Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Showing posts with label medical error. Show all posts
Showing posts with label medical error. Show all posts

Tuesday, July 11, 2017

Disruption and Mistreatment: Healthcare CEO/Doctor



Dr. Robert Pearl: His book offers a prescription to cure wait ails American medicine

By Patt Morrison

July 5, 2017   FiDA highlight
Dr. Robert Pearl has spent his life in medicine — most recently 18 years as executive director and CEO of Kaiser Permanente’s medical group in California, and president and CEO of its mid-Atlantic group. But it was the death of his father, and a simple medical miscommunication, that prompted him to look long and hard at an American medical system that doesn’t always deliver bang for its billions of bucks. In his book, “Mistreated, Why We Think We’re Getting Good Health Care — And Why We’re Usually Wrong,” Pearl lays out his four ways though the morass of American medical practice: integrated, not fractured care; a flat-fee capitated payment system instead of pay-per-treatment; embracing mobile and video medical technology; and most of all, care that’s led by doctors themselves.


Let me take a classic American playground taunt and turn it around: The line is, if you’re so smart, why aren’t you rich? So if the United States is so rich, and so smart, why aren’t we healthier?
This is exactly why I wrote “Mistreated,” because we spend 50% more than any other nation on the globe and our results are in the lower half. And the reason is because the American healthcare system is broken. It most closely reflects a 19th century cottage industry. It’s fragmented, with doctors scattered across most communities, hospitals in every town.
It’s paid on a piecemeal basis; we call it fee-for-service. It uses technology from the last century. You’d never bank someplace where you couldn’t access information on your account 24/7, but if you want to get your radiology results, your laboratory results, you’d have to call the doctor’s office between 9 and 5 Monday through Friday, or go there. You can’t use video; all the modern tools are not available.
You say our results as a country are in the lower half. Can you get specific?
We’re last in the world [among the 20 most industrialized nations] when it comes to life expectancy. A girl in Seoul, [South] Korea, being born now has on average a life expectancy of 90. The same girl in the United States, 83 — seven years fewer.
We’re second to last in terms of childhood mortality.
Colon cancer — half the colon cancer deaths in the United States are preventable with proper screening, and I don’t necessarily mean a colonoscopy. It’s called a FIT test, which is basically done in the privacy of a bathroom once a year, five minutes, no bowel prep required, you can do it every year for 10 years. It’s just as good as a colonoscopy, and yet across this nation, it’s done 50 to 60% of the time. The best medical groups do it 90% of the time.
What other industry, what business can you think of that would function like American medicine today?
— Robert Pearl
Americans are dying unnecessarily. Half a million people die every year from either failures of prevention, or from medical errors, like my father, or from avoidable complications of chronic illness that simply were not addressed.
We value intervention over prevention; we value the newest advance over the things that are tried and true.
You make a distinction between malpractice and mistreatment, which can simply result from haste or error.
You’re right. I think most physicians are dedicated, smart, hard-working, knowledgeable. That is not the big problem. I’ll give you an example, again my father. He was someone who had tremendous energy. He slept four hours a night, until one day he got tired. And he had to have his spleen taken out because he had hemolytic anemia.
Now, he spent half his time in New York and half his time in Florida. His doctors in New York knew he needed to have the vaccine, the pneumococcal vaccine, to prevent the complications that often follow removal of the spleen. The doctors in Florida knew that he had to have that same exact vaccine, but they each thought the other had given it.
And that’s the system. That’s the lack of an integrated, comprehensive electronic health record. If he had had that, he would have gotten the vaccine. He didn’t die because of malpractice. He died because of a broken system.
If you were able to wave your magic stethoscope and redesign the American healthcare system, what of it would you keep and what of it would you jettison?
What I would jettison or replace is the fragmented fee-for-service, out-of-date technology, lack of leadership that we have today. I’d replace it with an integrated system with the physicians and hospitals working together as one, paid in a prepaid or capitated way, using the most modern electronic health records along with the most modern and mobile devices, things like video, secured email. And I’d put it all inside a leadership structure with physicians.
And I would have multiple groups competing to provide the best value, making information available and transparent for patients so they can make the best choice for themselves and their families.
The main thing, though, that I would keep, and I’m afraid we’re losing it, is all of the mission-driven, wonderful spirit of American medicine that’s been handed down through five millennia. I think we’re seeing right now that physicians are spending almost half of their day hunched over a computer, trying to document things for a billing system rather than looking at the patients, being able to communicate or other things. We’re asking physicians to squeeze more and more into every day with less and less time.
I think we’re reaching a breaking point where one of two things will happen: If we don’t address the concerns and transform American medicine, what we’re going to see is we’re going to devolve into a two-tier system. Not the two-tier system of today, with the poor and everyone else, but the middle class and the Medicare patients not able to get access, similar to the Medicaid patient of today.
Or we’re going to see disruption. I think if we don’t do something about American medicine, the system will simply disintegrate, dissolve, and we’ll run the risk of being disrupted, as Kodak learned.
What’s the resistance to adding technology, when technology seems to be one of the great drivers in American healthcare?
Today what you’re describing, the ability to get paid to do a video visit, for most physicians doesn’t exist. It could happen. It’s just that it doesn’t exist. And I think part of why it doesn’t exist is that insurance companies are concerned that doctors will just generate more and more and more visits whether they’re needed or not, in order to be able to bill for them.
I was struck by your point in the book that the medical system is driven by fear, and it’s not necessarily the patient’s fear of pain or death.
What happens is that in part of our brain, the reward center and the fear center, we call it lighting up, because it activates, and within fractions of a nanosecond, the perceptual side changes. And so medicine is filled with reward and fear.
The problem is that in American medicine, that same brain process leads doctors and patients to do things that don’t make sense when you look at it through the lens of objective reality. As an example: I live in Silicon Valley, and between San Jose and San Francisco, there’s 10 hospitals doing heart surgery, three of which do 200 or 300 cases a year.
That means there’s at least 65 days a year when the team’s going to be there and available, with nothing to do. It’s hard to imagine you’re going to get great results when you’re doing less than one case a day. And similarly, the cost is going to be much higher.
Take the hospital administrators, and put them in one of my classes at the Stanford graduate school of business. They’ll immediately say, bring the three together, close two of the services and have one service that does 800 or 900 a year, a much higher volume service. But what they know is they’ll lose their jobs. They know the hospitals will lose their revenue. Fear of loss — how powerful losses are compared to gains.
I talk about sepsis, which is an infection that is now the leading cause of death among hospitalized patients, a systemic infection, the same problem that my father died from. The fear there is that, what we know is that half the people who come through the hospital with sepsis are very, very sick. Everyone in the United States knows how to treat them.
But a woman named Diane Craig, one of my associates at Kaiser Santa Clara, found that half of these patients looked very sick coming in. But she also found that the other half — they were sick, because otherwise they would not be at a hospital — but they were not nearly as sick. They were often younger people, sometimes with a kidney infection or maybe a mild kind of pneumonia, and then they progress rapidly over the next couple of days, [into] that intermediate zone [where] no one quite knows what to do. And if you treat all the people in the intermediate zone, you’re going to save lots of lives.
What’s the problem? Because the intervention requires doing very aggressive treatment, and the physician is worried because some patients who might have lived will actually be harmed. And in the mind of a doctor, not all deaths are the same. I hate to say it that way. The ones they cause are far worse than the ones they could have avoided.
And so there’s an imbalance. So rather than aggressively treating the patient, they just put them in the hospital, put them on some antibiotics, and they call a consultation. It’s now no longer on their hands.
It’s not that the doctor intentionally wants to harm anyone, it’s just their fear of being the one to cause the problem.
Again, it’s how our brains change perception. Those things that we cause, the problems we cause, the deaths we cause, are significantly greater in magnitude than the ones we otherwise could have saved. It’s also why we see intervention as being so much more valuable than prevention.
You saw some of these things first-hand when your father fell ill and died.
My dad survived the first acute episode he had, but he never overcame the complications. My brother and I got called; my dad had had a bleed into his brain in Florida. We got on an airplane and we flew there. When we arrived, there were a lot of doctors at the door. There was the [ears, nose and throat] doctor who wanted to do the tracheostomy, the [gastrointestinal] doctor who wanted to put the feeding tube in place, the neurosurgeon who wanted to take a piece of bone from his skull to let his brain expand. And we looked at the X-rays — we’re both physicians — and we said no, he’s not going to get better. It’s not what he wants.
The next two and a half days he was in the hospital, we never saw a physician. There’s no [current procedural terminology] code for how doctors bill for compassion. Doctors in the fee-for-service world don’t get paid for coming by and comforting a family in its time of greatest grief.
The system is making the lives of patients worse.
And I want to add one piece: It’s making the lives of doctors worse. What we see today is one in every three doctors reports being depressed. Over half of physicians say they would not tell their children to enter into medicine. There are over 400 physician suicides every year.
And the reason is, medicine is becoming less and less fulfilling. And yet somehow, because of the context, ask most Americans and they will tell you the medical care in the United States is the best in the world, even if it’s a little expensive. The data says exactly the opposite.
How do your suggestions work when, as you pointed out in your book, about 50% of medical care costs go to 5% of people?
If you look at the 50% that go to 5% of people, you have really three groups within it: one group of people who just have a terrible, unexpected problem. A baby is born very, very premature. But the reality is, they’re not going to have another baby born premature next year.
There are some people who have severe disease, and the problem in that group is that we missed the opportunity 20 or 30 years before to actually prevent them from developing those kinds of diseases.
But the places that most people look are individuals with chronic disease, multiple chronic diseases. And that’s where I think the approach I’m describing will make the biggest difference. All these patients are seeing physicians. It’s just that when they see the physicians, the system is not focusing in a way to get that best outcome. And what do I mean by that? People often have five or six doctors. Well, are those doctors working together as one, or are they all duplicating the same kinds of things? Are the computer systems they’re using coordinated with each other? Or does everyone basically have an office-based system?
Is there a leadership structure? Doctors are not going to follow hospitals or insurance executives — they don’t trust ’em. But they will follow physicians who are well-trained, whom they know and whom they respect.
What other industry, what business can you think of that would function like American medicine today? Try to think of a business where you wouldn’t have coordination between the people who design the products, the people servicing the products, the people selling the products, where you wouldn’t have modern 21st century computing systems so that everyone has information not just to do the care at the time, but to be able to analyze it in order to improve performance.
It just doesn’t exist in most of American medicine today.
I believe that change can best happen through the businesses of this nation, that if the businesses said, in a certain number of years — let’s say five years from now — we’re not going to purchase insurance from any organization, from any doctor, from any hospital that is not integrated, where the care is not coordinated among primary care, specialty care, inpatient care, outpatient care, where it’s not paid on a capitated or prepaid basis, where they don’t have the most modern electronic health records — I believe the American healthcare system would respond and would improve.
If we’re able to accomplish that, then my dad’s death will have served a purpose, because the result will be hundreds of thousands of patients who live who otherwise would die.

http://www.latimes.com/opinion/op-ed/la-ol-patt-morrison-robert-pearl-healthcare-20170705-htmlstory.html

Friday, May 22, 2015

Write to cures@mail.house.gov by June 13, 2014. Here's why!

21st Century Cures – Patients 

“There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”
For patients and their families, the gap between the number of diseases and the number of treatments is not a statistic; it is their daily struggle. Despite the medical breakthroughs of recent years, for many diseases, treatments or research simply do not exist. 
Through legislation such as the Food and Drug Administration Safety and Innovation Act and the PREEMIE Reauthorization Act, which included the National Pediatric Research Network Act, the Energy and Commerce Committee has sought bipartisan solutions to facilitate and accelerate patient access to innovative treatments. Although progress has been made, significant work remains. That is why we launched the 21st Century Cures initiative, and the involvement and guidance of those patients on the frontlines and their advocates is critical. Our goal of accelerating the cycle of discovery, development, and delivery of promising new treatments and cures is shared by many, but perhaps most of all by patients and their families. 
The committee appreciates that certain aspects of the discovery, development, and delivery cycle have different meanings for different patients. Depending on the condition or disease at issue, the state of biomedical research, and the translation of such research into treatments and cures, varies. We want to hear about the state of biomedical research and therapeutic innovation for specific diseases and better understand how Congress can help move the ball forward. 
To help the committee’s effort, we are seeking input from the patient community on the following questions: 
􏰀 What is the state of discovery of cures and treatments for your disease? Are there cures and treatments now or on the horizon? 
1 Statement of Margaret Anderson, Executive Director of FasterCures, at the 21st Century Cures Roundtable held on May 6, 2014, http://www.youtube.com/watch?v=Fr4Re7sfDzE&t=33m21s

  • 􏰀  What programs or policies have you utilized to support and foster research, such as patient registries, public-private partnerships, and venture philanthropy?
  • 􏰀  How can Congress incentivize, coordinate, and accelerate basic research for diseases we know relatively little about?
  • 􏰀  How can we work together to better translate advances in science into safe and effective new therapies for patients?
  • 􏰀  How do you coordinate your research and outreach with other patients?
  • 􏰀  How do you learn about new treatments and cures? How do you communicate with other
    patients regarding treatments and cures?
  • 􏰀  What can we learn from your experiences with clinical trials and the drug development process?
  • 􏰀  What is the role of government in your work, including any barriers to achieving your goals and advancing breakthroughs?
  • 􏰀  How should regulators evaluate benefit-risk? How do you work with regulators regarding benefit-risk? Can this process be improved?
  • 􏰀  What is the role of public and private funding in the research and development of cures and treatments?
  • 􏰀  Are there success stories the committee can highlight and best practices we can leverage in other areas?
  • 􏰀  How have you worked with other patients to support one another?
  • 􏰀  What is the financial burden of your disease? How would better treatments and cures help
    save money for your family and the federal government?
  • 􏰀  How can Congress help?
    Public input is critical to the 21st Century Cures initiative, especially from the patient community. With the staggering gap between the number of diseases and available treatments, there are undoubtedly countless untold stories that will provide guidance and perspective in this effort. We request all submissions and suggestions be sent to cures@mail.house.gov by June 13, 2014. 
http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140516PatientsWhitePaper.pdf


Thursday, April 23, 2015

Stop Military and Civilian Medical Error 'Death Without Disclosure': Petition

Please sign this petition!  Disclosure:  Death from Medical Errors




WE PETITION THE OBAMA ADMINISTRATION TO:
Mandate Reporting of All Medical Errors to an Independent Oversight Committee, and to the Patient or Their Next of Kin.
We call on President Obama to mandate a national 'Medical Error Transparency Plan'. Medical errors are known to be the third leading cause of death, and medical errors also create a high number of disabilities. Patient's human rights are being violated by the current lack of transparency. We call for mandatory reporting of medical errors by anyone that has knowledge of, or reasonably suspects, that a medical error has occurred. Reporting must be to an independent oversight committee as well as to the patient, or to the deceased / incapacitated patient's healthcare representative.


Background story:  

Service Members Are Left in Dark on Health Errors

By SHARON LaFRANIERE APRIL 19, 2015
FORT WAYNE, Ind. — Lt. Col. Chad Gallagher was T. J. Moore’s squadron leader when the 19-year-old recruit arrived for basic training last spring at Lackland Air Force Base in San Antonio. He was watching at the quarter-mile track nine days later when Mr. Moore, on an easy mile-and-a-half test run, collapsed at the finish line and was rushed to a hospital.
And he was in Indiana shortly afterward to deliver a sorrowful eulogy at Mr. Moore’s funeral. “He had tears in his eyes,” Mr. Moore’s mother, Anita Holmes, said in an interview at her home here. “He said, ‘I didn’t do enough to protect T. J.’ ”
A year later, Ms. Holmes says she still does not know what Colonel Gallagher meant by that.
Outside experts who reviewed her son’s medical records at the request of The New York Times identified a serious medical error at the Lackland clinic: a decision to allow Mr. Moore to make the run even though doctors had pulled him from normal training after he failed the same test just days before. Test results revealing a genetic condition that in rare cases can lead to sudden death during physical exertion were apparently overlooked.

But the official Air Force explanation — in a 15-page report in a white binder, delivered to Ms. Holmes in December after months of inquiries — was that the military had followed proper protocol. No mistakes were identified. No one was faulted.
“I raised T. J. as a single mother on little income for 19 years, and kept him safe. They had him for nine days and sent him home to me in a box,” said Ms. Holmes, who called the report “garbage.”
“No one,” she added, “has really given me good answers about why.”
Tens of thousands of serious medical mistakes happen every year at American hospitals and clinics. While a handful of health care organizations have opted for broad disclosure amid calls for greater openness, most patients and their families still face significant obstacles if they try to find out what went wrong. But as Mr. Moore’s case illustrates, the nation’s 1.3 million active-duty service members are in a special bind, virtually powerless to hold accountable the health care system that treats them.
They are captives of the military medical system, unable, without specific approval, to get care elsewhere if they fear theirs is substandard or dangerous. Yet if they are harmed or die, they or their survivors have no legal right to challenge their care, and seek answers, by filing malpractice suits.
Only 18 months ago did the Pentagon explicitly allow them to file complaints about their treatment, although some had done so earlier. But even then they are barred from learning the results of any inquiry. Under federal law, investigations at military hospitals and clinics are confidential, in part to keep the findings from the roughly two million civilian patients they treat per year — spouses and children of service members, retirees and others — who can and do file malpractice claims.
In scores of interviews, active-duty patients, relatives and military medical workers described how, in that information vacuum, attempts to ferret out the truth about suspected medical mistakes — through freedom-of-information requests, complaints, meetings with military medical officials — produced anodyne letters of condolence, blanket denials of poor care or simply nothing at all.

“There is just no transparency. You can’t sue. You have no insight into the process,” said Cheryl Garner, a military intelligence officer who retired last year. “As active duty, we just don’t have much recourse.”
What’s more, until 2009, clinicians found to have delivered substandard care to active-duty patients in most cases were not reported to a national database that tracks problem medical workers; instead they were reported to an internal database. Even now, those clinicians, typically doctors, are mainly reported only if the service member is disabled or dies, a higher bar than in cases involving civilians.
And comparatively few have been reported, to either database, Pentagon records show. The Army, which runs the bulk of the system’s hospitals, treats four civilian inpatients for every active-duty one. But from 2003 to 2013, it reported nearly 50 times as many medical workers for breaching the standard of care in cases involving civilians.
The experiences of active-duty patients point to broader questions of accountability in a system of 54 hospitals and hundreds of clinics that has recently come under intense scrutiny. As The Times has reported, military hospitals often fail to conduct safety investigations that the Defense Department mandates when patients suffer serious harm or die. Many medical workers report reprisals for speaking out about problems with care. And systemwide efforts to limit errors and bolster quality have often foundered in a convoluted bureaucracy.
Amid growing fiscal pressures, the Defense Department has ordered improvements and is pushing to close hospitals where surgeons and other specialists treat too few patients to keep skills honed. In a new report to President Obama and Congress, a blue-ribbon commission argued that the military hospitals are wrongly modeled after typical civilian hospitals and so are stumbling in their central mission — to train a medical corps for injuries in combat zones.
In an interview, Dr. Jonathan Woodson, the Pentagon’s top health official since 2011, said that the federal confidentiality law notwithstanding, the military explicitly requires its clinicians and facilities to be open and accountable to all patients. If patients and the public once were unnecessarily denied information about quality of care, he said, “that went out the door when I came in.”
“From the top we are fully committed to the standard of transparency,” he said, describing efforts that include retraining thousands of doctors. If that message is not being heeded, he said, “we want to know.”
Yet military culture makes service members the least likely to complain, for fear of being branded troublemakers. And when they have spoken up, some said, they have been brushed aside.
Ms. Garner was 35 in 2007 when she saw a physician assistant at the Langley Air Force Base hospital three times for breast pain and other symptoms she feared might point to cancer. The physician assistant not only dismissed her fears as irrational, she said, but threatened to place a note in her file that could have damaged her career if she came back again.

Nine months later, Ms. Garner was able to switch her care to a Navy hospital. A doctor there speedily ordered a mammogram — and discovered Stage 2 invasive breast cancer. Her persistence, he told her, had saved her life. A double mastectomy and chemotherapy followed.
After she recovered in late 2009, Ms. Garner filed a complaint against the physician assistant, hoping, she said, to protect other patients. But while sympathetic, the hospital’s chief of medical services told her that she had not been mistreated. Not long afterward, the physician assistant was promoted.
‘Drive Families Crazy’

“When it is pretty clear that something occurred, and nobody is being honest with them, that will drive families crazy,” said Dr. Robert Truog, a professor of medical ethics at Harvard Medical School.
To Belinda and Ronald Robinson, that aptly describes the five years they have spent seeking an explanation for what happened to their 27-year-old son, Sgt. Ronald Robinson Jr., at the hospital now called San Antonio Military Medical Center. A gregarious computer technician with a blue Mustang and a love of barbecue, Sergeant Robinson enlisted in the Army at 19, hoping for a long military career like his father’s. But six years later, he was found to have a heart condition called atrial fibrillation, shared by several million Americans and characterized by an abnormal heart rhythm. Exercise sometimes left him disoriented, dizzy, even unable to speak.
Facing a possible lifetime of medication, he decided on an outpatient procedure in which an electrode on a catheter threaded into the heart burns away the problem tissue. Tens of thousands of such procedures are conducted annually in the United States, with an estimated death rate below one in 1,000.
In April 2010, Mrs. Robinson was waiting at the hospital for her son’s procedure to end when a surgeon burst in. “Something went terribly wrong,” he told her. Despite an all-out effort, Sergeant Robinson died within hours.
Two days later, she said, the cardiac electrophysiologist who performed the procedure, Dr. Robert Eckart, telephoned her and her husband. “He said, ‘I wish I could tell you what happened,’ ” Mrs. Robinson recalled in an interview at the family’s restaurant in Slidell, La. “I can never ever forget what he said: ‘It is just an unknown.’
In his notes, Dr. Eckart described the case as an “unexplained rapid death.”
Experts say his caution may have been appropriate. It often takes a thorough inquiry to figure out what happened. But with that one phone call, the Army’s effort to explain Sergeant Robinson’s death came to an end.
Hospital records obtained by The Times suggest the required patient-safety inquiry was never conducted. When the Robinsons asked about the results of an investigation, the Army sent duplicate sets of their son’s medical records. Their Freedom of Information Act requests were answered with a copy of the Army secretary’s condolence letter.
“If we knew the truth, we could deal with what happened,” Mrs. Robinson said. “I could forgive them.”

Two specialists who reviewed Sergeant Robinson’s medical records at The Times’s request called his death both rare and perplexing. But one of them — Dr. Hugh Calkins, director of cardiac arrhythmia services at Johns Hopkins Hospital — said it was not a total mystery. Because of some unknown factor, possibly an equipment malfunction, he said, the doctor inadvertently cauterized too close to two crucial pulmonary veins and the veins shut down, causing fatal hemorrhaging.
“The best people in this field have inadvertently burned inside the veins, and almost always you get away with it,” he said. He called the outcome “a tragic, freak complication,” adding, “I hope that they were straight with the family.”
Told of his comments, Mrs. Robinson fell silent. “No one ever told us that,” she said.
Dr. Eckart, now a civilian physician, said in an email that patient-privacy laws prohibited him from discussing the case. But he wrote, “Sometimes there can be a bad outcome, even if everything was done right.”
Beyond helping bring closure, experts say, honesty about medical errors makes it harder for hospitals to gloss over serious lapses in care.
The San Antonio hospital, the military’s largest, has had a perennial problem with surgical infection control. In 2011, when Mark Probus underwent spinal surgery there, the infection rate of surgical wounds was 77 percent higher than expected, given the mix of cases, according to a Pentagon-ordered comparison with civilian hospitals.
Mr. Probus, then 44, was no average patient: A lieutenant colonel, he worked at Army medical headquarters, assessing hospitals.
But when he nearly died from a surgical infection, requiring three more operations and months of follow-up care, he got no better answers about what had gone wrong than did the Robinsons. When he asked whether the mandatory safety investigation had been conducted, he said, hospital staff members did not respond.
Mr. Probus retired on medical grounds in 2013, utterly disillusioned, he said, by the system’s lack of accountability. “I had no faith whatsoever in what I was doing anymore,” he said.
Honesty With Patients

Defenders of the federal confidentiality law argue that without it, medical workers would not speak freely about mistakes for fear of provoking malpractice suits by the system’s civilian patients. But evidence from some civilian hospitals increasingly raises questions about that argument.
In 2001, the University of Michigan Health System, the state’s largest medical center, decided that officials would inform patients and apologize whenever they discovered a serious preventable error or lapse in care. Administrators say physicians and nurses have grown more open about mistakes — not less — even though, unlike their counterparts in military hospitals, they can be individually sued for malpractice. The hospital has followed its disclosures by negotiating compensation, resulting in lower malpractice costs.
That level of honesty with patients is still rare, but momentum is growing to make it standard. The National Quality Forum, a nonprofit organization whose safety recommendations are followed by hundreds of hospitals, said in 2009 that hospitals should acknowledge and explain preventable errors to patients and apologize.



Dr. Thomas Gallagher, director of the University of Washington’s research center for patient safety and quality of care, said hospital officials can summarize the results of investigations without disclosing so much that medical workers would be afraid to talk. At Johns Hopkins, physicians routinely tell patients not only what inquiries found, but what changes resulted, said Dr. Albert W. Wu, a physician there and a health policy professor.
The Pentagon has taken steps to open up: Three years ago, officials successfully pushed Congress to narrow the 1986 confidentiality law, suspecting it was being used to withhold not only judgments about care but medical facts.
Regulations now require that those facts be shared, thousands of doctors are being retrained and a small band of mediators has been hired to help. The military’s policies, Dr. Woodson says, are no different from those of most civilian hospitals.
Still, in the eyes of leaders in the field, like Richard C. Boothman, the Michigan health system’s clinical safety chief, such policies fall short. “If you can’t be honest about the conclusion, about whether what you did was right or wrong, whether it was reasonable or not reasonable, I don’t see how you can say you have a culture of full disclosure,” he said.
Arguing the need to maintain military discipline, the Defense Department has opposed a series of congressional attempts to modify a law that the Supreme Court ruled in 1950 bars active-duty service members or their survivors from filing malpractice claims. Officials insist that the prohibition in no way lessens the quality or scrutiny of care provided to service members.
But it has led to a bifurcated system of review that has produced proportionally fewer reports of medical workers for substandard care of active-duty patients than of civilian ones.
If the department determines that a medical worker breached medical standards in a civilian case that resulted in a malpractice payment, the worker must be reported to the National Practitioner Data Bank, which health care and licensing organizations routinely check to spot problem physicians and nurses. A similar inquiry is supposed to ensue when the Pentagon authorizes death or disability benefits for an active-duty patient — although until 2009, clinicians who were faulted in those cases were reported only to an internal database.
But in practice, few active-duty cases reach that level of scrutiny. Col. Kimberly Kesling, the Army’s chief of patient safety, said that is because service members are typically young, healthy and in need of only routine care.
Even so, service members make up one-fifth of inpatients and one-fourth of the maternity cases at military hospitals. Yet from 2003 to 2009, the military reported just 15 clinicians for substandard care of active-duty patients, while reporting 710 clinicians — 47 times as many — for unacceptable care of civilian patients leading to a payment.

In interviews, other current and former senior health officials attributed the discrepancy to several factors. For one, analysts who review disability cases typically do not focus on whether bad care is to blame. Indeed, at seven military hospitals visited by inspectors, staff members who handled disability claims did not even know they were expected to look for signs of malpractice, according to a 2007 department report.

“The disability system has never been structured to be a quality-of-care review,” said a senior Air Force official in charge of risk management. “It is fundamentally a disconnect.”
Beyond that, clinicians can be reported for substandard care of a civilian patient who wins a malpractice claim no matter the level of harm — not just if the patient is disabled or dies. Finally, service members are often reluctant to even file disability claims for fear of being declared unfit for duty, making their cases less likely to be investigated.
The gap has narrowed since 2009, when the military tightened regulations and started reporting active-duty cases to the national database. But it has not vanished: In the next four and a half years, 17 times as many medical workers were reported for poor care of civilians than of active-duty patients.
From 2003 to 2013, the Army reported not a single clinician for breaching medical standards in a case that left a service member disabled — despite tens of millions of active-duty patient visits and roughly 250,000 hospitalizations.
‘A Terrible Error’
T. J. Moore enlisted in the Air Force two months after high school, telling his mother that he wanted to accomplish “something big” and help care for her and his sisters. “Now you can rest,” he told her.

A former football player with an engaging grin, he seemed to fit in well at the Air Force base in San Antonio. But on his first Saturday of basic training, he flamed out on the 1.5-mile run, part of a mandatory initial fitness test. Given 18 and a half minutes to run six laps, Mr. Moore stopped after three laps. “Running is not for me,” he declared.
The Times pieced together what followed from Mr. Moore’s medical records, the official Air Force report and records of the family’s meeting with Air Force officials.
Dr. Aasif Mirza, who examined Mr. Moore the next Tuesday at the base’s health clinic, pulled him from standard training. Neither alternative he proposed was viable under military regulations, so the next day, another physician, Dr. Charlie Collenborne, sent Mr. Moore to a medical hold unit for trainees with health issues.
A nurse wrote in his chart: “Pt reports that he can not run at all.” The official Air Force report said “a thorough medical evaluation” was ordered.
Had that occurred, someone most likely would have noticed the results of a blood test that had arrived at the clinic the previous afternoon. Routine lab work done when he arrived at Lackland showed that Mr. Moore had sickle-cell trait, a genetic condition affecting 8 percent of African-Americans.
The vast majority of people with sickle-cell trait lead normal lives, and many are not even aware of their status. But in rare cases, people with the trait who engage in sudden, intense exercise suffer a poorly understood metabolic storm that can end in sudden death. Risk factors include heat and poor physical conditioning.
The military has long worried about such cases: Studies decades ago found that African-American recruits with the trait had a 30 percent higher rate of exercise-related death than those without it. The Air Force screens recruits for the trait and requires precautions, not always enforced: Just three years earlier, a Lackland recruit with sickle-cell trait died after the same 1.5-mile timed run. He had never been issued the required armband to alert medics to his status.

In Mr. Moore’s case, a medical worker had scheduled a Friday appointment to inform him of his test results, sending an email to squadron leaders. But on Thursday, his situation came to a head. Squadron leaders wanted to know if he would repeat the run or should be sent home. A low-level nurse at the base clinic contacted the physicians who had seen him in the previous 48 hours.
Although both had restricted him from basic training, the Air Force report suggests they changed their minds. “Both physicians stated that the Trainee of Concern was medically qualified and simply ‘deconditioned,’ ” it states. It stresses that Mr. Moore himself reported feeling fine since his run five days earlier — the last time he had engaged in any exercise.
The nurse relayed the information to a physician assistant, Seth Kasunick, who cleared Mr. Moore; neither he nor anyone else conducted a physical examination. His note documenting the decision, written after Mr. Moore died, said he had been “informed the trainee was without health concerns.”
That afternoon, in 82-degree heat, Mr. Moore ran five laps quickly. One hundred yards from the finish line, he fell down, got up and collapsed again. He died that night of what the medical examiner later ruled were complications from sickle-cell trait.
Three independent experts who reviewed Mr. Moore’s medical records at The Times’s request agreed that medical workers had failed him. Dr. Janis Abkowitz, a well-known hematologist and medical professor at the University of Washington, said abandoning the precautions just ordered by two physicians “was a terrible error.”
Dr. Stephen Rice, a specialist recommended to The Times by the American College of Sports Medicine, said that based on Mr. Moore’s symptoms when running — especially that his legs felt very hot — physicians should have investigated whether his muscle tissue was breaking down and leaching proteins into the bloodstream. That condition, called rhabdomyolysis, has been associated with sudden death of people with sickle-cell trait who overexert. And the sickle cell test results “should have been communicated to everyone,” he said.
“There was a breakdown here, no question about it,” he said. “You have to gain some lessons here. You can’t just say this is a tragedy.”
The military’s clinicians — Dr. Mirza, Dr. Collenborne and Mr. Kasunick — did not respond to phone calls for comment. Nor did Mr. Moore’s squadron leader, Colonel Gallagher. In a statement late on Friday, the Air Force said that Mr. Moore had died from complications related to a pre-existing condition and that no one who had trained or cared for him was negligent.
Defense Department officials say it is important that patients or relatives hear directly, and promptly, from caregivers in cases of serious harm or death. Surrogates do not work because patients and families do not trust them.
But nine months after her son died, Ms. Holmes said she had only his death certificate, a condolence letter and assurances that inquiries were underway, one of which ultimately produced a report not covered by the confidentiality law. “How can you fight back when they won’t talk to you?” she asked then.
The four Air Force officers who arrived at her house the next month with that report were just messengers, with no ties to the recruit. Their message was that medical workers had come to a careful, deliberate consensus that he could safely repeat the test run. They did not address why the “thorough medical evaluation” described in the report had not been conducted. Nor did they say whether anyone had considered the sickle-cell test results.
Ms. Holmes told the officers that their remarks were scripted. “The people who were in contact with him should have been the ones who came here today,” she said. “It would make me feel so much better if they would just say, ‘We messed up,’ ” she said after reading the report they gave her on their way out. “I just want them to own up and say it, not put up some kind of front.”
In frustration, she wrote to Colonel Gallagher, the squadron leader who said at the funeral that he had not done enough to protect her son. She wanted to ask him directly what he had meant.
There was no reply.
Andrew W. Lehren contributed reporting from New York.


Tuesday, July 15, 2014

Consumers Union Press Release: Establish a National Patient Safety Board


     
Posted 07/15/14 at 8:53 am
News ReleaseConsumers UnionPublic Policy and Advocacy Division of Consumer ReportsTuesday, July 15, 2014
Patient Safety Advocates Urge the Creation of a National Patient Safety Board to Fight Medical Errors
Consumers Union’s Safe Patient Project to Highlight Need in Senate Testimony

WASHINGTON, DC – A network of patient safety advocates is urging Congress to take steps to improve patient safety by preventing hospital acquired infections and other preventable medical errors. The group, which includes Consumers Union, the policy and advocacy division of Consumer Reports, recently sent a letter to House and Senate lawmakers calling for the establishment of a National Patient Safety Board and additional Congressional committee action to improve the quality and safety of care.
Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said, “Hundreds of thousands of people enter the hospital each year for treatment of one ailment, but end up losing their lives due to another. Millions more survive but often after substantial health and financial losses.  Efforts to eliminate these preventable errors and infections must be stepped up to address this crisis – the third leading cause of death in the U.S.”
McGiffert will highlight the need for a National Patient Safety Board and other efforts to improve hospital safety in her testimony at a Senate Health Subcommittee hearing on Thursday, July 17. The proposed safety board would be modeled after the National Transportation Safety Board (NTSB) and investigate instances of medical harm. The hearing, More Than 1,000 Preventable Deaths a Day Is Too Many: The Need to Improve Patient Safety,” is scheduled to begin at 10am.
“We’re calling on Congress to create a National Patient Safety Board to ensure that we investigate medical harm cases properly and institute preventative measures to protect consumers. Just as the NTSB has made our airline industry safer for passengers, a National Patient Safety Board would improve the quality of care in hospitals and elevate patient safety by significantly reducing patients’ injuries and deaths from preventable medical errors,” said Yanling Yu of Washington state, lead organizer of the Congressional letter.
Medical harm is now the third leading cause of death in the United States. Reports show that one out of four hospital patients is harmed by adverse events. At the national level, it is estimated that as many as 440,000 patients die each year from preventable medical harm, including 75,000 deaths from hospital-acquired infections alone. And according to a recent Commonwealth Fund report, the U.S. ranks at the bottom among 11 advanced countries both on aggregate score and many individual health care measures such as outcomes, quality, and efficiency.
To read the full letter, click here or visit www.SafePatientProject.org. For more information on the Senate Subcommittee hearing, visit www.Help.Senate.gov.
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Media contact:  Kara Kelber, kkelber@consumer.org202-462-6262

Saturday, November 2, 2013

HealthwatchUSA conference focuses on device implants.


Published: October 31, 2013 

By Jim Warren — jwarren@herald-leader.com   FiDA highlight
A health conference Friday in Lexington will explore various patient safety issues, including the potential risks of joint replacement implants.
"Many people in their 40s and 50s are having these devices put in today, expecting them to last 30 or 40 years. But anything mechanical eventually fails," said Dr. Kevin Kavanagh, the conference coordinator.
The meeting also will focus on the new federal Sunshine Act, which requires public disclosure of payments to doctors by pharmaceutical companies and manufacturers of medical devices.
Kavanagh said that medical devices like artificial joint implants offer advantages, but they can pose risks to patients. "They are largely unregulated, and many of them have had inadequate testing," he said.
Implants don't come with a guarantee, he said.
"You buy a toaster, you get a guarantee," Kavanagh said. "But you get a complex hip implant that may cost tens of thousands of dollars, and it comes with no guarantee. Without that, it's very hard to find out how long these devices are even supposed to last."
The Consumers Union contends that implant manufacturers should be required to guarantee their products.
Joleen Chambers, founder of the Failed Implant Device Alliance, is a keynote speaker at Friday's conference.

Jim Warren (859) 231-3255.