Abstract
Automation has been improving the efficiency of the Clinical Laboratory for many years. Throughout the 1970's and 80's, diagnostic instrument manufacturers strived to improve the accuracy, precision, and speed of analytical systems. Total Laboratory Automation known as “TLA” has been available in the United States since 1992. Today, laboratories are using a variety of tactics to improve efficiency and provide high quality cost-effective results. Consolidation, automation, and integration of pre and post analytical specimen handling into the analytical processes provide tremendous opportunities for operational improvements. For many laboratories investing in TLA may be difficult to justify due to volume constraints and the cost involved with implementation. Roche Diagnostics designed a series of “stand alone” automation products to address a variety of customized automation tasks in a cost-effective manner. This approach allows for task specific automation that targets a variety of manual tasks, hence the name Task Targeted Automation (TTA).
TTA modules are designed to stand alone, versus being connected to each other or to analytical systems. Task Targeted Automation provides easy access to automation for many of the tedious, expensive, and hazardous tasks associated with pre and post analytical sample processing. Throughput, size of the components, and environmental requirements make the systems an easy fit into almost all laboratories. The fact that TTA systems are free standing provides maximum flexibility in locating the units and dealing with space constraints within a laboratory. Though not designed to automate every processing procedure, the Task Targeted Automation systems from Roche Diagnostics dramatically improve laboratory operations at a low investment cost. The return on investment is short, thus allowing a laboratory to meet financial goals more rapidly and more effectively than ever before possible.
The Roche PSD 1, Roche VS II, and Roche VS 250 sample input areas are designed to take advantage of the efficiency provided by the standard five position Roche BM/Hitachi rack. The Roche/Hitachi rack is a key labor saving device incorporated into systems such as the BM/Hitachi 747, 917, Betsys™ and the new BM/Hitachi MODULAR™ systems. This rack improves efficiency by decreasing the need to transfer samples from one rack to another, which is usually required when using multiple non-complementary testing platforms. Racks on trays holding up to 150 samples are simply transferred from one Roche/Hitachi analyzer or TTA system to another with no requirement for further sample tube rack transfers. Roche Diagnostic's TTA allows for consolidating to fewer workstations and performing more tests on fewer analyzers. TTA systems sort and target areas can be modified to accommodate various racks in addition to those used with Hitachi and Integra™ analyzers. A comprehensive workflow mapping study provided by a Roche Diagnostics Laboratory Process Consultant, educated and experienced in laboratory organization, can detail the most efficient configuration of TTA to meet the requirement presented by various applications.
The PSD 1 (figure 1) is a TTA system that solves many of the problems associated with pre-analytical sample handling and post analytical sample archiving. Samples requiring serum or plasma are centrifuged prior to placement into the Roche/Hitachi five position rack. Then all tubes requiring sample receipt identification, selective decapping and sorting are placed into Roche/Hitachi racks on trays holding up to 150 samples. Sample trays are then placed on the PSD 1 in-put area. The PSD 1 sorts and decaps a variety of tubes for almost all laboratory disciplines.
PSD 1 Sorting/Decapping/Archiving TTA system.
Once placed on the PSD 1, a scan of uniquely bar code labeled tubes is performed. The PSD 1 queries a host computer (LIS or LAS) for test selections. The query can trigger a “received” or “in-lab” status of the tube in the LIS. Test request information allows the PSD 1 to specifically sort the sample for further processing. Samples with no test request or unreadable labels are identified and sorted to a specified location for technical intervention. Batches of sorted specimens are then carried in racks, trays or other carriers to the next appropriate workstation. This could be an aliquoting TTA system or an analytical system such as the Roche Diagnostics Elecsys™, Integra™, 917 rack, 747 or MODULAR™ systems, serum work areas or an immunoassay, hematology or coagulation work area.
A unique feature of the PSD 1 is its ability to safely archive specimens in a cost-effective manner. Samples that require no further processing are placed on the PSD 1 for automated sorting into specially designed archiving trays. Locations of samples within these archive trays as well as archive tray tracking data are made available to an LIS or to sample tracking software for ease of future location and identification. PSD 1 archive trays are designed to be a more efficient, safe, and convenient alternative to current specimen storage practices. The PSD 1 can process up to 1000 primary tubes per hour depending upon the configuration and required functionality.
The VS II (figure 2) is a TTA system that features automatic aliquoting with secondary tube labeling and sorting of primary and secondary tubes. Samples are loaded on to the VS II via standard Roche BM/Hitachi five position racks on trays holding up to 150 samples. The racks and trays can be loaded with samples decapped manually or automatically decapped by the PSD 1. The VS II reads the bar code of samples placed on the system and queries the LIS or process controller for test requirements. Based on parameters set at the VS II, the system determines the number of aliquots, aliquot volumes and primary and secondary tube sort destinations. The VS II applies a user formatted and customizable barcode label to the required secondary tubes. This bar code can be a duplicate of the primary tube making integration of the tube onto analytical systems an easy matter. The VS II secondary tube is a standardized tube configured as a “cup in tube” to minimize dead volume and sampling compatibility issues within analytical systems. The VS II is designed to produce aliquots with minimal operator intervention. All functions are easily controlled via the data management system and consumables are loaded in bulk packaging.
The VS II Aliquoting/Labeling/Sorting TTA system.
The VS II provides the ultimate in sample integrity monitoring. Utilizing disposable tips and a combination of pressure and capacitance, all samples are checked for level of specimen as well as for clots. When a clot or problematic primary sample is identified, it is sorted to an exception area along with the empty labeled secondary tubes. This sensitive clot detection system eliminates waiting until an empty tube reaches an analytical system before knowing there is insufficient sample, thus saving critical time in the pre analytical processing stage. After sorting and placement of aliquot tubes into racks within the VS II, the tube filled racks are then manually carried to awaiting analytical workstations, or the aliquots are ready for storage and sendout. VS II can be customized to meet specific sorting and aliquoting needs. The VS II brings an economical solution to one of the most error prone and hazardous steps in pre-analytical processing. The VS II aliquots approximately 300 primary tubes per hour with two secondary tubes per primary tube.
The VS 250 (figure 3) TTA system is unique in its ability to aliquot into a variety of specimen containers. Trays of decapped primary samples placed into five position racks on trays holding up to 150 samples are loaded onto the VS 250 for processing. The VS 250 reads the bar code of samples placed onto the system and queries the OS or process controller for test requirements. Based upon test parameters set at the VS 250, the system determines the number of aliquots, aliquot volumes and aliquot targets.
The VS 250 Aliquoting TTA system
The VS 250 aliquots into sample vessels placed on to the aliquot table, usually not requiring a bar code label. However, aliquot labels for selected targets can be produced via the VS 250 or a process controller. These vessels can be any combination of instrument racks with sample cups, microtiter plates, electrophoresis racks, micro vessels, and sample disks with cups. Samples are checked for the proper level of specimen and are aliquoted via an individual disposable tip into awaiting vessels. The sample location is recorded and available via the VS 250 controller or a LIS. The VS 250 can aliquot at a rate of up to 300 primary tubes per hour depending on configuration. The completed racks, sample disks and sample cups are then manually placed onto analytical workstations. The primary tube remains in the Roche BM/Hitachi rack ready for analysis or storage.
Figure 4 is an example of a workflow that benefits from the placement of TTA. This facility, which receives approximately 9,000 blood samples per day, is not a candidate for TLA. This high sample volume would require a large investment in TLA, hardware, and since this is a commercial laboratory, rapid turnaround times such as those that can be delivered by TLA(1 to 2 hours) are not required. TTA however, is an ideal solution. TTA allows us to target those processes that require the greatest amount of labor to accomplish, are most inefficient, are biohazards, and are prone to errors. The arrows indicate those functions that can be best accomplished by TTA Cost justification dearly exists for this solution. Since hardware costs for TTA are relatively low, and since the tasks that are targeted for automation are labor intensive, there is a short ROI. In this particular laboratory, we have projected labor savings of $494,000 per year and an ROI of approximately 1.7 years.
An example of a workflow that benefits from the placement of TTA.
IN CONCLUSION
TLA received the attention of a laboratory world anxious to find ways to improve efficiency. Laboratory managers clearly recognize the requirement to cut costs and are beginning to understand that reallocating staff will allow them to make a more significant impact on their bottom line than cutting reagent costs by a few pennies per test. In large pan, we can thank TLA for this evolution of philosophy. Perhaps more than any new technology to appear on the American laboratory marketplace in the last several years, TLA has resulted in lab managers and vendor partners focusing beyond reagent cost per tests. Our studies have shown that, under the right circumstances, TLA is a valid solution for helping laboratories cut costs and increase efficiency. Roche continues to propose TLA solutions based upon new MODULAR™ technology when the situation warrants, but TTA is offering new possibilities for a variety of lab operations. Some of the anticipated benefits offered by TTA are decreased TAT, decreased exposure to biohazards, improved staff utilization, improved sample tracking, efficient archiving and improved job satisfaction with the end result being better patient care.
In the situations where TTA is the appropriate solution, Roche Diagnostics is able to target specific areas of inefficiency in laboratories. Implementation of appropriate levels of automation at these specific points of inefficiency will result in lower automation hardware costs, greater impact on laboratory efficiency, and an ability to demonstrate true cost justification and attractive ROI's.