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Friday, December 05, 2014

Revealed : 100 Safety Breaches At UK Labs Handling Potentially Deadly Diseases

Constructing cover stories for next "outbreak:" Ciprofloxacin still most effective antibiotic for prophylaxis, treatment of Anthrax

THE GUARDIAN
By Ian Sample
12/04/2014


High-security laboratories that handle the most dangerous viruses and bacteria have reported more than 100 accidents or near-misses to safety regulators in the past five years, official reports reveal.


Bacillus anthracis and Anthrax
One blunder led to live anthrax being sent from a government facility to unsuspecting labs across the UK, a mistake that exposed other scientists to the disease. Another caused the failure of an air handling system that helped contain foot and mouth disease at a large animal lab.

Wear and tear also caused problems and potentially put researchers in danger. At a top security Ministry of Defence lab, tears were found in isolation suits at a facility handling animals infected with the Ebola virus.


Reports obtained by the Guardian from the Health and Safety Executive (HSE) reveal that more than 70 incidents at government, university and hospital labs were serious enough to investigate. Many led to enforcement letters, or crown prohibition notices (CPN), ordering labs to shut until improvements were made. Some were so serious they ended in legal action.

Prof Richard Ebright, a US biosafety expert at Rutgers University in New Jersey, who reviewed the reports for the Guardian, said that, taken together, they revealed failures in procedures, infrastructure, training and safety culture at some British labs.

Alarmed at a run of incidents at facilities that work on animal diseases, Ebright asked: “Does British agriculture have a death wish?”

The figures amount to one investigation every three weeks at secure laboratories that are designed to carry out research on pathogens that can cause serious illness and spread into the community. Some of the organisms are lethal and have no vaccines or treatments.

Many of the incidents were one-off, almost inevitable human mistakes, such as spillages of infectious bugs. Others were down to old equipment and safety clothing. The most serious accidents arose from chains of mistakes that happened one after the other, and were often only discovered later.

The reports compiled by the HSE describe at least 116 incidents and 75 completed investigations since April 2010 at laboratories where the most dangerous organisms are handled. Other investigations are under way, but the HSE cannot disclose details of those in case they lead to legal action. All of the investigations were prompted by reports from lab managers who are obliged by law to tell the HSE when an accident or near-miss happens at their facility.

Backstory

Some of the most worrisome incidents happened at the Surrey-based Animal Health and Veterinary Laboratories Agency (AHVLA), renamed the Animal and Plant Health Agency (APHA) in October. In one case, scientists were handling anthrax when something went badly wrong. They meant to send harmless samples, killed by heat, to nearby AHVLA labs and others in York and Belfast. But somehow the tubes got mixed up. Instead of sending out dead material, the anthrax they sent was live and dangerous.


The Animal Health and Veterinary Laboratories Agency in Weybridge, Surrey. Photograph: Rex Features/Rex Features

The staff who made the mistake were safe enough. They worked in a high-security lab built to contain lethal agents. But some of those who received the bugs did not. In Belfast, the anthrax was handled in a higher containment lab, meaning those staff were safe. In York, the samples were never opened. But at another AHVLA site, scientists opened the tubes in a less secure lab and got to work on the open bench. The incident at the AHVLA is one of the more serious biological accidents that has happened in the UK in recent years. But it was far from being the only one.

Human Error

The HSE documents cast light on the endless ways that safety can be undermined at UK high-containment labs, where crucial research takes place into dangerous infections. Poor management, inadequate training, inappropriate procedures, equipment failures, human error and plain bad luck all come into play. Some incidents cannot be avoided. Humans will always make mistakes. Equipment will always break. But others are more troubling and result from multiple safety breaches, rather than single mistakes.

The anthrax incident at the AHVLA happened in May 2012 and drew an immediate CPN. That shut the lab so no more live anthrax could be sent out. The timing was ironic. The government had spent months stockpiling anthrax vaccines in case terrorists released the bug at the London Olympics. Now one of their own labs had put people at risk.

The HSE investigation found that two unsuspecting staff at the AHVLA were exposed to the deadly bug, though both had been vaccinated and neither fell ill. The incident received little attention. In the agency’s 2012-13 annual report, one line refers to the clampdown. It states: “CPN – labelling and tracking of biological materials inadequate – now resolved”.

American Blunder

The AHVLA incident bears a close similarity to a blunder in June that received global attention. Scientists in a high-security lab at the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, failed to kill batches of anthrax bacteria properly and sent them to other labs. Tom Frieden, the head of the CDC, told a House oversight committee that the incident was a “wake-up call”. Tim Murphy, the Republican chair, was unimpressed: “It was a potentially very dangerous failure,” he said.


Tom Frieden, director of the Centers for Disease 
Control and Prevention, said the Atlanta security lapse 
was a wakeup call.  Photograph: Johnny Clark/AP
The AHVLA has made dangerous slips before. Last year, the lab received a crown censure for nine safety lapses that exposed staff to live Mycobacterium bovis, an organism that causes TB in cattle but can cause serious illness and even death in humans.

Over a two-year period, from 2009 to 2011, 3,700 samples were sent from one AHVLA lab to another without managers knowing the organisms were still viable. Minutes of the crown censure hearing reveal an alarming picture. Staff had been given the wrong equipment to destroy the bacteria and were not trained in the right procedure. 


Management had failed to act when staff raised concerns. One person later tested positive for the infection.

Expert Analysis

Ebright, who testified to the House committee over the CDC anthrax incident, was struck by the similar failings at labs in the UK and the US. “The incidents at the AHVLA should really not occur. They involved not one error, but a whole chain of errors, and they are all essentially unforgiveable,” he said. “They reflect the most elementary lapses and they are potentially very serious. To see them happening like that suggests there is a deep problem.”

Prof Brian Spratt, an infectious disease specialist at Imperial College, London, echoed Ebright’s concerns. Sending out bovine TB, an organism that can infect people, posed a clear risk of infection, he said. “Sending anthrax to other labs incorrectly, believing it to be inactivated, is also clearly very serious with a real possibility of infection of recipient laboratory workers,” he told the Guardian. “What strikes me is that accidents do happen even in the best facilities, often due to operator error, or unrecognised breakdowns in containment measures.”

UK labs that study infectious organisms are rated by their containment level (CL). The higher the level, the more barriers there are to prevent the escape of pathogens. If one fails, the next should ensure there is no danger. CL1 and CL2 labs work on fairly benign bugs. More dangerous pathogens, such as those that cause anthrax, the plague and rabies, can be handled in secure CL3 labs. The most dangerous and often exotic organisms, such as Ebola, Marburg and Lassa viruses must be handled in CL4 labs. These bugs can kill, spread easily, and are often untreatable. The reports obtained from the HSE deal with incidents at CL3 and CL4 labs.

British Labs 

Britain has about 600 CL3 labs. Nine sites, all in south-east England, are home to CL4 labs, including the National Institute for Medical Research, which studies pandemic and avian flu, and the Ministry of Defence’s Porton Down lab, which studies Ebola and other pathogens that could be used as biological weapons.

The HSE documents reveal that one high-security lab, the Pirbright Institute (formerly the Institute for Animal Health), has been handed eight enforcement letters since April 2010. The Surrey lab is a world-class centre for animal virus surveillance. It studies foot and mouth disease, bluetongue, rinderpest and other infections. But it has a tainted reputation: the 2007 foot and mouth outbreak was traced to a leak from Pirbright’s drains. Scientists at the lab worked on the outbreak strain, but the virus was made in huge volumes by Merial, a vaccine manufacturer at the site.


News reports fail to mention the fact that there are many unregistered labs around the world capable of weaponising viruses and bacteria

In the wake of the outbreak, the Commons science and technology committee held an inquiry into biosecurity at UK research labs. Their report, published in 2008, stated: “It is critical such an incident does not happen again.” But near-misses are common at Pirbright.

In April, Pirbright managers pleaded guilty to eight breaches of safety legislation around foot and mouth experiments. The incidents happened in November 2012 and January 2013 when a ventilation system used to keep the lab at negative pressure – to prevent viruses escaping – was modified. The system failed, as did an alarm that should have warned staff of the danger. No virus escaped in the incident.

More incidents followed. The HSE investigated at least four more times at Pirbright since the lapses that led to their prosecution. Some were fairly minor, including the spillage of foot and mouth virus outside a safety cabinet. But in February, the lab had another problem with air circulation in a facility for cattle with foot and mouth disease. This time, high winds knocked the system out for two-and-a-half hours.

Spratt, who in 2007 wrote an independent review for government on biosafety at UK labs that handle foot and mouth, said the malfunctioning of the ventilation system could have been dangerous. “The air handling incident in the large-animal facility at Pirbright is potentially serious as, if foot and mouth disease virus from infected livestock was released outside the facility, exposure of livestock on neighbouring farms is a real possibility,” he said.

In January, scientists at Pirbright will move into new labs, the result of more than £100m refurbishment at the site. That could solve many of the problems the facility has had with failing equipment. But Ebright still has concerns. Some Pirbright incidents point to bad practice and moving labs will not change that, he said. More seriously, he questions whether Pirbright should still be allowed to work on the foot and mouth disease virus. “Is there an economic case that offsets the risk posed by their work, particularly with their sorry record of safety? To my mind, the answer is no,” he said.

Pirbright argues that major benefits come from its research. A statement from the lab said it played a crucial role in controlling and eliminating viral diseases of farm animals and viruses that can spread from animals to humans. Scientists there played a major role in eradicating rinderpest, saving African countries £1bn a year. Its work will lead to safer and cheaper foot and mouth vaccines, and greater understanding of bluetongue virus, which it helped eradicate from the UK in 2007, saving £500m a year, the statement said.

On Pirbright’s prosecution, the statement conceded that the lab “acknowledged its weaknesses in the area of activity involved and has reviewed and reformed its operational processes to ensure an incident such as this could not happen again”.

It continued: “The institute operates in a highly regulated and complex environment. Staff are actively encouraged to report incidents internally to allow us to learn lessons and improve. Any spills or leaks, or issues affecting the multiple and layered biosecurity systems, are reported to the regulators and classified by them as a dangerous occurrence. The reporting of such an incident does not mean there is any risk of release of virus to the environment as there are multiple layers of containment to ensure this does not happen.”

Solutions

The problems at the AHVLA, now the APHA, may be tougher to solve though. “As long as the management remains, the same problems will recur,” Ebright said. “You either close the facility, redirect it or rebuild it, starting with new management. It’s not the managers who send out putatively inactivated anthrax, but they have allowed that to happen. There has to be accountability all the way to the top.”

Labs that report the most incidents may not be the most lax. One factor that affects the number of reports – and investigations – is how professional staff are at reporting near-misses. A culture of blame makes people hide their mistakes and crucial lessons go unlearned.

Tom Inglesby, director of health security at the University of Pittsburgh Medical Center, said: “It’s very important that scientists are not punished for reporting accidents or near-accidents. That kind of punitive response will create pressures to not report. In other safety cultures, like airline safety, pilots are punished if they do not report near-misses, but not when they do report.”

The HSE investigated two incidents at the MoD’s Porton Down lab near Salisbury last year. They both involved splits in isolation suits. One was at a facility housing marmosets infected with Ebola virus. The tears were reported and the damaged parts replaced. “You will get tears in safety suits. People will spill things. Those kinds of accidents are unavoidable. If they are immediately corrected and reported, the people should be rewarded. They certainly shouldn’t be punished,” said Ebright. “That’s how the system should work.”

Richard Daniels, head of the HSE’s biological agents unit, said the safety of UK labs was good, if not perfect. He said the regulator urged lab directors to focus on their vulnerabilities and to improve safety by bringing in fresh measures to assess how well their staff were trained, and how well their equipment was maintained. “With the likes of large organisations, Pirbright, APHA and others, we expect leadership to come from the top, because that sets the culture and the expectations below it. The danger is that if you don’t look at these things proactively, complacency can perhaps affect an organisation, because you haven’t got anything to tell you that things are going awry,” he said.

Inglesby said: “Every lab system, whether university, government or private sector, should make it absolutely clear to its scientists that laboratory safety is a top priority and should be built in to every practice, not an add on, or a checkbox.”

A BIS spokesperson said: “We take any breach of security and safety procedures in animal disease testing facilities very seriously. In these instances, there was no risk to the public and no viruses were released. Health and safety procedures at Pirbright have been strengthened and the BBSRC [Biotechnology and Biological Sciences Research Council] have invested millions of pounds into facilities including the National Virology Centre, which boasts a brand new state-of-the-art high laboratory facility. An independent review was commissioned to promote the development of robust, effective systems and work practices at Pirbright and ensure public safety”.

A spokesperson for the Department for Environment, Food and Rural Affairs, which funded the AHVLA and now the APHA, said on Thursday afternoon:“UK animal disease laboratories are nationally and internationally recognised for their expertise, playing a crucial role in the swift diagnosis of notifiable disease, as shown in the recent avian flu outbreak. As with any laboratory, improvements in procedures are continually made and we always follow HSE advice.




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