Extreme honesty: Medical errors and full disclosure
The magnitude of medical errors in the clinical setting is staggering. The landmark 1999 Institute of Medicine (IOM) report To Err is Human: Building a Safer Health System concluded that “as many as 98,000 people die in hospitals each year as a result of medical errors that could have been prevented.” That IOM report accelerated the patient safety movement at both the federal and state levels.
More than a decade and a half later, the estimated number of deaths due to medical errors remains unacceptably high. According to a recent study by Johns Hopkins University School of Medicine published on May 3, 2016 in the British Medical Journal, medical errors may be the third leading cause of death in America. After reviewing the scientific literature and peer-review research, the patient safety researchers from Johns Hopkins estimated that the number of deaths in America due to preventable medical error exceeds 250,000 deaths per year.
Full disclosure as policy
In 1987, long before the 1999 IOM report, the Veterans Affairs Medical Center (VAMC) in Lexington, Kentucky instituted a then-controversial program of disclosing medical errors and apologizing and compensating patients for them. Apart from the ethical and moral rationale for transparency and full disclosure, the VAMC believed that a policy of extreme honesty or full disclosure might reduce malpractice claims. Twelve years after the VAMC instituted its policy, it reported that hospital administration and staff supported it and, counterintuitively, it yielded unanticipated financial results.
The “Blame and Shame” game
For too long, our society has put blame and shame on the nurse or physician who was believed (often unfairly) to have caused a medical error. Apart from the devastating effects that blaming a health care practitioner can have (e.g., possible loss of a job, adverse actions by a State licensing board, collateral civil litigation, and negative reputation among peers), such an ill-conceived approach tends to understandably result in under-reporting. What is the incentive for a physician or nurse to admit and error if it will result in all manner of punishment and potentially catastrophic professional damage?
We know—or should know—almost all medical errors are systems problems. There may have been a failure to incorporate safety nets and/or redundancies that could have prevented an error. A recent nursing home case illustrates how medical errors result from poor systems. A 68-year old resident was admitted to a nursing home from a hospital where she was prescribed 0.5 mg Risperdal po (by mouth) BID (twice a day). At the time of admission, the nurse performing the medication reconciliation transcribed the order as “Risperdal 5 mg PO BID”—a tenfold increase. The attending physician signed the order. The pharmacy dispensed the 5.0 mg dose, and for ten days, nurses administered 5.0 mg of Risperdal twice a day until, on the 10th day, the resident suffered a cardiac arrest and died. Was the death the fault of any one of the nurses who gave the ten-fold increase twice a day? Was the ordering physician, who admitted he “goofed,” to blame? What about the pharmacist, who testified at trial that she thought 5.0 mg BID was an appropriate dose for a 68-year-old resident weighing 102 pounds? No. It was a systems problem. There were multiple failures throughout the continuum of care and no single person shoulders the blame. The system was flawed.
One of the country’s leading experts on medication errors, Michael Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, the president and founder of the Institute for Safe Medication Practices (ISMP), testified in defense of a Colorado nurse who was charged with criminally negligent homicide for her role in administering a lethal dose of IV penicillin G benzathine to a newborn baby. “There were more than 50 deficiencies in the medication use system that contributed to the error,” Cohen says in an ISMP blog. Had even one of them been addressed before the incident, the error would not have happened or would not have reached the infant. Fortunately, in the Denver case, the nurse who stood trial was rightfully acquitted of the charges by a jury of laymen that deliberated for less than an hour.”
In spite of and because of the incidents described above, the author suggests that a non-punitive error-reporting system be adopted by every healthcare facility. In the context of nursing homes, too often a director of nursing, administrator or nurse is fired after an adverse resident outcome or a finding by surveyors that immediate jeopardy existed. A more enlightened approach may be to examine the systems in place that allowed an error to occur. That is where a root cause analysis and QAPI come into play.
Dr. Cohen, who has been on the vanguard of the patient safety movement for years, says, “Selecting the best strategy to remedy errors is not easy. But the focus must always be what allowed the error to happen, not who allowed it.”
Why report medical errors?
In addition to disclosing medical errors that result in harm, even medical errors that are non-harmful and near misses that could have had serious consequences should, at a minimum, be reported to a facility’s QAPI program. For decades, the airline industry has recognized the significance of reporting near misses. In so doing, the industry has discovered systems problems that have prevented fatal accidents. The healthcare profession can learn a valuable lesson from the airlines’ reporting of near misses.
Nursing homes that participate in the Medicare and/or Medicaid program must report a significant change in a resident’s clinical condition to the attending physician and family member or responsible party. Thus, nursing homes already have a duty to self-disclose. Self-disclosure frequently results in findings of immediate jeopardy and even collateral civil litigation. Nursing homes that voluntarily self-disclose harm suffered by residents to State survey agencies can receive a reduction in a civil money penalty (CMP) imposed by the Centers for Medicare and Medicaid Services (CMS). However, that reduction in CMP is only available in instances where there is no “immediate jeopardy,” “substandard quality of care,” or harm that resulted in a resident’s death. In an ideal world, nursing homes that voluntarily self-disclose medical errors that resulted in harm would not been punished by CMS as severely as if they failed to disclose the error.
Since 2001, the Joint Commission has required disclosure of unanticipated patient outcomes. Likewise, the National Quality Forum has supported full disclosure of serious adverse and unanticipated outcomes. Additionally, professional organizations such as the American Medical Association (AMA), the American Osteopathic Association (AOA) and the American Nurses Association (ANA) all support full disclosure of medical errors. For example, the AMA Code of Medical Ethics states that “Physicians should at all times deal honestly and openly with patients.”
Striking a balance: Extreme honesty vs. fear of litigation
The author believes that extreme honesty is the preferred policy. Historically hospitals and other providers followed a “deny and defend” approach. However, a proactive and transparent approach to medical errors is likely to provide positive results on multiple levels. Apart from the sound ethical and moral reasons for full disclosure, recent studies reveal that such a proactive approach strengthens the physician-patient bond and nurse-patient relationship. Few things can destroy trust like a cover-up. It is better to disclose a medical/nursing error than for it to subsequently be discovered in a malpractice or negligence case. As we recall the lesson of the Watergate break-in, which led to the resignation of a sitting president, the cover-up can be worse than the underlying facts.
According to a report published by the Joint Commission, the Sorry Works! Coalition claims that apologies for medical errors combined with compensation, reduces patient anger and leads to a reduction in medical malpractice lawsuits and related expenses. A report from the Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) further supports the notion that full disclosure and apologies are effective: 36 states have enacted legislation that precludes a health practitioner’s apology from being used in a negligence or malpractice lawsuit, the AHRQ report notes.
On balance, the ethical, moral and even legal reasons for full disclosure make sense. The long-term care industry has shifted focus to a resident-centered paradigm. As such, residents and their families should be told when an error occurs. Facilities, acting in concert with their risk management personnel and counsel as well as their ethics and compliance programs can determine the logistics of whom, how and under what circumstances full disclosure should be made to residents and their families.
Healthcare providers, including nursing homes should consider proactively developing a robust disclosure program. Mistakes will happen, and it is better for a provider to be prepared. Nursing facilities can gain insight from their compliance and ethics programs (ethics programs will be required by CMS) as well as their QAPI committees. Determining who will tell a resident or a resident’s family is important. While typically the attending physician and/or medical director, it may be that the circumstances warrant including one or more nurses who were involved. There is no cookie-cutter approach, and the circumstances will dictate who speaks with the resident and/or family. Also, empirical data suggests that in-person communication in such instances is preferable to a letter.
Dr. Susan Levy, President of AMDA–the Society for Post-Acute and Long-Term Care Medicine, says, “Disclosure of errors to patients and their families is an important component of an organization’s culture of safety. Leaders from the involved disciplines should meet with the patient and their family to discuss the events, general findings of the investigation and what is being done to avoid a recurrence.” Dr. Levy adds, “Involving patients and families in creating solutions reflects a patient centered approach to organizational safety.”
Our current tort system and the sometimes harsh consequences imposed by CMS hardly incentivize full disclosure of medical errors even though such disclosure is ethically, morally and legally required. However, extreme honesty with patients and residents seems not only to be the right thing to do; it also can build trust and strengthen the practitioner-resident relationship as well as reduce malpractice awards and settlements. To quote Alexander Pope, “To err is human, to forgive, divine.” Residents and their families are more likely to forgive providers who make full disclosure rather than attempt to shield unpleasant facts.
Alan C. Horowitz, Esq., is a partner at Arnall Golden Gregory LLP, where he focuses his legal practice on regulatory compliance for skilled nursing homes, hospices and home health agencies and manages cases where the Centers for Medicare and Medicaid Services (CMS) has imposed an enforcement action. He is a former assistant regional counsel Office of the General Counsel, U.S. Department of Health and Human Services. As counsel to CMS, he was involved with hundreds of enforcement actions and successfully handled appeals before administrative law judges, the HHS Departmental Appeal Board and in federal court. He also has clinical healthcare experience as a registered respiratory therapist and registered nurse. He can be reached at email@example.com.
Topics: Alan C. Horowitz , Executive Leadership , Medicare/Medicaid , Regulatory Compliance , Risk Management