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Keep up to date with the latest news, research and activity in patient safety.

Investigation launched after seven ‘never events’ in two years at leading trust

An external review has been launched at a leading children’s hospital after a series of “never events”.
According to local commissioners, a review by the Association for Perioperative Practitioners will look into seven incidents at Alder Hey Children’s Foundation Trust over the last two years. The probe had been delayed by the pandemic and began this month.  
Great Ormond Street Hospital for Children FT and Sheffield Children’s FT, the two other dedicated children’s trusts in England, reported one and four never events respectively, between April 2018 and July 2020, according to national data.
In a statement, Alder Hey claimed it could not provide further details of the incidents. But most have been described in its board papers over the past year. They include a 15-year-old who had the wrong tooth removed by the surgical division, a patient who had the wrong eye operated on, a swab that was left inside a patient having their adenoids and tonsils removed, and an incorrect implant being inserted into an orthopaedics patient.
Liverpool Clinical Commissioning’s group’s board papers for September said: “The trust has had a series of seven never events and there is a plan to undertake an external review that has been delayed due to the pandemic response. The trust has approached the Association for Perioperative Practitioners and have agreed the process."
“The trust also plans to work with Imperial College London on a peer review and bespoke human factors training to include simulation training and coaching. The trust also plans to produce an overarching action plan to bring together the themes and learning from the seven never events. This work is still underway and NHSE/I and CCG had requested a copy of this plan.”
Read full story (paywalled)
Source: HSJ, 24 September 2020
Sam

"I’m one of the legion of long-Covid sufferers"

Hundreds of thousands who survived the virus still have side-effects that range from loss of smell to chronic fatigue.
"It started with a mild sore throat. I was in Devon at the beginning of the lockdown, and because I hadn’t been on a cruise ship, gone skiing in Italy or partying with the crowds at Cheltenham races, I didn’t think it could be COVID-19. Then I developed sinusitis. My GP was practical: “This is not a symptom of the virus,” he emailed me. But my sense of smell had disappeared. At first this wasn’t a sign but six months later, I still can’t tell the difference between the smell of an overripe banana or lavender. I can distinguish petrol but not gas, dog mess but not roses, bacon but not freshly cut grass. Everything else smells of burnt condensed milk."
Read full story (paywalled)
Source: The Times, 23 September 2020
Sam

Coronavirus: Tens of thousands ‘wrongly given’ all clear by Lighthouse Labs

Tens of thousands of people infected with coronavirus were incorrectly given the all clear by England’s Lighthouse Laboratories, a High Court trial will be told next week.
Court documents seen by The Independent show the labs are accused of unfairly selecting software that was shown in a test to produce significant numbers of errors and false negatives, samples that should have been positive or classed as needing to be re-taken.
The two companies behind the Lighthouse Labs in England – Medicines Discovery Catapult Ltd and UK Biocentre Ltd – are accused of treating British company, Diagnostics.ai unfairly and giving preferential treatment to Belgian company UgenTec, despite the British firm’s software performing better in the test.
The case, first revealed by The Independent in June, also includes a judicial review of the procurement decision against health secretary Matt Hancock – one of the first court hearings over the procurement processes followed by the government since the start of the pandemic.
The Independent understands lawyers for Diagnostics.ai will accuse the laboratories of choosing a software solution that went on to produce tens of thousands of incorrect results which will have led to infected people going about their normal lives while at risk of spreading the virus.
In June, UgenTec chief executive Steven Verhoeven told The Independent the suggestion its software had made errors was “incorrect”.
The Department of Health refused to comment on the legal action but said in June that the UgenTec software had been used for several months and was subject to quality assurance processes, though it did not give any further details.
Mr Justice Fraser will hear opening arguments in the case on Monday at the High Court.
Read full story
Source: The Independent, 25 September 2020
Patient Safety Learning

Why India should worry about post-COVID-19 care

When 60-year-old Milind Ketkar returned home after spending nearly a month in hospital battling COVID-19, he thought the worst was over.
People had to carry him to his third-floor flat as his building didn't have a lift. He spent the next few days feeling constantly breathless and weak. When he didn't start to feel better, he contacted Dr Lancelot Pinto at Mumbai's PD Hinduja hospital, where he had been treated.
Dr Pinto told him inflammation in the lungs, caused by Covid-19, had given him deep vein thrombosis - it occurs when blood clots form in the body and it often happens in the legs.
Fragments can break off and move up the body into the lungs, blocking blood vessels and, said Dr Pinto, this can be life-threatening if not diagnosed and treated in time.
Mr Ketkar spent the next month confined to his flat, taking tablets for his condition. "I was not able to move much. My legs constantly hurt and I struggled to do even daily chores. It was a nightmare," he says.
He is still on medication, but he says he is on the road to recovery.
Mr Ketkar is not alone in this - tens of thousands of people have been reporting post-Covid health complications from across the world. Thrombosis is common - it has been found in 30% of seriously ill coronavirus patients, according to experts. These problems have been generally described as "long Covid" or "long-haul Covid".
Awareness around post-Covid care is crucial, but its not the focus in India because the country is still struggling to control the spread of the virus. It has the world's second-highest caseload and has been averaging 90,000 cases daily in recent weeks.
Dr Natalie Lambert, research professor of medicine at Indiana University in the US, was one of the early voices to warn against post-Covid complications.
She surveyed thousands of people on social media and noticed that an alarmingly high number of them were complaining about post-Covid complications such as extreme fatigue, breathlessness and even hair loss.
The Centre for Disease Control (CDC) in the US reported its own survey results a few weeks later and acknowledged that at least 35% of those surveyed had not returned to their usual state of health.
Post-Covid complications are more common among those who were seriously ill, but Dr Lambert says an increasing number of moderately ill patients - even those who didn't need to be admitted to hospital - haven't recovered fully.
Read full story
Source: BBC News, 28 September 2020
Sam

Did the NHS 111 Covid helpline fail hundreds of families?

Hundreds of people believe the 111 helpline failed their relatives. Now the Guardian reports that they are demanding a full inquiry into the service.
When the coronavirus outbreak hit in March, the NHS feared hospitals could be overwhelmed and so patients with suspected symptoms were directed to call the designated 111 helpline. Call volumes were massive and waiting times were often over an hour.
The Guardian’s David Conn has spent months talking to bereaved relatives about that difficult time and during his conversations he found many were deeply unhappy about the service they felt had been provided by the 111 helpline.
Lena Vincent’s partner Patrick McManus died from the virus in April following a short period in hospital. He had called 111 three times and had not been advised to seek further medical help. Lena tells Anushka she wants to know who is accountable for the service.
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Source: The Guardian, 28 September 2020
Sam

NHS announces independent review into gender identity services for children and young people

The NHS has announced that Dr Hilary Cass OBE, former President of the Royal College of Paediatrics and Child Health, will lead an independent review into gender identity services for children and young people.
The review will be wide-ranging in scope looking into several aspects of gender identity services, with a focus on how care can be improved for children and young people including key aspects of care such as how and when they are referred to specialist services, and clinical decisions around how doctors and healthcare professionals support and care for patients with gender dysphoria.
It will also set out workforce recommendations for specialist healthcare professionals and examine the recent rise in the number of children seeking treatment. Dr Cass will then make clear recommendations for children and young people’s gender identity services reporting back next year.
The Gender Identity Development Service for Children and Adolescents is managed by the Tavistock and Portman NHS Foundation Trust.
The Care Quality Commission (CQC) is due to carry out a focused inspection of The Tavistock and Portman NHS Foundation Trust, Gender Identity Services for children and young people, during the autumn. The inspection will cover parts of the safe, effective, caring, responsive and well-led key questions and will include feedback from people using the service, parents, relatives, carers, and staff. Separately, Dr Cass will also review the service’s clinical practice with the support of the Royal College of Paediatrics and Child Health and engagement of other professional bodies to provide multi-professional insight working closely with the CQC.
The review includes an examination of the issues surrounding children and young people who are prescribed puberty blocking and cross sex hormone drugs.
Dr Hilary Cass OBE, independent chair, said: “It is absolutely right that children and young people, who may be dealing with a complexity of issues around their gender identity, get the best possible support and expertise throughout their care.”
“This will be an inclusive process in which everyone will have the opportunity to make their views known. In particular I am looking forward to hearing from young people and their families to understand their experiences.
“This review provides an opportunity to explore the most appropriate treatment and services required.”
Read full story
Source: NHS England, 22 September 2020
Sam

Cwm Taf maternity: Mothers to be told of service failings

Parents affected by serious failings in maternity units at a Welsh health board will be told of the findings of an independent investigation this autumn. Ten more cases at units run by Cwm Taf Morgannwg in the south Wales valleys have been found by a review, bringing the total number to 160.
Maternity services at hospitals in Merthyr Tydfil and Llantrisant were placed in special measures last year. Failings at the maternity units were discovered after an investigation by two Royal Colleges, which found mothers faced "distressing experiences and poor care" between 2016 and 2018.
The services at the Royal Glamorgan Hospital in Llantrisant and Prince Charles Hospital in Merthyr Tydfil were also found to be "extremely dysfunctional" and under extreme pressure.
A number of recommendations were set to make the service safe for pregnant women and those giving birth at the hospitals.
The Welsh Government then appointed the Independent Maternity Services Oversight Panel (IMSOP) to look back at cases, including neonatal deaths.
Mick Giannasi, the chairman of IMSOP, said: "In the early autumn, we will start writing to mothers to say we have reviewed your care and this is what we found.
"That will be quite distressing for the women because they will have to revisit all those things again.
"But it's going to be a difficult period for staff as well because we know that the Royal Colleges review was very difficult for staff - some of the messages that they had to hear were very challenging and those things may be played out again."
Read full story
Source: BBC News, 28 September 2020
 
Sam

'A one-off test is a folly': The truth behind covid false negative covid results

When Sarah found herself suffering sudden bouts of breathlessness in May, she took herself to hospital. But after her COVID-19 swab test came back negative, doctors said she was probably anxious, and sent her home.
Despite this, Sarah’s symptoms continued to worsen. A week later, she was rushed to hospital in an ambulance. Paramedics told her that based on her clinic observations, she should be in a coma.
Then came more surprising news: She had tested positive for coronavirus
Sarah’s story – given to a patient safety charity under a pseudonym – is one that resonates with Dr Claudia Paoloni, president of the Hospital Consultants and Specialists Association. She detailed another case in which a patient tested negative twice: once when she was first admitted to hospital and once later in her hospital stay. She finally tested positive on her third test – by which time she was on a ventilator in intensive care.
Paolini believes COVID-19 swab tests produce a troublingly high rate of false negative results, and the problem lies in the reliance on a single test.
“To use as a one-off test in any capacity to exclude someone from having COVID-19 is a folly.” 
If you want to exclude someone from having the virus, Paoloni said, you must do multiple tests and collect multiple negative results. “If the test and tracing system is not working, which is the case here, transmission will continue unabated in the community.”
The most recent data published by the Office for National Statistics says the test’s sensitivity - which it says can tell us how likely it is to return a false-negative result, may be somewhere between 85% and 98%. 
Dr Deenan Pillay, Professor of Virology at University College London and member of Independent Sage, a group of scientists providing transparent advice during the crisis, said a significant number of self-administered tests could be coming back negative for people who do in fact have the virus.
“The single biggest reason why a swab from someone who has COVID-19 comes up as negative is the quality of the swab that is taken,” Dr Pillay said. “Swabbing your nose and throat in a way that will pick up the virus means really scraping down the side of the wall of the nose or back of the throat to get cells from the lining of the throat. That’s not a pleasant thing to do.”
This is of course true for at-home testing, which relies on the patient or a family member to collect the swab. But it could be true at testing centres, too.
Tom, a 29-year-old from London whose name has been changed for this story, said there were no medical staff on site when he visited a Covid testing centre in London. The only people he interacted with were staff from a third-party contractor paid to carry out testing.
“The man simply handed me a test, read out the instructions to self-administer the test, and asked me to do it myself,” he said.
Pillay agrees that testing methods are likely to have an impact on false negative results. “I have seen the documentation given out at testing centres and it is very confusing,” he said. “Centres often expect you to administer the test yourself or get someone else in your car to administer it for you, all of which creates difficulties.” 
Pillay believes the solution lies in having medically trained staff at testing centres. “The way the system is developed at the moment, outsourced to private companies like Deloitte and Lighthouse Labs, is just woeful,” he said.
“The whole system is failing at the moment. And it’s happening just as the numbers of infections are starting to rise,” Dr Pillay said.
Read full story
Source: Huffpost, 27 September 2020
Patient Safety Learning

Coronavirus: NHS faces pandemic 'triple whammy' this winter

The NHS is facing a "triple whammy" of rising COVID-19 cases, a major backlog in treatment and reduced capacity due to infection-control measures, according to health bosses. 
The NHS Confederation report on the English NHS said more investment was desperately needed. The NHS bosses also called on ministers to be "honest and realistic" about waiting lists for treatment.
It comes despite the government promising an extra £3bn this winter. That money - announced over the summer - was intended to help hospitals cope with the extra-infection control measures required and to pay for patients to be treated privately for routine treatment, such as knee and hip replacements. 
But hospitals are still performing only half the number of routine operations they normally would. Two million patients have already waited longer than 18 weeks for treatment, the highest number since records began, in 2007.
And services in other areas, such as cancer care, are running at about three-quarters capacity. 
Of the more than 250 bosses who responded to the confederation's survey:
fewer than one in 10 said the current level of funding allowed them to deliver safe and effective care nearly nine in 10 said a lack of funding would be a significant barrier to achieving waiting-time targets for everything from mental-health care to cancer treatment and routine operations. Read full story
Source: BBC News, 29 September 2020
Patient Safety Learning

Leaked data gives first view of growing cancer waiting list post covid peak

Official data from mid-September shows that nearly 6,400 people had waited more than 100 days following a referral to cancer services.
The leaked data reveals for the first time the length of the cancer waiting list in the wake of the first pandemic peak, during which much diagnostic and elective cancer care was paused.
The list consists of those waiting for a test, the outcome of a test, or for treatment. NHS England and Improvement only publish waiting times for patients who have been treated – not the number still waiting – so this information has been secret.
The data, obtained from official emails seen by HSJ, showed the total number of people on the cancer waiting list grew substantially, from 50,000 to around 58,000, between the start of August and the middle of September. 
Of the 6,400 people recorded to be waiting more than 104 days on 13 September, 472 had a “decision to treat classification”, meaning they have cancer and are awaiting treatment. 
NHS England has said reducing the cancer waiting list would be overseen by a national “taskforce”, which is being chaired by national director for cancer Peter Johnson.
Experts have warned the delays already stored up in the system could cost tens of thousands of lives as patients go undiagnosed or have their diagnosis and treatment later than they otherwise would.
HSJ asked NHS England if harm reviews had been carried out for those on the waiting list and whether it had discovered if those waiting longer than104 days had been harmed, but did not receive an answer.
Read full story (paywalled)
Source: HSJ, 29 September 2020
Patient Safety Learning

Covid ICU survivor: 'I have come out the other end'

Covid survivor Tam McCue is one of the lucky ones. Earlier in the year he was in intensive care in the Royal Alexandra Hospital in Paisley where he had been on a ventilator for nearly two weeks.
At one point Mr McCue, who could barely speak, didn't think he would live. 
Fast forward five months and Mr McCue, of Barrhead, East Renfrewshire, is back from the brink.
He became desperately ill but, thankfully, it only went as far as his lungs. With coronavirus some patients have have suffered multiple organ failure which also affected their heart, kidneys, brain and gut.
Mr McCue describes his recovery as a "rollercoaster".
He added: "It's a slow process. You think you can do things then the tiredness and fatigue sets in."
He said: "It lies in the back of your mind. As years go on, how are you going to be? Is it going to get you again? It does play on you. It definitely does."
As part of his recovery Mr McCue is attending the Ins:pire clinic online. It is normally a face-to-face rehabilitation clinic which involves multiple specialties, including pharmacists, physiotherapists and psychologists. Mr McCue is one of the first Covid survivors to take part in the five-week programme, which started earlier this month.
Read full story
Source: BBC Scotland News, 29 September 2020
Patient Safety Learning

COVID-19: Government poised to amend regulations to allow use of unlicensed vaccine

Experts say robust legal protections are needed to inspire public confidence. The UK government has set out plans to amend drug regulations in case it decides that COVID-19 vaccines should be used before they are licensed, in a bid to roll them out more quickly.
In a consultation on the proposals that ran from 28 August to 18 September the Department of Health and Social Care for England explained that if a suitable vaccine emerged with strong evidence of safety, quality, and efficacy the government would seek to license it through the usual route but could supply it in the meantime.
The document added, “A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality, and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested.”
The consultation, and the timeframe in which it was conducted, prompted some people to post their concerns on social media. 
However, the Human Medicine Regulations 2012 already allow the licensing authority to temporarily authorise the supply of an unlicensed product in response to certain public health threats, including the suspected spread of pathogens. The proposed change would allow conditions to be attached “to ensure product safety, quality, and efficacy”
The 2012 regulations also give healthcare professionals and manufacturers immunity from being sued in the civil courts for the use of some unlicensed products recommended by the licensing authority in response to a public health threat. The new regulations would extend the immunity to drug companies that have not manufactured the product but placed it on the market with the approval of the licensing authority, and they clarify the consequences for a breach of conditions imposed by the authority.
Social media posts play into existing concerns that many people might not accept the vaccine, as surveys indicate. Lawyers have told the Department for Health and Social Care that to inspire public confidence it must provide redress for the few people who might experience adverse effects.
Bozena Michalowska, a partner specialising in product liability at the law firm Leigh Day, said, “I do not believe that people will want to play Russian roulette with their health by taking a vaccine which they know nothing about, especially when they know that the risks they take are just taken by them and not a shared risk and they will not have sufficient protection should things go wrong.”
Read full story
Source: The BMJ, 28 September 2020
Patient Safety Learning

'Frail' people like me should not be denied lifesaving Covid care

A frailty index is rationing treatment for older and disabled people who catch coronavirus, says Patience Owen. Patience has has a debilitating connective tissue disorder and, like thousands of others with rare conditions, is already in a minority within a minority, marginalised by our NHS, battling increasing disability day by day.
Back in March, without consultation and days before the first lockdown, the Clinical Frailty Scale (CFS), a worldwide tool used to swiftly identify frailty in older patients to improve acute care, was adapted by the National Institute for Health and Care Excellence (NICE). It asked NHS staff in England to score the frailty of Covid patients. Rather than aiming to improve care, it seems the CFS – a fitness-to-frailty sheet using scores from one to nine – was used to work out which patients should be denied acute care. Nice’s new guidelines advised NHS trusts to “sensitively discuss a possible ‘do not attempt cardiopulmonary resuscitation’ decision with all adults with capacity and an assessment suggestive of increased frailty”.
"Checking the scale, I found I would score five, the 'mildly frail' category, and therefore should I get Covid I could be steered towards end-of-life care. Bluntly, if I catch the virus, the NHS may help me to die, not live," says Patience.
By early April, there was a proliferation of illegal “do not resuscitate” (DNR) notices in care homes for people with learning disabilities, and for older people in care homes and in hospitals. Many acutely ill patients stayed at home with Covid symptoms in the belief that they risked being denied care in hospital. Following warnings by the healthcare regulator, the Care Quality Commission, and other medical bodies, that the blanket application of the notices must stop, and legal challenges by charities, exclusions were made to the NICE guidelines.
These included “younger people, people with stable long-term disabilities, learning disabilities or autism”. Yet the guidelines remain in place, in spite of the fact that they appear to contravene the Human Rights Act (including the right to life, article 2, and the right to non-discrimination, article 14). 
A spokeswoman for NICE says it is “very aware of the concerns of some patient groups about access to critical care, and we understand how difficult this feels. Our COVID-19 rapid guideline on critical care was developed to support critical care teams in their management of patients during a very difficult period of intense pressure."
“'Difficult' is a hollow word for the feeling of being selected to die," says Patience. "It’s difficult not to conclude that those with long-term conditions and disabilities, like myself, have become viewed as a sacrificial herd."

Read full story
Source: The Guardian, 29 September 2020
Patient Safety Learning

Post-covid clinics in the US get jump-start from patients with lingering illness

Clarence Troutman survived a two-month hospital stay with COVID-19, and then went home in early June. But he's far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.
"Before Covid, I was a 59-year-old, relatively healthy man," said the broadband technician from Denver. "If I had to say where I'm at now, I'd say about 50% of where I was, but when I first went home, I was at 20%."
He credits much of his progress to the "motivation and education" gleaned from a new programme for post-covid patients at the University of Colorado, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable disease caused by this coronavirus.
As the US general election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurological concerns, anxiety and depression.
"We need to think about how we're going to provide care for patients who may be recovering for years after the virus," said Dr Sarah Jolley, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth's Post-Covid Clinic, where Troutman is seen.
That need has jump-started post-covid clinics in the US, which bring together a range of specialists into a one-stop shop.
One of the first and largest such clinics is at Mount Sinai in New York City, but programmes have also launched at the University of California-San Francisco, Stanford University Medical Center and the University of Pennsylvania. The Cleveland Clinic plans to open one early next year.
And it's not just academic medical centres: St. John's Well Child and Family Center, part of a network of community clinics in South Central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with covid since March for long-term effects.
The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists.
Read full story
Source: CNN Health, 28 September 2020
Sam

Kent and Medway: Review into patient harm after DMC 'failure'

At least 18 serious cases are being investigated by NHS bosses after GP and dermatology services were stripped from private medical company.
The Kent and Medway Clinical Commissioning Group (CCG) confirmed on Monday an independent review was taking place. It will see if delays to treatment for thousands of patients using DMC Healthcare services "caused harm".
The NHS removed contracts worth £4.1m a year from the private firm in July.
DMC was responsible for nearly 60,000 patients at nine surgeries in Medway, and skin condition services in other parts of Kent, the Local Democracy Reporting Service said.
In north Kent, there were 1,855 patients needing urgent treatment and a further 7,500 on the dermatology service waiting list. Of those, 700 had been waiting more than a year.
Nikki Teesdale, from Kent and Medway's CCG, said it was "too early" to reach definitive conclusions around the 18 serious cases. Speaking to Kent and Medway's joint health scrutiny committee on Monday she said of the 18, five had been waiting "significant periods of time" for cancer services.
"Until we have got those patients through those treatment programmes, we are not able to determine what the level of harm has been," she added.
Read full story
Source: BBC News, 29 September 2020
Sam

English hospitals 'have not learned lessons' of past maternity scandals

Too many English hospitals risk repeating maternity scandals involving avoidable baby deaths and brain injury because staff are too frightened to raise concerns, the chief inspector of hospitals has warned.
Speaking at the opening session of an inquiry into the safety of maternity units by the health select committee, Prof Ted Baker, chief inspector of hospitals for the Care Quality Commission, said: “There are too many cases when tragedy strikes because services are not not doing their job well enough.”
Baker admitted that 38% of such services were deemed to require improvement for patient safety and some could get even worse. “There is a significant number of services that are not achieving the level of safety they should,” he said.
He said many NHS maternity units were in danger of repeating fatal mistakes made at what became the University Hospitals of Morecambe Bay NHS foundation trust (UHMBT), despite a high profile 2015 report finding that a “lethal mix” of failings at almost every level led to the unnecessary deaths of one mother and 11 babies.
“Five years on from Morecombe Bay we have still not learned all the lessons,” Baker said. “[The] Morecombe Bay [report] did talk about about dysfunctional teams and midwives and obstetricians not working effectively together, and poor investigations without learning taking place. And I think those elements are what we are still finding in other services.”
Baker urged hospital managers to encourage staff to whistleblow about problems without fear of recrimination. He said: “The reason why people are frightened to raise concerns is because of the culture in the units in which they work. A healthy culture would mean that people routinely raise concerns. But raising concerns is regarded as being a difficult member of the team.”
Read full story
Source: The Guardian, 29 September 2020
Sam
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