Three Toronto colonoscopy clinics have had hepatitis C outbreaks since 2011, the Star has learned.

Toronto Public Health, which revealed the outbreaks when pressed by the Star, says 11 patients were infected and that tainted sedative injections were the “possible” cause in all cases.

The authorities responsible for investigating the spread of infection and inspecting the clinics — TPH and the College of Physicians and Surgeons of Ontario, respectively — kept the outbreaks secret.

NDP health critic France Gélinas said public awareness of the first outbreak might have prevented the next two.

“It has gone beyond appalling that the same mistakes are being repeated and are not being reported,” she said.

She is calling on the province to remove the CPSO as regulator of such clinics — known as “out-of-hospital premises” — charging that the outbreaks show the organization is failing in its duties to uphold quality of care and to be transparent, and is placing patients at risk.

The MPP for Nickel Belt also wants the province to suspend the downloading of hospital services into the community and place a moratorium on the creation of any new clinics until a new oversight body is created to ensure public safety.

“The minister of health has to realize that this push into the community is not safe. It won’t be safe until we have in place much more robust oversight,” she said.

Health Minister Eric Hoskins said he is seeking advice on ways to strengthen outbreak protocols and inspection programs to ensure patient safety in clinics outside of hospitals.

“We will work to identify new tools that can help us continue to protect patient safety no matter where (patients) are receiving treatment. Ontarians have my commitment as minister that we will do whatever is necessary to protect the safety of patients,” he said.

TPH told the Star 11 patients contracted the liver-damaging virus during three outbreaks over the last three years: three were infected at the Downsview Endoscopy Clinic on Dec. 7, 2011, three at the North Scarborough Endoscopy Clinic on Oct. 17, 2012, and five at the Finch Ave. W. site of the Ontario Endoscopy Clinic on March 15, 2013.

Nine of the 11 infected patients have gone on to develop chronic hepatitis C, meaning the virus has remained in their bodies, placing them at risk of serious, long-term problems, including cirrhosis of the liver and liver cancer.

None of the clinics offered up anyone to be interviewed, but all three provided written statements. They all expressed concern for the health and recovery of the patients, said they co-operated fully with investigations and emphasized that they are committed to ensuring outbreaks never occur again.

The Downsview Endoscopy Clinic also said it no longer uses multi-dose vials.

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Dr. Michael Finkelstein, associate medical officer of health for Toronto, told the Star while no definitive cause of the outbreaks was determined, it’s possible that the virus spread the same way at the three clinics. Vials of liquid sedative medication, each used on more than one patient undergoing endoscopic procedures such as colonoscopies, may have become contaminated.

“In all three investigations, the clinics were using multi-dose medication vials for anesthetic and pain management to sedate patients undergoing endoscopic procedures. It is possible that a vial of multi-dose medication used during the procedures became contaminated,” he said.

“There are examples in the medical literature of (hepatitis C) being transmitted between patients in this type of setting when a multi-dose vial of medication becomes contaminated with the blood of an infected patient. In all three cases, TPH ruled out contamination of the endoscopes as a possible source of . . . transmission,” he continued.

Multi-dose vials are often used in hospitals and community clinics because they are cheaper and easier to store than single-dose vials.

According to the Provincial Infectious Diseases Advisory Committee, clinic outbreaks caused by mishandling of multi-dose vials are an ongoing problem: “Outbreaks associated with multi-dose vials in outpatient settings are frequent and recurring. Multi-dose vials should be avoided when possible.”

Public Health Ontario, on its website, states “unsafe injection practices” involving the vials can cause disease transmission. When a patient infected with hepatitis C is injected with medication, backflow of traces of blood can contaminate the syringe.

When additional medication is then drawn from the vial and given to the same patient, the needle is often replaced, but the same syringe is used. The vial gets contaminated from the syringe, and the next patient to be injected with medication from it is then placed at risk.

A copy of an August 2014 interim report on the investigation into the outbreak at the North Scarborough Endoscopy Clinic obtained by the Star states: “It is possible that a vial of medication, most likely Xylocaine, became contaminated.”

Xylocaine is a local anesthetic.

The report suggests TPH began investigating the clinic after learning a 51-year-old man tested positive for hepatitis C on Dec. 14, 2012, two months after undergoing a colonoscopy there.

In the preceding weeks, he had come down with symptoms of the disease, including jaundice, pale stools, loss of appetite, fatigue, nausea and dark urine.

TPH and Public Health Ontario got a list of patients who had been to the clinic in the days immediately before and after the man’s Oct. 17, 2012 visit. On that list, they found a patient who was known to have already had hepatitis. It turned out this man had also visited the clinic on Oct. 17, just prior to the 51-year-old man.

To determine if anyone else had contracted the virus, letters were sent to other patients who had procedures done at the clinic on Oct. 17, 18 and 19. They were advised to get tested for the virus. This resulted in two other infected patients being identified. Both had been to the clinic on Oct. 17.

States the report: “The chances of inadvertent contamination increase with the use of multi-dose medication containers and rapid turnover between patients. Best practices for injection medication dictate use of single-use vials that are discarded after each procedure and in between patients.”

The outbreaks at the colonoscopy clinics are not the only ones in Toronto that have not been reported to the public. A Star investigation, published a week ago, found that nine patients contracted life-threatening bacterial infections, including meningitis, at a Toronto pain clinic in 2012.

At the Rothbart Centre for Pain Care on Dufferin St., improper handling of liquid medication vials was also identified as a problem.

Among 170 infection control deficiencies found during a TPH investigation of the clinic was the non-sterile use of both multi-dose and single-dose vials of medication. Stoppers were not wiped down with a solution of 70 per cent alcohol as required, according to a report obtained by the Star, marked confidential.

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Stoppers on vials have been known to become contaminated with bacteria if they are touched or if droplets from people breathing or talking settle on them.

On Wednesday, the CPSO ordered Dr. Stephen James, an anesthesiologist from the Rothbart clinic, to face a disciplinary hearing.

James told the Star that he was unknowingly colonized with Staphylococcus aureus bacteria, meaning it was present on his skin, but did not make him ill.

About 25 per cent of the population is colonized with the bacteria. It can become life-threatening if it enters the body through a wound.

Dr. Peter Rothbart, medical director and founder of the Rothbart clinic, is being investigated by the college.

Meanwhile, a proposed multimillion dollar class-action lawsuit has been launched on behalf of patients of the clinic who became ill.

Gélinas said that if there had been public reporting of the 2011 outbreak at the Downsview Endoscopy Clinic, subsequent outbreaks may not have happened.

Instead, the outbreaks “went under the radar and were repeated” because clinics did not learn from each other’s mistakes, she said.

Tom Closson, former president of the Ontario Hospital Association and a supporter of moving some services from hospitals to community clinics, is in agreement that outbreaks should be made public.

“I believe that public confidence in the health-care system will improve faster if people know that patient safety is being addressed in an open and transparent manner rather than through keeping errors hidden,” he said.

Gélinas called on the province to suspend the movement of hospital services to the community clinic sector.

“To me, it rings alarm bells as loud as can be. Minister, you cannot continue down this path until you put in place strong oversight, strong accountability and strong transparency,” she said in an interview, referring to Hoskins and his government’s ongoing expansion of the community sector.

Gélinas said the NDP is not opposed to community care as long as it is provided in not-for-profit facilities that have strong oversight, accountability and transparency.

“We are a long way from this in Ontario and good people are paying the price, most often with their health and well-being,” she warned.

The Liberal government is decreasing the amount of annual funding hikes to hospitals, forcing them to download services such as colonoscopies to community clinics. There are 274 out-of-hospital premises today, up from 251 in 2012. (The Liberal government says it favours the creation of more non-profit clinics, but most clinics in the province are for-profit.)

Finkelstein said TPH’s key responsibility during outbreaks is to contain the spread of infection and keep the public safe. The agency was able to do that during the colonoscopy clinic outbreaks by directly contacting patients of the clinics who may have been exposed.

He said outbreak investigation results are not posted on the TPH website because it’s not within the organization’s jurisdiction to do that.

However, he said the agency plans to explore ways to let the public know more about clinic outbreaks in future.

Finkelstein said TPH provided the CPSO with findings of its investigations into the three colonoscopy clinic outbreaks.

“The CPSO has provincial regulatory responsibility and oversight in this matter of practice,” he said.

On Friday afternoon, the Star was informed by the CPSO that the college is now in the process of inspecting the three colonoscopy clinics. Earlier in the day, it posted on its public register of out-of-hospital premises that results of the inspections are “pending.”

CPSO spokesperson Kathryn Clarke said the college inspects clinics after it receives investigation findings from public health authorities to ensure any measures ordered are being implemented.

There is no mention of the outbreaks under the public profiles of the clinics. Asked why, Clarke said in a statement: “It is the role of public health to describe the illness that occurred, the scope and magnitude of the outbreak, and determine the reasons it occurred to help prevent and control further cases and subsequent outbreaks in future. The CPSO does not post the results of public health investigations on our website. We post the outcome and/or status of our premises inspections.”

Asked what the college is doing to stop the multi-dose vial error from repeating itself, Clarke said medical directors of clinics are made aware that compliance with college program standards for out-of-hospitals premises is expected. Among the standards is this requirement: “Multi-dose injectable medications are used for only one patient. If they are not, the rubber septum must be disinfected with alcohol prior to each entry.”

Clarke said the medical directors receive program updates, including those that touch on infection control guidelines, through a newsletter. As well, educational sessions are held.

“The public should be reassured that there is now oversight of both the premises, and the physicians and other personnel who carry out procedures,” she said.

Theresa Boyle can be contacted at tboyle@thestar.ca or at 416-869-4915.

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