• Study: More Than 1 in 3 Heater-Cooler Devices Contaminated

    June 15, 2017

    Testing of heater-cooler units used in open heart surgery often turned up Mycobacterium chimaera -- an organism linked to fatal patient infections -- as well other bacteria and fungi, despite decontamination attempts.

    Among samples sent to one specialty testing laboratory from 89 heater-cooler devices at 23 centers, 51% tested positive for nontuberculous mycobacteria and 37% were positive specifically for M. chimaera.

    Four units were also colonized with Legionella, John Rihs, vice president of laboratory services at Special Pathogens Laboratory in Pittsburgh, reported at the Association for Professionals in Infection Control and Epidemiology meeting in Portland.

    Of the 653 samples cultured from July 2015 through December 2016, 15% were so contaminated with bacteria and fungi, with heterotrophic plate counts up to five million CFU/mL, that initial results were uninterpretable.

    The other species recovered from these units, such as M. abscessus/chelonae and M. gordonae, have not been associated with disease in this setting, Rihs said in an interview (which was monitored by conference media relations).

    "But if it's raining down M. chimaera over the surgical field, it's likely raining down those too," Rihs told MedPage Today, noting that such infections have probably occurred without being connected to the devices.

    (Excerpt from MedPageToday) 

  • Open-chest devices pose infection risk to more patients, new research shows

    June 15, 2017

     A device used routinely in open chest surgery may have put many more patients at risk of infection from a rare but deadly form of bacteria than earlier believed, according to a study by a Pittsburgh researcher released Wednesday.

    The research, released at a national conference of infection prevention experts in Portland, Ore., has prompted at least one local hospital system, Allegheny Health Network, to begin notifying about 3,000 patients who were involved in such surgeries at either Allegheny General Hospital or West Penn Hospital since 2012. UPMC said it is not notifying its patients.

    The problem with the device — heater-cooler units that are used to warm or cool patient bodies — has been known since early 2015, after research in European countries first linked infections in patients to contamination in one particular type of unit, the Stockert 3T made by LivaNova of Germany.

    U.S. regulators have since found the same problem they suspect led to the infections from the Stockert 3T — cooling fans aerosolizing leaking water — was possible with other manufacturers as well. Almost all of the reported cases of infection have come from the Stockert 3T, but a few have been associated with other manufacturers’ units as well.

    The new study by Jack Rihs, head of laboratory services at Special Pathogens Laboratory in the Pittsburgh Bluff neighborhood, found that the rate of contamination in heater-cooler units was much higher than the U.S. Food and Drug Administration believed last fall when it said up to 500,000 people might be at risk.

    In samples of water from the units — all of them Stockert 3Ts, which once made up 60 percent of the market in the U.S. — Mr. Rihs found that 33 of 89 of the heater-cooler units he tested from 23 states, the District of Columbia and Canada tested positive for mycobacterium chimaera.

    “I was surprised that so many were positive,” Mr. Rihs said, “because [M. chimaera] is such a rare pathogen and to find so many in these devices all over the U.S. is unusual.”

    (Excerpt from Pittsburgh Post Gazette)

  • Hot Tubs Eyed as Another Case of Legionnaires' Reported

    June 13, 2017

     

    Big buildings, hot tubs and warm weather might have led to the conditions that resulted in several local cases of Legionnaires’ disease, medical and building experts said.

    A day after news broke of four cases of Legionnaires’ disease tied to two LA Fitness gyms in Orlando, Lake County health officials confirmed a seniors community in Clermont is also being investigated.

    Health investigators are also focusing on hot tubs, which may help spread the deadly bacteria, at the Summit Greens community in Clermont....

    Buildings with large water systems can be susceptible to Legionella growth and hot tubs can help spread bacteria, said Bill Pearson, senior vice president of Special Pathogens Laboratory in Pittsburgh.

    “When the bacteria is able to find favorable conditions to multiply, it becomes a health hazard,” he said.

    (Excerpt from Orlando Sentinel)

  • SPL Changes to Suite Number 401 on August 29

    August 22, 2016

    On August 29, SPL's new address will be: 1401 Forbes Ave., Suite 401, Pittsburgh, PA 15219  

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

  • 40 years after the Legionnaires’ Disease Outbreak in Philly (Listen to Radio Times interview with Dr. Janet Stout)

    August 01, 2016

    Learn more about the historic Legionnaires' disease outbreak in WHYY's  Radio Times' interview on August 1. Forty years ago, dozens of American Legion members fell ill with a mysterious disease. The 1976 annual conference of thousands of veterans in Philadelphia and the sickness that followed lead to 34 deaths. Discussion includes the illness that was later identified and named after those afflicted veterans: Legionnaires’ disease. Get a first-hand account of the tension and fear that gripped the region from the doorman at the Bellevue Hotel at the time. Learn more from David Fraser, a Philadelphia area native who led the CDC’s federal field investigation. And Legionella expert Dr. Janet Stout, president and director of the Special Pathogens Laboratory and research associate professor at the the University of Pittsburgh Swanson School of Engineering, explains the new standard and regulations for Legionnaires' disease prevention.

  • Legionnaires' Disease Making a Comeback

    July 06, 2016

     

    Older Americans are at higher risk for the bacterial pneumonia.

    by Lisa Esposito | Staff Writer July 6, 2016, at 9:26 a.m.

    Legionnaires' disease is back on the rise, with several new outbreaks in June alone. A Hawaiian island resort, a Pittsburgh hospital and a Maryland senior-living community are all battling pneumonia-causing Legionella bacteria in their water systems. Older adults are at higher risk for getting sick after breathing in water droplets containing Legionella. Here's what you should know about this respiratory illness.

    Outbreak Response

    The first case in May could have been a coincidence. Just four days after moving into The Lutheran Village at Miller's Grant, a continuing care retirement community, a resident was diagnosed with Legionnaires' disease. On June 10, the Ellicott City, Maryland, facility informed residents and staff of what was then a single case of pneumonia.

    It was unclear whether the resident had been exposed in the community or elsewhere. But a second and then a third resident (who also recently moved in) developed Legionnaires' disease. By then, administrators had brought in a consultant, Janet Stout, director of the Special Pathogens Laboratory in Pittsburgh, and were already taking precautions.

    The facility "pulled out all the stops" to address the issue, says Stout, an associate research professor at the University of Pittsburgh and a Legionnaires' expert. That meant restricting access to tap water and providing bottled water to drink; adapting ways of cooking, tooth-brushing, shaving and showering; and bringing in a team to assess the water distribution system and test water samples. Treating water systems with extra chlorine is the first step for reducing Legionella bacteria, Stout says.

    In a three-hour meeting, Stout spoke with residents and staff members to address their many questions. "Can someone get Legionnaires' disease from somebody else who has it?" was a major concern. No, she told them. There's no person-to-person transmission with Legionella. Also reassuring: In general, people who've had Legionnaires' usually won't get it a second time.

    continued on US News & World Report website 

  • Special Pathogens Laboratory Approved for Legionella Testing by New York State Health Department ELAP

    June 30, 2016

    The New York State Department of Health (NYSDOH) ELAP has approved Special Pathogens Laboratory for Legionella testing in both the Nonpotable and Potable Water categories.

    Prior to the New York City Legionella regulation, there was no specific Legionella ELAP certification. Since then, the NYDOH has implemented a certificate program using the ISO 11731 standard, Water Quality – Detection and Enumeration of Legionella. Upon fulfilling the requirements, the NYDOH is issuing  "interim approvals" until an on-site inspection is conducted to receive full certification. 
     
    The Legionella testing approval we received on June 24, 2016 is in addition to our ELAP certifications for Coliforms, E. coli and HPC testing, as well as our A2LA accreditation specifically for Legionella testing as a field of testing. To view our interim ELAP approval and other accreditations, please click here.
     
    The NYSDOH ELAP also instituted a new requirement for Legionella sampling and handling, specifically that sample analysis cannot exceed two days from the time of collection. For our updated Legionella sampling and shipping instructions, click here.

    If there is anything we can do to assist you in meeting these new requirements or if you need more information, please call us at 412-281-5335.

    We appreciate your business and look forward to helping you promote safer water through managing risk from Legionella and other waterborne pathogens.

  • Preventing NTM Infections from Heater-Cooler Instruments

    June 23, 2016

    Nontuberculous mycobacteria (NTM) infections and contamination associated with heater-cooler devices, especially during cardiac surgery are a growing concern. According to the FDA’s Medical Device Review (MDR) database, US hospitals across 10 states account for 34% of infections or device contamination worldwide.

    NTM is a naturally occurring group of bacteria found in soil and water, including chlorinated water. Aerosolization from heater-cooler devices has been shown to contaminate the sterile operative field resulting in patient infections.

    In June 2015, LivaNova (formerly Sorin), the manufacturer of HT 3 heater-cooler devices, issued a field safety notice with disinfection protocols. Recommendations included implementing microbiological monitoring to verify effectiveness. Monthly tests include: heterotrophic plate count, coliform bacteria, Pseudomonas aeruginosa, and nontuberculous mycobacteria.

    Special Pathogens Laboratory (SPL) isolated Mycobacterium chimaera from 25 of 43 heater-cooler devices. Reports found this same species at LivaNova’s production facility in Germany. Diagnosing M.chimaera infections is complicated as symptoms may not appear until one to three years after surgery. However, SPL’s early data shows a decrease in contamination after clients disinfected their devices.

    For NTM testing and developing a quality monitoring plan, please contact Jack Rihs or call 412-281-5335. Learn more.

    Share your experience about disinfecting your heater-cooler system for our study.  

    Take survey

  • CDC concerned over growth in Legionnaires' cases

    June 11, 2016

    June 7, 2016 | By Sean D. Hamill / Pittsburgh Post-Gazette

    “The CDC has a long history of recommending not looking for Legionella as a prospective element to assess risk,” Dr. Stout said.

    The CDC has said for decades that it believed testing regularly for Legionella would give building owners a false sense of security since people have contracted the disease when there were no signs of the bacteria in the water system.

    Dr. Whitney said there is no testing recommendation in the Vital Signs study because “we didn’t want to get into it.”

    But she said because the ASHRAE standards now recommend testing water, the CDC has now changed its position on testing since last summer.

    “We are not against testing” water for the presence of Legionella, she said. “We think it has its place, particularly in healthcare facilities.”

    Legionnaires’ cases in the United States quadrupled from 2000 to 2014, with about 5,000 people a year — and probably many more — now being infected by the deadly form of pneumonia, but the exact reason for the growth is unclear, officials with the federal Centers for Disease Control and Prevention said Tuesday.

    And too many of those cases occur during an outbreak, CDC Director Tom Frieden said Tuesday in a phone call with reporters to announce the publication of a comprehensive study on outbreaks published on the CDC’s Vital Signs webpage.

    “I’ll give you the bottom line [of the study] right off the top: Almost all Legionnaires’ disease outbreaks are preventable with improvements in water system management,” he told reporters.
    During that 15-year period of 2000 to 2014, the CDC investigated 27 confirmed, land-based — as opposed to ship-based — Legionnaires’ outbreaks.

    Those outbreaks included the 2011 and 2012 Veterans Affairs Pittsburgh Healthcare System that the CDC determined infected 22 people and led to the deaths of six of them. Overall, 415 people were infected in the 27 outbreaks, and 65 of them died, the CDC said.

    The CDC study found that in 23 of the 27 outbreaks it investigated there were “gaps in maintenance that could be addressed with a water management program to prevent Legionnaires’ disease outbreaks…”

    There were many more people sickened and killed during other outbreaks the CDC was unable to investigate during that timeframe. It noted in the study that from just 2000 to 2012, it had requests to investigate about 160 outbreaks.

    CDC officials said this new study was prompted by two factors: First, the public notoriety of cases over the last three years that included, first, the Pittsburgh VA, then a cooling tower outbreak in New York City, and, last year, the outbreak in Flint, Mich.

    In addition, last summer, after nearly a decade of work, the American Society of Heating, Refrigerating and Air-Conditioning Engineers — known as ASHRAE — completed its recommendations for dealing with the water-borne disease of Legionella in building water systems.

    ASHRAE’s recommendations are expected to eventually find their way into many of the country’s state or local building codes, carrying the power of law. Since last summer, though, the CDC “heard the ASHRAE standards weren’t easy to understand unless you were a building engineer,” Dr. Frieden said.

    As a result, the CDC on Tuesday also released an online “Toolkit” that it hopes will make adopting the ASHRAE standards easier for building owners and managers. The Toolkit was piloted in Flint, where the CDC took it to building owners and managers who were impacted by the outbreak there that infected 91 people — including 50 cases in a local hospital.

  • Health Department Announces Plan to Reduce Risk of Legionnaires’ Disease Outbreaks in the City

    June 07, 2016

    Toughest cooling tower regulations in nation supported by increased inspection staff, enhanced capacity, lab improvements  

    Inspection of cooling towers in high-risk neighborhoods, including areas of last summer’s outbreaks, are already undergoing   

    All cooling towers in the South and East Bronx are prioritized for inspection

    “New York City has surpassed CDC and ASHRAE by producing a proactive public health regulation that requires specific measures for cleaning, treatment and testing of cooling towers for Legionella.  New York has redefined best practices for controlling Legionella in cooling towers to prevent Legionnaires’ disease,” said Janet E. Stout, PhD, President and Director of Special Pathogens Laboratory.

    June 7, 2016 – Ahead of the summer, the Health Department announced a comprehensive plan to reduce the risk of Legionnaires’ disease outbreaks in the city, including implementation of the toughest cooling tower regulations in the nation, the hiring of more inspectors and training of existing City personnel to inspect towers if needed, and improvements that will speed up community notification and lab testing if outbreaks occur.  

    The cornerstone of the City's preparedness is rigorous oversight and enforcement of the new cooling tower requirements outlined in Local Law 77, which focuses on preventive maintenance of the city’s cooling towers, which took effect on May 9, 2016. Last year, Mayor de Blasio signed Local Law 77, the strictest regulations in cooling tower oversight in the nation. The new requirements allow the City to quickly identify and remediate problematic towers, which are potential sources of Legionnaires’ disease. This year, the City is investing more than $7 million to increase staff for oversight, doubling the number of inspection teams this summer and more than tripling the inspection staff by 2017.

    “New York City has done more than any other city in the nation to regulate cooling towers and reduce the risk of Legionnaires’ disease,” said Health Commissioner Dr. Mary T. Bassett. “Since last summer, we have developed strict regulations for cooling tower maintenance, augmented our disease control infrastructure to better address Legionella in the city, and diminish the risk of community outbreaks. Although we know that there will always be cases of Legionella disease, we are confident that we are taking the steps necessary to reduce the risk of outbreaks.” 

    “We’re proud to support our partners at the Health Department in tracking cooling towers to protect New Yorkers’ health. Since last summer, the Health Department and DOB have registered more than 5,500 cooling towers citywide to make sure that building owners properly maintain their equipment,” said Buildings Commissioner Rick D. Chandler, PE.

    “New York City has surpassed CDC and ASHRAE by producing a proactive public health regulation that requires specific measures for cleaning, treatment and testing of cooling towers for Legionella.  New York has redefined best practices for controlling Legionella in cooling towers to prevent Legionnaires’ disease,” said Janet E. Stout, PhD, President and Director of Special Pathogens Laboratory.

    “The NYCDOH-MH was an excellent partner in addressing the Legionella outbreak in our Bronx communities last year. We look forward to working closely with the DOH and other partners in proactively putting in place Legionella prevention strategies for this season,” said Dr. Belinda Ostrowsky, Director of Epidemiology, Stewardship and Infection Prevention at Montefiore Health System, and associate professor of Medicine at Albert Einstein College of Medicine. 

    “With the summer months upon us, I applaud the NYC Department of Health for taking wide-ranging measures to reduce the risk of Legionnaires’ disease in our communities in the Bronx and throughout the city,” said Rep. Joe Crowley. “Making sure our cooling towers systems are properly maintained while implementing a comprehensive plan to improve our response to possible outbreaks are reassuring steps that let New Yorkers know their health is our number one priority.” 

    “I commend the New York City Health Department for their efforts to keep New Yorkers safe. As the cooling season approaches, it is critical that we assure residents and their families that every preventive measure is being taken to protect air quality so they can have a safe and enjoyable summer season,” said New York State Assembly Speaker Carl Heastie.

    “I am proud to see the New York City Department of Health develop a robust and proactive plan to address Legionella. This is a critical investment of resources to ensure the safety of our community. I commend the New York City Department of Health for prioritizing areas in the Bronx where there have been outbreaks and where there is the highest risk. This shows that we all must continue working together to serve the needs of those we serve,” said New York State Assembly Member Carmen E. Arroyo.

    “Last summer, the Council and Administration worked hand in hand with DOHMH and the CDC to address an outbreak of Legionnaire’s Disease and craft legislation that has set the standard for cooling tower regulation.  The work we have done will minimize Legionnaire’s outbreaks this summer and in the years to come,” said Chair of the Committee on Public Safety Council Member Vanessa L. Gibson. “As the weather heats up, I urge all those maintaining cooling towers to continue to adhere to the sterilization standards set forth by the Council and thank them for being our partners in protecting the public’s health and wellbeing, 

    “Given last year’s events, I’m glad that the East Bronx is being prioritized with regards to cooling tower inspections,” said Council Member James Vacca. “I’m encouraged that the City is being proactive in their efforts to prevent a major outbreak and to provide New Yorkers with as much information as possible. I will continuously work with the Department of Mental Health & Hygiene on Legionnaires’ Disease prevention and monitoring.”

    “I appreciate the de Blasio administration's concerted efforts to mitigate the potential impact of a possible Legionnaire's disease outbreak, via Local Law 77. Given the more aggressive and proactive initiatives being implemented--most notably, in targeted sections of the Bronx--ensuring that our cooling towers are fully operational, I am confident that we are as prepared as possible to contend with the vectors that cause this disease, and that affect some of our most at-risk residents,” said Council Member Annabel Palma. 

    "While we had a scare in the Northeast Bronx last year, I am pleased that it has lead our city to become a nationwide leader in setting higher standards for cooling tower regulations codified in law.  With the hiring of additional inspectors and additional training for City personnel to inspect towers, I am confident New York City is prepared in the event of an outbreak this summer. I want to commend the Health Department for its diligence to reduce the risk of Legionnaire’s Disease," said Council Member Andy King.

    “In anticipation for the summer, I am appreciative for the proactive action being taken by the New York City Health Department to continue its plan to treat and reduce the risk of the Legionella bacteria - especially for the hundreds of South Bronx families impacted by the disease last year," said Assemblywoman Latoya Joyner (D-Bronx, 77th AD). "Building upon local efforts to impose stringent regulations for inspections related to cooling towers in the Bronx and being able to locate registered cooling towers in buildings more easily is appropriate protocol to limit this major public health issue. On the state level, I have introduced legislation that will allocate funding to ensure that resources and measures are in place so that future generations do not have to worry about this preventable disease."

    “I support the Health Department's proactive stance to protect the health of New Yorkers, especially Bronx residents, by giving South and East Bronx neighborhood priority for inspections,” said Council Member Fernando Cabrera.

    Enforcement of NYC Cooling Tower Rules - Local Law 77 

    Effective May 9, 2016, the New York City cooling tower rules are the toughest oversight regulations in New York State and the nation. The law requires the registration of new and existing cooling towers with the NYC Department of Buildings (NYC DOB). Under the law, more than 3,500 buildings with at least one cooling tower must adopt protocols for the cleaning and disinfection of all towers in New York City. 

    The law mandates all cooling towers to be tested for Legionella every 90 days and requires the development of new maintenance and management plans to reduce the likelihood of outbreaks. The rules detail requirements for operations, quarterly inspections, reporting to the Health Department when testing detects increased levels of Legionella bacteria, and annual certification that the owner has complied with requirements. Failure to comply with requirements are subject to stiff penalties; cumulative violations can total up to $25,000. 

    The New York City Department of Buildings has registered a total of 5,544 cooling towers and received 25 notifications of towers that have discontinued operating in the same period.  

    Cooling Tower Inspections

    High Priority Inspections: In addition to required routine inspections, the Department will conduct yearly independent unannounced random spot inspections of cooling towers across the city. High priority inspections target cooling towers that tested positive for Legionella in 2015. All cooling towers in the South and East Bronx have been prioritized for inspection. Additionally, the City inspection schedule will prioritize cooling towers in neighborhoods where Legionnaires’ disease has been more prevalent. These neighborhoods are typically in high-poverty areas where infrastructure may be older and residents have a higher prevalence of chronic disease.  

    Increased Staffing for Inspections: To meet inspection targets, the City is adding staff to increase the number of teams in the field inspecting cooling towers. Additionally, more than 50 staff from sister agencies have been trained and will be made available to assist in various response activities, including water sampling.    

    Increased Testing Capacity

    The City funded five new lab positions to expand testing of Legionella and make the process more efficient. The new capacity will allow the department to conduct PCR testing – last summer it only had capacity to test water by culture. PCR is a laboratory method used to amplify trace amounts of DNA on almost any liquid or surface. In addition, environmental testing will be now in the electronic lab information system, making reporting more efficient.

    Multi-Agency Coordination 

    Data Sharing, Management and Transparency: The City’s plan enhances multiagency collaboration in data sharing and management to allow for a prompt and well-coordinated response to signs of Legionnaires’ disease. The Health Department and the Department of Buildings share a database of cooling tower registrations and inspections. The inspection system notifies the Department of Buildings when unregistered cooling towers are found in the field. The system generates monthly reports of inspected cooling tower locations and provides a list of inspected towers. City agencies, including DCAS, HPD, DEP, NYCEM and NYCHA, will be provided a list of known cooling towers. Cross-agency data sharing and management will also provide greater transparency to the public. Notices of violations adjudicated by the Environmental Control Board will be available for searching on NYC Open Data. 

    Community Communication

    Communication to Communities Affected: The Health Department has developed reporting procedures for an ongoing Legionnaires’ disease investigation, and, for suspected outbreaks, will notify landlords, residents, visitors and staff at buildings affected, providing timely updates and instructions on how to handle the disease. 

    Assessing Cooling Towers in an Affected Zone: Identifying quickly the source or sources of Legionnaires’ disease requires an aggressive assessment of cooling towers in an affected area. The process for assessing cooling towers in an affected zone involves reviewing inspection records, performing a physical inspection and taking samples for testing. The cooling tower samples will be taken to the Public Health Lab to be tested by Polymerase Chain Reaction (PCR) test and culture.  

    About Legionnaires’ Disease 

    There are 500-600 cases of Legionnaires’ disease in New York State annually, and 200-400 of these cases are in New York City. In 2015, there were 438 cases of Legionnaires’ disease in New York City, including 138 from the South Bronx outbreak. In 2013, there were about 4,500 cases of Legionnaires’ disease reported in the U.S., but it is likely the true count is between 8,000-18,000 cases annually.
      
    Cooling towers have been associated with large community outbreaks. An important way to reduce large community outbreaks of the disease is to maintain cooling tower systems so that they limit the growth of Legionella bacteria. In response to the Legionnaires’ outbreaks of 2015, the Mayor and City Council passed Local Law 77 to reduce and contain Legionella growth in cooling towers, becoming the first U.S. municipality to adopt a set of robust requirements to ensure cooling tower maintenance. 

    Legionnaires’ disease is caused by Legionella, a bacteria that grows in warm water. Legionnaires’ disease cannot be spread from person to person. Groups at high risk for Legionnaires’ disease include people who are middle-aged or older – especially cigarette smokers – people with chronic lung disease or weakened immune systems and people who take medicines that suppress their immune system.  

    Symptoms resemble other types of pneumonia and can include fever, chills, muscle aches and cough. Some people may also have headaches, fatigue, loss of appetite, confusion, or diarrhea.  Symptoms usually appear two to 10 days after significant exposure to Legionella bacteria. Those with symptoms should call their doctor and ask about testing for Legionnaires’ disease. To learn more about Legionnaires’ disease and the City’s plan to keep the disease in check, visit nyc.gov/health. 

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    MEDIA CONTACT: (347) 396-4177
    Christopher Miller: pressoffice@health.nyc.gov