Patient Safety

Erick & Linda von Schweber started SurveyorHealth around the time Health 2.0 started back in 2007, with the BHAG of massively improving medication safety using some very complex technology. And it has taken them a long time to embed themselves in the bowels of some huge health care organizations and to start getting traction. But it is finally happening and the impact may be substantial. I interviewed Erick and he gave me a comprehensive demo and update on their latest results. If you care about drugs and clinical care, this is compelling (if not lightweight!) viewing. (I suggest you switch to full screen for the demo).

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Michael MillensonThis year marks the 15th anniversary of the Institute of Medicine (IOM)’s To Err is Human report, which famously declared that from 44,000 to 98,000 Americans died each year from preventable mistakes in hospitals and another one million were injured. That blunt conclusion from a prestigious medical organization shocked the public and marked the arrival of patient safety as a durable and important public policy issue.

Alas, when it comes to providing the exact date of this medical mistakes milestone, the IOM itself is confused and, in a painful piece of irony, sometimes just plain wrong. That’s unfortunate, because the date of the report’s release is an important part of the story of its continued influence.

There’s no question among those of us who’d long been involved in patient safety that the report’s immediate and powerful impact took health policy insiders by surprise.

The data the IOM relied upon, after all, came from studies that appeared years before and then vanished into the background noise of the Hundred Year War over universal health insurance. This time, however, old evidence was carefully rebottled in bright, compelling new soundbites. Continue reading “Recalling To Err’s Impact and a Small (But Telling) IOM Mistake”

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flying cadeuciiThe Dallas/Fort Worth Healthcare Daily ran a fascinating excerpt from the Steve Jacob’s book So Long, Marcus Welby, M.D.* The excerpt contained some very interesting assertions and statistics. For example:

  • Consultant PwC, relying on that Congressional Budget Office (CBO) report, estimated that malpractice insurance and defensive medicine accounted for 10 percent of total health-care costs. A 2010 Health Affairs article more conservatively pegged those costs at 2.4 percent of healthcare spending.
  • In a 2010 survey, U.S. orthopedic surgeons bluntly admitted that about 30 percent of tests and referrals were medically unnecessary and done to reduce physician vulnerability to lawsuits.
  • A 2011 analysis by the American Medical Association found that the average amount to defend a lawsuit in 2010 was $47,158, compared with $28,981 in 2001. The average cost to pay a medical liability claim—whether it was a settlement, jury award or some other disposition—was $331,947, compared with $297,682 in 2001.
  • Doctors spend significant time fighting lawsuits, regardless of outcome. The average litigated claim lingered for 25 months. Doctors spent 20 months defending cases that were ultimately dismissed, while claims going to trial took 39 months. Doctors who were victorious in court spent an average of 44 months in litigation.
  • A study in The New England Journal of Medicine estimated that by age 65 about 75 percent of physicians in low-risk specialties have been the target of at least one lawsuit, compared with about 99 percent of those in high-risk specialties.
  • According to Brian Atchinson, president of the Physician Insurers Association of America (PIAA), 70 percent of legal claims do not result in payments to patients, and physician defendants prevail 80 percent of time in claims resolved by verdict. Continue reading “A Culture of Overtreatment”
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flying cadeuciiWhen building software, requirements are everything.

And although good requirements do not necessarily lead to good software, poor requirements never do.   So how does this apply to electronic health records?   Electronic health records are defined primarily as repositories or archives of patient data. However, in the era of meaningful use, patient-centered medical homes, and accountable care organizations, patient data repositories are not sufficient to meet the complex care support needs of clinical professionals.   The requirements that gave birth to modern EHR systems are for building electronic patient data stores, not complex clinical care support systems–we are using the wrong requirements.

Two years ago, as I was progressing in my exploration of workflow management, it became clear that current EHR system designs are data-centric and not care or process-centric. I bemoaned this fact in the post From Data to Data + Processes: A Different Way of Thinking about EHR Software Design.   Here is an excerpt.

Do perceptions of what constitutes an electronic health record affect software design?  Until recently, I hadn’t given much thought to this question.   However, as I have spent more time considering implementation issues and their relationship to software architecture and design, I have come to see this as an important, even fundamental, question.

The Computer-based Patient Record: An Essential Technology for Health Care, the landmark report published in 1991 (revised 1998) by the Institute of Medicine, offers this definition of the patient record:

A patient record is the repository of information about a single patient.  This information is generated by health care professionals as a direct result of interaction with the patient or with individuals who have personal knowledge of the patient (or with both).

Note specifically that the record is defined as a repository (i.e., a collection of data).   There is no mention of the medium of storage (paper or otherwise), only what is stored.   The definition of patient health record taken from the ASTM E1384-99 document, Standard Guide for Content and Structure of the Electronic Health Record, offers a similar view—affirming the patient record as a collection of data. Finally, let’s look at the definition of EHR as it appears in the 2009 ARRA bill that contains the HITECH Act:

ELECTRONIC HEALTH RECORD —The term ‘‘electronic health record’’ means an electronic record of health-related information on an individual that is created, gathered, managed, and consulted by authorized health care clinicians and staff.  (123 STAT. 259)

Even here, 10 years later, the record/archive/repository idea persists.  Now, back to the issue at hand: How has the conceptualization of the electronic health record as primarily a collection of data affected the design of software systems that are intended to access, manage, and otherwise manipulate said data?

Continue reading “Is the Electronic Health Record Defunct?”

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Leah BinderThe Veterans Affairs (VA) hospital scandal has policymakers calling for VA Secretary Eric Shinseki’s head, and this week they got it, when President Obama accepted the Secretary’s resignation.

Some policymakers are also calling for privatizing VA hospitals, allowing them to be owned and operated by the same entities that own and operate the hospitals the rest of us use. This idea assumes the hospital community as a whole performs better than the VA, and the sad truth is we don’t have any evidence of that.

We know that on average, other hospitals are not doing a great job. Upwards of 500 people each  day die from preventable errors in American hospitals, one in 20 admitted patients will get an infection, and one in four inpatients suffer some form of harm unrelated to the reason they went  to the hospital in the first place.

Evidence suggests waiting lists like the VA’s may be common, as well.

So how does the VA compare? We don’t know. We don’t have much data publicly available to begin with, and we have virtually nothing that compares VA hospitals with other American hospitals.

To be clear, data is being collected—it’s just not typically available to humble souls like you and me and the rest of the American citizenry. Hospitals get accredited to receive Medicare and Medicaid payments, but accreditation reports are not made public by hospital. Health plans collect claims data, but most of that is never released to the public. The Centers  for Disease Control,  the Centers for Medicare and Medicaid Services, and other federal agencies collect reams of data, but much of it is not made public,  either.

This dearth of information is why employers and other purchasers of health care formed my organization (The Leapfrog Group), to ask hospitals to report on data they can’t get anywhere else. Their support means it’s free for hospitals to publicly report and free for consumers to access information about hospitals in their community. But only about a third of hospitals participate.

Continue reading “Before Privatizing the VA, Publicize It”

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Ashish Jha

Last year, about 43 million people around the globe were injured from the hospital care that was intended to help them; as a result, many died and millions suffered long-term disability.  These seem like dramatic numbers – could they possibly be true?

If anything, they are almost surely an underestimate.  These findings come from a paper we published last year funded and done in collaboration with the World Health Organization.  We focused on a select group of “adverse events” and used conservative assumptions to model not only how often they occur, but also with what consequence to patients around the world.

Our WHO-funded study doesn’t stand alone; others have estimated that harm from unsafe medical care is far greater than previously thought.  A paper published last year in the Journal of Patient Safety estimated that medical errors might be the third leading cause of deaths among Americans, after heart disease and cancer.

While I find that number hard to believe, what is undoubtedly true is this:  adverse events – injuries that happen due to medical care – are a major cause of morbidity and mortality, and these problems are global.  In every country where people have looked (U.S., Canada, Australia, England, nations of the Middle East, Latin America, etc.), the story is the same.

Patient safety is a big problem – a major source of suffering, disability, and death for the world’s population.The problem of inadequate health care, the global nature of this challenging problem, and the common set of causes that underlie it, motivated us to put together PH555X.

It’s a HarvardX online MOOC (Massive Open Online Course) with a simple focus: health care quality and safety with a global perspective.

Continue reading “Harvard MOOC: Patient Safety and Quality with Ashish Jha”

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flying cadeuciiIn an era of sophisticated information technology and rapid communication, the medical device community lags far behind other fields in its ability to alert patients about safety concerns.

For example, auto manufacturers and government regulators are able to quickly identify potential safety concerns by linking reports of crashes, malfunctions and defects with individual vehicle identification numbers (VINs).

They can then communicate recalls to affected customers by using their VIN. Manufacturers will issue notifications via mail or e-mail, or offer customers the ability to search the manufacturer’s website using their VIN.

In health care, drugs are tracked using a system established in the 1970s called National Drug Codes (NDCs). The 10-digit NDCs are assigned to all manufactured medications. The code tracks the vendor, product, and package code, which can then be captured in electronic health records and the FDA’s national database.

Unfortunately, we do not yet have a similar national system that can identify and communicate potential concerns for the tens of millions of patients with implantable devices such as pacemakers, glucose meters, artificial joints, and defibrillators.

Patients are bombarded by news stories about device recalls, but unless they have access to information about the exact make and model of their device, they have no way of knowing if they should be concerned. Since most medical device procedures take place in a hospital, a patient’s health care providers may also lack this critical, sometimes life-saving information.

The patient is then burdened with the task of tracking down their specialist or surgeon, in hopes that they documented the specific device information.

Clearly, the current health care information infrastructure does not yet support a robust surveillance system.

Continue reading “Medical Devices and Patient Safety: A Promising Path Forward”

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Robert Berenson“Not everything that counts can be counted, and not everything that can be counted counts.”

This aphorism has been deliciously, but, alas, incorrectly attributed to Albert Einstein (the saying actually has mixed origins, but credit properly might be given to sociologist William Bruce Cameron, writing in 1963).

But, whatever its provenance, the saying is particularly appropriate in describing the woeful lack of attention paid to the long-standing problem of diagnosis errors in the provision of health care services.

Last week academic researchers from Baylor and the University of Texas published important research estimating that one in 20 adults in the U.S., or roughly 12 million people every year, receive an error of diagnosis—a wrong, missed or delayed diagnosis—in ambulatory care.

This likely represents a conservative estimate of the incidence of such errors in ambulatory care and does not attempt to include inpatient hospital care or care provided in nursing homes and post-acute care facilities, such as rehab hospitals.

The news media correctly decided that this peer-reviewed finding deserved prominent attention—it was a lead story on “NBC Nightly News” and other national news programs.

It seems that attaching a large number to the prevalence of such errors provided the needed news hook to give the problem the attention it has long deserved. Surveys reveal that the public is worried as much about a misdiagnosis or missed diagnosis as any other quality and safety issue in health care.

Autopsy studies performed over time find that unacceptably high rates of diagnosis errors persist; similarly, diagnosis errors continue to represent a leading cause of medical malpractice suits.

But even without newsworthy body counts, the problem of diagnosis errors has been known to clinicians for decades, if largely ignored by stakeholders and policy-makers as a major quality and safety problem.

Continue reading “Placing Diagnosis Errors on the Policy Agenda”

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The Pentax Colonoscope. Source: University of Illinois Wiki

Sorry to get all Katie Couric on you, but I’m going to have a colonoscopy on Friday. I turned 40 last October and I have some family history that leads my doctor to get one done now rather than at 50.

Unlike Katie, I won’t be broadcasting mine live, but I’ll share some articles and reflections on the process and, being process focused, what could go wrong. It’s a very necessary procedure, but there are, sadly, some very unnecessary and preventable risks.

According to  Dr. Wikipedia (backed by journals):

This procedure has a low (0.35%) risk of serious complications

That’s about 1 in 300 patients, put another way.

For those of you who speak Six Sigma, that’s a 99.65% first time yield and a 4.2 sigma level.

That’s not going to scare me away.

Maybe I should have asked what my physician’s complication rates are. What are the complication rates at the surgical center where this will be done? Is this safer than being at a full-blown hospital or doesn’t it matter? Should I be more of an “engaged patient?”

Should I have asked more questions of my primary care provider? Why did she refer me to this GI specialist? Is he a “Best” doctor? Does that matter?

If I treat them as a supplier (respectfully), should I be able to walk the process and see what they do to prevent, say, instrument or scope disinfection errors?

Should I have asked:

  • Show me how you disinfect the equipment
  • Show me your training records for the people doing this work
  • Show me your equipment maintenance records
  • How do you verify that the work is being done properly?
  • Have you had any complaints or incidents in the past?

I had my pre-procedure phone call on Monday. Maybe I should follow up and ask a few of these questions, even if I can’t go “walk the gemba” to check things out myself. What would you do?

Of course, I didn’t have data or information available to me to know:

  • Which specialist is best at this?
  • Who has the highest or lowest complication rates?
  • What are the prices for different doctors or locations?

I don’t know how a busy person makes an informed decision.

Continue reading “Things That Make Me Worry About My Colonoscopy”

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