C426 ETHICS DISCOVER SECTION

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DISCOVER SECTION TOPIC #1 What are the principles of healthcare ethics? It is difficult to comprehend how something like the Tuskegee study could have happened. Although this study seems unconscionable in modern society, the reality is that it proceeded for decades without any objection. Healthcare managers must understand how and why a particular case is unethical in order to prevent similar ethical breaches in their organizations. Healthcare professionals can use four basic principles as a lens through which to evaluate concerns from an ethical perspective:  Beneficence  Nonmaleficence  Autonomy  Justice Although each of these principles can become incredibly complex in application, almost all aspects of healthcare ethics can be explained through these four principles. For a manager, these principles can be used to help define an ethical challenge, evaluate that challenge, and communicate the challenge to others. Managers need to be able to do all three when addressing ethical concerns in a healthcare environment. Ethics Framework Reflect on what it would be like to work as a healthcare manager in a situation similar to the Tuskegee case. There might be a clear sense that what is happening is wrong, but a manager needs more than just a belief that something is wrong. A manager will need to evaluate, articulate, and communicate clear ethical principles to the organization. In order to objectively articulate ethical concerns, these four ethical principles—beneficence, nonmaleficence, autonomy, and justice—can be organized into what is known as an ethics framework. This framework assists in making sense of the questions and concerns that managers consider when faced with complex ethical challenges. Explore the provided Ethics in Medicine framework from the University of Washington School of Medicine before beginning the first challenge. The ethics framework will be used extensively throughout the course. Although all of the facts in the Tuskegee study can be studied in hindsight, healthcare managers will rarely have all of the facts of a case that is happening in real time. The ethics framework acts as a guide in asking the right questions and focusing energy on constructing and propagating a professional message or policy about a situation. Managers must develop such a framework and integrate it into the organizational culture. Ethics Committee

Managers have many resources, including organizational ethics policies and professional ethics codes, to assist them in making appropriate choices. An ethics committee can be one of the most effective resources. Many hospitals have an ethics committee. Members on an ethics committee may consist of, but are not limited to, an administrator, nurse, care provider, bioethicist, and risk manager. Managers should ensure that employees are aware of the function and mechanisms of the committee and know what situations should be referred to the ethics committee for deliberation. Intergovernmental organizations like the United Nations and the European Union have independent ethics committees. Any organization that deals with human life and human rights should have a committee like this. Some ethics committees use frameworks to organize their discussions of the cases being presented. Ethical frameworks can be used to ensure important discussion points are covered and as a way to document the deliberations and recommendations of the committee. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 1 PowerPoint Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 4 PowerPoint Implementing an ethics framework emphasizing the importance of an ethics committee to address unethical behavior could have prevented the tragedy of the Tuskegee study. Points to Remember A thorough understanding of the foundation of healthcare ethics requires a knowledge of how theoretical principles and concepts are applied in everyday healthcare settings.  Ethical principles: In most cases, ethics in healthcare can be explained through the four basic ethical principles of beneficence, nonmaleficence, justice, and autonomy . While these principles are clear in theory, their real-world application becomes more complex. Ethical dilemmas occur when these four principles come in conflict with one another.  Ethics framework: An ethics framework can prompt questions addressing these four principles and may be used as a guiding document for an ethics committee.  Ethics committees: An ethics committee should be an integral part of any healthcare organization. A manager's role is to support and supervise the committee and to consult with its members on a regular basis. A manager can support an ethics committee by ensuring that it has appropriate representation from the medical, nursing, and allied health staff; that it has access to legal counsel as needed; and that it has budgetary support to permit it to meet as often as necessary.

Beneficence, nonmaleficence, justice, and autonomy are the foundation that ensures that ethical, patient-centered care is consistently practiced in a healthcare organization. However, these principles and tools do not exist in a vacuum. As with any other issue in healthcare, ethics is influenced by cultural, social, and economic factors. Close "What are the principles of healthcare ethics?" Section What Other Factors Influence healthcare ethics? For tragic proof of systemic injustice preventing the distribution of ethical patient care, refer back to the Tuskegee case and the culture of the U.S. in the 1930s. The following factors affected decisions in the Tuskegee study:  Prejudiced beliefs about race  Patients studied as members of a racial category  The misguided belief that syphilis somehow affected African Americans differently than other populations  The use of free medical care, food, and burial insurance as incentives to attract a specific demographic  Exploitation of the socioeconomic conditions of sharecroppers, a predominantly African American occupation, who were specifically targeted in this study What factors exist in contemporary U.S. society that affect ethical considerations? Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 1 PowerPoint Consider all of the barriers to access that might face this population, including economic and language barriers. Clinical practices must adapt to accommodate the specific needs of this population. Because guesswork is insufficient to adequately isolate the variables that might be contributing to a lower quality of care for a special-needs population, the Ethics in Medicine framework can be used to systematically investigate whether or not principles of justice and patient preferences are taken into consideration when delivering care to a potentially vulnerable population. Points to Remember It is not enough to identify how the four ethical principles influence a situation. Fluctuating contextual features must also be taken into account in order to make a comprehensive evaluation.  Contextual factors: Cultural, social, and economic factors affect populations in a variety of ways. Good healthcare managers take these factors into consideration when

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determining ethical behavior throughout their organization. Every organization will have unique contextual needs that must be addressed with an ethics framework.  Marginalized populations: Being aware of and advocating for marginalized populations is the only way to address inequities in the healthcare system. The “Contextual Features” section of the ethics framework is a useful tool for analyzing the factors that contribute to injustice and unethical behavior. Contextual questions, combined with relevant considerations from other quadrants, can help healthcare managers identify areas that need to be examined for justice and fairness. In the next section, continue to practice implementing the questions from the ethics framework, this time in a different situation that a healthcare manager might face in a research scenario. SUMMARY TOPIC #1 Healthcare administrators can use an ethics framework to analyze the ethical principles and contextual features at stake in any situation. Key takeaways include:  Ethical principles: In most cases, ethics in healthcare can be explained through the four basic ethical principles of beneficence, nonmaleficence, justice, and autonomy . While these principles are clear in theory, their real-world application becomes more complex. Ethical dilemmas occur when these four principles come in conflict with one another.  Ethics framework: An ethics framework can prompt questions addressing these four principles, and it can be used as a guiding document for an ethics committee. Healthcare administrators should know how to use an ethical framework and how to implement that framework in an ethics committee.  Ethics committees: An ethics committee should be an integral part of any healthcare organization. An administrator's role is to support and supervise the committee and to consult with its members on a regular basis. An administrator can support an ethics committee by ensuring that it has appropriate representation from the medical, nursing, and allied health staff; that it has access to legal counsel as needed; and that it has budgetary support to permit it to meet as often as necessary.  Contextual factors: Cultural, social, and economic factors affect populations in a variety of ways. Good healthcare administrators take these factors into consideration when determining ethical behavior throughout their organization. Every organization will have unique contextual needs that need to be addressed with an ethics framework.  Marginalized populations: Being aware of and advocating for marginalized populations is the only way to address inequities in the healthcare system. A knowledge of these concepts enables administrators to make sound ethical decisions in any situation, from small disagreements to major organizational conflicts. Make Critical Connections

The knowledge and skills listed above aren't critical only for the objective assessment—they also provide a critical foundation for upcoming Topics and courses. For example:  Topic 2: Legal Principles, Standards, and Laws will explore how basic ethical principles and values are incorporated into legal standards that affect healthcare.  An understanding of ethical considerations will be crucial for making decisions about quality in healthcare management in the course Quality Improvement and Risk Management. Topic 2: Legal Principles, Standards, and Laws What An overview of the basic legal foundations of healthcare ethics, legislation, and compliance standards that affect healthcare delivery and patient rights, guided by the following questions:  What are the sources of law?  What is negligence?  What are the elements of a contract?  What laws exist to protect patients? Why Through contextualization of ethical and legal decisions in healthcare, a healthcare manager can develop a framework for assessing these types of issues. How Using these resources and tools: 'Henrietta Lacks': A Donor's Immortal Legacy Ethical Justice, but No Financial Rewards, for the Henrietta Lacks Family

Clinical Ethics and Law Altered States: State Health Privacy Laws and the Impact of the Federal Health Privacy Rule The following chapters of Legal and Ethical Issues for Health Professionals (5th ed.) READ CHAPTER 5, 6 AND 7 PAGES DISCOVER TOPIC 2 According to ' Henrietta Lacks': A Donor's Immortal Legacy , the world's oldest and most commonly used immortal cell line originated from a woman who died without even knowing her cells had been taken from her. Her cells continue to contribute significantly to the advancement of biology and medicine. These cells, known as HeLa cells, have been involved in countless research studies, medical achievements, and millions of dollars in profit, without any compensation to Lacks or her family ( Ethical Justice, but No Financial Rewards, for the Henrietta Lacks Family ). An immortal cell line is a population of cells that, because of mutation, proliferates indefinitely. In 1951, a poor African American woman named Henrietta Lacks underwent treatment for cervical cancer. During the treatment, doctors collected cervical cancer cells and sent them to a laboratory. Scientists discovered that under the right conditions this small sample of cells, called HeLa cells, could reproduce rapidly and endlessly. An entire industry was created for the purpose of proliferating this cell line. Today HeLa cells can be counted in the trillions and over the years have been used in important scientific research ranging from the first polio vaccine to cancer and AIDS research. HeLa cells have also resulted in huge profits for the medical researchers who commercialized them. Did you know? HeLa cells were sent on the very first space missions to test the effects of zero gravity on human cells. Yet neither Henrietta nor any of her family had any knowledge about HeLa cells until 20 years after they were collected. Until very recently, Henrietta and her family did not receive any recognition for her contribution to science. Scientists have published genetic information that could compromise the privacy of Henrietta Lacks's descendants—without consent. Only after a long battle was the Lacks family able to come to an agreement that would ensure they had a say in how, why, and in what setting the cells were used.

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The case of Henrietta Lacks raises important ethical concerns, especially regarding the connection of law and healthcare. Consider this case while learning about the laws that are in place to protect patients. ARTICLE INSERTION Excerpt: 'The Immortal Life of Henrietta Lacks' February 1, 20105:29 PM ET Rebecca Skloot The Immortal Life of Henrietta Lacks By Rebecca Skloot Hardcover, 368 pages Crown List price: $26 PROLOGUE The Woman in the Photograph There's a photo on my wall of a woman I've never met, its left corner torn and patched together with tape. She looks straight into the camera and smiles, hands on hips, dress suit neatly pressed, lips painted deep red. It's the late 1940s and she hasn't yet reached the age of thirty. Her light brown skin is smooth, her eyes still young and playful, oblivious to the tumor growing inside her — a tumor that would leave her five children motherless and change the future of

medicine. Beneath the photo, a caption says her name is "Henrietta Lacks, Helen Lane or Helen Larson." No one knows who took that picture, but it's appeared hundreds of times in magazines and science textbooks, on blogs and laboratory walls. She's usually identified as Helen Lane, but often she has no name at all. She's simply called HeLa, the code name given to the world's first immortal human cells — her cells, cut from her cervix just months before she died. Her real name is Henrietta Lacks. I've spent years staring at that photo, wondering what kind of life she led, what happened to her children, and what she'd think about cells from her cervix living on forever --bought, sold, packaged, and shipped by the trillions to laboratories around the world. I've tried to imagine how she'd feel knowing that her cells went up in the first space missions to see what would happen to human cells in zero gravity, or that they helped with some of the most important advances in medicine: the polio vaccine, chemotherapy, cloning, gene mapping, in vitro fertilization. I'm pretty sure that she — like most of us — would be shocked to hear that there are trillions more of her cells growing in laboratories now than there ever were in her body. There's no way of knowing exactly how many of Henrietta's cells are alive today. One scientist estimates that if you could pile all HeLa cells ever grown onto a scale, they'd weigh more than 50 million metric tons — an inconceivable number, given that an individual cell weighs almost nothing. Another scientist calculated that if you could lay all HeLa cells ever grown end-to-end, they'd wrap around the Earth at least three times, spanning more than 350 million feet. In her prime, Henrietta herself stood only a bit over five feet tall. I first learned about HeLa cells and the woman behind them in 1988, thirty-seven years after her death, when I was sixteen and sitting in a community college biology class. My instructor, Donald Defler, a gnomish balding man, paced at the front of the lecture hall and flipped on an overhead projector. He pointed to two diagrams that appeared on the wall behind him. They were schematics of the cell reproduction cycle, but to me they just looked like a neon-colored mess of arrows, squares, and circles with words I didn't understand, like "MPF Triggering a Chain Reaction of Protein Activations." I was a kid who'd failed freshman year at the regular public high school because she never showed up. I'd transferred to an alternative school that offered dream studies instead of biology, so I was taking Defler's class for high-school credit, which meant that I was sitting in a college lecture hall at sixteen with words like mitosis and kinase inhibitors flying around. I was completely lost. "Do we have to memorize everything on those diagrams?" one student yelled. Yes, Defler said, we had to memorize the diagrams, and yes, they'd be on the test, but that didn't matter right then. What he wanted us to understand was that cells are amazing things: There are about one hundred trillion of them in our bodies, each so small that several thousand could fit

on the period at the end of this sentence. They make up all our tissues — muscle, bone, blood — which in turn make up our organs. Under the microscope, a cell looks a lot like a fried egg: It has a white (the cytoplasm ) that's full of water and proteins to keep it fed, and a yolk (the nucleus ) that holds all the genetic information that makes you you . The cytoplasm buzzes like a New York City street. It's crammed full of molecules and vessels endlessly shuttling enzymes and sugars from one part of the cell to another, pumping water, nutrients, and oxygen in and out of the cell. All the while, little cytoplasmic factories work 24/7, cranking out sugars, fats, proteins, and energy to keep the whole thing running and feed the nucleus. The nucleus is the brains of the operation; inside every nucleus within each cell in your body, there's an identical copy of your entire genome. That genome tells cells when to grow and divide and makes sure they do their jobs, whether that's controlling your heartbeat or helping your brain understand the words on this page. Defler paced the front of the classroom telling us how mitosis — the process of cell division — makes it possible for embryos to grow into babies, and for our bodies to create new cells for healing wounds or replenishing blood we've lost. It was beautiful, he said, like a perfectly choreographed dance. All it takes is one small mistake anywhere in the division process for cells to start growing out of control, he told us. Just one enzyme misfiring, just one wrong protein activation, and you could have cancer. Mitosis goes haywire, which is how it spreads. "We learned that by studying cancer cells in culture," Defler said. He grinned and spun to face the board, where he wrote two words in enormous print: HENRIETTA LACKS. Henrietta died in 1951 from a vicious case of cervical cancer, he told us. But before she died, a surgeon took samples of her tumor and put them in a petri dish. Scientists had been trying to keep human cells alive in culture for decades, but they all eventually died. Henrietta's were different: they reproduced an entire generation every twenty-four hours, and they never stopped. They became the first immortal human cells ever grown in a laboratory. "Henrietta's cells have now been living outside her body far longer than they ever lived inside it," Defler said. If we went to almost any cell culture lab in the world and opened its freezers, he told us, we'd probably find millions — if not billions — of Henrietta's cells in small vials on ice. Her cells were part of research into the genes that cause cancer and those that suppress it; they helped develop drugs for treating herpes, leukemia, influenza, hemophilia, and Parkinson's disease; and they've been used to study lactose digestion, sexually transmitted diseases, appendicitis, human longevity, mosquito mating, and the negative cellular effects of working in sewers. Their chromosomes and proteins have been studied with such detail and precision that scientists know their every quirk. Like guinea pigs and mice, Henrietta's cells have become the standard laboratory workhorse.

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"HeLa cells were one of the most important things that happened to medicine in the last hundred years," Defler said. Then, matter-of-factly, almost as an afterthought, he said, "She was a black woman." He erased her name in one fast swipe and blew the chalk from his hands. Class was over. As the other students filed out of the room, I sat thinking, That's it? That's all we get? There has to be more to the story. I followed Defler to his office. "Where was she from?" I asked. "Did she know how important her cells were? Did she have any children?" "I wish I could tell you," he said, "but no one knows anything about her." After class, I ran home and threw myself onto my bed with my biology textbook. I looked up "cell culture" in the index, and there she was, a small parenthetical: In culture, cancer cells can go on dividing indefinitely, if they have a continual supply of nutrients, and thus are said to be "immortal." A striking example is a cell line that has been reproducing in culture since 1951. (Cells of this line are called HeLa cells because their original source was a tumor removed from a woman named Henrietta Lacks.) That was it. I looked up HeLa in my parents' encyclopedia, then my dictionary: No Henrietta. As I graduated from high school and worked my way through college toward a biology degree, HeLa cells were omnipresent. I heard about them in histology, neurology, pathology; I used them in experiments on how neighboring cells communicate. But after Mr. Defler, no one mentioned Henrietta. When I got my first computer in the mid-nineties and started using the Internet, I searched for information about her, but found only confused snippets: most sites said her name was Helen Lane; some said she died in the thirties; others said the forties, fifties, or even sixties. Some said ovarian cancer killed her, others said breast or cervical cancer. Eventually I tracked down a few magazine articles about her from the seventies. Ebony quoted Henrietta's husband saying, "All I remember is that she had this disease, and right after she died they called me in the office wanting to get my permission to take a sample of some kind. I decided not to let them." Jet said the family was angry — angry that Henrietta's cells were being sold for twenty-five dollars a vial, and angry that articles had been published about the cells without their knowledge. It said, "Pounding in the back of their heads was a gnawing feeling that science and the press had taken advantage of them." The articles all ran photos of Henrietta's family: her oldest son sitting at his dining room table in Baltimore, looking at a genetics textbook. Her middle son in military uniform, smiling and

holding a baby. But one picture stood out more than any other: in it, Henrietta's daughter, Deborah Lacks, is surrounded by family, everyone smiling, arms around each other, eyes bright and excited. Except Deborah. She stands in the foreground looking alone, almost as if someone pasted her into the photo after the fact. She's twenty-six years old and beautiful, with short brown hair and catlike eyes. But those eyes glare at the camera, hard and serious. The caption said the family had found out just a few months earlier that Henrietta's cells were still alive, yet at that point she'd been dead for twenty-five years. All of the stories mentioned that scientists had begun doing research on Henrietta's children, but the Lackses didn't seem to know what that research was for. They said they were being tested to see if they had the cancer that killed Henrietta, but according to the reporters, scientists were studying the Lacks family to learn more about Henrietta's cells. The stories quoted her son Lawrence, who wanted to know if the immortality of his mother's cells meant that he might live forever too. But one member of the family remained voiceless: Henrietta's daughter, Deborah. As I worked my way through graduate school studying writing, I became fixated on the idea of someday telling Henrietta's story. At one point I even called directory assistance in Baltimore looking for Henrietta's husband, David Lacks, but he wasn't listed. I had the idea that I'd write a book that was a biography of both the cells and the woman they came from — someone's daughter, wife, and mother. I couldn't have imagined it then, but that phone call would mark the beginning of a decadelong adventure through scientific laboratories, hospitals, and mental institutions, with a cast of characters that would include Nobel laureates, grocery store clerks, convicted felons, and a professional con artist. While trying to make sense of the history of cell culture and the complicated ethical debate surrounding the use of human tissues in research, I'd be accused of conspiracy and slammed into a wall both physically and metaphorically, and I'd eventually find myself on the receiving end of something that looked a lot like an exorcism. I did eventually meet Deborah, who would turn out to be one of the strongest and most resilient women I'd ever known. We'd form a deep personal bond, and slowly, without realizing it, I'd become a character in her story, and she in mine. Deborah and I came from very different cultures: I grew up white and agnostic in the Pacific Northwest, my roots half New York Jew and half Midwestern Protestant; Deborah was a deeply religious black Christian from the South. I tended to leave the room when religion came up in conversation because it made me uncomfortable; Deborah's family tended toward preaching, faith healings, and sometimes voodoo. She grew up in a black neighborhood that was one of the poorest and most dangerous in the country; I grew up in a safe, quiet middle-class neighborhood in a predominantly white city and went to high school with a total of two black students. I was a science journalist who referred to all things supernatural as "woo-woo stuff"; Deborah believed Henrietta's spirit lived on in her cells, controlling the life of anyone who crossed its paths. Including me. "How else do you explain why your science teacher knew her real name when everyone else called her Helen Lane?" Deborah would say. "She was trying to get your attention." This

thinking would apply to everything in my life: when I married while writing this book, it was because Henrietta wanted someone to take care of me while I worked. When I divorced, it was because she'd decided he was getting in the way of the book. When an editor who insisted I take the Lacks family out of the book was injured in a mysterious accident, Deborah said that's what happens when you piss Henrietta off. The Lackses challenged everything I thought I knew about faith, science, journalism, and race. Ultimately, this book is the result. It's not only the story of HeLa cells and Henrietta Lacks, but of Henrietta's family — particularly Deborah — and their lifelong struggle to make peace with the existence of those cells, and the science that made them possible. Excerpted from The Immortal Life of Henrietta Lacks by Rebecca Skloot Copyright 2010 by Rebecca Skloot. Excerpted by permission of Crown, a division of Random House Inc. All rights reserved. Ethical Justice, But No Financial Rewards, For The Henrietta Lacks Family David Kroll Former Contributor I'm a Denver-based natural products pharmacologist Aug 8, 2013,01:29pm EDT This article is more than 9 years old.  It took more than 60 years, but ethics has finally caught up to a particularly fast-moving area of science: taking tissue samples for genetic research. Thanks to the efforts of a dogged journalist, some very thoughtful science leaders in Europe and the U.S., and an ordinary family willing to learn about a complex subject and then to do the right thing to help you and me and our descendants, a long-standing wrong has now been fixed. ~ Art Caplan

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Cover of The Immortal Life of Henrietta Lacks by Rebecca Skloot Above is the central paragraph of Dr. Arthur Caplan's ethical take on yesterday's medical research milestone: An agreement has been reached between the U.S. National Institutes of Health and the family of Henrietta Lacks, a poor, Black, Virginia tobacco farmer whose voracious 1951 case of cervical cancer gave rise to one of the most seminal resources in medical science: the first population of human-derived cells to ever grow in a laboratory. PROMOTED The dogged journalist Caplan cites, science writer Rebecca Skloot , spent over ten years crafting the convoluted and emotional story of the Lacks family and their complex relationships with scientists in the best-selling book, The Immortal Life of Henrietta Lacks . The NIH agreement, detailed here , will now restrict the distribution and access to complete DNA sequences from Henrietta's cancer cells to scientific researchers funded by U.S. government grants. Researcher requests will now be reviewed by a six-person panel that includes two Lacks family representatives. Furthermore, publications resulting from such work will now be accompanied by an acknowledgement of Henrietta Lacks as the source of the cells ( PDF ). London-based Nature journal writer Ewen Callaway provided the most comprehensive and behind-the-scenes insights on the negotiations and agreement with the Lacks family in these two articles and podcast in the August 8th issue.

What's so special about HeLa cells? On October 4, 1951, Henrietta Lacks, a 31-year-old wife and mother of five, died of cervical cancer in the segregated colored ward of Johns Hopkins Hospital in Baltimore. As with the majority of Hopkins cancer patients at the time, biopsy samples had been taken of her cancerous tumors earlier and brought to the laboratory of Dr. George Gey, where his wife Margaret and technician Mary Kubicek worked. With Henrietta's unknowing donation, the Geys and Kubicek overcame more than 20 years of laboratory failures: The team succeeded in keeping human cancer cells alive and growing indefinitely. These cells, known as HeLa (HEE-luh), gave the medical world the first chance to experiment with human cells without having to go back to individual patients every time specimens were needed. However, neither Henrietta nor her family were fully informed that her tissue had been taken. Moreover, her survivors were completely unaware until the mid-1970s that cells from her cancer continued to grow around the world as medical research tools. After their original isolation, the cells quickly began to play a central role in medical research in the 1950s. University of Minnesota researchers discovered that HeLa cells could be infected with the virus that causes the debilitating muscular disease, polio. With that knowledge, the cells provided a quick way to test the effectiveness of the Salk polio vaccine, then under development. If a vaccinated patient made antibodies that would prevent the disease, then their blood plasma would prevent polio infection when mixed with HeLa cells and poliovirus in the lab. Ironically, the "factory" for growing and shipping these cells was led and operated by African- American researchers and technicians at Tuskegee University at the same time rural men were unknowingly being used as experimental subjects to study the long-term progression of untreated syphilis. Skloot's book follows the subsequent series of events that would be unconscionable, and some illegal, under today's standards of medical ethics and regulations of human subjects research. So widespread was the subsequent distribution of HeLa cells over the years that over 76,000 research articles have been written citing the use of these cells. Like so many other researchers and those in training, I was the beneficiary of Henrietta's cells for experiments that formed the basis of my 1989 PhD dissertation work. We also used HeLa cells for the first peer-reviewed publication from my independent laboratory at the University of Colorado in 1995 where we extended our findings into human leukemia cells. We're also still using HeLa cells as teaching tools, both for science and in the medical humanities. I recently did exercises with local AP high school biology students and my colleagues Christy Flint and Debra Bailey at the North Carolina Museum of Natural Sciences in

Raleigh where we visualized the chromosomes of Lacks's cells while discussing their class reading of Skloot's book. The latest storm Earlier this year, the majority of the DNA sequence from one population of Henrietta's cancer cells was published by German scientists at the European Molecular Biology Laboratory (EMBL) in Heidelberg, again, without the knowledge of the Lacks family. Nature had also been fielding a more extensive paper on the HeLa genome from University of Washington researchers led by Dr. Jay Shendure. As Shendure's team was funded by NIH, the medical research agency of the U.S., NIH director Francis Collins and Kathy Hudson, deputy director for science, outreach, and policy, initiated discussions in April with members of the Lacks family to inform them of the significance of this work to them and the world. Skloot was also involved via telephone as an observer but was instrumental in setting up the meetings as described in this Q&A yesterday with Bob Grant at The Scientist . continue reading... The money question One of the most common questions Skloot describes getting from readers is whether the survivors of Henrietta Lacks have benefited financially from the sales of HeLa cells and discoveries made using them in academic and industrial laboratories around the world. The NIH agreement provides no monetary compensation for the family. I've always sat in the middle on this conundrum: I don't believe legal grounds exist for anyone to provide compensation to the Lacks family (and which family members would qualify?), but they do deserve something out of simple common decency. (Disclosure: For this reason, I serve on the board of The Henrietta Lacks Foundation, established by Rebecca Skloot. Proceeds from her book and individual donations provide grants to individuals or their descendents who were subject to medical research without their knowledge. I also served as a scientific reviewer for Skloot's book.) The Lacks situation is unusual for several reasons, not the least of which is that the donor of the medical tissue is a known individual. Today, clinical samples are not identified by the donor's name but are rather annotated with all manner of medical descriptors. The ground rules of medical ethics and human subjects consent are very, very different today than in 1951. So too are academic intellectual property rules. Hopkins' George Gey gave away virtually all of the HeLa cells his lab could grow. In fact, the original deposition of HeLa cells in the non-profit cell bank called the American Type Culture Collection (ATCC) did not come from Gey. Instead, Dr. William F. Scherer, who received Gey's HeLa cells at the University of Minnesota, provided ATCC with their original stock .

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Skloot's description of George and Margaret Gey indicate that they lived a typically modest lifestyle for a 1950s physician family. In fact, they were reported to sometimes be in financial trouble because George spent so much of his personal money on laboratory equipment and reagents. While ATCC now sells these stocks of HeLa cells for $359 to non-profit institutions and $431 to for-profit entities, these fees justifiably support the personnel, maintenance, and storage of HeLa and thousands of other cell lines, microorganisms, and genetic material. ATCC charges the same for the vast majority of other cells, such as the mouse leukemia cell line, L1210 (used commonly in early anticancer drug discovery), so their pricing is not opportunistic. The Tuskegee HeLa cell mass production facility involved in the development of the polio vaccine was supported by grant money from the National Foundation for Infantile Paralysis, now the March of Dimes. But many point to the fact that HeLa cells were used in the development of several drugs, including the anticancer drug Taxol (paclitaxel). HeLa cells also serve as central components for very expensive molecular biology reagents. For example, Invitrogen sells various types of HeLa cells for $995 up to $10,250 . Why is that? Each of these HeLa cell products contain non-HeLa intellectual property in the form of genes for non-HeLa proteins or the ability to make proteins that HeLa cells don't normally make. In those cases, the human ingenuity added to each derivative HeLa cell line comes from someone else who hold patents on those technologies. Invitrogen must then pay a licensing fee and/or royalties for the use and sale of that technology. Back in February, 2010, a communications representative of Life Technologies, the parent company of Invitrogen, shared this explanation with me: Life Technologies strictly follows guidelines for the ethical sourcing of tissues and cell lines and we constantly strive to update our tissue and cell procurement guidelines to be in accordance with the latest ethical guidelines from agencies such as the NIH and NSF. The HeLa cell creation occurred before such guidelines were in place and far before Invitrogen (now part of Life Technologies) was in existence. Also, the cells we sell have had a lot of work and additional technologies put into them to ensure that they are most useful to researchers in making new life-saving discoveries. The price of products mostly covers this additional work that has been performed. Ultimately, the company believes that research conducted on human cell lines is crucial to helping scientists develop better and safer treatments for intractable diseases, which ultimately help drive down the cost of healthcare for everyone. So while readers may see in other articles that individuals and companies made millions or billions from HeLa cells, the truth is a bit more complicated. Most certainly, HeLa cells were an

enabling technology for a multitude of medical developments that continue to alleviate suffering and improve the human condition worldwide. Skloot covers these other issues in her FAQ page where she notes that many family members are benefiting from her Foundation and from their own speaking appearances . Johns Hopkins has also provided scholarships and a lecture series in the name of Henrietta Lacks. Some family members also receive health care from Hopkins, although details aren't given. Many of the Lacks family members are on record as stating that they only wanted information, respect, and acknowledgement of their matriarch's enabling contributions. Yesterday's announcements come just about a week after what would have been Henrietta's 93rd birthday. The creative non-fiction side of this writer can imagine the elder Black woman sitting on a porch 60 miles north of me in Clover, Virginia, sipping some sweet tea in this steamy Southern summer saying, "Well, look at that - finally!" I applaud all involved for doing the right thing. Additional information for more technical readers: News of the agreement is accompanied by the HeLa genome sequencing report in the original research section of this Nature issue. In this new report, the complete DNA sequence of the genome from the original deposit of HeLa cells from 1953 was compared with a population isolated a few years later by Dr. Philip Marcus while in Dr. Ted Puck's University of Colorado laboratory. The investigators also examined precisely where the cancer-causing human papillomavirus-18 (HPV-18) inserted itself into Henrietta's genome. Not only can this strain of HPV cause cervical cancer, and is one of the versions targeted by HPV vaccines, but it activated a broad-acting cancer causing gene encoding a protein called c-Myc.

David Kroll I'm a pharmacologist, freelance science and medicine writer, educator, and speaker with a passion for public understanding of science and medicine. I report on all t What are the sources of law? n the U.S., law comes from many sources. Ethical concerns raised by Henrietta Lacks case have resulted in a reexamination in existing common, statutory, and administrative laws. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 5 PowerPoint Consider the wide scope of common law, statutory law, and administrative law. Understanding these three sources and how they interact influences how healthcare managers respond to ethical issues. For example, healthcare organizations are especially inundated with administrative rules and regulations that affect their operations, and failure to abide by these laws could not only result in censure or other penalties but could also jeopardize the well-being of patients. Because common law, statutory law, and administrative law are ever evolving, healthcare managers must be cognizant of how current legal issues might potentially impact their organization.

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Points to Remember Familiarity with the legal processes behind healthcare further influences a healthcare professional's administration of patient-centered care.  Common law: Law that has evolved and expanded from judicial decisions that arise during the trial of court cases.  Statutory law: Federal and state law written by a legislative body.  Administrative law: Laws issued to govern administrative agency operations. Numerous governmental agencies direct the implementation of healthcare legislation. All three of these sources inform ethical principles. For managers, there are certain laws that will need to be addressed and enforced by their healthcare organization. What is Negligence? n the U.S., law comes from many sources. Ethical concerns raised by Henrietta Lacks case have resulted in a reexamination in existing common, statutory, and administrative laws. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 5 PowerPoint Consider the wide scope of common law, statutory law, and administrative law. Understanding these three sources and how they interact influences how healthcare managers respond to ethical issues. For example, healthcare organizations are especially inundated with administrative rules and regulations that affect their operations, and failure to abide by these laws could not only result in censure or other penalties but could also jeopardize the well-being of patients. Because common law, statutory law, and administrative law are ever evolving, healthcare managers must be cognizant of how current legal issues might potentially impact their organization. Points to Remember Familiarity with the legal processes behind healthcare further influences a healthcare professional's administration of patient-centered care.  Common law: Law that has evolved and expanded from judicial decisions that arise during the trial of court cases.  Statutory law: Federal and state law written by a legislative body.  Administrative law: Laws issued to govern administrative agency operations. Numerous governmental agencies direct the implementation of healthcare legislation. All three of these sources inform ethical principles. For managers, there are certain laws that will need to be addressed and enforced by their healthcare organization.

Because negligence is defined as failure to provide appropriate care or services, managers must know the early warning signs and the preventative steps they should take to protect their organization. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 6 PowerPoint In a situation like this, a healthcare manager could have prevented the unfortunate outcome of negligent care by enforcing more rigorous standards and policies. Though the care team had no intent to harm the child, the failure to perform an important diagnostic test to safeguard against risk constitutes a tort. This is an example of nonfeasance that could have damaging repercussions for the patient and legal consequences for the care team and potentially the hospital. A healthcare manager must ensure that the organization adheres to institutional policies and practices to prevent ethical breaches such as these. Points to Remember Managers must know the difference between civil and criminal law and the ways in which they connect.  Avoiding negligence: Negligence is the unintentional commission or omission of an act that a reasonably prudent person would or would not perform under given circumstances. Managers can prevent negligence on an organizational level by ensuring that ethical policies are institutionalized and enforced.  Criminal law: Although breaches of standards and codes are often addressed through civil law in a healthcare setting, criminal law is an important factor as well. Criminal negligence is reckless disregard for the safety of another that can be punishable by law. Criminal law involves a much higher standard of evidence and concerns the welfare of all citizens. Laws can be seen as a codification of a society's ethics, and consequently, they may vary from region to region. Lawful conduct does not necessarily result in ethical conduct. Having a thorough understanding of applicable laws and demonstrating competence in enforcing them can help healthcare managers avoid lawsuits for negligence. Preventing negligence is achieved partly through agreements between healthcare organizations and their employees dictating the types of policies, procedures, and standards that should be followed to avoid negligent care. These agreements come in the form of contracts. Famous Cases: O.J. Simpson was famously acquitted of murder in a criminal trial but found liable for the tort of wrongful death. Many actions in a healthcare setting, like negligence, have the possibility of being prosecuted in both civil and criminal contexts. WHAT ARE TH ELEMENTS OF A CONTRACT?

Many relationships in a healthcare environment are maintained through the use of contracts. Contracts often pose ethical dilemmas. Consider the following scenario: A local plastic surgeon has begun advertising his services on television. His ads feature several “before and after” results and promises that patients will look 20 years younger if they undergo his “mini lift” surgery. A woman reads the ads and makes an appointment for the elective procedure. After evaluating her, the surgeon indicates that she would be an excellent candidate for a mini lift and that it is a safe and effective operation, requiring no more than one week's downtime to heal before she can return to work. The woman writes a check and schedules the procedure, which the surgeon performs in his private office. After the surgery, the woman has extensive bruising and swelling, and by the third day after surgery, a surgical wound infection has developed. She returns to the plastic surgeon's office. He is startled at the extent of the infection, and he realizes she needs consultation from an infectious disease specialist. However, instead of referring her, he sends her home with oral antibiotics and suggests that she return if things aren't looking better within 72 hours. At home, the woman's infection and swelling worsen. She calls the surgeon, and he recommends she be hospitalized for a course of intravenous antibiotics. The antibiotics finally succeed in curing the infection, but the need for incision and drainage of her surgical wound has left a nasty scar, residual swelling, and some facial tissue scarring. She sues the surgeon for breach of contract in promising a result that he did not deliver, and she also reports the surgeon to the State Medical Board. Upon investigation, the Board finds that the surgeon was negligent, which resulted in an unnecessary and unethical delay in treating the patient. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 6 PowerPoint Not only did the surgeon in the previous scenario violate the Hippocratic oath to “do no harm," he also presented an unethical contract that promised results that could not be met. Contracts are not exclusive to written documents: contracts can be executed orally. Though the surgeon's advertisement in itself did not constitute an offer, the contract between the patient and surgeon itself, which consisted of an offer/communication, consideration, and acceptance, was inherently unethical, because he was unable to provide the outcome specified in the contract. Points to Remember In many organizations, healthcare managers have contracting responsibility for their departments.

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 Contracts in healthcare: A contract is composed of an offer, a consideration, and an acceptance. Healthcare organizations often enter into exclusive contracts with physicians and medical groups, and these exclusive contracts sometimes create conflicts of interest. Managers must be aware of basic contracting guidelines to follow to avoid conflicts of interest that affect patient well-being. Managers must also know the basic elements of contracts, because these types of agreements structure many diverse relationships in a healthcare environment, from employment to resource management. Failure to understand the implications of contract law can easily lead to a lawsuit against a healthcare organization. WHAT LAWS EXIST TO PROTECT PATIENTS? In recent years, several different pieces of legislation have been enacted to protect patients in a healthcare setting. Public policy dictates that no one can lawfully commit any action that intends to be injurious to the public or goes against the public welfare. Knowledge of these laws is not only necessary to ensure compliance, but ideally, the legislation that impacts a health organization is aligned with the patient's best interests. Adherence to these laws is a vital component of providing patient-centered care. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 7 PowerPoint HIPAA standards do not merely apply to electronic personal health information (ePHI). Health information in every format, whether it exists as an electronic or paper record, or even verbal communication, is restricted. Unauthorized disclosure of that information may not only have legal ramifications but could have a potentially destructive impact on a patient's quality of life. According to the Privacy Act, "the opportunities for an individual to secure employment, insurance, and credit, and his right to due process, and other legal protections are endangered by the use of certain information systems." A healthcare manager is responsible for ensuring organization-wide compliance with pertinent legislation. Ethical conduct does not merely consist of one's own individual behavior but monitoring the behavior of one's staff as well. Knowledge of legislation relating to healthcare ethics is of no avail unless a manager can appropriately disseminate that knowledge and ensure adherence to those laws. Not only should managers have a firm understanding of the laws that are established to protect patient rights, they must ensure that these laws are enforced at every level of the organization. This is not limited to monitoring staff but includes evaluating leadership as well. To promote ethical values, an organization needs a robust governing body that firmly establishes ethical principles. Abiding by ethical laws should occur at every level, including senior leadership. In 2002, pharmacist Robert Courtney, the owner and operator of Research Medical Tower in Kansas City, Missouri, was convicted of pharmaceutical fraud. Courtney had been filling

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prescriptions at his pharmacy by purchasing pharmaceuticals on the gray market—legitimate drugs acquired outside the supply chain from a retired pharmaceutical representative—and then began diluting the drugs to make more profit. How could self-diligence and whistle blowing at the Research Medical Tower have potentially prevented Courtney from diluting 98,000 prescriptions for 4,200 patients? Points to Remember Patient rights and privacy are enforced through professional standards and compliance regulations.  Patient privacy: Legislation like the Privacy Act of 1974 and HIPAA were enacted to ensure that patients' privacy is maintained. Healthcare organizations must comply with standards in order to ensure patient privacy.  Patient protection: Other key legislation that exists to protect patients includes the Emergency Medical Treatment and Active Labor Act (EMTALA), the Healthcare Quality Improvement Act (HQcIA), the Patient Self-Determination Act (PSDA), the Sarbanes-Oxley Act, and the Affordable Care Act (ACA). Several important pieces of legislation have been created to ensure the protection of patient rights and privacy and ensuring compliance with these laws will also ensure ethical behavior for a healthcare organization. Not surprisingly, many of these laws apply directly to the case of Henrietta Lacks and her protection, or lack thereof, under the law. In the next section, determine how legal principles and current legislation are relevant to this case. Close "What laws exist to protect patients? " Section Summary Topic #2 This Topic has explored how to contextualize ethical and legal decisions in healthcare and create a framework for assessing issues as a healthcare administrator. Key takeaways include:  Common law: This source of law is the body of principles that has evolved and expanded from judicial decisions that arise during the trial of court cases. Many decisions in healthcare ethics are guided by precedents established in court.  Statutory law: This source of law emerges from legislative bodies. A great deal of landmark healthcare legislation has been created in recent years.  Administrative law: This source of law originates from the extensive body of public law issued by administration agencies to direct enacted legislation. Numerous governmental agencies direct the implementation of healthcare legislation.  Avoiding negligence: Negligence is the unintentional omission or commission of an act that a reasonably prudent person would or would not perform under given circumstances.

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Administrators can prevent negligence on an organizational level by ensuring that ethical policies are institutionalized and enforced.  Criminal law: Although breaches of standards and codes are often addressed through civil law in a healthcare setting, criminal law is an important factor as well. Criminal negligence is reckless disregard for the safety of another that can be punishable by law. Criminal law involves a much higher standard of evidence as it concerns the welfare of all citizens. Laws can be seen as a codification of a society's ethics and consequently they may vary from region to region. Lawful conduct does not necessarily result in ethical conduct.  Contracts in healthcare: A contract is composed of an offer, a consideration, and an acceptance. Healthcare organizations often enter into exclusive contracts with physicians and medical groups, and these exclusive contracts sometimes create conflicts of interest.  Trial procedures: Healthcare administrators are sometimes asked to serve as fact witnesses during a trial. It is also likely that a healthcare administrator will be sued as a defendant in a case. In either case, administrators may be questioned about policies, procedures, staff training, the facts of a particular event, or medical record-keeping policies. Administrators should work with their organization's legal team to familiarize themselves with court procedures, what to expect, and the kinds of questions they are likely to be asked. Having a basic understanding of trial procedures will aid in this process.  Patient privacy: Legislation like the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA) were enacted to ensure that patients' privacy is maintained. Healthcare organizations must comply with standards in order to ensure patient privacy.  Patient protection: Other key legislation that exists to protect patients includes the Emergency Medical Treatment and Active Labor Act (EMTALA), the Healthcare Quality Improvement Act (HCQIA), the Patient Self-Determination Act (PSDA), the Sarbanes-Oxley Act, and the Affordable Care Act (ACA). Make Critical Connections The knowledge and skills listed above aren't only critical for the objective assessment—they also provide a critical foundation for upcoming Topics and courses. For example:  Having knowledge about the legislation that protects patients will provide a legal context for Topic 3: Patient Rights.  This investigation of laws as they pertain to ethical principles expands on the legislation and regulations that affect decisions in healthcare. These are explored in the course Healthcare Delivery Systems, Regulations, and Compliance. In 1973, Dax Cowart sustained severe, life-threatening burns on over 65 percent of his body. Even before he made it to the hospital, Dax was begging first responders to end his life so that he did not have to suffer anymore. Dax underwent painful treatments, including being submerged in chlorine disinfectant baths and having his bandages stripped from his skin on a

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regular basis. Dax described the treatments as being “skinned alive.” Dax repeatedly attempted to refuse care and demanded that the clinicians allow him to die rather than go through this painful ordeal. But healthcare workers denied his wishes, believing that saving Dax's life was the highest priority, and for ten months treated Dax despite his protests. Dax survived and is now an attorney and advocate for patient rights. He argues that his wishes should have been respected. However, Dax's family argues that doctors were justified in prioritizing Dax's survival over his desire to end suffering. This case presents a difficult ethical dilemma concerning patient rights. In addition to raising questions about the importance of patient autonomy, it challenges the notion of beneficence, especially concerning questions of the quality of life of a patient. This Topic will further explore the rights that a patient has in a healthcare setting, including autonomy and informed consent. Managers must be familiar with cases like Dax Cowart's experience and be able to support an organizational environment where all patients know their rights and have their rights respected. Topic Questions Every healthcare organization should prepare a reference and keep readily available what is known as a Patient's Bill of Rights and Responsibilities. This document should contain all of the information that patients need to know about their legally protected rights. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 14 PowerPoint Everything that a patient needs to know about their rights should be contained within a hospital's Patient Bill of Rights and Responsibilities and made available for easy access. If the patient does not understand these rights and responsibilities, they must be explained by a care provider. Ensuring patient's health literacy is not merely providing information to patients.

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Healthcare workers have a responsibility to make sure that the information they provide is fully understood by the patient. Points to Remember A Patient's Bill of Rights and Responsibilites is not a legal document. It is a document for patients that details the rights that they have at a particular organization.  Accessibility: Healthcare managers have a responsibility to make this Bill of Rights and Responsibilities easily accessible to patients, to ensure that employees understand the significance of their work duties and actively support patient rights.  Adaptability: Managers must also ensure that the Patient's Bill of Rights and Responsibilities addresses patient concerns specific to the organization. This can be done by performing comprehensive reviews of patient feedback and complaints. Legal Fact: Several attempts have been made in the U.S. to turn the Patient's Bill of Rights into law, but none have been successful. At the core of a patient-centered approach to care are patients who are well informed of all of their rights. Presenting treatment options to a patient, explaining risks and ensuring that a patient understands the risks are examples of autonomous behavior. Close "What is a Patient's Bill of Rights?" Section WHAT IS THE PRINCIPLE OF AUTONOMY? Autonomy is the right of a person to make his or her own decisions. Although the definition appears simple, the implications of autonomy are complex. The following situations involve the principle of autonomy. 1. A young child needs a blood transfusion for a life-saving surgery, but both parents reject the transfusion because of religious beliefs. 2. A mother wishes to keep her newborn on life-sustaining technology, despite the unanimous expert medical opinion that the infant has no chance of surviving. 3. A middle-aged man is involved in an automobile accident and enters a persistent vegetative state. He has no living will. His wife insists that he had previously expressed desires to have life-sustaining technology removed in an event like this. His adult children claim otherwise. 4. An older woman with terminal cancer declares that she wants to end all treatment plans and enter palliative care. Her family members and some medical staff claim that her state of mind is not sound enough to make this kind of decision.

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These are difficult issues to solve regarding autonomy. Understanding the components of autonomy is crucial in making difficult decisions. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 1 PowerPoint Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 3 PowerPoint Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 10 PowerPoint Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 12 PowerPoint Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 14 PowerPoint Autonomy may conflict with beneficence/nonmaleficence. Adult patients have the right to make their own decisions regarding their healthcare treatment options. Healthcare organizations that receive federal funds under Medicare are required to abide by the Patient Self-Determination Act (PSDA), which stipulates that patients have the right to refuse or accept medical or surgical treatment. Points to Remember Although autonomy has a simple definition, the implications of this concept are quite complex.  Right to refuse treatment: Patients have a right to refuse treatment. This sometimes conflicts with a physician's obligation to do the most good to a patient.  Withdrawal of treatment : Patients have the right to withdraw from treatment at any time. In some cases, doing what is clinically possible (sustaining his/her life) is not in the patient's best interest.  Advance directives: An advance directive is crucial for determining what is desired by a patient, especially when loved ones are faced with the decision of terminating ongoing care.  Capacity to consent: Some patients may be unconscious or have some cognitive impairment. Autonomy does not always come from the patient; sometimes that authority comes from someone acting on behalf of the patient. The refusal of blood transfusions is part of the belief system of Jehovah's Witnesses. To provide patient-centered care, managers have a responsibility to ensure that patient autonomy is valued in a healthcare organization. Autonomy is composed of several components. One important component of autonomy is informed consent . WHAT ARE ELEMENTS OF INFORMED CONSENT?

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Informed consent means that a patient has the right to know the potential risks, benefits, and alternatives of a proposed care plan. In order for patients to make their own decisions, they must be fully informed about treatment options and what each encompasses. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 12 PowerPoint Informed consent is often mistaken as signing a legal form; however, consent covers a spectrum of interactions. Some interactions may be invasive, while others may not be harmful but may provoke a strong reaction in the patient (e.g. side effects from research medication). All of these interactions require varying amounts of communication between the patient and the care provider. Informed consent reinforces a patient's autonomy by establishing their treatment or care desires. Points to Remember Informed consent allows patients to make their own decisions by knowing what those decisions entail.  Informed consent: A patient has the right to know the potential risks, benefits, and alternatives to treatment. To ensure patient autonomy, a manager needs to know how consent can be determined; whether the patient is capable of giving consent, and if not, who is in the best position to give consent.  Language barriers: Language barriers may exist, creating a communication issue for patients and the care team. Further, patients may also present with poor health literacy, even among educated populations or across socio-economic realm. Healthcare managers need to ensure that patients are provided with education materials written at an appropriate grade level and language for their organization's typical audience. People with poor health literacy have more difficulty in managing chronic or long-term conditions on a day-to-day basis. This includes planning and adjusting lifestyle, making informed decisions, and knowing when and how to access health care services. Euro World Health Organization (WHO) Patients have a right to be fully informed about their healthcare, regardless of the language that they speak. Procedures must be in place to overcome language barriers and health literacy related issues in order to ensure a valid informed consent from the patient. Patient rights, including informed consent, may vary based upon state requirements specific to the healthcare setting. Close "What are the elements of Informed Consent?" Section WHAT ARE A PATIENT’S RIGHTS IN A RESEARCH SETTING?

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The concept of patient rights in a research setting asks healthcare managers to evaluate how to balance the numerous scientific benefits of research with patient safety, autonomy, and consent. Watch the following video on the elements of a successful informed consent, created by the Human Subjects Protection Team of the National Institute of Mental Health (NIMH) Office of the Clinical Director: Consent forms must include the risks, benefits, and alternatives to the proposed treatment protocol. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 2 PowerPoint Informed consent is important in research settings as well as clinical settings. Healthcare organizations must develop appropriate protocols to protect the rights of patients participating in research studies. Not only must the patient be educated about the risks and benefits of the treatment protocol, but the staff administering the treatment must be fully informed about the potential side effects in order to best monitor the protocol. Points to Remember In a research setting, a patient has the right to know the purpose, benefits, and possible risks of a study.  Institutional review boards (IRBs): IRBs help balance the interests of scientific research and patient safety and approve and continuously evaluate research experiments.  Differences in research settings: Patient rights have similar considerations across different research settings. Managers in a research setting have a unique responsibility to ensure that patients are aware of their rights and that their safety is the highest priority. Institutional review boards are a result of the National Research Act of 1974, which was enacted partly in response to the Tuskegee syphilis study. Summary Topic #3 This Topic explored patient rights in healthcare and research settings. Key takeaways include:  Patient Bill of Rights accessibility: Healthcare managers have a responsibility to ensure this bill of rights is easily accessible to patients, that employees are aware of this document, and that the entire care team actively supports patient rights. Additionally, the organization must regularly update their organization's bill of rights in response to changing legal and ethical standards.

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 Patient Bill of Rights adaptability: Managers must ensure that the Patient's Bill of Rights and Responsibilities address patient concerns specific to their organization. This can be done by performing comprehensive reviews of patient feedback and complaints.  Right to refuse treatment: Patients have a right to refuse participation in a treatment.  Withdrawal of treatment : Patients have the right to withdraw from treatment at any time. In some cases, doing the most good to a patient (sustaining his/her life) is not in the patient's best interest.  Advance directives: An advance directive is crucial for determining what is desired by a patient, especially when loved ones are faced with the decision of terminating ongoing care.  Capacity to consent: In addition to the conflict between autonomy and beneficence, healthcare managers must also consider the reality that not all patients are in a position to express their wishes. Some patients may be unconscious or have some cognitive impairment. Autonomy does not always come from the patient; sometimes autonomy comes from someone legally acting on behalf of the patient.  Informed consent: A patient has the right to know the potential risks, benefits, and alternatives to treatment. To ensure patient autonomy, a manager needs to know whether the patient is capable of giving consent, who is in the best position to give consent, and how consent can be determined.  Language barriers: Language barriers to accessing healthcare and poor health literacy are inherent within the realm of any community served. Organizations can offer community education where medical experts make medical information accessible to lay audiences. Healthcare managers can also assist by having key patient education materials available that are written at an appropriate grade level and language for their organization's typical audience.  Institutional review boards: A board established to help maintain balance between the interests of scientific research and patient safety is known as an Institutional Review Board (IRB). These boards approve research experiments.  Differences in research settings: Patient rights have similar considerations across different research settings. Make Critical Connections The knowledge and skills listed above aren't only critical for the objective assessment—they also provide a critical foundation for upcoming Topics and courses. For example:  Comprehension of basic patient rights will guide your understanding about employee responsibilities toward patients in Topic 5: Professional Responsibilities and Corporate Ethics.  Understanding laws that affect ethical research decisions supplements the investigation of research's role in healthcare, which is explored in the course Healthcare Research and Statistics. Topic 4: Contemporary Ethical Dilemmas

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What An exploration of the current ethical dilemmas that affect patient-centered care, guided by the following questions:  How do managers evaluate beginning-of-life dilemmas?  How do managers evaluate end-of-life dilemmas?  How do managers evaluate organ donation, transplant, and research dilemmas?  What other contemporary ethical dilemmas exist for healthcare professionals? Why Healthcare managers must have a grasp of the issues affecting contemporary care so that they can evaluate a wide range of ethical dilemmas using an ethical framework . How By exploring these key resources: Mayo Clinic's Eligibility Requirements The following chapters of Legal and Ethical Issues for Health Professionals (5th ed.) : Chapter 2 Chapter 3 Chapter 9

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Chapter 12 Chapter 14 The previous Topics presented concepts, tools, and resources necessary to evaluate contemporary ethical dilemmas. This Topic explores a series of contemporary ethical dilemmas that will challenge future healthcare professionals. Use the ethical framework and the basic principles of healthcare ethics to evaluate each dilemma. Healthcare managers may make difficult decisions that conflict with their personal spiritual beliefs. There are no right or wrong answers when religious and spiritual beliefs are involved. HOW DO MANAGERS EVALUATE BEGINNING OF LIFE DELIMMAS? An ethical dilemma exists when a choice has to be made in which the consequences may have a potential positive or negative outcome. In beginning-of-life dilemmas, it may be necessary to consult both national and state legislation regarding the constitutionality of specific dilemmas. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 2 PowerPoint Physicians must balance the patient's autonomy against the medical opinion that her life is in jeopardy. The value and definitions of life must also be considered in Sarah's decision of whether or not to carry the pregnancy to term. From a legal perspective, the fact that Sarah is in her third trimester of pregnancy might be problematic. The hospital that performed the sterilization process could easily be found liable for an unsuccessful procedure. Ethical dilemmas are very challenging because of the connections of different ethical principles and legal standards. Points to Remember Beginning-of-life and reproductive dilemmas pose highly complex questions about the definition and value of life.  Beginning-of-life dilemmas: These dilemmas involve the definition of life, the value of life, and a patient's reproductive rights. Direct conflicts between

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beneficence/nonmaleficence and autonomy may be manifested in these types of ethical dilemmas. Balancing what may be the in best interest for each patient can be difficult. This situation is compounded when the potentially disparate interests of family members and loved ones are considered, especially common for patients facing end-of-life care. HOW DO MANAGERS EVAKUATE END OF LIFE DILEMMAS? Perhaps one of the most contentious issues in healthcare-related care decisions is end-of-life dilemmas. Though competent terminally ill patients may legally refuse life-sustaining treatment, disagreements may arise between patients and their families, or even between patients and healthcare practitioners who have been trained to save lives. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 3 PowerPoint There are many different types of euthanasia: active, passive, voluntary, and involuntary. Each type involves complex issues of consent, autonomy, and the need to protect the well-being of a patient. In states where physician-assisted suicide is a legal option, there may still be conflict between the wishes of the patient and the desires of family members. Points to Remember Healthcare providers are committed to the general wellbeing and clinical improvement of their patients which can make end-of-life dilemmas difficult, particularly when consent cannot be received directly from the patient.  End-of-life dilemmas: These dilemmas involve the definition of life, the authority and capacity to consent, direct conflicts between beneficence/nonmaleficence, and autonomy. Healthcare managers must balance preserving patients' lives with considerations of their quality of life, how the care team is emotionally handling the situation, as well as the operational considerations of life-sustaining treatment. Certain end-of-life situations may be seen as resource dilemmas: the financial considerations versus the benefit of sustaining a patient. Dilemmas involving organ donations and transplants also require managers to address issues of resource scarcity. HOW DI MANAGERS EVALUATE ORGAN DONATION, TRANSPLANT, AND RESEARCH DILEMMAS? Hospitals are required to develop and implement written protocols that delineate their organ procurement responsibilities due to federal regulations. These guidelines may not provide answers regarding whose life should be sustained through a transplant versus who will not receive a transplant.

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Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 2 PowerPoint Demand for organ transplants exceeds the supply, thus, the scarcity of organs leads to complex ethical issues. Points to Remember Organ transplants often present a situation in which justice and beneficence/nonmaleficence come into conflict. Organ transplant dilemmas become even more complex for those situations involving potential experimental procedures and research.  Scarcity dilemmas: These dilemmas involve conflicts in prioritization of scarce resources in the most equitable way possible. The healthcare team, informed by regulatory and ethical decision-making practices in partnership with the patient, must determine how scarce resources, such as organ transplants are appropriately allocated. Managers must consider a wide spectrum of ethical dilemmas across different spans of life, from pre-birth to death. Ethical dilemmas exist across a variety of healthcare disciplines. WHAT OTHER CONTEMPORARY ETHICAL DILEMMAS EXIST FOR HEALTHCARE PROFESSIONALS? Ethical dilemmas are not always limited to high-stakes, life-or-death decisions for patients in a hospital setting. Ethical considerations are present in most areas of healthcare. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 9 PowerPoint Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 10 PowerPoint It is important to consider the scope and boundaries of practice for healthcare professionals. An understanding of the unique actions, duties, and limits within the specific roles of the staff will help a healthcare manager examine the ethical issues that may arise in each type of healthcare position. Points to Remember There are as many ethical dilemmas as there are healthcare professions.  Personal ethical considerations: Healthcare managers often find themselves coming to conclusions that directly contradict their personal beliefs and sense of morality. These are the kinds of dilemmas that healthcare managers may have to confront. Managers need to be aware of the ethical concerns that directly affect their organizations.

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Balancing Ethical Priorities Conflicting ethical principles are not the only challenges that healthcare managers face when evaluating decisions. There can be challenges with conflicting or contradictory priorities of patients and a healthcare institution. How should these situations be consistently addressed? Consider the following scenario: A hospital has a surgeon on staff that would like to pioneer a new liver transplant technique. The risk from the technique is not considered to be life threatening, but it is still unproven based on current clinical studies. Activity The surgery is likely not life threatening, and the patient stands to benefit greatly from the surgery. True or False: The patient should be informed that the procedure is untested. Select the correct answer. The surgery will require new equipment and operational procedures. The surgeon is prepared to proceed the next morning, but one of the operating staff has expressed concerns that the staff members have not received adequate training. The patient has been informed of the lack of training of the staff but wants to continue with the procedure. True or False: The operation should continue as scheduled. Select the correct answer. The operation was a success. A local reporter comes to your hospital and asks questions about the surgeon and your organization. The reporter requests the name of the patient, who has been discharged. The reporter is in a hurry to publish this story. True or False: You should receive authorization from the patient to use his name in the article. Select the correct answer. After the success of the first operation, there is a high demand for the surgeon at the organization. The operation has high rates of success and is less invasive than other procedures.

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A small percentage of patients experience severe complications post-surgery. These complications are much more severe than initially anticipated. What is your next course of action to ensure patient-centered care? Select the correct answer. Continue providing the procedure. The high rate of success outweighs the few instances of severe complication. There is a high patient demand. As long as the patient is informed of all possible negative outcomes, surgery should proceed. Consult the ethics committee. In states where physician-assisted suicide is a legal option, there may still be conflict between the wishes of the patient and the desires of family members. Stop the procedure. The possible consequences are too severe to justify. Success with other procedures was slightly lower, but there were fewer risks involved. The ethics committee has determined that continuing to offer the new liver transplant procedure would be best for the patient and the organization. The procedure continues to be in high demand. The scarcity of eligible organ donors becomes a major issue for the organization, and the ethics committee is asked to draft a policy on the criteria to prioritize patients for transplants, aligned with national organ transplant criteria. There are several different rationales, including federal mandates, that an organization can follow when determining which patients will be given priority. Consider compliance from the principle of justice. Which of the following policies is fundamentally unjust? Select the correct answer. Determining patient priority for transplants based on age. Determining patient priority for transplants on a first-come, first-served basis. Determining patient priority for transplants based on prior history of alcoholism. Determining patient priority for transplants based on a lottery. Missed some answers? Here's some additional information.  To review issues on reproductive rights and beginning-of-life dilemmas, see Chapter 2 .  To review end-of-life dilemmas, see Chapter 3 .  To review issues of organ donation and research dilemmas, see Chapter 2 .

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In order to ensure patient-centered care, it is important to look beyond patient demand and other factors that may unnecessarily influence decisions in a healthcare organization. An ethics committee is invaluable as they help with interpretations regarding the organization's ethics and compliance standards and procedures. Summary Topic 4 This Topic has explored the ethical considerations that need to be made when evaluating ethical dilemmas. Key takeaways include:  Beginning-of-life dilemmas: These dilemmas involve the definition of life, the value of life, and a patient’s reproductive rights. Direct conflicts between beneficence/nonmaleficence and autonomy may be manifested in these types of ethical dilemmas.  End-of-life dilemmas: These dilemmas involve the definition of life, the authority and capacity to consent, direct conflicts between beneficence/nonmaleficence, and autonomy.  Scarcity dilemmas: These dilemmas involve conflicts with justice, as scarce resources must be distributed in the most equitable way possible. The organization must determine the criteria, aligned with national requirements, that must be applied when determining who will receive scarce resources, such as organ transplants.  Personal ethical considerations: Even with a firm understanding of principles and a standardized decision-making framework, making ethical decisions remains very complex, particularly when there are conflicts. Healthcare leaders often find themselves involved in shared decision-making that directly contradicts their individual beliefs and sense of morality. These are the kinds of dilemmas healthcare managers should expect to have to confront directly in their operational roles. Make Critical Connections The knowledge and skills listed above are part of the critical foundation for the objective assessment—and upcoming Topics and relate to other courses in the curriculum. The surgery is likely not life threatening, and the patient stands to benefit greatly from the surgery. True or False: The patient should be informed that the procedure is untested. Select the correct answer. Correct. The patient has a right to informed consent, which includes knowing all of the potential risks of the surgery. The organization has the responsibility to enforce the doctrine of informed consent within their organization by ensuring that physicians fulfill their legal obligation to disclose known and existing dangers associated with a proposed course of treatment.

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The surgery will require new equipment and operational procedures. The surgeon is prepared to proceed the next morning, but one of the operating staff has expressed concerns that the staff members have not received adequate training. The patient has been informed of the lack of training of the staff but wants to continue with the procedure. True or False: The operation should continue as scheduled. Select the correct answer. Correct. Delaying the procedure may result in irritating the surgeon and patient, but in the long term it will ensure that risks are managed and that high-quality patient care is administered. The hospital has a responsibility to take reasonable steps to ensure that the medical staff is competent. The manager has a responsibility to intervene when questions or concerns surface. Failure to accurately evaluate and train staff prior to treatment, or in this case, a surgical intervention, can lead to liability for injuries suffered by patients. Supervision of staff at all levels of the organization, including proactively addressing training needs is mandatory, not optional. The operation was a success. A local reporter comes to your hospital and asks questions about the surgeon and your organization. The reporter requests the name of the patient, who has been discharged. The reporter is in a hurry to publish this story. True or False: You should receive authorization from the patient to use his name in the article. Select the correct answer. Correct. Even if you know it is unlikely that the patient would care about having his name in the paper, failing to receive his consent would be a violation of his privacy. Expediting disclosure to save time and ensure the story is published is a deviation from generally accepted practice. Patients have a right to expect that information regarding their care and treatment will be kept completely confidential. Organization leadership must create a culture that values patient privacy. Written permission must be obtained before a patient's medical record can be made available to anyone not directly associated with the patient's care. After the success of the first operation, there is a high demand for the surgeon at the organization. The operation has high rates of success and is less invasive than other procedures. A small percentage of patients experience severe complications post-surgery. These complications are much more severe than initially anticipated. What is your next course of action to ensure patient-centered care? Select the correct answer.

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Continue providing the procedure. The high rate of success outweighs the few instances of severe complication. There is a high patient demand. As long as the patient is informed of all possible negative outcomes, surgery should proceed. Consult the ethics committee. In states where physician-assisted suicide is a legal option, there may still be conflict between the wishes of the patient and the desires of family members. Stop the procedure. The possible consequences are too severe to justify. Success with other procedures was slightly lower, but there were fewer risks involved. Correct. Your ethics committee will provide valuable insight and perspective that you may not have considered otherwise. It is important to consult a committee when making decisions like this. The ethics committee has determined that continuing to offer the new liver transplant procedure would be best for the patient and the organization. The procedure continues to be in high demand. The scarcity of eligible organ donors becomes a major issue for the organization, and the ethics committee is asked to draft a policy on the criteria to prioritize patients for transplants, aligned with national organ transplant criteria. There are several different rationales, including federal mandates, that an organization can follow when determining which patients will be given priority. Consider compliance from the principle of justice. Which of the following policies is fundamentally unjust? Select the correct answer. Determining patient priority for transplants based on age. Determining patient priority for transplants on a first-come, first-served basis. Determining patient priority for transplants based on prior history of alcoholism. Determining patient priority for transplants based on a lottery. Correct. Determining priority for transplants based on patient history is unjust, because it relies on subjective factors. Although the other three solutions may not solve the scarcity dilemma, they are based on objective criteria that can be measured without bias. Topic 5: Professional Responsibilities and Corporate Ethics What An overview of employee rights and responsibilities and best practices for ensuring professional and ethical behavior in an organization is guided by questions in the following domains:  What does ethics look like in a corporation?

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 What are the professional responsibilities of healthcare employees?  What are the professional behaviors and values that support patient-centered care?  What factors promote a culture that encourages employees to report unethical conduct?  What is the role of a corporate code of ethics and hospital accreditation? Why A healthcare leader must be able to identify and understand how to enforce nationally recognized standards and related organizational policies that are aimed at providing safe, effective, timely, efficient, and equitable patient- centered care. How By exploring these key resources: National Association of Healthcare Quality: Code of Ethics and Standards of Practice for Healthcare Quality Professionals The following chapters of Legal and Ethical Issues for Health Professionals (5th ed.) : Chapter 1 Chapter 8 Chapter 11 In 2013, a whistleblower revealed that the Veterans Affairs (VA) hospital had been falsifying records in order to disguise patient deaths due to long wait times. Read the article VA Deaths Covered up to Make Statistics Look Better, Whistle-Blower Says to learn more.

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How can a culture allow institutional irresponsibility to become acceptable? What are the keys to preventing these kinds of situations? This section will cover employee responsibilities and professional behaviors crucial to maintaining an organization that operates ethically. Topic Questions It is important for managers to understand healthcare ethics on an individual and case-by-case basis. Ethical breaches are typically the result of more than one person in an organization. The corporation as a whole must be held accountable. Corporate ethics remains a critical area of study for healthcare managers. Understanding corporate ethics allows the organization at every level to preemptively identify and prevent potential ethical breaches. Managers are responsible to analyze ethical breaches when these surface within their span of control. Corporate leaders must recognize how their actions and the actions of the entire organization constitute ethical behavior. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 8 PowerPoint The high mortality rates may be the symptom, but the lack of corporate ethics or a culture of indifference may be one of the causal factors. A corporation's governing body has the following responsibilities:  Appoint a CEO with ethical and patient-centered priorities  Determine the qualifications that must be met by medical staff  Make difficult decisions about the allocation of resources Healthcare managers have the duty and responsibility to collaborate with their organization's executive leadership to support the governing body's ethical values oversight. Points to Remember Healthcare managers have a fiduciary responsibility to prevent the mismanagement of their organization. An effective manager must foster an ethical culture within an organization by ensuring that all actions, including those of senior leadership, medical staff, and frontline stakeholders, are aligned with both the organization's mission and keeping patients safe - free from harm.  Corporate ethics: The executive leadership team must ensure that their organization's governing body is operating under ethical guidelines and maintains compliance with applicable rules and regulations. Employees have an obligation to fulfill the professional responsibilities and comply with the policies and procedures established by senior leadership.

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Close "What does ethics look like in a corporation? " Section Part of the corporation's responsibility to act ethically is to ensure that employees are acting professionally and ethically. Healthcare employees have specific rights that are directly associated with the work that they perform in the healthcare organizations. Healthcare employees also have several professional responsibilities. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 11 PowerPoint Employees have a responsibility to behave and perform their work duties in a professional and ethical manner. Care providers must act as advocates for their patients and at times may be confronted with situations that might conflict with their personal beliefs. Points to Remember Employees are responsible for behavioral performance that complies with safe practice and maintains professional standards.  Employee rights: In addition to other basic employee rights, healthcare employees have the right to refuse to participate in care as well as the right to privacy.  Employee responsibilities: In order to ensure ethical, patient-centered care, healthcare employees must be held to professional standards and practices. It is a manager's responsibility to ensure that these practices and standards are communicated, understood for consistency, and monitored for compliance. Healthcare managers must enforce practices and standards and promote core values that are conducive to fulfilling these responsibilities. Close "What are the professional responsibilities of healthcare employees?" Section Healthcare managers have a responsibility to ensure that the ethical values of their organization are evidenced in daily professional practice. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 1 PowerPoint The quality of care that employees provide is directly related to the types of values that their organization supports, regularly communicates and actualizes into daily practice. Points to Remember Policies and procedures are part of establishing a foundation that promotes and supports an organization-wide culture that values professionalism in delivery of optimal patient-centered care.

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 Organizational values: Values that support patient-centered care include integrity, compassion, honesty, and respect. Managers can ensure that their area of responsibility practices values-based ethics by creating a culture that supports these principles. Patients receive the best possible care when everyone - no matter what their role or responsibilities - complies with organizational practice standards. There are many components of the standards that are consistent with patient-centered values. One of the values that is particularly important is open communication. Close "What are the professional behaviors and values that support patient-centered care? " Section Even with well-established patient-centered practices and standards in place, unethical behavior may still occur. Employees have a responsibility to report misconduct. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 11 PowerPoint Patient-centered care begins and ends with the actions of employees and their ability to take immediate action when confronting behavior that could potentially endanger patients. Points to Remember A manager must promote the reporting of unethical behavior.  Culture of transparency: Managers must ensure that unethical behavior is reported by employees. Trust in reporting, as non-punitive, is exemplified in a number of ways including: o engaging staff in "What If..." discussions, o creating anonymous communication channels such as phone hotlines, and o establishing a culture that celebrates the improvements that come from employee reporting. It is not possible for managers to supervise every employee at every moment; however, they can make sure that systems are in place to encourage professional conduct. Systems and processes for professional conduct should be universal to ensure ethical behavior on all levels of a healthcare organization. A core component of maintaining ethical behavior is the codification of policies and procedures. This codification exists internally, in the form of a code of ethics, and externally, in the form of hospital licensing and accreditation. Close "What factors promote a culture that encourages employees to report unethical conduct?" Section

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While knowing a corporation's responsibilities and duties is important, a manager needs a framework to support ethical decision-making practices. Managers are obligated to understand an organization's code of ethics. Executive leadership is responsible for ensuring that their organization's code of ethics aligns with ethical principles and supports the provision of patient-centered care, especially for vulnerable and marginalized populations. Managers must ensure that they and their staff follow the code of ethics and any violations are immediately addressed. Examples of ensuring compliance might include:  Regularly performing comprehensive reviews of patient and family complaints received.  Performing daily rounds of an organization to ensure that privacy and other patient concerns are being addressed. In addition to internally managing and regulating ethical behavior, corporations must also be held to externally driven federal and state regulatory requirements and accreditation standards. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 8 PowerPoint There may be situations where potential conflicts of interest exist; for example, situations in which healthcare employees may promote self-interests that could have a negative impact on the healthcare organization. Read Legal and Ethical Issues for Health Professionals (5th ed.) Chapter 8 PowerPoint Managers have a responsibility to evaluate situations that might potentiate a conflict of interest for any stakeholders (for example, physicians, employees) working in their areas of responsibility. Points to Remember Unethical behavior can occur at any level or role within an organization. Executive leaders must implement changes that influence an entire organization's culture to avoid instances of unethical behavior.  Code of ethics: It is a manager's responsibility to ensure that an organization's code of ethics is given high priority and that it addresses the unique needs of the populations that the organization serves. Managers can monitor violations of the code of ethics by performing routine comprehensive reviews of patient complaints and by performing daily rounds to ensure that patient concerns are being addressed.

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 Accreditation: Accreditation can function as a seal of approval that the organization demonstrates a dedication to patient-centered care. Many accreditation agencies also include ethical considerations in their standards.  Conflicts of interest: Conflicts of interest may occur in all areas of healthcare. It is a manager's responsibility to address conflicts and ensure that they do not compromise operations or negatively affect patient care. By evaluating ethical concerns with a routine hands-on approach, healthcare managers can build and reinforce accountability within their organizations. Close "What is the role of a corporate code of ethics and hospital accreditation? " Section Summary Topic 5 This Topic has explored how to identify, understand, and enforce standards as well as policies conducive to patient-centered care. Key takeaways include the following:  Corporate ethics: Healthcare leaders must ensure that their organization's governing body is operating under ethical guidelines and is in compliance with applicable rules and regulations.  Employee rights: In addition to other basic employee rights, healthcare employees have the right to refuse to participate in care as well as the right to privacy.  Employee responsibilities: In order to ensure ethical, patient-centered care, healthcare employees must be held to professional performance in compliance with organization defined standards and practices.  Organizational values: Values that support patient-centered care include integrity, compassion, honesty, and respect. Managers can ensure that their organization practices values-based ethics by creating a culture that supports these principles.  Culture of transparency: Managers must ensure that suspected or actual unethical behavior is immediately reported by employees. Reporting is often facilitated by creating anonymous communication channels such as phone hotlines and by establishing a culture that celebrates the improvements that come about from employee reporting.  Code of ethics: It is a manager's responsibility to ensure that an organization's code of ethics is given high priority and that it addresses the unique needs of the populations that the organization serves. Managers regularly monitor for violations of the code of ethics by performing routine comprehensive reviews of patient complaints and by performing daily rounds to ensure that patient concerns are being addressed.  Accreditation: Accreditation can function as a seal of approval that demonstrates a dedication to patient-centered care. Many accreditation agencies also include ethical considerations in their standards.  Conflicts of interest: Conflicts of interest may occur in all areas of healthcare. It is a manager's responsibility to address these conflicts and ensure that they do not affect operations and optimal patient-centered care. Make Critical Connections

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The knowledge and skills listed above are critical for the objective assessment—they also provide a well-established foundation for previous Topics and related courses. COMPARING ORGANIZATIONS Using this information, predict the satisfaction levels of each organization. Click each link to learn about each organization. This organization values efficiency and productivity. Their standards are written to ensure that as many patient procedures as possible are performed in any given period of time. Success is measured by the time between when patients are admitted and when they are released. Some patients praise the short wait times, while others claim that their needs are not being met. This organization values compassionate care. Their standards are written to ensure that, above all else, patient needs are heard and addressed. Success is measured by patient satisfaction surveys. Some nurses really thrive on the patient-intensive work, while others complain that the way their organization handles operations is inefficient and time consuming. Rate the following satisfaction levels based on the information on Organization #1 above. Not at all Somewhat Mostly Very much 1. Patients are satisfied with their care. Some patients may be satisfied with the efficiency of the organization, but some may feel that their care is not the main priority. 2. Patients are satisfied with their wait times. Wait times at this organization are very short. 3. Employees are engaged in their work. Some employees thrive in the fast-paced culture, but there are also employees who feel disconnected from patients. 4. Employees are satisfied with the way things are managed. In general, employees approve of the efficient management practices. 5.

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Not at all Somewhat Mostly Very much Administration is satisfied with patient care. Patient satisfaction rates are significantly lower than those of other organizations. 6. Administration is satisfied with operations. Efficiency and productivity rates are significantly higher than those of other organizations. Rate the following satisfaction levels based on the information on Organization #2 above. Not at all Somewhat Mostly Very much 1. Patients are satisfied with their care. Most patients appreciate the dedication to patient-centered care, but some complain about the long wait times. 2. Patients are satisfied with their wait times. Wait times are significantly longer than those at other organizations. 3. Employees are engaged in their work. Although some employees complain about the time-intensive practices, most appreciate being able to provide meaningful care. 4. Employees are satisfied with the way things are managed. Some employees complain of the slow-paced culture, but nearly everyone agrees that their work feels valuable. 5. Administration is satisfied with patient care. Patient satisfaction rates are significantly higher than those at other organizations. 6. Administration is satisfied with operations. Efficiency and productivity rates are low, but this is counterbalanced slightly with attention to patient care.

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ADVANCE CARE PLANNING FOR SERIOUS ILLNESS POLST: You may ask your health care providers to discuss and complete a Physician Orders for Life-Sustaining Treatment or POLST form (name may vary by state). This is an option for people with a serious illness that is likely to get worse over time or people with frailty—such as advanced heart or lung disease— whose health care professionals would not be surprised if they died within a year. A POLST makes sure that decisions about care at the end of life are written as medical orders that health care providers must follow. The POLST should list the medical care people do or do not want, given their current health condition. It should include decisions for cardiopulmonary resuscitation (CPR) if your heart stops or if you stop breathing. Without a POLST, emergency care providers generally must provide such medical treatment to keep people alive. Not every state has POLST, and some states have similar forms that go by different names. Remember: You may change your mind about care as you get older or if you become ill, so it is important to review your advance directives or POLST regularly. States’ rules and regulations differ, so it is important to make sure your documents work in your home state and others where you spend a lot of time.

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C426 ETHICS DISCOVER SECTION

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