Chemistry Analyzers and Automation in the Clinical Lab


July-August 2016 - Vol.5 No. 6 - Page #2

Q&A with Eugenio Zabaleta, PhD
OhioHealth Mansfield Hospital
Mansfield, Ohio

Medical Lab Management: What are the most common chemistries run in your community-based hospital lab?

Eugenio Zabaleta: OhioHealth Mansfield Hospital (Mansfield) is indeed a community-based, 326-bed hospital. The laboratory at Mansfield supports numerous specialties in addition to our busy emergency department (ED), and given the wide-ranging nature of support provided by the laboratory, our most common chemistries include all the components of the metabolic panel, urine drug screening testing, cardiac markers, hormone testing, and some therapeutic drug testing (monitoring).

MLM: What chemistry-based diagnostic systems are currently in use in your laboratory?

Zabaleta: Generally speaking, our core chemistry automation system comprises two parts:

1. The first system manages the pre-analytical stage with pre-analytical-specific automation, including sample acknowledgement in the LIS, pre-sorting, centrifugation, volume check and clot detection, decapping, secondary tube labeling, aliquoting, and destination sorting into analyzer racks

2. The second system manages the analytical and post-analytical stages using an automation solution that includes two immunochemistry analyzers and two chemistry analyzers

While this system works well enough for us, Mansfield laboratory is currently in the process of acquiring a new automation system that will consolidate the two current systems into one creating a single point of interaction for the three analytical chemistry stages—pre-analytical, analytical, and post-analytical.

This new, integrated chemistry automation will have multiple benefits, including the ability to increase our outreach business, while simultaneously keeping our TAT for STAT samples consistent and predictable. It is worth noting that we also expect this automation will help protect our laboratory for what appears to be an eventual shortage of qualified medical technologists. When acquiring an instrument with a life expectancy of 5 to 7 years, it is necessary to consider aspects beyond just the analytical and clinical needs; projected labor force is one of those aspects.

MLM: How do you approach the processes of selecting new chemistry automation systems?

Zabaleta: It is important to develop a comprehensive process. While it can be easy to focus on specific, advanced functions of a piece of automation (no doubt an important aspect), it is best to approach these types of acquisitions from a more global perspective. Having experienced multiple transitions in chemistry diagnostics and automation over the years, the most successful projects are those that not only factor in the needs of the chemistry department and the clinical lab, but also the needs of our clinicians and physicians, the health care facility as a whole, and most important, our patients.

The basic elements to consider when approaching new chemistry acquisition include pre-implementation data that demonstrate a needs analysis. If the laboratory is being asked to provide more of a specific type of testing and chemistry needs to change or grow accordingly, this growth must be estimated and compared to the usual life span of the instrumentation you plan to implement. Standard return-on-investment analyses also are integral.

In addition to having basic acquisition plan metrics, it is vital to choose instrumentation with the thoughtful consideration of the most valuable resource available in the laboratory—your personnel. Ultimately, all new or updated clinical chemistry technology requires knowledgeable staff to utilize and leverage its capabilities to positively impact patient care.

MLM: Are additional considerations necessary when acquiring new chemistry automation for multiple health care sites?

Zabaleta: In recent years, many independent hospitals have merged or been acquired by larger hospital systems creating large networks of care. While this sometimes introduces challenges with regard to the interconnectivity of differing clinical systems, it also creates opportunities to acquire new technology that was previously unsubstantiated, and perhaps do so at a lower cost.

However, this is not the entire picture. Numerous published and unpublished research and study data have shown that clinical variability is one of the primary sources of medical errors and liabilities for health care providers and health systems. Further, clinical decisions are heavily influenced by and often based on laboratory results alone.1 So, if clinical labs are using different platforms, vendors, reagents, etc, across facilities in a system, clinical variability is taken for granted. For health systems with multiple hospitals, a patient seen in one community hospital ED could be transferred to the main hospital for cardiac workup because the community hospital does not have a cath lab. If the community hospital performs the first serial cardiac troponin with Troponin I and the main hospital performs the second measurement with Troponin T, the laboratory may produce results that are confusing to physicians and other clinicians.

Given this scenario, physicians and laboratorians need to work together to find a solution for the good of the patients. Can the first sample be sent with the patient for retesting? Can the transfer wait until a second measurement collection is performed?

With such issues facing laboratorians today, the ability to standardize and consolidate lab operations wherever possible benefits operational and clinical practice. When standardization is not possible, it is vital to educate laboratorians, physicians, and providers about testing differences so the proper clinical decisions can be made. This is becoming more important as the health care landscape in the US continues to evolve.

MLM: What are some ways to determine the best choice of measurement technologies?

Zabaleta: Independent of the vendor, each measuring platform or technology has its own utility, as well as limitations. This is why it is vital to approach new chemistry technology with a broad view. There is certainly much to learn about the technology from the literature and from the vendor, and attempts should be made to discuss the use of new systems with experienced users. Consider, for example, the differences between nephelometry and turbidimetry when used for protein quantification. Both methods measure scattered light, however nephelometry is more sensitive, whereas turbidimetry is more widely available due to it being performed in a spectrophotometer.

Learning about new technologies and determining whether the platforms will provide a solution to your laboratory’s needs is important, but so is making sure your staff have the skill set necessary to operate the devices and are comfortable doing so. This requires a training plan to develop the necessary skill set if the technology is required.

MLM: What are the necessary technical specifications for today’s clinical chemistry applications?

Zabaleta: As with any new acquisition, the lab should be prepared with its own specifications going into the acquisition process. This includes having a detailed understanding of testing metrics and needs, an assessment of clinical practices, and a familiarity with the types of patients in the treatment population. In our experience, when reviewing clinical instruments, the following specifications are key:

  • Random access ability and overall indices
  • Ease of sample loading (redundancy in sample loading is important, especially if the system is connected to an automation line and a secondary point of entrance is needed when the track system is down)
  • Throughput (both in normal and peak times)
  • Turnaround time consistency (clinicians work best with predictable and consistent TAT, particularly in the ED)
  • Menu and assay availability (the ability to bring third-party reagents is key for an open system)
  • Clot detection
  • Minimal necessary maintenance (particularly for ion-selective electrode [ISE] testing given its expected use life and how often it requires calibration and QC)
  • Reagent handling (eg, onboard stability, calibration frequency, assay limitations)
  • Ease of quality control and calibration management
  • Water supply and connection requirements
  • Remote diagnostic capabilities
  • Inter-laboratory quality control capabilities
  • Range of IT connectivity with middleware and software
  • Sample volumes (particularly for pediatric populations)
  • Vendor reputation and track record
  • Input from staff and fellow users

MLM: How often does your lab completely replace chemistry diagnostic equipment and why?

Zabaleta: While there may be other reasons to replace fully functional equipment (such as a major acquisition by a health system or other disruption to normal lab activities), most replacements are triggered by the end of the 5 to 7 year life cycle. In some cases, the analyzer or platform simply does not work well with existing infrastructure or staff capabilities, but these scenarios can be mitigated by properly vetting the product and vendor prior to acquisitions.

As a community hospital lab (and not an academic or reference lab), we do not perform laboratory develop tests in the clinical chemistry department, deferring to FDA approved tests for on boarding.

MLM: Lastly, what developments do you see in the near future for clinical chemistry automation?

Zabaleta: My expectation is that the greatest improvement to clinical chemistry automation will be in taking advantage of the further integration of middleware capabilities into automated instruments. If given the ability to conduct QC management and auto-verification in a middleware environment, in the event of a QC failure, we can stop patient testing immediately and withhold results release until the problem is addressed. Once the problem is resolved, samples could be re-run automatically, thereby improving technologist efficiency as well as the quality of our results.

Reference

  1. The Lewin Group. The Value of Diagnostics Innovation, Adoption and Diffusion into Health Care. Advanced Medical Technology Association. July, 2005. Available at: advameddx.org/download/files/Lewin Value of Diagnostics Report.pdf

Eugenio H. Zabaleta, PhD, is a clinical chemist at OhioHealth Mansfield Hospital in Mansfield, Ohio, and is a lecturer in Cleveland State University’s clinical chemistry graduate program. He graduated from the Catholic University of Cordoba (Argentina) with a degree in biochemistry and received his PhD in chemistry from the University of Akron.

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