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

Covid-19: US approves emergency use of convalescent plasma despite warnings over lack of evidence

The US Food and Drug Administration (FDA) has approved convalescent plasma for emergency use in hospital patients with COVID-19.
The announcement on 23 August said that the FDA had concluded that plasma from recovered patients “may be effective” in treating the virus and that the “potential benefits of the product outweigh the known and potential risks.” The move came despite the absence of results from randomised controlled trials, with only a preprint paper on the effects on hospitalised COVID-19 patients being published to date.
Experts have warned that although these early findings show promise there is not enough evidence to show that it works.
Plasma from recovered patients was approved on a case by case basis by the FDA for people critically ill with COVID-19 in March. Since then more than 70 000 patients have been treated with plasma. Emergency use approval allows clinicians to use unapproved medical products to diagnose, treat, or prevent serious or life threatening diseases or conditions when there are no adequate, approved, and available alternatives.
The FDA’s commissioner, Stephen Hahn, said, “I am committed to releasing safe and potentially helpful treatments for covid-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from covid-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.”
But Martin Landray, professor of medicine and epidemiology at the University of Oxford and lead researcher for the RECOVERY trial, which is comparing treatments for COVID-19, including convalescent plasma for hospital patients, urged caution. He said, “There is a huge gap between theory and proven benefit. That is why randomised clinical trials are so important. At present, we simply don’t know if it works."
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Source: BMJ, 25 August 2020
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Make It Public – new strategy marks step-change in making health research findings available to the public

The Health Research Authority has launched a new strategy to ensure information about all health and social care research – including COVID-19 research - is made publicly available to benefit patients, researchers and policy makers.
The COVID-19 pandemic has highlighted the importance of sharing details of research taking place - to understand the virus and find the tests, treatments and vaccines - so that results can inform best quality care and preventive measures. This also means researchers do not duplicate efforts and can build on each other’s work while the public can see what research is going on. Now the new Make it Public strategy aims to build on this good practice and make it easy for researchers to be transparent about their work.
The strategy, delivered by the HRA in partnership with NHS Research Scotland (NRS), Health and Care Research Wales and Health and Social Care Northern Ireland, is about making transparency ‘the norm’ in research and making information more visible to the public. New measures set out in the strategy – will improve transparency and openness in health and social care studies, by:
expecting researchers to plan how they will let research participants know about the findings of the study from the beginning introducing additional monitoring to check that researchers are reporting results and to collect information about study findings making information on individual research projects – and their transparency performance - available to the public introducing a system to consider past transparency performance when reviewing new studies for approval and in the future introducing sanctions. 
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US nurse sues Kindred Healthcare, alleges retaliation for his patient safety complaints

A nurse in the US sued Louisville, Ky.-based Kindred Healthcare this week, alleging the organisation fired him in retaliation for raising patient safety concerns.
Sean Kinnie worked as an intensive care unit nurse at Kindred Hospital-San Antonio. Mr Kinnie claims he was suspended twice and then fired after leaders at the 59-bed transitional care hospital learned he anonymously reported patient safety concerns to The Joint Commission in November 2019 and January. 
Mr Kinnie said issues related to inadequate staffing and unsanitary care environments put patients in "grave danger," according to the lawsuit. He also said the hospital created a culture in which employees were afraid to stand up for patients for fear of retaliation from management. 
In January, Mr Kinnie told the hospital's chief clinical officer Sharon Danieliewicz that he was the staff member who reported the patient safety concerns to The Joint Commission. Mr. Kinnie claims he faced increased scrutiny after this disclosure and was ultimately fired Feb. 24 for violating facility policy.
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Source: Becker's Hospital Review, 24 August 2020
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Coronavirus: Thousands of health and care staff infected at work, new data shows

At least 6,500 health and care workers may have been infected with coronavirus through their work, including 100 who died, according to data from the Health and Safety Executive (HSE).
The regulator told The Independent it was reviewing each case and could launch investigations under the Health and Safety at Work Act if hospitals or care homes are suspected of not taking adequate steps to protect staff from infection.
This could result in a hospital or care home being prosecuted.
The latest data from the HSE shows between 10 April and 10 August there were a total of 3, 382 healthcare workplace infections, including 50 fatal incidents. In residential care there were 3,168 infections reported to the watchdog with 48 fatal cases.
The results of the review, first revealed earlier this month by The Independent, is being kept secret but where a medical examiner finds a worker may have died as a result of a workplace infection the death will have to be reported to the HSE for possible investigation. Coroners may also hold inquests into deaths.
It will also make it easier for families to claim compensation from the government’s additional death in service payments of £60,000 which was announced by health secretary Matt Hancock in April.
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Source: The Independent, 25 August 2020
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Review launched after ‘injustices suffered by BAME staff’

A clinical commissioning group (CCG) has ordered an independent review of its culture which it said was prompted by the “injustices experienced by black Asian and minority ethic colleagues” during the pandemic, HSJ has learned.
The review at Surrey Heartlands CCG, due to report in the autumn, is being led by Duncan Lewis, emeritus professor of management at Plymouth University. He has led several major reviews into culture at NHS organisations, including one into bullying and harassment at South East Coast Ambulance Service Foundation Trust in 2017 and one into workplace culture at Whittington Health Trust in 2018.
HSJ asked the CCG for the terms of reference of the review and the reasons why it felt it necessary to commission such an inquiry. It said the review’s scope would be determined by what staff felt was important regarding “our organisational culture, policy and practice – things we do well and things we need to improve”.
It added in a statement: “We will listen to the findings of the review and we will make any changes that are necessary.”
It is not yet clear if specific events within the organisation itself prompted the CCG to take the unusual step of commissioning the work. But the commissioner’s interim chief did say “feedback from staff” had been a driver.
Read full story (paywalled)
Source: HSJ, 26 August 2020
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UK flu jab rates prompt complacency warning

Complacency over the flu jab risks overwhelming the NHS, experts warn, as data reveals the scale of the challenge in expanding the vaccination programme.
Last month, the government announced plans to double the number of people who receive the influenza jab. But BBC analysis has found the take-up rate among people in vulnerable groups eligible for a free jab has declined.
Health secretary Matt Hancock said he did not want a flu outbreak "at the same time as dealing with coronavirus".
The government wants to increase the number of people vaccinated from 15 million to 30 million amid fears coronavirus cases will rise again in the autumn.
Local authorities in England saw an average 45% of people with serious health conditions under 65 take up the offer of a free vaccine last winter, data shows. That represents a drop from 50% in 2015.
The UK government has an ambition to vaccinate 55% of people in vulnerable groups, which includes people with multiple sclerosis (MS), diabetes or chronic asthma.
The World Health Organization (WHO) has previously said countries should vaccinate 75% of people in "vulnerable" categories.
Read full story
Source: BBC News, 27 August 2020
 
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Obesity increases risk of COVID-19 death by almost 50%, study suggests

Obesity may double the risk of falling seriously ill with Covid-19 and increase the chances of dying by almost 50 per cent, according to researchers, who also warned any future vaccine may be less effective for the clinically overweight.
Health issues caused by obesity include a number of pre-existing conditions known to exacerbate a Covid-19 infection – including heart disease, diabetes and high blood pressure.
Now a global assessment of health data gathered since the start of the the pandemic by researchers at the University of North Carolina has found people with a Body Mass Index (BMI) of more than 30 were 113 per cent more likely to be hospitalised.
Those admitted to hospital were found to be 74% more likely to be admitted to an intensive care unit, while the risk of death among obese patients increased by 48%.
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Source: The Independent, 26 August 2020
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NHS on life support: Patients face diagnosis delays as hospitals struggle with surge in screenings

Hospitals are not equipped to deal with the surge in screenings and tests as the health service restarts care – leaving patients facing delays in diagnosis and treatment for conditions including cancer, according to medical leaders.
As the NHS tries to recover from the worst of the coronavirus crisis, more than a million laboratory samples from cancer screening services are expected in pathology labs, while as many as 850,000 delayed CT and MRI scans need to be carried out.
But 97% of labs do not have enough pathologists to carry out the work – with staff already working unpaid hours to tackle the existing backlog – while the number of radiology posts nationally would need to be increased by a third to deal with the rise, experts say. Precautions to protect against the spread of coronavirus also limits the number of scans that can be carried out. The royal colleges of pathologists and radiologists warned that cancers would go undiagnosed and treatments for all patients across the NHS could be further delayed as a result.
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Source: The Independent, 27 August 2020
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CQC steps in at troubled trust over covid infections

The Care Quality Commission (CQC) has taken immediate enforcement action at East Kent Hospitals University Foundation Trust citing “serious concerns” over patient safety.
The regulator confirmed it was taking action today after inspectors visited on 12 August following concerns being raised about the standard of care and risk to patients.
The CQC confirmed the action had been taken, but it said it could not comment further due to legal restrictions and the trust’s right to appeal the decision.
HSJ understands the enforcement action was taken due to concerns over infection prevention control and the number of patients who have contracted COVID-19 in hospital. It is believed to be the first such action against a trust.
Read full story (paywalled)
Source: HSJ, 27 August 2020
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Unclear UK advice on PPE cited in home care COVID-19 death inquiry

A home care worker who did not wear protective equipment may have infected a client with a fatal case of coronavirus during weeks of contradictory government guidance on whether the kit was needed or not, an official investigation has found.
The government’s confusion about how much protection care workers visiting homes needed is detailed in a report into the death of an unnamed person by the Healthcare Safety Investigation Branch (HSIB), which conducts independent investigations of patient safety concerns in NHS-funded care in England. It was responding to a complaint raised by a member of the public in April.
The report shows that Public Health England published two contradictory documents that month. One advised care workers making home visits to wear PPE and the other did not mention the need. The contradiction was not cleared up for six weeks.
The government’s guidance had been a shambles that had placed workers and their vulnerable clients at risk, the policy director at the United Kingdom Homecare Association, Colin Angel, said on Wednesday. The association also accused the government of sidelining its expertise and publishing new guidance with little notice, sometimes late on Friday nights, meaning that it was not always noticed by the people it was intended for.
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Women forced to wait more than five times ‘longer than men for heart failure diagnosis’

Women are forced to wait more than five times longer than men for a heart failure diagnosis, a new study has found.
Researchers discovered women are 96 per cent more likely to get an incorrect diagnosis of heart failure than men – attributing sharp disparities to such problems being wrongly viewed as “a man’s disease”.
The study, conducted by leading heart failure charity the Pumping Marvellous Foundation, found men said they waited an average of just over three and a half weeks to get a formal diagnosis after their first GP visit, but women waited just over 20 weeks instead.
Researchers warned such delays were linked to “poorer quality of life, financial losses, mental health issues and avoidable deaths” – adding that health professionals do not give heart failure the same attention and gravity as cancer and other diseases.
"One of them [GP] actually said, your symptoms are probably not to do with your heart because you’re young and you’re female. Even though my father had a heart condition," says Sarah, who was diagnosed at the age of 42.
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Source: The Independent, 27 August 2020
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NHS test and trace hit by delays and COVID home test failures

England’s test-and-trace system has been hit with fresh problems after there were delays in contacting nearly 2,000 people infected with coronavirus, and one in seven home tests failed to produce a result.
An internet outage meant nearly 3,000 more people than usual were transferred to the contact-tracing system after testing positive for COVID-19 in the week ending 19 August. Two-thirds of these people had been tested days or weeks earlier, meaning there was a delay in reaching them and their close contacts when they should have been self-isolating.
The proportion of home tests kits failing to produce a result that week rose sharply, from 4% to 15% of the total, equating to more than 18,000 tests.
The Department of Health and Social Care figures also show that test and trace failed for a ninth week running to reach its target of contacting 80% of close contacts of people who test positive for COVID-19.
Matt Hancock, the health secretary, acknowledged on Thursday that the programme was “not quite there” in reaching that target. He told LBC radio: “One of the challenges is we want to get NHS test and trace up to over 80% of contacts, getting them to self-isolate – we’re at just over 75%, so we’re nearly there but not quite there.”
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Source: The Guardian, 27 August 2020
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Data on Covid care home deaths kept secret 'to protect commercial interests'

COVID-19 death tolls at individual care homes are being kept secret by regulators in part to protect providers’ commercial interests before a possible second coronavirus surge, the Guardian can reveal.
England’s Care Quality Commission (CQC) and the Care Inspectorate in Scotland are refusing to make public which homes or providers recorded the most fatalities amid fears it could undermine the UK’s care system, which relies on private operators.
In response to freedom of information requests, the regulators said they were worried that the supply of beds and standards of care could be threatened if customers left badly affected operators. The CQC and Care Inspectorate share home-by-home data with their respective governments – but both refused to make it public.
Residents’ families attacked the policy, with one bereaved daughter describing it as “ridiculous” and another relative saying deaths data could indicate a home’s preparedness for future outbreaks.
“Commercial interest when people’s lives are at stake shouldn’t even be a factor,” said Shirin Koohyar, who lost her father in April after he tested positive for Covid at a west London care home. “The patient is the important one here, not the corporation.”
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Source: The Guardian, 27 August 2020
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Coronavirus: High-risk health workers 'may not be protected' in Wales

Guidance to protect at-risk healthcare workers in Wales from coronavirus infection has been relaxed, the BBC has learned.
A risk assessment tool initially recommended high-risk workers should not work in the parts of a hospital where infection was most likely. But it now says their personal protective equipment (PPE) should be reviewed or duties changed.
The Welsh government says this reflects latest data and low infection rates. However, healthcare professionals say the change to the all-Wales COVID-19 workforce risk assessment tool was made without consultation, and are concerned it was done to prevent hospitals from losing frontline staff ahead of a potential second wave of the virus.
Mr Amol Pandit, a urologist who helped to design the tool, has written to the Welsh government four times seeking clarity on the basis for the changes, and why no one was made aware of them before the tool was rolled out.
"The changes could have been made in order to keep as many healthcare workers on the frontline as possible, which is why I sent a specific list of questions to the Welsh government, so that I could have assurances that it wasn't done for that reason, but for clinical, evidence-based reasons," Mr Pandit said.
Mr Pandit believes healthcare workers who fall into the high-risk category and work in environments where aerosol-generating procedures are performed - considered to carry a high risk of transmission of the virus - may not be fully protected by the current version of the tool if PPE supplies fall short and additional safeguarding measures aren't put into place.
"The government needs to be absolutely sure that there is adequate PPE and that it is going to be available to everybody - we have to trust them on that," he said
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Source: BBC News, 27 August 2020
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UK to give emergency approval to any Covid vaccine breakthrough

Any new and effective Covid vaccine will be given emergency approval for use in the UK and an expanded workforce will be trained to give the injections to immunise as much of the population as possible quickly, the government has said.
A change in the law will allow the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), to grant temporary approval for a vaccine from October, before it has been given a licence by the European authorities, which would be the normal procedure. The UK will be out of the EU from January and will approve drugs and vaccines without Brussels’ involvement.
Ministers say there will be no shortcut on safety or effectiveness, and that any vaccine will be approved for the UK only if it meets the highest standards.
The deputy chief medical officer for England, Prof Jonathan Van-Tam, said: “We are making progress in developing COVID-19 vaccines, which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future.
“If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met. The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.”
The MHRA has the power to grant an unlicensed medicine or a vaccine temporary authorisation where a product is proven safe and effective and in the best interest of the patient on the basis of available evidence.
Read full story
Source: The Guardian, 28 August 2020
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Coronavirus: Winter plans revealed in leaked Sage report

A leaked government report suggests a "reasonable worst case scenario" of 85,000 deaths across the UK this winter due to COVID-19.
The document also says while more restrictions could be re-introduced, schools would likely remain open.
But it says the report "is a scenario, not a prediction" and the data are subject to "significant uncertainty".
However some are critical of the modelling and say some of it is already out of date.
The document, which has been seen by BBC Newsnight, was prepared for the government by the Sage scientific advisory group, which aims to help the NHS and local authorities plan services, such as mortuaries and burial services, for the winter months ahead.
Read full story
Source: BBC News, 29 August 2020
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