Editor’s note: This article was adapted from a paper submitted toward fulfillment of the requirements of Fellowship in the American College of Medical Practice Executives. Learn more about ACMPE certification: mgma.com/acmpe.
Imagine receiving a call from your doctor telling you that you do not have cancer after all. For most of us, a call like this would bring great relief. But imagine if the call came 48 hours after you had your right breast removed due to a cancer misdiagnosis.
Across the country, patients are subjected to treatment, surgery and unnecessary visits to specialists due to lab labeling errors. The impact of these mistakes speaks to more than the misdiagnosis; it speaks to a larger problem that starts the moment the patient arrives for the visit. Properly identifying the patient and protecting the integrity of specimens means that protocols, safety processes and workflows must be in place, standardized and followed with every patient, every visit, every time.
Healthcare professionals promise to do no harm, yet specimen labeling errors have caused unnecessary and preventable damage to patients and healthcare organizations alike. One egregious error could financially doom a practice while at the same time cause human suffering that is impossible to repair. David E. Newman, PhD, associate professor, Johns Hopkins University School of Medicine, wrote that labeling mistakes are “… more evidence that diagnostic errors could easily be the biggest patient safety and medical malpractice problem in the United States. There’s a lot more harm associated with diagnostic errors than we imagined.”1
The Joint Commission has implemented a national patient safety goal designed to eliminate this problem by improving the accuracy of patient identification.2 Most hospitals and outpatient clinics have policies designed to adhere to The Joint Commission’s safety goal; however, having a written policy is not enough to ensure the protection of patients from harm. If staff and providers are not equally engaged in following protocols and workflows, harm will happen.
The struggle is real
In 2003, a woman in St. Paul, Minn., was told she had breast cancer. Her doctor advised her to undergo a double mastectomy, a radical yet life-saving surgery for someone with her type of cancer.3 The patient complied with the medical advice and had the recommended surgery. Two days later, she was told there had been a mix-up with her biopsy and she had been misdiagnosed. The physical and emotional harm from the misdiagnosis had been done. The patient’s biopsy specimen was placed in the same tray with another patient’s biopsy, which caused a cascade of errors and immeasurable emotional suffering.
A similar error occurred in 2017 when a gentleman from Abingdon, Md., received word from his provider that his biopsy indicated he had prostate cancer.4 In this instance, the patient took a few days to research his options, which turned out to be his saving grace. Two days after his diagnosis, he was informed that his biopsy had been mixed up with someone else’s specimen.
Stephen E. Kahn, PhD, professor of pathology, Loyola University Medical Center, wrote that “many continuous quality improvement (CQI) opportunities exist with these components of the total testing process, since the final goal is to ensure that the appropriate specimen type is collected in the appropriate specimen container at the right time from the correct patient. Accurate patient identification is thus fundamental and cannot be taken for granted.”5
Plenty of harm to go around
On the other side of this issue are the patients who receive a call or letter stating their tests were normal or negative. This type of error can be just as upsetting and sometimes even more devastating. An article in the American Journal of Clinical Pathology states that “labeling errors can result in inappropriate therapy or the withholding of therapy in patients with unrecognized malignancies. Such errors may result in significant patient inconvenience or harm.”6 The patient who receives news misinforming him or her of a normal test result is now effectively denied potential life-saving treatment. When a patient receives notice that all is well, they rarely second guess it.
In Kahn’s 2010 Loyola University study, it was determined that the average cost of a lab labeling error is $712.7 This monetary cost is difficult to measure due to the many different types of specimens collected, but it is the human cost that is more difficult to quantify. Sometimes it is a jury or a judge that determines what a patient should be compensated when medical errors such as the ones described above occur.8
Some law offices now advertise services and specifically solicit patients who suspect they have been harmed due to a labeling error. This alone should be concerning to all healthcare professionals, that law firms have a lucrative reason to advertise their services regarding possible lab mistakes and mix-ups.
What can be done?
The University of Colorado Hospital (UCH) implemented several training objectives and processes to reduce labeling errors in its hospital. UCH created a specimen collection and handling guide that includes a test catalog outlining laboratory and labeling guidelines according to the type of specimen collected.9 In 2016, UCH also implemented the tagline “Get It Straight” to remind clinic staff how to accurately adhere a label to a specimen container.10 These types of initiatives engage staff while driving change that positively impacts patient safety.
Legacy Health and Kaiser Permanente have also built clearly defined workflows and processes in accordance with The Joint Commission’s primary goal to “use at least two patient identifiers … when collecting blood samples and other specimens for clinical testing. …”11,12 These are just three examples of large healthcare entities that established clear and simple steps to protect the safety of their patients and the integrity of the labeling process.
Even with the above examples, the question remains: Is this enough? If staff and providers do not sense the urgency of the situation, what will motivate them to take the steps needed to improve accuracy? Can a written procedure make a difference, or is there another way?
Healthcare administrators have found that simply reminding staff to “be careful” or to “pay attention” when labeling a specimen is not enough to avoid errors. Furthermore, solely having written policies and procedures is not adequate to reduce errors. In fact, staff do not always take personal ownership or assume accountability for the process, which could be the origin of the error.
Outpatient labeling process revisited
Due to an 8% lab labeling error rate, one outpatient women’s clinic on the West Coast did a complete overhaul of its labeling process to address staff’s nonadherence to labeling standards. The project was implemented after the practice manager noticed an increase in labeling errors that continued to increase month after month over one year. To determine why errors and mistakes were occurring regularly, the practice manager studied the clinic’s labeling process and found that although there were clear written procedures specific to lab labeling, each medical assistant (MA) and nurse developed his or her workflows, which were inconsistent at best. Relaxed attitudes and a seeming disregard for policy compliance pointed to a probable culprit of the increasing labeling errors. Some of the observations included:
- Transporting of specimens throughout the clinic was relaxed.
- Batching labeled and unlabeled specimens at the nurse’s station until lunch or the end of the day was routine.
- Several unlabeled specimens from different patients were grouped together with little or no identifying information.
- Staff members felt they could keep track of which specimen belonged to which patient based on his or her workflow process.
- Methods for resolving potential confusion about which specimen belonged to which patient differed among MAs.
Specimen integrity was not first priority for clinical staff. In fact, staff often felt pressure from providers to move quicker, turn rooms around faster and pick up the pace in general. These pressures routinely caused patient safety to take a back seat. Efficiency began to trump accuracy, which created risk for the patients.
Changing a culture
The first obstacle to overcome was to identify the specific barriers causing the clinical staff to not prioritize patient safety. The ultimate goal for staff was to turn rooms over as quickly as possible, but efficiency was a pseudo result. If staff felt they did not have time to slow down enough to ensure labs were labeled correctly, they did not have time to revisit the same specimen again when errors occurred.
In a busy, 19-provider clinic with a 1:1 MA-to-provider staffing model, the other glaring obstacle to overcome was staff resistance to change. Clinical staff used the providers as justification to avoid changing their workflows using rationalizations such as:
- “My provider likes me to follow this workflow.”
- “That process does not work for us. He is the busiest provider in the clinic.”
- “Clearly, management does not understand how busy my doctor is.”
The best way to begin the course of change was to first enlist the providers in the process. Change can happen quickly, but to make it last, you need the right people on the bus.
During regularly scheduled, all-provider meetings, labeling error statistics were shared with the providers to alert them to the overall error rate and impact on the patient and clinic. Items addressed during the meeting included:
- Labeling inconsistencies; e.g., wrong patient name, wrong date of birth, no label, illegible handwritten labels and mismatched specimens
- Nurse and MA workflow inconsistencies
- Pressure felt by nurses and MAs to turn rooms over quicker
- Seemingly relaxed attitudes related to labeling specimens.
It was not surprising to hear that patient safety was a top priority for all providers. Furthermore, many of them were not clear where the misconception came from that they were not willing to change their workflows to improve patient safety. The majority were uncomfortable with the percentage of labeling errors reported and felt it was important to get to the heart of the issue and implement necessary change.
Two provider champions were enlisted to take part in rewriting workflows and policies. The group recommended the formation of a lab-labeling, process-improvement committee to begin the implementation of meaningful and sustainable change.
The beginning of change
Having physician champions was a key element to the realization of the project. In light of the fact that clinical staff will follow their lead, this component was likely to be the basis of triumph or failure. Another key element to successful implementation involved enlisting individual contributors who would be directly affected by the changes.
Other departments were leveraged to assist with the process and to help determine what primary objectives would guide the team to the best outcome. Workflow changes and process improvements can be difficult, particularly when people are being asked to meet a higher standard. To avoid the pitfalls of process fatigue and conflicting objectives, it was vital to remember the audience in this process — the patient. Using this as the heart of the project, committee members were selected and objectives were outlined.
With the framework and process-improvement committee in place, the real challenge was still ahead. As discussed, a written document is a great start, but more work was needed for significant change to take hold. It was time to begin the training phase.
To avoid training burnout, it was essential to make training fun, informative and impactful to create the best odds for success. It was also vital to communicate with all providers and staff the reason for the impending change.
Touch their hearts and the mind will follow
To explain the “why,” a training video was created illustrating real-life scenarios in which labeling processes went wrong. The video included patient impact stories involving labeling mistakes that caused significant harm and how the patient was affected by the error.
The training video took the staff through the entire new labeling process from check in to check out. Staff and providers were used as “cast members,” which brought an element of fun to the process. Following UCH, Legacy and Kaiser’s lead, the video demonstrated the step of asking the patient to verify demographic information at check-in. The patient was asked by the MA to verify each printed label to confirm that his or her name and date of birth were correct, in line with The Joint Commission’s goal.
To complete the labeling process, the video demonstrated ownership of the specimen by following the MA as he added his initials to each patient label, affixed the label to the specimen in front of the patient, put it into the specimen bag with the correctly labeled requisition and walked the specimen from the exam room to the lab drop-off location without interruption. After watching this portion of the training video, the staff created their own tagline of “You collect it, you label it, you transport it, you own it.” The last part of the video showed the MA shredding the unused label.
Having seen a mock walkthrough on video, it was time for practical training. Every clinical staff member was given a fake name and placed on the clinic schedule. Each employee went through the process of checking in for the fake appointment, which included reviewing demographics with the front office and waiting to be called back to a room by the fake name. They went through the entire process a patient would experience including verifying their label and watching as the MA, nurse or phlebotomist went through each step as outlined in the video. Every MA and nurse had the opportunity to practice as both the patient and the staff member. Providing hands-on, practical training was a vital step in the teaching process.
What could go wrong?
One of the key performance indicators used as a measurement for success was the labeling error rate, which is quantifiable as laboratories are mandated to report back to the clinic if there are any discrepancies on the specimen label. For the first few weeks after initial training, labeling errors were reduced. However, after a couple of months, the error rate began to creep up again. Some of the same mistakes were beginning to take hold such as no labels, handwritten labeling, batching specimens at the nurse’s station and mismatched specimens. A cursory observation revealed that old habits die hard. It became apparent that there were still several staff members who were not implementing the new workflows and changes outlined in the policy and training.
Critical steps for sustained success
As mentioned, a written document cannot inspire meaningful or sustained change on its own. It takes action, continued monitoring and transparent communication for change to take hold. To ensure the labeling process was consistently adopted and maintained by all staff and providers, more steps needed to be taken to create positive momentum:
- Lab labeling workflow discussions were added to the beginning of every bimonthly all-staff/provider meeting. Open discussion was encouraged to uncover any concerns, workflow discrepancies or unintended consequences of the new process.
- Finding legitimate reasons to celebrate successes and recognize outstanding achievements were implemented. MAs, nurses, phlebotomists and front office staff were rewarded for having a “perfect record” over a specified period of time.
- Reviewing the new labeling policy often and reminding staff of key performance indicators that impacted annual reviews became routine.
- Training new staff in the labeling process was key. Mentors were assigned to follow all new staff members for a period and pass them off when proficiency was achieved and observed.
- Staff were held accountable when errors occurred or when workflows were ignored.
Once the above initiatives were implemented, lab errors were virtually eliminated. The initial error rate of 8% was reduced to less than 1% over a period of 12 months. The ultimate goal of improving patient safety through stringent yet achievable labeling processes was realized. Staff became proficient in the process and began to embrace the redundancies surrounding the new labeling workflow. One nurse remarked, “Never deviating from the process, even when I am familiar with the patient, makes it less likely I will make a mistake.” The tagline, “You collect it, you label it, you transport it, you own it,” was often heard in the hallways.
No quality improvement initiative is ever without problems. There were several staff members who ultimately did not meet the bar. This resulted in written warnings and two terminations in accordance with the new lab labeling policy. These were the exception and not the rule.
Adopting a process of continued communication and recognition seemed to be the missing link in the overall success for this outpatient women’s clinic. None of the measures taken were extraordinary or innovative. The key to their success was combining a written policy with practical training and ongoing discussion. Written documents are helpful, but they are not dynamic. They provide vital information, which can often be open to interpretation. Bringing the policy to life through real-life scenarios, engaging the right people, finding fun in the process and celebrating accomplishments proved to be the recipe for their success.
Healthcare is a profession like no other. It is a relationship built on trust and open communication. From the moment a patient selects a provider, he or she is embarking on a relationship that should be met with honor and respect. One of the key components to realization of this goal is to remember whom we serve. The patient is our priority, and it is our responsibility to provide quality care at every visit, every time. Patient safety is of the utmost importance.
It is likely that most patients do not give it a second thought when they leave a specimen behind. The expectation that it will be correctly identified and protected is assumed. When patient safety and specimen integrity is not at the forefront of the healthcare worker’s mind in every encounter, significant harm can be done.
By coupling policies with a culture of safety, it may just be the perfect combination for eliminating error and improving patient outcomes. This is the least healthcare workers can do for the patients who put their trust in them.
- Iannuci L. “Medical test results pose serious risk.” Poughkeepsie Journal. June 1, 2014. Available from: bit.ly/2loGLF7.
- The Joint Commission. “National Patient Safety Goals Effective January 2017.” Available from: bit.ly/2mnRUpY.
- “Breasts removed by mistake; paperwork slip-up blamed.” CNN. Jan. 21, 2003. Available from: cnn.it/2mXX6kA.
- Kolata G. “The lab says it’s cancer. But sometimes the lab is wrong.” The New York Times. June 26, 2017. Available from: nyti.ms/2n8iIut.
- Kahn SE. “Specimen mislabeling: A significant and costly cause of potentially serious medical errors.” Acute Care Testing. April 2015. Available from: bit.ly/2lwECHH.
- Layfield LJ, Anderson GM. “Specimen labeling errors in surgical pathology.” American Journal of Clinical Pathology, 134(3), 466-470. doi: 10.1309/ajcphlqhj0s3djfjk.
- Delaney BJ. “Legal review and commentary: Mislabeled blood sample leads to inappropriate diagnosis of HIV, $20,000 settlement, and $52,000 verdict.” Healthcare Risk Management. March 2007. Available from: bit.ly/2luaTPz.
- University of Colorado Hospital. “Specimen collection and handling guide.” Available from: bit.ly/2lasnQQ.
- University of Colorado Hospital. “Get it straight.” Available from: bit.ly/2lxV4Yb.
- “Labeling specimens.” Legacy Health. Available from: bit.ly/2l8MsXG.
- “Labeling of laboratory specimens policy.” Kaiser Permanente NW Laboratories. Available from: k-p.li/2ndfXZ4.