Refining Excellence: Continually Improving with ISO 15189

March 2016 : Clinical Leadership & Management Review - Vol. 5 No. 2 - Page #22


The Advanced Diagnostic Laboratories at National Jewish Health leverage the ISO 15189 standards to ensure the testing results provided to our customers are of the highest quality. We are passionate about continually improving and building processes that are efficient, fast and of the highest quality. The entire laboratory staff has worked together to evolve and refine our processes, creating excellence and continuously raising the standard in all that we do. The laboratories were re-assessed for fulfillment of the standards in 2014 with a successful reaccreditation. This manuscript will provide insight into the improvements undertaken and how they were accomplished. The improvements all reflect a singular focus on delivering improved services to our patients, doctors, and clients.


The laboratories at National Jewish Health in Denver, Colorado perform more than 600 different tests in a variety of disciplines, spanning immunology (including a complete level and functional analysis of each complement component), mycobacteriology, molecular diagnostics, pharmacokinetics, microbiology, chemistry and hematology. ISO 15189 standards serve to refine excellence and continuously improve our laboratory. While voluntary, ISO 15189 accreditation is a robust quality system with fundamentals such as reliance on a quality manual and routine measurements of key quality indicators. According to our accreditor, the College of American Pathologists, ISO 15189 establishes additional requirements of the quality management system, including:

  • Demonstrated understanding of processes and their interactions (ie, process mapping)
  • Designating a quality manager
  • Periodic review of the quality management system (ie, management review)
  • Creation of a quality manual summarizing the quality objectives and corresponding metrics
  • Review of service agreements
  • Evaluation of referral laboratories and suppliers
  • Internal audits
  • Proficiency testing for all tests
  • Demonstrated continuous process improvement

Click here to see Table 1.

In January 2014, the laboratory made final preparations for an ISO 15189 re-accreditation assessment scheduled for the following month, in which both general and technical components of the laboratory would be assessed. The preparation activities included assessing the status of laboratory improvements and gauging the robustness of the quality systems. The laboratory was deemed ready, as we live by the axiom that the laboratory always be inspection ready. Following the assessment, the laboratory was successfully reaccredited to ISO 15189 and continues to embrace a collaborative, process-based approach to raising the bar on our quality.

Methods and Results

Key to any quality system is the event documentation and correction process, and it was central to our improvement efforts. Events (ie, incidents or nonconformities) are defined as deviations from requirements and are documented to ensure that the resulting impact on the patient, process and medical significance are recorded and addressed. Most important, any action taken must demonstrate its effectiveness in preventing recurrence of the initial problem.

In the first quarter of 2014, a major focus was placed on event closure, wherein impact from the event is documented and addressed, corrective and preventive actions are put in place to prevent future occurrences, and the actions taken are measured and evaluated over a defined timeframe to verify their effectiveness. To accomplish this, events were categorized, summarized, and action plans were developed to enable closure.

Prior to January 2014, events were managed passively by the quality department, which primarily requested updates via email on the investigation in general, and on progress with corrections, specifically. The process worked, but our goal was to be able to examine open events from a macro perspective. We considered, for example, that reviewing them with multiple members from each of the laboratories would reveal additional trends along with new ideas for solving multiple event root causes. Plus, we thought that if we were able to increase the visibility of the process and engage the teams in face-to-face conversation about the root causes and possible solutions, we might discover additional opportunities within the discussion itself.

For example, at one meeting, seven events were reviewed and categorized as pre-analytical, or pre-testing, events. The events were reviewed in a dedicated event closure triage meeting with the pre-analytical supervisor, the director of operations, and the director of quality management. After a thorough review, the attendees developed an action plan to facilitate closure for each event. Table 1 outlines the output of this pre-analytical meeting, including action items and timelines.

Individual actions were tracked for each event, and the team worked together to support each other in completing the activities. Several additional small team meetings were managed in a similar manner to address the analytical and post-analytical events, broken down by laboratory department. With the action plans in hand, the team worked together to measure and communicate the data, since in our culture, data and outcome measurement drive performance.

Click here to see Figure 2.

With close to 50 open events, including some held over from previous years, it was clear action had to be taken—not just to close the open events, but also to improve the event process itself. We recognized through the measurement of the data and the length of time the events had remained open that there were opportunities to improve the event documentation and resolution process. In addition, the documentation captured for each event varied dramatically, from as little as a brief statement about what happened, to detailed explanations describing the event. In the triage meetings, events that were accompanied by little documentation were hard to understand and correct, while it was much easier to act on those with more detail.

To address this, we formed a team to develop a new way to capture events electronically. The team was comprised of individuals throughout the entire laboratory. We met, developed a new tracking tool with new documentation requirements and benchmarked it with peers in the industry (see Figure 1).

To ensure the improvements we were putting in place were as robust as possible, the same laboratory team members that convened to address the event triage also performed an in-depth root cause analysis. This was based on feedback from our ISO 15189 assessment, in which the assessors provided insight into opportunities for improving our processes. As a result of the root cause analysis. This was the entire event process was optimized. Events were defined via a user-friendly question process map that allowed staff to quickly determine if a given situation required the initiation of an event (see Figure 2).

Additionally, the event database was rebuilt, in order to clarify what information was required and when it was required. The result was a systematic way to conduct a root cause analysis and determine the best corrective action, preventive action and effectiveness verification. The improved process enabled us to capture, investigate, document and improve our systems quickly and effectively.

The final phase of the continuous improvement effort was redefining how events were managed and discussed. Routine event triage meetings were instituted on a weekly basis starting in April 2014, and all members of the laboratory staff are invited to attend. At the meetings, new events are discussed and reviewed. The root cause analysis and corrective and preventive actions are defined, leveraging the ideas of everyone in the room. The actions taken to prevent recurrence are more robust because the solutions reflect the input of a variety of staff, all of whom bring a range of experiences to the process, including the different barriers they encounter in their daily workflows.

The medical laboratory director at National Jewish Health, who often participates in the triage meeting, is very complimentary of the process. He states that he enjoys it because “Everybody participates and has something to say. There is typically high turnout for the triage meeting, and the attendees represent all levels, from leaders at the highest level of the laboratory (ie, the executive director and the director of operations), to managers, supervisors, technical staff, pre-analytical staff, and client services. As we discuss the events, I am impressed with the positive tone of the meetings where everyone is open and encouraged to participate and offer ideas. Everybody is respectful of their coworkers’ comments and if the meetings were sparsely attended, the solutions would not be as robust.”

Collaboration that delivers effective results is a direct output of our laboratories’ efforts to continually improve under ISO 15189. Figure 3 demonstrates the continuous improvement achieved in managing open events. The ongoing decline in the number of open events (shown on the vertical axis) reflects the progress we have made in addressing issues and putting solutions in place to prevent future errors.

Click here to see Figure 3.

Client Service Phone Calls

The face of the laboratory is our client service department as they interface with our customers via telephone, email, fax and online requests throughout the day. In an effort to refine the patient and client experience, the laboratory has focused improvement efforts on the timely answering of phone calls to ensure satisfied customers.

Historically, our laboratory had unacceptably high abandoned call rates, in which clients would abandon the call before we had the opportunity to provide the assistance desired. In fact, the July 2013 abandoned call rate for incoming phone calls hovered near 33 percent. In response, the laboratory worked aggressively to lower this rate. At that time, the client services team was dispersed among various locations throughout the laboratory in two different buildings. The team answered calls, processed specimens and handled other administrative duties. Many members were dedicated to specific laboratories as opposed to the laboratory department as a whole. As such, their understanding of overall laboratory operations was somewhat limited.

To begin the journey toward process improvement, the client services staff was realigned to work under the direction of the client services supervisor, a newly created role. The supervisor and team set goals for lowering the abandoned call rate, along with other objectives, such as better metrics tracking and improved client follow up. A tool was developed to enter customer complaints. The tool was modeled on the event database discussed earlier. Having a formal tool helped to ensure that sufficient information was captured allowing staff to address the complaint and follow up with the client.

The team was moved to a central location so that the members could work side by side. Troubleshooting guides were created to provide readily available tools for the staff to answer questions fully and efficiently. The guides, in turn, helped to create better service for the clients and also led to reduced time per call as the information was now available at the teams’ fingertips. Additionally, the team began to shadow staff members in laboratories they had received several questions about, such as pre-analytical. The additional education gave the team members a thorough understanding as to how samples flow through the laboratory and provided insight into general laboratory operations. We learned that the more information and training provided, the better the service to clients, and the lower the abandoned call rate.

Tracking specific data, setting measurable goals, and focusing on improving the overall phone call experience led to an improved total abandoned call rate of only 3 percent in March, May and June 2014, with a leveling off to about 5 percent in the months following (see Figure 4). The impetus for the communication improvements was our ISO 15189 assessment; ultimately our follow-up discussions led to the provision of the best service possible for our clients.

Click here to see Figure 4.


The ISO 15189 standards are an excellent tool in the effort to continually refine excellence in the laboratory. Through internal collaboration, we have been able to create robust processes that aim to continuously improve our operations, ultimately leading to ever increasing efficiency and effective service for our clients. With our newly developed tools and communication mechanisms, we are confident in our department’s current and future capacity to deliver excellent results.


• Dawson J et al., Journey to ISO 15189 Accreditation; Clinical Leadership and Management Review. 2014 Q4 publication

• Internal Organization for Standardization, ISO 15189:2012: Medical laboratories – Requirements for quality and competence. 2012. Geneva, Switzerland

• CAP 15189 Quality Management Program. What is CAP 15189?.!%40%40%3F_afrLoop%3D1362049700229306%26_adf.ctrl-state%3Ddw8flbq5a_4. Accessed 2/9/16.

Lara Yourkin, MBA, is the director of quality for National Jewish Health Advanced Diagnostic Laboratories, a role she took in January 2014. Previously, she was senior quality manager for the Quality Control Laboratories at Amgen. Her responsibilities included working under the Food and Drug Administration’s cGMP regulations as well as regulations from multiple countries across the globe. Yourkin’s areas of professional interest include operational and quality improvements that ultimately serve the customer.

Ronald J. Harbeck, PhD, D(ABMLI), FAAM, is the medical director and laboratory director, Core and Microbiology Laboratories, at National Jewish Health Advanced Diagnostic Laboratories.

Amy Marrs, MS, is the former manager of quality at National Jewish Health Advanced Diagnostic Laboratories.

Max Salfinger, MD, FIDSA, FAAM, is the executive director and laboratory director, mycobacteriology & pharmacokinetics, at National Jewish Health Advanced Diagnostic Laboratories.


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