A recent study by Johns Hopkins Medicine caught the attention of Doug Beigel and his colleagues at COLA, the Columbia-based national laboratory accreditor and advocate for quality in laboratory medicine and patient care.

That’s not unusual, but this study was different — and for an eye-popping reason: The findings revealed that, if medical errors were tabulated similarly to diseases, they would rank as the third leading cause of death in the U.S. with more than 250,000 each year, behind only heart disease and cancer.

Assessing such figures is COLA’s function, and the double-take was necessary, since most people would want to know if that figure is real.

“Our side of this equation is the human side,” said Doug Beigel, CEO of COLA, the largest private laboratory accreditor in the nation, serving nearly 8,000 labs.

“We care about the competency of the people who take the samples and interpret the data,” he said. “We care about the patients who will be impacted by those results. We have to worry about how accurately labs are evaluated, and the ongoing competency and training of technical lab workers, and even non-lab workers.”

Similar Report

The Hopkins study, which was recently published in The BMJ (formerly the British Medical Journal), indicated that most medical errors represent systemic problems, including the absence of safety nets and standard protocols, poorly coordinated care and human error. The researchers conclude that shortcomings in the International Classification of Diseases (ICD) coding system for cause of death have concealed the severity of the problem, and hinder the ability to both cultivate and fund system-wide solutions.

In 2015, the National Academies of Sciences, Engineering and Medicine (formerly the Institute of Medicine) issued a similar report, entitled Improving Diagnosis in Health Care, which asserted that most people will experience at least one diagnostic error in their lifetime.

“What caught my attention with the Hopkins article was that, from my perspective, laboratory medicine plays a key role in diagnosis and patient outcomes,” said Beigel. “It is estimated that 70% of all diagnostic decisions are based on the results of laboratory tests. If you don’t do the test right, it can lead to adverse patient outcomes.”

“There is so much going on in health care that sometimes we’re not focusing on the simple things,” he said. “Now for instance, under federal law, there are no personnel requirements to perform waived tests. In other words, individuals performing these tests don’t even need a high school diploma. These point-of-care tests have a reputation for being relatively error-free, but unfortunately, are not immune to human errors.

“There is much demand about the needs of physicians at this point. So what I interpret this Hopkins study to say is, we need to stop and take a look at the protocol, don’t take things for granted and aggressively measure the effectiveness of what you do,” said Beigel. “Quality starts with each of us.”

15 Years Ago

Those words were echoed by Tyler Cymet, past president of Med Chi, the Maryland State Medical Society. “The human cost and pain that results from any kind of medical error is huge,” he said. “In medicine, patient safety is considered a core competency that is expected from every physician, and every medical school includes education and training in multiple issues falling under the category of medical error.

“Better communication and teamwork, constant analysis of actual errors and near-misses, and technology and checklists use are some of the tools being used to minimize medical errors,” Cymet said.

Renee Demski, vice president of quality for The Johns Hopkins Hospital and The Johns Hopkins Health System, said the results of the Hopkins survey were “interesting, because the Institute of Medicine report about 15 years ago had a similar message,” as it revealed about 100,000 deaths due to medical errors. “So, we’d been focusing on preventing this type of problem” from worsening.

“Here at Hopkins, we also have a Comprehensive Unit-based safety program, where staff meets with the respective units to talk about safety issues and try to prevent them before they happen,” Demski said.

She added that Howard County General Hospital (HCGH), specifically, uses a reporting system called HERO, where staff members present data to quality committees and the themes are identified and discussed. Then education is provided as a follow-up.

Demski noted that, in 2015, HCGH was named the top performer by The Joint Commission, which accredits more than 21,000 health care organizations and programs in the United States.

‘Struck by Cow’?

Dr. Michael Daniel, a resident in internal medicine at The Johns Hopkins Hospital, Baltimore, explained how the study was conducted.

“What we did was look at the recent medical research studies on the lethality of medical errors. Using those studies, we created a point estimate, which is how we came up with the 250,000 number,” said Daniel. “The reason this information was not previously included is that the numbers are created using death certificates, which use ICD 10 codes.”

Apparently, it might be an idea to update the code listing options. “There are code listings for things like ‘Struck by Cow’ (W55.22), but it does not account for medical or systems errors,” he said. “What that says to me is that it isn’t a priority for the [Centers for Disease Control and Prevention] (CDC) to incorporate medical errors into the list or the profession/public doesn’t care to know.”

What Daniel and his colleagues would like to see on the death certificate is an option to “tabulate the errors using real-time information that we use when we report deaths by heart disease or cancer, for instance,” he said. “Oddly enough, these are updated fairly frequently.”

The Hopkins study comes down to the idea that human error is not considered, and “we have to figure out how to make that tabulation,” Daniel said. “Now, discussions on medical errors are done in secret, behind the closed doors of each individual hospital. It’s not until we make this topic public that we can learn from it.”

While litigation is an obvious concern when discussing making medical errors public knowledge, that leaves two options, Daniel said. “One option is not to broadcast the fact that errors occur, which leads to less litigation; however, people would continue to be harmed by medical errors. The second is to broadcast that medical errors occur. This will increase litigation, but we, as a society, will learn from the errors and use what we learn to save lives.”

To make his point about what needs to happen, he offered this analogy.

“Think of it this way,” he said. “You put your card in the ATM and the money comes out at the same time your card comes back, but you walk away without your card; at another ATM, you have to take the card back before you get the money.

“That’s kind of what we’re hoping for here. In the first situation, you could have walked away without the cards; in the second, you can’t do that. We need a similar system in medical care, because we are human, and we will make mistakes,” said Daniel. “The idea is to create a system that leads us toward making less of them.”

What to Do

Daniel said the next step in addressing the matter has already been taken.

“Our research group sent an open letter to the Centers for Disease Control and Prevention so we can improve the Death Certificate form and get everyone on board [care providers, community, politicians, etc.],” he said, “so we can make the proper effort to stop this.”

What patients can do, he said, is be a big advocate of their own health care. “They need to learn about the meds they’re taking, and maybe bring a family member or close friend along to appointments to encourage the conversation with the doctors.”

And that, hopefully, will also lead to more accurate tests.

“We think there have to be higher standards for certain laboratory jobs,” said Beigel. “We are seeing the continued rise of these Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver testing sites. In 1988, when the CLIA law was passed, there were only a couple of thousand across the country; now there are more than 165,000 Certificate of Waiver sites (accounting for 70% of all laboratories in the United States).

Moving forward, he said he’s “not fearful.

“I think the Hopkins report will help bring more attention to this issue,” Beigel said, “and that some good things will come from it, as the health care community begins to create sustainable solutions.”