Panel of webinar speakers included several physicians, a pathologist, and a director from the Food and Drug Administration (FDA)

Patient safety continues to be a major factor in the ongoing transformation of healthcare in the United States. As it does, more scrutiny is being given to how medical laboratories and anatomic pathology groups can contribute to improving patient safety.

One example of the heightened scrutiny of patient safety as it relates to clinical laboratory testing services was a recent webinar at the Harvard T.H. Chan School of Public Health and the online healthcare site, Stat. Titled “Medical Tests: Inaccuracies, Risks and the Public’s Health,” this webinar featured nationally-known healthcare experts and policy makers.

Issues of patient safety associated with medical laboratories was a major topic during this webinar, including discussion about concerns associated with the clinical use of laboratory-developed tests.

Why Is Medical Laboratory Industry Slow to Adopt Patient-Friendly Services?

The webinar featured patient safety expert Lucian Leape, MD, who is a member of the Institute of Medicine’s Quality of Care in America Committee; the Founding Chair of the Lucian Leape Institute of the National Patient Safety Foundation; and an Adjunct Professor of Health Policy at the Harvard T.H. Chan School of Public Health.

Leape took the medical laboratory industry to task for being slow to adopt patient- and physician-friendly services that most consumers take for granted. He illustrated this point by noting that when Amazon delivers a package to his home or office, he gets an alert on his smartphone. So, why can’t physicians get similar alerts about critical laboratory test results, he asked.

“With regard to the problem of critical test results, we want an immediate and fail safe system,” declared Leape. “What’s the big deal? We should just do the obvious and take care of those things.

“Also, I’m old fashioned, but I think that when the pathologist finds that the patient has a diagnosis of cancer, that pathologist ought to pick up the phone and call clinician right then,” recommended Leape. “Why that doesn’t happen? These are the issues that we need to explore at the local level.”

Suggestions for Pathologists and Clinical Laboratory Professionals

During the webinar, Leape and his co-presenters offered a number of suggestions for pathologists and clinical laboratory professionals about how to prevent patient harm. They recommended more teamwork among pathologists, treating physicians, consulting specialists, pharmacists, and even patients themselves. They also recommended finding ways to introduce more guidelines into electronic health record (EHR) systems to support appropriate laboratory testing, and finding ways to make communication within hospitals and health systems more efficient.

Among the webinar speakers was Alberto Gutierrez, PhD, Director of the U.S. Food and Drug Administration’s (FDA’s) Office of In Vitro Diagnostics and Radiological Health. Gutierrez explained why the FDA is pursuing oversight of laboratory-developed tests and why the FDA produced a 39-page report in November titled, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies”. The agency believes it has enough evidence to demonstrate harm to patients from laboratory-developed tests (LDTs), he said. (See The Dark Report, December. 28, 2015.)

In addition to Gutierrez and Leape, the other webinar presenters were Aaron S. Kesselheim, MD, JD, MPH, an internal medicine specialist and Associate Professor of Medicine at Harvard Medical School, and Director, Program on Regulation, Therapeutics, and Law, Brigham and Women’s Hospital; and Ramy Arnaout, MD, PhD, an Assistant Professor of Pathology at Harvard Medical School, Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center (BIDMC), and a staff pathologist at the BIDMC.

Lucian Leape, MD, delivering a keynote address to members of Vanderbilt’s Quality and Patient Safety Pioneer Program at Vanderbilt University Medical Center in 2012. (Photo copyright: Susan Urmy/Vanderbilt University Medical Center.)

Lucian Leape, MD, delivering a keynote address to members of Vanderbilt’s Quality and Patient Safety Pioneer Program at Vanderbilt University Medical Center in 2012. (Photo copyright: Susan Urmy/Vanderbilt University Medical Center.)

How Hospitals Can Improve Patient Safety Associated with Lab Testing

During the webinar, Leape, was asked to speak about how hospitals and health systems can improve patient safety related to clinical laboratory testing and to comment on the need for FDA oversight of LDTs. In his remarks, Leape did not address the issue of LDTs much except to make a comment about the nine-year timeframe that the FDA has suggested for implementing its risk-based proposal for oversight of LDTs.

Earlier in the webinar presentation, Sharon Begley, a senior editor at Stat, had showed a short video about a couple who got a false-positive result from a prenatal LDT screening test that was emotionally devastating to them. These parents were critical about how their physician and other clinicians had explained the test to them. They said they were unprepared for the false-positive result.

Leape spoke to that episode, saying, “From the point of view of the patient, I have to say, when you [Gutierrez] said nine years out [for full implementation of LDT oversight by the FDA], I thought—‘Wow!’ What would that couple who we saw think about that? And how many more couples like that who have that problem [associated with a lab test result] will have a similar experience as that one couple before the nine years is up? I’m sorry, nine years is not acceptable.”

In addition to this comment about LDTs, he also had several specific suggestions about how to improve medical laboratory testing in general.

Overuse of Clinical Laboratory Testing Raises Costs and Increases Risk of Harm

“I’ll try to put this into the perspective of patient safety, which, of course, is preventing patient harm,” stated Leape. “Overuse of testing is a very major cost issue and it certainly puts patients through unnecessary procedures, but not a lot of people are actually harmed from overuse of laboratory tests.

“Many patients get harmed from the other types of misuse,” he continued. “When the whole patient safety movement started, we did a major medical practice study here at the Harvard School of Public Health. We found that 23% of all the errors that we discovered that caused harm to patients were related to the use of tests. It was a very major percentage of the whole picture. Only 10% were due to medication errors for example. So, there is a big potential for hurting people.

“Now it is also important to emphasize that the actual performance of drug tests, urine tests, bacteriology, and those sorts of tests is incredibly accurate,” added Leape. “Studies have shown that the error rate in a blood count or chemical determination is about two in 1,000, which in the trade is called five sigma. If we could get one tenth of that rate in everything else we do in healthcare, we would be delighted. So, the folks in the labs do a fantastic job.

Problems Are Often Pre-Analytical and Post-Analytical

“It’s what happens before and after [the lab test] that is the problem,” he explained. “And there are basically three areas where patients get hurt from misuse of testing. The first is related to the underuse problem, and that is that you did not get a test that you really needed. For example, a patient in the ER has chest pain and doesn’t get a cardiogram. Or the patient who has new onset cough and trouble breathing and some fever and doesn’t get a chest x-ray. That turns out to be a very significant portion of the problem.

“On the other side, once the test gets done, then what happens? It turns out that a significant number of tests do not get followed up with a proper response [by physicians],” noted Leape. “This is largely a communication problem. The test result doesn’t get to the right doctor in a timely fashion and sometimes the outcome can be absolutely disastrous.

“If we’re talking about critical test results, which is a term we use for medical laboratory tests for which the result can make a difference in providing treatment that can be literally life-saving, time is truly of the essence. For example the patient has a potassium level of 11. That’s the kind of thing that the doctor needs to know right away. If a biopsy shows a patient has cancer, then a doctor needs to know within a few days and not a week or two later. The communication of critical test results causes a lot of trouble and a lot of harm.

Misinterpretation of Tests and Disagreement among Physicians

“The third area where test results cause harm is in the misinterpretation of tests, meaning x-rays, mammograms, cardiograms, and that sort of thing. And here we are talking about expert judgments,” he emphasized. “Study after study over years have shown that when two highly qualified experts make an independent judgment—such as both read a cardiogram or a mammogram—there is a 10% to 50% disagreement among them. So, that has the potential for very serious harm [to the patient].

“Now, all of these together are lumped into diagnostic errors. It turns out that diagnostic error is the number one cause of malpractice suits and is one of the leading errors that we’re working on,” declared Leape. “And just in the last few weeks, the Institute of Medicine has come out with an excellent report on the problem of diagnostic error. It’s a report that’s worth reading. (See, Dark Daily, “New Institute of Medicine Report Finds Diagnostic Errors Continue to Put Americans at Risk,” December 7, 2015.)

“The report deals with all of these issues, which I think come back to communication,” noted Leape. “Are the clinicians, the laboratorians, and the radiologists talking to one another and exchanging information? I think we have a long way to go on that issue.”

On the issue of communication, Leape recommended that pathologists and all clinicians recognize that patients should be included in discussions about treatment. “There is a real movement to engage patients much more in their care and it is gathering steam,” he explained. “The evidence is quite clear that when patients are part of the process we make better decisions.

“In some hospitals in this town [Boston], patients are members of every committee in the hospital, and when that happens, the process of care improves,” he said. “We should have patients being members of the team, and by the team, I mean the responsible or treating physician, the consulting physicians, the nurse, and the patient together.

“What is also important is developing meaningful teamwork among clinicians, and this is a fairly significant culture change. In general, teamwork is not the way we’ve practiced,” he added. “We tend to each do our thing. The implications of this are a little more difficult than how they sound on the surface. When you have a complex problem, sit down and talk about what needs to be done.

Using Technology to Guide Diagnosis and Other Clinical Actions

“There is also a lot that we can do with simple measures and with technology. One of the great things about the electronic medical record is—unlike the human brain—it doesn’t forget things. It can be programmed so that when a physician puts in a potential diagnosis it can ask, have you thought of this or that? You can use it for the whole issue of overuse and underuse, and a number of guidelines are already developed that can be cranked into electronic medical records to make it easy for them to happen.”

Medical errors and patient harm might be prevented if more physicians were involved in reviewing diagnostic test results, Leape added. Too often the idea to add staff to review results is criticized as being too costly. But saving the cost of one malpractice suit could pay for more staff to review diagnostic results, he suggested. “We really need to look at some of these things in a serious fashion,” Leape concluded.

These comments capture most of Leape’s thinking, observations, and recommendations about patient safety and the opportunity for medical laboratories and anatomic pathology groups to contribute to improvements in this field. He believes that the laboratory medicine profession could do more to apply the same technologies and service capabilities to improving patient safety that are commonly used by leading companies outside healthcare.

Leape’s recommendations are a reminder to all pathologists and clinical laboratory leaders that it is timely to become proactive about implementing enhanced patient services. In future years, providers will be measured in more detail about patient safety and patient satisfaction. That should motivate medical labs to act now in order to earn high scores on both goals in the future.

—Joseph Burns

Related Information:

The Nature of Adverse Events in Hospitalized Patients—Results of the Harvard Medical Practice Study II

IOM: Public Release of the Report of the Committee on Diagnostic Error in Health Care

More Harm than Good? Use of Genetic Mental Health Tests Has Grown Rapidly. But Evidence They Work Is Scant

Laboratory Testing in General Practice: A Patient Safety Blind Spot

Oversold and Misunderstood; Prenatal Screening Tests Prompt Abortions

Poll Finds Many in Massachusetts Have Firsthand Experience with a Medical Error

The Public’s Views On Medical Error in Massachusetts: Harvard School of Public Health

The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis

New Institute of Medicine Report Finds Diagnostic Errors Continue to Put Americans at Risk

Study at Boston’s Beth Israel Deaconess Medical Center Determines that 30% of All Clinical Laboratory Tests Are Overused or Medically Unnecessary