EXECUTIVE SUMMARY

Surgery centers that fail to pay close attention to their reprocessing processes could end up causing dangerous — even fatal — infections.

  • Although the rate of infection from endoscopy is low, it’s likely that some infections related to reprocessing problems are not reported because patients do not attribute their illness to a procedure they might have undergone several weeks earlier.
  • One best practice in reprocessing is to create site-specific training and policies.
  • Another strategy is to follow federal and/or other expert guidelines on reprocessing.

Reprocessing problems can cause surgery centers major headaches during surveys or worse problems when infections occur. They also can result in illness and death, media attention, and federal investigations.

Endoscope reprocessing has been in the news in recent years, including in 2015 when there was an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) at a UCLA medical center, says Laura Schneider, RN, CGRN, CASC, senior director of clinical services at AmSurg in Dallas.

The CRE outbreak at the Ronald Reagan Medical Center in 2015 resulted in two deaths, seven illnesses, and was attributed to inadequately sterilized endoscopes. Earlier, inadequate cleaning procedures of duodenoscopes are suspected of causing an outbreak of superbugs at two hospitals in Highlands County in Florida in 2009. That outbreak killed 15 people and affected 70 patients. National media focus on cases like these can grab people’s attention. But some worry that there are many more infections that are not reported because of inadequate surveillance, undiscovered breaches, infections with long incubation periods, and for other reasons, Schneider notes.

“Statistics show that the rate of infection from endoscopy is low statistically,” she says. “So, it’s hard to connect the dots when there are infections connected to endoscopic procedures.”

For instance, patients who contract hepatitis or HIV will recall the procedures they underwent that exposed them to blood. But patients who receive a colonoscopy months earlier will not think to connect their bacterial illness to that procedure, she explains. Schneider speaks about reprocessing at national conferences and she oversees surveys, audits, and credentialing for 16 ambulatory surgery centers (ASCs) in Texas and Oklahoma.

The cleaning process for scopes is extremely complex. ASCs must pay close attention and follow all standards and manufacturer’s instructions for use to ensure it’s performed adequately, she says. Reprocessing medical devices and sterilizing equipment cannot fall short of standards, despite the time and space constraints.

“The challenge with surgery centers is they typically don’t have a lot of training and education in reprocessing,” says Michele McKinley, LVN, CMQ/QE, CQA, senior clinical education specialist at STERIS.

Sometimes, scrub techs clean, but they haven’t been trained to conduct the actual process, McKinley notes.

“Surgery centers have to follow the same guidelines as health centers, but they might not have the resources to identify where they might be out of compliance,” McKinley says.

Schneider and McKinley suggest ASCs take these actions to improve their reprocessing and instrument cleaning processes:

Assign a point person to oversee reprocessing. Someone in a surgery center should oversee reprocessing, ensure guidelines are followed, and make sure training is adequate with competencies. The ASC’s infection control expert or a supervisor might handle training and quality assurance regarding reprocessing. The focus would be on consistency and competency to ensure training was a success. In some organizations, a group could be assigned to the task, Schneider suggests.

“The person who oversees scope processing and education can be a center leader, an administrator, or an infection control professional,” Schneider says.

There is discussion whether endoscope reprocessors should be certified, although only a few states require certification. One well-designed certification program is the Certification Board for Sterile Processing (CBSP), she notes.

“Several of us took the exam to see if we could recommend it, and we all agreed the exam was excellent and covered all of the essential principles of endoscope reprocessing,” Schneider adds.

The certification exam contained questions that were not just about reprocessing and following manufacturer’s instructions, but also about using critical thinking skills, she adds.

Develop site-specific training and processes. “Each of my centers use different machine chemicals, different scopes, and they have different automated endoscope reprocessors [AERs], so I can’t develop one education program for all of my centers,” Schneider laments. To develop training, examine all scope equipment, their manuals, and nationally accepted guidelines. Then, create a step-by-step process for reprocessing with their specific equipment, Schneider suggests. Everyone who will be reprocessing equipment needs training, whether the employee is a sterile processing technician or an operating room tech, McKinley says.

“I started my career as an operating tech and found that you don’t get a lot of training in processing or sterile processing,” McKinley explains. “There are courses staff can take to learn about sterile processing.”

Also, the ASC can develop training by following existing guidelines.

“We didn’t want to reinvent the wheel, so we went to manufacturers of each piece of equipment or product and looked at their educational materials first,” Schneider recalls. According to Schneider, training should be detailed, explaining each necessary cleaning action, including these steps:

- Check for leaks before washing the scope;

- Flush by hand or with a pump;

- Clean with enzymatic detergent, following specific manufacturer’s instructions.

“A lot of people think of it as soap — like dishwashing liquid — and so they add more enzymatic detergent,” Schneider notes. “I ask how much they added because there are specific instructions to add one ounce per gallon, and if you add too much it can cause a buildup on the scope and contribute to bacterial growth. It can be detrimental if you don’t follow enzymatic detergent instructions.” Additionally, Schneider recommends disinfecting water bottles connected to scopes and maintaining a temperature range and time for soaking. This latter tip can be tricky. In Schneider’s 30 years as a gastrointestinal nurse, she followed the guidelines of keeping the high-level disinfectant (HLD) at room temperature.

“And then, all of a sudden, they changed their instructions to say a minimum of 68 degrees,” Schneider recalls. “The room temperature in scope reprocessing areas is usually set lower. Because staff are wearing gowns and masks and are hot, the room temperature could be 67 degrees or less.”

When Schneider called the scope manufacturer to clarify if the HLD had to be 68 degrees or could be room temperature, the company told her that it must be at least 68 degrees.

“I said, ‘We can’t get it to 68 degrees,’ and they said, ‘Other facilities have put in heating pads,’” she recalls.

Heating pads didn’t work, so Schneider’s site used terrarium heaters that are waterproof and can be placed underneath the container or floating aquarium heaters and permit the water temperature to be measured and adjusted.

Create consistency to avoid common errors. The CDC offers a reprocessing toolkit for ASCs (http://bit.ly/2HyoNpR). Other toolkits and information also are available. (See story on reprocessing guidelines in this issue.)

ASC directors should be a little cautious about which guidelines they’ll use to ensure consistency and quality of reprocessing. Consider that different guidelines might offer conflicting suggestions. Or, the guidelines might contain recommendations that are impractical in an ambulatory surgery setting, Schneider notes. For example, one set of guidelines could recommend surgery centers use disposable valves, which would add $7 to the cost of each procedure, Schneider says.

“An ASC can’t add $7 to each procedure — that’s ridiculous,” Schneider says. “So, why don’t we just read the cleaning instructions and clean the valves correctly?” Inconsistent reprocessing behavior can lead to common errors that might affect patient safety. Here are a few such errors, according to Schneider:

- Improper cleaning;

- Improper leak testing;

- Not following enzymatic instructions for use;

- Equipment not maintained correctly, such as flushing device and AER;

- Lack of documentation of expiration dates;

- Re-use of single-use items, including sponges and brushes;

- Failure to document patient and scope numbers;

- Different reprocessing method after treating HIV or hepatitis patients;

- General infection control practices are not followed;

- There’s no verification of the AER cycle printout with scope after each cycle.

Focus on patient safety. “Our main goal in anything we do in sterile processing is patient safety,” McKinley says. Those who are dedicated and passionate about patient safety should handle reprocessing.

“I would look for someone who works hard,” McKinley adds. “When I hire somebody for sterile processing, the first thing I tell them is, ‘If you don’t want to work hard, don’t take this job — you can’t skate by with this.’”

ASCs renovate or invest in new construction as their services and practices expand. These construction changes also should make administrators focus on improving patient safety by creating adequate space for reprocessing and cleaning equipment. The room needs appropriate ventilation and negative air pressure, if cleaning involves decontamination, McKinley says.

“Do you have space to house a lot of equipment and trays needed for total joint and other new procedures and to wash equipment effectively,” she asks. “Part of the challenge with anything in medicine is that you want to add new procedures, but people don’t think about the space or supporting sterile processing and what needs to be done to accommodate that. It may mean increasing the space and ventilation, and it’s costly.”

It’s clear that ASCs will continue to expand their procedures and surgeries, which means these types of design issues related to patient safety are paramount, McKinley adds.