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).
By John Tingle
Tragic stories of mental health care failings leading to injury and in some cases death have featured strongly in the English media in recent years. The reports reveal common threads such as poor resources, inadequate staffing levels, limited service availability, poor inter-agency cooperation, poor patient engagement, poor understanding of the Mental Capacity Act 2005 and so on. This care area seems to largely remain a Cinderella health care service provision, existing in the shadows, with the focus being predominantly on physical acute care. There are however now welcome and firm Government commitments to drive improvement into mental health care supported by a raft of promising initiatives.
When patient stories of learning disability and autism care failings are read from several reference sources a picture emerges. Care for people with learning disability and autism can be seen to share many of the patient safety and health quality problems that beset patients who are classified as being mentally ill: Read More
By John Tingle
One thing that strikes the UK visitor to the USA is the vast array of large public and private hospitals that exist with many having trauma and emergency rooms. Private hospitals don’t exist on this scale in the UK. Our major hospitals are public, state run NHS (National Health Service) hospitals. Independent, private acute hospitals are generally small in size, have no emergency rooms and maintain a bespoke health care provision. The focus is on patients with a single condition and routine elective surgery. The myriad number of complex multiple conditions, dementia etc that the NHS regularly face as a norm are not covered in the independent sector here with such cases being screened out. This limited focus on the type of care provided does mean that staff within independent acute hospitals have a sheltered and more controlled work remit and environment. This is a significant patient safety issue.
The Independent Health and Social Care Regulator of England, the Care Quality Commission (CQC) have recently published their findings of independent acute hospital inspections. They inspected and rated 206 independent acute hospitals and the majority were assessed as providing high quality care. At 2nd January 2018, 62% were rated as good,16 (8%) as outstanding. The report contains some very positive findings on health care provision in these hospitals but also some major governance and patient safety failings were found which are very concerning.
The Independent Newspaper reported back in 2015 reported that private hospitals ‘lack facilities to deal with emergencies’, and quoted a study that found that between 2010 and 2014, 800 patients, including those referred by the NHS, died unexpectedly in private hospitals. Read More
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.
- 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. Read More
By John Tingle
The Guardian newspaper recently published it’s investigation into Coroners Prevention of Future Deaths Notices (PFDN’s) issued between 2012-2017 involving people receiving NHS care for mental health conditions. The findings from its investigation are shocking; many cases deaths could have been prevented had better care been given. Some errors identified are classic patient safety errors and these included:
- Poor communication between agencies and/or staff, non-observation of protocols or policies (or lack of protocols or policies.
- Lack of appropriate care or continuity of care.
- Poor record keeping, poor communications with the patient or his or her family.
- Insufficient risk assessment and delays.
The investigation revealed 45 cases reported by the coroner where patients were discharged too soon or without adequate support. Seventy-two instances of poor or inappropriate care, 41 cases where treatment was delayed.
Children and young people’s mental health
The Care Quality Commission (CQC) is the the independent regulator of health and social care in England and they have recently reviewed children and young people’s mental health services and have found significant systems failures which could well put children and young people at risk of harm. Mental health problems are the report states, quite common in children and young people with estimates suggesting around 1 in 10 being affected.
By John Tingle
The Care Quality Commission (CQC) is the independent regulator of health and social care in England and they have recently produced their annual report to Parliament on how health services are applying the Mental Health Act 1983 (MHA) .This report, shines a very strong light on failing health care practices in mental health care relating to the MHA. Shocking failures are revealed and the errors are compounded by the fact that the poor practices have been identified in previous reports and are long standing in nature.
The CQC state that national data from the last 25 years shows an increasing use of the MHA to treat people in hospitals. From 2005/06 to 2015/16, the reported number of uses of the MHA to detain people in hospital increased by 40%. There was a 9% increase from 2014/15 to 2015/16 rising to 63,622 uses of the MHA. The CQC can find no single cause for the increases in detention rates over the last 10 years.
The CQC once again draw attention to the persistent theme present in its previous reports of black and minority ethnic over representation figures in the use of the MHA.
The CQC found that there are still services that continue to fail in their legal duties to give patients information about their rights, verbally and in writing as soon as possible after their detention or community treatment order commences. They found no evidence that staff had discussed rights with the patient on admission in 11 % (378) of patient records that they checked. In a further inspection of 9%, (286) of records, no evidence could be found to say that patients received the information in an accessible format.
Consent to treatment
The CQC state that they have concerns about whether the patient consents, refuses consent or is incapable of consent. They expect to see capacity assessments to support views and possibly evidence that staff have considered ways in which they could help the patient gain or regain capacity. They have frequently raised concerns over whether clinicians have recorded evidence of their conversations with patients who are detained over their proposed treatment and their views. Read More
Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.
The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.
Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Read More
Biobanks as Knowledge Institutions
“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)
Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison.
The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Read More
By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie
The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).
Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.
Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy. But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Read More
I am happy to announce our “Global Genes, Local Concerns Symposium on Legal, Ethical and Scientific Challenges in International Biobanking” to be held at the University of Copenhagen (DK) on 16 March 2017, 08:00-18:30. Among the many prominent experts speaking at this conference we find the PFC’s very own Glenn Cohen and several speakers with a PFC “history” or close PFC links, such as Bartha Knoppers, Tim Caulfield, Nicholson Price and Jeff Skopek.
This Symposium marks the final phase of the Global Genes-Local Concerns project. In accordance with the goals of this large cross-faculty project, the Symposium deals with legal, ethical and scientific challenges in cross-national biobanking and translational exploitation. Leading international experts and invited speakers will discuss how national biobanks contribute to translational research, what opportunities and challenges regulations present for translational use of biobanks, how inter-biobank coordination and collaboration occurs on various levels, and how academic and industrial exploitation, ownership and IPR issues could be addressed and facilitated. Special emphasis will be laid on challenges and opportunities in addressing regulatory barriers to biobank research and the translation of research results, while at the same time securing ethical legitimacy and societal interests.
These issues will be dealt with in 4 main sessions covering (1) BIG DATA AND MODES OF COLLABORATION; (2) PATIENT INVOLVEMENT; (3) TRANSLATIONAL MEDICINE & TECH TRANSFER, as well as (4) GUIDELINES & GOOD GOVERNANCE.
- Bartha Knoppers, Mc Gill University (Canada)
- Glenn Cohen, Harvard University (US)
- Timo Minssen, University of Copenhagen (DK)
- Tim Caulfield, University of Alberta (Can)
- Michael Madison, University of Pittsburgh (US)
- Jeff Skopek, University of Cambridge (UK)
- Brian Clark, Director, Human Biosample Governance, Novo Nordisk A/S (DK)
- Jane Kaye, University of Oxford (UK)
- Anne Cambon-Thomsen, INSERM, Toulouse / CNRS Director (Fr)
- Klaus Høyer, University of Copenhagen (DK)
- Aaro M. Tupasela, University of Copenhagen (DK)
- M. B. Rasmussen, University of Copenhagen (DK)
- Åsa Hellstadius, Stockholm University (Sweden)
- Peter Yu, A&M Texas University (US)
- Esther van Zimmeren, University of Antwerp/Leuven (Belgium)
- Nicholson Price, University of Michigan Law School (US)
- Karine Sargsyan, BBMRI/Head of Biobanking-Graz (Austria)
- Eva Ortega-Paino, BBMRI, Lund University (Sweden)
- Nana Kongsholm, University of Copenhagen (DK)
- Klemens Kappel, University of Copenhagen (DK)
- Helen Yu, University of Copenhagen (DK).
For participation in the event please use this registration form no later than Friday, 10 March 2017, 12:00 at the latest.
We are looking very much forward to welcoming you in wonderful Copenhagen on 16 March 2017.