APIC Conference: Infection preventionists at the 'pressure point' between CMS, hospital CEOs

Is CMS overstepping its regulatory authority?

By Gary Evans, Executive Editor

Allan Morrison, MDThe Centers for Medicare and Medicaid Services (CMS) controversial plan to survey the nation's hospital infection control programs is drawing fire for both going beyond its regulatory authority in some areas and not mandating more specific infection prevention resources in others.

The issues came to the floor in a packed session recently in San Antonio at the annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC). Wary of another unfunded mandate from a regulatory agency, an infection preventionist in the audience asked whether the CMS will establish a minimum number of full-time equivalent (FTE) staff for infection control programs to ensure all areas of the survey are met.

"CMS is not going to do that, but I will tell you that the way around [this is the] governing board, the hospital leadership, is required to make sure you have an effective infection control program," said Daniel Schwartz, MD, MBA, chief medical officer of the CMS Survey and Certification Group in Baltimore, Maryland. "I know right now if you went to your CEO, you may not get much time to make that case. But I think there is going to be a lot more focus on the quality assessment, performance improvement part of the [CMS survey] so you might want go back and look at that carefully. I think that's the pressure point. We are trying to emphasize that the hospital should provide the resources necessary to be able to protect patients from developing HAIs."

"Sir with all due respect," the IP replied from the APIC audience microphone. "Until there is a minimum standard [for FTEs], we're not going to get this [support]."

There is some historical accuracy to the perception, but Schwartz emphasized the collaborative efforts to sharply reduce health care associated infections (HAIs) from agencies within the Department of Health and Human Services and coalitions like the Partnership for Patients. These federal plans and collaborations include aggressive goals to dramatically reduce HAIs and other hospital acquired conditions in the near term. "All of these activities show that now is the right time to develop this kind of survey tool, and the hospital is the right place to focus our efforts," he said. "There is a tremendous federal effort underway to reduce HAIs."

It hasn't always been that way — indeed you could argue that it never has. So there is a bit of future shock as the bold new expectations become clear to both IPs and hospital administrators.

"I feel for you all because you have a job that has really risen up in importance in the last couple of years," he told APIC attendees. "Going back 20 years ago — for those of you who have been infection control officers a long time — you were probably running around waving a flag and trying to get attention. And nobody really thought this was important. That's changed dramatically in the last couple of years."

As we previously reported, the CMS 42-page pilot survey — created in collaboration with the Centers for Disease Control and Prevention — will assess hospital infection control programs across a broad range of areas. The specific sections of the CMS survey Schwartz referred to at APIC call for IPs to identify and address problems through interventions and corrective actions that are supported and resourced by administration. "Hospital leadership, including the CEO, Medical Staff, and the Director of Nursing Services ensures the hospital implements successful corrective action plans in affected problem area(s)," the CMS survey states.

"The surveyor should be able to get information showing an identifiable link between the infection control program and the hospital's [quality improvement] activities," he said. "Hospital leaders should be able to explain how they have enacted successful corrective action plans in affected problem areas."

Seeking a culture of safety

The CMS survey also asks for evidence that the hospital has a non-punitive approach to reporting infection control and patient safety concerns. "Essentially this is asking is there a culture of safety in the hospital?" Schwartz said. Moreover, the "safety culture" aspect of the survey includes a citation that can be issued by surveyors — one that is actually tagged more directly to CMS quality requirements than the infection control CoP. "We included that because we think this is really important," Schwartz said.

The CMS also thinks antibiotic stewardship is important, though asking its surveyors to assess evidence for it — even in the absence of any citations — has drawn pushback from IPs. There also are other areas of the survey where the CMS tries to emphasize best practices in the absence of regulatory authority.

"Since CMS is a regulatory agency, citing and potentially affecting reimbursement, I find it very unusual for you to include things that are not citable in your [regulations]," said James Marks, an infection preventionist from San Diego, CA. "It gives the surveyor more power to dictate infection control practices. I would strongly recommend you remove anything that is not citable since you are a regulatory entity. I think you are overstepping the bounds of your requirements to do surveys of things that are not citable."

The pilot survey is still subject to revision before the final document is used to inspect hospitals nationwide, which is now projected to begin in the spring of 2013, Schwartz said.

"That's a very valid criticism," he said. "This is not a punitive survey; we are testing a tool. So for a hospital that is deemed accredited by an accrediting organization we are only citing a standard level deficiency and they are not required to submit a plan of correction. So there is no penalty for a hospital letting us in the door to do the survey. Whether we include those questions that are not citable [in the final version] is an open question. Right now, I think this is a really important version for you all specifically. This is a self-assessment tool as far as I am concerned. I really don't know if any of those [sections] that are not citable will remain in the final version."

Other questions included the general, somewhat vague nature of the requirement to use "national guidelines" for infection prevention, but the CMS intentionally left the selection of guidance at the local level. "We didn't specify," he said "I think you as infection control officers would know which ones are based in science and which ones you are able to support. If the surveyors come in, sees something and ask for your policy and procedures — if you pull out a nationally recognized guideline and you are following that guideline then you should not be cited. But it is incumbent on you to choose which national guidelines you want to use, and as long as you [follow that] they shouldn't cite you. If they do, I would let somebody know about that."

There's the rub

The CMS survey includes some basic assessment of hand hygiene, though not really in the area of assessing compliance by health care workers. The CMS does not seem to have any new answers to the problem that has plagued hospital infection control since its inception.

"How are we going to really reduce HAIs in the hospital, when hand hygiene compliance is what — 40%, 50%, 60%?" Schwartz said. "When I see articles that some new technology or some new program has hand hygiene up to 80% to 90% that's considered a major success. [But], 10% to 20% of the time they are still not washing their hands. It's a major problem. CMS surveys and certification can't solve [it], but we are trying to bring as much attention to bear as we possibly can. If you look on the tool you will see many times beyond just that hand hygiene [section it is included] in multiple areas. We're trying to send a message that it is important, but it's hard for us to get a hospital, an individual to make a change."

Though he clarified again that the survey is not tied directly to CMS funding, Schwartz seemed to foreshadow that possibility in referring to the HAIS previously targeted for reimbursement cuts: "I think [hospitals] are starting to understand how important this is. Obviously, HAIs are starting to be a [bigger] problem. Hospitals are not getting reimbursed. There are ways around this, but it's not going to be unfortunately something that we do from the survey process."

APIC attendees also questioned the role — or lack thereof — of the Joint Commission, which has said little beyond a relatively cryptic statement of awareness and support of the survey since the CMS made its bold move into hospital infection control.

"This [will be done] just strictly by state agency surveyors," Schwartz said. "[The Joint Commission is] not required to use this survey tool. They are held to the same standard as a CMS survey, so they must assess the minimum health and safety standards in order to comply with the CoP. Just like you are free to exceed that minimum standard, the Joint Commission could have a program in place that exceeds that minimum standard. If the Joint Commission wanted to use this survey — either this tool or the final tool going forward — we would be happy for them to do that. We are very close to them and they are very aware of this patient safety initiative."

The CMS has undergone something of a culture change itself, one which suggests that it had to take the lead in reducing HAIs rather than delegating it to the Joint Commission. The flashpoint was the "ambulatory surgery center debacle," as Schwartz described it, which can be read as the 2008 Las Vegas hepatitis C outbreak that led to follow-up testing of tens of thousands of patients. As we previously reported, CMS surveyors had been to the endoscopy facility in question, but had not been sufficiently trained to detect the ongoing reuse of syringes and needles that led to the outbreak. "[The CDC and CMS] got together and really decided that we needed to be working very closely on infection control policy," he said.

In addition, the CMS has hired its first infection preventionist and other new employees with clinical experience, he said.

"We are hiring people with a long history of clinical experience — managers in hospitals — for survey and certification," he said. "We have hired four or five people with extensive experience. The training is very important, and the surveyor really needs to understand — almost at your level — infection control and what it takes to have good compliance with the CoP."

Indeed, the next revision of the survey may reflect more feedback from surveyors on the practical use of the tool than anything else, he said. "I think the final version will change and be more tailored to meet surveyor needs — not necessarily the self-assessment needs for the infection control officers," Schwartz said. "We need this to be effective for the surveyors, help them [record] their survey findings and be efficient. So we really don't want to give them something that is going to triple the amount of time it takes to [assess] infection control. We are very cognizant of that issue."

APIC keynote: IPs must make the tough calls

Zero HAI expectations create pressure

A stone's throw from the Alamo, infection preventionists were told they must "draw the line" for patient safety by identifying and reporting infections despite pressure from consumers, colleagues and administrators in a new age of transparency.

Allan Morrison, MD, epidemiologist at INOVA Fairfax (VA) Hospital and professor at the Graduate School of Public Policy at George Mason University in Washington, DC, delivered a rousing keynote address before 2,300 IPs at the annual conference of the Association for Professionals in Infection Control and Epidemiology (APIC).

"Sometimes it is not enough to do our best. Sometimes we must do what is required," Morrison said, quoting Churchill at the June 4th opening session of APIC.

A former Green Beret and a 20-year veteran of hospital epidemiology, Morrison mixed a serious message with levity in a call to action for IPs to make a difference for patient safety.

"We are quintessential lone wolves," he said. "You walk on a unit and what is the first thing that happens? 'I'm washing my hands! Why are you here?' Nobody ever said, 'How are you doing?' We are pariahs. We don't get a lot of 'atta boys.'"

In particular, IPs must make the tough calls in many cases to make sure infections are correctly reported. The downside of increased transparency about infection reporting and campaigns for "zero infections" is an increased pressure in health care to meet the high expectations of administrators and consumers. This leads to questionable claims about zero infections for "38 months" or attempts by clinicians to parse and narrow the definition of infections, he said.

"What about honesty?" Morrison asked. "I am not going to say that zero is not achievable — it is not sustainable."

There should be zero tolerance of "passivity" toward patient safety, he emphasized, but consider the patient population many are expecting zero infections to occur in: aging patients with immune deficiencies requiring a complex array of invasive devices. That is currently complicated by economic woes and insurance problems that may create patient incentives to defer care until absolutely necessary. Bacterial strains of whatever subsequently infects them could be any of the increasing variety of pathogens resistant to antibiotics, he added.

"Zero? Difficult," he said.

In addition to HAI definition challenges, beware of "avoidance strategies" like blaming other units or facilities for an infection, Morrison said.

"It's our job to draw the line," he said. "To say, 'No, that is [an infection].' Last time I checked we are a vertebrate species. Have one."