Patient Safety and Clinical Risk in Neonatal Care

By John Tingle                                     

The CQC (The Care Quality Commission)  is the independent regulator of health and adult social care in England. They make sure that health and social care services provided to people are safe, effective, compassionate, high-quality care and they encourage care services to improve. The  CQC inspects health facilities and they have important statutory regulatory powers and sanctions.They have recently produced a report on neonatal care and  on  providing care for infants in the community who need respiratory support. As well as some positive findings, the report does reveal a number of major patient safety risks and failings.

In England, one in every nine babies is born needing care from neonatal services and  this is on the increase. The care process here can be challenging with sick babies with complex health needs receiving hospital care and then care at home and in the community. The care of the baby traverses’ distinct pathways or care areas and sometimes problems can occur:

A lack of consistency in care and communication across a pathway can result in poor outcomes for both babies and parents.” (p.3)

The report looks at current practice in three different aspects of care: Continue reading

Child safeguarding: the National Health Service (NHS) can do much better

By John Tingle

Our children are our future and we need to look after them well. There is however a lot of evidence to suggest that we are failing our children in a number of key health areas. UNICEF in a report put the UK in 16th position – below Slovenia, the Czech Republic and Portugal – in a league table of child well-being in the world’s richest countries. The report considers five dimensions of children’s lives – material well-being, health and safety, education, behaviours and risks, and housing and environment – as well as children’s subjective well-being.

There are a number of health and other child well-being challenges for the UK to meet. The UNICEF report provides some useful context from which to view the recently published Care Quality Commission (CQC) report on the arrangements for child safeguarding and healthcare for looked after children in England.The CQC is the independent regulator of health and social care in England.Whilst the report does contain some positive findings, when read as a whole, these seem subsumed by the large number of negative findings, some of which are very worrying. Continue reading

The vexed problem of properly discharging elderly patients from hospital back into the community

By John Tingle

The National Health Service (NHS) just does not seem to be able to deal properly with discharging elderly patients from hospital back into the community. There have been major issues in this area going back decades. Stories in the media and official reports regularly appear about ‘bed blocking’ by elderly patients or hospitals discharging them back into the community without proper care arrangements being made.

There is a real fear that the NHS will never be able to turn things around here and that the lessons of the past are not being learnt .There are seemingly intractable problems being faced by trusts, social services and others in doing a proper job with elderly patient discharge.The high financial cost to the NHS of keeping well elderly patients in hospital has also been widely discussed.

Hospitals and social services have faced a barrage of criticism of failing to have coordinated care policies and arrangements leading in some cases to deaths of patients.
Two reports have been published recently which show that patient safety is being seriously compromised in this area. Continue reading

NOW ONLINE! Oxford Union Debating Society DNA Manipulation Debate

DNA fingerprints.The Oxford Union Debating Society at Oxford University has published full video of its DNA Manipulation Debate, filmed on May 26. The Motion under debate was, “This House Believes the Manipulation of Human DNA is an Ethical Necessity.” Oxford billed its DNA Manipulation Debate as “historic” in a year when rapid advances in gene editing and genome synthesis suddenly confront humans with the possibility of being able to write, edit, re-write, and ultimately control their own genetic destinies.

The team supporting the Motion was led by Sir Ian Wilmut, famous for cloning Dolly the Sheep and now Chair of the Scottish Centre for Regenerative Medicine at the University of Edinburgh, and included Oxford’s noted moral philosopher Julian Savulescu and Oxford student debater Lynda Troung, a fast-rising star in RNA research.

The team opposing the Motion included Dr. Norman Fost, professor emeritus of pediatrics and director of the medical ethics program at the University of Wisconsin; Professor Barbara Evans, Director of the Center for Biotechnology & Law at the University of Houston Law Center and a frequent participant in Petrie-Flom conferences; and Oxford student debater Dr. Rahul Gandhi, a young medical doctor and monk focusing on rural healthcare, who is pursuing an MBA at Oxford this year as a prelude to seeking an MPH at Harvard next year.

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Human Rights Advocacy under Attack

One of the world’s most important human rights law firms is now under attack from a government whose leader has, to put it mildly, a mixed record on human rights.  The firm is the Lawyer’s Collective, which has done some of the most important work within India on HIV, LGBT and gender issues.  The firm’s lawyers have also made great contributions internationally. Indira Jaising has served as a member of the UN Committee on the Elimination of Discrimination Against Women. Anand Grover was the UN Special Rapporteur on Right to Health from 2008 to 2014, during which service he issues several fearless reports that helped move the world forward towards an enabling environment for HIV among the most legally marginalized people.

On June 1, the Indian Union Ministry for Home Affairs suspended the firm’s license to receive foreign funding, contending that the Lawyer’s Collective had violated the Foreign Contribution Regulation Act. The Lawyer’s Collective faces the prospect of having their license cancelled permanently, which would seriously impact their work. Both the suspension order and the Lawyer’s Collective’s response have been widely reported in the Indian media. Continue reading

Brexit: I woke up this morning and the world had changed

By John Tingle

I voted in the referendum yesterday along with many others. The referendum turnout was 71.8%, with more than 30 million people voting. It was the highest turnout in a UK-wide vote since the 1992 general election.

My area, Broxtowe in Nottingham where I live, voted to leave the EU, 54.6%, 35754 votes, remain 45.4% 29672 votes. I live in the East Midlands, Middle England. Deep regional divisions have been laid bare by this referendum. It was notable that London largely voted to stay in the EU whereas in my region there was a notable push to leave, 58.5%.The  referendum result shows British politics has, according to the Guardian newspaper, fractured beyond all recognition since the last referendum on Europe in 1975.

The issues around EU membership have been hotly debated and there was a high level of public interest in what went on. Immigration has been the dominant theme in many areas and health along with a number of other issues has also come up. At this moment we are in a post referendum, after shock stage and picking through the fallout to see what is happening and what is going to happen. People are happy, sad and anxious over the result.It was not that long after the vote was announced by the BBC that our Prime Minister David Cameron said he was going to stand down in October, that was a lot to take in so soon after the result. Looking at some of the posts on Facebook it is striking how many young people feel a sense of betrayal by the vote to leave the EU. Many seem to harbour a deep sense of resentment that they have been robbed of a future by an elder generation, it’s the baby boomers against the millennials. Continue reading

General Medical Practice: Complaint Handling Issues

By John Tingle

There is a new report from Health Service Ombudsman (HSO) on GP (General Medical Practitioner) complaint handling and major failings are revealed. The HSO makes the final decisions on complaints that have not been resolved in England and lies at the apex of the NHS complaints system. The report reveals that some GP practices are failing to handle patient complaints properly. The report is based on evidence from HSO casework files and intelligence gathered by the Care Quality Commission (CQC) , NHS England and Healthwatch England. One hundred and thirty-seven closed complaint cases from November 2014 – November 2015 were analysed. General medical practice forms 90% of all NHS interactions with the general public.The quality of complaint handling by GPs was found to be highly variable:

“…over half of the cases were either good (46%) or outstanding (9%). However, over a third required improvement (36%) and a tenth were inadequate (10%) (p7).”

The report states that there are five areas where general practice has the most scope for improvement: Continue reading

Use of Estimated Data Should Require Informed Consent

Guest post by Donna M. Gitter, Zichlin School of Business, Baruch College, based on Professor Gitter’s presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

The Icelandic biotech firm deCODE Genetics has pioneered a means of determining an individual’s susceptibility to various medical conditions with 99 percent accuracy by gathering information about that person’s relatives, including their medical and genealogical records. Of course, inferences have long been made about a person’s health by observing and gathering information about her relatives. What is unique about deCODE’s approach in Iceland is that the company uses the detailed genealogical records available in that country in order to estimate genotypes of close relatives of individuals who volunteered to participate in research, and extrapolates this information in order to make inferences about hundreds of thousands of living and deceased Icelanders who have not consented to participate in deCODE’s studies. DeCODE’s technique is particularly effective in Iceland, a small island nation that, due to its largely consanguineous population and detailed genealogical records, lends itself particularly well to genetic research.

While Iceland’s detailed genealogical records enable the widespread use of estimated data in Iceland, a large enough U.S. database could be used to make similar inferences about individuals here. While the U.S. lacks a national database similar to Iceland’s, private companies such as 23andme and have created rough gene maps of several million people, and the National Institutes of Health plans to spend millions of dollars in the coming years sequencing full genome data on tens of thousands of people. These databases could allow the development of estimated data on countless U.S. citizens.

DeCODE plans to use its estimated data for an even bolder new study in Iceland. Having imputed the genotypes of close relatives of volunteers whose DNA had been fully catalogued, deCODE intends to collaborate with Iceland’s National Hospital to link these relatives, without their informed consent, to some of their hospital records, such a surgery codes and prescriptions. When the Icelandic Data Protection Authority (DPA) nixed deCODE’s initial plan, deCODE agreed that it will generate for only a brief period a genetic imputation for those who have not consented, and then delete that imputation from the database. The only accessible data would be statistical results, which would not be traceable to individuals.

Are the individuals from whom estimated data is gathered entitled to informed consent, given that their data will be used for research, even if the data is putatively unidentifiable? In the U.S., consideration of this question must take into account not only the need for privacy enshrined in the federal law of informed consent, but also the right of autonomy, which empowers individuals to decline to participate in research. Although estimated DNA sequences, unlike directly measured sequences, are not very accurate at the individual level, but rather at the group level, individuals may nevertheless object to research participation for moral, ethical, and other reasons. A competing principle, however, is beneficence, and any impediment to deCODE using its estimated data can represent a lost opportunity for the complex disease genetics community.

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Legal Dimensions of Big Data in the Health and Life Sciences

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

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Healthcare complaints matter: the need to improve the system

Today consumerism is an essential part of the fabric of British society and complaint systems are heralded in many retail and professional environments. The British public have got used to complaining over the years and this attitude has seeped into the provision of health care services.

Records levels of complaints about the National Health Service (NHS) can be seen to be made every year but the NHS just does not seem to be able to get to grips with developing a good patient complaints handling system.

The Health Service Ombudsman (HSO) lies at the top of the NHS complaints structure and makes the final decisions on complaints that have not be resolved by the NHS in England. The HSO has looked into the quality of NHS complaint investigations where serious or avoidable harm has been alleged.Systemic failings in complaint, patient safety investigations were revealed. Failures which unsurprisingly have appeared in numerous complaints reports over the years before.

For the report, the HSO reviewed 150 NHS complaint investigations where avoidable harm or death was alleged. The HSO also spoke to six different trusts and surveyed over 170 NHS complaint managers to gain insights. An advisory group was later convened by the HSO to test findings.

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When Global Health Norms Meet Medicaid

Special guest post by Nicholas J. Diamond

Medicaid is currently facing a timely, although largely underappreciated, challenge: rebalancing Medicaid long-term services and supports (LTSS). For context, LTSS refer to a broad range of paid and unpaid medical and personal care assistance for individuals who experience difficulty completing self-care tasks due to aging, chronic illness, or disability. According to 2013 estimates, there are approximately 12 million individuals in the U.S. who rely on LTSS, mostly paid for through Medicaid, with a projected increase to approximately 27 million individuals by 2050.

Medicaid has a historical structural bias toward institutional care, such as nursing homes, as opposed to home and community-based services (HCBS), such as home health aides, personal care, chore services, supported employment, rent and food for live-in caregiver, and nonmedical transportation, among many others. Medicaid LTSS rebalancing, therefore, shifts spending away from institutional settings and toward HCBS, which is less expensive and generally preferred by beneficiaries. States may provide HCBS through a complex panoply of federal statutory authorities, including waiver authorities, which afford states wide latitude in designing programs. As you might imagine, with flexibility comes significant variations in how states provide HCBS, which specific types of HCBS they provide, and whether, for instance, cost containment strategies available under certain authorities negatively impact access to needed services. Continue reading

Bioethicist Arthur Caplan: Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do

A new piece by Bill of Health contributor Art Caplan on Forbes:

When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.

The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]

Read the full article here.

Patient safety perspectives from other countries: introducing the WHO Geneva safe childbirth checklist

By John Tingle

Healthcare providers and policy makers can avoid the expense of reinventing the wheel if they try and look beyond their shores for solutions to patient safety problems. In the UK the work of the patient safety unit of WHO in Geneva helps NHS healthcare providers through the development of patient safety tools and other projects. The  WHO multi-professional patient safety curriculum guide is one example. The learning from error – video and booklet is another. Recently launched by WHO is the Safe Childbirth checklist and guide to implementation.

The Checklist will be a useful patient safety tool in developing, transitioning and developed countries. The scale of the problem is very disturbing. WHO calculate that in 2013, 289,000 women died during and following pregnancy and childbirth, and 2.8 million new-borns died within 28 days of birth. Most of these events could have been prevented and mostly occurred in low resource settings. Women and their babies are being very conspicuously failed by health systems which should be helping them. Continue reading

Minnesota: Leading The Way In Patient Safety

By John Tingle

The UK Government and the Department of Health are taking patient safety very seriously and, since the publication of ‘An organisation with a memory’ in 2000, the UK has like the USA been a world leader in the field of patient safety policies, practices and developments.

In the UK we have a very sophisticated patient NHS (National Health Service) patient safety infrastructure and system along with a NHS Adverse incident reporting system, the NRLS (National Reporting and Learning System). Despite having such a ‘Rolls Royce’, well-established patient safety infrastructure and system, terrible patient safety incidents such as that which happened in Mid Staffordshire a few years ago seem to plague the NHS. Patients died because of poor care and, according to the report, “[t]he Inquiry identifies a story of terrible and unnecessary suffering of hundreds of people who were failed by a system which ignored the warning signs of poor care and put corporate self-interest and cost control ahead of patients and their safety.”Our patient system missed the terrible care failings identified in this inquiry report. We are working hard on improving the system and my posts will provide regular updates on what is happening in the UK, Europe and beyond in patient safety.

Patient Safety: A World Problem Continue reading

Introducing Guest Blogger John Tingle

Editor’s Note, June 2016: Thanks to John’s many contributions, he is now a Regular Contributor.

John TingleJohn Tingle is joining Bill of Health as a guest contributor. John’s main area of focus will be on what is happening in the UK in the areas of patient safety, clinical negligence litigation and complaints in health care. Policy documents issued in these areas by various governmental health bodies, NGOs and international health organisations such as WHO will be discussed. He will also be taking a comparative perspective and will be exploring the policies and publications of other countries on these issues. Issues such as human rights in healthcare, medical and nursing accountability, hospital transparency, governance and accountability are also key concepts for discussion.

John is Reader in Health Law at Nottingham Law School, Nottingham Trent University in the UK. He has a fortnightly magazine column in the British Journal of Nursing where he focusses on patient safety and the legal aspects of nursing and medicine. John teaches Tort and Medical Law on the LLB at Nottingham Trent and Patient Safety on the LLM in Health Law and Ethics. Continue reading

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part II)

Special guest post by Nicholas J. Diamond

In Part I, I argued that the Affordable Care Act (ACA), while a monumental step toward improving health care in the U.S., does not fully advance the right to health in a few key respects. Responding to shortcomings in the ability of the ACA to fully advance the right is, in my view, a matter of coalescing domestic health policymaking around the right to health.

Full advancement of the right to health in the U.S. requires a normative commitment to the content of the right as articulated in General Comment 14 and related instruments. This commitment requires internalization of human rights-based norms in domestic health policymaking. Such a commitment would not only encourage the consensus required to design appropriate domestic health policies, but also provide valuable guiding principles to shepherd implementation.

Given the current political climate around the ACA, coupled with an ongoing Presidential election, statutory amendment of the ACA in order to more fully advance the right to health is highly unlikely. What is more, reliance on the rulemaking process to advance the right to health, absent an appropriate statutory foundation, would be misplaced because agency rulemaking authority is itself a statutory construct.

In the alternative, ratification of the International Covenant on Economic, Social and Cultural Rights (ICESCR) could provide just such a commitment. The U.S. is, however, very unlikely to ratify the ICESCR as an Article II treaty. Historically, the U.S. has been reluctant to commit to international human rights instruments and the current Administration has expressed its intention not to pursue ratification (at least as an Article II treaty). Absent ratification, through which international norms are internalized in national policies, it remains unlikely that the right to health becomes a guiding norm in U.S. health policymaking. Continue reading

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part I)

Special guest post by Nicholas J. Diamond

The right to health has played a significant role in global health fora since the World Health Organization first identified the “enjoyment of the highest attainable standard of health” as a “fundamental right of every human being without distinction of race, religion, political belief, economic or social condition” in 1946. Twenty years later, the International Covenant on Economic, Social and Cultural Rights (ICESCR) would set out the right to health in a binding international instrument. Subsequent guidance in 2000 from the United Nations Committee on Economic, Social and Cultural Rights, referred to as General Comment 14, clarified the content of the right to health, as well as articulated four elements—availability, accessibility, acceptability, and quality—that constitute the right.

Despite widespread support in the international community, the U.S. has not ratified the ICESCR. Many have argued that the Affordable Care Act (ACA) is doubtless a significant step toward realization of the right to health in the U.S. Indeed, its design speaks directly, to varying degrees, to each of the four elements of the right to health. While I acknowledge the significance of the ACA in advancing the right to health in the U.S., there are at least three reasons to doubt its ability to fully advance the right. Continue reading

Senator Cruz’s RESULT Act Contains a Particular View of the FDA’s Role – But What About CMS?

Last week, I blogged here about the introduction of the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text) by Senators Ted Cruz and Mike Lee. As I noted, the Act would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. If the FDA declines to grant reciprocal marketing approval, the Act would permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

My post, and additional commentary from numerous other outlets (including RAPS, Vox, and Marginal Revolution) largely focused on the Act itself – on the merits of the various provisions, and on whether those provisions would be effective at accomplishing the Act’s stated goals. But each commentator’s view of the situation depends in large part on their priors about what the purpose of the FDA is, and relatedly, how it should behave to achieve those purposes. In this post, I want to first briefly explain these different views about the purpose of the FDA before explaining the ways in which our views about pharmaceutical regulators are often tied to our views about public health insurers – a point which has largely gone unmentioned in the debate about the RESULT Act.

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New Developments in the Guatemala STD Experiments Case

In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards.  They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.

Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.

As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative.  We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential.  Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles.  The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.

There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed.  But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.

More information on the petition is available here.

Senator Cruz’s RESULT Act Unlikely to Achieve Results

On Thursday, Senators Ted Cruz and Mike Lee introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text), which would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. The Act would require the FDA to grant such “reciprocal marketing approval” within 30 days, unless the FDA makes affirmative determinations about the drug or device’s lack of safety and efficacy. If the FDA declines to grant reciprocal marketing approval, the Act would also permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

Zachary Brennan at RAPS has already provided a helpful explanation of the problems with this proposal, and in particular the problems created if Congress were permitted to override FDA denials of approval. In this post, I want to focus primarily on the Act’s premise. Senators Cruz and Lee argue that this bill would speed approval of drugs and devices “which are currently saving lives in other developed countries, but have not been approved in the U.S. because of FDA red tape.” The implication is two-fold: 1) that drugs are often left languishing at the FDA while they enjoy approval in other countries, and 2) that the FDA has no grounds for failing to approve these drugs. The first argument, about the speed of FDA approval, is made quite frequently by legislators who seek to weaken the FDA’s gatekeeping authority over new drugs and devices in the United States. Unfortunately, it hasn’t really been true for decades. The second argument ignores the historical context of the FDA’s decision-making authority.

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