Risk Management and Patient Safety in the Ambulatory Environment

Risk Management and Patient Safety in the Ambulatory Environment

By Jennifer Schraag

The movement toward transparency is a very real issue facing today’s healthcare organizations. As it eventually trickles through every facet of healthcare, the success of a healthy risk management program is going to play an ever-increasing role.

Risk management is quickly shifting from the behind the desk, financially-focused position it has held in the past. It is now infiltrating every aspect of clinical care, and today’s risk management programs are heavily incorporating patient safety as a mainstream school of thought. Rightly so, as increased safety equals decreased risk.

“We are seeing in risk management a significant amount of change because the discipline has moved toward becoming more proactive,” asserts Diane C. Pinakiewicz, MBA, president of the National Patient Safety Foundation. “Having that role not be like it was in its origins — so much reactive and getting involved in situations only when there was a potential for some malpractice claim. Now, risk management discipline is a patient safety discipline. It is very much a part of the team and it is very much out there in the middle of the mix.”

Pinakiewicz says she finds it quite encouraging to see the evolution in the field of risk management. “Clearly they have been at the center of the error situation for a very long time and the discipline has become quite proactive about playing the broader role and I applaud them for that. This is really the first time that our industry has taken such a comprehensive approach, I think, to fixing the infrastructure that we have and everyone should be welcoming that because it’s a bit overdue.”

Patient safety wasn’t the traditional way that risk management has always been viewed, according to James Bagian, MD, PE, chief patient safety officer and director of the Department of Veterans Affairs (VA) National Center for Patient Safety. He says risk management was born on the premise of protecting an organization’s financial well being. “The risk that they are managing is not the risk of the patient, they are managing the risk of the organization, mainly financial,” he explains. “And most risk managers, if you talk to them, and I do all the time, I ask: ‘Whose risk are you managing? The risk of the patient or the risk of the organization?’ and they will all tell you the risk of the organization; which is not proactive and it is not about patient safety. It is only parenthetically about patient safety. Whereas if you looked at it from the standpoint of what I would call primary prevention — if the patients were safe and you never hurt anybody — you wouldn’t have to worry about reducing the tort awards because there wouldn’t be any torts. The point is,” he asserts, “don’t have bad things happen and the amount of risk you have is markedly, substantially reduced.”

Safety is the absence of bad things happening, Bagian says, and only by creating that underlying culture throughout every aspect of care, can a risk management program be effective. “When the culture changes toward safety, that’s when you get sustainable change. If all you’ve done is tell them to do this task and this task and this task, then you didn’t really teach them anything. Are you giving people fish or are you teaching them to fish? If you want sustainable change, teach them to fish.”

Pinakiewicz agrees, adding, “The issue of culture change is one that never goes away because it is such a far reaching issue and it is one that is not a short term project. It is about trying to move everybody toward looking at everything from more of a systems perspective and understanding what that means: teamwork, effective leadership, and recognition of the changing skills needed by leadership in today’s healthcare environment. From the bedside to the boardroom, everyone has a role in the patient safety movement. It may seem daunting but it’s not. It is an ongoing process. Patient safety should not be a discrete process; it should be a design element to everything that you management is quickly shifting from the behind the desk, financially-focused position it has held in the past. It is now do — almost a lens through which you should approach everything that you do. Success in this area is not only going to result in an improved process, but a more satisfactory experience for the patient, for the provider, and at the end of the day, more efficiency.”

Peter H. Reilly, MS, AIC, ARM, senior vice president of William Gallagher Associates, has over 20 years of risk advisory experience in healthcare risk management. He says risk management, from his point of view, is the handling of any and all risks from things that are not insurable to the things that are. But how do you quantify risk financially?

When estimating the level of insurance coverage as it relates to risk management, Reilly’s company investigates how an organization operates in minimizing risk. They then use that information for quantifying the overall cost of risk for an organization.

“It involves a lot of discussion about how a physician or the hospital administrator or the nursing home administrator actually operates their business,” he says. “Where do they spend their time and how do they lower the risks associated with that? The delivery of care is what will make or break an institution. Quality does matter. It is about a transparent delivery of care.”

Reilly has viewed many risk management programs and processes. One that he says stands out to him was that of a client physician group that hired a part-time nurse whose job it was to look through all of the charts and reports of the practice solely to try to identify any possible areas of risk. Reilly says the group has now been loss free in excess of eight years.

Kathleen Shostek, RN, ARM, BBA, FASHRM, senior risk management analyst with ECRI, a non-profit organization that offers self assessment tools, research-based publications, and consulting services in risk management, agrees that clinician involvement is imperative to making a risk management program successful.

She says clinicians need to take the opportunity to learn as much as possible about risk and safety because that is equally as important as their clinical skills. “It enables them to protect themselves and their patients,” she advises. “I think the important thing to understand, especially if they are involved with a task force or a group looking at an event after it occurred, I think they need to understand up front that determining the root or the primary cause of a sentinel event or an adverse event is that it is important to uncover the underlying systems that cause or contribute to the occurrence — or increase their severity. Only by determining why an adverse event occurred can workable corrective measures or improvements be made. It’s crucial to preventing future similar events which of course is the primary goal in risk management.”

Shostek goes on to say that the whole movement “needs to come from the grassroots” in order to be successful and involvement from the frontline staff in doing the assessment and collecting the information is vital. She adds it is also important to then do a comparison study to what the standards currently are or what other facilities are seeing. “Ask yourselves, ‘Is our practice the safest it can be?’”

Something that has taken on a life of its own in risk management is not your traditional safety inspection but rather a patient safety walkthrough. This walk-through allows management to talk to the staff and ask, “What’s the next thing that is going to harm a patient in this unit?”

“The frontline staff members are the people who really know where potential problems lie,” Shostek points out. “This opens up communication and allows the staff to know their concerns are valued. Patients and providers are both very good sources of what went well and what didn’t.”

No Blood — No Foul

Bagian says the VA handles “close calls” or “near misses” with the same exhaustive investigation and corrective action activities as if somebody has died. “You can’t distinguish between the two,” he asserts. “We think that in places that have it right, that’s how you do it.

You don’t say ‘Oh, somebody didn’t get killed, don’t sweat it.’ “The close calls are a good way to learn because nobody got hurt and people are more likely to be honest since nobody got hurt.” He also says that the research has shown that close calls occur anywhere from 10 to 300 times more often then the event that it is a precursor of. “So that means you have 10 to 300 times that you can learn before anybody has to get hurt. If you use this approach and look at close calls then things can get better faster without hurting anybody.”

Bagian adds that most healthcare facilities in the United States do not report close calls. “And even the ones that do, very few have explicit written down criteria by which they decide they get a full blown root cause analyses, corrective action plan, etc., rather than just kind of look at it and say ‘Eh, it’s not worth it.’ We don’t do it like that.”

At the VA, Bagian says approximately 50 percent of all full root cause analyses stem from reported close calls. He says they look at what happened, why did it happen, and what to do to prevent it in the future.

Shostek says clinicians often are reluctant to take the time to report close calls because they face time pressures and workload challenges and so forth. “But there is evidence now that even one near miss can make a lot of difference. Problems that are not easily recognized otherwise can be documented for frequency because obviously the more frequently a near miss might occur, the more likely an actual event will occur.”

Shostek shares that the value of reporting a close call with a potentially dire impact was demonstrated in a recent case where a Pennsylvania hospital submitted one such report to the Pennsylvania Patient Safety Reporting System (PA-PSRS). The report describes an event in which clinicians nearly failed to resuscitate a patient who had a cardiopulmonary arrest. The patient had been incorrectly “tagged” as a DNR (do not resuscitate) with a color-coded wristband.

The source of the confusion stemmed from a nurse incorrectly placing a yellow wristband on the patient. In the hospital in which the incident occurred, the color yellow signified that the patient should not be resuscitated, however in a nearby hospital, one in which this nurse also worked, yellow signified “restricted extremity,” meaning that the arm donning the band was not to be used for drawing blood or obtaining IV access. Fortunately, in this case, another clinician identified the mistake in a timely manner and the patient was indeed resuscitated.

In response to the incident, the PA-PSRS surveyed area hospitals and ambulatory surgical centers (ASCs) to evaluate the prevalence of use of color-coded wristbands throughout the state. The survey found:¹ 

• Nearly 78 percent of respondents’ facilities use patient wristbands to communicate clinical information other than the patient’s identity 
• Of those, nearly all (98 percent) report that color is significant 
• Among Pennsylvanian hospitals, color-coded wristband use is nearly 87 percent, and in ASCs, 67 percent 
• Some facilities report using as many as five different colored wristbands, in addition to the patient identification band 

To add to the confusion, the PA-PSRS also found that a DNR status is most commonly associated with the color blue, but other facilities use this same color to signify as many as nine other things such as the patient being prone to fall or that the patient has a pacemaker. Ultimately, the importance of this incidence is not only the discovered need to streamline the meaning of each color-coded band, but more importantly that this reported close call raised awareness to a potentially fatal threat to patients and has worked to affect change.

Prevention, Not Punishment

This is how Bagian conveys the message. Fear of punishment is a very real detriment to reporting near misses. But it’s not No. 1. According to Bagian, the frontrunner is actually shame.

For example, the VA conducted a cultural survey on reporting close calls and adverse events. The survey found shame to be the biggest determent to reporting a near miss. More-over, 49 percent of respondents gave a rating of five for shame on a scale of one to five, with five being the highest.

“When you talk to people generally the first thing they will say is malpractice, but when they really think about it, that’s not it,” Bagian explains. “So the fact was we had to recognize that and then say, ‘How do we construct our system such that the issues that are real to them — shame, embarrassment, etc., — aren’t going to be the real issue?’ If I design a system that requires you to be perfect in order to provide perfect overall care, then all I have destined my patients for is failure.”

Pinakiewicz says it is also more than that. “It is about moving away from a culture of blame and moving to an environment that is a learning environment.”

Bagian says it would not be effective to implement an anonymous reporting system to curtail the shame or fear of punishment in reporting near misses because there is a real need for a thorough investigation.

“Knowing what happened is a symptom,” he explains. “You don’t fix things by knowing the symptom. You have to understand why it occurred. By understanding the cause then you figure out what the mitigating action is. That’s hugely important because people want to do these counting exercises which are inaccurate to begin with because you only know what was reported, you don’t know what really happened. You just know the things that were reported which can be an overrepresentation or an under-representation. If you can find out what the cause is, that’s when you can act. You can have the same outcome be caused by five different causes. Or you can have a cause, cause five different outcomes.”

Focusing on prevention and not punishment goes back to proper leadership, according to Shostek. “It really all starts there. Being able to communicate concerns or reporting events without fear of retribution or punishment is a cultural thing.” She adds that it all ties in very closely with having a strong safety culture instilled throughout the facility. “Having a strong risk management program and key aspects to developing safety culture are intricately linked,” she asserts. “It’s empowering staff to be able to speak up when they are concerned about a safety issue or to report a safety issue or an event that’s already occurred and be confident that it will be acted on.”

It takes leadership and education to affect culture change in an organization. As Shostek points out, each manager of each unit of each department has to make sure it is integrated into their operations and practiced at all levels in order to really get through to the frontline staff.

“You want to engage in primary prevention which means the bad event doesn’t happen to begin with,” Bagian adds. “The big issue is that we think about how do we proactively understand where vulnerabilities exist and then what steps do we take to minimize the impact of those vulnerabilities or eliminate them entirely when you can do that.

“You can substantially reduce the risk. Risk management is not damage control after it happens.” 

Reference

1. Patient Safety Advisory. Use of Color-Coded Patient Wristbands Creates Unnecessary Risk. Vol. 2, Sup. 2. Dec. 14, 2005. www.psa.state.pa.us/psa/lib/psa/advisories/v2_s2_sup__advisory_dec_14_2005.pdf