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Disclosure: Who, What and Whether To


 

The concern for public safety has spawned both regulatory (1) and legislative (2) requirements for the reporting of medical errors. The evolution of this process has caused the discussion of issues related to the full disclosure of errors to patients. While the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has stated that patients are entitled to be informed about unanticipated outcomes (3), there is concern about what should be disclosed, who should disclose, and the possibility of resulting legal action. Concern is well placed as to the latter because there is little data from facilities with disclosure policies to show that the benefit of communicating errors to patients outweighs the risk of lawsuits.

Error has been defined by JCAHO as “…an unintended act, either of omission or commission, or an act that does not achieve its intended outcome”(4). It seems obvious that a major error which causes damage, e.g., sudden death related to a treatment or the wrong surgical procedure, will trigger disclosure of at least some information. However, a recent survey (5) surprisingly revealed that even death or serious harm related to an error is not always disclosed. To the author the harmless error creates a bigger dilemma. By extension it could be argued that based on the JCAHO entitlement (3) these errors have not affected outcome and therefore do not need to be communicated to the patient. On the other hand, if informed communication is a goal then even harmless errors should be disclosed. The bottom line is that required disclosure will be dictated by regulatory bodies, state requirements (2), and the policy of each health care facility or insurance carrier.

If events creating an unanticipated outcome are to be disclosed, a communicator must be identified. The designee should be carefully chosen based on communication skill, sensitivity, and awareness of the disclosure process. “Done incorrectly, disclosure may be an admission of liability (with possibly incorrect information) to a patient”(4). It is recommended that the attending physician at the time of the error be present at the time of disclosure if he is not the spokesperson (3). The rationale is that the attending physician has an established relationship with the patient and will be the most constant link in the communication chain to the patient. This should help to provide continuity of information and discourage inaccuracies. If the information conveyed is inconsistent, this could give rise to suspicion and may be the deciding factor to pursue legal action (4).

It is paramount that the spokesperson give thoughtful attention to what is conveyed to the patient. Consensus is that the information should be factual, accurate, yet broad (3). The emphasis should be on revealing the known facts and the immediate care to be given to the patient. Events take time for complete investigation and speculation is never beneficial (4). It is suggested that one should speak slowly, use simple language, be interactive, and not overwhelm the listener (3). There should never be the placement of blame. A study reported in JAMA showed that patients believed that the way an error was revealed to them affected their response to the experience (6). It has been suggested that expressing sincere regret, in effect an apology, may help to establish trust and even avoid litigation (7). In Healing Words by Michael Woods, MD practical hints are given about what to say and how to phrase information. The goal is for the patient/family to know that the provider genuinely cares for and respects them (3).

The Joint Commission on Quality and Safety has enumerated some of the potential advantages and disadvantages of full disclosure of medical errors (1). Understandably it may be difficult for a physician to approach a person with the news that an injury or potential for injury has occurred. The JAMA study indicated that physicians would feel guilty about doing harm, disappointed about failing to practice to their own high standards, fearful about a possible lawsuit, and anxious about repercussions to their reputation (6). Of these, the most difficult hurdle may be the legal barriers to disclosure which are “entrenched in years of punitive attitudes and cultures of blame”(3).

Although there is the fear of increasing claims and lawsuits, increasing malpractice insurance, and increasing jury awards, there is no clear evidence of the impact on litigation. There has been no determination that lawsuits have increased. On the contrary it can be argued that failure to reveal medical errors “…could impair patient trust and satisfaction and increase the chances of a malpractice suit” (6). “Nearly 90 percent of jurors polled felt that there should be disclosure when there is a medical error or mistake” (4). So if disclosure is an expectation of jurors, this should give added credibility to an attending physician. There are anecdotal reports that verdict awards may be limited because of disclosure (4). In addition, the claim of concealment/“a cover up” and the request for punitive damages could be nullified by disclosure.

When disclosure is triggered by an outcome, prompt disclosure is encouraged but only after considering the following steps:

Steps:

  1. If your facility has a disclosure policy, become familiar with it. Be certain what is considered an “unexpected outcome.”
  2. Consult with risk management or your professional liability carrier.
  3. Carefully review the known facts and anticipate what care will be required by the patient.
  4. Decide who should do the disclosure.
  5. Decide who should be present.
  6. The content of the conversation should be prepared being careful not to place blame or admit liability.
  7. If the unexpected outcome is a recognized complication of treatment, this should be pointed out, including the fact that it was covered during the process of obtaining the patient’s consent.
  8. Disclosure should conclude with an offer to be available for further discussion. Do not avoid the patient or family.
  9. Documentation should conform to the policy of the facility or principles of risk management.

To make the theoretical more practical consider the following clinical scenarios.

  • A 74 year old man weighing 63 Kg. with multiple co-morbidities (insulin dependent diabetes mellitus, congestive heart failure, coronary artery disease) underwent an anterior cervical laminectomy. His pain was difficult to control in the recovery room. Despite several doses of intravenous (IV) fentanyl, the pain level remained at 4. Over the next 6 ½ hours he received additional fentanyl, Percocet and Tylenol #3 without significant relief. The patient’s respiration rate and blood pressure remained stable. The nurse called the resident-physician and suggested Dilaudid because of the patient’s history of Demerol and morphine intolerance. An order was given for Dilaudid 2-4 mg. IV every 2‑3 hours as needed. Because of the uncontrolled pain the nurse gave 4 mg. Four hours later the patient was found pulseless and resuscitation was unsuccessful. After a discussion with the Risk Management staff, the surgeon disclosed to the family that the patient had received a large dose of narcotic but that he did not know if this contributed to the patient’s death. The family refused an autopsy initially but changed their decision with this added information.
  • An infant with a congenital hypoplastic left heart syndrome underwent a modified Norwood procedure. The infant was doing well until a TPN programming error occurred. The baby received a 24 hour volume of TPN over a 2 hour period. There were symptoms of tamponade and the heart rate dropped from 140 to 43. The team opened the chest and resuscitated the infant. The TPN overload was not detected until the grossly abnormal laboratory values were reviewed. Because many hypoplastic-heart babies also have neurological problems, it will be impossible to determine the origin if any deficits become apparent. The mother was given the facts surrounding the event. The mother responded with support for the nurse in that she knew the nurse cared deeply about her child and then expressed that mistakes happen.
  • A 55 year old man with a large pericardial effusion after a coronary artery bypass graft became hypotensive and was transferred to an intensive care unit. Dobutamine 7.5 mcg/kg/minute was ordered. However, dobutamine 18 mcg/kg/minute was administered. The patient did well and was discharged. The medication error was discovered on an audit. There was no indication of an associated injury. The Risk Management department recommended not disclosing to the patient. However, it was suggested that if the physician felt an obligation to inform the patient of the discrepancy, the physician should discuss the facts with a medical ethicist to work through his concerns which were separate from the legal ones.

Each of these scenarios presents a disclosure conundrum. Should there be disclosure when there is an unanticipated outcome without clear linkage to an error? How should you most appropriately disclose an obvious error with unknown damage? What is the correct action when there is a non-consequential mistake that is incidentally detected? Because each situation has unique facts and nuisances, there is no way to provide an exact roadmap.

Disclosure is a ripe topic for discussion but recognized to be in its practical and legal infancy. It is clear that education is the key to overcoming the pitfalls of this process. Outcomes should be measurable based on patient reaction. Because the lack of communication has generally been regarded as a source of patient dissatisfaction, it is reasonable to speculate that disclosure done properly should decrease litigation.

Agnes Yost can be contacted at ayost@proassurance.com.

References

  1. Kachalia A, Shojania K, Hofer T, et al. Does Full Disclosure of Medical Errors Affect Malpractice Liability? Joint Commission Journal on Quality and Safety. October 2003. Volume 29 Number 10:503-11.
  2. Rosental J, Booth M. Defining Reportable Adverse Events: A Guide for States Tracking Medical Errors. National Academy for State Health Policy. March 2003.
  3. Task Force of the American Society for Healthcare Risk Management. Monograph. Disclosure of unanticipated events: the next step in better communication with patients. May 2003. American Society for Healthcare Risk Management of the American Hospital Association.
  4. Popp P. How will disclosure affect future litigation? ASHRM J. Winter 2003:5-9.
  5. Safety Institute, Premier Inc. Survey on Disclosure Practices in Hospitals. 6th Annual NPSF Patient Safety Congress. Boston. May 3-7, 2004. (ECRI’s Healthcare Risk Control Weekly News. July 7, 2004).
  6. Gallagher T, Waterman A, Ebers A, et al. Patients’ and Physicians’ Attitudes Regarding the Disclosure of Medical Errors. JAMA. 2003;289:1001-1007.
  7. Apologies lead to trust, healing, help avoid litigation, new book says. Medical Liability Monitor. July, 2004. Vol 29, No. 7.

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