Under the Microscope

The close of another calendar year holds little solace for hospitals preparing for a site visit from any of the three big regulatory agencies that survey their facilities. The clock is always ticking on the next walk-through, the next standards issue, the next potential vulnerability to which their center could be susceptible.

Looking ahead to 2012, Medical Dealer spoke with a compliance expert, a regulatory officer and a clinical engineering director on what types of hurdles – and how high – facilities can expect to have to jump in the year to come.

Knowing the Players

Britton Berek is the director of regulatory compliance for ARAMARK, a national independent service organization based in Downer’s Grove, Ill. In that position, he has become intimately acquainted with the nuances of each surveying agency and can offer a thumbnail sketch of each.

“Since 1965, The Joint Commission has had fairly free reign in accreditation,” Berek says. “They would write standards, and CMS would comment on them, but they didn’t change them a whole lot. They had a significant influence, but not like they do now.”

One of the most notable events in the accreditation marketplace in the 50-plus years hence, Berek says, is the emergence of risk management services provider Det Norske Veritas (DNV) as another Deemed-Status agency. As a third source of accreditation, Berek says DNV provides “a little bit of directional push” in interpreting standards, as well as some healthy competition.

Of the Centers for Medicare & Medicaid Services (CMS), Berek says, “Obviously they’re driving the bus. It’s their money.” Berek describes CMS investigators as typically thorough and without operational or time constraints.

“They will take as much time as they need to look through an organization,” he says. “Their bar can be set pretty high – they can drill down as far as they want.”

CMS can consider individual event outcomes with the luxury of that time, Berek says. DNV and TJC, by comparison, have had to develop processes that increase the efficiency of their evaluations because time is a factor. If, as the thinking goes, flawed processes lead to flawed outcomes, the tracer methodology pioneered by TJC is “very effective at finding process-related issues,” Berek says. DNV uses a mix of both strategies.

If it’s a question of picking your poison, Berek says, there’s not necessarily any incentive to inviting one agency over another. He says the CEO is “usually the biggest driver of who comes in,” but it might have as much to do with subtler issues.

“DNV’s marketing position is that their surveyors are more collegial,” Berek says. He characterizes the DNV approach as “a little simpler and more stable” in everything from the annual scheduling of visits to the way their findings are scored.

Alternatively, Berek says, the three-year cycle on which TJC operates leads facilities to ramp up their policy evaluations to keep up with its frequent adjustments, whereas the “annual, steady approach” keeps “a constant pressure on performance.”

“From a patient’s perspective, you shouldn’t be able to detect a difference,” he says. “The differences are fairly subtle on balance when you think of all the things that have to be done.”

Among the three bodies, Berek says, differences may not emerge in the frequency and regional assignment of surveyors. Geographically, the same TJC or DNV surveyor could be in Texas one day and Florida the next, but “you’ll pretty much get the same survey throughout the country.” CMS inspections, however, which rely on state resources, can vary greatly from place to place. Furthermore, he says, surveyors will always gravitate towards their areas of specialization once onsite.

“Where you have a radiology surveyor, he might go to X-ray; a surgeon might go to the OR. Until the guy’s there, there’s no way to tell,” Berek says.

The emergence of multiple accrediting bodies also has helped drive a causal shift in priorities in the clinical engineering department, Berek says. Rather than weighting more heavily questions of preventive maintenance in their overall calculus, the newer survey directions emphasize what he terms “human factors.”

“The man-machine interface thing is more significant,” Berek says. “We were stuck in a rut of preventive maintenance and some of the very fundamental things in the operations of biomed. I think these guys are taking a harder look as to where there are negative outcomes and using them to steer the direction of their surveys.”

Berek calls such issues “much more intellectually difficult” and harder to integrate into a survey process than “looking at a graph of how many PMs did you do.”

New in 2012

Standards at each agency evolve consistently due to a variety of pressures and the release of additional information, but one issue that is emerging across the board is that of infection control.

To that end, says Maureen Carr, project director of standards and survey methods at TJC, a new National Patient Safety Goal (NPSG) on catheter-associated urinary tract infections will be introduced in 2012 with full implementation expected in 2013.

The urinary tract infection focus is one of six hospital-acquired infections identified in the “Compendium of Strategies to Prevent Healthcare Associated Infections” published by the Society for Healthcare Epidemiology of America. The others include surgical site infections, central line-associated bloodstream infections and medication-resistant organism infections such as methicillin-resistant Staphylococcus aureus (MRSA), clostridium difficile and ventilator-associated pneumonia.

Currently, there are NPSGs on multi-drug resistant organisms covering MRSA and clostridium difficile, surgical site infections, and central line-associated blood stream infections.

“We periodically look at issues that should be given the spotlight as a National Patient Safety Goal,” Carr says. “We chose not to introduce the six health care-acquired infection topics in the compendium at the same time because we thought it would be very difficult for hospitals to engage significant initiatives on each of these different infections.”

Berek concurs that the shifting focus of emphasis on infection control issues is being given greater priority across the board.

“Two years ago, you never saw a surveyor in central sterile,” Berek says. “You might have seen them in endoscopy; now it’s 100 percent. They have folks looking at all that and trying to sort out root causes, and they will try to direct their survey process to look into those issues. If there have been problems in certain organizations, chances are there’s problems in the next organization.”

Although compliance agencies only concern themselves with whether a process has been established to address such issues, Berek says that from the standpoint of practical fixes, many questions of responsibility around the intersection of device management and infection control remain unresolved.

“Typically our housekeepers are told they should clean the bed itself and some of the peripheral things, but when it comes to the electronic medical devices, they’re told ‘don’t touch it,’” he says.

Carr says TJC draws its awareness of potential issues from a multitude of sources, including experts, literature and news stories, and that most NPSGs are evidence-based. TJC is currently evaluating the information from the FDA alarm summit to develop a set of priorities including whether to issue a Sentinel Event Alert or to develop a National Patient Safety Goal to address the issues related to medical alarms.

“Our Patient Safety Advisory Group advises on what topics we might address,” Carr says, “but we don’t always put them in National Patient Safety Goals. Other tools for communicating patient safety issues to the field include Sentinel Event Alerts, publications, standards and education programs, among others. Our standards are continuously evaluated to make sure that they’re current and contemporary.”

Surviving the Survey

The confluence of issues that converge during a site survey can often reflect the priorities of the agency as filtered through the lens of the surveyor, says Craig Bakuzonis, CCE, MEng. Bakuzonis is the director of clinical engineering at Shands at the University of Florida in Gainesville, Fla.

“The people who are auditing you have their own unique framework and background, and therefore part of dealing with this is trying to understand what the person’s really asking for, and guiding the appropriate response so that they get the information they’re looking for in a method that they understand it,” he says. “We’ve had situations where surveyors have cited us on things that weren’t correct according to their interpretation of the code.”

Sometimes facilities are investigated under “decades-old” standards, Bakuzonis says, despite their evolution with changes in technology, as building programs and with safety analyses. But if your state follows a prescribed code that hasn’t changed, he says, that’s the code you have to follow.

“If the state regs say you have to inspect electrical equipment in the OR every six months, there you go,” he says. You have to understand what the requirements are and how they’re truly subject to interpretation.”

Furthermore, there’s always the possibility that one inspection can open the door for other, higher-level check-ins. Shands uses TJC as its accrediting body, he says, but the Florida Agency for Health Care Administration (AHCA), which has jurisdiction over its operations, can visit at any time it deems appropriate. The occurrence of sentinel events is one such way to trigger a visit from AHCA, which performs its surveys under the Medicare Conditions of Participation (CoP) regulations.

“CMS is using state surveyors from AHCA to perform the survey, so this kind of opens the door for surveying for the CoP elements while the state is here,” Bakuzonis says. “This allows the state to survey for any of its additional requirements above and beyond the conditions of participation, so this kind of opens the door for everything.”

Such a survey could bring with it local and municipal authorities, and differs immensely from a TJC survey, which is process- and outcome-focused.

“The Conditions of Participation survey follows regulations that are the ‘you shall’ variety,” Bakuzonis says, whereas CMS surveys “are much more focused on patient care activities, appropriate procedures and the billing practices associated with that,” he says. CMS surveys can bring with them a crew of 10-14 people over a two-week span, whereas TJC usually caps out at five people over a week.

“Generally people try to be survey-ready because of the service status of TJC,” Bakuzonis says. “They can show up sooner than expected, at any time, for any particular situation. We’ve always operated under the anyone-can-come-in-and-survey-us-at-any-time methodology, and with TJC requiring people to do an annual review of their programs for programmatic changes, all of us are much more attuned to the fact that we need to have the ability to provide documentation clearly available at any time.”

The potential for inspections at any time helps curb bad habits, he says. When workaround evolves into standard operating procedure, you’ve got something that can become a larger concern. Preparing for site surveys offers the opportunity of “a reboot,” Bakuzonis says. “Start fresh, clear your memory.” He advises clearing the decks of any outstanding issues, like firmware or software updates, backups or other issues where the downtime can be scheduled, prior to a visit. Such things “have unintended ripple consequences.”

“You don’t want to be running a big installation project if you don’t have to. Maybe you’re not going to have your contractor crews onsite and you’re just going to suspend renovation activities for a while when they show up. If you’re routinely processing stuff, make sure you’ve got that all out of the way for when the surveyors show up,” he says.

Once the reviewer shows up, Bakuzonis says, staff onsite have to be able to provide responses fairly quickly. For that reason, he says, internal process reviews prior to the visit can help solidify any questions of what information is out there and whether any internal documents can resolve outstanding questions.

Most importantly, however, Bakuzonis says, staff should “let the auditor guide the process,” and be ready to respond to findings after the fact.

“Bad news gets out right away,” he says, but facilities also have the ability to respond to an initial finding with more information and documentation on corrective action within 45 days.

“Pretty much, once they leave, you almost have to immediately start in on the corrective plans that are necessary, and normally those corrective plans have a follow-up survey,” he says. “A lot of times we debrief to figure out where we could improve even more – what they were looking for, what are better ways for us to present that information. Only when you’re done with all that do you finally consider it over.

“But it’s never really over because someone can show up at the door at any time,” he laughs.

Published in December 2011 issue of Medical Dealer Magazine