Category: Professional Regulation

Sisaket,Thailand,09 April 2019;Medical staff wearing face shield and medical mask for protect coronavirus covid-19 virus in CT scan room,Sisaket province,Thailand,ASIA.

The Future of Acute and Critical Care Nursing

The Petrie-Flom Center Staff Leave a comment

By Sarah A. Delgado

We need to change the future for nurses. Even before the pandemic, nurses suffered high rates of burnout and a disproportionate risk of suicide. But the pandemic could be a tipping point that leads many nurses to change careers, leave their jobs, or retire early.

Moral distress, the consequence of feeling constrained from taking ethical action, was well-documented before the pandemic, particularly among critical care nurses providing end-of-life care. Additional research conducted before 2020 demonstrates that nurses were experiencing post-traumatic stress due to the suffering they witnessed and the demands of their work.

During the pandemic, surges in critically ill patients have led to untenable workloads. The distress of end-of-life care is heightened by restrictions on visitation and increased mortality rates. In addition, shortages of basic personal protective equipment contribute to fear and a sense of betrayal.

While the pre-pandemic state of the nursing profession was concerning, the pandemic creates imminent peril.

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Prison watch tower.

Government Report Finds Care Deficits for Pregnant People in Federal Custody

Elyssa Spitzer Leave a comment

By Elyssa Spitzer

Pregnant and postpartum people in the custody of the Bureau of Prisons (BOP) and U.S. Marshals Service receive care directed by policies that fail to meet national standards, according to a report recently issued by the Government Accountability Office (GAO). 

This, despite the fact that, incarcerated women are among the most vulnerable people, according to the American College of Obstetricians and Gynecologists. In the GAO report’s terms, incarcerated women: “often have medical and mental health conditions that make their pregnancies a high risk for adverse outcomes, which is compounded by inconsistent access to adequate, quality pregnancy care and nutrition while in custody.”

Notably, the report found that the BOP and U.S. Marshals’ policies failed to satisfy the national standards — to say nothing of the gaps that may exist between written policy and the care that is, in fact, provided. Read More

New York, NY/USA - 08.31.2018: Overdose Awareness March.

Advancing a Public Health-Promoting National Opioid Policy

The Petrie-Flom Center Staff Leave a comment

Register to attend “Addressing the Overdose Epidemic: Substance Use Policy for the Biden Administration” on March 24th.

By Jennifer D. Oliva & Kelly K. Dineen

“America’s drug regime is a monstrous, incoherent mess.”
– Dr. Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)

By any measure, American drug policy is an ineffective and costly failure.

The U.S. drug policy regime’s defining quality is its persistent adherence to the same approaches in the face of overwhelming evidence that they are unsuccessful, including supply-side tactics, fear mongering, and misinformation dissemination. These policies are racist by design and their myriad, negative impacts are disproportionately borne by marginalized and stigmatized communities.

The “war on drugs” and its repeated loop of lost battles have earned the nation the highest incarceration rate in the world, fomented a number of serious health issues related to drug use, and fueled a drug overdose and suicide crisis. Our shape-shifting overdose crisis recently claimed the highest number of overdose deaths ever recorded during a twelve-month period in American history.

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Busy Nurse's Station In Modern Hospital

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

John Tingle Leave a comment

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

James W. Lytle Leave a comment

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

The Petrie-Flom Center Staff Leave a comment

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

The Petrie-Flom Center Staff Leave a comment

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

Leslie Francis Leave a comment

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

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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