NHS pathology labs are ripe for privatisation and cuts

“Every sample is a patient … Every sample is a patient …”

I repeat it like a mantra, so that amid the relentless workload we don’t lose sight of who we work for. We say it as we navigate crumbling floors – in one of our labs, a hole in the lino flooring has been patched up with heavy-duty gaffer tape.

In my work, I see only names, not faces. But every sample is a patient, and every patient has hopes, fears, family and friends. Doctors and nurses get to see their charges in the flesh, whereas I see only the flesh. Paramedics and porters see the blood spilt, I see only the blood. Some names become familiar – a premature baby on the neonatal unit, a 90-year-old with a broken hip – but we never see them recover, never witness the reunions and taxi rides home. Not that my colleagues and I need it, but we never hear their thanks. When we stop receiving their samples, we can but hope for the best.

I work in a pathology laboratory and they are involved in 70% of all diagnoses within the NHS, but very little of what we do is known to the public, or indeed, to many of our healthcare colleagues. We are the definition of behind the scenes, providing doctors with the vital information they need to assess and treat patients.

We are the definition of behind the scenes, providing doctors with the vital information they need to assess and treat

The inner-city microbiology lab where I work as a technician processes thousands of samples a week, from A&E departments, GP surgeries, intensive care, maternity units, and everywhere in-between. We run a full seven-day service (including bank holidays), and with biomedical scientists covering the lab throughout the night, I’m happy to say that we make a mockery of Jeremy Hunt’s calls for a 24/7 NHS.

Sadly, and as with the NHS as a whole, we are short-staffed, under-funded and often ill-equipped. I’m often expected to attempt the workload of two members of staff. What little morale remains is nurtured from the ground up, an esprit de corps forged in a shared adversity, and in taking inspiration from colleagues going about their duties with a quiet efficiency.

Throughout the day porters and couriers deliver a constant stream of samples that are immediately triaged. Urgent specimens are processed within a matter of minutes. What might seem to the untrained eye to be an overwhelming mound of bloods, swabs, tissues and every bodily fluid imaginable is swiftly organised; well-rehearsed procedures are carried out so that every diagnostic test is performed with the minimum of delay.

The sheer amount of equipment and consumables necessary for the lab to function often surprises visitors and those new to the job. The NHS is truly a system, with every part reliant on the other. The labs do not stand alone, and indeed, would be worthless if they did so. Just as the pen is of little use without the paper, so the NHS cannot treat its patients without laboratories. The staff themselves are of course any lab’s greatest asset, a biomedical scientist needs years of education and training to become qualified.

Even though it can be difficult to find a moment in which to draw breath, we are forced to confront our fears about the future. The vital ancillary services of estates, cleaning, security and portering (to name but a few) have been tendered out to the private sector within the trust where I am employed, as they have been across the wider NHS.

Financial pressures are causing more and more laboratories to merge, and it is now the case that many individual trusts no longer directly own their pathology services – instead there are “joint ventures” and “partnerships” forced to bid against one another for customers and business.

While efficiency savings are possible, fewer labs equal longer transport times, and longer transport times equal potentially life-threatening delays. At night, our (private) courier company sometimes has to send a driver from 30 miles away to bring an urgent sample to the lab from a hospital five miles from us.

Given how behind the scenes we are, and how fragmented the NHS is becoming, there is an acute dread that pathology is ripe for the picking in terms of
the work we do being tendered-out to private contractors, or the joint ventures themselves morphing into entities no longer under the control of NHS trusts.

We want to cooperate with our colleagues, not compete against them, even if not many realise what we really do. We want to use the best diagnostic tools, not the cheapest ones. We want the time to treat every sample we receive as a patient, not a commodity. Help us to help you.

If you would like to write a blogpost for Views from the NHS frontline, read our guidelines and get in touch by emailing sarah.johnson@theguardian.com.

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NHS pathology labs are ripe for privatisation and cuts

From anthrax to bird flu the dangers of lax security in illness-management labs

For the danger they posed, the lapses have been appalling. They place lives at threat, that significantly is clear. But they had been surprising, too, due to in which they took place. The US government’s large-security disease-handle laboratories – which property samples of the most harmful germs in the globe – can not afford to screw up.

Very first came news of a single incident. Personnel functioning on deadly bioterrorism agents at the Centres for Condition Manage and Prevention (CDC) in Atlanta followed the incorrect method to “inactivate” batches of Bacillus anthracis, the bacterium that brings about anthrax. However probably nonetheless lethal, the bugs had been sent to one more CDC lab in which personnel have been not outfitted to deal with reside spores. A report into the lapse published last week exposed a worrying pattern of employees failures, and found that dozens had been potentially exposed. The CDC doled out antibiotics and anthrax vaccine. Impacted rooms had been sterilised. They had been fortunate: no one particular got the disease. But that is hardly the point.

It was not an isolated occasion. As CDC investigators finalised their report into June’s anthrax scare they unearthed a more alarming incident that had gone unreported. In March, lab workers sent samples of a pretty harmless strain of bird flu to scientists at the US Division of Agriculture. To the agricultural team’s alarm, every single chicken they contaminated with the virus died. It was only soon after 21 birds had succumbed that they discovered why: the CDC samples had been contaminated with a strain of highly lethal H5N1 bird flu. Organic outbreaks of the virus have killed hundreds of folks in Asia.

The director of the CDC, Tom Frieden, took swift action. He closed the CDC’s anthrax and influenza labs and imposed a ban on the shipment of biological material in or out of the CDC’s highest-protection labs even though safety procedures are revamped. At a press conference last week, Frieden mentioned the behaviour of some workers had been “completely unacceptable … Frankly, I’m angry about it.” On Wednesday, Frieden was referred to as ahead of a US Residence oversight committee to describe himself. The chairman, Tim Murphy, did not hold back. The incident was “troubling”, “totally unacceptable”, the CDC’s reputation “tarnished”. Frieden, he mentioned, had referred to as the anthrax scare a “wake-up phone”. But that was a “hazardous understatement”, Murphy warned. “It was a probably really dangerous failure,” he mentioned.

The incidents cast a lengthy shadow more than the organisation charged with defending the US public. But a third incident points to a broader failure in US biosecurity. In early July, 6 vials of smallpox have been identified in a storage area at an unguarded FDA lab in Maryland that after belonged to the US Nationwide Institutes of Wellness. Following the eradication of smallpox, a horrific disease that kills 30% of individuals it infects, official stocks are stored only at the CDC in Atlanta and at the Russian Vector lab in Novosibirsk. The samples located in the NIH lab probably date back to the 1950s, but tests at the CDC discovered that despite their age, smallpox in two of the 6 vials was even now alive and hazardous. (The last fatal situation of smallpox in the United kingdom took place in 1978, when the virus escaped from a laboratory at the University of Birmingham.) The bad news did not finish there. On Wednesday, federal investigators reported far more harmful materials from the very same room. In all, they found twelve boxes containing 327 vials labelled with a variety of unpleasant pathogens, from influenza and dengue fever to rickettsia and Q fever.

CDC director Tom Frieden was named just before a US Property oversight committee to explain the current lapses, which he admitted had been ‘totally unacceptable’. Photograph: Mandel Ngan/AFP/Getty Pictures

It was the NIH’s turn to apologise. Its director, Francis Collins, stated that “overlooking such a sample collection for years is obviously unacceptable”. He ordered a total search of all fridges, freezers, cold rooms, storage shelves and cabinets, as properly as offices linked to laboratories, in case other unsafe agents had gone missing. To the outdoors globe, the most trusted keepers of lethal germs had proven themselves to be dangerously incompetent.

The failings will have direct consequences at the CDC and NIH, but the fallout from the lapses will be felt far past the US. There are main lessons to be discovered about human error that even the most vigilant high-safety labs in Europe, Asia and elsewhere must heed. But for some scientists, the incidents contact for a lot more drastic action. Some want the variety of laboratories holding lethal bugs to be slashed, to minimise the chance of a catastrophic accident. Other people want the highest-risk experiments curtailed, arguing that the fresh understanding they bring is not well worth the actual danger of an accidental outbreak.

“This is not just getting noticed as some thing across the Atlantic. There will be knock-on considerations, there have to be,” said John McCauley, director of the WHO influenza centre at the National Institute for Health-related Analysis in London. “These incidents remind us that accidents, even though incredibly uncommon, can take place, and we need to be conscious of how they occurred so we can minimise or even eliminate that kind of accident occurring elsewhere.”

Eight labs in the United kingdom are permitted to function with the most dangerous pathogens, and aside from two animal vaccine makers, all are government-sponsored. Some, which includes the military labs at Porton Down, are planet class, but other people, this kind of as the Institute for Animal health at Pirbright are reportedly much more run-down. The 2007 outbreak of foot-and-mouth disease practically certainly came from the Pirbright lab, in accordance to a Commons science committee report.

At Wednesday’s US hearing on the CDC anthrax scare, Richard Ebright, a biosafety specialist at Rutgers University, known as for a dramatic reduction in the quantity of labs permitted to perform on the bugs, from one,500 or so in the US to nearer 50, in order to minimise the risk of a severe accident. He urged the government to set up an independent federal company to regulate the operate, one particular with actual powers to shut down labs that operated dangerously.

The US government is unlikely to embrace Ebright’s plan. On Sunday evening, the NIH sacked half of its biosafety panel by e-mail. The move ousted 11 of the government’s authentic advisers, who in the previous had raised issues about experiments to produce hazardous new pathogens. Critics are now waiting to see who will exchange the fired advisers. A single advised the Guardian the replacements would be “yes guys”.

Anthrax bacteria related to individuals transported among US CDC labs in violation of security protocol last month Photograph: EPA

Ron Fouchier, a virologist at Erasmus health care centre in Rotterdam, mentioned slashing the number of labs working with dangerous pathogens would be a huge blunder. “The cause so many labs are undertaking pathogen analysis is due to the fact there is so significantly to be investigated, in the curiosity of public and animal wellness,” he stated. The number of organisms that need to have higher-protection labs is growing. There are ongoing outbreaks of anthrax, various strains of bird flu, Ebola, and Middle East Respiratory Syndrome (MERS), which has killed hundreds in the Middle East, and a handful more in Africa, Asia, Britain, France and Germany. “I locate it difficult to believe theat Dr Frieden or Dr Ebright may well consider that some of the work is not necessary and can be hence be lowered,” Fouchier advised the Guardian. He mentioned his lab currently employed harmful pathogens only when there was no alterative. Working in large-safety labs “is not exciting, and is extremely high-priced”.

But the breaches in the US have fuelled concerns about some of the far more intense studies that scientists do. When the CDC declared its anthrax incident, Marc Lipsitch, professor of epidemiology at the Harvard College of Public Well being, explained we should be glad it was only anthrax. He fears that scientists, Fouchier incorporated, pose far greater dangers to the public by intentionally making harmful pathogens. In 2011, Fouchier announced that he had mutated bird flu to make it spread very easily in animals by way of coughs and sneezes. Advocates for these experiments, recognized as gain-of-function research, say they give scientists essential insights into the varieties of viruses to concern in nature. To Lipsitch and several other individuals, the irony is all as well clear. In striving to avoid the next pandemic, they say Fouchier and his colleagues make a disastrous outbreak more most likely.

Earlier this week, Lipsitch convened more than a dozen researchers who shared his considerations. The end result of their meeting was the Cambridge Working Group consensus statement calling on the US government to “curtail” experiments that produce probably pandemic pathogens, right up until proper danger assessments have been carried out. Even though Fouchier and other folks describe that they have previously been by means of numerous risk assessments, and operate underneath very tight protection, their critics are not reassured.

A single of the signatories of the Cambridge Operating Group statement is Sir Richard Roberts, a British scientist and Nobel prize winner, who now works at New England Biolabs in Massachusetts. Roberts hasn’t seen the risk assessments for Fouchier’s experiments, but notes that even the CDC labs, “which were typically regarded as to be the safest labs out there”, had had problems. “How can you believe in anyone? Humans are human. Men and women make problems.”

Lipsitch’s group desires to convene a meeting that brings together scientists and other professionals to debate the possible hazards of creating unsafe pathogens, and to draw up binding suggestions to ensure that potential experiments are safe. The program mirrors the landmark Asilomar conference in California in 1975, which was largely driven by younger scientists who had concerns over the unknown risks of swapping genes in and out of various organisms. The meeting set critical ground guidelines – like the introduction of biosafety containment levels all around the world – for genetic scientific studies to this day.

Vincent Racaniello, a virologist at Columbia University in New York, explained the Cambridge Operating Group was “infuriating” due to the fact it misled folks into believing that viruses created in laboratories were a serious risk to the public. But because the experiments are done in ferrets, he argues, it is not possible to know if the bugs would spread in men and women, and how unsafe they may possibly be. He added that determining which experiments went ahead on the basis of a risk-benefit analysis was “absurd”, since it was typically unattainable to know the positive aspects of an experiment beforehand.

McCauley largely supports the experiments at the centre of the controversy, arguing that they reveal how viruses in the wild transform from harmless strains to far more unsafe types. “I need to have to be in a position to advise folks,” he said. “And it tends to make me really feel a whole good deal happier being aware of a lot more.”

Roberts, however, is having none of it. “The dangers are massive and the positive aspects, to my mind, are non-existent,” he said. “If I recommended that you consider to make the most virulent and harmful virus that we can picture, some thing that could destroy a quarter of the world’s population if it received out, does that look a sensible factor to do? That strikes me as being definitely ridiculous.”

From anthrax to bird flu the dangers of lax security in illness-management labs

Inquiry into US government labs finds flu virus cross-contamination

Senior US science officials have shut down two government laboratories that were the subject of “serious and troubling” safety lapses, and suspended some transfers of potentially dangerous germs.

Dr Tom Frieden, director of the Centers for Disease Control, revealed on Friday that in addition to the exposure of anthrax and the discovery of insecure smallpox vials, which had already been disclosed, inquiries had discovered the cross-contamination of flu viruses.

Frieden said the discoveries raised “serious and troubling questions” in announcing the new safety measures on Friday. “Fundamentally, what they revealed was totally unacceptable behavior,” said Frieden. “These events should never have happened.”

Frieden said he was disturbed to learn of the influenza virus cross-contamination in the last 48 hours, the incident was not previously known.

In June, news first broke that CDC bioterrorism scientists may have accidentally exposed 84 of their colleagues to live anthrax by deviating from a protocol meant to kill the bacteria and spores. Just a few days ago, 16 vials labeled “variola”, or smallpox, from 1954 were discovered in a storage room by a scientist at the Maryland campus of the National Institutes of Health.

Two of those vials were found be viable, or potentially infectious. Frieden said it does not appear that workers or the public were exposed to the dangerous pathogens in either incident.

Just two days ago, Frieden said he found out that a cross contamination in one of the CDC’s influenza laboratories led to a highly pathogenic strain of “bird flu”, or H5N1, to be accidentally shipped to a Department of Agriculture lab that was expecting a safer strain.

It does not appear anyone was exposed in that incident

Frieden said bioterrorism researchers who nearly exposed their colleagues to anthrax broke lab protocol, had a “lack of scientific knowledge in this laboratory about anthrax”, and should have known a method used to kill anthrax bacteria could leave small amounts of spores viable.

“The root cause, fundamentally, was that the scientists failed to follow a scientifically derived and ensured protocol that ensured that anthrax was deactivated,” said Frieden. There is a “lack of standard operating procedure, [and] lack of adequate laboratory oversight,” that allowed the incidents to happen, he said.

Frieden said he found the cross-contamination of influenza the most disturbing of the three incidents.

“It’s most distressing not because it’s most dangerous,” he said. “What’s distressing about it is that our influenza laboratory is a superb laboratory … So, to me, the fact that something like this could happen in such a superb laboratory is unsettling.” Frieden said it was also disturbing that the incident took about six weeks for scientists to report to superiors.

In response to the incidents, a moratorium on the transfer of biological materials from high-security CDC laboratories is being immediately issued, and will not be lifted until a lab-by-lab review is conducted.

The influenza laboratory is closed pending an investigation, and the laboratory that improperly handled anthrax is suspending work with that and other dangerous pathogens. Employees will be disciplined where appropriate, Frieden said.

New laboratory safety initiatives include naming Dr Michael Bell, currently the deputy director of health care quality promotion, as director of laboratory safety. Bell previously worked in the CDC’s infectious disease control division.

Current lab protocols for transferring and deactivating biological material, such as the flu, will be reviewed and updated. An external advisory committee has been established, as well as a working group headed by Bell.

Frieden said any lessons the CDC learns through its review could be absorbed into its function regulating labs around the country, such as private or university labs.

A 23-page report issued by the director comes before his hearing before the House energy and commerce committee next week. Frieden has headed the CDC since 2009, and previously headed the New York City department of health.

Inquiry into US government labs finds flu virus cross-contamination

Inquiry into US government labs finds flu virus cross-contamination

Senior US science officials have shut down two government laboratories that were the subject of “serious and troubling” safety lapses, and suspended some transfers of potentially dangerous germs.

Dr Tom Frieden, director of the Centers for Disease Control, revealed on Friday that in addition to the exposure of anthrax and the discovery of insecure smallpox vials, which had already been disclosed, inquiries had discovered the cross-contamination of flu viruses.

Frieden said the discoveries raised “serious and troubling questions” in announcing the new safety measures on Friday. “Fundamentally, what they revealed was totally unacceptable behavior,” said Frieden. “These events should never have happened.”

Frieden said he was disturbed to learn of the influenza virus cross-contamination in the last 48 hours, the incident was not previously known.

In June, news first broke that CDC bioterrorism scientists may have accidentally exposed 84 of their colleagues to live anthrax by deviating from a protocol meant to kill the bacteria and spores. Just a few days ago, 16 vials labeled “variola”, or smallpox, from 1954 were discovered in a storage room by a scientist at the Maryland campus of the National Institutes of Health.

Two of those vials were found be viable, or potentially infectious. Frieden said it does not appear that workers or the public were exposed to the dangerous pathogens in either incident.

Just two days ago, Frieden said he found out that a cross contamination in one of the CDC’s influenza laboratories led to a highly pathogenic strain of “bird flu”, or H5N1, to be accidentally shipped to a Department of Agriculture lab that was expecting a safer strain.

It does not appear anyone was exposed in that incident

Frieden said bioterrorism researchers who nearly exposed their colleagues to anthrax broke lab protocol, had a “lack of scientific knowledge in this laboratory about anthrax”, and should have known a method used to kill anthrax bacteria could leave small amounts of spores viable.

“The root cause, fundamentally, was that the scientists failed to follow a scientifically derived and ensured protocol that ensured that anthrax was deactivated,” said Frieden. There is a “lack of standard operating procedure, [and] lack of adequate laboratory oversight,” that allowed the incidents to happen, he said.

Frieden said he found the cross-contamination of influenza the most disturbing of the three incidents.

“It’s most distressing not because it’s most dangerous,” he said. “What’s distressing about it is that our influenza laboratory is a superb laboratory … So, to me, the fact that something like this could happen in such a superb laboratory is unsettling.” Frieden said it was also disturbing that the incident took about six weeks for scientists to report to superiors.

In response to the incidents, a moratorium on the transfer of biological materials from high-security CDC laboratories is being immediately issued, and will not be lifted until a lab-by-lab review is conducted.

The influenza laboratory is closed pending an investigation, and the laboratory that improperly handled anthrax is suspending work with that and other dangerous pathogens. Employees will be disciplined where appropriate, Frieden said.

New laboratory safety initiatives include naming Dr Michael Bell, currently the deputy director of health care quality promotion, as director of laboratory safety. Bell previously worked in the CDC’s infectious disease control division.

Current lab protocols for transferring and deactivating biological material, such as the flu, will be reviewed and updated. An external advisory committee has been established, as well as a working group headed by Bell.

Frieden said any lessons the CDC learns through its review could be absorbed into its function regulating labs around the country, such as private or university labs.

A 23-page report issued by the director comes before his hearing before the House energy and commerce committee next week. Frieden has headed the CDC since 2009, and previously headed the New York City department of health.

Inquiry into US government labs finds flu virus cross-contamination

Vaginas grown in labs efficiently implanted into girls with uncommon disorder

A scientist at the Wake Forest health care centre, demonstrates the approach to engineer vaginal organ tissue. Photograph: Reuters

Scientists have successfully implanted vaginas grown in laboratories into four teenage women who have a congenital situation which meant their personal did not build properly.

The artificial vaginas, engineered from the patient’s personal cells and individually made to match them, allowed the females to later have full intercourse lives. As well as being a breakthrough in vaginal reconstruction, the US and Mexican scientists responsible for the procedures stated it probably meant other tissues or organs could be laboratory grown and implanted.

“This pilot examine is the initial to show that vaginal organs can be constructed in the lab and utilized efficiently in humans,” explained lead researcher Dr Anthony Atala from Wake Forest Baptist health care centre in Winston-Salem, North Carolina.

“This may signify a new alternative for individuals who need vaginal reconstructive surgeries. In addition, this research is one a lot more illustration of how regenerative medicine approaches can be applied to a assortment of tissues and organs.”

The patients, who had been among 13 and 18, have been all born with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome (pdf), a uncommon genetic issue in which the vagina and uterus are underdeveloped or absent.

Utilizing vulva tissue from each sufferers, the crew grew tissue around vagina-shaped biodegradeable scaffolds ahead of implanting the fully formed vagina.

Adhere to-up tests over a quantity of years – the initial of the implants took area eight years ago, though findings have only just been reported – found the engineered vaginas worked as hoped, with the girls reporting they had been capable to have intercourse usually, with out discomfort. None had however become pregnant, but that is believed to be attainable. The study is published in the health-related journal the Lancet.

One particular of the patients, speaking anonymously, was quoted as saying the procedure had been hugely crucial to her lifestyle: “Really I really feel quite lucky due to the fact I have a typical life, totally normal.”

Atala mentioned: “Yearly tissue biopsy samples demonstrate that the reconstructed tissue is histologically and functionally equivalent to regular vaginal tissue. This technique is a viable alternative for vaginal reconstruction and has a number of rewards more than recent reconstructive approaches since only a small biopsy of tissue is needed, and using vaginal cells could decrease complications that arise from employing non-vaginal tissue, such as infection and graft shrinkage.”

Separately, he informed the BBC: “Truly, for the initial time we’ve created a whole organ that was by no means there to start off with. It was a challenge.” Seeing the distinction the breakthrough created to the women’s lives was really rewarding, he extra.

Vaginas grown in labs efficiently implanted into girls with uncommon disorder