Recent Cases of Infection during GI Endoscopy and Other Surgical Procedures: A Focus on Patient Notification

September 30, 2014  This article discusses a number of recent instances of transmission of the hepatitis C virus and other infectious agents during gastrointestinal (GI) endoscopy and other surgical procedures, as reported by a number of newspapers.

In most of these cases, patients were not informed of the outbreak, which, first, raises for discussion when patients should be — or reasonably need not be — informed of an ongoing outbreak (or similar type of adverse event); and, second, suggests that not all infections are likely accounted for in the national infection databases.

This latter consideration necessarily yields the conclusion that the risk of disease transmission during GI endoscopy and other medical procedures could be significantly higher than public reported.

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Introduction

Several newspaper articles discussing infection control, disease transmissions, and healthcare quality were published in mid-September, 2014.

For example, The Orange County Register published the article (October 26, 2014): “Mission Hospital kept operating rooms open after unsound conditions uncovered.”

According to this newspaper, “Hospital administrators said … they first became aware of high humidity in one operating room – a condition that can lead to growth of bacteria and infection as early as February (more than 6 months ago). With a temporary heating, ventilating and air-conditioning system in place, they elected to continue allowing surgeries in that room until the The Joint Commission intervened two weeks ago.”

The Toronto Star published the article (September 27, 2014): “Hepatitis C outbreaks at three Toronto colonoscopy clinics kept secret.”

Suggesting that the risk of hepatitis C transmission during GI endoscopy may be higher than reported in Canada (and, possibly, in the U.S.), this article reported three Toronto colonoscopy clinics have had hepatitis C outbreaks since 2011.

Toronto Public Health determined that 11 patients were infected with the virus, concluding that contaminated sedative injections was the “possible” cause in all cases.

According to the Toronto Star, the authorities responsible for investigating outbreaks and for inspecting the clinics — Toronto Public Health and the College of Physicians and Surgeons of Ontario, respectively — “kept the outbreaks secret.”

The Des Moines Register published the article (September 28, 2014): “Iowa City VA patients not told about bacteria problem.

According to this newspaper, this Veterans Affairs hospital in Iowa City (IA) identified Legionella in the hospital’s water pipes, several sinks and other water outlets during the past few years.

Legionella is a potentially deadly type of bacteria typically found in water.

These findings notwithstanding, the Iowa City VA did not inform patients of the potential infection risk of infection posed by exposure to the bacteria. Patients were not informed because hospital officials concluded that the Legionella contamination was under control.

The Des Moines Register quoted a consumer advocate who favors hospitals being more open with patients when there is a risk of infection. “If a patient gets Legionella while at the hospital, and the hospital didn’t provide at least general information to patients about what it knows about the bacteria being present in the water, everyone will say it should have.”

To be sure, however, when a healthcare facility should inform patients of a bacterial outbreak, or when reasonably not to, can be a complicated calculus that usually requires expert assessments, literature reviews, and precedent.

Almost two years ago, CNN reported that 29 patients at the VA hospital in Pittsburgh (PA) had been diagnosed with Legionnaires’ disease.  This cable news source reported that hospital officials learned in December 2011 that its water system was contaminated in December 2011, but chose not to disclose the problem until almost a year later.

Going public

In some instances, however, the public is told of a breach that could pose an increased risk of infection.

For example, Denver’s ABC 7NEWS published the article (September 25, 2014): “Denver VA Medical Center shuts down surgical unit due to problems with equipment sterilization.”

According to the report, “The Denver Veterans Affairs Medical Center has temporarily halted surgeries due to a problem with sterilizing surgical instruments.”

In a statement provided to 7NEWS, the medical center added that, “We have detected trace mineral deposits on select surgical instruments, and are in the process of resurfacing these instruments. As a result, we are rescheduling affected procedures at the Denver VAMC.”

A similar type of error occurred at the John Cochran Division of the VAMC in St. Louis (MO), in February, 2011.

Other cases of potential infection

Like these recent newspaper reports, several other instances did not result in patients being promptly informed. One of these cases involved a fungal outbreak investigated by the Centers for Disease Control and Prevention (CDC).

These cases include:

  • CDC investigator discusses probe in 2008, 2009 fungal outbreak at Children’s” (a New Orleans, LA, TV affiliate, June 9, 2014). According to this report, “A senior federal infectious disease investigator said there was no attempt to hide information about a deadly fungus that killed five children at Children’s Hospital between 2008 and 2009. A study detailing the outbreak and deaths is only now being published in the May (2014) edition of Pediatrics Infectious Disease Journal.”

Are published infection rates reliable?

These finding that in some instances patients are not informed of an ongoing bacterial or viral outbreak raises a reasonable question:

  • How can the public reliably compare the safety and quality of hospitals, as they are often advised in the U.S. media, if important data about infections (and other types of adverse events) may not have been made public?

For example, entitled “How to Check Up on Your Hospital,” a recent article in the Huffington Post writes (October 7, 2014): “While you may not always have the opportunity to choose your hospital, especially in the case of an emergency, having a planned procedure can offer you a variety of choices.”

This article further advises that: “Another important reason to do some research is the all too frequent occurrence of hospital infections, which kill around 75,000 people in the U.S. each year. So checking your hospital’s infection rates and cleanliness procedures is also a wise move.”

Similarly, the Deseret News published the article “Health department reports hospital-associated infections” (October 8, 2014), which states the otherwise important claim: “The Utah Department of Health on Wednesday released its annual report on health care-associated infections, giving Utahns one more tool in the process of selecting a facility for surgery or other procedures.”

But, such infection data and comparisons of the infection rates and cleanliness of hospitals are arguably not of significant value, because these comparisons assume — actually, they necessarily require — first, that hospitals publicly disclose every serious threat, including identified infections and outbreaks, and second, that these infection data have been independently validated for accuracy and completeness.

The findings that patients are not always informed of an outbreak raise fair questions about the validity of annual department of health infection reports, and of comparisons of the safety of hospitals, at least those that use published infection rates as a metric for evaluating safety.

A hospital’s disclosure of infections (e.g., an outbreak) may not be commonplace in the U.S., in part, because the CDC may neither encourage nor recommend patient notification of the potential for disease transmission, as suggested by its earlier comments and stance regarding the fungal outbreak in New Orleans.

When asked if hospitals should inform their patients when Legionella spp. have been identified in the water supply, the CDC replied in one recent instance that it would be “a judgment call on their (the hospitals’) part.”

Some states require hospitals, surgery and dialysis centers, for example, to report specific types of health care-associated infections (e.g., central line-associated blood stream infections), but these data can be incomplete, as these laws often merely require that infection data be reported, not that these data first be necessarily validated for accuracy and completeness.


Dr. Muscarella’s related articles

Articles by Dr. Muscarella that address the topics discussed in this article include:


Recommendations

In response to these newspaper article, the following recommendations are provided to healthcare facilities to improve quality and safety.

  • Confirm that your medical facility’s policies and procedures (“P&Ps”) detail the required actions in the event of a confirmed bacterial outbreak. Review these P&Ps and ensure they are not incomplete, vague or confusing.
  • Confirm that these P&Ps vis-à-vis patient notification (and/or the notification of the respective state’s department of health) are consistent with the medical facility’s quality mission, safety goals, and both state and local regulations.
  • In the event of an outbreak, ensure that your medical facility’s resulting actions (e.g., patient notification) comply with the facility’s documented P&Ps. Failure of a medical facility to adhere to its P&Ps is a deviation that could justify citation by a surveyor.

A hospital’s P&Ps might be based on the following recommendation published in 2010 in the New England Journal of Medicine: “(Patient) disclosure should be the norm, even when the probability of harm is extremely low. Although risks to the institution are associated with disclosure, they are outweighed by the institution’s obligation to be transparent and to rectify unanticipated patient harm.”


Article by: Lawrence F. Muscarella, Ph.D., President of LFM Healthcare Solutions, LLC. E-mail: Larry@LFM-HCS.comArticle posted: September 30, 2014.