Congratulations on being the first clinical laboratory in the United States accredited to the new version of ISO 15189. For those unfamiliar with ISO 15189, would you explain how this accreditation supports the pre-analytical, analytical, and post-analytical stages of testing?
Thank you so much. We have found accreditation to ISO 15189 to truly build upon the standards that labs already follow under CLIA, and it places even more focus on continual improvement of processes. By using the tools of ISO 15189, such as quality indicators and risk analysis, we have found many instances that we have been able to preemptively identify problem areas and address them before they ever occur. We continually review our procedures in all analytical stages and assess risk and improvement to patient care, accuracy of testing, and consistency of reporting.
How large is the laboratory at ADL Health and who are your primary customers?
Our current team includes twenty staff from management to technical team to customer service. We have a wide variety of customers, including rehabilitation facilities, drug monitoring, nursing and assisted living, family practitioners, home healthcare, and specialty providers like wound care physicians and urologists.
Are there particular lessons learned you can share with other laboratory managers and directors on reducing laboratory errors?
I have found that the process of risk analysis in the laboratory is often underrated and overlooked as a tool for reduction of laboratory error. Laboratory directors and management need to find a way to seamlessly implement risk evaluation into their current processes.
For example, in our lab this has become an ongoing conversation in our team meetings. When you involve the entire team in the evaluation of risk and improvement, it allows everyone to take responsibility for the quality of lab work, and to bring attention to potential problems that may never be seen by more than one or two people. Making this a normal conversation between staff can truly improve quality and reduce errors.
The other great opportunity we have found for risk assessment is during competencies. As a manager or technical supervisor, observing the daily hands-on processes gives a window into possible risks in the procedures that aren’t necessarily thought of during the SOP-writing process. Observing different personnel performing the same task will often provide valuable insight into potential risks that can be addressed with procedure changes.
What is a lesson learned you can share with fellow laboratory managers and directors on the accreditation process?
I think the biggest lesson is that accreditation checklists can all-to-easily be viewed as a long list of tedious work to be added to our already full schedule. But what we have found is that most of these processes can easily be included in what we are already doing. If we have a meeting scheduled quarterly, for example, we can use that time for periodic review of quality indicators and proficiency testing. As laboratory managers and directors, we have the freedom to implement the standard requirements in a way that works for our laboratory, and it may not look like other labs. But if we can use the tools as they are intended, the quality of all laboratory work will improve, which is the point of accreditation in the first place.
What do you see the future laboratory looking like?
The future laboratory is going to continue to become more automated, and with AI development, this will affect how data is processed, reviewed, and reported. In addition, medicine is becoming more and more personalized and local. This means that patients are expecting to be able to test on-demand, in a convenient location or even at home. These types of changes will require laboratories to be evolving continually, striving to meet these needs while ensuring the highest level of quality.
