Category: Medical Quality

Adverse Health Event Reporting in Minnesota a Valuable Tool

John Tingle Leave a comment

By John Tingle

doctors performing surgery
Medical errors are a common cause of death globally. (thinkpanama/flickr)

“Medical errors are the third leading cause of death in the United States,” says a new report by the World Health Organization. And in the United Kingdom, “recent estimations show that on average, one incident of patient harm is reported every 35 seconds.”

Patient safety remains an issue of concern for all countries across the globe. But by observing what other countries do and report about patient safety we can avoid the costly mistake of trying to reinvent the wheel when information is already available about important trends.

The Minnesota Department of Health (MDH) have recently published their 14th Annual Public Report on Adverse Health Events in Minnesota. The report contains a lot of detailed patient safety information, analysis, and trends which will be of use to health carers and patient safety policy developers everywhere.

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From bioethics to medical anthropology to humanities and back: A year in review

ylenfest Leave a comment

I thought I would take this opportunity to reflect on the past year, where I will be in the future, and how the student fellowship has impacted me. I still hope to contribute to the Bill of Health blog going forward, but as my last official post as a Petrie-Flom Student Fellow, I would be remiss if I did not express my sincere gratitude to everyone at the Petrie-Flom Center, the faculty and staff, the other student fellows, and especially my mentors: Professors I. Glenn Cohen, Carmel Shachar, and Intisar A. Rabb.

My own project took a few different turns this year. My original proposal was to explore the ways in which bioethics and biomedical issues will play a significant role in reviving the dialectic between secular scholars and religious authority. Ayman Shabana rightly argues that respect for Islamic religious norms is essential for the legitimacy of bioethical standards in the Muslim context, wherein he attributes the legitimating power of these norms—as well as their religious and spiritual underpinnings—to their moral, legal, and communal dimensions. Building off of Shabana’s work, my initial argument held that the relationship between the secular and religious worlds is important because the discourse between the two, although often presumed to be dichotomous, is not necessarily antithetical nor is it impassable. This led me back to the arguments of the venerable philosophers Alasdair MacIntyre and Charles Taylor whereby, in critiquing the concept of secularism itself along with its historical contexts, furthered my argument and helped me to clarify the significant role that religion plays vis-à-vis categorical issues such as fundamental beliefs and metaphysics. I still maintain this, and it is something I continue to work on, although I decided to take my project in another direction.

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Mass embryo destruction, reproductive never events, and the not-quite-Wild West

Dov Fox Leave a comment

By Dov Fox

Information found in this new post by Dov Fox is also available in Slate’s March 19th article In Vitro Injuries: How should courts compensate would-be parents when assisted reproductive technology goes terribly wrong?

More than 1 in 10 Americans seek fertility treatment. IVF and similar technologies result in 64,000 babies—1.6% annually—of all those born in the U.S. each year. For people willing to move heaven and earth to form a family, this is the medicine of miracles. But reproductive mishaps turn these dreams into nightmares. Some result in unplanned pregnancies. Others, lost chances for parenthood. I’ve considered the legal complexities elsewhere at law review length. (A reply to critics Robert Rabin, Carol Sanger, and Gregory Keating is out shortly with Columbia.) But it’s the facts that have made headlines of late.

The Today Show and Nightly News interviewed me in the wake of recent storage tank malfunctions at two major fertility clinics—one in San Francisco, the other outside Cleveland—that destroyed more than 4,000 cryopreserved eggs and embryos. The Cleveland facility said that “alerts that should have been sent to staff were never sent.” These incidents have left over a thousand affected couples mourning future children who would never be; practitioners wondering how something like this could have happened; and prospective parents around the country worrying that tragedy could strike again.

It’s not the first time. NBC News uncovered a history of freezer malfunctions. Over a decade ago in Florida over 60 cancer survivors lost their stored sperm “when a tank made by the same manufacturer failed.” Exact figures for such breakdowns are hard to come by, however. Elsewhere in health care delivery, most states mandate reporting of “never events,” such as surgery on the wrong body part or patient. But the United State has no public or private system for tracking what I’ve referred to as “reproductive” never events, let alone less serious errors. So it’s impossible to know with any reliability or precision the incidence of professional mistakes in matters of procreation.

Available data points are bracing. A 2008 survey of nearly half of all U.S. fertility clinics found that more than one in five misdiagnosed, mislabeled, or mishandled reproductive materials. A 2014 study revealed that popular methods of prenatal screening for fetal abnormality sound “a false alarm half of the time.” And in 2016, a national ratings website found that 18-24% of fertility patients reported damaged or destroyed samples among a host of other errors.

None among regulators, agencies, insurers, medical boards, or professional societies require safeguards that might prevent mistakes like these from happening in the first place. The U.S. stands out among developed countries for its failure to rein in wrongdoing that forces parenthood on people who don’t want it or that denies it to those who do. In the United Kingdom, by contrast, a national agency requires that all facilities comply with a standard of professional conduct that covers “all details of the clinical and embryological practice associated with assisted reproductive technology.”

That agency—the Human Fertilisation and Embryology Authority—maintains rigorous laboratory inspections, often without notice. And even under its careful oversight, the agency reports that 1 out of every 100 fertility procedures—over 500 each year—involve reproductive materials that’s lost, damaged or destroyed. It stands to reason that these errors are at least as common in the United States, where fertility clinics, sperm banks, and surrogacy agencies aren’t monitored or supervised in any meaningful way. My own research uncovered hundreds of American cases in which procreation was negligently imposed, deprived, or confounded.

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Learning the lessons from patient safety errors of the past

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By John Tingle

A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000  stated:

“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identified but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).

In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.

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Save the Date, April 12-13, 2018! Diseases of Despair: The Role of Policy and Law

The Petrie-Flom Center Staff Leave a comment

Diseases of Despair imageDiseases of Despair: The Role of Policy and Law
April 12 – 13, 2018
Various locations – check agenda for details
Northeastern University, Boston, MA

Description

Anne Case and Angus Deaton shocked the world with their 2015 report that noted an increase in all-cause mortality among middle-aged white non-Hispanic men and women in the United States. This pattern is not occurring in other groups within the United States and Europe. Their report, and others since then, have linked this trend to so-called deaths of despair (death from suicide, chronic substance use, and overdoses) and their linkage to other determinants of health (education, labor markets, marital patterns). A recent update to the report makes it clear that this trend is no longer limited to any particular geographic region within the United States.

This year’s NUSL Center for Health Policy and Law annual conference and associated scholarship will bring together experts, policymakers, and academics to discuss the causes behind such trends, and to explore potential political, policy, and legal responses for addressing broader determinants that affect the physical and mental health of Americans dying from these diseases of despair. Deeper examination into similar patterns among diverse populations, as well as analysis of continuing racial, ethnic, and socioeconomic disparities, will be central to the discourse.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

Mason Marks 3 Comments

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Read More

An Analysis of Five Years of Cerebral Palsy Claims in the UK

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By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Read More

Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

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Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

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The Problematic Patchwork of State Medical Marijuana Laws – New Research

Temple University Center for Public Health Law Research 2 Comments

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

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Making Health Care Safer: What Good Looks Like

John Tingle Leave a comment

It’s fair to say that patient safety and health quality reports in recent years have tended to focus on what is going wrong in the NHS and what needs to be done to put things right.We have had some dramatic health care systems failures which have resulted in unnecessary deaths of patients.The naming and shaming of errant health care providers has taken place and we have now through the CQC (Care Quality Commission), a much more open, stronger, intelligent and transparent way of regulating health care quality than we have ever had before.

The health care regulatory system does seem to be making a positive difference to NHS care judging from recent CQC reports with some good examples of health quality and safe care practices taking place. Other trusts can learn from these practices.

The CQC have just published a report which includes several case studies illustrating some of the qualities shown by care providers that are rated good or outstanding overall. These hospitals known as hospital trusts in the NHS have been on a journey of improvement some going from special measures to good (CQC inspection ratings). The views of some of the people involved in the care improvement initiatives are stated in the case studies revealing important insights on improvement strategies and the nature of the problems overcome. Read More