Published 4/1/2011
James H. Herndon, MD, MBA

Patient safety means patients first

Adverse events are more than just complications

Although medical errors, adverse events, and complications have always been around, I, like most orthopaedic surgeons, had lumped them all into the category of complications—until I read Michael L. Millenson’s Demanding Medical Excellence: Doctors and Accountability in the Information Age. He introduced me to the concepts of medical errors and adverse events in a new way, clearly separating a preventable adverse event resulting from a medical error and an adverse event that is truly a complication of treatment.

Adverse events due to errors that are preventable should be rare or nonoccurring with medical care. Two common examples are wrong-site surgery and a retained instrument or sponge following surgery.

Adverse events that are complications of medical care are not preventable in most situations. Some common examples include a postoperative wound infection in a patient without risk factors (if the patient had received the necessary antibiotics before, during, and after surgery and the proper surgical technique was used), a postoperative myocardial infarction in a healthy individual without obvious risks, or a postoperative deep vein thrombosis in a healthy individual, without risks, who received appropriate prophylaxis.

A postoperative wound infection after a total hip replacement in a patient who was never given antibiotics is not a complication but a medical error (adverse event). Complications are a fact of life for all surgeons, but we should take every opportunity to decrease them and to minimize any possibility of errors.

In the past 10 years, however, minimal progress has been made in reducing errors. In fact, many physicians continue to deny that a significant problem exists and refuse to change their practice habits. As a profession, physicians have not listened to the scientific data (something we usually do) that recommend actions that should be taken to place patients first and minimize the occurrence and recurrence of medical errors.

In three areas—wrong-site surgery, sleep deprivation/fatigue, and training—surgeons in general need to accept the scientific data and make the necessary and appropriate changes to improve patient safety.

Wrong-site surgery
Both The Joint Commission and the Pennsylvania Patient Safety Authority (PPSA) provide yearly updates on the incidence of wrong-site surgery, but because information is voluntary, the true extent of the problem remains unknown. Data suggest that the number of wrong-site, wrong-procedure, or wrong-patient surgeries is not decreasing despite programs such as “Sign-Your-Site” and the “Universal Protocol.” How can this happen, and what is the evidence for best practices to avoid wrong-site surgery?

The PPSA’s most recent report states that in the last quarter of 2010, wrong-site anesthetic blocks were the most commonly reported events, followed by wrong vertebral level, wrong-site hand surgery, wrong-eye surgery, and wrong-side pain blocks. Some common examples of problems to avoid include the following:

  • misinformation on the operating room (OR) schedule
  • misinformation on the history and physical examination
  • misinformation during the informed consent process

Any discrepancies should be reconciled with the surgeon, who should have supporting information in the office records at the surgical facility on the day of surgery, and resolved before the patient enters the OR. All information supporting the correct patient, procedure, and site should be verified by the surgeon and nurse before the patient enters the OR. All verbal verifications (including during the time out) should be done with an active response—not a passive one.

The site should be marked by the provider’s initials, and separate, formal time outs should be done for separate procedures, including anesthetic blocks. All noncritical activities should be stopped during the time out. The site mark should be visible and referenced in the prepped and draped field during the time out. Finally, the surgeon should encourage operating team members to speak up with any concerns—and resolve them.

Unfortunately, in speaking with orthopaedic surgeons, I’ve found that many—especially older surgeons—don’t think signing the surgical site is important. Some prefer their own method of signing, or they delegate the signing to someone else. Even though studies have disproven the risk of infection from the ink used to sign the site, some surgeons use this as an excuse not to sign the site.

Surgeons must follow the evidence to minimize the possibility of a wrong-site, wrong-procedure, or wrong-patient surgery, just as we follow clinical guidelines for specific diagnostic and treatment options.

Sleep deprivation/fatigue
The published evidence supporting the links between sleep deprivation/fatigue and medical/surgical errors is overwhelming. Yet surgeons continue to argue and disagree with the data.

As a resident, I was on call every other night and every other weekend (mostly operating at night and weekends). During my first 4 years in practice, I had a large elective surgical volume and was on call every other night (operating on most of them). I continued my on-call obligations as a department chair for more than 20 years. For long periods, I got only 4 or 5 hours of sleep at night. I must have been chronically fatigued.

It is too bad that physicians (including me) did not tackle this problem before administrative changes were forced upon us. A recent article in the New England Journal of Medicine by sleep study experts is alarming and should stimulate serious reflection by all surgeons and residency program directors to adopt changes in our practice style and residency training.

According to these experts, performing surgery after a sleepless night is comparable to driving with a blood alcohol level of 0.1 percent (a level considered legally drunk in all 50 states and the District of Columbia). Attending surgeons who performed elective surgery after having slept less than 6 hours had an 83 percent higher risk of serious complications. A previous study showed that “sleep deprivation doubles error rates.”

The authors recommended that surgeons who have scheduled elective surgery after a sleep-deprived night should inform the patient that they are fatigued and offer the patient a chance to reschedule the operation or have a nonfatigued surgeon perform the surgery. They also recommended that institutions implement policies to avoid elective surgeries by fatigued surgeons and facilitate the rescheduling of elective operations.

The Sleep Research Society (SRS) has endorsed legislation “that would require physicians who have been awake for 22 of the previous 24 hours to inform their patients of the potential safety impact of their sleep deprivation and to obtain consent from such patients prior to performing any medical or surgical procedures.”

Certainly rescheduling elective surgery may be difficult, but shouldn’t the patient be first? All would agree that no preventable harm should occur to the patient.

The American College of Surgeons, although agreeing that surgeon fatigue can lead to errors, recommended that “surgeons should be trained to identify and address the problem.” Unfortunately, research shows that chronically sleep-deprived individuals are unaware of their cognitive deficits. Physicians cannot continue to be protective and defensive; it is time to lead with facts in hand.

10,000 hours of practice
All surgical residency training programs (including orthopaedics) are being challenged by the limits on resident hours. But as important as it is to avoid fatigue, it is also important to provide the correct training environment. That includes time taking care of patients under supervision, time operating as assistant or surgeon under supervision, adequate experience (volume) of specific cases done during training, and a comprehensive curriculum that addresses the six core competencies and provides transparency for any hidden curriculum.

I have heard discussions about changing residency programs, usually increasing the length of the program to provide adequate surgical experience. But orthopaedic programs are long—5 years of residency, plus another 1 or 2 years in fellowship programs. Shouldn’t we consider other options? The time for change is now, because indications are that work hours will be limited in the future for residents and possibly even for practicing physicians/surgeons.

Educational psychologists have shown that to become an expert in anything requires 10,000 hours of intense practice. Residents who spend 3 days per week in the OR operating 10 hours a day would have 7,500 hours of practice OR experience at the end of 5 years. It would take 6.7 years for them to “practice” surgery 10,000 hours. If they only spent 2 days per week in the OR for 5 years, they would have only 5,000 hours of surgical practice at the end of a 5-year residency. Of course, this assumes that they are practicing and learning surgical procedures or techniques each day in the OR.

It seems to me that we are at the tipping point. Further reduction in residency work hours will be hazardous to a 5- or 6-year long surgical program. Even so, not every resident operates 10 hours per day, 3 days per week. Nor do residents practice all their skills during each operation they attend. Residents at each level of training need practice under supervision in the OR as well as more and improved use of simulation. Senior residents cannot take cases from junior residents. A more careful documentation of each resident’s surgical experience is required.

I think a national task force of educators and clinicians needs to develop consensus on an orthopaedic residency curriculum. Surgical training must address the surgical skills required for graduates, the skills required for specific surgical techniques and procedures, and methods to evaluate the attainment of knowledge and surgical skills before surgeons can enter clinical practice. Reducing medical errors during and after residency and fellowship training must remain our top priority.

Recently, a white paper by the National Patient Safety Foundation made several recommendations for change, including encouraging educational leaders to do the following:

  • Place the highest priority on emphasizing patient safety and professionalism
  • Encourage transparency and value the individual learner and promote interpersonal skills, leadership, and teamwork
  • Provide incentives and resources to support faculty to diagnose patient safety problems, improve care processes, and deliver safe care
  • Emphasize professionalism in medical school applicants and core competencies.

These recommendations, plus important changes in residency training programs and careful assessment of the knowledge and surgical skills of each potential graduate, are needed for the education of orthopaedic surgeons in the 21st century.

James H. Herndon, MD, MBA, is a past president of the AAOS. He can be reached at jherndon@partners.org

Editor’s Note: Articles labeled Orthopaedic Risk Manager are presented by the Medical Liability Committee under the direction of contributing editor S. Jay Jayasankar, MD.

Articles are provided for general information and are not legal advice; for legal advice, consult a qualified professional.

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