Busy Nurse's Station In Modern Hospital

What’s in a Name? The Value of the Term ‘Never Events’

By John Tingle 

The Healthcare Safety Inspection Branch (HSIB) in England, which conducts independent investigations of patient safety concerns relating to the country’s National Health Service (NHS), has just published a learning report that examines the findings of investigations they have carried out on incidents classified as “Never Events.”

England’s NHS defines Never Events as “patient safety incidents that are wholly preventable,” in accordance with the implementation of “guidance or safety recommendations that provide strong systemic protective barriers.”

In the National Health Service’s policy and framework, Never Events are listed under the following headings: surgical, medication, mental health, and general. These headings include incidents such as overdose of certain medications, failure to remove a foreign object used during a procedure, and transfusion of incompatible blood.

The investigations for the HSIB report cover seven of the 15 types of Never Events listed in the National Health Service (NHS) Never Events policy and framework published in 2018. These seven categories account for over 96% of the total Never Events recorded in 2018 – 2019.

Controversially, the HSIB report recommends that NHS England and NHS Improvement revise the Never Events list to remove several which don’t have “strong and systemic safety barriers.” “These events,” the report states, “are therefore not wholly preventable and do not fit the current definition of Never Events.”

This suggestion is, arguably, not in the spirit of advancing the patient safety agenda in the NHS in England.

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Empty hospital bed.

New Data Reignites Concerns over COVID-19 and Nursing Homes in New York State

By James W. Lytle 

Concerns over New York State’s response to the COVID-19 pandemic, particularly with respect to its treatment of nursing homes, have recently re-emerged in light of a new report and court ruling related to the matter.

Almost from the outset of the pandemic, the State faced scrutiny as to whether it was accurately reporting deaths of nursing home patients.

After nursing homes complained in April about the lack of PPE and other resources to combat the pandemic, Governor Andrew Cuomo responded that it was not the state’s responsibility, and asked the Department of Health and the Attorney General to launch investigations into nursing homes’ response to the pandemic.

Nine months later, in late January 2021, the report by New York State Attorney General Letitia James of the nursing home investigation was released.

Among the report’s headlines, the Attorney General’s preliminary analysis found that the Department of Health had undercounted deaths of nursing home residents due to COVID-19 by about 50%, largely because of the failure of the State to count the deaths of those residents who were transferred to hospitals immediately prior to their deaths. No other state excluded patients who had been transferred before death to hospitals from their nursing home fatality reports.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Recent Organ Procurement Organization Regulations Will Save Lives

By Matthew Wadsworth

Thirty-three Americans die every day for lack of an organ transplant. As the CEO of an organ procurement organization (OPO) — one of the network of 57 government contractors responsible for organ recovery across the country — this is what I think about every day: how to help the 3,000 people waiting in my home state of Ohio and the more than 100,000 others around the country who wake up each morning hoping they get a call that a transplant is available.

Fortunately, the U.S Department of Health and Human Services (HHS) recently published new, pro-patient regulations to bring baseline accountability to OPOs. While some of my peers have opposed the reform effort, I see it as long overdue.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Weaknesses in Medical Device Regulation Worsened by Trump Administration

By Jacob Howard

In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.

Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.

As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.

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USB drive

The False Dilemmas of the Fifth Circuit’s HIPAA Ruling

By Leslie Francis

In a caustic opinion issued on January 14, the Fifth Circuit vacated penalties assessed by the U.S. Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center for HIPAA security breaches.

As has happened to many other health care entities, M.D. Anderson had employees who were not careful with their laptops and thumb drives (and the data therein). A laptop with the unencrypted protected health care information of nearly 30,000 patients was stolen. Unencrypted thumb drives with information on another almost 6,000 patients were lost. M.D. Anderson disclosed the security breaches to HHS, which assessed civil monetary penalties for violation of HIPAA’s encryption and disclosure rules. M.D. Anderson then filed a petition for review, which resulted in the Fifth Circuit holding that the agency action was arbitrary and capricious for failure to consider an important aspect of the problem.

Commentators have already pointed out that this decision will reverberate throughout the HIPAA enforcement world. As it does, I hope it is met with scorn, for it trades on the informal logical fallacy of the false dilemma in two noteworthy ways.

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Close up of a mosquito sucking blood on human skin. This mosquito is a carrier of Malaria, Encephalitis, Dengue and Zika virus.

Responsibly Developing Gene Drives: The GeneConvene Global Collaborative

By James Toomey

Researchers believe that gene drives could eliminate vector-borne diseases such as malaria, by modifying mosquito species or eradicating those that carry disease, kill off invasive species, and combat the growing problem of pesticide resistance.

A gene drive is a technique for genetically modifying entire species of wild organisms. Genetically modified individuals of the species are released into the wild, so as to raise the probability that a particular gene will be passed onto the species’ progeny via reproduction.

Over the course of many generations, the gene — even if detrimental — can spread to an entire population.

But as of now, this is all hypothetical. No gene drive has been tested in the wild, and many people are skeptical that they should ever be used.

The GeneConvene Global Collaborative, a project of the Foundation for the National Institutes of Health, was started this past July to promote the responsible development and regulation of gene drive technologies. It brings together researchers, regulators and stakeholders around the world to develop best practices for gene drive research and implementation.

Because of my prior writing on this topic, I participated in GeneConvene’s fall webinar series and spoke with scientists there about the project. Read More

adult and child hands holding red heart, organ donation concept image.

Opt-in vs. Opt-out Organ Donation Schemes: Evidence from the US and UK

By James W. Lytle

We need to encourage organ donation. In the U.S. alone, even with a record number of about 40,000 transplants in 2019 and some progress made towards closing the gap, approximately 108,000 Americans are on the waiting list.

In considering the best way to increase organ donation, much of the debate has focused on how to make organ donor registries more successful: nothing facilitates the prospect for organ donation more than knowing that a potential donor has already indicated their intention to donate.

Should registries, like those in the U.S., require people to elect to join (the “opt-in” approach) or should they presume consent to organ donation and register everyone except those who explicitly “opt-out,” as is the case in certain other countries?

I asked two transplant professionals, one from the U.S. and one from Wales, to help consider this question and related issues involving organ donation.

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organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

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Police car.

Police Should Not Be Enforcing Emergency Public Health Orders

Cross-posted from COVID-19 and The Law, where it originally appeared on November 9, 2020. 

By Daniel Polonsky

On a weekend when police officers were handing masks to white residents in parks around New York City, NYPD Officer Francisco Garcia forced Donni Wright, a 33-year-old Black man, to the ground and knelt on his neck. Officer Garcia was one of 1,000 NYPD officers dispatched to enforce social distancing and mask-wearing. He had been investigating a report of individuals not wearing masks, although he himself was not wearing one. Police Chief Terence Monahan had previously assured reporters that the police would be educating the public and only breaking up large gatherings, not bothering individuals merely walking outside—“They don’t have a mask, we’ll give them a mask.” But Officer Garcia, who has settled six lawsuits for police misconduct for a combined $182,500, did more than educate that day. Multiple officers were in the middle of arresting two individuals after allegedly spotting a bag of marijuana when Mr. Wright spoke up in their defense. In response, Officer Garcia called him a racial epithet and accosted him, causing severe injuries to Mr. Wright’s back, ribs, and chest. What started as social distancing enforcement ended in racist, excessive use of force.

This incident highlights the overlap between the twin crises state and local governments face: halting the spread of COVID-19 and grappling with the systemic racism that characterizes the American system of policing.

Click here to read the full post on COVID-19 and The Law.