What rights do American patients have as they navigate through the American healthcare system? You have rights that are granted and enforced by law, such as the Health Insurance Portability and Accountability Act (HIPAA). You also have rights that stem from the ethical practice of medicine and basic human rights. 

Let’s take a look at your rights.

The Right to Be Treated with Respect

All patients, regardless of their means or health challenges, should expect to be treated respectfully and without discrimination by their providers, practitioners, and payers.

The Right to Obtain Your Medical Records

The HIPAA Act of 1996 provides patients in the United States a right to obtain their medical records, including doctors’ notes, medical test results and other documentation related to their care.1

The Right to Privacy of Your Medical Records

The HIPAA Act also outlines who else, besides you (the patient), may obtain your records, and for what purposes. Patients are often surprised about who has these rights. Access may be denied to people you might think would have access. Improper access has consequences.

The Right to Make a Treatment Choice

As long as a patient is considered to be of sound mind, it is both his right and responsibility to know about the options available for treatment of his medical condition and then make the choice he feels is right for him. This right is closely associated with the Right to Informed Consent.

The Right to Informed Consent

No reputable practitioner or facility that performs tests, procedures or treatments will do so without asking the patient or his guardian to sign a form giving consent. This document is called “informed consent” because the practitioner is expected to provide clear explanations of the risks and benefits prior to the patient’s participation, although that does not always happen as thoroughly as it should.

The Right to Refuse Treatment

In most cases, a patient may refuse treatment as long as he is considered to be capable of making sound decisions, or he made that choice when he was of sound mind through written expression (as is often the case when it comes to end-of-life care).

There are some exceptions, meaning that some patients may not refuse treatment. Those exceptions tend to occur when others are subsidizing the patient’s income during the period of injury, sickness, and inability to work.

The Right to Make Decisions About End-of-Life Care

Each state in the United States governs how patients may make and legally record the decisions they make about how their lives will end, including life-preserving measures such as the use of feeding tubes or ventilators.

Corresponding to these patients’ rights are a number of patients’ responsibilities. There are also some rights Americans think they have as patients that are missing. It’s important that you are aware of all of these so that you can be sure to take steps to ensure the care you need, want and deserve.

If you believe your patients’ rights have been violated, you can discuss it with a hospital patient advocate or your state’s department of health. Stand up and exercise your patient rights.

By Rebecca Robbins & Erin Brodwin, State News, July 15, 2020.

That’s because frontline clinicians at M Health Fairview generally don’t mention the AI whirring behind the scenes in their conversations with patients.

At a growing number of prominent hospitals and clinics around the country, clinicians are turning to AI-powered decision support tools — many of them unproven — to help predict whether hospitalized patients are likely to develop complications or deteriorate, whether they’re at risk of readmission, and whether they’re likely to die soon. But these patients and their family members are often not informed about or asked to consent to the use of these tools in their care, a STAT examination has found.

The result: Machines that are completely invisible to patients are increasingly guiding decision-making in the clinic.
Hospitals and clinicians “are operating under the assumption that you do not disclose, and that’s not really something that has been defended or really thought about,” Harvard Law School professor Glenn Cohen said. Cohen is the author of one of only a few articles examining the issue, which has received surprisingly scant attention in the medical literature even as research about AI and machine learning proliferates.

In some cases, there’s little room for harm: Patients may not need to know about an AI system that’s nudging their doctor to move up an MRI scan by a day, like the one deployed by M Health Fairview, or to be more thoughtful, such as with algorithms meant to encourage clinicians to broach end-of-life conversations. But in other cases, lack of disclosure means that patients may never know what happened if an AI model makes a faulty recommendation that is part of the reason they are denied needed care or undergo an unnecessary, costly, or even harmful intervention.

That’s a real risk, because some of these AI models are fraught with bias, and even those that have been demonstrated to be accurate largely haven’t yet been shown to improve patient outcomes. Some hospitals don’t share data on how well the systems work, justifying the decision on the grounds that they are not conducting research. But that means that patients are not only being denied information about whether the tools are being used in their care, but also about whether the tools are actually helping them.

The decision not to mention these systems to patients is the product of an emerging consensus among doctors, hospital executives, developers, and system architects, who see little value — but plenty of downside — in raising the subject.

They worry that bringing up AI will derail clinicians’ conversations with patients, diverting time and attention away from actionable steps that patients can take to improve their health and quality of life. Doctors also emphasize that they, not the AI, make the decisions about care. An AI system’s recommendation, after all, is just one of many factors that clinicians take into account before making a decision about a patient’s care, and it would be absurd to detail every single guideline, protocol, and data source that gets considered, they say.

Internist Karyn Baum, who’s leading M Health Fairview’s rollout of the tool, said she doesn’t bring up the AI to her patients “in the same way that I wouldn’t say that the X-ray has decided that you’re ready to go home.” She said she would never tell a fellow clinician not to mention the model to a patient, but in practice, her colleagues generally don’t bring it up either.

Four of the health system’s 13 hospitals have now rolled out the hospital discharge planning tool, which was developed by the Silicon Valley AI company Qventus. The model is designed to identify hospitalized patients who are likely to be clinically ready to go home soon and flag steps that might be needed to make that happen, such as scheduling a necessary physical therapy appointment.

Clinicians consult the tool during their daily morning huddle, gathering around a computer to peer at a dashboard of hospitalized patients, estimated discharge dates, and barriers that could prevent that from occurring on schedule. A screenshot of the tool provided by Qventus lists a hypothetical 76-year-old patient, N. Griffin, who is scheduled to leave the hospital on a Tuesday — but the tool prompts clinicians to consider that he might be ready to go home Monday, if he can be squeezed in for an MRI scan by Saturday.

Baum said she sees the system as “a tool to help me make a better decision — just like a screening tool for sepsis, or a CT scan, or a lab value — but it’s not going to take the place of that decision,” she said. To her, it doesn’t make sense to mention to patients. If she did, Baum said, she could end up in a lengthy discussion with patients curious about how the algorithm was created.

That could take valuable time away from the medical and logistical specifics that Baum prefers to spend time talking about with patients flagged by the Qventus tool. Among the questions she brings up with them: How are the patient’s vital signs and lab test results looking? Does the patient have a ride home? How about a flight of stairs to climb when they get there, or a plan for getting help if they fall?

Some doctors worry that while well-intentioned, the decision to withhold mention of these AI systems could backfire.

“I think that patients will find out that we are using these approaches, in part because people are writing news stories like this one about the fact that people are using them,” said Justin Sanders, a palliative care physician at Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston. “It has the potential to become an unnecessary distraction and undermine trust in what we’re trying to do in ways that are probably avoidable.”

Patients themselves are typically excluded from the decision-making process about disclosure. STAT asked four patients who have been hospitalized with serious medical conditions — kidney disease, metastatic cancer, and sepsis — whether they’d want to be told if an AI-powered decision support tool were used in their care. They expressed a range of views: Three said they wouldn’t want to know if their doctor was being advised by such a tool. But a fourth patient spoke out forcefully in favor of disclosure.

“This issue of transparency and upfront communication must be insisted upon by patients,” said Paul Conway, a 55-year-old policy professional who has been on dialysis and received a kidney transplant, both consequences of managing kidney disease since he was a teenager.

The AI-powered decision support tools being introduced in clinical care are often novel and unproven — but does their rollout constitute research?

Many hospitals believe the answer is no, and they’re using that distinction as justification for the decision not to inform patients about the use of these tools in their care. As some health systems see it, these algorithms are tools being deployed as part of routine clinical care to make hospitals more efficient. In their view, patients consent to the use of the algorithms by virtue of being admitted to the hospital.

At UCLA Health, for example, clinicians use a neural network to pinpoint primary care patients at risk of being hospitalized or frequently visiting the emergency room in the next year. Patients are not made aware of the tool because it is considered a part of the health system’s quality improvement efforts, according to Mohammed Mahbouba, who spoke to STAT in February when he was UCLA Health’s chief data officer. (He has since left the health system.)

“This is in the context of clinical operations,” Mahbouba said. “It’s not a research project.”
Oregon Health and Science University uses a regression-powered algorithm to monitor the majority of its adult hospital patients for signs of sepsis. The tool is not disclosed to patients because it is considered part of hospital operations.

“This is meant for operational care; it is not meant for research. So similar to how you’d have a patient aware of the fact that we’re collecting their vital sign information, it’s a part of clinical care. That’s why it’s considered appropriate,” said Abhijit Pandit, OHSU’s chief technology and data officer.

But there is no clear line that neatly separates medical research from hospital operations or quality control, said Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin-Madison. And researchers and bioethicists often disagree on what constitutes one or the other.

“This has been a huge issue: Where is that line between quality control, operational control, and research? There’s no widespread agreement,” Ossorio said.

To be sure, there are plenty of contexts in which hospitals deploying AI-powered decision support tools are getting patients’ explicit consent to use them. Some do so in the context of clinical trials, while others ask permission as part of routine clinical operations.

At Parkland Hospital in Dallas, where the orthopedics department has a tool designed to predict whether a patient will die in the next 48 hours, clinicians inform patients about the tool and ask them to sign onto its use.

“Based on the agreement we have, we have to have patient consent explaining why we’re using this, how we’re using it, how we’ll use it to connect them to the right services, etc.,” said Vikas Chowdhry, the chief analytics and information officer for a nonprofit innovation center incubated out of Parkland Health System in Dallas.

Hospitals often navigate those decisions internally, since manufacturers of AI systems sold to hospitals and clinics generally don’t make recommendations to their customers about what, if anything, frontline clinicians should say to patients.
Jvion — a Georgia-based health care AI company that markets a tool that assesses readmission risk in hospitalized patients and suggests interventions to prevent another hospital stay — encourages the handful of hospitals deploying its model to exercise their own discretion about whether and how to discuss it with patients. But in practice, the AI system usually doesn’t get brought up in these conversations, according to John Frownfelter, a physician who serves as Jvion’s chief medical information officer.

“Since the judgment is left in the hands of the clinicians, it’s almost irrelevant,” Frownfelter said.

When patients are given an unproven drug, the protocol is straightforward: They must explicitly consent to enroll in a clinical study authorized by the Food and Drug Administration and monitored by an institutional review board. And a researcher must inform them about the potential risks and benefits of taking the medication.

That’s not how it works with AI systems being used for decision support in the clinic. These tools aren’t treatments or fully automated diagnostic tools. They also don’t directly determine what kind of therapy a patient may receive — all of which would make them subject to more stringent regulatory oversight.

Developers of AI-powered decision support tools generally don’t seek approval from the FDA, in part because the 21st Century Cures Act, which was signed into law in 2016, was interpreted as taking most medical advisory tools out of the FDA’s jurisdiction. (That could change: In guidelines released last fall, the agency said it intends to focus its oversight powers on AI decision-support products meant to guide treatment of serious or critical conditions, but whose rationale cannot be independently evaluated by doctors — a definition that lines up with many of the AI models that patients aren’t being informed about.)

The result, for now, is that disclosure around AI-powered decision support tools falls into a regulatory gray zone — and that means the hospitals rolling them out often lack incentive to seek informed consent from patients.

“A lot of people justifiably think there are many quality-control activities that health care systems should be doing that involve gathering data,” Wisconsin’s Ossorio said. “And they say it would be burdensome and confusing to patients to get consent for every one of those activities that touch on their data.”

In contrast to the AI-powered decision support tools, there are a few commonly used algorithms subject to the regulation laid out by the Cures Act, such as the type behind the genetic tests that clinicians use to chart a course of treatment for a cancer patient. But in those cases, the genetic test is extremely influential in determining what kind of therapy or drug a patient may receive. Conversely, there’s no similarly clear link between an algorithm designed to predict whether a patient may be readmitted to the hospital and the way they’ll be treated if and when that occurs.

“If it were me, I’d say just file for institutional review board approval and either get consent or justify why you could waive it.” Pilar Ossorio, Professor of Law and Bioethics, University of Wisconsin-Madison

Still, Ossorio would support an ultra-cautious approach: “I do think people throw a lot of things into the operations bucket, and if it were me, I’d say just file for institutional review board approval and either get consent or justify why you could waive it.”

Further complicating matters is the lack of publicly disclosed data showing whether and how well some of the algorithms work, as well as their overall impact on patients. The public doesn’t know whether OHSU’s sepsis-prediction algorithm actually predicts sepsis, nor whether UCLA’s admissions tool actually predicts admissions.

Some AI-powered decision support tools are supported by early data presented at conferences and published in journals, and several developers say they’re in the process of sharing results: Jvion, for example, has submitted to a journal for publication a study that showed a 26% reduction in readmissions when its readmissions risk tool was deployed; that paper is currently in review, according to Jvion’s Frownfelter.

But asked by STAT for data on their tools’ impact on patient care, several hospital executives declined or said they hadn’t completed their evaluations.
A spokesperson from UCLA said it had yet to complete an assessment of the performance of its admissions algorithm.

A spokesperson from OHSU said that according to its latest report, run before the Covid-19 pandemic began in March, its sepsis algorithm had been used on 18,000 patients, of which it had flagged 1,659 patients as at-risk with nurses indicating concern for 210 of them. He added that the tool’s impact on patients — as measured by hospital death rates and length of time spent in the facility — was inconclusive.

“It’s disturbing that they’re deploying these tools without having the kind of information that they should have,” said Wisconsin’s Ossorio. “Before you use a tool to do medical decision-making, you should do the research.”

Ossorio said it may be the case that these tools are merely being used as an additional data point and not to make decisions. But if health systems don’t disclose data showing how the tools are being used, there’s no way to know how heavily clinicians may be leaning on them.

“They always say these tools are meant to be used in combination with clinical data and it’s up to the clinician to make the final decision. But what happens if we learn the algorithm is relied upon over and above all other kinds of information?” she said.

There are countless advocacy groups representing a wide range of patients, but no organization exists to speak for those who’ve unknowingly had AI systems involved in their care. They have no way, after all, of even identifying themselves as part of a common community.

STAT was unable to identify any patients who learned after the fact that their care had been guided by an undisclosed AI model, but asked several patients how they’d feel, hypothetically, about an AI system being used in their care without their knowledge.

Conway, the patient with kidney disease, maintained that he would want to know. He also dismissed the concern raised by some physicians that mentioning AI would derail a conversation. “Woe to the professional that as you introduce a topic, a patient might actually ask questions and you have to answer them,” he said.

Other patients, however, said that while they welcomed the use of AI and other innovations in their care, they wouldn’t expect or even want their doctor to mention it. They likened it to not wanting to be privy to numbers around their prognosis, such as how much time they might expect to have left, or how many patients with their disease are still alive after five years.

“Any of those statistics or algorithms are not going to change how you confront your disease — so why burden yourself with them, is my philosophy,” said Stacy Hurt, a patient advocate from Pittsburgh who received a diagnosis of metastatic colorectal cancer in 2014, on her 44th birthday, when she was working as an executive at a pharmaceutical company. (She is now doing well and is approaching five years with no evidence of disease.)

Katy Grainger, who lost the lower half of both legs and seven fingertips to sepsis, said she would have supported her care team using an algorithm like OHSU’s sepsis model, so long as her clinicians didn’t rely on it too heavily. She said she also would not have wanted to be informed that the tool was being used.

“I don’t monitor how doctors do their jobs. I just trust that they’re doing it well,” she said. “I have to believe that — I’m not a doctor and I can’t control what they do.”

Still, Grainger expressed some reservations about the tool, including the idea that it may have failed to identify her. At 52, Grainger was healthy and fairly young when she developed sepsis. She had been sick for days and visited an urgent care clinic, which gave her antibiotics for what they thought was a basic bacterial infection, but which quickly progressed to a serious case of sepsis.

“I would be worried that [the algorithm] could have missed me. I was young — well, 52 — healthy, in some of the best shape of my life, eating really well, and then boom,” Grainger said.

Dana Deighton, a marketing professional from Virginia, suspects that if an algorithm scanned her data back in 2013, it would have made a dire prediction about her life expectancy: She had just been diagnosed with metastatic esophageal cancer at age 43, after all. But she probably wouldn’t have wanted to hear about an AI’s forecast at such a tender and sensitive time.

“If a physician brought up AI when you are looking for a warmer, more personal touch, it might actually have the opposite and worse effect,” Deighton said. (She’s doing well now — her scans have turned up no evidence of disease since 2015.)

Harvard’s Cohen said he wants to see hospital systems, clinicians, and AI manufacturers come together for a thoughtful discussion around whether they should be disclosing the use of these tools to patients — “and if we’re not doing that, then the question is why aren’t we telling them about this when we tell them about a lot of other things,” he said.

Cohen said he worries that uptake and trust in AI and machine learning could plummet if patients “were to find out, after the fact, that there’s a rash of this being used without anyone ever telling them.”

“That’s a scary thing,” he said, “if you think this is the way the future is going to go.”

Article link: https://www.statnews.com/2020/07/15/artificial-intelligence-patient-consent-hospitals/

By Charlotte Huffman, Mark Smith, November 21, 2019, from wfaa.com, updated November 21, 2019.

Patients who’ve gone through the effort to carefully select a surgeon likely believe that will be the person holding the scalpel during the operation. But that’s not always the case. It’s called “ghost surgery.”

“Ghost surgery is when the surgeon cutting into you is not actually the person you thought was going to be doing the surgery,” said Dr. Michael Greger, a physician and professional speaker on public health issues. 

Greger said ghost surgery is all too common in hospitals affiliated with medical schools.

“This is a nationwide issue,” he said. “If you walk into a teaching hospital, odds are, not only are you not going to have the surgeon you thought was going to do it, but it’s going to be a surgeon-in-training – a resident actually doing the surgery. And the surgeon you thought was going to do it may not even be in the room.”

Often, the only way patients find out is when something goes wrong, Greger told WFAA.

Kathryn Weber said that’s what happened to her.

Earlier this year, Weber chose to have a breast reduction after she learned she had the BRCA2 gene, which puts her at high risk for breast cancer. 

Weber had private insurance.

“I have great insurance,” she said. “I could go anywhere.”

Weber selected a double board-certified surgeon at the University of Texas Southwestern Medical Center in Dallas. The surgery took place at William P. Clements Jr. University Hospital.

“I feel like I did everything right in researching and vetting [my] doctor, and yet this is how it all turned out for me,” she said.

The surgery didn’t go as expected. One breast is fine, but Weber described her other breast as “mutilated.”

“I’m disfigured,” she said. 

The complications from her surgery resulted in numerous hospital visits, follow-up procedures, infections and months on a wound vac.

So, what happened?

Weber said when she returned to the hospital, the anesthesiologist from her surgery recognized her and asked why she was back.

“I lifted up my gown and I showed her,” she said.

“[The anesthesiologist] said, ‘I know why this happened. You know this is a teaching hospital. The doctor did one side and the residents did the other… but please don’t tell,'” Weber said.

WFAA’s calls to Weber’s anesthesiologist were not returned.

Her medical records said the board-certified plastic surgeon she selected “supervised” the operation. Two residents-in-training were listed as “assistant surgeons.”

Weber told WFAA she feels like a guinea pig. And, as WFAA reported in a prior story, she has little recourse against a public facility like UT Southwestern and its faculty due to governmental immunity laws.

“I mean, they basically gave my body to their medical residents to experiment on,” Weber said.

Is this legal?

Residents-in-training can legally perform surgery but only if two conditions are met: The surgeon supervises the surgery and the patient gives the hospital “informed consent,” which includes written permission allowing residents to participate.

Texas law doesn’t define “supervision.” But in order to qualify for reimbursement by Medicare and Medicaid, the federal government takes it one step further. Federal rules require a surgeon to be “physically present” during the “supervision.”

In letters to Weber, UT Southwestern officials told her that her doctor often uses residents to assist. But they said the surgeon was present in the operating room.

UT Southwestern also said Weber gave her consent.

Technically, that’s true.

Weber signed a three-page informed consent form, records show.

However, her initials are missing from the second page, which contains a critical sentence that notifies patients that “residents… may perform portions of the surgical procedure.”

Weber told WFAA she never initialed the second page because she never saw it.

That’s because she was presented the consent form for the first time while on a gurney with an IV already in her arm, just minutes prior to surgery, she said. And the individual who presented the consent form, she said, failed to hand it to her because it was attached to a clipboard, making it impossible to scroll through.

“I never initialed page two,” she said. “There was no way to sign it. And I never got a chance to read it. I could only see it on the clipboard.”

Weber said the resident told her she was signing a surgery consent form for her doctor.

“That was the only time I saw the consent form,” she said. “The resident kept the form on a clipboard and held on to it. He told me, ‘Initial here and here,’ and I made marks where he said to initial.”

“Why wasn’t I given these forms when I was given.. this nice glossy packet selling me on why I should go with [this doctor]?” Weber said.

Not an isolated incident 

Greger told WFAA he has heard similar stories.

“That’s just so typical,” Greger said. “The reason they do it that way is to railroad you in. They know you’re not going to be reading anything… And, of course, you’re in no mental state to be going through it. You’re being rushed through the process.”

WFAA contacted several doctors and organizations. They all said “informed consent” is not just a signed document. Instead,  they said, it should be a conversation between the surgeon and patient, ideally had several days prior to surgery.

“It’s verbal communication. It should be clear to the patient who is doing the procedure and who is [going to be] present,” said Dr. Janis Orlowski, the chief health care officer for the Association of American Medical Colleges.

According to the American College of Surgeons’ policy, informed consent is a “discussion conducted by the surgeon” about “the different types of qualified medical providers who will participate in [the patient’s] operation and their respective roles.”

But Weber said her doctor never had a verbal conversation notifying her that medical residents might be involved in her surgery.

“Absolutely not,” she said. “I would have never tolerated that.”

Weber filed a complaint with the Texas State Medical Board, which determined her doctor’s treatment was “consistent with established practices,” and pointed to the fact that Weber signed the informed consent form.

UT Southwestern declined WFAA’s requests for an on-camera interview. Instead, a spokesperson for the medical school sent a statement.

It said, in part:

“Academic medical centers and teaching hospitals educate the next generation of physicians and at UT Southwestern, that is no different… [The surgeon] determines the level of involvement of residents… The safety of patients remains paramount at all times.”

… [Patients] are given the opportunity to ask questions at clinic visits and leading up to surgical procedures. Additionally, patients are not taken to the operating room until seen in the preoperative area by their attending surgeon to make sure patients have all their questions answered before being taken to the operating room.”

But Weber, responding to the UT Southwestern statement, said her surgeon never discussed possible residents.

“I had seen my surgeon once at his office, where he saw me the first time,” she said. “He never mentioned using residents, and it never crossed my mind he would have residents do my surgery.”

“It is totally designed to scam you,” Weber said. “I consider myself an intelligent person but they really got me on this.”

The issue spans beyond UT Southwestern to its teaching hospital, Parkland Hospital.

Hospital records obtained by a Dallas law firm in a 2007 “whistleblower” complaint shows from 2007 to 2008, there were 161 surgeries at Parkland where the surgeons left the residents to operate without supervision.

Examples from the records include:

• A surgeon left 13 minutes into a four-hour surgery.
• A surgeon left five minutes after an amputation procedure started.
• A surgeon left the operating room before a four-hour surgery started.

According to records, the 161 surgeries –performed by 20 different doctors –totaled about 200 hours of surgery. Of those 200 hours of surgery, the doctors were only present 17% of the time. Meaning, 83% of the time, the attending physician-surgeon was not present in the operating room.

In 18% of those 161 surgeries, records show, the surgeon was a “no show.”

But many patients would never know it because they’re out cold.

‘Not ethical at all’

Dr. Larry Gentilello told WFAA he’s seen it happen first hand.

“I didn’t believe what I was seeing,” he said.

In 2007, Gentilello was a head surgeon and the distinguished chair of UT Southwestern’s Burn, Trauma and Critical Care Division of Surgery. He often performed surgeries at Parkland, the medical school’s teaching hospital.

Genilello had been a world-renowned trauma surgeon and academic at Harvard Medical School. But he told WFAA that his experience at UT Southwestern ran contrary to his prior training. 

“I remember being told early on in my first few days, ‘Larry, you’ve done enough operations, just stay out of the operating room and let the residents do it. They’ve got to learn,’” he recalled.

“Well, no one wants a resident to learn on them,” he said. “I mean, that’s not ethical at all. But that was the sort of culture at Parkland was the patient was there for you to learn on, not there for you to serve.”

Gentilello said he’s even aware of times when the surgeon who was listed as the one performing the surgery wasn’t even in the country, let alone the operating room.

“For example, I had a faculty member whose parent died in England and he was over there for a month disposing of her house and her goods,” he said. “And for a month, his name was on the consent form for dozens of operations when he wasn’t even in the Western Hemisphere.”

“At Parkland, the patients were described as clinical fodder, resident learning material,” he said. “They were not described as patients who are entrusting their lives to your care.”

Gentilello said he finally reached a breaking point.

“I had a sort of a final straw moment,” he said. “I saw that I was on the board to do a gallbladder operation on a woman who I’d never seen, didn’t know anything about her… And so, I quickly checked and went back and there was a third-year resident operating on this woman. And it was a blood bath. I just had enough. I said, ‘I’m going to put a stop to this. It’s my division.’”

But when Gentilello voiced his concerns, he was demoted, he told WFAA.

He filed a “whistleblower” complaint that alleged UT Southwestern had retaliated against him for reporting billing fraud. His suit, ultimately, was thrown out on legal grounds before ever going to trial.

However, the Justice Department gained a $1.4 million settlement from Parkland over allegations of false billings to Medicare and Medicaid. The suit included concerns – mirrored by Gentilello – that there had been inappropriate supervision of residents. Parkland settled the complaint but did not admit any wrongdoing.  

Parkland also was cited for numerous deficiencies, including medical care questions about unsupervised resident trainees. Threatened with losing their Medicare and Medicaid eligibility, Parkland agreed to allow federal oversight of patient safety for 19 months.

In 2013, the feds announced Parkland had made the required improvements to patient safety.

Gentilello said he feels he helped trigger the investigations and ultimate improvements.

“There must be a voice to communicate with the patient explaining the procedures and the risks,” he said. “The patient must acknowledge that they understood those risks in what they were going to undergo… very importantly who was going to do their surgery. You can’t have one surgeon’s name on the consent form and have another surgeon sneak in and do it without the patient knowing.”

Parkland Hospital denied WFAA’s requests for an on-camera interview about the changes they’ve made.

Instead, April Foran, a spokeswoman for the hospital, sent WFAA an email stating, “Residents cannot do surgery without supervision of an attending physician.”

But for patients like Weber, that answer isn’t good enough.

“It’s just shameful,” she said. “… And we deserve better than this… I know I’m not the only one that this has happened to and I know I won’t be the last.”

See the original article.

> see also:

Overtreatment and Informed Consent

Making Informed Consent an Informed Choice.

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> More about patient rights

From the American Hospital Association:

A Patient’s Bill of Rights was first adopted by the American Hospital Association in 1973.

This revision was approved by the AHA Board of Trustees on October 21, 1992.

Introduction

Effective health care requires collaboration between patients and physicians and other health care professionals. Open and honest communication, respect for personal and professional values, and sensitivity to differences are integral to optimal patient care. As the setting for the provision of health services, hospitals must provide a foundation for understanding and respecting the rights and responsibilities of patients, their families, physicians, and other caregivers. Hospitals must ensure a health care ethic that respects the role of patients in decision-making about treatment choices and other aspects of their care. Hospitals must be sensitive to cultural, racial, linguistic, religious, age, gender, and other differences as well as the needs of persons with disabilities.

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The American Hospital Association presents A Patient’s Bill of Rights with the expectation that it will contribute to more effective patient care and be supported by the hospital on behalf of the institution, its medical staff, employees, and patients. The American Hospital Association encourages health care institutions to tailor this bill of rights to their patient community by translating and/or simplifying the language of this bill of rights as may be necessary to ensure that patients and their families understand their rights and responsibilities.

AHA Patient’s Bill of Rights

These rights can be exercised on the patient’s behalf by a designated surrogate or proxy decision-maker if the patient lacks decision-making capacity, is legally incompetent, or is a minor.

1. The patient has the right to considerate and respectful care.
2. The patient has the right to and is encouraged to obtain from physicians and other direct caregivers relevant, current, and understandable information concerning diagnosis, treatment, and prognosis.
3. Except in emergencies when the patient lacks decision-making capacity and the need for treatment is urgent, the patient is entitled to the opportunity to discuss and request information related to the specific procedures and/or treatments, the risks involved, the possible length of recuperation, and the medically reasonable alternatives and their accompanying risks and benefits.
4. Patients have the right to know the identity of physicians, nurses, and others involved in their care, as well as when those involved are students, residents, or other trainees.
5. The patient also has the right to know the immediate and long-term financial implications of treatment choices, insofar as they are known.
6. The patient has the right to make decisions about the plan of care prior to and during the course of treatment and to refuse a recommended treatment or plan of care to the extent permitted by law and hospital policy and to be informed of the medical consequences of this action. In case of such refusal, the patient is entitled to other appropriate care and services that the hospital provides or transfer to another hospital. The hospital should notify patients of any policy that might affect patient choices within the institution.
7. The patient has the right to have an advance directive (such as a living will, health care proxy, or durable power of attorney for health care) concerning treatment or designating a surrogate decision-maker with the expectation that the hospital will honor the intent of that directive to the extent permitted by law and hospital policy. Health care institutions must advise patients of their rights under state law and hospital policy to make informed medical choices, ask if the patient has an advance directive, and include that information in patient records. The patient has the right to timely information about hospital policy that may limit its ability to implement fully a legally valid advance directive.
8. The patient has the right to every consideration of privacy. Case discussion, consultation, examination, and treatment should be conducted so as to protect each patient’s privacy.
9. The patient has the right to expect that all communications and records pertaining to his/her care will be treated as confidential by the hospital, except in cases such as suspected abuse and public health hazards when reporting is permitted or required by law. The patient has the right to expect that the hospital will emphasize the confidentiality of this information when it releases it to any other parties entitled to review information in these records.
10. The patient has the right to review the records pertaining to his/her medical care and to have the information explained or interpreted as necessary, except when restricted by law.
11. The patient has the right to expect that, within its capacity and policies, a hospital will make reasonable response to the request of a patient for appropriate and medically indicated care and services. The hospital must provide evaluation, service, and/or referral as indicated by the urgency of the case. When medically appropriate and legally permissible, or when a patient has so requested, a patient may be transferred to another facility. The institution to which the patient is to be transferred must first have accepted the patient for transfer. The patient must also have the benefit of complete information and explanation concerning the need for, risks, benefits, and alternatives to such a transfer.
12. The patient has the right to ask and be informed of the existence of business relationships among the hospital, educational institutions, other health care providers, or payers that may influence the patient’s treatment and care.
13. The patient has the right to consent to or decline to participate in proposed research studies or human experimentation affecting care and treatment or requiring direct patient involvement and to have those studies fully explained prior to consent. A patient who declines to participate in research or experimentation is entitled to the most effective care that the hospital can otherwise provide.
14. The patient has the right to expect reasonable continuity of care when appropriate and to be informed by physicians and other caregivers of available and realistic patient care options when hospital care is no longer appropriate.
15. The patient has the right to be informed of hospital policies and practices that relate to patient care, treatment, and responsibilities. The patient has the right to be informed of available resources for resolving disputes, grievances, and conflicts, such as ethics committees, patient representatives, or other mechanisms available in the institution. The patient has the right to be informed of the hospital’s charges for services and available payment methods.                      
    

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The collaborative nature of health care requires that patients, or their families/surrogates, participate in their care. The effectiveness of care and patient satisfaction with the course of treatment depends, in part, on the patient fulfilling certain responsibilities. Patients are responsible for providing information about past illnesses, hospitalizations, medications, and other matters related to health status. To participate effectively in decision-making, patients must be encouraged to take responsibility for requesting additional information or clarification about their health status or treatment when they do not fully understand information and instructions. Patients are also responsible for ensuring that the health care institution has a copy of their written advance directive if they have one. Patients are responsible for informing their physicians and other caregivers if they anticipate problems in following prescribed treatment.

Patients should also be aware of the hospital’s obligation to be reasonably efficient and equitable in providing care to other patients and the community. The hospital’s rules and regulations are designed to help the hospital meet this obligation. Patients and their families are responsible for making reasonable accommodations to the needs of the hospital, other patients, medical staff, and hospital employees. Patients are responsible for providing necessary information for insurance claims and for working with the hospital to make payment arrangements, when necessary.

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By Trisha Torrey,  Verywellhealth.

There are four goals of medical treatment—preventive, curative, management, and palliative. When you are asked to decide whether to be treated or to choose from among several treatment options, you are choosing what you consider to be the best outcome from among those choices. Unfortunately, sometimes the choices you have won’t yield the outcomes you prefer. Whether you have the right to refuse care depends on the patient’s circumstances and the reasons why you choose to refuse care.

Informed Consent and the Right to Refuse Treatment

The right to refuse treatment goes hand in hand with another patient right—the right to informed consent.  You should only consent to medical treatment if you have sufficient information about your diagnosis and all treatment options available in terms you can understand. Before a physician can begin any course of treatment, the physician must make the patient aware of what he plans to do. For any course of treatment that is above routine medical procedures, the physician must disclose as much information as possible so you may make an informed decision about your care.

When a patient has been sufficiently informed about the treatment options offered by a physician, the patient has the right to accept or refuse treatment for two reasons:

1. A patient has the freedom to decide what a physician or other healthcare professional will and won’t do.
2. It is unethical to physically force or coerce a patient into a treatment against his will if he is of sound mind and is mentally capable of making an informed decision.
3. If patient competency is questionable, the physician can give the information to a legally appointed guardian or a family member designated by the patient to make decisions for the patient.

Exceptions to the Right to Refuse Treatment

However, there are some patients who do not have the legal ability to say no to treatment. Most of these patients cannot refuse medical treatment, even if it is a non-life-threatening illness or injury.

• Altered mental status: Patients may not have the right to refuse treatment if they have an altered mental status due to alcohol and drugs, brain injury, or psychiatric illness.
• Children: A parent or guardian cannot refuse life-sustaining treatment or deny medical care from a child. This includes those with religious beliefs that discourage certain medical treatments. Parents cannot invoke their right to religious freedom to refuse treatment for a child.
• A threat to the community: A patient’s refusal of medical treatment cannot pose a threat to the community. Communicable diseases, for instance, would require treatment or isolation to prevent the spread to the general public. A mentally ill patient is another example of a patient that cannot refuse treatment if the person poses a physical threat to himself or others.

In instances of an emergency situation, informed consent may be bypassed if immediate treatment is necessary for the patient’s life or safety.

Non-Life-Threatening Treatment Decisions

Most patients in the United States have a right to refuse care if the treatment is being recommended for a non-life-threatening illness. You have probably made this choice without even realizing it. Maybe you didn’t fill a prescription, chose not to get a flu shot, or decided to stop using crutchesafter you sprained an ankle.

You may also be tempted to refuse a treatment for more emotional reasons. Perhaps you know it will be painful or you are afraid of the side effects. There is nothing illegal about choosing to forgo treatment for any of those reasons. They are personal choices, even if they aren’t always wise choices.

End-of-Life-Care Refusal

Choosing to refuse treatment at the end of life addresses life-extending or life-saving treatment. The right to refuse end-of-life care was guaranteed to Americans in 1991 with the passage of the federal Patient Self-Determination Act (PSDA). The PSDA mandated that nursing homes, home-health agencies, and HMOs were required by federal law to provide patients with information regarding advance directives, including do not resuscitate (DNR) orders, living wills, and other discussions and documents. It also guaranteed that Americans could choose to refuse life-sustaining treatment at the end of life.

When you choose not to be treated, knowing that the refusal will shorten your life, it is usually because you are choosing what you believe will be a better quality of life, rather than a longer life that may be less pleasant. Some people, knowing they are going to die soon, even choose to end their own lives rather than be faced with decisions that will, in reality, be executed by others.

Be aware that if you choose not to receive life-sustaining treatment, it does not mean you are required to forfeit palliative care, which can be administered even for patients who do not want to be kept alive. Palliative care focuses on relieving pain at the end of life but does not help extend life.

Before you decide against receiving treatment at the end of your life, be sure you’ve followed steps to help you to make that informed decision.

Refusing Treatment for Financial Reasons

You might also consider refusing treatment if you have been diagnosed with a medical problem that requires very expensive treatment. You may prefer not to spend so much money. Patients make this decision when they believe treatment is beyond their means. They decide to forgo treatment instead of draining their bank accounts.

Those who live in a country with a for-profit healthcare system may be forced to choose between their financial health and their physical health. Americans can refuse treatment when they know it will have a negative impact on their finances.

Using Religion to Refuse Treatment

Jehovah’s Witnesses and Christian Scientists, plus a few non-affiliated churches in different parts of the United States, may be willing to undergo some forms of treatment, but restrict or refuse other forms based on their religious beliefs. The two main denominations offer clear guidelines for making that determination.

Adults may rely on their church affiliation and its tenets to refuse treatment for themselves if they choose. However, they have less legal standing when it comes to making those choices for their children. Several court cases regarding children with different diseases and medical needs have addressed the legality of refusing treatment based on religious reasons with varying outcomes.

Knowing and Using Your Right to Refuse Medical Care

Take these steps if you are trying to make a refusal decision:

• Call on a professional shared decision-making expert to help you make this difficult decision. The shared decision-making process helps you weigh your values and beliefs against your options to make the choice that is best for you.
• Be sure you are a patient who allowed to refuse medical treatment and that you are not in a category where refusal is restricted.
• Take steps to be sure you are making an informed decision.

Advance Directives

The best way for a patient to indicate the right to refuse treatment is to have an advance directive, also known as a living will. Most patients who have had any treatments at a hospital have an advance directive or living will. This document is kept on file and tells the treatment team the wishes of the patient in the event that they are unable to speak for themselves regarding their medical care.

Medical Power of Attorney

Another way for a patient’s wishes to be honored is for the patient to have a medical power of attorney. This designates a person to make decisions on behalf of the patient in the event they are mentally incompetent or incapable of making the decision for themselves.

Updated April 08, 2018