Before we dive into our process improvement initiative, we felt it important to share a patient story that underscores the responsibility health care professionals have to do our best by our patients. This story is a personal account from our Director of Laboratory Services, but we believe it will resonate with anyone who has been through serious health issues with a family member. This experience prompted us to turn inward to examine our own culture and then seek help outside of our own organization. To this day, we are reminded of the words our director shared with us—Every tube is a patient, and every lost specimen is a lost opportunity to provide the best care our patients deserve.
A Patient Story
“As director of laboratory services, I attend our morning lab huddle where we report on turnaround times; service concerns, such as down instruments; and service and quality issues, such as lost specimens and complaints. On this particular day, I decided to share the whole story of a lost specimen that was brought to my attention the previous evening.
Our laboratory staff and clinicians were treating a patient identified as a 72-year-old female with liver cancer who was having her CA-125 levels monitored weekly at the hospital. She had difficult-to-access veins, so she drove 40 miles each way to be cared for by the lab. Those treating her knew her levels had been rising and the decision to treat or not treat was looming; the decision would be based on this week’s specimen. But the specimen was lost. We knew it had been collected around 3pm the previous day, so when my phone rang at 6pm, I was surprised to learn the caller was not from the lab; rather, it was my mother-in-law.
She was the 72-year-old female patient, and she had just received a call from the lab asking her to come back in, as they had lost her specimen. Naturally, she was angry and extremely upset. My mother-in-law was battling liver cancer and had to decide whether to go in for another chemo-embolization. I was crushed that the lab I directed had such an impact on a patient so close to home. I could not keep from crying as I retold the story to my lab leaders in the huddle that morning.
She died 3 months later after deciding to forego further treatment.”
Overcoming a Culture of Tolerance
In 2016, a trend of lost specimens was detected at the University of Minnesota Medical Center (UMMC) laboratories. Upon investigation, we found that on average, the laboratory could not account for 6-7 specimens per week, or 25-30 specimens per month, which we deemed unacceptable for quality patient care and service (see FIGURE 1). To determine the cause of each lost or missing specimen, in October 2016, we formed a Lost Specimen Review Committee made up of front line laboratory supervisors, leads, and staff. Our qualitative data revealed that the common responses to a lost specimen were, “Just redraw the specimen,” or “Ask the provider if they still need this result” In essence, our culture tolerated lost specimens.
Despite our initial efforts to mitigate lost specimens, in June 2017, fifteen anatomical pathology specimens were lost in a single instance (see FIGURE 2). Once again, our culture was challenged and our processes revealed vulnerabilities. In response, a subgroup of the Review Committee was formed in August 2017: The Lost Specimen Project Team comprised six members with representation from the different UMMC laboratories (see FIGURE 3 – Lost Specimen Committee Template). Their mission was to propose best practice solutions for the pre-analytic phase of laboratory work to prevent lost specimens once root causes were identified.
Seek Best Practices and Develop Standards
At the outset, the Lost Specimen Project Team posited two core questions:
We determined that the UMMC culture was to avoid looking externally for help because as a university, we did not need outside help. After coming to this understanding, it was clear we needed to examine other health care organizations’ efforts to prevent lost specimens. In the fall of 2017, we committed to conducting multiple site visits at various facilities to learn how other organizations mitigated the risk of lost specimens. To support this effort, we developed a standard laboratory site visit checklist (See FIGURE 4) to ensure that the same questions were asked at each site. We then broke into groups and performed site visits with other laboratory leaders who graciously welcomed us into their work spaces. We visited all of the laboratories in our health system, multiple hospitals in the Twin Cities metro area, and two major US-based reference laboratories.
Simultaneously, we developed a Missing Specimen Checklist and Policy (See ONLINE at medlabmag.com/lostspecimens1). In order to root out lost/missing specimens instead of tolerating them, laboratory staff required a tool delineating proper investigative steps, common failure points, and processes for escalation and communication. To acknowledge the problem and indicate a desire for culture change, we changed our verbiage from “lost” to “missing” specimens. For us, a “missing” specimen could be found, whereas “lost” implied there was no hope for locating that specimen. The goal is to promote dedication to exhausting every possibility before a viable specimen is determined to be lost. Once piloted at UMMC, the Missing Specimen Checklist and Policy were shared and deployed at each of our UMMC hospital system laboratories.
In addition to the checklist, we created a standardized Pending Log Policy, which enables laboratory staff to identify when a specimen is missing and initiate the appropriate investigation. Several individual laboratory sites had their own version of pending log policies, but this new standardized document served to create uniform expectations for when and how to create urgency behind locating a missing specimen. We developed a workflow diagram to accompany the policy (See ONLINE at medlabmag.com/lostspecimens2) as a tool for real time investigation. This policy was also shared across our system through our Transportation Committee, which is responsible for ensuring all system sites are aware of courier and transport expectations.
Best Practice Recommendations
Incorporating the data compiled from our site visits, we established four major areas of focus for reducing and preventing lost specimens: facility design, couriers, staffing, and workflow. Each of these areas is dependent upon the others; one area cannot succeed without the proper functioning of the other areas. Following are the best practices we determined. Many of the steps are simple and may seem obvious, yet attention to detail demonstrates the value of basic resources to quality care and service.
Maintaining a transparent and thoughtfully organized workspace is essential to proper specimen management. In reviewing our site visit data, it was clear that a single receiving location per site coupled with open sightlines above and below work stations would improve specimen receiving and tracking in the lab.
During our site visits, we found that laboratories utilizing a single point of entry along with a designated site for courier drop offs enabled laboratory staff to efficiently triage incoming specimens. This approach ensures all expected specimens are accounted for, allows for the determination as to which specimens are time or temperature sensitive, and then permits the distribution of all specimens to their proper destinations for processing. Furthermore, those laboratories that located the functions of Specimen Receiving, Send Outs, and Blood Bank in close proximity were able to efficiently receive couriers with specimens and blood products, distribute those specimens using a first-in/first-out methodology (non STAT), and use a water spider delivery cart or front line automation line to move specimens quickly to each testing department. This system reduces the number of touches on a specimen, as well as the number of points at which an error or lost specimen could occur. See SIDEBAR for additional facility design considerations that can help avert missing specimens.
In observing the courier workflow at the various UMMC lab sites, we discovered multiple couriers arriving and dropping off samples simultaneously, often with inadequate workspace for the number of courier bags, and without sufficient means by which to sort the specimens (eg, clearly marked bins). Furthermore, there was no interfaced, real-time verification of specimen receipt (eg, bar code or RFID). At that time, the couriers were viewed as merely a means of transportation; they received no training as to the needs and requirements of the lab. Thus, courier accountability and reliability was low. In fact, the root cause analysis showed that at the time of our investigation, transport or delivery problems were the most common source of missing specimens and other deviations.
Our site visit data indicated that best practice was to employ a single point of entry with one-way directional flow for couriers to enter and then exit the laboratory. In our case, we put up a sign reading: Attention Couriers: Please, one at a time. Wait here until laboratory staff is available. Thank you. Some sites include a posted greeting card with the name of the laboratory staff member expected to interact with the courier to help encourage professional relationships and emphasize the value of interdependence. The goal is to create an environment of trust between couriers and laboratory staff to handle all specimens with care. Additional best practice recommendations include:
We found staffing the receiving area to be a recurring challenge, as our schedule did not accommodate staffing to workload or consider the appropriate mix of laboratory staff skill sets. Technical staff members were commonly pulled from testing areas to help in the receiving area and our receiving staff members were often pulled to draw blood on the patient units. Further stressing the system were high overtime rates due to open positions, turnover, and leaves of absence.
The best practice recommendations we developed include flexible staffing to workload to meet the demands of frequent and infrequent specimen receiving times, establishing dedicated receiving and send out staff, separating phlebotomy from the receiving area, and creating a Triage Greeter position to perform an in-person or “warm” hand off and warm pick up with couriers during pick up and retrieval. During these hand offs, the number of bags or individual items is conferred verbally between the courier and the greeter.
Our research revealed that the workflow in our specimen receiving areas was unevenly distributed and job duties tended to be ambiguous. Due to space constraints, we were not able to employ a true first-in/first-out methodology. Furthermore, samples often were not received test ready, but instead required additional processing.
With the aim of creating efficiency and clarity in our workflow, our best practice recommendations included the addition of tools such as a front-end receiving and processing automation line, a test tracking board for pending logs, and an LIS collection manager indicating real time specimen receiving. We also found it best to avoid placing garbage containers in or near specimen receiving areas and paths, or next to bench tops.
In reflecting upon the collective best practices we determined as a result of our site visits, we had to remind ourselves that we cannot address every single deficiency at once. Thus, we prioritized change initiatives based on the degree of impact and the resources required. Accordingly, some projects were fairly straightforward and easy to green light, whereas others required a more deliberate plan. The following is a high-level list of accomplishments to date:
Sustaining Continuous Improvement
The greatest change in our culture is that we no longer tolerate missing or lost specimens. To support this change, we continue to monitor deviations and problems in real time and during monthly Lost Specimen Committee Meetings. With robust data sources at our disposal, we are able to make small process tweaks when any gaps are identified in our systems. Most reassuring is that we now recognize when a deviation occurs, and we can categorize it to better understand the root cause.
As our missing and lost specimen numbers diminished, in early 2019, we created a standard work observation form and began using our meeting times to observe staff in each step of the specimen receiving process (See FIGURE 4). The goal is to see the work in process, coach in real time if deviations are observed, and compile any weak points that require improvement. By observing staff doing the work, leaders reinforce the standard and demonstrate the importance of proper sample handling in ensuring patient safety.
We continue to be challenged in sustaining a zero tolerance culture for lost specimens when new staff members are onboarded, as would be expected. To address this, we are currently working on a plan to ensure front line staff knows where to find and how to use existing tools in order to investigate and problem solve, even when we introduce new team members.
We appreciate the value of venturing outside our own lab to gain insight and help hone our practices through the experiences of our laboratory partners. Although this project began in 2016, we are constantly learning and fine tuning our processes to drive continuous improvement. We endeavor to keep in mind that every tube is a patient, and every lost specimen is a lost opportunity to provide the best care our patients deserve.
Kayla Fahey-Ahrndt, MLS(ASCP)CM, SBBCM, is the transfusion services manager at the University of Minnesota Medical Center (UMMC) and the University of Minnesota Medical Center Children’s Hospital. She oversees the Blood Bank, the Apheresis Donor Center, and the cellular therapies laboratories, and enjoys teaching and working with her team to find creative ways to improve. Kayla is pursuing a Master of Public Health degree from The George Washington University with a focus on health communication and public health policy.
Marya Awker, MLS(ASCP), SCYM(ASCP), is the manager of the core laboratory at UMMC. This lab functions as the central lab for the MHealth Fairview system, receiving and testing samples 24 hours a day, 7 days a week. With over 30 years of progressive experience working in the field of medical technology, she is dedicated to following organizational goals with a focus on the patient experience and safety. Marya also serves as an advocate and educator for UMMC’s SAFETY ALWAYS initiative.
Vicki Erickson, MT, is the laboratory manager for quality, safety, compliance, and regulatory affairs at UMMC and Masonic Children’s Hospital. With over 30 years of experience in the field of medical technology, she oversees quality management, safety, and regulatory compliance programs for M Health Laboratories. Vicki participates as a key member in system committees and leads more than 6 regulatory agency inspections for M Health laboratories.
Facility Design Considerations
Innovative tools, furniture, logistics, and infrastructure can be leveraged to improve the functionality of the drop off space: