Among the fundamental components of an effective Quality Management System (QMS) is the monitoring and management of nonconforming events (NCEs)—commonly referred to as nonconformances, nonconformities, events, occurrences, or incidents. The formal definition of an NCE is the “nonfulfillment of a requirement,”1 while a more simple and direct explanation may be, “something in the lab went wrong.”
It is worth noting up front that tracking NCEs is a regulatory requirement.2 Recognizing, understanding, and correcting problems allows a laboratory to continually improve, yet many laboratories have implemented a policy and process for NCE management solely for regulatory compliance and have not fully leveraged NCE management to drive continuous improvement as part of a culture of quality. While it is true that upon regulatory or accreditation inspection, laboratories with this approach can “check the box” to avoid a deficiency, those labs miss out on key benefits that an effective NCE management system can provide.
In my years as a clinical laboratory quality leader, I have held many monthly and quarterly quality committee meetings where quality metrics are reviewed and discussed. Without fail during each meeting, there is a laboratory section that indicates zero nonconformances on their quality metric report; a feat often proudly announced. However, any seasoned laboratorian knows it is incredibly unlikely that not one thing went wrong in a given lab section for one month, let alone an entire quarter. Remediation of issues and continuous improvement can only occur once the organization recognizes the existence of NCEs and takes steps to eliminate their root causes. An effective NCE management program allows a laboratory to capture and tackle these issues in a systematic manner. In order to fully leverage your NCE management program, there are a few key steps that will position your lab for success.
Articulate the Benefits of Nonconforming Event Management
In order to gain key leadership buy-in for the allocation of resources for an NCE program, as well as gain staff buy-in and participation, it is critical to understand and effectively articulate the benefits of such a program. Of course, reliance on the regulatory requirement to track and remediate problems is one argument for such a program; however, explaining and reinforcing the underlying reasons for an NCE management system is a more persuasive argument. It also provides justification for the implementation of a comprehensive program that does not aim solely to check a regulatory box.
Through the recognition of issues, root causes are eliminated, and then quality improves. Money is saved through the reduction of rework and other costs of poor quality as well as improved efficiency associated with remediation of NCEs. Through effective integration of external feedback (including complaints) and internal staff concerns into the NCE program, patient, employee, and client satisfaction can be improved. Ultimately, a well implemented and effective NCE management program will focus on the establishment of a culture of quality in the laboratory.
A Reporting Culture is Essential
Specifically related to quality, an NCE program will not be successful without a culture that encourages the reporting of such instances. A manager who blows up or interrogates staff when problems occur will deter reporting and thus limit identified opportunities for improvement. Likewise, an organization that rewards metric reports with zero NCEs will deter reporting. NCEs must be reported before they can be managed, triaged, and remediated, and this requires a culture that encourages reporting.
In turn, a reporting culture requires leaders who are committed to continuous improvement and rectification of reported issues. If reported issues are not corrected, reporting is likely to drop off. Management should embrace an attitude of organizational honesty, where issues are directly addressed rather than burying their heads in the sand. Furthermore, staff members will be reluctant to report an issue if they feel doing so may implicate themselves or their coworkers as being responsible for an error (and therefore subject to some penalty). In order to be expected to report problems in the laboratory, staff need to feel safe in doing so, making mutual trust a critical aspect of the quality equation. This is where systems-thinking and just-culture approaches can help.
Systems thinking involves placing management focus on the system(s) involved in an NCE, as opposed to the individual(s), particularly the vulnerability or vulnerabilities that allowed the event to occur. In taking this approach, the staff member(s) involved in the error should help to redesign the system to mitigate or eliminate any identified issues. Likewise, just culture balances a blame free environment with accountability by establishing trust in the event management process and ensuring consistency and fairness in handling NCEs. Staff members do not want to be blamed for errors or mistakes that are not their fault, but most do believe in fairness and having a professional obligation to hold careless and negligent employees accountable.
To operationalize this philosophy there is a just culture algorithm that can help provide a framework for determining managerial course of action following an NCE, and allow for a fair and standardized management response.3 Proactive reporting of vulnerabilities also should be encouraged and incentivized such that issues are corrected before they introduce the potential for patient or employee harm, and/or financial losses. In a reporting culture, NCEs are viewed as valuable continuous improvement opportunities.
Introducing new quality metrics aimed at reflecting management’s philosophy toward continuous improvement and reporting of NCEs can be beneficial. Listed below are metrics that I recommend incorporating into your quality program and trending in quality reports to help foster a reporting culture, and measure performance for NCE management (see FIGURE 1 for an example of an NCE metrics report).
Where defects and errors are detected is another useful metric that allows a laboratory to understand how proactively issues are being detected. This metric is usually presented as a percentage of total events reported on a departmental and overall laboratory basis. The 1:10:100 rule (see FIGURE 2) illustrates that the further down the workflow from the point of origin that an event is detected, the costlier it will be for the laboratory.4
Leadership must show a commitment to continuous improvement in order to incentivize participation in a successful NCE program. This can be accomplished in a few different ways:
Experiencing fewer reported nonconforming events is not always better. Rather, it is worthwhile to capture as many events as possible, as each reported event can provide valuable information to the laboratory for continuous improvement. A reporting culture can be fostered and staff incentivized to make a successful NCE program more likely. Reported NCEs can be triaged and prioritized for remediation based on severity, and metrics can be tracked to demonstrate reporting and remediation performance. As a conscientious laboratory leader, do not bury your head in the sand when it comes to errors, mistakes, and nonconforming events in the laboratory. Demonstrating organizational honesty by recognizing that nonconformances occur and vulnerabilities exist in laboratory processes, then actively correcting those issues, will result in improved quality, efficiency, and financial bottom line.
Typical Progression after Introduction of NCE Program
After emphasis is placed on NCEs and a reporting culture is fostered, do not panic if you receive an influx of NCEs. This probably does not indicate that more is going wrong in your laboratory; rather, it is more likely that you are simply experiencing more reporting. This is a critical point for the program where events must be triaged and remediated in a timely manner to create confidence in the NCE program amongst staff. Once reporting catches up for lost time, event reporting will decline and likely plateau. It is also common to experience a shift over time from higher severity events being reported proportionally to lower severity and near miss events being reported. An evolution from reactive to proactive reporting helps the laboratory expend less money due to rework and other failure costs.
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