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Was the IOM estimate of medical errors correct?

By SAURABH JHA

In 1999, the Institute of Medicine (IOM) in their landmark report – To Err is Human – estimated that the number of deaths from medical errors is 44 ,000 to 98, 000. The report ushered the Quality and Safety Movement, which became a dominant force in all hospitals. Yet the number of deaths from medical errors climbed. It is now touted to be the 3rd leading cause of death. How easy is it to precisely quantify the number of deaths from medical errors? Not many physicians challenged the methodologies of the IOM report. Some feared that they’d be accused of “making excuses for doctors.” Many simply didn’t have a sufficient grip on statistics of measurement sciences. One exception was Rodney Hayward – who was then an early career researcher, a measurement scientist, who studied how sensitive the estimates of medical errors were to a range of assumptions.

Saurabh Jha (aka @RogueRad) speaks with Professor Hayward for the Firing Line Podcast about his research in JAMA published in 2001 – Estimating Hospital Deaths Due to Medical Errors: Preventability Is in the Eye of the Reviewer. It was a landmark publication of the time, and its objective methods have stood the test of time.

Rod Hayward a Professor of Public Health and Internal Medicine at the University of Michigan and Co-Director of the Center for Practice Management and Outcomes Research at the Ann Arbor VA HSR&D. He received his training in health services research as a Robert Wood Johnson Clinical Scholar at UCLA and at the RAND Corporation, Santa Monica. His current and past work includes studies examining measurement of quality, costs and health status, environmental and educational factors affecting physician practice patterns, quality improvement, and physician decision making. His current work focuses on quality measurement and improvement for chronic diseases, such as diabetes, hypertension and heart disease.

Listen to their conversation on Radiology Firing Line Podcast here.

Why Developers Should Enter Health IT Contests

Patient safety is a movement within healthcare to reduce medical errors. Medical errors are a substantial problem in the healthcare industry, with a size and scope similar to car accidents: approximately the same number of deaths per year, about the same number of serious injuries. Personally I think working in patient safety is the simplest way for a geek to make a meaningful difference.

With that in mind I would like to promote a new developer contest sponsored by the Office of the National Coordinator (ONC), Partnership for Patients and hosted by Health 2.0: Ensuring Safe Transitions from Hospital to Home Challenge. As the name suggests, the contest is focused on the process of handing a patient over from an in-patient environment (in the hospital) to an out-patient environment (all the care that is not in a hospital).

I will be one of the judges for this contest and there are already enough “star players” submitting as teams in the contest that I know judging is going to be hard. The first prize is $25,000. That kind of money starts looking like seed-round funding rather than just a pat on the head. That is intentional on the part of both Health 2.0 and ONC. These contests are a way for ONC to find really amazing health IT ideas and help them transition into more substantial projects, with no strings attached. If you can prove to the judges that you have the best new idea and you can flesh it out well enough to make it clear that it has a chance of working, then you can walk away with enough cash to launch that idea. But don’t take my word for it.

Of course, even just submitting in the contest is a good way to get the attention of various investors.

Generally, the coordination of care in the United States is one of the greatest weaknesses in the system. Doctors here in the U.S. are generally well educated and held to high standards. As long as a doctor has a good understanding of your situation and has taken responsibility for your care, the U.S. healthcare system provides excellent care, on par with any other national system. The problem comes when a healthcare transition occurs, where a different doctor takes responsibility without necessarily getting all the needed information and sometimes without knowing that they are “on the hook” for care. Healthcare in the United States is coordinated via fax machines, and coordination for payment, which is sometimes associated with transitions of care, frequently uses ancient EDI standards. When this coordination fails things turn into a kind of communication comedy, which really would be quite funny except that there are sometimes tragic consequences. It actually helps to have a somewhat morbid sense of humor working in healthcare, since laughter, even inappropriate and macabre laughter, can help to manage the stress and pressure inherent in this high-stakes environment.

There are new standards and technologies available for the coordination of care during transitions that ONC is specifically encouraging in this contest, including the Direct Project, which is of course a favorite of mine (I am a sometimes-developer on the project).

These new technologies allow you rethink the basic assumptions in healthcare coordination, (i.e. Direct is basically “email that doctors can use without breaking the rules”) and should enable teams without extensive health IT experience to do something truly innovative.

More importantly, Partnership for Patients and ONC are providing specific guidance about content. Partnership for Patients is an HHS program that “partners” with hospitals and clinics that have committed to proactively reduce patient error and complications. The Partnership has very specific goals: “To reduce preventable injuries in hospitals by 40 percent and cut hospital readmission by 20 percent in the next three years by targeting those return trips to the hospitals that are avoidable.” This contest is only a small part of how they hope to achieve those goals.

CMS has released a patient checklist for hospital discharge, and the contents must be incorporated into winning contest submissions. But I can tell you from previous judging experience, thinking that “incorporate” = “regurgitate” is not a winning strategy. Instead, try to get your head around the complex hospital discharge phenomenon. PubMed is your friend. In my experience doing something amazing with one of the checklist items would be a better strategy then doing something derivative with all of the items. Doing something amazing with all of the items on the checklist would obviously win, but it may be impossible to do that well. (I’d be happy to be proven wrong on this.)

My day job is with the Cautious Patient Foundation (CPF). They hire me to write software to improve the communication between doctors and patients, which is part of their mission to provide software tools that enable patients to help reduce their own medical errors by being fully engaged, educated and aware. If the healthcare system were a highway the Cautious Patient Foundation would be a defensive driving course. CPF has a grant program that they use to fund innovations that impact patient safety. Contest participants are encouraged to submit their ideas to the Cautious Patient Foundation grant process. We are interested in innovative ideas that impact patient safety generally, not just in transitions of care. So if you have a winning patient safety concept that does not fit into this particular contest, we might be interested.

Moreover, there is nothing to stop you from submitting the same technology to one of the other Health 2.0 contests or even to another joint ONC/Health 2.0 contest. Many of these contests could easily be won by an application that does something with a patient safety impact. If you have a great idea for improving healthcare with software, just wait … there will eventually be a contest asking for just the kind of innovation you have.

All of this is to say: There is some real money in these developer contests. Traditional health IT experts who feel trapped can use contests to fund and promote their non-traditional ideas. Developers who are new to the field of health IT can use the contests as a way to break in and get attention for their ideas. Great ideas that improve the healthcare system can get traction, funding and attention. If you can get your great idea working and you submit it to one of these developers contests you can get some feedback.

Maybe your idea actually sucks, but if you knew why, then you could come up with a new idea that really would be great. In any case, it is pretty hard for a developer to just lose by participating in these contests. Worst case scenario is that is ends up being a free education. Who knows? You might be an important part of another developer’s free education.

No matter what, working on software that addresses patient safety issues is one of the few ways that a software developer can impact quality of life rather than convenience of life. These contests, especially the in-person code-a-thons, are fun enough that you might even find yourself forgetting that you are changing the world.

Fred Trotter is a recognized expert in Free and Open Source medical software and security systems. He has spoken on those subjects at the SCALE DOHCS conference, LinuxWorld, DefCon and is the MC for the Open Source Health Conference. This post first appeared at O’Rielly Radar.

He is co-author of Meaningful Use and Beyond. THCB readers can buy the ebook at 50% off until the end of November by mentioning “HITBlog.”

Training Day

Screen Shot 2015-04-06 at 7.20.19 PMDr. Samuels’ day-long training experience is unfortunate, but it’s only the opening chords of a much longer symphony of time commitments required by electronic medical records (EHRs).  Many studies document the extra time that EHRs impose on doctors and patients. Research in U.S. hospitals and medical offices suggest that these systems can add a half-hour or much more time to a day. A study by McDonald et al (2013 JAMA Internal Medicine) found EHRs added 48 minutes/day to ambulatory physicians, and Hill et al found that in a large  community hospital emergency room 43% of all physician time was spent entering data into the EHR. This almost doubled the time spent caring for patients, and tripled the time needed to interpret tests and records. (Annals of Emergency Medicine, 2014).

Some of that extra time is spent with clunky interfaces and  hide-n-go seeking for information that should be immediately available, such as arbitrary or unexpected  presentations of data, e.g., having to find a patient’s history by clicking on her current room number, or lab reports that may be arranged by chronology, by reverse chronology, by the lab company, by the organ system, by who ordered them, or by some informal heading, such as “blood work” or “tests” or “labs.”  Then there’s the constant box clicking (or what clinicians call “clickarrhea”).  EHRs also send thousands of usually irrelevant alerts that desensitize doctors to legitimate clinical recommendations.
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Recalling To Err’s Impact and a Small (But Telling) IOM Mistake

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…

Doctor, I’m Not Comfortable with That Order

A little more than 13 years ago, the Institute of Medicine (IOM) released its seminal report on patient safety, To Err is Human.

You can say that again. We humans sure do err.  It seems to be in our very nature.  We err individually and in groups — with or without technology.  We also do some incredible things together.  Like flying jets across continents and building vast networks of communication and learning — and like devising and delivering nothing- short-of-miraculous health care that can embrace the ill and fragile among us, cure them, and send them back to their loved ones.  Those same amazing, complex accomplishments, though, are at their core, human endeavors.  As such, they are inherently vulnerable to our errors and mistakes.  As we know, in high-stakes fields, like aviation and health care, those mistakes can compound into catastrophically horrible results.

The IOM report highlighted how the human error known in health care adds up to some mindboggling numbers of injured and dead patients—obviously a monstrous result that nobody intends.

The IOM safety report also didn’t just sound the alarm; it recommended a number of sensible things the nation should do to help manage human error. It included things like urging leaders to foster a national focus on patient safety, develop a public mandatory reporting system for medical errors, encourage complementary voluntary reporting systems, raise performance expectations and standards, and, importantly, promote a culture of safety in the health care workforce.

How are we doing with those sensible recommendations? Apparently to delay is human too.

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Is the Readmissions Penalty Off Base?

I’ve been getting emails about the NY Times piece and my quotation that the penalties for readmissions are “crazy”.  Its worth thinking about why the ACA gets hospital penalties on readmissions wrong, what we might do to fix it – and where our priorities should be.

A year ago, on a Saturday morning, I saw Mr. “Johnson” who was in the hospital with a pneumonia.  He was still breathing hard but tried to convince me that he was “better” and ready to go home.  I looked at his oxygenation level, which was borderline, and suggested he needed another couple of days in the hospital.  He looked crestfallen.  After a little prodding, he told me why he was anxious to go home:  his son, who had been serving in the Army in Afghanistan, was visiting for the weekend.  He hadn’t seen his son in a year and probably wouldn’t again for another year.  Mr. Johnson wanted to spend the weekend with his kid.

I remember sitting at his bedside, worrying that if we sent him home, there was a good chance he would need to come back.  Despite my worries, I knew I needed to do what was right by him.  I made clear that although he was not ready to go home, I was willing to send him home if we could make a deal.  He would have to call me multiple times over the weekend and be seen by someone on Monday.  Because it was Saturday, it was hard to arrange all the services he needed, but I got him a tank of oxygen to go home with, changed his antibiotics so he could be on an oral regimen (as opposed to IV) and arranged a Monday morning follow-up.  I also gave him my cell number and told him to call me regularly.

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The Good Doctor

Dr. Brian Goldman is right.

We expect a level of perfection from our doctors, nurses, surgeons and care providers that we do not demand of our heroes, our friends, our families or ourselves. We demand this level of perfection because the stakes in medicine are the highest of any field — outcomes of medical decisions hold our very lives in the balance.

It is precisely this inconsistent recognition of the human condition that has created our broken health care system. The all-consuming fear of losing loved ones makes us believe that the fragile human condition does not apply to those with the knowledge to save us. A deep understanding of that same fragility forces us to trust our doctors — to believe that they can fix us when all else in the world has failed us.

I am always surprised when people say someone is a good doctor. To me, that phrase just means that they visited a doctor and were made well. It is uncomfortable and unsettling — even terrifying — to admit that our doctors are merely human — that they, like us, are fallible and prone to bias.

They too must learn empirically, learning through experience and moving forward to become better at what they do. A well-trained, experienced physician can, by instinct, identify problems that younger ones can’t catch — even with the newest methods and latest technologies. And it is this combination of instinct and expertise that holds the key to providing better care.

We must acknowledge that our health care system is composed of people — it doesn’t just take care of people. Those people — our cardiologists, nurse practitioners, X-ray technicians, and surgeons — work better when they work together.

Working together doesn’t just mean being polite in the halls and handing over scalpels. It means supporting one another, communicating honestly about difficulties, sharing breakthroughs to adopt better practices, and truly dedicating ourselves to a culture of medicine that follows the same advice it dispenses.

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Can Quality Be on India’s Health Care Agenda? Should it Be?

Currently, India spends about $20 per person per year on healthcare and spending more once seemed like a peripheral concern, taking a back seat to basics like food and sanitation.  However, in the past decade, as the Indian economy has grown and wealth followed, Indians are increasingly demanding access to “high quality” healthcare.  But what does “high quality” mean for a country where a large proportion of the population still goes hungry?  Where access to sanitation is so spotty that the Supreme Court recently had to decree that every school should have a toilet?  What is “high quality” in a setting where so many basics have not been met?

It turns out that “high quality” may mean quite a lot, especially for the poor.  A few weeks ago I spent time in Delhi, meeting with the leadership of the Indian health ministry.  I talked to directors of new public medical schools and hospitals opening up around the country and I met with clinicians and healthcare administrators at both private and public hospitals.  An agenda focused on quality rang true with them in a way that surprised me.

The broad consensus among global health policy experts is that countries like India should focus on improving “access” to healthcare while high income countries can afford to focus on the “quality” of that care.  The argument goes that when the population doesn’t have access to basic healthcare, you don’t have the luxury to focus on quality.  This distinction between access and quality never made sense to me.  When I was a kid in Madhubani, a small town in in the poor state of Bihar, I remember the widespread impressions of our community hospital.  It was a state-run institution that my uncle, a physician, once described as a place where “you dare not go, because no one comes out alive”.

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Is the Nurse Incompetent?

This case is prompting a lot of comments, some of them taking issue with the concept of systemic failures and instead asserting that the young nurse was clearly incompetent, in that her error was inexplicable.  So, let’s turn from a clinic in Brazil to a recent case in a hospital in the US, cited in this article on AHRQ’s Web M&M.  A summary:

The order was written correctly in the electronic medical record (EMR) for phenytoin, 800 mg IV. The drug-dispensing machines stocked phenytoin in 250 mg/1 mL vials. The correct dose therefore would require 4 vials and be equal to 3.2 mL to be added to a small IV bag. The nurse misread the order as 8000 mg (8 g) and proceeded to administer that dose to the patient, which was a 10-fold overdose and 2 to 3 times the lethal dose. The patient died several minutes after the infusion.

This nurse had to work hard to make the error:

An audit of the pharmacy system revealed that the nurse had taken 32 vials out of 3 different pharmacy dispensing machines to accumulate 8 g of IV phenytoin. Moreover, the nurse had to use two IV bags and a piggyback line to give that large a dose.

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