically is an additional capability that reduces overall TAT. The techs do not have to search for tubes, tubes do not get missed, and it is much faster than pulling the tubes individually.
5. Cost
The impact of the efficiency, productivity and quality improvements translates to significant savings for the serology lab.
Savings are realized not only in supplies and labor, but in reduced repeats and sendouts. In addition, the improved capacity utilization increases revenue to offset costs.
In the case of MCA, there were a several documented areas of cost saving:
- Annualized labor costs for ID serology testing were reduced by € 15921, based on the Dutch annual technician costs. There was a 71% reduction in labor cost.
While reagent costs were held static, the lab increased its capacity to perform additional testing.
Assuming the same test mix and utilizing the spare capacity could achieve at 65% increase in test volume in an eight hour shift. This increase would yield a cost-savings of €19552, or 0.5 FTE.
The lab utilized this capacity to bring 40% incremental testing in-house though consolidation of three other hospitals.
Total annual cost per reportable is apportioned:
Costs
Supplies 2%
Instrument i%
Labor 11%
Reagents 85%
SUMMARY
The implementation of micro-automation in the serology lab can bring significant improvements in efficiency, productivity, quality and cost to operations. While traditional automation schemes are not practical in most serology lab settings, the combined effect of high volume immunoassay platforms with large ID portfolios in addition to the unique front-end and sample management capabilities of the VersaCell System, enable labs to achieve dramatic improvements in their operations.
Automation delivers predictable and consistent service coupled with a reduction in staff. Walk-away time is increased with the VersaCell, enabling staff to perform other duties.
In the typical menu mix of infectious disease, the VersaCell offers the maximum menu consolidation.
Case Study Background
Medical Center Alkmaar (MCA) is a 900-bed institution in the Netherlands that employs nearly 3,100 people. Its microbiology laboratory serves not only the MCA facility, but also Gemini Hospital, a 300-bed hospital in Den Helder, plus outpatient testing for about 300 local physicians. Each year the lab receives about 40,000 serology samples and runs about 82,000 infectious disease (ID) serology tests on these specimens.
As with most ID testing, MCA traditionally relied on tried-and-true manual methods. Fortunately, new technological developments in methodologies, robotics, and computerization are rapidly advancing in the field of ID serology. Until 2000, MCA’s initial shift to automation depended primarily on its Dynex™ micro-titer plate and Vidas® analyzers, while syphilis tests were processed manually. This approach worked well for nearly a decade, but the need for more technological advancement provided an opportunity.
After recognizing the shortage of highly trained technicians, along with the need to improve efficiency and productivity in the lab, MCA connected an IMMULITE® 2000 XPi System and an ADVIA Centaur® XP Immunoassay System with the VersaCell System and doubled the percentage of ID serology tests run and reported in one day while significantly reducing the number of technicians required to operate the system.
The IMMULITE 2000 XPi and the ADVIA Centaur XP menus best matched the testing needs of the lab. In 2000, MCA acquired an IMMULITE 2000 system, which was upgraded to an IMMULITE 2000 XPi System in 2009 consolidating syphilis, ToRCH, and EBV testing onboard. At the end of 2008, MCA added the ADVIA Centaur XP system to add the full range of hepatitis, HIV, and pregnancy testing.
The VersaCell System, installed in the MCA lab in July 2009, completed the consolidation and automation of processes for the institution’s ID serology testing. The VersaCell system links the ADVIA Centaur XP and the IMMULITE 2000 XPi instruments to form one consolidated ID serology testing system. In an effort to quantify the impact the VersaCell System had on laboratory operations, we conducted Time/Motion studies before the VersaCell System was installed and compared the data to workflow after installation.
Significant improvements were seen in the following areas:
- 96% of the ID serology results reported the same day
- VersaCell consolidates 96% of all samples onboard
- One FTE’s reduction for the ID serology workload
- Reduced manual errors
- More efficient laboratory workflow
- Effective resource utilization
- Improved diagnostic service / patient care to the clinic
- Increased capacity for future growth
Methodology
In order to ensure that a direct comparison was made of activity and other workflow metrics, a standardized protocol was used to collect data on two occasions for 2 days.
Data collection
A standard protocol for data collection was used; the same technical staff and data collector was used. Data was collected on days with representative processing volumes and no account was taken for monthly or unscheduled maintenance. All hands-on labor time to run the work, time taken to process and complete the tests including reruns, reflex, and add-on testing was collected and test numbers were also counted. The same operator collected the timing data across both measuring periods and test numbers were collated from the LIS data sheets and analyzer logs.
Results
The results obtained from the study have been incorporated throughout the white paper as demonstrative of the impact of micro-automation in the serology lab.
A1
Dr. Ferdinand Vlaspolder, MD, PhD, is a Consultant Microbiologist who serves as Head of the Medical Microbiology Laboratory at Medical Center Alkmaar (MCA) in the Netherlands.
Dr. Vlaspolder was born in Rotterdam in1952, where he also received his laboratory training. After military service he studied medicine at the Erasmus University in Rotterdam and became a medical doctor in 1981. Before he started his specialization in medical microbiology at Utrecht in1984 he worked as a public health physician. During this time (1984-1989) he started his scientific work, completing his thesis in 1990. He worked for three years in three hospitals in The Hague as a consultant microbiologist. In 1992 he joined Medical Centre Alkmaar and Gemini hospital in Den Helder.
Dr. Vlaspolder is head of the laboratory for medical microbiology, the department of hygiene and infection control, and the outdoor clinic for travelers. He is published widely on different subjects in medical microbiology.
Patricia Glasius, Ing, is a senior technician in Medical Microbiology Laboratory at Medical Center, Alkmaar, The Netherlands.
We would like to acknowledge Alastair Gammie, PhD, and Dr. Hans IJpelaar of Siemens Healthcare Diagnostics for providing support for the time and motion studies.
A-2
Medical Center Alkmaar (MCA) is a 900-bed institution in the Netherlands that employs nearly 3,100 people. Its microbiology laboratory serves not only the MCA facility, but also Gemini Hospital, a 300-bed hospital in Den Helder, plus outpatient testing for about 300 local physicians. Each year the lab receives about 40,000 serology samples and runs about 82,000 infectious disease (ID) serology tests on these specimens.
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A-6
Sue has over 30 years’ experience in the hospital diagnostics industry, including clinical chemistry, immunochemistry, and plasma proteins. This experience includes hospital, marketing management, health economics, marketing communications and consulting. She has consulted with over 50 clients globally, including Siemens, Dade Behring, J&J, DuPont, and others, and has generated over $17 million in sales for critical health networks.
As president of Labsim, Inc., she leads development of custom software applications for laboratory cost accounting in addition to strategic marketing and marketing communications consulting in the healthcare sector.
She has been cited in articles in Advance, Clinical Research and Management Review, and College of American Pathologists. Her expertise is in laboratory workflow simulation, cost accounting, and decision modeling, leading the development of laboratory simulation software for multiple product lines. She served on the NCCLS Subcommittee on Total Cost Management in the Laboratory. Sue has a BA and MA from the University of North Carolina, Chapel Hill.
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