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What progress in patient safety?

Recently, AAOS Now editorial board member Howard R. Epps, MD, conducted a roundtable discussion with three leaders in the orthopaedic patient safety movement: James H. Herndon, MD; Norman A. Johanson, MD; and Claude Martin Jr., MD. Their wide-ranging discussion addressed the ongoing issue of wrong-site surgery, the impact on patient safety of changes in resident work weeks, and a recent shift in the approach to reducing errors.

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Howard R. Epps, MD

James H. Herndon, MD

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Norman A. Johanson, MD

Claude Martin Jr., MD

Dr. Epps: It has been more than 10 years since the Institute of Medicine (IOM) published the eye-opening report “To Err is Human.” In terms of addressing the issues that report raised, what grade would you give the orthopaedic profession and why?

Dr. Herndon: Although many areas have improved, I would have to give the medical profession, our healthcare system, and orthopaedic surgeons a C minus.

The reasons for my decision are many: a doubling of serious injuries from medications from 1998 to 2005, an apparent increase in the number of wrong-site surgeries in the United States as reported by the Joint Commission, and studies that show providers are performing inadequate patient histories and physical exams, failing to order appropriate tests, and developing insufficient follow-up care plans.

In my opinion, the medical profession—physicians and surgeons—must improve their leadership in patient safety.

Dr. Johanson: I would give the orthopaedic community a B. The AAOS has been at the forefront of identifying and moving to solve several problems that could be considered serious patient safety threats. The “Sign Your Site” campaign is a good example. I think that much of the perceived failure to lower the rate of wrong-site surgeries can be attributed to the increase in reporting since the awareness of the problem was raised.

I am proud that the AAOS has championed patient safety causes. The leadership has been there, but the resources to support the effort are not limitless. It will therefore be necessary to capitalize and collaborate with other organizations to improve patient safety.

Dr. Martin: An overall grade requires an analysis of the different areas of patient care. Orthopaedic surgeons provide multiple levels and facets of musculoskeletal care. In terms of pre-, peri-, and postoperative care for patients, for example, some areas require collaboration with hospitals and institutions, and many are dependent on factors beyond a surgeon’s control.

We are still aware of wrong-site surgery cases, failure to administer preoperative antibiotics, and failure to adhere to venous thromboembolism (VTE) prophylaxis guidelines. For care during surgery, orthopaedic surgeons certainly are competent. For the care outside the operative theatre, they have not done well. Dropped hand-offs occur too frequently.

Dr. Epps: It is surprising that, despite the concerted efforts of AAOS, Joint Commission, and other organizations, the rates of wrong-site surgery have been increasing. Why do you think wrong-site surgery is increasing?

Dr. Herndon: Apparently, documented wrong-site surgery is decreasing in Canada. It is easier to follow the trend there because of the small number of orthopaedic surgeons and professional liability insurance carriers. The United States has a much larger number of orthopaedic surgeons, numerous professional liability insurance companies, and different reporting requirements in each state.

I believe that the Academy’s Sign-Your-Site program and the Joint Commission’s Universal Protocol have had a beneficial impact. The actual incidence of wrong-site surgery is unknown due to voluntary reporting; the literature gives us only some possible answers.

The limited publications on wrong-site surgery suggest that only 35 percent of surgeons followed the Joint Commission’s protocol, surgeons signed the site in only 56 percent of surgeries, and only 38 percent of surgeons used their initials.

These programs require a real culture change, especially for surgeons who have been in practice for more than 10 years. I don’t believe any physician, nurse, or hospital wants to have a wrong-site surgery. If system protocols are in place, I can only surmise that the culture of the staff in the institution doesn’t support Universal Protocol or the Sign-Your-Site program. Residents accept the value of these programs, but older surgeons in practice must do the same.

Dr. Martin: Whether wrong-site surgery is increasing or not is irrelevant. Our efforts in the arena of patient safety should be concentrated on identifying the causes of wrong-site surgical error in general and of wrong-side surgical error in particular.

If the causes can be identified, then ways can be developed to avoid this preventable adverse event. Any incidence reporting will have a numerator and a denominator. In the case of wrong-site and wrong-side surgery, the numerator is too small and the denominator is too big. Cases are better identified and reported, which makes us think there is an increase.

Dr. Johanson: It seems to me that three points should be made. First, the increased awareness of a problem such as wrong-site surgery has naturally increased the reporting of it, and the reporting process itself has not universally stabilized nor has it been standardized. Therefore, analyzing trends from this kind of data has limited validity.

Second, the inclusion of such disparate procedures as knee surgery and regional blocks carries with it a serious difficulty in finding ways to improve the situations. For example, in a large joint such as the hip or the knee, the determination of the correct site is relatively simple and straightforward. The axial skeleton and the very peripheral joints are more problematic and require more sophisticated intraoperative scrutiny, because the positioning, prepping, and draping of the patient does not necessarily signal a successful identification of the correct finger or the correct spinal level. Quality improvement efforts to address wrong-site surgery need to be individualized to the point of understanding where the real problem areas are.

Finally, the culture of disregard for wrong-site surgery must be eliminated by all means necessary. Anyone who does not have a healthy fear of performing a procedure at the incorrect location should engage in a lengthy period of self-examination. I believe that many nonpreventable complications are incorrectly being referred to as preventable for the purposes of shifting risk. Wrong-site surgery is not one of them. The risk and responsibility in this case is squarely on the shoulders of the surgeon, and he or she is bound to embrace any system or protocol that may reduce this risk.

Dr. Epps: An editorial in the New England Journal of Medicine earlier this year argued for more accountability in the patient safety movement, including punishing individuals who make errors. This is clearly a shift from the systems approach that avoided blaming individuals. What role do you think this concept should play in patient safety efforts?

Dr. Herndon: I think this is timely and correct—a call to physicians to take leadership in patient safety and minimize all medical errors. After more than 10 years of attempting to improve patient safety with a systems approach, medical errors and adverse events are still too common. The experts are now directing their focus on individual accountability, and I agree with this additional approach to patient safety.

I have always believed that each surgeon is responsible for the safety of his or her surgical patient. Medicare has recently created a category of “never events” for which it will not reimburse hospitals. It is only a matter of time, I think, before Medicare (and possibly other payers) will not reimburse the surgeon for a never event.

I don’t know if such penalties will be effective, but they are a start. I think medical professional organizations need to develop, with their members, guidelines for patient safety practices and accountability penalties if these guidelines are not followed.

Dr. Martin: The “system” can only assume so much blame for patient safety lapses that occur on a daily basis. The newer generation of surgeons and physicians may be better sensitized to the importance of being accountable for their participation in the treatment plan.

Being reprimanded may not have the desired effect. But taking away operating time could have a viral effect on reducing disruptive behavior. The question we are addressing is not what happens to busy or distracted caregivers who forget to clean their hands or perform a time-out once. Rather, it is what happens when they do so habitually and willfully, despite education, counseling, and systems improvements.

As a present consumer of health care, I want my surgeon, his or her team, and the entire organization to maximize my safety and optimize my care. I do not want a healthcare worker’s egregious behavior for no evidence-based reason compromising it.

Dr. Johanson: The foundation of good medicine is professionalism—an attitude of dispassionate reason that naturally leads to the adoption of habits and behaviors that reflect a respect for the well-being of the patient and a recognition of the value and importance of all the professionals who work at and around the bedside.

The AAOS has demonstrated a commitment to evidence-based practice, which I see as an evolutionary process that continually evaluates the effectiveness of these protocols. The true professional will make every effort to adopt protocols put in place for the benefit of patients. Continued emphasis on the fundamentals is needed, and the best person to lead this effort is the physician.

Dr. Epps: Medical societies, public interest groups, hospitals, and government agencies all have separate initiatives to improve patient safety. Is there a way to better coordinate these efforts? Should one sector take the lead?

Dr. Herndon: I think a physician—or physicians as a profession—should take the lead. Each major group you mentioned has their own agenda…often speaking only to themselves. Until the medical profession, possibly in partnership with others, seriously takes ownership of patient safety, I am afraid that we will continue to have a system of care with far too many medical errors. Change will come only because of government, legal, or insurance mandates.

Dr. Johanson: One approach to developing true solutions is to make a better attempt to operationally define various patient safety issues and show contexts in which solutions may be found, with different champions in each domain. For example, both wrong-site surgery in the operating room (OR) and surgical site infection involve surgeons. But in the OR, the surgeon is in direct control of the surgical site. Surgical site infections are much more complex. The surgeon may order the appropriate antibiotic for the correct number of doses, execute the surgery in a timely fashion with good sterile technique, and handle the wound properly postoperatively. But other factors, such as optimal intra-operative soft-tissue management, wound care, patient behavior, and host factors, may be even more important.

Practitioners are being pushed to improve patient safety by becoming more knowledgeable, improving their behavior, and complying with an ever-increasing array of disjointed agendas. The patient safety movement should be divided into bite-sized chunks that tailor research and quality monitoring to each problem.

Dr. Martin: The lead needs to come from physicians. They may not be the best group to propose better and safer processes, but they certainly know patients, the technology, the environment, and the challenges. Crew resource management, which has helped improve aviation safety, is now being applied to medicine, especially in the OR. Specialty societies need to work with hospitals to standardize protocols and clinical guidelines. National standards require adherence. Unsafe trends that are identified through sentinel event reporting require action.

Ensuring patient safety is a fundamental element of high-quality health care. Providing safe, quality health care is a priority for all governments, healthcare professionals, organizations and institutions. If only all these groups could talk to each other rather than blame each other for the ongoing adverse events occurring in health care.

Dr. Epps: The ACGME recently recommended further reducing resident work hours as a way to improve patient safety. What do you think of this approach?

Dr. Herndon: Too little sleep leads to errors. But I think we need more research, more data. I would guess that fatigue thresholds are different in different individuals.

I think the main problem with the work hour rules is that they have not been coupled with curriculum reform that is outcomes-focused. Most clinical educators in the surgical fields are concerned that graduates will not have the required skills to practice independently. Some surgical specialties require each resident to complete a certain number and type of surgical procedures to graduate; obstetric residencies in England have been increased by a year to allow the trainees enough deliveries to be considered independent practitioners.

Until we have data that establish the skills, experience, and ability to operate independently and safely, we will be in a transition period, and I fear some residents may not have the required experience and skills when they enter independent practice.

I don’t see how making rounds (one or two hours) on a day off is unacceptable…it doesn’t lead to fatigue. How long one can stay awake and avoid errors while operating or caring for patients is still unknown, but physicians and surgeons must do what is right to prevent errors from fatigue.

This issue is not going away. Further research will help clinical educators understand fatigue and push all of us to reform our graduate surgical programs.

Dr. Johanson: Dramatic changes have already occurred in the contours of contemporary residency training. The recommendation to further reduce work hours for the sole purpose of improving patient safety in the midst of those changes ensures that an adequate scientific study of the changes to date will never be performed. If the trend continues, the next generation of physician trainees will be introduced to a system that is totally disconnected from the one that evolved during the twentieth century.

Residency training is adult education combined with the induction into a profession that traditionally put patient care above all other values. The integration of these two processes has typically required significant self-sacrifice. Medical students once self-selected into surgical specialties based on several factors, one of which was the ability and desire to get up early in the morning. My own opinion is that we are now being controlled more by politics and ideology than sound science and real concern for patients and the integrity of our profession.

Dr. Martin: If resident work hours continue to decrease, the perverse effect may be safer immediate patient care, but—as echoed by many senior educators, especially in the surgical fields—graduates who can’t operate. Physician shortages and the lack of successors for current physicians about to retire is a real concern. To lengthen an already long training program for most (more debt), when the availability of training opportunities vanishes with the reorganization of health care, is not the solution.

There are enough hours in the 80-hour workweek to maximize resident education and minimize patient risk due to resident fatigue. An example is the initiative of formalized hand-over rounds.

Dr. Epps: Medicine has made substantial progress in patient safety—particularly in awareness of the issue—but there is still room for improvement. Are there any final points you’d like to make?

Dr. Herndon: I believe that patient safety must be the goal of each physician, healthcare provider, and healthcare organization, which requires a change in culture. Organizations and physicians can do much to build a culture of safety. For example, we need to accept that humans make errors. Punishment is not effective and should only be implemented for incompetence or intentional noncompliance of safety guidelines. But all errors and near misses should undergo a root cause analysis to understand the reasons for adverse outcomes and avoid repeats of the same errors or near misses.

Surgical safety checklists and the Joint Commission’s guidelines need to be followed as standard operating procedures. Reporting systems should be used to uncover threats and sources of errors. This important information needs to be used for overall patient safety improvement and not be suppressed or minimized.

An area that has not received much attention is diagnostic errors. Missed or delayed diagnosis is frequently the leading or second cause of malpractice claims.

Dr. Martin: All physicians, residents, medical students, and healthcare workers I know want to provide good, if not great, and safe medical care. But deficiencies in healthcare quality are common, serious, systemic—and largely preventable. Overuse, underuse, and misuse of medical treatment are widespread, and medical errors and adverse events are disturbingly common.

As a future candidate for a total hip replacement, I can think of several simple things that need to occur to offer me a chance at a good outcome, including preoperative antibiotics, VTE prophylaxis, and temperature regulation in the OR. Patient safety must become part of the daily routine, not an afterthought. Great medical care and patient safety should be one.

Healthcare providers must work to ensure that patients participate in their own health care as decision makers and managers of risk. Providing timely and comprehensible medical information remains a challenge. The complexities of navigating the system only add to the confusion.

AAOS Now
December 2010 Issue
http://www.aaos.org/news/aaosnow/dec10/clinical2.asp