Book:Justifying LIMS Acquisition and Deployment within Your Organization/Introduction to LIMS and its acquisition and deployment/LIMS acquisition then
1.3 LIMS acquisition then
The laboratory environment of the 1980s, viewed from a behavioral standpoint, would be easily recognizable today: growing test workloads, everyone’s sample was a top priority, and everyone was very busy as all work was manually done. From a technology perspective, things were a lot different. For the most part, there were no computers, and instrument data systems (IDSs) were entering the marketplace. Still, IDSs hadn't become the almost automatic combined instrument-computer combination they are today. Networks were in their early stage of development. Robotics was also in an earlier part of its evolution; Zymark Corporation of Hokinton, Massachusetts (which later became Caliper Life Sciences), was an early developer of lab robotics, which was just beginning to impact the laboratory market. Additionally, there was no severe shortage of educated laboratory personnel to fill open lab positions. However, few were knowledgeable in laboratory informatics.
The cost of lab operations was becoming a serious concern for lab management. Although people were available, there was a limit to how many you could hire, given the limitations of laboratory space and equipment utilization. As a result, economics played a significant role in the justification for equipment and instrumentation, in general, and LIMS, a new technology, in particular. One of the significant differences between then and today is that installing a LIMS meant installing a local computer system; cloud-based systems didn't exist.
As the productivity issue became more acute, the interest in automation and the efficiency of lab operations grew. In clinical chemistry work, the response was particularly strong with the development of an industry-wide total laboratory automation (TLA) initiative that focused on driving down the cost of laboratory testing through automation and the development of communications standards to make it easier to connect instruments and computers together into fully functioning networks, which would relieve much of the manual clerical effort.
Much of the information we have on the effectiveness of laboratory automation and LIMS installations comes from the life science and clinical industries. The results of TLA could be seen in 1992, when Markin and Hald noted[1]:
The tangible [financial] benefits which were measured prior to LIS justification totaled $153,471.84 per year based upon fiscal year 1985-86 dollars. The objective re-evaluation of these activities four years after implementation and operation resulted in a measured $115,326.93 per year savings ... Implementation of the laboratory information system at our institution resulted in a 75% capture of the estimated/projected cost avoidance or cost savings.
In a more modern example from 2018, Yu et al., who wishing to improve workflow efficiency in their clinical laboratory, implemented TLA "that connected our pre-analytic processing system with various testing (hematology, coagulation, and chemistry)."[2] They reported their results as such[2]:
The implementation of our TLA system resulted in 86% fewer discrete processing steps in specimen handling, even when starting from a partially automated laboratory. Instrument consolidation reduced the testing footprint by 45% and reduced the number of testing personnel by 2.5 full-time employees (FTEs). An 82% reduction in hands-on time associated with add-on processes was achieved. Combining STAT and outreach work on the testing system did not impact turnaround time.
Outside of TLA, lacking other driving factors, the primary motivation for implementing automation and LIMS or LIS in the lab early on was productivity and, as a result, finances. A 1986 article by Joseph H. Golden (then at Laboratory Management Systems, Inc.), titled “Economic Considerations of Laboratory Information Management Systems,” addressed that point directly. Considerations and concerns he had included (quoting directly)[3]:
- the "impact on lab operations, reducing administrative work [and] speeding up work";
- "how the laboratory contributes to the corporate bottom line";
- the "need to consider not just what LIMS will do but what it’s worth";
- in regards to R&D, that "productivity improvements amount to at least 10% to 20% of the total staff resources of a laboratory complex”;
- in regards to QA/QC, that "time-value of information" and "ability to accept/reject raw material and avoid off-spec products" is considered, "plus 10-20% saving on clerical costs";
- that commercial testing saw "improved profitability";
- the consideration of "common lab management problems," such as "increasing data volume from increased use of smart instruments and from increased testing and record retention requirements imposed by the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), and other regulatory agencies; constantly rising operating and material costs; and ever-tightening constraints on staff and material expenditures, which in turn are "manifested by increasingly burdensome paperwork, inefficient utilization of resources, and exasperating searches for misplaced samples and data"; and
- the costs of "equipment, facilities, cost of money, and investment tax credits."
The justification for LIMS acquisition in the 1980s was based on comparing two states: the status quo vs. the introduction of laboratory informatics in the form of an on-premises LIMS. Among the more significant management concerns were whether the costs could be contained and the project kept on track. Large software projects were notorious for cost overruns and scheduling delays during that time. However, demand for improved processes in labs was also increasing, particularly in regulated settings like the pharmaceutical industry. Failure to keep accurate records, and be able to find them, could result in plant closures, and that alone could justify the acquisition for a LIMS.
Table 1 compares concessions and considerations made in the 1980s of maintaining existing lab operations vs. acquiring and implementing an on-premises LIMS.
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References
- ↑ Markin, Rodney S.; Hald, David L. (1 December 1992). "Cost justification of a laboratory information system: An analysis of projected tangible and intangible benefits" (in en). Journal of Medical Systems 16 (6): 281–295. doi:10.1007/BF00996362. ISSN 0148-5598. http://link.springer.com/10.1007/BF00996362.
- ↑ 2.0 2.1 Yu, Hoi-Ying Elsie; Lanzoni, Harold; Steffen, Tracy; Derr, Warren; Cannon, Kim; Contreras, Jeanene; Olson, Jordan Erik (1 January 2019). "Improving Laboratory Processes with Total Laboratory Automation" (in en). Laboratory Medicine 50 (1): 96–102. doi:10.1093/labmed/lmy031. ISSN 0007-5027. https://academic.oup.com/labmed/article/50/1/96/5047095.
- ↑ Golden, J.H. (1986). "Chapter 2: Economic Considerations of Laboratory Information Management Systems". In Provder, Theodore (in en). Computer Applications in the Polymer Laboratory. ACS Symposium Series. 313. Washington, DC: American Chemical Society. pp. 6–16. doi:10.1021/bk-1986-0313.ch002. ISBN 978-0-8412-0977-0. https://pubs.acs.org/doi/book/10.1021/bk-1986-0313.
