Volume 38 Number 6 | December 2024
Kamal Smith, MBA, CSSGB, MLS(ASCP), ASCLS Patient Safety Committee
Having joined the clinical laboratory science profession around a decade ago, our key performance indicators were safe and quality results, which still remains our top indicators to this day. From quality controls (QCs) to quality assurance (QA), the word quality has become almost a characteristic trait for medical laboratory science professionals, as maintaining this type of quality is crucial to patient safety.
I often reminisce about my initial exposure to the Levey-Jennings chart and the Westgard rules that have been the backbone of laboratory QC procedures. “Make sure your QCs are within +/- 2SD” was almost the slogan for our laboratory instrumentation classes, as the instructor would often make this reference on a daily basis. But little did we know that the outcome of our actions directly impacted the reporting of safe patient results.
What are safe results, you may ask? These are accurate, reliable, reproducible, and ethical reports displaying vital information for a requested test. Each specimen we process is a representation of the patient and should be treated as such, ensuring that we produce safe results that can aid in their diagnosis and treatment.
“ … our laboratory at NYU used Six Sigma tools, such as process mapping and failure mode effect analysis (FMEA), to reduce reporting errors by approximately 50 percent.”
As healthcare evolves and becomes more innovative, the traditional methods of achieving safety and quality must also evolve, and the principles of Six Sigma can aid the laboratory in this evolution. Six Sigma, a set of problem-solving principles that is utilized to improve processes, can be used to identify potential root causes that lead to errors and improve patient safety.1 Though these principles were initially used primarily in manufacturing, the healthcare industry saw it as a useful tool to improve their own processes. It focuses on the needs of the customer and aims to constantly try to meet their demands, and in clinical laboratory science, the patient is our number one customer, whose most basic needs are safe and reliable results.
From reducing laboratory errors to eliminating waste, Six Sigma has slowly become an agent for change and continuous improvement in clinical laboratory science. Projects such as reducing corrected reports and improving inventory cycle time were improvements made at the NYU Langone Hematology Laboratory using Six Sigma principles. While we maintain our status as humans who aren’t perfect and prone to mistakes, medical errors are those that must be avoided, as the consequences can be dire for our patients. Results being reported with errors, whether by human or analytical causes, are one of the leading causes of patient harm. As such, our laboratory at NYU used Six Sigma tools, such as process mapping and failure mode effect analysis (FMEA), to reduce reporting errors by approximately 50 percent. As we strive to achieve perfection, Six Sigma has become the gold standard for reducing reporting errors and variations aiming to achieve less than 3.4 DMO (Defects Per Million opportunities).1
It takes a systematic approach to root out defects in order to publish safe and reliable results, and the Westgard rules, over the years, have done well in allowing us to achieve and maintain this standard. However, more recently, we have seen where even James and Sten Westgard have incorporated Six Sigma metrics together with the Westgard rules to create the Westgard Sigma Rules that provides an even more efficient way of performing and evaluating QC performance while remaining even more cost effective.2
Many facilities struggle to understand QC performance and resort to simply repeating QCs until they pass. However, the issue could lie with either the instrument or its user, and Six Sigma offers a solution to this problem. Performing a Gage Repeatability and Reproducibility Study can determine if the issue lies with a particular instrument or user; steps could now be taken to address the root cause of the problem by either having the instrument fixed or by improving the competency of its user. With competent users and efficient instrumentation, patient results can remain safe and reliable.
As laboratories embark on various projects, such as new instrument implementation, validations, and even inspection preparations, Six Sigma principles provide a viable option to help foster a smoother transition and offer options for improvements. The “DMAIC” Six Sigma methodology for problem solving has been used for years to allow manufacturing companies to solve problems, improve their processes, meet KPIs, and overall increase their bottom line.1
Surprisingly, with all the benefits that Six Sigma principles offer, it still appears to only be known to a few medical laboratory science professionals and is usually limited to those in management. As medical laboratory scientists we are by profession problem solvers, and that is exactly what Six Sigma is—a problem-solving metric. It then begs to ask the question, why is there such a lack of awareness?
Perhaps it may be time to incorporate Six Sigma concepts in the very beginning stages of educational programs in the clinical laboratory sciences, as we did with the Westgard rules. Prior history shows that clinical laboratory science education focuses on quality in terms of processing QCs and meeting regulatory requirements. However, while this allows us to meet the standards of quality, it rarely affords the opportunity for the standards of our quality to increase. Having Six Sigma principles taught to medical laboratory science professionals at every level will only offer a higher standard of safety and quality as everyone participates.
As we look towards the future of our profession, let us, with Six Sigma principles, shape the young minds with the best and most current methods in problem solving, safety, and quality management. As laboratory medicine changes and new problems arise, let us advocate for the use of Six Sigma principles to define, measure, analyze, improve, and control our processes and maintain the highest level of safety and quality in healthcare.
References
- Munro, R. A., Ramu, G., & Zrymiak, D. J. (2022). The ASQ certified six sigma green belt handbook (3rd ed.). ASQExcellence.
- Westgard, J. O., & Westgard, S. A. (2014, September). Introducing Westgard Sigma Rules. Westgard. https://westgard.com/lessons/westgard-rules/westgard-rules/westgard-sigma-rules.html
Kamal Smith is a Lead Clinical Laboratory Scientist at NYU Langone Health in New York, New York.