Blame Anderson Cooper

I jokingly blame Anderson Cooper for my ultimate selection of Vanderbilt Medical and Dental Clinic to do my reconstruction work as it is connected to him via his Mother’s familial legacy. I doubt that Anderson has ever set foot on the campus or inside the medical facility that bears the name of his predecessors and as the University and Medical facility have long split and only share a name I see no reason why anyone would think this hospital is as elegant and as intellectually interesting as either he or his Mother were or are.

Vanderbilt is a medical behemoth in Nashville and largely responsible for some of the reimagining of everything from malls to neighborhoods thanks to their growth and ever expanding footprint in Nashville, a city dominated by many legacy medical landmarks, one tied to the Frist family, another said family with a storied legacy in America. Perhaps one recalls the former Senator from the state of Tennessee, William Harrison Frist; He is an American physician, businessman, and politician who began his career as a heart and lung transplant surgeon. He later served two terms as a Republican United States Senator representing Tennessee. He was the Senate Majority Leader from 2003 to 2007 and nowhere near as divisive as the current Southern leadership. The Frist family founded HCA and in turn is why the area is known for its role in remaking Nashville as more than music city. Bill worked at Vanderbilt and was a successful transplant surgeon and is still affiliated with them and I am sure like all the wealthy families in the area have no interest in day to day operations as their legacy and footprint in contemporary Nashville is secure and well defined. That is the South, where money talks and the people talk out of two sides of their mouth to tell you what they think you want to hear and what they think they need to hear to be believed. Everyone lies in the South like a dog on a carpet on a hot day so they assume you too lie and if not it does you no favors.

The main players in almost every city, especially the South, are defined by “old money” meaning that most of the family earnings are at least three generations old and come from a business or industry started by a senior Patriarch. Think the Rockefeller’s, the Kennedy’s, the Mellon’s and so forth. Then we have “new money” and that is the first generation who created wealth usually already from a well established family but they were not at that level until they hit the big well.  The Gates family define as such as the senior Bill was already a well established Attorney and the same for Warren Buffett whose father was well connected and in turn those connections enabled the son to better the father.  The Nouveau Riche are the current Tech heads like Zuckerberg who simply just got fuck all lucky.

Now the reality is that it takes three generations to piss off the cash and they usually do through a series of bad decisions and often you see that in many families, like the Hilton’s who have Paris that can explain that a name can buy you entry but you still need to work for a living its just the kind of work one does that defines the distinction.  Anderson Cooper has the cache of Vanderbilt but he made his own way through the access that the name provides its just that he chose to actually develop an intellect and manner that demonstrates class is in fact earned and learned.  Try that Countess!  (Watch the housewives of NYC for that reference)

But Vanderbilt is just a name of the past for those in the present and when one thinks of it you think of the school, the football team and the reputation as the “Ivy League” school of the Athens of the South.   A dated reference that has no relevance in the New South as few who live and come from the area go to Vanderbilt let alone any of the schools that encircle the area.  Keep em dumb and they stay stum.   Which is why they rarely vote, have few opinions as those requires thoughts and the ability to think critically, a skill set lacking in the South given its attitude and history regarding public education.   Smarts is for the rich and the rich keep it that way.

I go for my next surgery in a few days the one that was fucked up by the incompetence of the last Intern who was so busy worrying about my Vagina (meaning as a woman how can I function and cope on my own – just fine, thank you.) then the jaw and the bone structure where the implant was being placed. And naturally the implant failed.  A bone graft and implant replacement made simultaneously was done and I was sent on my way pushing back all of my work for another three months. Thanks asshole as he is like all of them in the revolving door of medical care, fuck up one and done.

Vanderbilt has a legacy of problems and a history that includes many issues like the one below.  It is probably why they are pushing back against those who do not want to be anesthetized. Trust me if I had an option on my first run around I would have, they did not even bother to give me a Valium to ease my nerves and were so utterly bizarre pre-surgery that my already high blood pressure was rising and in turn putting me further at risk after keeping me under two hours longer than necessary as they were overbooked. Another problem which they have repeatedly.   My former neighbor who was just out of Nursing school two years earlier was the senior Nurse in the NICU, that must be comforting to parents of at risk babies.   That is nothing compared to all the folks I have seen come and go in my three years there.  I finally quit trying to know names there was no purpose.  Vanderbilt is a dump. But then little in Nashville is anything but.

And this may be why…..

After a patient was killed by the wrong drug, Vanderbilt didn’t record fatal error in four ways
Brett Kelman, Nashville
The Tennessean Published  Dec. 15, 2019 |

Vanderbilt University Medical Center’s actions effectively hid the cause of death of Charlene Murphey for 10 months until an anonymous complaint prompted investigations by federal health officials and state law enforcement.

Charlene Murphey, 75, died at Vanderbilt after being injected with the wrong drug.
The hospital didn’t report the error to government regulators or its accrediting agency.
Vanderbilt doctors falsely told the medical examiner the death was “natural.”

After a Nashville-area woman died two years ago from a grievous medication mistake at Vanderbilt University Medical Center, the hospital’s response obscured the error from the government and the public. Vanderbilt violated state law, reported the patient’s death as “natural” and swore her family to silence, according to a Tennessean review of hundreds of pages of county, state and federal records.

The hospital’s actions effectively hid the cause of death of Charlene Murphey, 75, for 10 months until an anonymous complaint in October 2018 prompted investigations by federal health officials and state law enforcement.

Those investigations detailed how Murphey was accidentally given a fatal dose a vecuronium, a paralyzing medication that sent her into cardiac arrest while she waited for a medical scan in Vanderbilt’s radiology department.

The nurse who injected Murphey with the drug, RaDonda Vaught, was criminally charged with reckless homicide and impaired adult abuse in February, and her case has become a rallying cry for medical professionals who fear honest mistakes will be criminalized. Meanwhile, Vanderbilt, the biggest and most renowned hospital in Nashville, largely avoided repercussions. For the first time, this story explores how the actions — and inaction — of Vanderbilt delayed and hampered scrutiny of Murphey’s death.

In the months after Murphey died in December 2017, Vanderbilt officials did not document or report the deadly medication error in four ways.

Two Vanderbilt neurologists provided false information about Murphey’s death, saying she died naturally from a brain injury, according to the Davidson County Medical Examiner.
Vanderbilt did not report the fatal error to The Joint Commission, an independent organization that accredits the hospital, said a commission spokeswoman. Joint Commission policy strongly encourages but does not require hospitals to report fatal medical errors.

Vanderbilt officials “failed to report this incident” to the Tennessee Department of Health even though state law requires the hospital to do so, according to a federal investigation report.
The report also found that Vanderbilt staff did not document the medication mix-up in Murphey’s medical records, then subsequently provided different explanations for the omission.

More: 4 revelations from our story about Vanderbilt and the RaDonda Vaught case

Vanderbilt officials declined to comment for this story. Spokesman John Howser said the hospital would not speak further about Murphey’s death “to avoid impacting either our former employee’s right to a fair trial or the district attorney’s ability to pursue the case as he deems necessary and appropriate.”

In prior statements about Murphey’s death, Vanderbilt officials stressed the medication error was immediately disclosed to her family. The hospital negotiated an out-of-court settlement that bars those family members from discussing her death or revealing the settlement agreement to anyone.

Vanderbilt officials confirmed the settlement during a public hearing earlier this year.

Charlene Murphey’s grandson, Allen Murphey, 35, who is not part of the settlement, said he thinks the hospital tried to hide its mistake and protect its reputation.

“A cover-up — that’s what it screams,” he said. “They didn’t want this to be known, so they didn’t let it be known.”

Court records show syringes and a vial of vecuronium that have become potential evidence in the trial of RaDonda Vaught, a former Vanderbilt nurse accused of killing patient Charlene Murphey with a medication error.

Vanderbilt leaders have acknowledged their response to Murphey’s death was flawed. During a February meeting with the Tennessee Board for Licensing Health Care Facilities, Vanderbilt Health System CEO C. Wright Pinson confirmed Murphey’s death wasn’t reported to state regulators and said the hospital’s response was “too limited.”

At the same meeting, Mitch Edgeworth, who was then CEO of the hospital, said an internal review of Murphey’s death led to “opportunities to improve the knowledge of our clinicians regarding reporting” to the medical examiner.

The health care facilities board, which oversees hospitals throughout the state, took no disciplinary action against Vanderbilt.

RADONDA VAUGHT: Vanderbilt largely to blame for deadly medication error, attorney says
‘She held us all together’

Charlene Murphey, who lived most of her life in the Gallatin area, was married for nearly six decades to her teenage sweetheart, Sam, and they had two sons, Gary and Michael.

She was the quintessential Southern matriarch who was always quick with a warm smile, a quip or a plate of food, said grandson Allen Murphey.

“She really was the glue of the family. She held us all together,” he said.

Charlene Murphey fell ill on Christmas Eve 2017. She was diagnosed with a subdural hematoma at Sumner Regional Medical Center, then transferred by ambulance to Vanderbilt, where her condition began to improve.

By Christmas Day, she appeared to be on the verge of leaving the hospital, her grandson said. Family members were so confident she was recovering they decided to delay celebrating the holiday until she was back home in a day or two.

“Everyone was saying at that point the best Christmas present ever would be to not have Christmas at the hospital,” Allen Murphey said. “But it didn’t work out that way.”

On Dec. 26, in preparation for her release, Charlene Murphey was scheduled for a PET scan in the hospital’s radiology department. This scan, similar to an MRI, requires a patient to lie still in a tubular machine for about 30 minutes. Murphey was claustrophobic, so a doctor prescribed her a sedative, Versed, to keep her calm.

In court records, prosecutors said Vaught, the Vanderbilt nurse, attempted to retrieve the Versed from an electronic medication dispensing cabinet but could not find it. She then disengaged one of the cabinet’s safeguards, unlocking more powerful medications, documents show, and typed “VE” into the cabinet’s search tool.

She picked the first drug that was offered, documents show. It was not Versed. It was vecuronium.

In court records, prosecutors say Vaught ignored multiple warning signs that she had the wrong drug. While drawing the vecuronium into a syringe, Vaught must have looked directly at a medication bottle cap that said “WARNING: PARALYZING AGENT.”

Prosecutors say Vaught then injected Murphey with the syringe and left her for the PET scan as the vecuronium paralyzed her body. By the time the error was discovered, she had suffered cardiac arrest and partial brain death.

About nine hours later, Muprhey’s family, who were once so confident she was coming home, gathered at the hospital to say goodbye.

“But it wasn’t really a goodbye,” Allen Murphey said with tears in his eyes. “I was talking to her, but she wasn’t there. She was long gone.”

Charlene Murphey officially died at 1:07 a.m. on Dec. 27, 2017, when she was disconnected from a breathing machine.

RADONDA VAUGHT: Health officials reverse decision not to punish ex-Vanderbilt nurse for fatal error

Vanderbilt didn’t report error to state, feds or medical examiner

Vanderbilt staff told Murphey’s family what happened but never documented the vecuronium injection in her medical records, according to a federal investigation report of the death.

One unnamed Vanderbilt official told federal investigators Vaught didn’t document the injection because “everyone was focused on resuscitation” and there was “no opportunity” to update the records, the federal report states. Although Vaught is not named in the federal report, the document states the nurse who gave the vecuronium injection said she did not document it in medical records because she was told by a nursing manager it was unnecessary and would be recorded automatically.

The deadly injection wasn’t reported to the Davidson County Medical Examiner’s Office, which is responsible for investigating non-natural deaths in Nashville. Medical examiner records state Vanderbilt neurologist Dr. Adam Hartman reported the death as having “no foul play suspected” while another neurologist, Dr. Eli Zimmerman, attested Murphey died from “natural causes of complications of the intra-cerebral hemorrhage.”

If a vecuronium injection had been mentioned, it would have immediately triggered an investigation, said Dr. Feng Li, the medical examiner.

“Especially with that kind of medication given, we would have investigated the case,” Li said. “We would have taken jurisdiction.”

Li said he changed Murphey’s manner of death — from natural to accidental — in August 2019 to correct the official record.

Vanderbilt did not report the fatal error to The Joint Commission, said commission spokeswoman Maureen Lyons. The commission did not learn about Murphey’s death until after media reports began the following year. It then evaluated the incident and took “appropriate actions,” which are confidential, Lyons said.

The hospital didn’t report the fatal medication error to the Tennessee Department of Health, which would have then alerted the state Board for Licensing Health Care Facilities and the federal Centers of Medicare and Medicaid Services (CMS). State law requires Vanderbilt to report all incidents of abuse or neglect with within seven days.

Instead, regulators learned about the death from an anonymous complaint in October 2018. CMS responded with a surprise inspection at Vanderbilt, then threatened to suspend Medicare payments if the hospital did not take steps to prevent a similar death. Within days, Vanderbilt created a written “plan of correction” for CMS.

The Tennessean obtained a copy of Vanderbilt’s correction plan in November through a Freedom of Information Act request.

The corrective plan says Vanderbilt changed its medication dispensing cabinets so vecuronium can no longer be accessed by overriding a safeguard.

The hospital also made the process of obtaining other paralyzing medications more deliberate. These medications can only be accessed by searching a cabinet specifically for “PARA” and require two nurses for an “independent double check.” Cabinets display new messages warning these drugs cause “respiratory arrest.”

Vanderbilt also revised policies on documenting medical errors and reporting errors to the medical examiner and the Tennessee Department of Health. Hospital policy now specifically requires a medication error to be documented in medical records and reported to the medical examiner if it contributes to a death. Vanderbilt’s Office of Risk and Insurance Management is now responsible for reporting errors to the health department.

The hospital added instructions to its medication policies, telling medical staff how to monitor patients after giving them drugs. Previously, Vanderbilt’s policies included no such instructions, according to the federal investigation report.

Numerous officials would not comment or answer questions for this story. The Tennessee Department of Health said it would not comment because of pending litigation. CMS declined an interview request and to answer emailed questions. Tennessee Board for Licensing Health Care Facilities officials did not respond to requests for comment. Vaught and her attorney did not agree to an interview. The two Vanderbilt neurologists who misreported Murphey’s death did not respond to multiple email requests for comment. Edgeworth, who left Vanderbilt last year for an executive job at TriStar Health, declined to comment through a spokesperson.

Prison or Hospital

 The is the last season of Getting On, an HBO series that is funny, distressing and utterly fascinating about the hospice side of care.  If you have not seen it you must as it brings humor to the little dignity that is faced when one is now in the stages of final care.

 Below are three articles that discuss gerontology, the practice of caring for the elderly. From force feeding to over treatment and expensive drugs that do nothing to aid the individual nor enrich their quality of life that remains on the receiving end but do so for those on the giving side, it becomes a Pas de deux – a duet only less as tranquil and beautiful.

And it is not limited to age but it seems targeted largely regarding gender and of course financial opportunity. The abuse by the medical industrial complex is like the criminal justice one – they take prisoners and release them in less than productive states when they arrived. The parallels cannot be overlooked as they treat those with less that human parameters, id numbers, odd “uniforms”, poor nutrition, abusive and neglectful care givers and of course demeaning and demanding little from family and support networks. 

Prison or hospital? It is my new drinking game.

Force-Feeding: Cruel at Guantánamo, but O.K. for Our Parents

By HAIDER JAVED WARRAICH
The New York Times 
NOV. 24, 2015

THE practice of forced feeding has been highlighted by its use on hunger strikers in Guantánamo Bay and, more recently, in Israel, where a vigorous debate about the ethics of such a practice is taking place. But you don’t have to be in prison to have a feeding tube jammed up your nose. Millions of elderly Americans are fed through tubes despite a lack of substantial evidence pointing to any clinical benefit.

Tube feeding was developed to provide nutrition for patients — increasingly patients with dementia — who are unable to eat on their own. Most of them, especially as they approach the terminal end of the disease, develop difficulties in swallowing and frequently aspirate food or other stomach contents into their lungs, developing pneumonia.

Study after study, however, has shown that tube feeding doesn’t provide any benefit compared with feeding these patients by hand, which is more labor-intensive but much better for the patients. It doesn’t improve survival, reduce infections, reduce the incidence of aspiration pneumonia or improve patients’ nutritional status over those who are hand fed or even over patients not fed at all.

If anything, feeding tubes can be harmful. One study showed that patients with feeding tubes had a higher incidence of pressure ulcers in their backs from being immobilized and lying in bed. Feeding tubes also have frequent complications of their own like being dislodged or being clogged. (Feeding tubes are a necessary evil in some cases, such as after surgery or after a serious accident.)

Tube feeding typically starts with the placement of a silicone tube, about 20 inches in length, that goes up the nostril into the back of the throat, ending in either the stomach or the small intestine. Tubes are usually placed without any anesthesia or sedation, and a viscous nutritional formula is then pumped down the tube.

The closest I ever came to experiencing what it might feel like was last winter when I came down with the sniffles and went to the clinic for a nasopharyngeal swab to rule out the flu. The swab inserted in my nose was perhaps a tenth the size of the smallest feeding tube, and I felt as if it were tearing all the way into my brain stem. My eyes watered uncontrollably, my hands gripped the chair and every muscle in my body was taut. No wonder an inmate in Guantánamo described forced feeding by saying he “never experienced such pain before.”

Much of the pressure to place feeding tubes comes from the patients’ families, but physicians are equally to blame. Doctors are known to be an overly optimistic bunch, and a survey revealed that almost two-thirds of them erroneously believed feeding tubes would improve survival in their patients. In fact, given that tube feeding has now been shown to be harmful in patients with dementia, it should not even be offered to this population.

Every weekday, get thought-provoking commentary from Op-Ed columnists, The Times editorial board and contributing writers from around the world.

The overuse of feeding tubes is also an example of how financial incentives drive some deplorable practices in medicine. Research by Susan Mitchell, a professor of geriatrics at Harvard Medical School, has shown that patients in for-profit nursing homes are much more likely to have feeding tubes. Nursing homes charge higher rates for patients with feeding tubes, and they require much less involvement of nursing staff compared with careful hand feeding, a practice recommended for patients with dementia. “If you get paid less, but require more staffing, it’s hard to make the case for hand feeding,” Dr. Mitchell said.

Like any other problem in medicine, cutting this epidemic to size will require cooperation from all the interested parties. Financial incentives that may be driving overuse need to be discarded. Patients who are expected to live at least a few days should be fed by hand, but families must accept that in some cases, the inability to eat is itself often a sign that the disease has progressed to its final stage. For those patients who can’t be hand fed and who don’t want to be fed, inserting a tube only compounds their agony.

Not long ago, I walked to the bedside of a glassy-eyed patient looking at the ceiling. Suffering from dementia, he had a tube in his chest, draining excess fluid that had collected in his lungs because of pneumonia, and now the family had requested a feeding tube, hoping to prevent food from going down the wrong pipe.

My intern lathered the tube with lubricant, and started to swivel it up his nose. The man, who had endured much without uttering even a whimper, started to shake, and went on to say the first pair of words he had spoken in months: “Kill me.” What started as a faint, shivering whisper, was repeated until he was screaming “killmekillmekillmekillme!” as loudly as his lungs would allow.

Meanwhile while Pfizer claims their merger is good for America? It is? Then why is Congress concerned? Not that that means anything or they would actually do something as proposed by the op ed page of the Times

Personal Health
A Prescription for Sticker Shock Caused by Drug Costs
By Jane E. Brody
The New York Times
November 23, 201

There are millions of people out there, like me, who are frustrated with the maddening obstacles to obtaining prescribed medications with your insurance.

My doctor calls the system byzantine, a rip-off in which the government, including Medicare, is not permitted to negotiate costs with drug companies, instead allowing them to charge whatever they think the market will bear.

“Escalating drug prices have alarmed physicians and the American public and led to calls for government price controls,” Peter J. Neumann and Joshua T. Cohen of Tufts University Medical Center wrote last week in The New England Journal of Medicine.

Most manufacturers maintain that drug prices should be be based on research, development and production costs, but Dr. Neumann and Dr. Cohen suggested that these costs should reflect the value the drugs provide, including such factors as health benefits and cost-effectiveness.

The rising cost of prescription drugs is especially worrisome given the recent escalation in their use in the United States.

Elizabeth D. Kantor, an epidemiologist at Memorial Sloan Kettering Cancer Center, and colleagues recently reported in JAMA that from 1999 to 2012, the number of American adults using prescription drugs rose to 59 percent from 51 percent, and those who took five or more medications increased to 15 percent from 8.2 percent. The increases, which occurred in 11 classes of drugs, persisted even when the rising age of the population was considered.

The researchers arrived at their numbers by analyzing seven cycles of the National Health and Nutrition Survey, each involving personal interviews with thousands of adults. Americans today are using more drugs than ever to lower cholesterol, blood pressure and blood sugar, treat depression and pain, control acid reflux and breathing problems, and relax muscles.

Among other concerns, the findings “raise the question of how much the rise in obesity is affecting increased drug use,” Dr. Kantor said in an interview. “As obesity continues to rise and people develop the consequences, it remains to be seen how effective drugs are in treating them.”

Using medications to treat what is primarily a consequence of unhealthy living habits means rising drug costs that neither the government nor the public can control.

Unfortunately, it is likely to take an act of Congress to change the current system, so we’re all stuck with it for some time to come, perhaps indefinitely. Within the system, however, it pays to know how to get what you need at the lowest cost and with the fewest hassles.

Every drug insurer has its own annually issued “formulary” — a booklet listing the drugs it will cover during the year and the required co-pay. Some policies also have large deductibles that force consumers to shell out hundreds of dollars starting in January for needed medications.

It is not unusual for consumers to need a new drug that doesn’t happen to be in their insurance company’s formulary, though the insurer must cover it until the end of the year, when policy holders may be able to switch to a different insurer. (People who obtain medical and drug insurance through an employer-funded health plan are most likely stuck with those plans.) Furthermore, companies change their formularies each year, adding drugs or, more likely, deleting ones previously covered.

I get my drug insurance through Medicare Part D. But since signing up in 2006, when the program began, I have had many hassles with the company that was suggested to me by the Medicare adviser I consulted on the phone. Among other issues (like the company denying coverage because it erroneously insisted I had other drug insurance), the most expensive of the four medications I use — the only one not available generically — is not included in that company’s formulary.

The company suggested two alternatives that my doctor and I knew were medically inadvisable. So he had to file an appeal every year to have the drug covered (albeit at a high co-pay), and when that was denied, he had to file a second appeal. What an aggravation and a waste of medical office time.

During the current enrollment period, from Oct. 15 to Dec. 7, I decided to switch to another insurer. Since everyone with a computer is supposed to be able to do this, I gave it a try.

I am most happy to report that, despite the problems many consumers initially had signing up for insurance under the Affordable Care Act, the government did a great job with the website for Medicare Part D. Expecting the task to take hours, I enrolled with a new company in about 15 minutes. Here is the link: https://www.medicare.gov/find-a-plan/questions/home.aspx.

You start by entering your ZIP code and answering two questions about your Medicare coverage. (Be sure to have your subscriber number handy.) Type in the name of each prescription drug you take, up to 25, as well as the dosage, quantity and frequency, and whether you get it from a pharmacy or by mail order.

If you choose a pharmacy, you are given a list of those near your home (the distances vary depending on your ZIP code). You are then asked to select the desired type of Medicare and drug plan. For example, I selected “drug plan with original Medicare.”

You can then refine your search according to such options as “limit to the monthly premium” (up to $290), “limit to annual deductible” (up to $360) and the company’s rating (I chose one with four stars out of five, the highest among the companies that fit my criteria).

The next screen estimated my annual drug and health care costs. Nineteen Part D plans were found in my ZIP code, listed from least to most expensive. For each company, the website showed my estimated annual drug costs if purchased retail or by mail order (cheaper by mail); the monthly premium, which in my case is deducted from my Social Security benefit; the annual deductible, if any; the drug co-pay amount; whether all my drugs are in the company’s formulary; and the company’s star rating.

By the way, if you can get your prescriptions written for a 90-day supply, the cost is less than for a 30-day supply refilled twice.

And then we have this news that the tests we take we are not the ones who are failing. And this might also explain the sudden rise in Ovarian cancer.

F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs

By ROBERT PEAR
The New York Times
NOV. 23, 2015

WASHINGTON — Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.

Life-threatening diseases go undetected in some cases. In others, patients are treated for conditions they do not have.

“Patients have been demonstrably harmed or may have been harmed by tests that did not meet F.D.A. requirements,” federal investigators concluded in a report to Congress last week.

The findings come at a time when the use of laboratory-developed tests is booming, the Obama administration is seeking new regulatory powers and even Republicans in Congress are working on legislation to set stricter standards. The new standards, whether set by Congress or by the administration, would be the most significant change in the regulation of laboratories since 1988, lawyers say.

Elizabeth Holmes, the founder and chief executive of Theranos, has become a Silicon Valley celebrity. But recently questions have been raised about how well the company’s testing technology works.

In 20 case studies — half involving tests used to diagnose and treat cancer, others focused on heart disease, autism and Lyme disease — the F.D.A. laid out a compendium of serious problems.

One blood test to help detect ovarian cancer was never shown to be effective, the report said, but was used anyway. False-positive tests may have led to “unnecessary surgery to remove healthy ovaries.”

Pregnant women have considered or had abortions because other tests inaccurately indicated abnormalities in the fetus.

Several tests now on the market detect a genetic variant that was once thought to increase the risk of heart disease, a link that has not been confirmed. Yet more than 150,000 people have been given these tests, the report said, and “many were likely over- or undertreated with statins,” cholesterol-lowering drugs, at a cost estimated at more than $2.4 billion.

“The problems are more prevalent than people want to recognize,” said Dr. Jeffrey E. Shuren, the director of the Center for Devices and Radiological Health at the F.D.A. “Doctors and patients rely on these tests to make well-informed health care decisions. If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result.”

Dr. Shuren said officials did not know how many people might have been harmed, because information on “adverse events” associated with laboratory-developed tests is not systematically collected or reported — a gap that many in Congress and the administration want to close.

Inaccurate test results pose a significant threat to President Obama’s plan to develop treatments tailored to the genetic characteristics of individuals. Many of the new “personalized medicines” are used with a diagnostic test that identifies patients who are most likely to benefit, or to suffer serious side effects. If the tests are unreliable, the treatments could be ineffective.

The maker of one of the tests cited by the F.D.A., Genomic Health of Redwood City, Calif., rejected the criticism. Victoria Steiner, a spokeswoman for the company, said that “a wealth of evidence has supported use of our test to help guide chemotherapy treatment decisions in more than 500,000 breast cancer patients to date.”

Diagnostic tests are now regulated differently depending on where they were developed and manufactured. Products that will be sold to multiple labs — “commercial test kits” — are typically subject to review by the F.D.A. before they go on the market. Manufacturers are supposed to inform the government if they learn that their products may have contributed to a death or a serious injury, and they may have to notify the government if they recall defective products.

But for tests manufactured and used within a single laboratory, the agency has not actively enforced regulatory requirements, even though doctors around the country may submit samples to that lab for testing.

The Obama administration is moving to assert its enforcement authority over such laboratory-developed tests, saying they have become more complex, more widely used and more similar to commercial tests that the government has regulated for nearly 40 years.

Democrats and consumer groups have generally supported the efforts to regulate or legislate.

“Patients and their physicians should be able to trust the results of their tests, regardless of how or where a test is developed or performed,” said Representative Frank Pallone Jr. of New Jersey, the senior Democrat on the House Energy and Commerce Committee. “It does not make sense to regulate tests differently based on who develops them.”

Republicans are divided between those who are willing to consider a larger federal role and others who are skeptical.

“This is a tough area for conservative Republicans who think that government is too big and costs too much,” said Representative John Shimkus, Republican of Illinois. He indicated that he was willing to consider legislation because “the volume and complexity of these tests have grown exponentially,” and federal standards may be needed to ensure that the tests do what they are supposed to do.

But Representative Michael C. Burgess, Republican of Texas and a physician, expressed concern that the proposals “could stifle medical innovation and open the door to federal regulation of the practice of medicine.”

Jeffrey N. Gibbs, a Washington lawyer who represents medical device companies and laboratories, said he had seen a shift in the past six months: People once adamantly opposed to the regulation of laboratory-developed tests are now open to the idea.

“It is more likely that the F.D.A. will have a role in regulating laboratory-developed tests as a result of either congressional action or a guidance document issued by the agency,” Mr. Gibbs said.

The American Clinical Laboratory Association, a trade group, contends that “the F.D.A. lacks the statutory authority to regulate laboratory-developed tests.”

But Jayson S. Slotnik, a consultant to drug and device companies, said: “There will be more regulation, and it need not stunt innovation. The right regulation would separate good from bad tests and encourage use of the better ones.”

The Death Watch

Much is made of those that die in jails by their own hands or by those due to neglect by jail/prison guards. But we expect medical facilities to be different.

There is the estimate that over 100K die due to medical malpractice. That is the number that means they die either at the hospital or documented by lawsuits filed by survivors. It does not include those in transport to varying facilities, died at home or in other facilities or simply died and family had no idea nor could prove that the death was due to medical negligence or abuse.

Scientific American attempted to find the real numbers of such and this was their estimate:

In 2010, the Office of Inspector General for Health and Human Services said that bad hospital care contributed to the deaths of 180,000 patients in Medicare alone in a given year.

Now comes a study in the current issue of the Journal of Patient Safety that says the numbers may be much higher 2014 between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death, the study says.

That would make medical errors the third-leading cause of death in America, behind heart disease, which is the first, and cancer, which is second.

Then add any secondary care facilities from senior homes to mental health and I suspect those numbers would grow. We already have many mentally ill being sent to jails and prisons and many are simply released after the required three day holding periods to to streets where their ability to care for themselves is non existent, so little numbers are available to accurately account for those deaths.

But if there is anything we have learned is that like jails hospitals in America are no less safer.

My son died in a mental health facility. If we keep protecting dangerous hospitals, he won’t be the last.
Questionable patient deaths keep getting swept under the rug.

The Washington Post
By Mia St. John
August 5 2015

Mia St. John is a five-time world and international boxing champion. She is founder of the El Saber es Poder/Knowledge is Power foundation.

On Nov. 23, I received the call no parent wants to get – my only son was dead. My beautiful, 24-year-old boy was gone. It is a nightmare I have yet to wake up from; one I will never wake up from.

I could barely hear the words from the other end of the line; my cries were drowning them out. I was driving when I received the call, and had to pull over to call my son’s father. Then I had to drive home to deliver the news to my daughter, Paris. How I made it home without getting in a wreck is a mystery to me.

Two-and-a-half months prior, my ex-husband, Kristoff St. John, and I had placed our son, Julian, at Telecare’s La Casa Mental Health Rehabilitation Center in Long Beach, Calif. on a 72-hour involuntary psychiatric hold. Julian had been diagnosed with paranoid schizophrenia when he was 17 and had become suicidal while off his medication and on a powerful substance – meth. The staff upgraded him to a 14-day hold, and then lengthened it again for an indefinite period, to give him adequate time to get off of meth.

Like many parents of children with mental health issues, our goal was to find help for our son who suffers from a horrific illness for which there is no cure. We knew that, with proper medication and therapy, Julian had a chance of living a comfortable life. So we sought help from Los Angeles County’s Department of Mental Health, which referred us to Telecare’s facility. The county says it pays Telecare $17 million per year to contract 190 beds at La Casa. We had hoped that the facility would help him withdraw from meth and get back on his meds, and that within the year, Julian would come home – alive.

But we made a fatal mistake placing our son in the care of La Casa, one of many mental health facilities in this country that contracts with state and local governments. Like many before him, Julian didn’t make it out alive.

La Casa staff told us that our son, because of his suicidal behavior, would be checked every 15 minutes. Yet, a little more than six weeks after he arrived, Julian escaped from the facility by climbing the fence. When I asked management and several of the employees of La Casa how my son, who was supposed to be checked on regularly, could escape, they responded, seemingly unconcerned, “it happens.”

Julian was missing for several hours before police, whom La Casa had notified, found him at a bus stop. But in the days after he returned to the facility, Julian managed to smoke in the bathroom and even consume alcohol, all on the watch of La Casa’s staff.

Then, five days after he escaped, Julian attempted suicide using a plastic bag. His roommate discovered him and alerted the staff. I was terrified to leave Julian at La Casa, but staffers vehemently assured me that plastic bags would be banned from the section of the facility where he lived, and Julian would never be left alone. But after about two weeks, he was taken off 24-hour watch and put back on 15-minute precautionary watch. Three days later, my son was found face down in the bathroom with a plastic bag over his head – the same plastic bags that were supposedly removed.

[Editor’s note: Contacted by The Post about these allegations, legal representatives of La Casa denied negligence and wrongdoing in Julian St. John’s death.]

Unfortunately, Julian’s story isn’t unique. La Casa employees, who went on strike in 2013 because of the dangerous conditions, said patients regularly escape from the facility. More than two patients per month fled La Casa in 2012, according to the Press-Telegram. In 2013, 20-year-old Christian Torres broke through a locked gate at La Casa and police found him hours later in a nearby industrial area. Torres died soon after in police custody.

La Casa employees blame these problems on low staffing, inadequate training, and a culture that values profit over safety, according to the Press-Telegram. There are similar complaints at the nearby College Hospital, where there have been multiple sexual assaults and suspicious patient deaths in recent years, according to the employee union. That hospital had to pay $1.6 million in a legal settlement with the city of Los Angeles for dumping 150 mentally ill patients on the city’s notorious Skid Row over two years.

This problem exists beyond California. About 1,800 people commit suicide while hospitalized in the United States each year. In 2012, poor medical care led to the deaths of at least four patients at Milwaukee County’s Mental Health Complex, which inspectors had cited nine times in eight years for putting patients in immediate danger, according to the Journal Sentinel. Three patient deaths in 18 months involved staff failures at Arbour Health System, which operates mental health clinics in Massachusetts, according to the Boston Globe. And in Florida, a 2011 investigation found that three patients in the privately run South Florida State Hospital died in cases that may have involved overmedication and neglect. In one of those cases, the patient was found dead in a scalding bath after staff failed to perform a required 15-minute check on him, according to the Sun Sentinel.

La Casa employees recorded that they had checked on Julian every 15 minutes, as mandated. But surveillance cameras show otherwise. The video revealed that, once Julian entered his room that afternoon and shut the door behind him, no one else entered except his roommate. A staffer found him 45 minutes later. The sickening insult is that La Casa’s records show the staff was performing the mandatory checks on Julian dutifully until 3:15 p.m. My son was already dead and taken out of the facility by approximately 1:30 p.m.

La Casa also says that staffers attempted to save Julian’s life, but according to 911 tapes and the Long Beach Police Department, no one from the facility called for emergency assistance until 17 minutes after he was found. And his toxicology reports showed no sign of the vital anti-psychotic medication my son was supposed to be taking.

Had Julian been medicated and monitored by La Casa, as we and the county paid the facility to do, my son would surely be alive today.

We never would have sent Julian to La Casa had we known about the facility’s track record of safety problems and patient escapes. But Los Angeles County doesn’t publicly report patient deaths and other failures at the health care facilities where it sends sick residents. The public didn’t know about the problems at La Casa until employees went on strike and revealed them.

The same lack of transparency exists at mental health agencies nationwide. In a 2009 report, the National Alliance on Mental Illness criticized the limited data available on mental health services, saying it lags far behind data collection in other health care disciplines: “Across the country, there is an extremely limited capacity to provide even the most rudimentary information on mental health services.”

Neglect and falsifying records is unfathomable and deplorable, but unfortunately, it is not uncommon in our nation’s mental health facilities. As long as the scope of this misconduct and its fatal outcomes are hidden from the public, there will be little incentive to fix them. Local and state governments that pay millions to each of these facilities to shelter, protect, and treat their patients, our loved ones, must provide better oversight. Patients and their families should be made aware of each facility’s safety record, and the worst offenders – facilities that wrack up numerous complaints and lawsuits – should be shut down.

Julian was a gifted artist, writer, and musician. His art had been displayed in several galleries, including self-portraits of a beautiful, but tormented, soul. We have transformed his art studio, Stone Art, into a center for those who, like him, express themselves through art, because words aren’t sufficient. His art lives on to inspire children and young adults that suffer from addiction and mental illness. We accept anyone and everyone, from the homeless, the mentally ill to the “addict that still suffers.” I knew this is what Julian would have wanted.

Julian was insightful and compassionate, and always in awe of the world’s beauty. He desperately wanted to live. Unfortunately, my son’s dreams will never materialize. His paintbrushes will never touch another canvas. We’ll never have long talks about life, love and the universe again. I’ll never hug or kiss my little boy again. La Casa did not just take the life of my son, it took my life as well. It’s been eight months since my son’s death and the future ahead feels so long that time has come to a stop. Trying to move forward feels so daunting.

Our son wasn’t the first victim of inadequate mental health care, but it is our mission to make sure he is the last. In May, Kristoff and I, working with our attorney, Mark Geragos, filed a wrongful death law suit against La Casa and its parent company, Telecare. Our mission is to shine a bright light on the nation’s broken mental health care institutions. This will be one case mental health hospitals won’t be able to settle out of court, hidden from public view. I asked my sister, “Why my son?” She responded, “Because this is one case they will not be able to sweep under the rug, and his death will save the lives of many.”

Fighting the Fight

I beg you and urge you to read the below email I received from Pro Publica with regards to patient harm. I have written endlessly about my experience and their site has been a tremendous help to me. Now with new changes and additions perhaps more will be done to improve the abuse of patients by the hands of medical professionals.

A while back, you shared your patient harm story with ProPublica. Today, we wanted to thank you again for taking the time to do that, and to share our first major investigative piece from this project. We’re also working to prepare the overall results of our patient safety survey, so please read on for more details about what’s next and how you can help.

Today, ProPublica is publishing Surgeon Scorecard, which allows you to search for the adjusted complication rates for 16,827 surgeons. You can search the database by location, hospital or surgeon to learn how these surgeons perform routine elective procedures, such as knee replacements and gall bladder removals, relative to their peers.

This is information that’s never been available before and can’t be found anywhere else. Patients can immediately use Surgeon Scorecard to help decide where they go for medical care. The medical community can use it to see where they need to improve — so they can put a dent in the problem of patient harm.

ProPublica’s story by Marshall Allen and Olga Pierce — Making the Cut: Why Choosing the Right Surgeon Matters Even More Than You Know — examines the stark differences in complications rates for some of the most routine elective procedures. Here’s a brief look at what we found:

It’s conventional wisdom that there are “good” and “bad” hospitals – and that selecting a good one assures patients they’re safe from the kinds of medical errors that injure or kill hundreds of thousands of Americans each year.

But a ProPublica analysis of Medicare data found that, when it comes to elective operations, it is much more important to pick the right surgeon.

Today, we are making public the complication rates of nearly 17,000 surgeons nationwide. Patients will be able to weigh surgeons’ past performance as they make what can be a life-and-death decision. Doctors themselves can see where they stand relative to their peers.

The numbers show that the stark differences that Stiles confronted at Citrus Memorial are commonplace across America. Yet many hospitals don’t track the complication rates of individual surgeons or use that data to force improvements. And neither does the government.

A small share of doctors, 7 percent, accounted for 21 percent of the complications. Hundreds of surgeons across the country had rates double and triple the national average. Every day, surgeons with the highest complication rates in our analysis are performing operations in hospitals nationwide.

Subpar performers work even at academic medical centers considered among the nation’s best.

Your feedback

We hope you will find our reporting and data resources useful, and are very interested in your feedback. We put together this FAQ to answer basic questions about our data analysis, and Marshall and Olga will be taking your questions about this report today at 1 pm EST on Twitter. Tweet us your questions with #SurgeonScorecard or email them to getinvolved@propublica.org.

What’s next?

Your stories! Since we first launched our patient safety survey, nearly 900 of you have told us about your experiences with medical harm. Here’s a bit more about what’s next — and how you can help. You can submit your stories via email direct to getinvolved@propublica.org

Our plan is to encourage news organizations around the country to report on this issue by publishing excerpts of your stories on our site (these excerpts will be anonymized, and you will have the opportunity to review before publication). In addition, there are two new questions we’re hoping you can answer to help us better tell your stories.

This is Randall Chensut the Doctor who signed my medical release against medical advice, a Doctor whom never actually saw me while in hospital, never actually spoke to any medical staff that I can find on record and who is someone whom I have never met nor spoken to despite filing a medical malpractice lawsuit with his name actually in the suit itself. I lost that case on appeal due to technicalities and none on merit despite the appellate court attempting to find something of merit to cite in their opinion it came down to notification and to expert testimony. That had nothing to do with the Doctors, the Hospital, the treatment or lack thereof by the scummy staff at Harborview Medical Center.

All of my legal briefs, all my medical records I steadfastly filed so that they are all a matter of public record to ensure that anyone with the desire to see the truth and find out the facts could do so.

So go to Pro Publica review the data, tell your story and fight the fight. I can no longer do this on my own. I tried, I lost but I am not a loser when it comes to knowing that I still can do something.

What Does Not Kill You

Does not make you stronger it just makes you alive.

I find myself still to this day trying to understand why a hospital treated me like a dirtbag and it breaks me apart. I realize that this is more common then not but somehow it has never lessened my pain. I hope when I move away that distance will do what time has failed. As I read my records and the stories of others there are common factors. There was no communication between staff, nor anyone actually intelligent enough to take command, ask questions and seek appropriate advice. And you see that in every story about some hospital or clinic mishap from private to public to the Veterans Hospitals, the medical industrial complex cranks out victims on a daily basis and they do so without recourse.

When you look at the stories I have found about Doctors, Nurses and other care givers whose abuse and neglect have killed people and walk away most often unscathed leaving in their wake lives ruined or destroyed I continue to be amazed at how the knee jerk obsessed legislators ignore the problem. Yet when a victim of crime comes forward the press conferences are held and laws re-written, amended or created to show how they care about their constiuents. Being tough on crime means being tough on crime by blue aka black collars, white collars not so much. Look at bankers and the millions whose lives were ruined in their pursuit of the mighty dollar.

So we have Cops, Doctors, Bankers as the most destructive forces in America and it is the only time the blue and the white collars meet as they need each other in a course of co-dependancy that is about control. How sad. How grim. How pathetic.

There was another article today about Doctors who are accusing parents of child abuse when it comes to the parents and their childrens medical care. I have nothing to say or comment about this as frankly once again it is intervention that depends on the situation and individual but again why are charges filed, children taken when this could be resolved by mediation and the voice of a third party who is both informed and engaged in the well being of others without the need of law and enforcement to resolve the conflict. But again this is about control.

And we have a Judge who took children away from a parent as they would not have lunch with another parent. This all was sad and grim and pathetic again as what did this resolve? And what damage is the result of this. Well nothing but it reminds everyone that Judges are in control.

And caring about the long term is abandoned when it comes to the short term. It is about control and about ensuring one’s own position and security over another. The abuse and mistreatment of people in society focuses first on color, then gender and then age. We treat children and seniors as bookends, sweet individuals who seem to not be able to make decisions and must be handled as such.

I fear getting older in this country. The level of abuse and mistreatment is legendary and once again another story about another senior couple being murdered and abused by those in the position of his care. Not a new story but just another on the long list. Yet you will see no legislator up in arms or willing to tackle this industry as there is money to be paid and earned by the lobbyists of this profit generating industry and we boomers are not getting any younger. That was does not kill you doesn’t…. right now.

Health & Science
Popular blood thinner causing deaths, injuries in nursing homes

By Charles Ornstein | ProPublica July 12

When Loren Peters arrived in the emergency room in October 2013, bruises covered his frail body and blood oozed from his gums.

The 85-year-old had not been in a fight or fallen down. Instead, he had been given too much of a popular, decades-old blood thinner that, unmonitored, can turn from a lifesaver into a killer.

“My goodness, I’ve never seen anything like it,” recalled Lorna Finch, Peters’s daughter, of the ugly purple bruise that sprawled from the middle of her father’s stomach to his hip. “It was just awful.”

Peters took Coumadin at his Marshalltown, Iowa, nursing home because he had an abnormal heart rhythm, which increases the risk of stroke. It’s a common precaution, but the drug must be carefully calibrated: too much, and you can bleed uncontrollably; too little, and you can develop life-threatening clots.

When nursing homes fail to maintain this delicate balance, it puts patients in danger. From 2011 to 2014, at least 165 nursing home residents were hospitalized or died after errors involving Coumadin or its generic version, warfarin, a ProPublica analysis of government inspection reports shows. Studies suggest there are thousands more injuries every year that are never investigated by the government.
Problems with a popular anticoagulant View Graphic

“It’s an insidious problem,” said Rod Baird, president of Geriatric Practice Management, a firm that creates electronic health records for physicians working in long-term care facilities. Because it’s so easy to get wrong, “Coumadin is the most dangerous drug in America.”

Nursing homes around the country are routinely cited for lapses that imperil residents, from letting those with dementia wander off to not stopping elders from choking on their food. For years, advocates, researchers and government officials have worried about the overuse of anti­psychotic medications that can put elderly patients into a stupor and increase their risk of life-threatening falls. A national initiative helped reduce the use of such drugs among long-term nursing home residents by 20 percent between the end of 2011 and the end of 2014.

But the dangers of the widely used Coumadin have drawn relatively little scrutiny, perhaps because the drug has clear benefits. Still, improper use has caused some patients incalculable suffering and, in some cases, greatly hastened deaths.

Dolores Huss, an 89-year-old grandmother of eight, died from internal bleeding after a San Diego facility gave her an antibiotic that multiplies the effects of Coumadin and then didn’t alert her physician that she needed additional blood tests to measure how long it was taking her blood to clot.

Shirley Reim, recovering from hip surgery, was hospitalized with blood clots in her legs after a Minnesota nursing home failed to give her Coumadin for 50 days in a row and also didn’t perform the blood test ordered by her doctor. She suffered permanent damage. Details of the cases come from government inspection reports and lawsuits filed by the patients’ families, which were settled confidentially.

Periodic inspections document hundreds of additional errors that were caught early enough to prevent serious harm, but the real toll is likely much higher, experts say.

A 2007 peer-reviewed study in the American Journal of Medicine estimated that nursing home residents suffer 34,000 fatal, life-threatening or serious events related to the drug each year. North Carolina data shows more medication errors in nursing homes involving Coumadin than any other drug.
“I asked his doctor: ‘What really is going on here?’ ” Lorna Finch said. “ ‘Do we have any hope of getting Dad back?’ [The doctor] said, ‘You know he’s pretty weak.’ ” (Danny Wilcox Frazier/For The Washington Post)

Despite such evidence, Coumadin deaths and hospitalizations have drawn only limited attention from the Centers for Medicare and Medicaid Services (CMS), the federal agency that regulates nursing homes. Federal officials haven’t tallied Coumadin cases to see the full extent of the damage or identify common problems involving the use of the drug. Neither has the American Health Care Association, the trade group for nursing homes.

The government investigates incidents like the one involving Peters that trigger complaints or surface in routine inspections. Sometimes, the CMS slaps homes with “immediate jeopardy” citations, fining them and threatening to cut off federal funding if quick action isn’t taken. Villa del Sol, where Peters lived, received such a citation related to his care and was fined $33,345.

More commonly, though, homes are not fined and are simply asked to correct the problems and put policies in place to keep them from happening again, ProPublica’s analysis shows.

Last year, the Department of Health and Human Services identified Coumadin and other anticoagulants as one of the drug categories most frequently implicated in “adverse drug events,” calling on government agencies to work on solutions. In a statement, the CMS, which is part of HHS, said it is raising awareness of such events, training its inspectors to do a better job at identifying them and working with nursing homes to prevent them.

In Peters’s case, no one at the nursing home conducted the blood test needed to see the effect Coumadin was having, even as bruises spread across his body over a two-week period, government inspectors later found. Peters never recovered, dying a few days after he was brought to the hospital.

Villa del Sol recently changed its name to Hawkeye Care Center Marshalltown. Doug Johnson, president of the home’s parent company, Hawkeye Care Centers, said by e-mail, “We adhere to privacy rules and practices and do not comment on litigated matters.”
A breakthrough, with risks

Coumadin’s roots go back to the 1940s, when scientists at a nonprofit affiliated with the University of Wisconsin at Madison — the Wisconsin Alumni Research Foundation — came up with a rat-and-mouse killer called warfarin, a play off the nonprofit’s initials.

It was derived from a chemical in spoiled sweet clover that had caused cattle to bleed to death after dehorning, castration and other procedures. The substance disrupted the clotting process, so that animals hemorrhaged internally and died.

In the 1950s, drugmaker Endo Laboratories began selling warfarin for human use under the brand name Coumadin. It is in a category of drugs known as anticoagulants. An early user was President Dwight D. Eisenhower, who was prescribed the medication after having a heart attack.

Coumadin was a breakthrough for patients with an array of heart troubles associated with blood clots. These include abnormal heart rhythms, along with pulmonary embolisms and deep-vein thrombosis.

But the drug interacts badly with certain foods and medications, particularly antibiotics, and it requires regular blood tests to ensure it’s working as intended. The test measures the time it takes for blood plasma to clot.

In Medicare’s prescription drug program, known as Part D, 2.4 million seniors and disabled people filled at least one prescription for warfarin, the generic of Coumadin, in 2013, making it one of the most-used drugs. About 280,000 were prescribed brand-name versions, Coumadin and Jantoven. Many people, including health inspectors, continue to call the generic versions Coumadin because it is so well known.

About 1 in 6 of the nation’s 1.3 million nursing home residents take an anticoagulant, according to federal data from earlier this year; the majority are believed to be on Coumadin or its generic.

Newer anticoagulants, including Eliquis, Pradaxa and Xarelto, have entered the market in recent years and, in some ways, are easier to use than Coumadin. Patients taking these drugs don’t need regular blood tests and don’t have to avoid certain foods.

But unlike Coumadin, the effects of which can be reversed with vitamin K, there currently is no antidote if patients taking the newer drugs begin bleeding uncontrollably.

Some doctors also are reluctant to use the new drugs on seniors, particularly those with multiple health problems, because they carry their own risks, including gastrointestinal bleeding.
‘Perfect setup for bad things’

Coumadin is tricky to manage even for otherwise healthy patients who don’t live in nursing homes. A study published last year by the lab company Quest Diagnostics found that patients taking Coumadin or its generic had lab results showing that the drugs had the desired effect only 54 percent of the time.

A 2011 report in the New England Journal of Medicine found that the drug accounted for some 33,000 emergency hospitalizations among the elderly from 2007 to 2009, more than twice as many as the next-highest drug, insulin. The study did not look exclusively at nursing home residents.

Given Coumadin’s challenges — and the coordination required among doctors, nurses, pharmacists and laboratories — nursing homes are the “perfect setup for bad things happening,” said Jerry Gurwitz, chief of geriatric medicine at the University of Massachusetts Medical School. Since the 1990s, when he first wrote about the problems of Coumadin in nursing homes, “very little, unfortunately, has changed,” he said.

Federal inspection reports repeatedly cite the same types of problems: patients not getting the drug as ordered, or given the wrong doses, or given without a doctor’s order.

A Texas nursing home resident received Coumadin for 34 days “without a physician order or adequate monitoring.” Blood was pooling in his mouth when he was sent to the hospital. A patient at a Minnesota home needed three surgeries for a blood clot in the left leg after not receiving 17 doses of the medication.

Failure to monitor the drug can lead to dangerous side effects. At a North Carolina home, a patient on Coumadin wound up in the hospital after no clotting tests were done for a month. An internal review found that a nurse “mistakenly put the February labs on the wrong month.”

Sometimes, the tests were done, but nursing homes didn’t alert doctors when the results were abnormal. At a Maine nursing home, a doctor wasn’t told when lab results showed a resident’s blood took too long to clot. Days later, when staff assisted the resident to the bathroom, the resident passed out and had no heartbeat. It is unclear if the resident survived.

In several cases, patients taking Coumadin fell, and nursing homes were cited for not doing enough afterward to ensure their safety. In Arkansas, a resident on the drug fell and hit his head during exercise class. A nurse said she didn’t call his doctor because the doctor “didn’t like to be called at night unless it was an emergency.” The resident died from the consequences of massive bleeding in the brain.
Vigilance difficult to enforce

Most patients who are taking Coumadin need it, experts agree. But problems with monitoring occur even at facilities trying to be vigilant.

A report published last year in The Consultant Pharmacist journal found that 12 New York nursing homes given tools to improve how they handled patients on Coumadin — including staff education programs — largely failed to improve their management of the drug.

“Improvements were not seen despite active intervention,” the report’s authors wrote. “If long-term care facilities are unable to voluntarily implement necessary improvements, then regulatory changes may be necessary to assure patient safety regarding anticoagulant use.”

David Gifford, senior vice president of quality and regulatory affairs at the American Health Care Association, said Coumadin errors can’t be viewed in isolation. “Those that approach one area at a time, they’re chasing their tail and they’re not going to see improvements,” he said. “This week, the soup du jour is Coumadin errors . . . then next week, it’s insulin errors.”

The association recently announced a quality initiative aimed at, among other things, reducing “unintended health care outcomes” — a broad category that covers various types of errors, including those involving medication.

Some long-term care associations say it would be better for CMS to work with the nursing home industry to change its practices rather than to take each incident in isolation, using citations and other sanctions to bring homes in line. Another concern is not to discourage doctors from prescribing Coumadin.

“It may be distorting a little bit to look at the immediate jeopardy outcomes [cited by regulators] without looking at the overall population that’s on it and needs to be on it,” said Cheryl Phillips, senior vice president of public policy and advocacy at LeadingAge, an association of nonprofit senior service organizations. “In fact, to not put people on blood thinners is a huge risk and in many cases malpractice.”
‘Things didn’t get any better’

Peters, a retired factory worker, moved into Villa del Sol in 2011 with his wife of more than 60 years, Arleta, who had fallen and could no longer walk on her own.

In September 2013, during a week-long hospital stay, Peters was diagnosed with a variety of abnormal heart rhythms and sent back to the nursing home on Coumadin, the government’s inspection report said.

Both the hospital and Peters’s doctor left instructions for the nursing home to give him a particular test to assess his clotting rate. But it was never done. Instead, the staff gave him a different test intended for patients taking heparin, another blood thinner.

One nurse told inspectors that “it never occurred to her to look to see if the blood work was for what the physician ordered.” Another said “it never occurred to her that this resident was on Coumadin” and needed his blood monitored, according to the government report.

In the first two weeks of October, staff members made several notes in Peters’s chart about bruises on his body. Several entries mentioned scattered bruising; one noted a large bruise on the right abdomen that was purple in the center, green and yellow on the outside. The nurses decided among themselves that the bruises must have been from the lift they used to transfer him, the inspection report said.

Peters was taken to the emergency room after midnight on Oct. 15, 2013, because of the bleeding from his gums.

There, a quick test showed that his blood took so long to clot that he might never stop bleeding on his own — a result his doctor told inspectors she’d never seen before.

The doctor later told an inspector that Peters’s bruises were so “horrible” she asked the hospital to take pictures of them. (Photos were taken, said Jeffrey Pitman, an attorney for Peters’s family.)

“They had to have noticed the bruises, and why didn’t they do something about it?” said Finch, Peters’s daughter.

At the hospital, doctors gave Peters vitamin K to try to counteract the Coumadin.

He grew confused, agitated, almost belligerent. He had trouble breathing.

“It just got to a point where things didn’t get any better,” said Finch, 59. “I asked his doctor: ‘What really is going on here? Do we have any hope of getting Dad back?’ [The doctor] said, ‘You know he’s pretty weak.’ ”

As hopes for Peters faded, his wife, too, became ill and was taken to the same hospital. Peters’s family decided to move him to his wife’s room so they could be together in his final hours.

When Peters was wheeled into the room, he was “pretty much unresponsive,” inspectors wrote. “However, when they put [his] spouse’s hands in [his], the resident woke up and was able to talk.”

He died the next morning; Arleta, three weeks later.

“When Dad passed away, she quit,” Finch said. “She just broke down and she screamed, ‘I am so mad at him, he didn’t take me with him.”