Diagnostic errors, like delayed or missed diagnoses, pose a significant threat to patient safety. But the good news is, they are largely preventable, so long as the U.S. healthcare industry adopts a total system safety approach, according to Marcus Schabacker, M.D., Ph.D., president and CEO of patient safety nonprofit ECRI.
"In the United States, we lose about 45,000 to 100,000 patients every year due to preventable medical errors," Schabacker said in an interview, citing the seminal "To Err Is Human" report. "If you compare this proportionally to aviation, that would mean that in the United States, every single day, two airliners crash with a hundred percent fatalities. What do you think would happen if that actually happened for two days in a row? No airplane in the United States would take off anymore."
It's not as if healthcare can simply halt operations until it can completely eliminate its patient safety problems, but Schabacker and his colleagues at ECRI suggest that the industry does need an overhaul.
But still, that 65,000 number is too high, Schabacker argued, and it is incumbent upon healthcare leadership to chip away at those problems in the highest yield area.
That might mean starting with diagnostic errors.
"There are about 800,000 Americans each year who experience permanent disability or even death due to misdiagnosis of a dangerous disease or disease state," he pointed out, citing figures from this study. "That number alone indicates that that is a serious problem we've got to tackle."
According to ECRI, diagnostic errors are defined as "incorrect diagnoses after clinical examination or technical diagnostic procedures."
Schabacker said diagnostic errors, which can include missed, incorrect or delayed diagnoses, often start a chain of adverse patient safety events. If the diagnosis is wrong, then treatments will be wrong. If a diagnosis is delayed, then treatments will be delayed.
Rooting out diagnostic errors
Rooting out diagnostic errors will require healthcare leaders to understand the primary causes of these errors. In nearly every case, it's not a doctor misinterpreting results.
Instead, diagnostic errors are usually attributable to process errors.
Almost 70% of diagnostic errors actually occur during the testing process, Schabacker said, citing numbers from the ECRI database. This includes when tests are ordered, when samples are collected, when the samples are processed, when the results are obtained or during the communication of results.
This is all very preventable, Schabacker argued. With extra analysis of where the process breaks down and where most errors occur, healthcare organization leaders can create a total system safety approach.
"That's when we talk about our total system safety approach, which is using clinically informed human factor engineering approaches to look where mistakes actually can happen and then put redundancies, processes, cognitive aids or visual aids in place to make sure that people are doing the right thing every single time," he explained.
Humans are fallible, he continued. Statistically speaking, if a human were to complete a repetitive task, they'd get it right 80% of the time and get it wrong 20% of the time. But if health system leaders can identify where failures most often occur, they can take steps to intervene.
Engaging the system team to boost patient safety
There isn't a single hospital or clinic staff member who should not be involved in patient safety improvement, Schabacker explained, but the momentum for these efforts needs to come from the top.
"It really starts with leadership," he asserted. "It starts with the acknowledgment that our healthcare systems today are not perfect and that we, as humans, will fail. Hence, we need to design the system in a way that it knows where those failures can happen and then put safeguards in place so they don't happen."
We need to design the system in a way that it knows where those failures can happen and then put safeguards in place so they don't happen.
Marcus Schabacker, M.D., Ph.D.President and CEO, ECRI
Leadership buy-in is crucial because patient safety improvement requires a shame-free culture of accountability. All staff members need professional and psychological safety to identify mistakes and bring them to light.
In fact, that kind of transparency needs to be celebrated and rewarded, Schabacker said, and that can only happen if the hospital's leadership shirks the "shame and blame" culture that often pervades professional spaces.
"Let's analyze where the highest likelihood for error is and then make it acceptable that these mistakes are talked about, that they're not addressed with a shame and blame culture, but that they're seen as a learning opportunity to prevent further instances and then instill an agile learning system in this organization where near misses are celebrated," Schabacker urged.
This doesn't just mean the doctors and nurses working in a facility, either. Schabacker mentioned that every staff member, from administration all the way to environmental and custodial services, has a role to play in flagging potential errors.
"Each one of them, and I really mean each one of them, the person who cleans the room, the person who delivers the food, the person who is transporting the patient from one place to the other, they're all part of the care team, and they often see a lot of things, but they don't dare to speak up," Schabacker pointed out. "They don't have a medical degree. So how do we create this environment?"
"That's a question to the leaders," he added. "My workforce must be empowered to speak up, respected for what they have to contribute and seen as an equal in the care journey."
From there, healthcare organizations can pinpoint frequently made errors and rethink the processes that go into different tests or services. Without pointing fingers, healthcare organizations need to be able to think critically about how they can improve upon the errors and mistakes they have made in the past.
But it's not just the staff members who need engagement and encouragement to speak up. According to Schabacker, patients also play a critical role in their own safety.
Putting the 'patient' into 'patient safety'
In an age of value-based care and healthcare consumerism, it might not be shocking to consider the patient an engaged member of the clinical care team. But healthcare organizations still need to create an environment where patients truly feel like experts in their own care so that they can speak up when they sense something is wrong.
"You wouldn't believe how many patients are too afraid to challenge or even ask a question," Schabacker stated. "And that's why, from a total system safety approach, we need to include the patient and the caregiver as part of the solution."
In an ideal world, patients would feel comfortable asking their clinicians to elaborate on their care plans to explain why they need a certain test. Patients who proactively seek that kind of information might be more likely to notice -- and, importantly, speak up -- when a testing error is about to occur.
But healthcare is rife with power hierarchies, including some that affect the patient-provider relationship. Although patient empowerment is becoming a bigger and bigger priority in healthcare, it can still be hard for patients to feel comfortable speaking up to their doctor, who they expect to be the expert in their care plans.
Again, this goes back to the culture of safety that is spearheaded by hospital or health system leadership. Healthcare providers who remind patients that it's okay to ask questions, establish a strong sense of trust with patients and regularly engage patients or account for their preferences might see patients ultimately feel more comfortable participating in patient safety efforts.
Emphasizing equity in patient safety
As with most parts of the healthcare journey, patient safety rates face steep health disparities.
According to a 2023 report from the Leapfrog Group and Urban Institute, patient safety faced steep racial health disparities even at the top-rated hospitals. Although top-rated hospitals had overall better patient safety rates than lower-rated ones, patient safety challenges were comparable for traditionally marginalized races at all organizations.
Similar trends occur when breaking down patient safety by other demographics, like gender or sexual orientation/gender identity, according to Schabacker.
"The unfortunate truth is we can't fix patient safety if we do not fix health inequities," he said. "And it's a sad fact that in this country, which spends the most in healthcare per capita, the care and the care quality are distributed quite inequitably."
The reasons behind these inequities are as multifold as the mistakes that are happening, Schabacker said, but one of the most common themes is implicit bias. Mindsets such as patients of different races having different pain thresholds can quickly turn into missed or inaccurate diagnoses.
As part of an organization's overall effort to promote patient safety, Schabacker recommended leadership look at what they are doing in terms of health equity: Does the hospital employ a diverse medical workforce? Can it enable patient-provider racial concordance? What about language access?
The answers to these questions are important because they account for the linguistic and cultural backdrop that can promote better patient-provider communication and, therefore, better opportunities for patient safety.
These recommendations are not promotional for ECRI, Schabacker stressed. The nonprofit aims to make healthcare safer, better and more equitable without pointing fingers or promoting a certain product or ideology.
"I, as a clinician, like every other clinician, have sworn an oath, and that oath is to do no harm," Schabacker concluded. "And still, we do harm every single day, and we have to get better. We owe it to ourselves, we owe it to our patients, we owe it to our society, and that's what we're here for. That's what we want to talk about."
Sara Heath has covered news related to patient engagement and health equity since 2015.
