Interesting times for clinical chemistry

July 1, 2012

An aging population and critical shortages of trained personnel are keeping work interesting and professionally challenging for managers in core laboratories. Demand for diagnostic tests is increasing, but the qualified staff to perform them is dwindling. According to the U.S. Department of Labor, the pipeline of laboratory recruits is woefully insufficient to fill the nearly 14,000 new laboratory positions required every year for the next decade to handle burgeoning demand for laboratory services. So it will take years, maybe decades, to solve the lab staffing shortage problem. Laboratories can’t wait for the job applications to start pouring in.

The key challenge for laboratories and their suppliers, therefore, is to find innovative and cost-effective ways to improve testing quality and efficiency, conserve labor, and relieve workload pressure as much as possible. One compelling, high-impact area for improvement is clinical chemistry testing, which accounts for 35 percent of a core laboratory’s testing volume.

Consolidation reigns supreme

Most major diagnostic companies today offer instrument systems that combine clinical chemistry testing with immunoassay (integrated systems). These systems also have sophisticated technologies offering higher throughput, automated sample processing, integrated results reporting, and customizable software (middleware) to help standardize decision making. “Families” of systems are available for labs with high-to-small clinical chemistry testing volumes.

While improved technologies have brought improvements in clinical chemistry test processing, throughput, and sample and data management capabilities, are they really helping laboratories where they desperately need help the most? Focus on clinical chemistry testing accuracy and quality control is a top priority for many healthcare providers aligning with Accountable Care Organization (ACO) priorities, such as minimizing costly patient safety errors and avoiding hospitalizations. The ACO model links reimbursements to quality metrics and reductions in the total cost of care for an assigned population of patients. ACOs reward prevention and early detection in low-cost settings such as primary care practices. The laboratory can play a vital role in achieving such improvements.

Clinical chemistry testing volumes are increasing steadily as baby boomers advance into their sixties and visit doctors more often for exams that require lab tests. It is well documented that older individuals are the largest consumers of healthcare. Certain analytes are in high demand, such as the cholesterol and other lipid markers for cardiac disease screening and C-reactive protein tests to measure inflammation. As these and other analytes are more widely used, testing demand will continue to soar and labs will face more pressures to deliver top quality results in less time with fewer resources.

Six sigma metrics

Dr. James Westgard, professor emeritus, University of Wisconsin, and author of the widely followed laboratory professionals’ website Westgard QC, has done extensive research showing how adoption of Six Sigma standards can improve performance in clinical chemistry testing. He explains that for busy laboratories seeking to improve throughput and save costs, Six Sigma quality metrics provide assurances that higher testing volumes and workflow pressures will not increase testing errors and impact patient care. Six Sigma metrics can help laboratories demonstrate quality and develop safeguards to prevent errors and identify potential problems before the test result leaves the lab.

On his blog, Westgard writes: “To assure safety characteristics are acceptable, performance must be compared to a defined requirement for quality, such as the allowable total error (TEa) at a specified critical medical decision concentration. Next, the right risk model is required, which should be a three-factor model that includes occurrence, severity, and detection. Integration of Six Sigma concepts facilitates improvements in the ranking or scoring of risk factors and estimation of residual risk in meaningful terms, such as residual defect rate that can be translated into the number of potentially harmful patient test results.”1

Informatics for IVD

Clearly, laboratory customers are expecting much more of their suppliers in terms of value-added services such as professional education and state-of the-art informatics. Diagnostic testing is all about information—how to get it, how to use it, and how to store and access it. Laboratory systems for running clinical chemistry and immunoassays must not only provide fast and accurate results but communicate seamlessly with middleware, laboratory information systems, and other data collection and reporting resources. Sophisticated, built-in informatics capabilities no longer are a luxury add-on for high volume clinical chemistry systems; they are a critical component that enables laboratories to communicate better with clinicians, prevent errors in transcribing test results, and optimize the overall efficiency of the laboratory.

Clinical decision making requires access to timely and accurate information, but many laboratories still are constrained by manual processes and multiple data management platforms that can impede result reporting.

Informatics provides reliable and timely information for automating many routine procedures, centralizing information management, fostering and improving real-time laboratory decision making through rule-based coding, and supporting laboratory accreditation reporting requirements. Automating routine tasks allows technologists to focus on activities that require close attention. Minimizing human interaction generates faster and more accurate results, reduces potential for errors by reviewing quality controls in real time, and links autoverification to Quality Assurance (QA) results.

Future trends

Workload consolidation will continue to drive the future for laboratories of all sizes and further increase throughput requirements for clinical chemistry systems. Menu expansions will come from further migration of immunoassays to clinical chemistry systems. A good example is the movement of transplant drugs to clinical chemistry platforms with high throughput. More high volume historical immunoassay tests, such as HbA1c, have, over the years, migrated to Clinical Chemistry, and volumes will continue to increase as it becomes widely accepted for diagnosing diabetes.2

With more consolidation, there will be a greater need to maintain and advance performance and quality management. An encouraging trend is the movement lead by the In Vitro Diagnostics Directive in Europe and professional societies such as the International Federation for Clinical Chemistry for global standardization of clinical chemistry calibrators, assay harmonization and standardization, lot-to-lot variability reduction, improved CVs (coefficient of variation), and ISO 15189 laboratory accreditation. Universal adoption of Six Sigma metrics will be valuable for achieving these global standardization goals.

Preferences for open and closed systems will vary in different parts of the world. Labs in emerging markets will continue to rely on multiple reagent vendors, whereas labs in the U.S. and European markets will select the instrument and reagents from the same vendor to assure compliance with accreditation standards. Japan provides a different perspective in that it is a highly established market, yet continues to be dominated by multiple reagent vendors and an open system ethos.

Increasing demand for clinical chemistry testing will not subside in the near future, so laboratories will continue to place high value on increasing throughput and efficient utilization of floor and storage space. More efficient inventory management will be achieved with informatics solutions, as well as proactive remote monitoring and online troubleshooting by instrument manufacturers. The need for more efficient and sophisticated technologies that can maximize throughput and productivity without compromising performance quality will bring laboratories and their IVD suppliers closer together in long-term contracts.

Finally, future development of new system solutions will look to incorporate the use of new technologies and solutions that result in faster turnaround times to physicians as well as further miniaturization of the analytical aspects of clinical testing. Additionally, automation of the pre- and post-analytical aspects of laboratory workflow will become even more commonplace and scalable as the focus of Lean and Six Sigma shifts up and down stream into higher error and lower efficiency areas of the lab. These advances may offer excellent potential for maximizing testing ease, efficiency, and speed while optimizing performance quality.


  1. James Westgard, PhD, Westgard QC.,
  2. Saks DB, ed. Guidelines and recommendations for laboratory analysis in the prognosis and management of diabetes mellitus.

Cass Grandone, BS, is Divisional Vice President, Systems Development and Core R&D, Diagnostics, for Abbott Laboratories. He oversees Diagnostics Global New Product Development of Immunoassay and Clinical Chemistry Assays & Systems. Esther Yang, PhD, is Senior Director, Assay and Systems Research, Diagnostics, Abbott. She is responsible for strategic development of the company’s assay menu and technologies pipeline as well as discovery research of new and novel biomarkers.

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