31 July 2012

Tainted Platelets Biggest Blood Supply Risk

Story first reported from WSJ.com

Hospitals and blood banks are adopting new measures to improve the safety of donated platelets—the tiny cells that make blood clot and heal injuries but that also present the No. 1 infection risk in the U.S. blood supply.

The biggest risk in the nation's blood supply is no longer HIV or hepatitis C, it's bacterial contamination of platelets, resulting in at least 20 deaths and hundreds of adverse reactions in recent years, health experts say.

A growing number of studies show that standard tests performed by blood banks before they ship platelets to hospitals miss the majority of contaminated platelets. Unlike other blood components such as red cells, which are refrigerated, platelets must be stored at room temperature to remain effective, but during storage periods that last up to five days bacteria can grow and multiply.

About 150 hospitals have adopted a new contamination test, made by Verax Biomedical Inc., that can be administered immediately before patients get a transfusion. Initially approved by the Food and Drug Administration in 2007, one barrier is cost: It adds about $25 to $30 to the average $540 cost of a unit of platelets.

The infection risk from platelets beats that of HIV and hepatitis C, researchers say, since advances in testing and screening have all but eliminated the risk of contracting those viral infections through donated blood. The federal government is stepping up scrutiny: A congressional committee has asked the FDA to determine what further actions should be taken to reduce the risks and spread awareness among hospitals.

More than two million doses of donated platelets are transfused annually in the U.S. to prevent uncontrolled bleeding in trauma, cancer and surgical patients. Most are safe and well-tolerated. New safety standards adopted by blood banks in 2004 have reduced the average rate of fatalities from sepsis, or blood poisoning, to three a year from between seven to 11 annually. Still, hundreds of nonfatal sepsis cases and other adverse reactions are still linked to contaminated platelets. Experts say the rate may be much higher than reported because infections might have been attributed to other causes.

The closer to time of use platelets are tested, the more likely of finding and avoiding infections, says Richard Benjamin, chief medical officer of the American Red Cross.

In a study of over four million platelet units the Red Cross collected and distributed to hospitals from January 2007 to December 2011, it found 381 suspected septic reactions in platelets it distributed, 38 definite or probable cases and four deaths. That is a big improvement over the four deaths per million in a 2003 study, but even with a fatality rate of one in a million, says Dr. Benjamin, is not going to be acceptable to any family member.

Six-year-old Jessica Rose Kohut died in 2009 while undergoing treatment for a rare form of cancer at All Children's Hospital in St. Petersburg, Fla. According to a lawsuit brought by her family—settled by the hospital for an undisclosed sum—the cause wasn't cancer, but septic shock from a contaminated platelet transfusion at its Tampa outpatient clinic.

Maureen Massari, her mother, pleaded for wide use of the same-day test at a meeting of industry and government officials convened by the AABB, formerly called the American Association of Blood Banks, earlier this month in Bethesda, Md.

Platelets can become contaminated if the donor has even a low-grade blood infection, or when the skin isn't properly cleaned, drawing surface bacteria into the platelets during collection. In 2004, the AABB began requiring accredited facilities to detect and limit bacteria, generally by taking cultures of donated platelets to measure bacteria growth within 24 to 48 hours.

But bacteria levels may be too low that early for detection, and studies show as many as 1 in 1,000 units that tested negative were actually contaminated. Hospitals, which may also operate their own blood banks, don't typically culture products again, since getting results can take another day.

AABB President Darrell Triulzi says blood centers have taken other steps to improve safety, such as diverting some initial blood drawn from the donor into a separate pouch to capture any skin bacteria, and swirling blood bags to visually spot signs of contamination. Hospitals have also been cautioned to watch patients for signs of infection such as fever and chills after a transfusion, and administer antibiotics if need be.

While the FDA says the rapid test has "important value for bacterial detection," there are concerns about its sensitivity, a spokeswoman says, and some users have found it difficult to interpret, which could add "significant complexity to operations in transfusion services." Verax says its clinical studies show the test, which detects antibodies present on bacteria cells, is highly sensitive, adding its customer studies found the test was easy to use and interpret.

But the extra cost can be a barrier for some when the risk of infection is relatively low. John Hess, a pathology professor and medical director of the blood bank at University of Maryland Medical Center, says he spends about $16 million a year on platelets, and calculates it would add $500,000 a year to use the test. Given the risk, he says he doesn't believe the test is cost effective compared with other expenditures that could help save lives.

But Mindy Greene, administrative director of transfusion medicine at UMass Memorial Medical Center, which has a large cancer clinic, says after learning of deaths from tainted platelets, it was more important to find the money to serve patients better. In tests of nearly 5,000 platelet units between August 2010 and January 2012, four that tested negative by standard cultures were shown to be positive using the Verax test and were confirmed positive by a second culture.

Ms. Massari says that after Jessica Rose's treatment for cancer "she was not only surviving but thriving," almost cancer-free and receiving low-dose chemotherapy and routine maintenance treatments. But during a checkup, because her platelets were low, a transfusion was ordered.

That sent her into septic shock and while antibiotics killed the bacteria, she suffered organ failure and after nine days suffered a massive stroke. Ten days after the transfusion Jessica died in her mother's arms.

A spokesman for All Children's says it believes the blood products it is supplied with exceed industry safety standards, but welcomed the opportunity to work with the blood-bank industry to improve standards and procedures.

Severe trauma patients, cancer patients on chemotherapy, burn patients and those undergoing open-heart surgery and bone-marrow transplants need platelets.

To acquire platelets, blood is drawn from a donor and is sent to a separator, which spins the blood, forcing platelet cells to the bottom.

Platelets are stored in a plastic bag while the other blood components such as plasma and red cells are returned to the donor.

About 10% of platelet donations are collected by separating the cells from four to six whole blood donations and pooling them into a single dose.

Platelets are stored at room temperature for up to five days because refrigeration renders them ineffective, but bacteria can grow over that period.

A test for contamination has been approved by the FDA, but it adds $25-$30 to the average $570 cost of a unit of platelets.

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30 July 2012

DMC Hospitals Rank High

Story first reported from DMC.com

DMC hospitals rank in 20 specialties in U.S. News & World Report rankings.


The Detroit Medical Center (DMC) is again taking high honors for nationally and regionally ranked hospitals in the U.S. News Media &World Report’s 2012-13 Best Hospitals rankings. The 23rd annual edition showcases more than 720 of the nation’s roughly 5,000 hospitals.

The U.S. News hospital ratings, widely regarded as a standard of excellence in patient care, listed national and regional rankings in multiple specialties for four DMC hospitals, DMC Detroit Receiving Hospital, DMC Harper University Hospital, DMC Huron Valley-Sinai Hospital and DMC Sinai-Grace Hospital.

“We are proud to be recognized again by U.S. News Media and World Report. Their rankings are a testament to the hard work and dedication of our physicians and clinical staff and exemplify the depth of quality and specialty care delivered every day at Detroit Medical Center,” states Mike Duggan, CEO, Detroit Medical Center.

DMC Harper University Hospital, stood out again this year with two national rankings, #34 in Neurology & Neurosurgery and #43 in Pulmonology.

In addition to Harper’s national rankings, the hospital ranked #3 overall in the Detroit Metro area and #3 in Southeastern Michigan. Harper is also high-performing in nine additional specialties: Cardiology & Heart Surgery; Diabetes & Endocrinology; Ear, Nose & Throat; Gastroenterology; Geriatrics; Gynecology; Nephrology; Ophthalmology and Urology.

DMC Sinai-Grace Hospital ranked #9 overall in the Detroit Metro area and #11 in Southeastern Michigan. Sinai-Grace is listed with nine high-performing specialties: Cardiology & Heart Surgery; Diabetes & Endocrinology; Gastroenterology; Geriatrics; Nephrology; Neurology & Neurosurgery; Orthopedics; Pulmonology and Urology.

Ranked #11 overall in the Detroit Metro area and #15 in Southeastern Michigan is DMC Detroit Receiving Hospital. U.S News lists Detroit Receiving as high-performing in Diabetes & Endocrinology; Gastroenterology; Geriatrics; Nephrology; Neurology & Neurosurgery; Orthopedics; Pulmonology and Urology.

DMC Huron Valley-Sinai Hospital ranked #12 overall in the Detroit Metro area and #16 in Southeastern Michigan. Gastroenterology; Geriatrics; Gynecology; Nephrology, Orthopedics, Pulmonology and Urology are Huron Valley-Sinai’s high-performing specialties.

The four DMC hospitals combined to rank in 12 specialties. Last month, DMC Children’s Hospital of Michigan garnered national U.S. News rankings in eight pediatric specialties, bringing DMC’s total to an impressive 20 specialties.

The hospital rankings, said U.S. News Health Rankings Editor Avery Comarow, are like a GPS-type aid to help steer patients to hospitals with strong skills in the procedures and medical conditions that present the biggest challenges. “All of these hospitals are the kinds of medical centers that should be on your list when you need the best care,” said Comarow. “They are where other hospitals send the toughest cases.”

The rankings are published by U.S. News in collaboration with RTI International, a research organization based in Research Triangle Park, N.C. Highlights of the 2012-13 rankings will appear in the U.S. News Best Hospitals 2013 guidebook, to go on sale in August. The complete rankings and methodology are available at http://health.usnews.com/best-hospitals

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18 July 2012

New York Hospitals: Also Uninsured



Story first reported from nytimes.com

Every hospital makes mistakes. But some New York City hospitals may not have enough money to pay for them.

Several of the city’s most troubled hospitals are partially or completely uninsured for malpractice, state records show, forgoing what is considered a standard safeguard across the country.\

Some have saved money to cover their liabilities, but others have used up their malpractice reserves, meaning that any future awards or settlements could come at the expense of patients’ care, and one hospital has closed its obstetric practice, in part out of fear of lawsuits.

Executives of these hospitals, most of which are in poor neighborhoods, say their dire financial circumstances and high premiums make it impractical to pay millions of dollars a year for insurance.

But insurance experts say that though dropping coverage may make economic sense in the short term, it is hardly in the best interest of patients, and in the long term it may be costly to hospitals and their bondholders, including some bonds backed by the state, should large judgments force them into bankruptcy.

Hospitals in New York do not need malpractice insurance to function, and they need not tell patients when going “naked” or “bare,” in industry parlance.

Many states do not require malpractice insurance, and New York is not the only city where hospitals go without coverage. Generally the uninsured hospitals are in areas where juries award big judgments, insurance executives say.

There is no central record of which hospitals have insurance. But in 2009, the state Health Department took a survey of so-called self-insured hospitals. It found that three — Interfaith Medical Center, Kingsbrook Jewish Medical Center and Wyckoff Heights Medical Center, all in Brooklyn — were completely self-insured.

Twelve other hospitals across the city were partially self-insured, including St. Vincent’s Hospital in Manhattan, which went bankrupt and closed in 2010; Lenox Hill in Manhattan; Jamaica Hospital Medical Center in Queens; and New York Hospital Queens.

Some of the 12 had bought insurance to cover lower-dollar or “primary” claims, but not “excess” judgments. The others had excess coverage but not primary.

The Health Department has not done a follow-up survey, but hospitals that responded to questions about their coverage said it had not changed.

In interviews, some hospital executives said their physicians had separate insurance which is subsidized or reimbursed by the hospital. Interfaith, for one, gives its emergency-room physicians a letter promising to assume liability, said Luis A. Hernandez, the hospital’s chief executive.

Without insurance, many hospitals set aside money to pay for claims, but a review by The New York Times of state records and hospital financial records indicates that several of the hospitals have insufficient reserves to cover their malpractice liabilities.


 Two of the hospitals without insurance have no money set aside, according to their financial documents and interviews with hospital officials. In the case of the third, Kingsbrook, it is unclear from financial statements if it has any money in reserve.

Dr. Linda Brady, the hospital’s chief executive, was overseas and was unavailable for comment, said Enid Dillard, a hospital spokeswoman. But Ms. Dillard, when asked if the hospital was paying malpractice claims out of its day-to-day budget, said that it was a fair conclusion. 
In 2009, Wyckoff Heights Medical Center, in Bushwick, had $50,000 in its malpractice fund; in 2010, the amount put aside to cover claims had dwindled to “0,” according to its financial statements. Yet the hospital listed professional liabilities of $37 million. Ramon Rodriguez, the chief executive, declined to comment.

A jury awarded a $31.6 million judgment against the hospital in 2006, which was later reduced to $12.9 million and is being paid out in installments through 2018. As a result of that case, Mr. Hernandez said, the hospital closed its obstetric unit because it could not afford the liability. The hospital was also not delivering enough babies to justify the expense, he said.

Henry W. Fust of Fust Charles Chambers, a Syracuse firm that provides accounting services to hospitals across New York State, said that for hospitals to “go totally naked” was very unusual and “would draw into question the viability of the entity.” It would also be difficult for any patient to recover money from hospitals like Wyckoff and Interfaith, which are already deeply in debt.
An absence of insurance is generally a sign of double trouble, signifying that rates have gone up because of high claims. Many commercial insurance companies pulled out of New York years ago because litigation was frequent and excessive said Edward J. Amsler, vice president of Medical Liability Mutual Insurance Company, which is owned by its policyholders. Financially stable hospitals have responded by banding together in groups like Mr. Amsler’s, setting premiums and reserves and sometimes sharing risks. (Lenox Hill has primary liability coverage through this company, setting aside reserves for larger claims.)

Some hospital executives say, however, it is better to be effectively uninsured, because lawyers follow the money.

Having malpractice insurance is like asking for a lawsuit to be filed, said a former hospital administrator who did not want to be named to avoid upsetting potential employers. Malpractice lawyers said that underinsured hospitals put them in a tricky position.

Lawyers say they were often forced to take payment on installment, or to try to pin more blame on physicians, who may have their own insurance. Martin Seinfeld, a malpractice lawyer, said he had had three cases this year involving Jamaica Hospital and New York Hospital Queens in which hospital lawyers had held out the specter of bankruptcy if he did not reduce his demands.

When a hospital is bankrupt, its creditors, including malpractice plaintiffs, are often forced to accept less than they are owed through litigation. 

Camela Morrissey, a spokeswoman for New York Hospital Queens, declined to comment on Mr. Seinfeld’s assertion or on the hospital’s financial condition. Jamaica also declined to comment.
Mr. Hernandez, of Interfaith, said the hospital was not trying to duck responsibility. 

Correction: 

An earlier version of this article said incorrectly that Kingsbrook Jewish Medical Center’s chief executive, Dr. Linda Brady, declined to comment. She was in fact overseas and unavailable for comment, according to a hospital spokeswoman.        

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Common Myths About Obamacare


Story first reported on nytimes.com

ON the subject of the Affordable Care Act — Obamacare, to reclaim the name critics have made into a slur — a number of fallacies seem to be congealing into accepted wisdom. Much of this is the result of unrelenting Republican propaganda and right-wing punditry, but it has gone largely unchallenged by gun-shy Democrats. The result is that voters are confronted with slogans and side issues — “It’s a tax!” “No, it’s a penalty!” — rather than a reality-based discussion. Let’s unpack a few of the most persistent myths.

OBAMACARE IS A JOB-KILLER.
The House Republican majority was at it again last week, staging the 33rd theatrical vote to roll back the Affordable Care Act. And once again the cliché of the day was “job-killer.” After years of trying out various alarmist falsehoods the Republicans have found one that seems, judging from the polls, to have connected with the fears of voters.

Some of the job-killer scare stories are based on a deliberate misreading of a Congressional Budget Office report that estimated the law would “reduce the amount of labor used in the economy” by about 800,000 jobs. Sounds like a job-killer, right? Not if you read what the C.B.O. actually wrote. While some low-wage jobs might be lost, the C.B.O. number mainly refers to workers who — being no longer so dependent on employers for their health-care safety net — may choose to retire earlier or work part time. Those jobs would then be open for others who need them.

The impartial truth squad FactCheck.org has debunked the job-killer claim so many times that in its latest update you can hear a groan of weary frustration: words like “whopper” and “bogus” and “hooey.” The job-killer claim is also discredited by the experience under the Massachusetts law on which Obamacare was modeled.

Ultimately the Affordable Care Act could be a tonic for the economy. It aims to slow the raging growth of health care costs by, among other things, using the government’s Medicare leverage to move doctors away from exorbitant fee-for-service medicine, with its incentive to pile on unnecessary procedures. Two veteran health economists, David Cutler of Harvard and Karen Davis, president of the Commonwealth Fund, have calculated that over the first decade of Obamacare total spending on health care, in part by employers, will be half a trillion dollars lower than under the status quo.

OBAMACARE IS A FEDERAL TAKEOVER OF HEALTH INSURANCE.
Let’s be blunt. The word for that is “lie.” The main thing the law does is deliver millions of new customers to the private insurance industry. Private niches already exist in the healthcare industry, providing quality care, such as Physical Medicine and Rehabilitation companies. Indeed, a significant portion of the unhappiness with Obamacare comes from liberals who believe it is not nearly federal enough: that the menu of insurance choices should have included a robust public option, or that Medicare should have been expanded into a form of universal coverage.

Under the law, to be sure, insurance will be governed by new regulations, and supported by new subsidies. This is not the law Ayn Rand would have written. But the share of health care spending that comes from the federal government is expected to rise only modestly, to nearly 50 percent in 2021, and much of that is due not to Obamacare but to baby boomers joining Medicare.
This is a “federal takeover” only in the crazy world where Barack Obama is a “socialist.”

THE UNFETTERED MARKETPLACE IS A BETTER SOLUTION. 
To the extent there is a profound difference of principle anywhere in this debate, it lies here. Conservatives contend that if you give consumers a voucher or a tax credit and set them loose in the marketplace they will do a better job than government at finding the services — schools, retirement portfolios, or in this case health insurance policies — that fit their needs.
I’m a pretty devout capitalist, and I see that in some cases individual responsibility helps contain wasteful spending on health care. If you have to share the cost of that extra M.R.I. or elective surgery, you’ll think hard about whether you really need it. The same will apply to the cost of prescription drugs. But I’m deeply suspicious of the claim that a health care system dominated by powerful vested interests and mystifying in its complexity can be tamed by consumers who are strapped for time, often poor, sometimes uneducated, confused and afraid.

LEAVE IT TO THE STATES. THEY’LL FIX IT. 
The Republican alternative to Obamacare consists in large part of letting each state do its own thing. Presumably the best ideas will go viral.

States do have a long history of pioneering new ideas, sometimes enlightened (Oregon’s vote-by-mail comes to mind) and sometimes less benign (see Florida’s loopy gun laws). Obamacare actually underwrites pilot programs to reduce costs, and gives states freedom — some would argue too much freedom — in designing insurance-buying exchanges. But the best ideas don’t spread spontaneously. Some states are too poor to adopt worthwhile reforms. Some are intransigent, or held captive by lobbies.


 You’ve heard a lot about the Massachusetts law. You may not have heard about the seven other states that passed laws requiring insurers to offer coverage to all. They were dismal failures because they failed to mandate that everyone, including the young and healthy, buy in. Massachusetts — fairly progressive, relatively affluent, with an abundance of health providers — included a mandate and became the successful exception. To expand that program beyond Massachusetts required ... Barack Obama.

OBAMACARE IS A LOSER. RUN AGAINST IT, RUN FROM IT, BUT FOR HEAVEN’S SAKE DON’T RUN ON IT. 
When Mitt Romney signed that Massachusetts law in 2006, the coverage kicked in almost immediately. Robert Blendon, a Harvard expert on health and public opinion, recalls the profusion of heartwarming stories about people who had depended on emergency rooms and charity but now, at last, had a regular relationship with a doctor. Romneycare was instantly popular in the state, and remains so, though it seems to have been disowned by its creator.

Unfortunately, the benefits of Obamacare do not go wide until 2014, so there are not yet testimonials from enthusiastic, family-next-door beneficiaries. This helps explain why the bill has not won more popular affection. (It also explains why the Republicans are so desperate to kill it now, before Americans feel the abundant rewards.)

Blendon believes that because of the delayed benefits and the general economic anxiety, Demorats will have a difficult time with the issue this election year.

He may be right, but shame on the Democrats if they don’t try. There’s no reason except cowardice for failing to mount a full-throated defense of the law. It is not perfect, but it is humane, it is (thanks to the Supreme Court) fiscally viable, and it comes with some reasonable hopes of reforming the cockeyed way we pay health care providers.

Even before the law takes full effect, it has a natural constituency, starting with every cancer victim, every H.I.V. sufferer, everyone with a condition that now would keep them from getting affordable coverage. Any family that has passed through the purgatory of cancer — as mine did this year, with decent insurance — can imagine the hell of doing it without insurance.
Against this, Mitt Romney offers some vague free-market principles and one unambiguous promise: to dash the hopes of 30 million uninsured, and add a few million to their ranks by slashing Medicaid.


This article has been revised to reflect the following correction:
Correction: July 18, 2012

An earlier version of this column referred incorrectly to one consequence of the 2010 health care law. While it is estimated to provide coverage to 30 million Americans who are currently uninsured, the estimate includes both an expansion of Medicaid and additional enrollment in private insurance plans, not only the latter.


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