TO ERR IS HUMAN

MINI-CASE STUDY: TO ERR IS HUMAN (chapter 9)
In 1999, the Institute of Medicine (IOM) published the groundbreaking report To Err Is Human: Building a Safer Health System. It reported 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” (Kohn, Corrigan, and Donaldson 1999). In fact, more people died from preventable medical errors in hospitals than from motor vehicle accidents and breast cancer combined. In response to the report,The Joint Commission issued a cluster of standards in support of patient safety (effective in 2001). One standard specifically required that all unanticipated outcomes of care be disclosed to patients (Henry 2005); see the “Disclosing Medical Errors” section in Chapter 4.Congress enacted the Patient Safety and Quality Improvement Act of 2005. The goal of the act is to improve patient safety by encouraging voluntary and confidential reporting of medical errors and other adverse events. Healthcare providers report data about adverse events to patient safety organizations, which, in turn, collect, aggregate, and analyze the data. The act provides federal legal privilege and confidentiality protections for conducting patient safety activities. Regulations implementing the act were effective in 2009 (HHS 2014).Over the past 15 years, only some small improvements have been made in the US healthcare system’s safety and quality, despite accreditation standards; federal law; and healthcare organizations’ investment of considerable time, energy, and resources into the effort. However, the improvements are not widespread and are insufficient given the magnitude of the problem (Chassin 2013).MINI-CASE STUDY QUESTIONS
Why do healthcare organizations have an ethical obligation to provide a safe environment?How do ethical principles support The Joint Commission’s standard requiring that all unanticipated outcomes of care be disclosed to patients?A nonmoral concern is the cooperation clause in policies for malpractice and professional liability insurance. An admission of error (fault) can void the coverage for related claims (Banja 2004). How does this nonmoral concern affect the disclosure of unanticipated outcomes?What ethical obligations do healthcare managers have to contribute to the safety of their organization’s environment?Which standards of professional codes of ethics relate to establishing and maintaining patient safety?
MINI-CASE STUDY: GROUPTHINK AND THE TUSKEGEE STUDY (chapter 8)
Why did the PHS researchers involved in the Tuskegee Study continue their experiment long after penicillin was discovered as a treatment for syphilis and after the Nuremberg Code was developed? Experts suggest groupthink as the answer (Braithwaite, Griffin, and De La Rosa 2011).Groupthink exists in cohesive groups—groups with an esprit de corps. Irving Janis (1971, 43), the research psychologist who developed the theory and coined the term, defined groupthink as the “mode of thinking that persons engage in when concurrence-seeking becomes so dominant in a cohesive ingroup that it tends to override realistic appraisals of alternative courses of action.” Three types of groupthink exist:Type I: Overestimation of the group’s power and moralityType II: Closed-mindednessType III: Pressure of uniformityTo understand how groupthink played a role in the decisions of the PHS researchers involved in the Tuskegee Study, consider the background information we present in this section about the PHS and its researchers.Nuremberg CodeA set of ten statements requiring that human participation in research must be voluntary and informed
GroupthinkA manner of thinking in which every member of the group supports the dominant perspective and thus fails to consider alternative and contradictory ideas
THE PHSThe PHS dates back to 1798 when it was called the Marine Hospital Service and provided hospital care for sick merchant seamen (Reverby 2009). In 1912, it became officially known as the Public Health Service and was charged by the federal government to oversee all of its health activities.The PHS was built on a military model; it had a commissioned corps of medical officers led by a surgeon general. The commissioned officers were the medical elite, given that passing the PHS exams to become an officer was more difficult than passing state medical board exams (Reverby 2009). Once commissioned, officers were moved from station to station and were taught by experienced senior medical officers. This model engendered esprit de corps; loyalty to the PHS; and a cohesive network of officers who had the special relationship of being friends, teachers, and students.As part of their medical research, PHS researchers conducted auto-experimentation—that is, they exposed themselves to the diseases and thus made themselves the subjects. Walter Reed and his three colleagues—Jesse Lazear, James Carroll, and Aristides Agramonte—conducted auto-experimentation on yellow fever in 1900 through 1901. In August 1900, at Columbia Barracks, a US military base near Havana, Cuba, Carroll and Lazear allowed mosquitoes to bite them. Both men developed yellow fever, and Lazear’s case turned fatal on September 25, 1900. This tradition of self-sacrifice imbued the PHS medical researchers with a sense of martyrdom in the name of science (Reverby 2009).THE TUSKEGEE STUDYIn 1918, under Congressional mandate, the PHS created a special unit to combat venereal diseases called the Division of Venereal Diseases (or VD Division). PHS officers of the VD Division saw themselves as elite crusaders and called themselves “syphilis men” (Jones 2008).In the late 1920s, researchers from the VD Division conducted studies to determine the prevalence of syphilis among African-Americans in the rural South and to investigate the possibilities of mass treatment (Brandt 1978). These studies were funded by the Julius Rosenwald Fund. After the Wall Street Crash in 1929, however, the Rosenwald Fund could no longer finance the studies. To “salvage” what the researchers had found during the initial studies, the chief of the VD Division, Dr. Taliaferro Clark, proposed a prospective experiment on living people (Thomas and Quinn 1991). That was the root of the Tuskegee Study, which began in 1932 and over the years enrolled 600 African-American men—399 of whom had untreated syphilis and 201 did not have the disease.High-ranking PHS medical officers and researchers were involved in the Tuskegee Study. Dr. Clark was not only the chief of the VD Division but also the assistant surgeon general at the time. Other officers involved during the first ten years of the Tuskegee Study were Dr. Hugh Cumming, the surgeon general at the time the study commenced, and Dr. Raymond A. Vonderlehr, the assistant surgeon general who succeeded Dr. Clark. All three officers were graduates of the medical school at the University of Virginia (Lombardo and Dorr 2006). In 1933, when Dr. Clark retired, Dr. Vonderlehr became chief of the VD Division. He was especially committed to continuing the experiment because of his scientific interest in cardiovascular complications of syphilis. Over the next 40 years, the PHS’s policy of promoting from within resulted in VD Division chiefs who had worked on the Tuskegee Study early in their careers (Jones 2008). Beginning in 1936, the researchers published their findings in scholarly medical journals, such as the Journal of the American Medical Association and Public Health Reports. By the end of the Tuskegee Study (1972), the researchers had published more than a dozen research articles about the men in the study and the toll of their disease (Reverby 2009).Initially, the study was meant to be short-term, lasting six months to eight months. However, after Dr. Vondelehr became the chief of the VD Division, the Tuskegee Study was modified into a “death as end-point study” (Brandt 1978). The researchers did not tell the 399 men who had syphilis that they had the disease. Instead, the men were led to believe that they were receiving special treatment for their “bad blood” (Katz 1992). This “treatment,” however, was not the conventional treatment for syphilis but rather consisted of only vitamins and aspirins (Reverby 2001).Efforts to retain the men as experiment subjects and to prevent treatment of their syphilis were extraordinary (Thomas and Quinn 1991). For example, the PHS researchers tracked the men to other public health departments, intervened with local physicians, and blocked them from being drafted into military service during World War II (drafted soldiers were routinely treated) (Katz 1992; Reverby 2001). In 1951, when penicillin became the standard medical intervention for syphilis, the researchers continued to deny treatment, insisting the study was all the more urgent because it afforded a unique opportunity that would never exist again (Jones 1981). As a result, the Tuskegee Study became the “longest nontherapeutic experiment on human beings in medical history” (Jones 1981, 91).For the first 24 years of the study, no one in the PHS ordered or performed a periodic reassessment of the study’s scientific value or ethics. However, in 1956, its first external criticism emerged. Dr. Count Gibson heard Dr. Sidney Olansky of the PHS speak about the study. After reading published articles on the study, Dr. Gibson wrote Dr. Olansky to question its ethics. However, Dr. Gibson was convinced by colleagues that questioning the PHS was inadvisable if he wanted a successful career (Reverby 2009). In 1957, on the 25th year of the study, the PHS held a meeting in which the decision was made to continue the study and to give the subjects fake treatments of iron tonics and aspirin, “special certificates of participation” signed by the surgeon general, and $1.00 for every year of “service.”In the late 1950s and the 1960s, discussions about ethics in medical research began in earnest. In the mid-1960s, the PHS and the Tuskegee Study came under the oversight of the Communicable Disease Center (now the Centers for Disease Control and Prevention [CDC]). In 1965, PHS researchers met about the study and decided it still served a purpose and rationalized the “racial aspects of the experiment” (Brandt 1978, 26; Reverby 2009). In 1966, the surgeon general issued Policy and Procedure Order Number 129 (see Exhibit 8.1) that required institutions receiving PHS research grants to put mechanisms in place to protect human subjects. Technically, the order did not apply to the PHS’s own research studies; however, ethically, PHS researchers should have complied in the true spirit of the order. Unfortunately, they remained morally blind.THE WHISTLEBLOWERFortunately, Peter Buxton was not blind to the immorality of the Tuskegee Study. Buxton was a PHS psychiatric social worker who investigated cases of venereal disease in San Francisco (Jones 2008). Upon learning about the study in 1966, he conducted his own investigation, wrote multiple letters, and met with PHS officials expressing his concerns (Jones 2008). He made parallels between the study and the Nazi experiments at the concentration camps (Reverby 2009). As a result of his complaints, in 1969 the CDC convened a blue-ribbon panel to consider whether the Tuskegee Study should be continued. Only one panel member—who was unfamiliar with the study—insisted that the study be terminated and that the men receive treatment for their condition (Lederer 2005). That one panel member was outvoted. In 1967, Buxton resigned from the PHS to attend law school.In 1972, Buxton, after finishing law school, decided to pursue the termination of the Tuskegee Study. He showed copies of the published research articles and his correspondence with PHS officials to Edith Lederer, an Associated Press reporter (Jones 2008). Lederer forwarded the materials to her superiors at the Associated Press, who gave the story to Jean Heller, another of its reporters. Heller conducted telephone interviews with CDC officials who confirmed the study’s existence (Jones 2008). The CDC officials stated that the PHS physicians were rendering medical services to the survivors and were continuing to investigate syphilis’s effects on the men (Heller 1972). On July 25, 1972, Heller broke the story, titled “Syphilis Victims in U.S. Study Went Untreated for 40 Years,” in the Washington Star, and it was reposted by the New York Times the following day. A public outcry ensued. In August 1972, the CDC convened another blue-ribbon panel, the Tuskegee Syphilis Study Ad Hoc Advisory Panel. On the panel’s recommendation, the HHS Assistant Secretary of Health Dr. Merlin K. DuVal terminated the Tuskegee Study on November 16, 1972 (DuVal 1972).MINI-CASE STUDY QUESTIONS
Which types of groupthink do you believe the PHS researchers and CDC officials showed? Support your choices with evidence from the Mini-Case Study.How do the historical and cultural elements of the PHS, its researchers, and the CDC relate to the groupthink types you chose?Janis (1982) explains that groupthink leads to poor decision making through seven different defects:Incomplete survey of alternativesIncomplete survey of objectivesFailure to examine the risks of the preferred choiceFailure to reappraise initially rejected alternativesPoor information searchSelective bias in processing information at handFailure to work out contingency plansWhich defects of decision making do you see in the decisions of the PHS researchers and the CDC?To avoid poor decision making as a result of groupthink, how can you, as a healthcare manager, use the ethical decision-making process framework and steps described in Chapter 7 (see Exhibit 7.1)?What forces other than groupthink could explain the PHS researchers’ decisions

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