Patient Safety

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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flying cadeuciiThe Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?

The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.

Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.

I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:

  • The suggestion that quality programs should start to look at electronic health records (p. 8). EHRs have been certified by various bodies, but usually just to check off boxes and declare that the systems comply with regulations–neither the quality of their user interfaces nor the quality of their implementations have been questioned. Reportedly, the FDA considered “safety and quality standards” for electronic health records in 2010 but couldn’t get them adopted. It also checks certain forms of clinical decision support, but only if they are built into a regulated device. The current HHS report refers back to aspirational documents such as a Health Information Technology Patient Safety Action & Surveillance Plan and a set of guidelines on the safety of EHRs.
  • A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
  • A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.

Don’t imagine that the FDA is unused to regulating software. For quite some time they have instituted practices for the software used in some medical devices , and have tried to keep them up-to-date.

A waterfall-like process of risk assessment and testing called computer system validation has long been required for pharma and devices.

Continue reading “Health IT: The Coming Regulation”

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Berg, the company the brought along fun internet-connected concepts and products such as the Little Printer released this interesting video recently.

The amazing part of this is that Cloudwash is foundational and will just be built on. It shows where the current state of the Internet of Things is and where it can go in the future. What Berg did was amazing to me.

It took a regular “dumb” appliance with software and electronics that were trapped in and made the interaction richer and its meaning and value richer.

In a way, they radically changed the way I viewed how devices could be connected and created the possibility for a new class of devices in our daily lives.

And in a way, I saw so many parallels to healthcare.

In the video, Berg mentioned how the action of washing clothes can be quite complicated. There are baroque symbols on how clothes should be treated and this in turn is reflected by different sets of complicated icons on machines

Healthcare delivery can be far more complex though.

“In any given hospital, as many as 15 medical devices, including monitors, ventilators and infusion pumps, are connected to an ICU patient, but because they are made by different companies, they don’t “talk” with one another. Patient-controlled analgesic pumps that deliver powerful narcotics, where a known side effect is respiratory depression, aren’t linked to devices that monitor breathing, for example.”Today’s ICU is arguably more dangerous than ever,” says Peter Pronovost.

Just last week, I had the privilege of shadowing the pain service team at work. The team had to go one by one to each patient while rounding throughout the hospital. At each patient, a nurse practitioner checked their PCA. These are supposed to the safest ways to deliver analgesics and are self-containing boxes that are locked except for their interface.

No one except the pain service team is supposed to even touch those boxes due to the level of training needed to even interface with them. But it relies on human systems to ensure that the correct concentration of drug is put in with the right dosage according to each patient.

Yet like Dr. Pronovost mentions, these pumps aren’t linked to devices that monitor breathing so that IF a wrong dosage is placed in the PCA, there is no way of stopping it before its too late.

Continue reading “How a Washing Machine Inspired Me to See the Future of a Safer ICU”

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Quality improvement (QI) and patient safety initiatives are created with the laudable goal of saving lives and reducing “preventable harms” to patients.

As the number of QI interventions continues to rise, and as hospitals become increasingly subject to financial pressures and penalties for hospital-acquired conditions (HACs), we believe it is important to consider the impact of the pressure to improve everything at once on hospitals and their staff.

We argue that a strategy that capitalizes on “small wins” is most effective. This approach allows for the creation of steady momentum by first convincing workers they can improve, and then picking some easily obtainable objectives to provide evidence of improvement.

National Quality Improvement Initiatives

Our qualitative team is participating in two large ongoing national quality improvement initiatives, funded by the Agency for Healthcare Research and Quality (AHRQ). Each initiative targets a single HAC and its reduction in participating hospitals.

We have visited hospital sites across six states in order to understand why QI initiatives achieve their goals in some settings but not others.

To date, we have conducted over 150 interviews with hospital workers ranging from frontline staff in operating rooms and intensive care units to hospital administrators and executive leadership. In interviews for this ethnographic research, one of our interviewees warned us about unrealistic expectations for change: “You cannot go from imperfect to perfect. It’s a slow process.”

While there is much to learn about how to achieve sustainable QI in the environment of patient care, one thing is certain from the growing wisdom of ethnographic studies of QI: buy-in from frontline providers is essential for creating meaningful change.

Frontline providers often bristle at expectations from those they believe have little understanding of the demands of their daily work.

Continue reading “The Dangers Of Quality Improvement Overload”

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