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by Kelly McCormick

With the massive decrease in procedure volume during COVID-19 and the sharp decreases in revenue that followed, physicians cannot afford any slipups or failures when it comes to compliance. Compliance failures can result in lost revenue and damaging medical malpractice claims.

Risk management is of special concern in the endoscopy unit. Any number of factors can increase compliance risk in the endoscopy unit. These factors include patient factors, such as the planned level of sedation and the individual’s medical condition. They also include staff/personnel variables, procedure-related factors, and issues specific to the facility or institution. Other factors can affect compliance risks, such as staffing shortages, quality of documentation and communication, human error. It may even include vicarious liability. Controlling these factors can help minimize compliance risk and mitigate financial risk.

Minimize Compliance Risks by Getting Back to the Basics

Maintain exceptional documentation

Documentation should be clear, concise, timely, and complete. Reports for all endoscopic procedures must include:

  • Date of procedure
  • Patient information, including at least two patient identifiers
  • Names of the endoscopists(s) involved
  • Procedure performed
  • Indications
  • Medications administered
  • Instrument(s) used
  • Extent of the examination, including all findings and any tissue or fluid samples taken
  • Results of therapeutic interventions
  • Estimated blood loss
  • Complications
  • Clinical recommendations

Note disposition and follow-up to describe the extent of duty in the physician–patient relationship.

Always get clear informed consent

Informed consent should involve a discussion about the endoscopic procedure, including its nature, need, risks, benefits, and alternatives. Gastroenterologists should address the potential for serious complications, but emphasize that these complications are uncommon and rarely occur. The consent form for colonoscopy should mention that perforation of the colon is possible, for example, and that it may require emergency surgery and could result in colostomy.

A parent or legal guardian must consent for minors. The use of a healthcare proxy (HCP) may be necessary for adults who do not have the capacity to provide informed consent due to sedation, dementia, or acute illness.

Adhere to IFU

Infection prevention is an important part of risk mitigation. Healthcare professionals work hard to adhere to manufacturer’s instructions for use (IFU). However, biological contamination of the various scopes can still occur. Infectious transmission associated with endoscopes is always a concern for clinicians and patients alike. In fact, ECRI Institute includes the mishandling of flexible endoscopes after disinfection in their list of the top 10 health technology hazards in 2019. The ECRI report listed a number of missteps that can increase compliance risk. These included failing to follow reprocessing protocols, improper handling and storage practices, not allowing scopes to dry completely after high-level disinfection (HLD), and compromised disinfection status resulting from handling instruments with unclean gloves or otherwise allowing contaminates to contact scopes during transport or storage.

Following each use and prior to high-level disinfection (HLD) or sterilization, teams must pre-clean, leak test, and manually clean flexible endoscopes within the timeframe specified in the IFU. Proper timing and attention to detail are crucial to prevent the accumulation of residual organic material that reduces the overall effectiveness of sterilization and HLD. Inappropriate temperature, insufficient exposure time, and inadequate enzymatic concentrations can dramatically impair the quality of reprocessing.

Verifying cleaning brush bristles integrity prior to each use is essential. Brushing flexible endoscopes until the head of the brush is free from debris is also essential. It is also important to perform leak testing, manual cleaning, and HLD before using new, repaired, or on-loan endoscopes to minimize compliance risks.

Store PPE in an accessible place

Poor PPE compliance is a danger to safety and health of both the staff and the facility. It leaves workers vulnerable to occupational injuries and creates liability for the organization as a worker’s compensation case. However, PPE often gets pushed to the back of the shelves in busy endoscopy units.

Make it easy for staff to be compliant by storing PPE where they can easily see and access it. Store eye protection at the scrub sinks to create a visual reminder for staff to don their gear, for example.

Double glove

Hospital-based healthcare professionals experience approximately 385,000 needlesticks and other sharps-related injuries each year, and approximately 83 percent of all glove breaches go unnoticed. Evidence supports double gloving, as it provides significantly higher protection than donning a single pair.

Reduce human errors whenever possible

Following the manufacturer’s IFU is the cardinal rule in preventing human errors in reprocessing. Hiring certified technicians, following proper hand hygiene and PPE protocols, and fully documenting competency and training protocols are other important steps in reducing human errors.

Perform lower risk procedures whenever possible

Opt for choledochoduodenostomy, for example, as the CDS technique seems to present a lower risk of adverse events among the EUS-BD techniques.

Look for and address occupational hazards

Every person involved in endoscopy procedures is at risk for exposure to body fluids, chemicals, and radiation. Identifying risks, providing proper PPE, and offering training can help reduce these risks, as can measuring, analyzing, and minimizing radiation exposure.

Poor ergonomics is a major occupational hazard in the endoscopy unit. In fact, prevalence of musculoskeletal complaints from those working in endoscopy units ranges from 37 to 89 percent. Thumb, hand, neck, and back pain are common among these workers. Simply adjusting the heights of monitors and exam tables can help address poor ergonomics among workers.

Hire a replacement staff and train them well

Maintaining a well-trained staff is essential in minimizing compliance risks, but that can be easier said than done these days. The pandemic has caused staffing shortages in many industries, including healthcare, in which one case of COVID-19 can sideline an entire team. Training replacement staff in IFUs and other procedures can help cover staffing shortages without increasing compliance risks.

Recognize vicarious liability

Vicarious liability is a situation in which one part is responsible for the actions of another party, which may include employers, administration, hospital, preceptors, proctors, or ostensible agency. Supervision of gastroenterology fellows may present vicarious liability, for example, in which the supervising gastroenterologist would be legally responsible for any adverse events resulting from an endoscopic procedure. Providing close supervision of fellows can reduce risks of errors and oversights.

Keep lines of communication open

Risk management in endoscopy units involves the collection and use of data to minimize errors, injuries, and adverse events. It starts with identifying potential events and their significance, determining the frequency at which these events occurs, applying this knowledge in the endoscopy unit and beyond, and developing preventive measures to reduce injury and loss.

Identifying compliance issues is only half of the solution. Inspiring healthcare workers to make the changes necessary to minimize compliance risks without disrupting workflow or causing resistance is also important. Creating an atmosphere in which staff can voice opinions and offer solutions can foster a team approach to diminishing compliance risks.

COVID-19 has put the pressure on gastroenterology groups and other medical professionals in a way that increases risk for compliance failures. By going back to basics, gastroenterologists can mitigate some of these risks and avoid damage to their bottom lines and their reputations.



Lynn Hetzler was a Medical Assistant for 20 years, working in hospitals, universities and medical laboratories, and has been a leading writer in the medical field for another 20 years. She specializes in creating informative and engaging medical content for readers of all levels, from patients to researchers and everyone in between.



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