Surgical ‘Never Events’ in the NHS

By John Tingle

NHS Improvement has just published a report on Surgical ‘Never Events’.The report presents an analysis of the local investigation reports into 38 surgical, ‘Never Events’ from across England that occurred between April 2016 and March 2017 (the last full year with data available).

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Patient Safety and Emergency Room Care in the NHS

By John Tingle

UCL A&E entrance

Pedestrian entrance to the Accident and Emergency Unit at University College Hospital as viewed from the pavement on the Euston Road. (Amanda Lewis/Thinkstock)

In the UK, emergency and urgent care patients visit the A & E (Accident and Emergency) units of local hospitals (known as ERs in the U.S.) A & E service provision is the public face of the NHS. It is seen by many as the bellwether of the national health care system and the basis on which its performance is judged.

The Health and Social Care Regulator of England, the Care Quality Commission (CQC), which maintains important patient safety and health quality reviews, has recently published a report on A & E urgent care that found that the 2017-2018 winter season saw an unprecedented demand for emergency services, continuing a year-over-year increase. The number of emergency admissions has grown by 42 percent over the last 12 years, adding pressure to the NHS.

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The Health Service Ombudsman: NHS Failing Patients with Mental Health Problems

By John Tingle

Failings in National Health Service (NHS) care for patients with mental health problems is a worryingly persistent story in the English media. Many reports show harrowing and dramatic failings in NHS care provision for the mentally ill some of which result in avoidable deaths.The Health Service Ombudsman  (HSO) represents the final stage in the NHS complaints procedure and is an independent  office reporting  directly  to Parliament.The HSO carry’s out investigations into complaints  and makes the final decisions on those that have not been resolved by the NHS in England.In a recently published report the HSO reveals reveals unjust, shocking and tragic failings  in NHS care provision for patients with mental health problems.Some mental health care complaints figures are given in the report.In 2016-2017 there were 14,106 complaints made to NHS mental health trusts (hospitals) with ,65% being upheld or partly upheld by the local organisation.Case work data between 2014-15 and 2017-18 was analysed and five key themes showing persistent failings that the HSO see in complaints being made emerged from this exercise:

  • Diagnosis and failure to treat.
  • Risk assessment and safety
  • Dignity and human rights.
  • Communication.
  •  Inappropriate discharge and provision of aftercare.

The HSO also points out in the report that the other common factor in the cases examined is too frequent substandard complaint handling by the NHS organisation. This adds insult to injury, compounding the impact of failings. Continue reading

The New NHS Never Events Policy and Framework

By John Tingle

In tort law we have a very well-known Latin phrase, ‘Res Ipsa Loquitur’ (the thing speaks for itself). An inference of negligence can be raised by the events that occurred. In the National Health Service (NHS) in England there is a similar concept,‘the Never Event’. The Never Event concept is a USA import into the NHS and was introduced  from April 2009. The list of what is to be regarded as a Never Event has been revised over the years in the NHS and is currently set out by NHS Improvement.

Never events include, wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route and so on. Never Events are defined in NHS policy documentation as:

“…patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers.  Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.” (p.6) Continue reading

Current trends in clinical negligence litigation in the National Health Service (NHS)

By John Tingle

NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.

NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.

Facts, figures and trends Continue reading

WHO: Global Patient Safety Leadership

By John Tingle

The World Health Organisation (WHO) has just produced a very informative and helpful report on the need to view patient safety as a global concern and to highlight resources that they have made available to deal with the problem and those in development. Patient safety is a fundamental principle of health care and this is fully acknowledged in the report. The report begins by quoting several facts and figures which emphasize the fact that medical errors should be regarded as a matter of acute global concern:

“According to a new study, medical errors are the third leading cause of death in the United States. In the United Kingdom, recent estimations show that on average, one incident of patient harm is reported every 35 seconds. Similarly, in low- and middle income countries, a combination of numerous unfavourable factors such as understaffing, inadequate structures and overcrowding, lack of health care commodities and shortage of basic equipment, and poor hygiene and sanitation, contribute to unsafe patient care (p1).”

Approximately two-thirds of all adverse health events happen in low-and middle-income countries. Fifteen per cent of hospital expenditure in Europe can be attributed to treating patient safety accidents. Continue reading

Patient Safety in the NHS: The Culture Change Agents

By John Tingle and Jen Minford 

It is important to take a broad holistic approach when looking at patient safety policy development and practice in the NHS. There cannot be a one size fits all approach and a number of possibly quite disparate organisations and stakeholders in the NHS and beyond must be consulted and involved so that effective and positive culture change takes place.

The  CQC (Care Quality Commission) is a major patient safety culture change agent whose job is to ensure that health and social care services provide people with safe, effective, compassionate and high-quality care. The CQC encourages care service providers to be on an upward trajectory of improvement. They have recently produced a report to analyse what impact they have on quality and improvement in health and social care. The report provides evidence that the CQC is having a significantly positive impact  on regulating care and ensuring good standards.

A majority of new providers and registered managers responding to a CQC survey said that their guidance and standards are clear. The CQC approach to regulation and their standards have an influence on how some providers measure their own quality. CQC inspection reports were also said to be useful. Continue reading

Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.

There is also the concept of ‘reverse innovation’.  Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Continue reading

The National Health Service (NHS) in England is standing on a burning platform?

By John Tingle

In the introduction to a new report on the state of acute hospitals in the NHS in England, the Chief Inspector of Hospitals, Professor Sir Mike Richards of the Care Quality Commission (CQC) controversially states:

“The NHS stands on a burning platform — the model of acute care that worked well when the NHS was established is no longer capable of delivering the care that today’s population needs. The need for change is clear, but finding the resources and energy to deliver change while simultaneously providing safe patient care can seem near impossible.” (p.4)

This statement raises the fundamental question of whether the current model of the NHS is,’ fit for purpose’? The NHS since its formation has always had both a good and bad press. Since its inception it always been short of resources. Changing times bring with them new demands which can make established health care delivery structures obsolete and no longer capable of delivering optimal performance. One important NHS developing health care trend is the need to keep pace with a growing elderly population with more complex health needs along with other trends. Continue reading

Undocumented Organ Transplants

By Brad Segal

Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.

He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.

The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Continue reading

Improving the safety of maternity care in the National Health Service (NHS) and other medico-legal matters

By John Tingle

There are some very interesting Government patient safety and access to justice policy development activities currently going on in England.

Maternity Services

In maternity services, there is a clear recognition by Government that safety is inconsistent and that there is significant scope for improvement. Our still birth rates are amongst the highest in Europe despite the National Health Service (NHS) making advances in patient safety in this area. In the National Maternity Review we are reminded that half of the Care Quality Commission (CQC) inspections of maternity services result in safety assessments that are either ‘inadequate’ (7%) or ‘requires improvement (41%) (page 22). The CQC is the independent regulator of health and social care in England.

In a speech to the Royal College of Obstetricians and Gynaecologists (RCOG) in London, the Secretary of State for Health, 17th October, 2016, Jeremy Hunt laid out plans to make giving birth safer, including maternity safety funding and other related matters. The Government’s ambition is to halve neonatal death, stillbirth, maternal death and brain injuries caused during or shortly after labour by 2030 and a series of measures were  launched. There will be a £250,000 maternity safety innovation fund and a new national Maternity and Neonatal Health Quality Improvement Programme. New maternity ratings will also be published to help improve transparency, raise standards and will give families better information about the quality of local maternity services.

A safe space Continue reading

Learning from adverse health care events in Scotland

By John Tingle

We can learn a lot from how other countries deal with patient safety issues and it can save us from reinventing the wheel at some financial cost.Healthcare improvement Scotland  (HIS) is the national healthcare improvement organization for Scotland and is part of NHS Scotland. The organization provides some excellent patient safety resources. The work of HIS involves supporting and empowering people to have an informed voice in managing their own care and shaping how services are designed and delivered. Delivering scrutiny activity, providing quality improvement support and providing clinical standards, guidelines and advice. HIS produce a rich range of programmes and publications that are relevant to all those concerned with patient safety and health quality in England, USA and elsewhere.

A recent report from HIS focuses on the adverse event lessons learned by health boards and the improvements they subsequently put into place after the events,Learning from adverse events – Learning and improvement summary: May 2016 There is some very good thinking in the report which should be essential reading for all staff involved in patient safety policy development.

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Trap for the Unwary: Records compiled by a hospital’s risk-management specialist held discoverable

By Alex Stein

In a recent case, Frankfort Reg. Med. Ctr. v. Shepherd, 2016 WL 3376030 (Ky. 2016), the Kentucky Supreme Court held that the attorney-client privilege and its work-product extension do not protect records compiled by a hospital’s risk-management specialist. Records that the Court held to be discoverable contained information pertaining to a baby delivery that went badly. The risk-management specialist gathered that information with an eye on a possible medical malpractice suit, but her primary goal was risk management (which presumably precluded the applicability of the “subsequent remedial measures” privilege).

The Court’s decision relied on the familiar “dominant purpose” test, under which the attorney-client privilege only covers documents compiled primarily in preparation to litigation. Understandable as it may be from a purely doctrinal viewpoint, this decision makes no economic sense. All it does is create a trap for the unwary and an opportunity for hospitals familiar with the law to protect their risk-management information against disclosure. To obtain the needed protection, all that a hospital needs to do is ask its in-house counsel or outside attorney to control the risk-management procedures and decisions, so that risk management becomes part of the attorney’s work as a protector of the hospital’s legal interests. Doing so isn’t difficult but costlier than simply relying on a risk-management consultant.

Can Negligent Providers of Medical Care Use the Patient’s Self-Destructive Behavior to Fend Off Liability?

By Alex Stein

The Colorado Supreme Court recently delivered an important decision on medical malpractice, P.W. v. Children’s Hospital Colorado, — P.3d —- (Colo. 2016), 2016 WL 297287. This decision denied a hospital the comparative negligence and assumption of risk defenses that purported to shift to the patient the duty to eliminate or reduce the risk that the hospital was obligated to guard against.

The defendant hospital admitted a known suicidal patient to its secure mental health unit and placed him under high suicide-risk precautions. The hospital’s staff failed to follow those precautions by allowing the patient to be alone in a bathroom for twenty minutes. During these twenty minutes, the patient hanged himself with his scrub pants and suffered a devastating anoxic brain injury. Continue reading

Hospitals’ Exposure to Products Liability Suits

By Alex Stein

The United States District Court for the District of Connecticut has recently delivered an important decision that opens up new possibilities for suing hospitals and clinics. This decision allowed a patient alleging that hospital employees injected her with a contaminated medication to sue the hospital in products liability. Gallinari v. Kloth, — F.Supp.3d —- (U.S.D.C. D.Conn. 2015), 2015 WL 7758835. Continue reading

“Medical Malpractice or Ordinary Negligence?” in the Context of Psychiatric Treatment

By Alex Stein

“Medical Malpractice or Ordinary Negligence?” is an issue that will stay on the courts’ agenda for long. See hereherehereherehere, here, and here.

As I explained in these posts and in a foundational article on medical malpractice, categorizing a plaintiff’s action as “medical malpractice” rather than “ordinary negligence” determines whether it must satisfy rigid limitations and repose provisions, comply with special and costly requirements with regard to expert testimony, face the difficult burden of proving the defendant’s deviation from the medical profession’s customary practices and protocols, and suffice itself with the compensation amounts allowed by the statutory caps on damages.

A recent Florida court decision, Shands Teaching Hosp. & Clinics v. Estate of Lawson, — So.3d —- 2015 WL 5057325 (Fla. 5th DCA 2015), illustrates the centrality of this issue for suits complaining about a psychiatric hospital’s neglect. Continue reading

Uninsured Practice of Medicine as Actionable Tort

By Alex Stein

A week ago, the Supreme Court of New Jersey has delivered an important decision on whether uninsured practice of medicine is actionable in torts. Jarrell v. Kaul, — A.3d —- 2015 WL 5683722 (N.J. 2015). This decision involved an uninsured anesthesiologist who allegedly provided negligent pain management treatment to a patient. Under New Jersey statute, N.J.S.A. 45:9–19.17; N.J.A.C. 13:35–6.18(b), a physician’s license to practice medicine is only valid when she holds medical-malpractice liability insurance in the requisite amounts. Continue reading

“Medical Malpractice” vs. General Negligence: The Case of Falling Accidents

By Alex Stein

As I wrote previously – see here, here, here, here, here, here, here, here, and here – whether a tort action sounds in “medical malpractice” as opposed to general negligence, or vice versa, can be crucial. Suits sounding in “medical malpractice” must satisfy special requirements that include shortened limitations periods, statutes of repose, and expert affidavits (or certificates of merit) at filing. In many states, those suits are also subject to special damage caps. Suits sounding in general negligence are free from these constraints. Filing and prosecuting those suits is consequently not as onerous and expensive as filing and prosecuting medical malpractice actions. For that reason, we witness many disputes over this pivotal categorization issue. Continue reading

Do Medical-Malpractice Time Bars Apply to Hospitals’ Indemnification Suits Against Doctors?

By Alex Stein

The South Carolina Supreme Court has recently decided that a hospital’s indemnification suit against doctors whose malpractice made it pay compensation to the aggrieved patient is subject to the same time bars as patients’ actions against defaulting physicians. Columbia/CSA-HS Greater Columbia Healthcare System, LP v…., — S.E.2d —- (2015), 2015 WL 249536 (S.C. 2015).

Chief Justice Jean Hoefer Toal wrote a vehement dissent in which she was joined by Justice Kaye Hearn. In that dissent, she wrote that “The majority’s holding represents a fundamental misunderstanding of the nature of indemnification actions which I fear will have far-reaching effects on the ability to seek indemnification.”

The Chief Justice was absolutely right. Continue reading

Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

By Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen

This new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen appears on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.