May 20, 2016 — California health officials last year declared patients at UCLA’s Ronald Reagan Medical Center in “immediate jeopardy,” just weeks after the Los Angeles hospital publicly disclosed its deadly ‘superbug’ outbreak, according to a recently released 42-page inspection report.
The report presents the findings of the state’s Department of Public Health, which inspected the hospital in March 2015. Two weeks earlier, on February 18, The Los Angeles Times reported that at least seven patients at UCLA had been infected with a resistant bacteria linked to contaminated duodenoscopes.
That Times report notified the public for the first time about UCLA’s outbreak. Two of the infected patients expired. According to the hospital, the infection was a contributing factor in their deaths.
On the same day as the Times report, the UCLA Health System began notifying 179 patients of their potential exposure to the superbug — known as CRE — while undergoing ERCP at Ronald Reagan Medical Center.
ERCP — or “endoscopic retrograde cholangiopancreatography” — is performed at least 650,000 times annually in U.S. hospitals using a duodenoscope to diagnose and treat certain disorders and diseases of the biliary and pancreatic ductal systems.
Hospital officials had traced the outbreak to two contaminated duodenoscopes. The seven infected patients, and the other 179 “at risk” patients, had undergone ERCP at UCLA between October 2014 and January 2015.
The next day, on February 19, the FDA notified the public for the first time that duodenoscopes can infect patients with CRE and other deadly bacteria, “even when manufacturer reprocessing instructions are followed correctly.” The FDA further warned that the complex physical designs of duodenoscopes may “impede effective cleaning.”
“Institutions appear to have been doing the recommended disinfection procedures, and doing them extremely well.” — Stephen Ostroff, MD (FDA chief scientist)
The state’s 42-page report details the California Department of Public Health’s findings during its inspection of UCLA’s hospital. The report termed this inspection a “Complaint Validation Survey.”
Most of this outbreaks discussed in her report — including UCLA’s CRE outbreak — were linked to the Olympus TJF-Q180V duodenoscope — which Olympus recalled two days later, on January 15.
Carbapenem-resistant Enterobacteriaceae, or “CRE,” is a potentially deadly bacteria that can be found in soil, water, and a patient’s gastrointestinal tract. These superbugs can be transmitted by unclean hands and contaminated endoscopes, among other routes. CRE are so named because of their resistance to carbapenems — the “last-resort” class of antibiotics.
While almost otherwise unnoticed, UCLA officials told the Los Angeles Times earlier this week that the hospital had linked seven more infected patients to the hospital’s superbug outbreak.
These additional patients were identified after the hospital contacted and tested the 179 “at risk” patients who underwent ERCP last year. In total, UCLA’s outbreak infected 15 patients with CRE, three of whom died.
The mortality rate of patients infected with CRE during ERCP can be as high as 50%.
In addition to Olympus, duodenoscopes sold by Pentax (Montvale, NJ) and FujiFilm (Wayne, NJ) have been linked to bacterial outbreaks.
“Immediate jeopardy”
Last year, on March 4, 2015, state health officials declared UCLA’s patients to be in “immediate jeopardy” — or, at risk of serious injury, including healthcare-acquired infections.
In less than four hours, the state “abated” this declaration, determining that the hospital had promptly implemented an effective plan that addressed each safety concern.
Hospital officials told The Los Angeles Times earlier this week that no patient infections had been linked to any of the safety lapses, or “deficiencies,” cited by the state in its March 2015 inspection report.
The Centers for Medicare and Medicaid Services, or CMS, defines “immediate jeopardy” as “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” The CMS oversees the safety and quality of care provided by participating hospitals, including UCLA’s Ronald Reagan Medical Center.
Hospitals cited for placing patients in “immediate jeopardy,” but that do not promptly correct the identified lapses, may be fined or prevented from participating in the Medicare program, which reimburses hospitals caring for federally insured patients.
These “immediate jeopardy” findings underscore the importance of training, education, and audits.
According to the Times, Los Angeles County public health department had inspected UCLA’s cleaning procedures shortly after the hospital’s CRE outbreak, and a few weeks before the state’s inspectors surveyed the hospital. Unlike the state, the county officials identified no deviations.
Confidential Quality, Safety and Legal Reviews for Hospitals, Manufacturers and the Public: Click here to read about Dr. Muscarella’s quality and safety services committed to assisting manufacturers, hospitals and patients reduce the risk of healthcare-associated infections, including ‘superbug’ outbreaks linked to contaminated duodenoscopes.
Cedars-Sinai Medical Center
Three weeks after UCLA’s inspection, state health officials inspected Cedars-Sinai Hospital, on March 25, where they identified a number of infection control breaches. In response, the state’s Department of Public Health declared the hospital’s patients, as it did at UCLA, to be in “immediate jeopardy.”
The next day, state health officials determined that Cedars-Sinai had implemented an effective plan that addressed their cited safety violations, resulting in an abatement of the “immediate jeopardy” declaration.
Cedars-Sinai officials told The Los Angeles Times that no patient infections had been linked to any of the safety violations cited by health officials in the state’s inspection report. The report termed this inspection a “Complaint Validation Survey.”
In early March 2015, just two weeks before the state’s inspection, Cedars-Sinai linked four patient infections to a single duodenoscope suspected to be contaminated with CRE. The hospital notified 67 “at risk” patients who underwent ERCP between August 2014 and January 2015 at the hospital, and might have been exposed to this deadly superbug.
The Los Angeles Times reported that one of the four infected patients expired, but that, according to the Cedars-Sinai, the patient’s infection was not the cause. The other three patients reportedly recovered.
The inspections of both UCLA and Cedars-Sinai included state health officials observing infection-control practices, interviewing hospital staff, and taking a hospital tour, among other quality reviews.
It is unclear whether the California Department of Public Health informed these two hospitals beforehand about these forthcoming inspections, or whether both were unannounced.
Cedars-Sinai’s CRE outbreak, like UCLA’s, was linked to Olympus’ recalled TJF-Q180V duodenoscope.
The state’s Department of Public Health did not respond when the Times asked whether either UCLA or Cedars-Sinai had been fined in response to inspection’s “immediate jeopardy” finding.
Both UCLA Medical Center’s state inspection report and Cedars-Sinai’s report are available on-line.
Recommended Reading: Hospitals investigating measures to prevent deadly superbug outbreaks linked to ERCP can read my peer-reviewed article — “Risk of transmission of carbapenem-resistant Enterobacteriaceae (CRE) and related ‘superbugs’ during gastrointestinal endoscopy” (World Journal of Gastrointestinal Endoscopy) — which provides a number of recommendations.
University of Colorado Hospital
Duodenoscopes were also recently linked to deadly bacterial outbreaks at hospitals in Aurora (CO) and Pasadena (CA).
Earlier this month, I published an article that informed the public for the first time about a previously undisclosed E. coli outbreak at the University of Colorado Hospital also linked to the recalled Olympus TJF-Q180V duodenoscope model.
Nine of this hospital’s patients were infected with the superbug earlier this year during ERCP, three of whom reportedly died. Strains of E. coli that are resistant to carbapenem antibiotics are a type of CRE.
Huntington Hospital
The Los Angeles Times reported earlier this month for the first time, based primarily on my research, that at least three patients infected last year during ERCP at Huntington Hospital, in Pasadena (CA), had died. This news was also reported in the Pasadena Star News newspaper.
Each of Huntington’s patients was infected with a multidrug-resistant superbug called Pseudomonas. The implicated model was determined to be the Olympus TJF-160F (not the recalled TJF-Q180V model).
Earlier this year, however, the FDA published a safety communication — “Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF” — confirming that the original cleaning instructions of Huntington’s duodenoscope model had not been properly validated for safety until just recently, months after Huntington’s outbreak.
Although this deadly outbreak was identified in August 2015, only this month did Huntington Hospital officials tell the Times that all three of the infected patients had expired. Because no statements by the hospital since last August discussed further the three infected patients’ progress, it was not clear whether each had recovered.
Article by: Lawrence F Muscarella, PhD. Posted 05/20/2016, Rev A. LFM Healthcare Solutions, LLC. All rights reserved.
E: Larry@LFM-HCS.com. Twitter: @MuskiePhD
Publishing UCLA’s inspection report is important. Even though the general public pays little attention to matters of grave importance until they are personally impacted, healthcare facilities do consider their risk factors. If no more than to protect their liability, one hopes their attention results in real benefits for patients. Reform, if it comes, may be generated by damages suffered by facilities like UCLA. It is apparent manufacturers like Olympus benefit from these tragedies I selling more of their defectively designed devices. The FDA is either impotent or untouchable, despite their complicity. Change will come from healthcare providers, if at all.
Thank you, Chad Terhune, Melody Petersen, LA Times.