A Year in Review: Managing Risk of Laboratory Non-Conforming Events (NCEs)
Presented by Andrea Park, MLT

It is now estimated that over 98,000 people die each year due to preventable medical harm, including laboratory errors. While a true estimate of the number of diagnostic errors is difficult to establish, it is believed that the prevalence of such errors may be as high as one every 330–1000 events, one every 900–2074 patients, or one every 214–8316 laboratory results.¹ These alarming statistics have led to the development of quality improvement programs to minimize error, improve patient safety, and provide a focus on patient-centered care.

Integral to improving patient safety in laboratory medicine is the positive evolution of regulations and the application of risk-management strategies and risk-based thinking in error minimization. Standards such as ISO 9001:2015 specifically address risk and actions to mitigate risk, and ISO 15189:2012 Medical Laboratories — Requirements for Quality and Competence requires risk assessments to evaluate the impact of work processes on patient safety.

Integrating risk management involves improving the effectiveness and efficiency of the quality and service delivered to our customers—patients and physicians—and is part of the evolution of a clinical governance strategy of patient safety. This process must start with an evidence-based approach to non-conforming event (NCE) trending and data analysis. Incorporating risk-based thinking, NCE improvement plans, and knowledge sharing to prevent reoccurrence are all part of an integrated clinical governance framework that helps raise error awareness and lead to the development of preventive action strategies to minimize risk.

In this session, participants will learn how NCE improvement plans begin with incorporating evidence-based error trend analysis. By understanding the type and frequency of errors, laboratories can be proactive and apply risk mitigation strategies to reduce the risk of reoccurrence. Understanding how to use risk tools and seek insightful guidance during the writing of improvement plans increases overall risk awareness. Furthermore, participants will learn how performing audits, post improvement, is part of a continuous improvement journey.

Applying probability and frequency matrices to NCEs reduces NCE reoccurrence and improves the effectiveness and efficiency of the quality, safety, and service delivered to our customers. This session will cover a year in review of NCE risk analysis, trending, and improvement plans highlighting the accomplishments achieved in 2016. Using the health care analogy of flipping from asking “what is the matter” to “what matters to you,” participants will learn how flipping from reactive thinking and error repair to proactive, risk-prevention thinking, and prioritizing risk mitigation, helps trend clinical laboratory medicine toward patient-centered care.

Reference:
1. Ottomano C. Errors in medicine and errors in laboratory medicine: what is the difference? Blood Transfus. 2010;8(2):79-81.