Legislating Full Disclosure of Medical Errors: Protecting Health Care Providers for Increased Patient Safety

This is a copy of what I wrote in February 2007 while a student in a local RN program, as I was disheartened by the clear cover-your-ass attitudes and policies of local health care providers, or even what was taught by our own school. I consider myself more of a consumer, than as a provider in health care, and thus find myself identifying with concerned patients and loved ones; than with professionals and facilities trying to stay in business or protect their reputations. (Also why I never pursued a career in business, my original degree – “The goal of the organization is to increase stakeholder benefit” = mo money, for the for profit, is not something I can stand behind. I believe in service.)

I believe what I was taught in nursing – that nurses are client advocates: we stand up for the rights and choices of the clients, even if it goes against the convenience or sensibilities of physicians or our employers (which is why I find it so disheartening to read of women being pressured by labor and delivery NURSES, even, to have unnecessary cesareans simply to speed things along). My own belief is if I make a serious error or cause someone harm as a nurse, I’d sooner GTFO and find myself another line of work, than watch my own ass.

And I mean it. Prior to my current nursing job, when hiring seemed bleak in my community and I said, screw nursing (as a career anyway), I got a job as a part-time maintenance worker (custodian) at the local big box store a block from my house, and intended to rebuild a life for myself and my family of four there (at the age of 39) for less than $16,000 a year, in a community where I’ve calculated it will cost at least $43,000 simply to pay bills and not save a thing. After more than three years of unemployment due mostly to full time schooling.

Legislating Full Disclosure of Medical Errors: Protecting Health Care Providers for Increased Patient Safety

As a student who began study of nursing to learn to care for the elderly and other vulnerable clients in the long-term setting, it was disheartening to learn about the extent of medical errors, adverse effects of treatments, and adverse outcomes that occur in the U.S. Stories about errors, much less actual negligence or malpractice, can be appalling, and the defensive stance health care providers may feel forced to take when challenged can be upsetting. For example, we were taught from our first semester that words like “error” or “mistake” that implied liability were not to be put into the client’s chart, even when factual. “Sounds sneaky,” was the reaction of one classmate, and I thought so as well. We had not yet been instilled with the fear of a malpractice suit, nor appreciated the threat of losing our license.

Seeing the reality of the demands made upon health care providers from the inside has been sobering. I now understand the need for greater safeguards for health care providers, which will improve patient safety. Health care providers can feel hindered from carrying out their ethical or moral obligation to express their feelings or tell patients the entire truth because of fear of liability. By encouraging health care providers to communicate openly, situations which lead to errors can be investigated and corrected.

The need for continued improvement in patient safety is undeniable. The Institute of Medicine of the National Academies defines error as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim” (IOM, 1999, p.1). Medical errors can cause serious harm. Mainstream media and medical researchers alike cite figures from the 1999 Institute of Medicine report, To Err is Human, which found that “at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented” (p.1). In 1999, these figures would have made medical error the fifth or ninth leading cause of death in the U.S., ahead of motor-vehicle accidents, breast cancer, and AIDS. (CDC, 2001). The Institute of Medicine estimated “total costs (including the expense of additional care necessitated by the errors, lost income and household productivity, and disability) of between $17 billion and $29 billion per year in hospitals nationwide” (IOM, p.1).

The American Medical Association (AMA) encourages disclosure of errors to patients and families. Section E-8.121 of the American Medical Association Code of Medical Ethics: Current Opinions with Annotations defines error as follows: “In the context of health care, an error is an unintended act or omission, or a flawed system or plan, that harms or has the potential to harm a patient” (AMA, 2003). The section reads in part,

When patient harm has been caused by an error, physicians should offer a general explanation regarding the nature of the error and the measures being taken to prevent similar occurrences in the future. Such communication is fundamental to the trust that underlies the patient-physician relationship, and may help reduce the risk of liability. (AMA, E-8.1.121.3)

This passage recognizes the importance of the fiduciary relationship between patient and health care provider, and the need for continued improvement of patient safety.

The American Nurses Association (ANA) Code of Ethics for Nurses is less clear. For example, Provision 3.5, Action on questionable practice, requires to the nurse to “be alert to and take appropriate action regarding any instances of incompetent, unethical, illegal, or impaired practice by any member of the health care team or the health care system or any action on the part of others that places the rights or best interests of the patient in jeopardy” (ANA, Provision 3.5). However, concerns are to be expressed to “the person carrying out the questionable practice,” or to “the responsible administrator,” or to “an appropriate higher authority within the institution or agency, or to an appropriate external authority” (Provision 3.5), but not the patient or family. Disclosure of medical errors to patients and families is recognized as “an ethical dilemma” for nurses, because nurses lack clear guidelines (McNulty, 2003).

The Joint Commission, a national body for accreditation and evaluation of health care organizations, as part of their campaign to improve quality standards in health care, enacted Standard RI.2.90 which states, “Patients, and when appropriate, their families are informed about the outcomes of care, treatment, and services that have been provided, including unanticipated outcomes” (Wojcieszak, Banja, & Houk, 2006, p.344). In their recent report,“What Did the Doctor Say?:” Improving Health Literacy to Protect Patient Safety, the Joint Commission states, “Be accountable to patients. Make a commitment to be transparent with patient about outcomes, whether good or bad. Approach errors with an intent of full, open disclosure” (Joint Commission, 2007, p.36).

However, one article citing JAMA findings, claims “physicians perceived a number of barriers to disclosing errors, including fear of litigation, fear of being reported to a public registry, and not knowing how to talk to patients about errors” (Hoy, 2006, p.412). In one 2003 survey, “77% of hospitals indicated that malpractice fear was the principal barrier to error disclosure” (p.412). One study of approximately 5,200 citations on disclosure of medical error, malpractice, and liability, likewise identified “increase in number of malpractice claims and lawsuits,” “increase in total malpractice liability,” “increase in malpractice insurance costs,” and “higher litigation costs through increased claims and lawsuits” at the top of their list of ten “theoretical advantages and disadvantages of full disclosure of medical errors” (Kachalia, Shojania, Hofer, Piotrowski, & Saint, 2003, p.505). In an apparent violation of the AMA Code of Ethics, it has even been argued, “An admission of fault exposes the doctor and/or institution to damages per se. And the medical malpractice […] insurance policies usually provide that an admission of the insured of error voids coverage for the related claims for damages. In today’s world, that situation is simply not one that a doctor or hospital, etc., can accept” (Banja, 2004, p.15).

Health care providers need to remember that patients are families are not ignorant to the possibility of error simply because they are not told. Studies have shown that patients are “potentially acute observers of their own care, and are highly motivated to ensure that correct treatments are correctly delivered” (Weingart, et al., 2005, p.830). In addition, “In consumer surveys, 12% to 42% of U.S. adults report having personally experienced a medical error, or seen an error affect the health of a close friend or relative” (p.830). When it comes to adverse drug events, “among the most common medical errors, harming at least 1.5 million people every year,” according to the Institute of Medicine (2006), studies have shown “adult patients readily identify adverse drug events that are subsequently confirmed by investigators” (Weingart, et al., p.830).

Kachalia’s group tried to determine “the impact of full disclosure [of errors or patient harm] on malpractice liability” (p.503). Their findings were inconclusive. They reported that there has been only one published study, in 1999, which documented the economic impact of malpractice liability before and after a program of full disclosure was implemented at the Veterans Affairs Medical Center (VAMC), in Lexington, Kentucky. Under the program, “When an untoward outcome occurs or an error is reported or discovered, the patient’s case is investigated. If it is determined that a medical error or negligence led to patient injury, the patient or family is informed of the circumstances and offered a settlement” (p.505). The patient is even “advised to retain an attorney” during this process, through whom the hospital may communicate (Hoy, p.410).

While the original study did claim a decrease in number of claims and malpractice lawsuits, cost of settlements, time to close cases, and litigation costs, the study did have its limitations. Specifically, the Lexington VAMC does not have the same exposure to liability as health care providers in the private sector, because “employees of the federal government are generally protected from being personally sued for malpractice,” and “the federal government cannot be held liable for punitive damages” (p.509). Furthermore, patients of a VA facility [active service military personnel and their dependents, and veterans of active service] are considered less likely than the general public to file malpractice lawsuits or demand compensation. They may fear losing their VA benefits, or have limited health care choices outside the VA system (2003).

More recently, in 2001, the University of Michigan Health System also adopted a policy of apology and open communication with patients and families for “unreasonable care,” and view “court as a last resort” (University of Michigan Health System, 2007). Like the Lexington VAMC, the U-M hospital is a government funded not-for-profit entity, and is self-insured, limiting exposure to liability. The applicability of the UMHS full disclosure program to the private sector is likewise limited.

Dr. Steve Kraman, former chief of staff at the Lexington VAMC, and Rick Boothman, chief risk officer at the University of Michigan, claim the Lexington VAMC and University of Michigan [Health System] are “the two best publicized and successful disclosure programs in American hospitals,” and are also the only two hospitals nationwide to publicly release financial outcomes of their policies (Kraman & Boothman, n.d.). This further limits the research that can be done on the actual impact of a full disclosure policy on a wider scale. The effects of a full disclosure policy on private health care providers remains anecdotal.

According to the AMA Code of Medical Ethics, physicians “should” already be telling patients and/or their families about errors that cause patients harm (AMA, E-8.1.121.3). At the same time, the AMA recognizes the need for legal protection for health care providers: “Physicians should seek changes to the current legal system to ensure that all errors in health care can be safely and securely reported and studied as a learning experience for all participants in the health care system, without threat of discoverability, legal liability, or punitive action” (AMA, E-8.1.121.5).

There is currently no federal law requiring health care providers to disclose medical errors to patients or families. In 2005, U.S. Senators Hillary Rodham Clinton (NY) and Barack Obama (IL) introduced S.1784, a bill informally called the National Medical Error Disclosure and Compensation (MEDiC) Act. Under the act, program participants “would be required to disclose the matter to the patient, and offer to enter into negotiations for fair compensation to the patient” (Public Health Service Act, 2005). Under the act, participation by health care providers would be voluntary, and participants would be eligible for federal funds to implement research and programs to improve patient safety, as well as train providers “how to effectively disclose medical errors and other patient safety events to patients” (Public Health Service Act, 2005). The bill was referred to the Committee on Health, Education, Labor, and Pensions (THOMAS, 2007).

At the state level, as of 2006, “29 states have enacted laws excluding expressions of sympathy after accidents as proof of liability” (AON, 2006). In addition, there are five states that require “notification of adverse events to patients” (AON, 2006). Vermont is the most recent state to have done both, in 2006. On the one hand, Vermont requires hospitals to “disclose to patients, at a minimum, adverse events that cause death or serious bodily injury” (Common sense initiatives, 2005, p.16). However, providers can protect themselves from liability in case of error, by means of “an oral expression of regret or apology” or even a “good faith explanation,” as such expressions are inadmissible as legal admission of liability (Sorry Works!, 2005, p.1).

Disclosure of medical error to affected patients and families is already a part of the AMA Code of Ethics, as well as JCAHO standards and philosophy. Health care professionals need to be freed from fear of litigation, and encouraged to disclose errors in the interest of improving patient safety.

References consulted

An act relating to common sense initiatives in health care, S.310, Vermont, Senate. (2006). Retrieved February 1, 2007 from

http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2006/bills/senate/S-310.HTM

 

An act relating to establishing a “Sorry works!” program, S.198, Vermont, Senate. (2006). Retrieved February 1, 2007 from

http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2006/acts/ACT142.HTM

 

American Medical Association. (2003). Section E-8.121, Ethical responsibility to study and prevent error and harm. Code of Medical Ethics: Current Opinions with Annotations. Retrieved February 1, 2007 from http://www.ama-assn.org/ama/pub/category/11968.html

 

American Nurses Association, Center for Ethics and Human Rights. (2005). Code of Ethics for Nurses with Interpretive Statements. Retrieved February 1, 2007

http://www.nursingworld.org/ethics/code/protected_nwcoe303.htm

 

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http://www.hcs.harvard.edu/~hhpr/publications/previous/04s/Banja.pdf

 

A bill to amend the Public Health Service Act to promote a culture of safety within the health care system through the establishment of a national medical error disclosure and compensation program, S.1784 IS, 109th Cong. (2005) Retrieved February 1, 2007 from http://thomas.loc.gov

 

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