Hospitals cry foul over ambiguity in HCFA’s new restraint standards
Rules, especially one hour’ requirement, don’t square with reality of delivering patient care, critics say
The Health Care Financing Administration’s (HCFA) new Conditions of Participation (CoP) regulations regarding the use of restraints and seclusion continue to generate controversy as hospitals struggle to adapt to policies that many consider vague and out of touch with how real-world patient care is provided.
"The private hospitals are hysterical," says Renee B. Lameka, RN, MPA, chief of performance improvement at New Mexico VA Health Care System in Albuquerque. "Part of the problem is that rules like this are made by people who don’t have to work in the trenches. You can have rules and standards, but you also have to be realistic about what happens in the real world, without hurting patients. There’s always a common ground."
Richard Wade, senior communications advisor for the American Hospital Association (AHA) in Chicago, says his office was "flooded with calls from members" as soon as the new regulation was published in the Federal Register on July 2. Wade says the AHA has received more complaint calls about restraints than on anything in recent memory. "The essence of our members’ message has been that the way this is worded, they’ll all be out of compliance all the time," he says. "This thing has so many gray areas and is [so] vague, how can anyone comply?"
Based on the complaints it received, the AHA attempted to file a restraining order against HCFA to stop the Aug. 2 implementation date for the regulation. The court, however, declined to take action. Subsequently, the AHA launched a letter-writing campaign, urging members to tell HCFA about their objections to the restraint and seclusion regulations. At press time, Wade reports that the number of member letters sent to HCFA has risen into the hundreds.
Mary Marinaro, RN, MPA, assistant vice president and corporate compliance officer at Contrastate Healthcare System in Freehold, NJ, who recently sent a collaborative letter to U.S. senators and representatives about the restraints issue, calls the rule "ridiculous" and argues that it hits rural and community hospitals particularly hard. Most troubling, she says, is the so-called "one-hour rule," which requires that a patient placed in restraints be evaluated in person within one hour by a physician or other "licensed independent practitioner [LIP]."
Physicians aren’t always available
"I agree with the basic premise that the physicians should know more about their patients and do the assessments," Marinaro says. "But in reality, nurses are the ones who are doing it. If you’re in a community hospital and you don’t have residents, it’s next to impossible to get a physician to come back here within an hour of putting a patient in restraints to do a face-to-face assessment. Realistically speaking, they’re not going to do it. And we have no way to hold them to do it. It’s like we have no recourse."
Matt Wall, JD, associate general counsel for the Austin-based Texas Hospital Association (THA), which represents 454 hospitals (about half of them rural), also worries about the effect the rule will have on smaller facilities. For the last few years, Texas hospitals have operated under the restraint standards in the state’s own Mental Health and Mental Retardation rules, which allow a "clinically privileged nurse" to perform assessments. The nurse then is instructed to call the physician, who issues a verbal order. Now, says Wall, "there’s a question as to whether those clinically privileged nurses may continue that function."
Although HCFA spokeswoman Michelle Robinson says a "licensed independent practitioner" can be a physician assistant or clinical nurse practitioner, Wall cites language in the preamble to the regulation stating that "there be no directional supervision of the LIP. But then there’s also language that talks about the ability to use telephone orders protocols. There seems to be an inherent contradiction there. We think this area needs some clarification."
Wade says the authors of the restraint and seclusion standards failed to understand how broadly the standards could be interpreted. He cites the example of a small child taken to the emergency department of a local hospital with a cut on his chin. "To sew the child up, they put him in something called a papoose. I’ve held my little daughter while she was in the papoose, which they use to hold the child’s arms down so they don’t strike the nurse or physician assistant," Wade says. "Is that restraint and seclusion? What about holding a person’s arm in place for certain kinds of injections or putting in an IV? [The regulation] encompasses a lot of things in the normal course of care that don’t have anything to do with the intent of the rule, which was to protect against the inappropriate use of restraint and seclusion."
Critics of the new restraint rule also complain that the new standards were rushed into taking effect on Aug. 2, only one month after the Federal Register notice was published. "Some argue that there was not a full, complete discussion of this one-hour provision in the proposed rule," Wall says. "So the rule, I think, came as a surprise to a number of people. And then the fact that there was a 30-day implementation period surprised them also."
Fast action can backfire
Wade acknowledges that "it was very unusual that HCFA went around all of its own processes to put the thing out. "The obvious justification was pressure from the media, with the very high visibility of stories that had been broadcast on the inappropriate use of restraint and seclusion, as well as the desire of HCFA to look as if it were trying to take strong action on something the public was legitimately concerned about. But when you do something quickly like that, and you try to cover a lot of bases with one vehicle, this is the kind of thing that happens."
When HPR went to press, HCFA was still in private talks with the Oakbrook Terrace, IL-based Joint Commission on Accreditation of Healthcare Organizations, which is considering revising its own restraint and seclusion standards to conform with HCFA’s regulations. Whether those talks might lead HCFA to revise its own policy remains to be seen. So far, the AHA is taking a wait-and-see attitude. "We’re waiting to see what the Joint Commission does," Wade says. "We’re hoping that whatever the Joint Commis sion comes out with may be helpful to HCFA as it goes through the rule-making process. All this stuff has to coordinate in some way. The standards have to connect with what the regulations are going to say, in terms of what happens in the deemed status process."
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