Risk managers should expect patient safety to dominate their work in 2020. Increasingly, regulators and accreditors are focused on patient safety.

  • Use technology wisely to free up nurses for more skilled work.
  • Technical malfunctions that threaten patients need attention.
  • Changes to pharmaceutical management may reduce adverse events.

Patient safety will be the primary concern for risk managers in 2020 as government regulators and accrediting bodies continue to raise their expectations in this area for healthcare organizations, several experts predict.

Regulatory requirements concerning patient safety will continue to expand in the coming year, says Bette McNee, RN, NHA, clinical risk management consultant at insurance broker Graham Company in Philadelphia. Healthcare organizations are beginning to look for ways to make better use of nurses and other staff, helping them to work at the top of their abilities rather than handling menial tasks, she says.

McNee notes that some hospitals are even experimenting with the use of robots that can fulfill minor tasks such as delivering items to a patient. This can help address a growing concern over the patient experience, in which a hospital can be downgraded for nonclinical concerns such as a family member unhappy with how long it took a nurse to bring a requested item, she notes.

Improving the patient experience is important because it can reduce liability risks, McNee says. Disgruntled patients and family are more likely to press for litigation, she says, even when their source of dissatisfaction is relatively minor and not associated with patient care.

“One of the things we expect to be a priority for risk managers is using technology to improve efficiency. That can increase patient safety and reduce nursing burnout,” McNee says. “We have this increased scrutiny on patient safety. If we can save the staff and nursing time for what matters most to the patient’s safety, that’s an improvement for everyone.”

Also Threats From Technology

But at the same time, McNee notes, healthcare organizations are becoming increasingly wary of patient safety threats from malfunctions of machines and medical devices.

“When you have a cool IV pump that is tied to the call bell system and does all these other things, a failure in any of those machines can increase the liability risk,” McNee says. “For risk managers, it will be a huge concern to make sure that maintenance and failsafes with existing technology are addressed with this new technology.”

The prudent deployment of technology should be a goal for 2020, says Tracey Kilcullen, Esq., vice president of claims services with Graham Company. Work toward using technology to reduce the staff’s work burden of menial tasks requiring no special skill or training, allowing nurses to focus on patient safety and improving the patient experience, she says.

“If you are trying to use technology to do things that in the past trained clinicians have done and you’re doing it perhaps too fast or not in the best way, you might just create more fodder for plaintiffs’ attorneys claiming profit over patients,” Kilcullen says.

Improve Root Cause Analyses Now

McNee also encourages risk managers to look at how well they have been performing root cause analyses. If you have let yours become routine exercises, now is the time to improve, she says.

“Some people do a great job at root cause analysis, and sometimes it is more of a perfunctory, checkbox kind of thing. If hospital risk managers have not truly engaged all staff in good root cause analysis and robust process improvement, doing it on a high level and getting by without engaging frontline folks, your successes are going to be short-lived,” McNee says. “If you haven’t implemented that just culture and pulled people from the floor to engage in the analysis of an adverse event, near miss, or good catch, now is the time to do that. You will not be able to survive the coming changes if you haven’t.”

The medical community will see an increased effort to reduce adverse events in 2020, says Albert Wertheimer, PhD, MBA, adjunct professor of social, behavioral, and administrative sciences at the Touro College of Pharmacy in New York City. In addition to the concern for patient safety, healthcare organizations increasingly are aware of the costs associated with an adverse event, he says.

“ln 2020, we will see several avenues employed to reduce risks. One is through what has come to be called customized or personalized medicine. By genotyping patients, prescribers will have a far better idea about which drugs can be more safely and effectively used in different patients, depending on their metabolic characteristics, enzyme production, and other physiologic parameters,” Wertheimer says. “This includes customizing the dosage.”

The FDA also has contracted with large health insurers for signal detection services, Wertheimer notes. This initiative is aimed at addressing how, if a single doctor in Boston sees only one adverse event with a specific product, he or she probably does not worry about it. But if similar individual reports of that same problem come to light in Seattle, Los Angeles, and Chicago, the FDA and the manufacturer can investigate the situation before it becomes huge and causes needless harm.

The signal detection services are intended to warn physicians so they can use an alternative product, he explains.

Drug Interactions Targeted

Medical education is focusing more on adverse event avoidance, Wertheimer says. For instance, pharmacists are providing medication therapy monitoring services to help patients taking multiple medications to prevent drug-drug interactions and related problems, and insurers are reimbursing for these services as they have proven their worth, he says.

Another technique to reduce adverse event risks or to prevent less-than-desirable outcomes is by using technology assessment principles. ln the United States, new drug products are tested against a placebo to learn whether a drug is effective and safe, he notes, but those clinical trials are limited in what they can reveal.

“In the European Union, they conduct head-to-head clinical trials, testing the new drug candidate against the usual and customary current drug of choice,” he says. “This latter method tells us not only if the new drug is safe and effective, but whether it is superior, equal, or inferior to the existing product. That is a huge improvement.”

This health technology assessment is called comparative effectiveness research when it involves pharmaceuticals, he explains. Wertheimer also notes that patient safety may improve with the FDA’s upcoming Tack and Trace system. Every individual bottle of medication would be assigned a unique faculty number, he explains.

“This list will be kept in a huge database. lf someone offered a hospital in Cleveland some drug products, one would be able to see that this drug is shown as being in inventory at a wholesaler in Denver and the product offered in Cleveland must be counterfeit, or a bad batch that was supposed to be destroyed,” he says. “This should eliminate most subpotent counterfeits.”


  • Tracey Kilcullen, Vice President, Claims Services, Graham Company, Philadelphia. Email: tkilcullen@grahamco.com.
  • Bette McNee, RN, NHA, Clinical Risk Management Consultant, Graham Company, Philadelphia. Email: bmcnee@grahamco.com.
  • Albert Wertheimer, PhD, MBA, Adjunct Professor, Social, Behavioral, and Administrative Sciences, Touro College of Pharmacy, New York City. Phone: (646) 981-4700.