Programming errors led to overdoses with pain-medicine pumps

Building off a state health department report showing that, as The Morning Call’s Tim Darragh wrote, “Nurses at St. Luke’s Hospital three times in 2010 and 2011 improperly programmed patient-controlled pumps to deliver pain medication, causing patients to overdose themselves,” Darragh dug deep into each incident, uncovering patient details and adding perspective to the errors, which were severe enough that the feds decided the hospital’s patients were in “immediate jeopardy” until steps were taken.

In each of those cases and in three others, the nursing staff failed to document the errors properly, state investigators found.

Employees told the investigators that St. Luke’s did not require annual competency training on the pumps. Unnamed employees offered conflicting statements about when and whether all the staff had received retraining in 2010.

For their part, hospital officials say they have bought new patient-controlled pumps, developed a restricted dosage plan and retrained staff.

“When St. Luke’s nursing staff members identified the dosing pump programming issues, the events were promptly reported to all the appropriate individuals and regulatory agencies as outlined in our Network Patient Safety Plan,” said Carol Kuplen, chief nursing officer for St. Luke’s Hospital & Health Network.

“There was complete transparency in these events,” she said in an interview Thursday.

Related

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, appeared at a newsmaker briefing at Health Journalism 2010 to announce an FDA initiative to reduce risks associated with infusion pumps. Log in to the AHCJ website to see his presentation and listen to his announcement.

• Press release: FDA Launches Initiative to Reduce Infusion Pump Risks
• FDA page on infusion pumps and FDA’s new safety initiative
• White Paper: Infusion Pump Improvement Initiative
• Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
• Letter to Infusion Pump Manufacturers
• Public Meeting: Infusion Pump Workshop, May 25-26, 2010
• Generic Infusion Pump Project

Florida hospitals sidestep state constitution, keep records under wraps

Writing for BrowardBulldog.org, an independent investigative news site serving South Florida, Amber Statler-Matthews reports that hospitals are going to what one man called “extraordinary lengths” to prevent patients from accessing records that, according to the Florida constitution’s “Patient’s Right to Know Act,” should be made available.

Seven years ago, Florida voters overwhelmingly approved a Constitutional amendment that gave patients who had been hospitalized the right to see reports dealing with botched medical procedures and poor care. While the amendment could be used to give patients vital information before a medical mistake is made, its practical and more much publicized purpose was to give aggrieved patients more power in court by opening up malpractice complaints and confidential internal reviews of doctors and hospitals.

In the years since the amendment, the state’s courts have been pressed on both sides, with hospitals dedicating considerable resources to throwing up “roadblocks and legal challenges to block access to patient records,” Statler-Matthews writes. “In response, patients across Florida are using the law to ask judges to pry open reports about medical errors.”

For more on how the battle has evolved and details on how Florida hospitals are circumventing the constitution, see Statler-Matthews’ full piece.

Agency’s restrictions on data about disciplined doctors continue to get attention

The Kansas City Star and The Sacramento Bee ran editorials over the weekend to denounce the recent decision by the U.S. Health Resources and Services Administration to place restrictions on the public use file of the National Practitioner Data Bank.

The Star says the restrictions “display an appalling disrespect for journalists and researchers and for the public’s right to gain information about the doctors to whom they entrust their health and safety.”

It calls the move a “clumsy attempt to restrict access to public information [that] promotes nothing but confusion and darkness.”

Meanwhile, The Bee says the Obama administration has “positioned itself on the side of protecting the privacy of doctors who maim patients.” It also suggests that President Obama reread the First Amendment.

On Sunday, the Society of Professional Journalists hosted AHCJ President Charles Ornstein, SPJ President John Ensslin and Kansas City Star reporter Alan Bavley for a discussion of the data bank and the importance of its information being open to the public without restrictions.

As regular Covering Health readers know, the public use file has been used regularly by reporters who have covered lax oversight of troubled doctors. When Bavley was working on such a story, however, a doctor he was investigating contacted HRSA and complained the data was being used improperly. That doctor’s complaints led to HRSA threatening Bavley with a fine, which it later backed down from, and pulling the data off of the website.

After protests from journalism organizations, consumer groups, academic researchers and U.S. Sen. Charles Grassley, the agency republished the data file last Wednesday but placed restrictions on how it was to be used. In a letter to U.S. Health and Human Services Secretary Kathleen Sebelius, the journalism groups called the new restrictions “ill-advised, unenforceable and probably unconstitutional. Restricting how reporters use public data is an attempt at prior restraint.”

Grassley also has expressed his disappointment in the restrictions: “HRSA is overreaching and interpreting the law in a way that restricts the use of the information much more than the law specifies.”

For more background, this timeline tracks the story:

Agency re-posts National Practitioner Data Bank file, but restrictions draw fire

The U.S. Health Resources and Services Administration today republished the public version of the National Practitioner Data Bank, after intense pressure from journalism groups, researchers and members of Congress.

But the action comes with a major catch: Those who want to access the data will have to agree to certain restrictions that were not in place before.

The National Practitioner Data Bank is a confidential system that compiles malpractice payouts, hospital discipline and regulatory sanctions against doctors and other health professionals. For years, HRSA has posted aggregate information from the data bank in a Public Use File that did not identify individual providers.

HRSA officials removed the public file from the data bank website on Sept. 1 because a spokesman said the agency believed it was used to identify physicians inappropriately. The Association of Health Care Journalists has protested the action, along with Investigative Reporters and Editors, the Society of Professional Journalists, the National Association of Science Writers, the Reporters Committee for Freedom of the Press and the National Freedom of Information Coalition.

Other groups likewise protested, including Public Citizen, Consumers Union and prominent health researchers. U.S. Sen. Charles Grassley has twice written to federal officials condemning the action.

AHCJ president Charles Ornstein commended the Obama administration for working with reporters on this issue but said he is concerned about the restrictions HRSA is imposing for those seeking access to the data.

“How can the government say data is public but then say it’s only public with strings attached?” Ornstein said. “I am troubled that HRSA is overstepping its legal authority with these new rules and may be imposing unconstitutional prior restraints on reporters.”

To gain access to the Public Use File, reporters must agree to three conditions: they will not use it alone or in combination with other data sets to identify any individuals or entities; they will not repost the raw data; and they will return it to HRSA upon request. Violating the rules could result in having to return the data and being barred from receiving it in the future, HRSA says.

“Having access to information on physician discipline, malpractice payouts and hospital sanctions is important for those who care about patient safety and oversight of physicians across the country,” Ornstein said. “But the restrictions put in place by HRSA are unworkable.”

Ornstein encouraged HRSA to abide by its longstanding practice of refusing to confirm or deny the identity of individual physicians in the Public Use File. In doing so, reporters and their news outlets bear the legal liability for ensuring their information is correct, and newsrooms must ensure they have exercised due diligence in their reporting.

Reporters have used the Public Use File for two primary tasks. The first is for statistical information (the number of doctors in their state with malpractice payouts who have not been disciplined) and that would be allowed under the new rules.

The second is to fill in information about particular physicians whom they have identified through other records and means. That would be barred under the new rules.

“In the past, the Public Use File has been a vital tool for journalists writing about insufficient oversight of physicians in their states,” Ornstein said. “Without such articles, some unsafe doctors would very likely continue to be practicing with clean licenses and patient protection legislation in several states likely would not have been enacted. I worry such reporting may be chilled by those new rules.”

HRSA removed the public version of the data bank only after the urging of a Kansas neurosurgeon with a long history of malpractice payouts, according to records released Nov. 3 by Grassley. The doctor, Robert Tenny, sent six letters to HRSA before and after The Kansas City Star wrote a story that said he had been sued at least 16 times for malpractice and had paid out roughly $3.7 million since the early 1990s.

An earlier version of the Public Use File, accessed in August before it was removed, is available on IRE’s website. It does not include some updated information that is available in the file that HRSA republished today. At the same time, reporters are not bound by the new restrictions imposed by HRSA.

Update: Comment from Grassley

Grassley released this statement this afternoon:

“HRSA is overreaching and interpreting the law in a way that restricts the use of the information much more than the law specifies. Nowhere in the law does it say a reporter can’t use the data in the public use file to combine that with other sources and potentially identify doctors who have been disciplined in their practice of medicine.This agency needs to remember that half of all health care dollars in the United States comes from taxpayers, so the interpretation of the law ought to be for public benefit. It’s also hard to see how HRSA has the resources to require the return of supposedly misused data or how that would even work. It seems the agency’s time would be better used in making sure the database is up to date and as useful as possible. I continue to expect a briefing from HRSA on this situation, including participation from the person who pulled the public data file after a single physician complained that a reporter identified him through shoe leather reporting, not the public data file. One complaint shouldn’t dictate public access to federally collected data for 300 million people.”

Ohio’s hospital transparency law under fire

Thanks are due to blogger and one-time hospital executive Paul Levy for drawing our attention to the Ohio hospital industry’s recent push to overturn much of the state’s recently passed transparency legislation.

The law required hospitals to post performance data, such as infection rates and patient satisfaction, on the Ohio Hospital Compare site.

According to Brandon Glenn’s report in the MedCity News, the hospital industry opposes the site, online since Jan. 1, 2010, because it serves the same purpose as the federal Hospital Compare site.

The OHA supports the new legislation… because it wants to remove “duplicative” reporting requirements on the state’s hospitals. Ohio hospitals already report the same data to a federal Hospital Compare website maintained for the public by the Centers for Medicare & Medicaid Services, said OHA spokeswoman Tiffany Himmelreich.

The new legislation “doesn’t reduce reporting. It just eliminates reporting the same information to two different places,” she said. “We don’t want the public to feel that this is taking a step backwards in terms of data availability.”

For their part, consumer advocates say website maintenance is not an onerous burden, and that the hospital association’s push is part of a larger, statewide antitransparency trend.

As an interesting side note, Glenn found the Ohio Hospital Compare site to be rendered inoperable by apparent bugs on an initial visit but discovered that, after his inquiries to the state health department, the site was put into working order.

Public hospitals, not nonprofits, shoulder burden of charity care

Writing in the Contra Costa Times, Sandy Kleffman reports that while nonprofit hospitals in the East Bay are given millions in tax breaks, “The responsibility of caring for the indigent falls largely on the region’s public hospitals.”

Kleffman’s findings are based on her analysis of publicly available California Office of Statewide Health Planning and Development reports, documents which she learned to access and process at a September webinar led by AHCJ board president and ProPublica senior reporter Charles Ornstein.

Her analysis revealed a substantial imbalance in the numbers, especially between public hospitals and nonprofits. For example, Contra Costa’s county hospital provided more than three quarters of the total amount of charity care given in the country in 2010, while the six nonprofits together accounted for just under 23 percent.

For their part, representatives of nonprofit hospitals protested that the numbers do not take into account the other community benefits they provide, nor are they adjusted to compensate for the differences in demographics across each institution’s patient pool.

For more on what went into Kleffman’s report, see her sidebar on “How we made comparisons.”

Medicare providers get reinstated when feds fail to attend hearings

Using data obtained through a public records request, Associated Press reporter Kelli Kennedy (@kkennedyap) reviewed federal Medicare fraud reports from between 2006 and 2009 and found that “Regulators fighting an estimated $60 billion to $90 billion a year in Medicare fraud frequently suspend Medicare providers, then quickly reinstate them after appeals hearings that government employees don’t even attend.”

Officials revoked the licenses of 3,702 medical equipment companies in the fraud hot spots of South Florida, Los Angeles, Baton Rouge, La., Houston, Brooklyn, N.Y., and Detroit between 2006 and 2009, according to data provided to the AP under a public records request. Those areas represent the highest concentrations of Medicare fraud in the country, according to federal authorities who have set up task forces there.

Of the providers who lost their licenses in those cities, about 37 percent, or 1,371, were eventually back in business, sometimes within days and often within months.

Furthermore, she writes, officials have not taken advantage of security bonds put in place two years ago to provide redress should a fraudulent provider vanish from the map. “Officials blame the delay on personnel changes,” she writes.

The gaps in the system grow out of poor communication between one set of contractors paid to inspect Medicare providers and alert officials to suspicious activity; a separate set of contractors that handles payments; and the agency that runs Medicare.

Kennedy’s report dives deep into the Medicare fraud reinstatement program, and reporters looking to better understand the system would be well served to read the full investigation.

Quake damage could cripple Calif. hospitals

In her series on earthquake preparedness at California hospitals, California HealthCare Foundation Center for Health Reporting senior reporter Deborah Schoch look at what she calls the “Achilles heel” of hospitals in earthquake territory: internal damage to pipes and equipment.

While much of the legislative focus has been on preventing structural damage, Schoch writes that recent seismic disasters in places such as Chile and Japan have demonstrated that a broken water pipe or sprinkler system can shut down a hospital every bit as effectively as a crumbled wall.

To better avoid internal damage, Schoch writes, hospitals need to bolt down equipment, anchor water tanks and set up back-up generators. According to Schoch, “Many facilities locally and statewide are still years or decades away from making those non-structural internal fixes, even though they are required under California law.” This is largely thanks to a variety of deadline extensions and loopholes requested by cash-strapped hospitals which refer to the law as the largest unfunded mandate in state history.

As of 2009, fully 1,357 hospital buildings statewide had not made fixes that should have been finished at the start of 2002, according to a December 2009 report from state regulators.

Another 1,233 buildings, or 95 percent of buildings statewide, had not yet done improvements that were due Jan. 1, 2013, according to the report. State officials caution that some hospitals may have completed upgrades, but they do not have up-to-date statistics.

In the second installment of the series, Schoch uses state records to show that more than 40 hospitals close to the fault are rated at high risk of collapse in a major earthquake.

California hospitals were supposed to have fixed hospitals by 2008 or the state would shut them down. But that deadline has been pushed back multiple times: “Championing the delays, the state Legislature repeatedly extended the 2008 deadline to 2013, 2015, even 2020, under pressure from hospitals that said they can’t afford the fixes.”

Former Practitioner Data Banks official says HRSA ‘erroneously interpreting the law’

A former federal official criticized a decision by the U.S. Health Resources and Services Administration for removing the Public Use File of the National Practitioner Data Bank from the agency’s website – a major development as journalism groups fight to restore access to the important tool.

Robert Oshel, who created the Public Use File in the mid-1990s and managed it until his retirement in 2008, said in a statement released to the Association of Health Care Journalists on Sunday that HRSA is “erroneously interpreting the law” governing the data bank.

The National Practitioner Data Bank is a confidential system that compiles malpractice payouts, hospital discipline and regulatory sanctions against doctors and other health professionals. For years, HRSA has made a public version of it available without identifying information about the health providers.

HRSA officials removed the public file from the data bank website last month because a spokesman said they believe it was used to identify physicians inappropriately.

But in his letter to AHCJ, Oshel said HRSA officials have confused the requirements of the law.

“HRSA’s current management seems to confuse the law’s requirement that a public data file not permit use of its records to identify individual practitioners with a very different requirement, and one not in the law: that the file not allow the records of previously identified practitioners to be identified in the file,” Oshel wrote.

Oshel further wrote that HRSA’s view will “seriously hinder use of the file for important public policy research.”

“For example, it will be impossible to identify state licensing boards which are not taking action to protect the public from physicians with records of repeated malpractice payments and serious sanctions against their hospital clinical privileges based on the quality of their care or their behavior,” he wrote.

As he notes in his letter, Oshel served as associate director for research and disputes for HRSA’s Division of Practitioner Data Banks, which operates the National Practitioner Data Bank, from 1997 *(updated) until his retirement in 2008. Among other duties, he personally designed the Data Bank’s Public Use File in about 1995 and oversaw its development and quarterly updating.

AHCJ President Charles Ornstein said Oshel’s letter reaffirmed what AHCJ and five other journalism groups are fighting for. He said the Public Use File has been a vital tool for journalists writing about insufficient oversight of physicians in their states. Without such articles, some unsafe doctors would very likely continue to be practicing with clean licenses and patient protection legislation in several states likely would not have been enacted.

“It is abundantly clear that HRSA made a mistake in taking the Public Use File offline, putting physicians’ interests ahead of patient safety,” Ornstein said. “With Robert Oshel’s detailed statement, we call on HRSA and HHS Secretary Kathleen Sebelius to make the right decision and restore access to the public version immediately.”

In his letter, Oshel also criticized the process that HRSA introduced as an interim way for reporters and researchers to request data from the data bank. To get information, individuals must disclose the focus of their work and HRSA officials must approve – or reject the request. If the request is granted, HRSA officials will be the arbiters of what data fields an individual needs to complete the research.

“I believe HRSA’s current policy is contrary to the law,” he wrote.

* There was a typo in the date in an earlier version of this post.

Earlier coverage

• AHCJ, other journalism organizations protest removal of data from public website
• Journalism organizations offer data government blocked from public
• More journalism groups join effort to restore access to National Practitioner Data Bank
• Agency declines to restore public data
• Journalists turn to Sebelius for access to National Practitioner Data Bank file

Investigation finds chart falsification endemic in Calif. nursing homes

In a two-part series (one | two) in The Sacramento Bee, Marjie Lundstrom reveals the results into the widespread falsification of patient records in California nursing homes.

While regulators have dogged facilities for years over fraudulent Medicare documentation, the issue of bogus records is more than a money matter. In California and elsewhere, nursing homes have been caught altering entries and outright lying on residents’ medical charts – sometimes with disastrous human consequences, according to a Bee investigation.

Medications and treatments are documented as being given when they are not. Inaccurate entries have masked serious conditions in some patients, who ultimately died after not receiving proper care, The Bee found.

Lundstrom writes that while chart falsification is a misdemeanor, nursing home workers are rarely prosecuted, because it’s difficult to prove and time consuming to track down. Instead, she found, sources say its become a pervasive part of the culture in such workplaces. Based on a review of 150 incidents that occurred over the course of two decades, Lundstrom spells out the most common reasons for such mistakes – reasons that will be immediately familiar to anyone with experience in a checklist-driven workplace.

• Covering up bad outcomes. A patient dies or is injured, and the nursing home staff or administrators rewrite the records to minimize blame or liability.
• Fill-in-the-blank charting. Overworked or lazy staff members take massive shortcuts, filling out charts en masse, not knowing whether treatments took place or if the information is accurate.
• Missing medicines. Medications are checked off as being given, but investigators later find unopened boxes or discrepancies with pharmacy records.

She explores each of these bullet points and ideas in subsequent headings and, in the process, lays out a blueprint for other reporters interested in looking for similar issues in their neck of the woods. The first story includes a number of heavy-hitting anecdotes, but Lundstrom doesn’t fully dig into one of the most affecting cases until the second installment of the series.

In two key paragraphs, Lundstrom lays out all you need to know about the significance of the story, one that began with the falsification of medical records. The whole story is well worth a read, and you’ll emerge with a deeper understanding of what makes records falsifications such a unique and tricky subset of nursing home infractions.

Johnnie Esco’s death on March 7, 2008, led to a contentious civil lawsuit, investigations by California’s Department of Justice and Department of Public Health – and the exhumation of her body from Arlington National Cemetery.

Last week, amid inquiries from The Bee, the state Department of Justice reopened its criminal investigation into Johnnie Esco’s treatment at the facility.

In a response published in The Bee, an industry representative took issue with significance of Lundstrom’s findings, accusing her of sounding the alarm “on behalf of trial lawyers” and not putting the problem in perspective.

…in a single day in California there are 30 million entries made on medical charts. The Bee examined 20 years of charting history from 1990 to 2010 – or 219 trillion entries – and found that during that period, regulators issued 209 citations for willful material falsification.

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