Total lab automation takes teamwork
By Octavia M. Peck-Palmer, PhD, October 2009
Within two miles of each other in western Pennsylvania are the two largest hospitals among those served via the University of Pittsburgh Medical Center (UPMC) system. UPMC Presbyterian, a 997-bed academic hospital, is designated as a Level 1 Regional Trauma Center. UPMC Shadyside is a 517-bed tertiary-care facility. In 2008, Presbyterian and Shadyside clinical chemistry laboratories processed 4.5 million and 1.09 million billable tests, respectively. With test volumes increasing yearly by 8% to 10%, implementing technologies to meet their high-volume 24-hour testing demands was critical. In a concerted effort to standardize laboratory testing and improve patient care, UPMC sought total laboratory automation.
Choosing an automated system
The laboratory leadership employed a multidisciplinary group to evaluate, select, and implement the "best fit" automation system. The Laboratory Automation Group (the Group) included laboratorians (clinical chemists, pathologists, and medical technologists), laboratory information system (LIS) analysts, clinicians, nurses, and representatives from the offices of UPMC's Facilities Management, as well as its Center for Quality Improvement and Innovation.
The overall goal was to improve patient care through accuracy and consistency in laboratory analyses. The strategic goals of the UPMC Automated Testing Laboratories were to:
- install new chemistry and immunochemistry analyzers, and an automated platform with sample management capabilities;
- integrate sample analyses and sample management;
- improve and standardize test turnaround times (TAT), and improve the management of analyses through interactive management software (middleware);
- reduce multiple blood collections and aliquot preparation; pre-analytical, analytical, and post-analytical errors; and operation costs;
- minimize laboratory staff exposure to biohazards associated with sample processing; and
- increase test-volume growth potential.
The Group's first overall task was to identify companies with commercially available laboratory-automation systems capable of satisfying the overall objective. The Laboratory Automation Group was then separated into five teams. While supporting the Group's main objective — improving patient care through accuracy and consistency in lab analyses — each team delineated its specific needs. The Sample Management team sought automation technologies requiring minimal operator intervention for sample acquisition, sample integrity assessment, centrifugation, aliquoting, storage, and sample retrieval.
The Instrument and Methods team wanted automation systems that offered comprehensive chemistry and immunochemistry test menus with the potential of test expansion. At the time of the project, the labs' analyzers were supplied by a variety of companies; identifying one that offered both general chemistry and immunochemistry analyzers was important. Cost of operation, as well as system reliability and flexibility, were equally significant.
The LIS team itemized the cost of potential software upgrades needed to ensure the highest performance of the automation system. The system's scalability and its ability to satisfy security and regulatory compliance were also determined.
The Site Planning and Facilities Preparation team assessed the facility infrastructure needed to support the new automation system. This included evaluation of such factors as appropriate space accommodation for both staff and instruments, wiring for normal and emergency power, additional lighting, water access and drainage, and appropriate ventilation.
The Transition to Automation System team evaluated the companies' technical support, user training courses, and continuing education sessions. This team identified areas in the laboratories' current workflow processes that needed to be addressed prior to the implementation of the new automation systems.
Automation improves workflow
After a thorough review of four commercially available automated laboratory systems, the Group selected one that demonstrated cost efficiency, user friendliness, reliability, and robustness. The total laboratory automation system installed in March 2009 at Presbyterian (February 2009 at Shadyside) is comprised of sorters, centrifuges, aliquoters, general chemistry and immunochemistry analyzers, and a refrigerated storage (stockyard) — all connected to a robotic track. Samples are automatically managed once loaded into the inlet station by the operator. The system scans the bar-coded sample, and the patient demographics and test requests are downloaded.
Periodically, samples are scanned as they are transported along the robotic track, allowing the operator to be cognizant of samples' locations at all times. The system loads and unloads centrifuges, de-caps samples, and detects sample volume. Samples requiring additional offline testing are aliquoted from primary tubes to daughter tubes by the system. Samples analyzed online are routed to the online chemistry and immunochemistry analyzers.
Following analysis, samples are re-capped and transported to the stockyard (stores up to 3,200 samples). In the event that a physician requests additional testing from an earlier sample, the automated system will retrieve the stockyard sample and transport it to the appropriate analyzer. Samples analyzed offline (in-house or send-out testing) or those requiring special attention are diverted to the outlet station for operator intervention.
The automation system manages samples from beginning to end. The middleware autoverifies results that pass pre-established criteria and files results to patient records electronically; alerts the operator of abnormal results that require further review; notifies the operator of the sample's pre-analytical status; and prompts the operator of samples that require offline dilution.
"The middleware technology enabled us to implement autoverification for all chemistry and immunochemistry testing. With the elimination of manually resulting normal results, the lab staff have more time to manage critical results," says Raymond Bezila, MLT, administrative director for Automated Testing.
In addition to installing total laboratory automation, the Group also took advantage of re-educating the hospital staff on sample management. Prior to the automation install, the clinical chemistry labs relabeled between 40% to 60% of samples received. Relabeling reduced lab performance because it added a minute to TAT for results. Relabeling has the potential to introduce identification errors and is not cost effective. Moreover, the laboratory received a high volume of samples with accompanying paper requisitions that required manual order entry. Paper requisitions added three minutes per test order and increased TAT for results.
Another area of concern was tube sizes and types. Before automation, the lab accepted samples in a variety of tube sizes and types. It was necessary, however, to standardize the tube sizes since the new system requires 13x100 vacutainer tubes. The UPMC Automated Line Implementation Improvement Project was instrumental in developing a learning module entitled "Correct Collecting, Labeling, and Sending samples to the Lab: The Right Way Every Time." The laboratory has seen significant improvement in sample labeling. The installation of label printers on hospital units has significantly reduced (by 21%) the volume of paper requisitions received by the lab. To date, correct tube sizes have been stocked on every unit, and tube sizes are now standardized between the two hospitals; 89% of samples received can be placed directly onto the laboratories' automated systems without operator intervention.
Nine months have passed since the conclusion of the total laboratory automation project, and performance has been enhanced significantly. The automation system directly affects the laboratory staff, the hospital community, and, most importantly, the patients.
"The automated line project represents state-of-the-art in high-volume laboratory testing," says Alan Wells, MD, DMSc, and vice chairman of Pathology. "Laboratorians now have the technology that improves workflow of routine testing and creates the capacity to focus closely on the most difficult cases."
The first six months of operation challenged the operators as they increased their familiarity with the technology, while the hospital community became compliant with revised sample-processing procedures. Since both Presbyterian and Shadyside have identical automation systems, each campus can perform its own testing; and the need for sharing samples between the laboratories is reduced. Testing is now standardized between the two because it is not unusual for patients to receive treatment at both hospitals.
A meaningful reduction in the recorded volume of samples that med techs manually handle translates to reduced exposure to biohazards and reduced risk of injury. Med techs have more time to devote to troubleshooting critical cases, performing quality-improvement research studies (in collaboration with residents and researchers), and researching and developing new assays. Currently, the laboratory staff is being cross-trained, which not only presents development opportunities for individuals but also creates depth and flexibility for laboratory operations.
The hospital community has benefitted from the faster STAT and routine turnaround times, which are surprisingly comparable and suggest that in the future, distinguishing STAT from routine testing will be unnecessary, because all samples will be analyzed STAT. The TATs for add-on testing have improved and are directly related to the automation system's ability to retrieve the sample with minimal human intervention. Med techs no longer have to physically locate and retrieve the specific sample, which once could take a half hour.
Prior to implementing the automation system, serum indices were graded by visual inspection. The lab has begun the process of standardizing the assessment of serum indices. Hemolysis, lipemia, and icteria are detected via a spectrophotometry method, and semiquantitative unitless values are provided for each sample on the chemistry analyzer. Standardization of the pre-analytical, analytical, and post-analytical phases has an enormous impact on ensuring the reliability of test results. Patients have benefited with the consolidation of testing because the volume of blood necessary to perform testing has decreased, reducing the need for multiple blood draws, thus saving the patient time and discomfort.
The success of total laboratory automation at Presbyterian and Shadyside is a direct result of teamwork among the vendor, laboratory leadership and staff, and the hospital community. Implementation of total laboratory automation requires change for the laboratory staff as well as for the hospital community (nurses, phlebotomist, and clinicians). Automation is not a substitute for laboratory personnel but a complementary technology that aids in optimizing laboratory performance.
As performance through automation continues to be optimized, the clinical chemistry laboratories at Presbyterian and Shadyside now are truly living up to their names as UPMC Automated Testing Laboratories.
Octavia M. Peck-Palmer, PhD, is assistant professor in the Department of Pathology at the University of Pittsburgh, and medical director at the UPMC Presbyterian and Shadyside Automated Testing Laboratories in Pittsburgh. UPMC includes 15 general hospitals in western Pennsylvania, related clinics and healthcare facilities, and partnerships in five international hospitals.
By Scott Henwick, David Chow, and Sabrina Smith
Faced with shrinking budgets, growing volumes, and personnel shortages, clinical laboratories are increasingly moving to automation to maximize output and efficiency. But some are finding that the anticipated rewards of automation are not necessarily automatic. In fact, such moves may actually highlight a lab's hidden operational inefficiencies, as getting samples to the automated system becomes the critical link and the rate-limiting step. This, however, can present an opportunity to implement LEAN practices in order to reap the full benefits of automation.
This was the case with BC Biomedical Laboratories in 2006 when we increased the level of automation to address our rapidly growing Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) testing volumes. BC Biomedical is the largest physician-owned lab in British Columbia, Canada, serving 1.8 million patients and running 25,000 tests per day. At the time, our CT/GC testing volume was at 250 samples per day and rising by about 10% per year.
We acquired a system which replaced manual pipetting involved in sample transfers, amplification, and analysis steps with robotics, with the objective of saving time as well as reducing manual, repetitive tasks. We incorporated the new system into the current workflow and quickly realized that our processes, which were previously adapted to manual CT/GC processing, were not taking full advantage of the automation the new system could deliver. We questioned if we could achieve higher productivity by adjusting how we handle pre- and post-analytical steps, as well as those that interact with the system. In order to make process changes that would maximize the productivity and efficiency of the new system, we turned to LEAN.
Specifically, we invited a LEAN/Six Sigma consultant to perform a process review. He worked with our entire team of two clinical supervisors, 30 medical technologists, and 15 lab assistants for three days examining and applying LEAN principles to each step of our CT/GC sample processing. What followed was a journey toward enhanced productivity and cost efficiency, which inspired our staff to apply this continuous improvement tool across all aspects of our work.
We worked with the consultant to make changes that brought dramatic productivity improvements in just the first few days. This gained the immediate support of our entire team — many of whom had been hesitant to change — for the LEAN process. Over time, we implemented more than 200 process improvements throughout the department, many of which were small, incremental changes but all of which contributed to dramatic productivity gains.
A new way of looking at workflow
Working with the consultant, the first thing we did was to adopt the "single-piece flow" approach, a core tenet of LEAN, to sample processing. Single-piece flow embraces the importance of considering each sample individually, rather than as part of a batch in order to avoid build-up of samples at any given stage, thus improving efficiency. Specifically, decisions are made about each sample in real time as it moves through the system, and problem samples are set aside for processing later so they do not delay other specimens.
The single-piece flow concept also helped us think differently about how we use the instrument. For example, we started preparing the specimens when we had just one of two trays full (46 samples), rather than waiting for a full batch of specimens on both trays (92 samples). This enabled us to reduce instrument lag time every morning and to complete the runs earlier each afternoon. We also began processing samples at the end of the day, so they would be ready the next morning. This decreased instrument lag time in the morning from 90 to 30 minutes — which freed up our techs for other tasks while the machine is running.
One area where single-piece flow helped eliminate waste was in the central-processing area. This is where samples first arrive in a large bin from doctors' offices and are labeled and entered into the LIS system. Prior to LEAN implementation, we would enter all samples from that box, label them all, and then return them to the bin unsorted. This approach was inefficient since it created a lag in the system and was prone to labeling errors. By mapping and optimizing the accessioning process, we saved about 30 minutes in the first iteration of the new process. As we further optimized the process by running pilot projects and refining the physical workspace, the incremental time savings added up. Additionally, this change to single-piece flow helped cut errors in central processing by 22%. By working with one specimen from beginning to completion, single-piece flow eliminated the potential for mislabeling specimens.
Standardizing the work
Standardization of work processes is another fundamental LEAN principle. Previously, each staff member had developed his own way of performing various manual tasks. These included creative "work-arounds" for typical process problems that might arise. When we installed a more automated instrument and tried to apply to it our ad hoc processes, our work system did not run smoothly, especially for processes that required a handoff to another person. In contrast, by standardizing how we performed each process, we were able to identify and institute best practices.
For example, previously, each technologist had his own technique for loading samples into the instrument racks. The technologist would typically label the sample before placing it in the rack and would later go back to pick up each sample from its slot in order to scan the bar code. To streamline the process, we established that all bar codes would be scanned before being applied to the samples and that all samples would be stacked from right to left, beginning in the back. These changes enabled us to save 20 to 40 minutes per day. Additionally, by loading samples from right to left, we were able to avoid having to move the wand cord out of the way each time we loaded a sample. This allowed us to save a couple of seconds per specimen, which by the end of the day could add up to several minutes.
We also standardized work areas. For example, we used to organize work lists into binders. For greater efficiency, we organized paperwork into folders, each labeled by day of the week. We also color-coded the racks to easily identify them. Additionally, we taped off and labeled each work area. These changes enabled us to save several minutes each day. Further, the physical separation of the specimen handling area from other tasks such as administrative tasks minimized the risk of contamination. Further, we reconfigured work spaces so that we all worked from left to right, in a linear fashion. This increased efficiency and further minimized risk of contamination.
In just two years, BC Biomedical's CT/GC volume increased 22% to more than 300 samples per day, while we maintained our current head count of two technologists plus one-quarter of a lab assistant's time dedicated to CT/GC testing. Our current staffing level for this bench can handle an additional 25% capacity due to the continual process improvements we have made in this area. Further, we are now able to complete the day's CT/GC run by 2:30 p.m. vs. 5:30 p.m. previously. This means that doctors are more likely to get results and, thus, may be able to treat patients a day sooner.
Our adoption of LEAN has also produced less quantifiable benefits, namely, reduced stress level of our staff, boosted staff morale, and superior staff retention. All levels of our staff feel empowered because each one has had a voice in our LEAN implementation. While our consultant gave us the initial ideas for how to implement LEAN systems, our staff came up with most of the process changes we implemented — and continue to challenge ourselves to further improve our processes.
The move to LEAN has also changed how we communicate with one another. We now have daily five-minute team meetings, usually first thing in the morning, during which we identify and resolve work-process issues we are experiencing. This enables us to fix problems quickly and makes weekly staff meetings much more efficient. We also put in place a formal workflow review process, which we conduct at least twice a year as a group. Our LEAN efforts for CT/GC testing were so successful we were then able to secure management approval to implement LEAN management throughout the microbiology lab. We subsequently deployed it to the parasitology, bacterial I.D., resistance testing, and blood-culture areas, all with similar success.
We plan to continue applying LEAN principles to work processes, particularly as we further increase automation throughout the lab. We have recently installed the next-level, fully automated system that incorporates DNA extraction for the ever-growing CT/GC volumes. This time, the move to increased automation is paying off immediately: In workflow analysis, we are achieving completion of testing duties by 11:30 a.m. and are utilizing about half of the FTE component compared to the current methodology.
LEAN has given us tools to better assess the actual workload impact of bringing any new technology into the laboratory. Additionally, with LEAN we are now more confident that before we go "live" with production, we have mapped out the process to a more efficient starting state. And by standardizing work processes, we have created a common baseline upon which to run pilot projects to continuously improve the process.
Our success with LEAN in the microbiology department has also prompted its adoption across the entire organization. The lessons learned in microbiology about single-piece flow, eliminating waste, and standardization of work processes are now being applied successfully to all areas of the organization.
Scott Henwick, MD, F(RCPC), clinical director of microbiology, David Chow, manager of microbiology and parasitology; and Sabrina Smith, supervisor of microbiology — all employed at BC Biomedical Laboratories Ltd. in Surrey, British Columbia, Canada — used a BD Diagnostics' LEAN/Six Sigma consultant, and first installed a BD Viper System, which was followed by the installation of the BD Viper System with XTR technology.