The types of citations have stayed the same, but the repercussions are more severe. CMS survey trends show the same pattern of mistakes caught by federal surveyors. In response, a new trend has emerged: harsher citations.
“What used to be a standard-level citation is now becoming a condition-level citation, meaning they’ll come back and survey you again in a month,” says Jan Allison, RN, CHSP, senior director of regulatory at AMSURG in Nashville, TN. “Or, they’ll give you immediate jeopardy, meaning you fix it now, or we’ll shut you down. I’ve tried to figure out why they’re doing this, and I think it’s perhaps because CMS is weary of seeing these same issues becoming trends. Their tolerance level is at the end.”
There is yet another, more severe penalty: immediate jeopardy findings. This means the ASC has to fix the problem today, Allison says. “If there is immediate jeopardy, the site has to write a plan of correction that day, and it has to be acceptable,” she says.
Allison offers the example of surgery centers that are found to have performed immediate-use sterilization inappropriately. This had been a standard-level deficiency; now, Allison sees surgery centers issued immediate jeopardy or condition-level findings. Handled correctly, immediate-use sterilization is supposed to be a shorter cycle with no dry time, used only for emergency purposes.
“When someone does something quickly, they’re more at risk of missing a step or not doing it right,” Allison observes. “The normal cycle is a longer cycle with complete dry time. That’s what people should be doing routinely, saving immediate use for emergency purposes.”
But some ASCs have used immediate-use sterilization as a way to squeeze more use out of a single instrument set. Instead of keeping several instrument sets, so one is available while others are going through sterilization, they will perform immediate-use sterilization on fewer instrument sets. This is a deficiency, Allison explains. If there is a situation in which a surveyor sees someone perform immediate-use sterilization while skipping steps or not conducting the procedure correctly, then that is a more serious violation than simply performing immediate-use sterilization when it should be a longer cycle.
“But if they’re doing the process correctly, even if it’s the wrong time to do it, it shouldn’t be an immediate jeopardy,” Allison says. “If a site has a tough survey with a lot of citations, then CMS might come back within a year, thinking the site is a high-risk site.”
ASC staff also might trigger a CMS survey by complaining about patient safety to federal officials. Another common citation involves safe injection practices. ASCs need to maintain policies and practices that ensure syringes of medication are prepared in a clean environment.
“If someone did not clean the cart before preparing medication, then it could be an unclean environment,” Allison says. There was one surgery center survey in which CMS issued an immediate jeopardy citation because a syringe was prepared in an unclean environment, she notes. CMS issued a memorandum on immediate jeopardy on March 5, 2019, and provided surveyors with an immediate jeopardy template (Learn more at: ).
The new guidance states that “to cite immediate jeopardy, surveyors determine that (1) noncompliance (2) caused or created a likelihood that serious injury, harm, impairment, or death to one or more recipients would occur or recur; and (3) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment, or death to one or more recipients.”
Allison hopes the template will result in fewer immediate jeopardy citations that might be better suited for standard or condition-level citation. “The guidance tweaked the verbiage of defining immediate jeopardy, and it forces surveyors to give their reasons in writing,” she explains. “Before, surveyors did not have to give them anything in writing.”
Even when it appears CMS has been especially harsh, the agency is within its rights. “Some clients feel it’s absurd, but I tell them, ‘If you think they’re wrong with what they cited, you can discuss it with them and maybe they’ll change it,’” Allison offers. “But if [clients] were doing what the citation says, and they believe the citation is too severe, then they should understand it’s the surveyor’s judgment call.”
When CMS surveyors levy condition-level citations and immediate jeopardy citations, they can motivate surgery centers to act. “I do believe the tougher citations are forcing people to drive up to a level of compliance they haven’t reached before,” Allison says.
Another citation trend that surgery centers should watch involves management of controlled substances. “The focus on management of controlled substances will be more intense than in times past because of the issue of opioid abuse,” she explains. “There has been a lot of publicity and a high rate of abuse among healthcare workers.” CMS wants ASCs to monitor these drugs closely because they are highly addictive and vulnerable to diversion and misuse.
Surgery centers can improve compliance and reduce the risk of citations by following certain best practices, including these suggestions:
• Keep best practices current. A good ASC leader will stay knowledgeable about regulations and ensure staff will follow all current requirements and best practices. “People will say, ‘I didn’t know that,’ but why didn’t you know that?” Allison asks. “It’s been out for 10 years.”
• Educate staff on best practices. ASC leaders need to educate staff on how to conduct activities, such as sterilization procedures, preparing syringes, and washing hands. Leaders need to monitor staff to ensure they are following the written policies and maintaining compliance. “A good leader will get out there and monitor to ensure employees are doing the right thing all the time,” Allison says.
For example, an ASC could monitor monthly infection control rounds, looking at logs, expired medications, and observing staff practices. “Make sure employees are doing the right thing, and you can monitor quarterly or monthly, depending on findings,” she says.
• Create a robust quality improvement program. Maintaining a robust quality improvement (QI) program is important because it involves monitoring and collecting data. “Everyone is required to have a quality committee, and we’re supposed to monitor indicators that impact patient safety,” Allison says. “Take what your data is telling you to the QI committee and say, ‘Are we doing poorly or good? Do we have an opportunity to improve?’ What can we do to make it better?’”
For example, a surgery center can conduct internal audits and surveillance activities and take the results to the quality committee. “That’s the core of what drives compliance when you look at really good committees and see the data they’ve collected,” Allison says.
• Learn more about life safety. “I feel like life safety is one of the most misunderstood areas,” Allison says. “We’re clinical professionals, not engineers. We have vendors come in and do inspections and maintenance to our systems. We assume vendors are doing everything that’s required.”
But that is not always the case. ASC leaders should learn what they can about life safety regulations and their own facility’s compliance with regulations.