New patient safety rules: It’s time to lead, follow, or get out of the way

Joint Commission demands hospitals take up issue

Infection control professionals can take a leadership role in the nation’s expanding patient safety movement by helping their facilities meet landmark new accreditation standards by the Joint Commission on Accreditation of Healthcare Organi-zations, experts tell Hospital Infection Control.

The Joint Commission requirements come as the latest development in a sweeping move to raise the profile of patient safety efforts in a health care system stung by a much-publicized 1999 Institute of Medicine report on medical errors. The IOM report struck a chord with the public and politicians, and veteran epidemiologists have advised ICPs to enter the fray or risk getting swept aside. (See HIC, April 2000, pp. 45-48, under the archives at www.HIConline.com.)

Though calling for a systemwide emphasis, the new standards require "designation of one or more qualified individuals or an interdisciplinary group to manage the organizationwide patient safety program." While risk management and safety officers were listed as examples in the standards, ICPs also are an obvious choice of such clinical leaders, says Carole Patterson, RN, MN, deputy director of standards at the Joint Commission in Oakbrook Terrace, IL.

"[ICPs] certainly bring a huge knowledge and expertise in statistical process, [surveillance], and epidemiology," she says. "They bring a sound scientific background to this whole issue. The have focused on infections, but certainly they can assist in applying those same techniques as statistical tools to any error or any adverse outcome."

Finalized Jan. 2, 2001, the Joint Commission patient safety standards go into effect July 2001. They require establishing ongoing patient safety programs in organizations accredited under the Comprehensive Accreditation Manual for Hospitals. (See new standards, p. 20.)

The Joint Commission requires hospital leaders to "create an environment that encourages error identification" and take "remedial steps to reduce the likelihood of future, recurring errors." Although the standards focus on patient safety, the Joint Commission clearly expects such efforts to include staff and visitors.

"Many of the activities taken to improve patient safety [e.g., security, equipment safety, infection control] encompass staff and visitors as well as patients," the new standards state.

The standards do not specifically require the creation of a new structure or "office" within the organization. They call instead for any existing and newly created patient safety efforts to fall under an umbrella of "accountability" within the organization’s leadership.

Calling out the leaders

"What this set of standards does is call it out’ and make [patient safety] a leadership requirement," Patterson says. "There is no standard that [requires] a new job. We have said [previously] that you have to have an infection control practitioner — someone assigned that function. I think this will be variable. I know a lot of ICPs who have become facilities managers. They have added a job or added a role to their job. I’m sure the hospitals will look around and find the [people] who can do this and give them the assignment."

Indeed, ICPs and epidemiologists are expressing increasing interest in drawing that assignment, at least as reflected by the calls and inquiries that are coming into the Centers for Disease Control and Prevention, says Steve Solomon, MD, chief of special studies activity in the CDC division of healthcare quality promotion.

"The people who are contacting us are very in tune to the issue and very concerned about it," he tells HIC. "Obviously, I can’t tell you about the people who aren’t contacting us, but the ones [who] are [appear] very eager to expand their role into patient safety. [They] recognize the fact that infection control is really one aspect of patient safety and is not a separate entity."

For its part, the CDC is in discussion with other patient safety groups about including bloodstream infections (BSIs) in patient safety data systems. The CDC already collects such data in its National Nosocomial Infections Surveillance (NNIS) system, which has been lauded by patient safety advocates as a model for other surveillance efforts.

"Patient safety is an issue that everyone in the health care field is focusing on," Solomon says. "It’s an issue to consumers, to payers, to insurers. I think our perspective here is that it is the most important issue in health care — certainly for the next few years. That is why we are orienting so many of our programs to be sensitive to patient safety concerns."

Still, the very scope of patient safety, from BSIs to wrong-site surgery, underscores the need to bring diverse medical disciplines to the same table. The Joint Commission’s accreditation requirements, as the latest example, would certainly appear to go beyond the purview and power of an infection control program.

"We have always said that infection control is everybody’s business, everybody’s responsibility," says Ona Montgomery, RN, MSHA, CIC, infection control coordinator at the Department of Veterans Affairs Medical Center in Amarillo, TX. "I think that it is going to be the same thing with patient safety. There is going to have to be this ownership by all of the health care team, not just somebody trying to coordinate some kind of data collection program."

How ICP involvement may take shape

Already involved in the issue, Montgomery and colleagues conduct 20 hours a year of staff education on patient safety. The effort is combined with inservicing on infection control and employee health issues such as compliance with bloodborne pathogen regulations.

"One of the things that we have done here is that anytime an educational process has to do with patient safety — whether it relates to infection control, preventing falls, or medication errors — it is labeled as patient safety-related education," she says. "Infection control participates in what we call a Safety Academy, where we combine all of the safety-related educational content together."

With regard to the new Joint Commission requirements, hospitals may assign some of the data collection components to infection control, particularly as part of existing surveillance programs targeted at, for example, surgical patients, she notes.

For instance, one of the Joint Commission’s core quality measures under its ORYX initiative — introduced in 1997 to integrate outcomes and other performance measurements into the accreditation process — emphasizes appropriate timing of antibiotic administration prior to surgery.

"That is an act, and the failure to do that properly is documented to have a direct relationship to a negative outcome: infection," Montgomery says. "So I could see that infection control could indeed be part of that data collection and aggregation. I would think that the [patient safety] measures will be linked to existing measures of outcome."

ICPs may be asked, with other quality improvement clinicians, which of their respective routine clinical measures should be compiled into a patient safety database, she notes. "If they identify those, then somehow that information would probably be earmarked and [sent on] for leadership-level evaluation," she adds. Similarly, ICPs also may be called upon as unbiased investigators of adverse patient safety events that occur in other areas. The Joint Commission requires that a root-cause analysis be conducted when such sentinel events are identified.

While the CDC is trying to move away from the "medical error" concept to develop patient safety systems free of punitive overtones, the Joint Commission more directly addressed the issue and defined the term. By its new standards, a medical error is "an unintended act, either of omission or commission, or an act that does not achieve its intended outcome."

Failure to wash hands an error of omission’

Thus historic disregard of hand-washing recommendations by health care workers, which places patients at risk of cross-infection from other hospital sources, would fall under the definition of a medical error. "That’s an omission,’" Patterson says.

"Other groups are working on definitions, and ours may change. [But] we have always had infection control standards that talk about risk reduction, and that’s what these new set of patient safety standards talk about. There is a direct corollary there between nosocomial infection transmission," she adds.

While conceding that hand-washing compliance is historically poor, she noted that an error designation can lead to new efforts and novel ideas such as getting patients to remind workers about hand hygiene. "Patient safety is being taken to the bedside," she says. "We all know that hand washing is the most effective break in the chain of [infection] transmission. But getting people to take the time to do it or to use the alternatives to soap and water have [been] major challenges."

Along the same lines, many in the epidemiology community have noted that nosocomial infections should more correctly be termed outcomes — albeit adverse ones — rather than preventable medical errors.

"I concur with others in the field that infections in and of themselves are not errors," Montgomery says. "Certainly, there is a pervasive problem of perception of nosocomial infections as being completely preventable. It kind of depends on what kind of organizational environment exists. If it is a punitive witch-hunting environment in general, than it might be more and more of a problem."

To offset such a development, the Joint Commission standards call for creation of a patient safety environment that minimizes "individual blame or retribution for those involved in an error or in reporting an error." While trying to tease out the punitive aspect out of the process, the Joint Commission does seem to run the risk of creating a surveillance briar patch of errors, near misses, and sentinel events. (See definitions, p. 19.)

"What is intended is that there is confidential tracking of errors and [data] contributions to whatever data systems exist," Patterson says. "[This could be] either internally in the health care organizations, or [externally] if it becomes required as mandatory database submissions as part of state or national tracking systems. There is language there that will support . . . mandatory reporting."

Nevertheless, a lot of the new accreditation requirements already may be in place due to existing infection-control and safety-management programs, she adds.

"Great, then you’re ahead of the game. But you need to go through what you are doing and see if it is defensible in terms of what the new standards require. If the leaders have embraced infection control and prevention activities, and they have really put in place a good safety management program, they have already created a [patient safety] culture," Patterson says.

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