Legal Review & Commentary

Colonoscopy with unclean equipment causes hepatitis C, results in 1.25M award

By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY

Stacey L. Schwimmer, Esq.
Associate
Kaufman Borgeest & Ryan
New York, NY

Leanora Di Uglio, CPHRM, CPHQ
Corporate Director, Clinical Risk Management
Health Quest Systems
LaGrangeville, NY

News: This case involves a 69-year-old male who underwent a colonoscopy with lesion removal at the hospital. Following the procedure, the patient received a letter advising him to be tested for certain bloodborne illnesses, including hepatitis, because it was discovered that some of the equipment that was used in the endoscopies and colonoscopies that were performed at the hospital were not properly sanitized in between patient procedures. The patient was tested four days later and tested positive for hepatitis C, which can cause severe liver damage. After a bench trial, the plaintiffs were awarded $1.25 million.

Background: On June 13, 2007, the patient presented to the hospital for a colonoscopy with lesion removal. The procedure was performed that day with an endoscope. Two polyps were removed during the patient’s colonoscopy. On March 23, 2009, the patient received a letter from the hospital stating, that although the endoscopic equipment was properly cleaned and disinfected, an attached section of the tubing was rinsed rather than disinfected according to the manufacturer’s recommendations. The letter further explained that he was at risk for infection and suggested he undergo a blood test. The patient subsequently had a blood test on March 27, 2009, and tested positive for hepatitis C. On Aug. 4, 2006, plaintiff had been tested for hepatitis C, and the results were negative.

About 10 months after his hepatitis C diagnosis, plaintiff and his wife filed a medical malpractice action against the hospital for improperly sanitizing medical equipment and infecting patients with bloodborne diseases, including HIV, hepatitis C, and hepatitis B. To prove their claim, plaintiffs’ explained the hospital was rinsing the tubes, rather than sterilizing the tubes with steam and chemicals as instructed by the manufacturer. The hospital’s cleaning method placed patients at a risk for developing bloodborne pathogens, as biological materials could be transferred from one patient to another. This risk was demonstrated further by investigators who dismantled water tubes on some of the equipment at the hospital that allegedly were clean and ready for use, but instead were found to have discolored liquid and debris.

Plaintiff argued that it was because of the hospital’s improper sterilization procedures that the patient contracted hepatitis C after his colonoscopy. Specifically, plaintiff explained, through the testimony of his expert hepatologist, that because this patient had two lesions removed during his colonoscopy, he was placed at an increased risk of becoming infected with a bloodborne pathogen. A biopsy that was taken after the patient was diagnosed with hepatitis C further supported plaintiff’s argument that the disease was newly acquired. These facts, combined with the fact that the patient had no other risk factors for hepatitis C, led plaintiffs’ experts to conclude that the patient’s colonoscopy caused his hepatitis C.

Although defendant conceded that the hospital breached the duty of care by failing to properly sterilize the endoscope, defendant denied that this failure caused plaintiff’s injury. Defendant introduced testimony from an expert in internal medicine who explained that a number of unlikely circumstances would have had to occur in order for a patient to contract hepatitis C from an unsanitized endoscope. He concluded that there was a 0% chance that the patient contracted hepatitis through his colonoscopy.

After the non-jury trial and an extensive deliberation, the judge ruled in favor of the patient and his wife, and the judge awarded them a total of $1.25 million for their injuries. The judge acknowledged that although he recognized the chances of the patient acquiring hepatitis C under these circumstances was slight, “there was nothing to preclude the patient from being one of those two persons in a trillion or billion who do get the virus.”

What this means to you: The estimated frequency of contracting an infectious agent after a GI endoscopic procedure is 1 in 1.8 million procedures (Kimmey MB, et al. Transmission of infection by gastrointestinal endoscopy. Gastrointest Endosc 1993; 36:885-888). Failure to adhere to infection control practices generated by governmental and professional organizations, as well as the manufacturer’s recommendations, might dramatically increase the risk of infectious microorganism transmission to the patient and the healthcare provider. In this case, the hospital acknowledged it failed to properly sterilize the endoscope, and the judge concluded that this breach in the duty of care resulted in plaintiff contracting hepatitis C.

Endoscopy infection control guidelines have been published by numerous organizations, including the Centers for Disease Control and Prevention (CDC) and the American Society for Gastrointestinal Endoscopy (ASGE). (Editor’s note: See guidelines at http://bit.ly/WJQazi and http://bit.ly/WJPzO1.) These guidelines have been standard operating procedures in hospitals for many years. So the question must be asked, “What special circumstances were present that created the opportunity to breach operating procedures?”

To answer this question, a thorough review must be undertaken to identify and minimize opportunities for non-compliance with established guidelines and policies. An evaluation of the current infection control policies is a good first step.

The policies should be reviewed to confirm the manner in which endoscopic equipment is cleaned, disinfected, and processed is in compliance with governmental and professional organizations as well as the manufacturer’s recommendations. The policy should not just focus on infection control practices for cleansing and disinfecting the endoscope, but it should also address infection control practices for equipment that is needed during the endoscopic procedures, such as needles, forceps, or tubing. The endoscope and the related equipment might require different post-use handling and cleansing.

Staff education and competency also should be assessed. Hospitals traditionally have good processes in place to provide in-service education sessions when new equipment or procedures are introduced into the work environment, but the hospital also needs to have a process to provide in-service sessions when policies have been changed or revised. Providing updates to staff on revised policies is a hospital responsibility that is often overlooked and can become difficult to defend during a professional liability trial.

Staff competency should be assessed throughout the year and not only annually to meet requirements from the human resources department for compensation purposes. Staff competency assessments can blend in nicely with ongoing quality audits of infection control practices. The quality audit can focus on environmental infection control practices (i.e., availability of cleansing/disinfection chemicals) but also should include direct observation of staff in the cleansing, disinfection, and post processing of the equipment. Staff also should be asked to demonstrate how to access internal policies as well as the manufacturer’s instruction.

Other very important, but sometimes overlooked, areas that require assessment are patient volume, staffing levels, and staff fatigue. Did the breach in the standard result from staff trying to keep up with the high patient volume, or was there a lower number of staff on duty that might have caused staff to work around a normal process, or both? The Joint Commission urges healthcare entities to create a fatigue management action plan that includes scientific strategies to minimize fatigue as a contributing factor in adverse events.

Although it is not clear that the hospital’s failure to properly sterilize the endoscope caused the patient to contract hepatitis C, it is clear that plaintiff now has a chronic and life-altering medical condition. However, assessing current policies, staff education, and competency processes; ensuring ongoing quality audits; and establishing fatigue management strategies are action steps risk managers can take to identify and mitigate potential adverse events associated with infection control practices not only in the GI suite but throughout the organization.

Reference

10-21439-CIV-JORDAN, U.S. District Court, Southern District of Florida, Miami Division (2012).