How to Achieve Zero Retained Foreign Objects with DMAIC

Occasionally after surgery, foreign objects such as instruments, needles (sharps), sponges or other materials, which are referred to as "retained foreign objects," are accidentally left behind. Impaired processes such as poorly performed counts, not having a standardized process, not adhering to established protocols, poor handoffs and poor communications are common reasons cited that lead to retained foreign objects. Retained foreign objects are preventable events and are one of the 28 events that are reportable in the State of Minnesota. Estimates for retained foreign objects range from one in 1,500 surgeries to one in 18,000 surgeries. From 2003 to 2008, the Minnesota Department of Health reported 161 retained foreign objects events (ranked 2nd) of the nearly 800 adverse events reported to the state.

Mitigation of retained foreign objects is a priority initiative for the Mayo clinic. Using the Six Sigma DMAIC model, a systematic rigor was applied to define the problem and measure and analyze the historical data; tests of changes were piloted to assess impact on retained foreign objects mitigation and developed controls to sustain the gains.

In the past, whenever a retained foreign objects event occurred, the sentinel events team did analysis, identified the root cause and developed a solution for the issue. This was effective for preventing the retained foreign objects problem, but then another retained foreign objects event would occur and the discussion would center on how the new event was different from the previous retained foreign objects events. Essentially, each retained foreign objects incident was treated in isolation. Over the years, there were several fixes for each individual problem, but there wasn't a systematic approach to the issue. The sentinel events process was reactive and time consuming.

Using the DMAIC Approach: The Define Phase of the Retained Foreign Objects Project

The team decided to use the structured Six Sigma DMAIC approach to look at the retained foreign objects problem. The retained foreign objects initiative was led by a multi-disciplinary team and consisted of surgical, nursing and administrative leadership from surgery (Mayo Clinic Rochester has about 100 operating rooms). The team was in charge of its main goal of eliminating all retained foreign objects. Team members were selected based on their knowledge and expertise, including front-line staff, radiologists, anesthesiologists, surgeons, process improvement experts, sentinel events analysts, financial services and human factor experts. The goal of the retained foreign objects project was in alignment with the primary value of the Mayo Clinic: "the needs of the patient comes first"; the mission: "to provide the best care to every patient, every day, through integrated clinical practice and research"; and the vision of the organization: "to be the premier patient centered academic medical organization." It is important for the Six Sigma DMAIC process to be aligned with the strategic and tactical goal of the organization to get the necessary resources.

The zero retained foreign objects goal was seen as a "stretch goal," but it was not impossible; and early on the team members committed time and resource to this important retained foreign objects initiative. Getting the support of the leadership as well as the front-line staff working in the retained foreign objects project is a key pre-requisite to ensure success for the Six Sigma DMAIC framework. It is also important to identify the key stakeholders for the process and develop a communication plan early on in the process to obtain buy-in and support.

Once the team was formed and the goal was established, the next step was to measure the current state of the process, benchmark internally and externally, collect data and do process observations. We will take a closer look at the Measure phase of the Six Sigma DMAIC framework in the next column.