Restraint and seclusion: CMS issues new rule
New regulations allow for face-to-face evaluation
Hospitals failed to report 44 of 104 documented deaths related to restraint and seclusion to the Centers for Medicare & Medicaid Services (CMS) between 1999 and 2004, according to a September 2006 report from the Department of Health and Human Services Office of Inspector General. (For a complete copy of the report, go to http://oig.hhs.gov/oei/reports/oei-09-04-00350.pdf.)
The report urges CMS to seek legislation for intermediate sanctions for hospitals that fail to report these deaths. "I don't think that hospitals are intentionally avoiding the CMS reporting requirements," says Patrice L. Spath, BA, RHIT, a health care quality specialist with Forest Grove, OR-based Brown-Spath & Associates. "It's quite likely many quality managers weren't aware of the requirement."
The focus in hospitals is often on meeting Joint Commission standards, and CMS regulations can get overlooked, says Spath. "For quality managers, this report reinforces the importance of being familiar with CMS regulations," she says. "There are elements in the CMS regulations that aren't covered by the JCAHO standards, and reporting restraint- or seclusion-related deaths is one of them." Another difference is the definition of restraint: The CMS regulations cover both physical or medication-induced restraints, whereas the Joint Commission's standards only apply to physical restraints.
Now, new regulations from CMS, part of its final rule on patients' rights, impose stricter standards for when a facility must report a death associated with the use of restraints or seclusion. (To download a complete copy of the final rule, go to http://www.cpidirections.com/AA/Advisories.htm and click on "Medicare/ Medicaid Final Rule: Patients' Rights – Restraints & Seclusion.")
When a patient dies while being restrained either physically or chemically, or while in seclusion, the quality or risk manager must be notified immediately, says Spath. "The case should be evaluated to determine if it meets the CMS definition of a reportable event," she says.
The reporting window is short — within one business day after the event — so prompt evaluation of the case is necessary. "The hospital cannot wait for completion of the root cause analysis investigation to determine whether or not the patient's death is a result of restraint or seclusion," says Spath.
The new regulations have a new requirement: That deaths occurring within one week after a restraint episode must be reported to CMS. "This expanded reporting requirement may be challenging. Quality or risk managers will need to recognize the potential link between a patient's death and prior restraint situation," says Spath.
An added twist to the new CMS regulations is the requirement that staff must document in the patient's medical record the date and time the death was reported to CMS, she says. "Documenting reports of events to outside agencies is not usually done in this manner and will require a change in usual practices," she says.
Other changes in regs
More rigorous training for health care staff who employ restraints and seclusion to curb violent or self-destructive behavior is required by CMS. "We have special programs put on by risk management and security on how to handle out-of-control patients," says Ann D. Law, RN, outcomes specialist at Covenant HealthCare in Saginaw, MI. "I believe those classes will need to be given to larger groups and more frequently." Currently, training is given by security staff twice a year to staff in the emergency department and critical care units.
The CMS rule also adds trained registered nurses and physician assistants to the category of practitioners who may conduct the "face-to-face" evaluation required within an hour of a patient being restrained or secluded. However, the nurse or physician assistant performing the evaluation must consult a physician or other licensed independent practitioner as soon as possible.
"Anything we can do to curtail any danger associated with restraints is worthwhile. We will certainly follow the new regulations and adjust our policies accordingly," says Nancy Hersch, psychiatric nursing director at Sacred Heart Hospital in Allentown, PA. "We also just instituted a more comprehensive program for safety training including restraints, and we now train a wider group of staff than previously."
The current regulations requiring a physician to see the patient within one hour are very challenging to comply with, says Hersch. "This is very difficult because of the availability of the physicians," says Hersch. "I am sure that we will amend our policy to include nurse and physician assistant interviews."
For the same reason, many organizations will do likewise. "I would suspect that we will entertain the idea of adding the RN to the category of those who may conduct the face-to-face," says Kristine Von Ruden, RN, the organization's quality improvement specialist and Joint Commission coordinator at La Crosse, WI-based Franciscan Skemp-Mayo Healthcare System. "However, I am sure this will generate great discussion."
Quality professionals must ensure that there is appropriate documentation to support that the standards and Conditions of Participation are being followed, says Patti Muller-Smith, RN, EdD, CPHQ, a Shawnee, OK-based consultant working with hospitals on performance improvement and regulatory compliance. Specifically, documentation must show that staff are trained in the use of restraints, the reason for use of restraints, contact with the primary physician, and monitoring of the patient.
"Restraints are used as a last resort to manage patient behavior and provide a safe care environment for patients as well as staff," says Muller-Smith. The documentation requirements are often viewed as a burden on staff, but they are a critical element in order to demonstrate safe patient care is being provided, she adds.
"Both JCAHO and CMS have been focusing on this area over the last few years," says Muller-Smith. "The surveyors always want to see patient charts where the patient has been restrained and look at staff training, communication between the physician and direct care giver and the validity of requiring restraints. Since communication is a hot issue, this may be the area that gets attention."
It's especially important to document the reason for restraint, says Muller-Smith. "Most hospitals have found that they don't have huge numbers of patients with disruptive behavior in acute care. Restraint that is used for the patient's safety does not fall under the same guidelines," she says. For example, "restraint" doesn't include devices that hold the patient for the purpose of routine physical examinations or diagnostic tests, or to protect the patient from falling out of bed. However, the CMS regulations do address the patient's right to be "free from restraint or seclusion of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff."
"This may be causing more problems if not clearly and carefully read, since the basic intent is to protect patients from inappropriate restraint practices — not those that are clearly intended to keep the patient from harm," says Muller Smith.
Once again, documentation is a key issue, says Muller-Smith. "If a patient does become disruptive or a danger to the staff or himself, the other guidelines become important," she says. "Communication with the physician, using least restrictive methods first and close monitoring of the patient while restrained, must be documented."
Hospitals failed to report 44 of 104 documented deaths related to restraint and seclusion to the Centers for Medicare & Medicaid Services (CMS) between 1999 and 2004, according to a September 2006 report from the Department of Health and Human Services Office of Inspector General. (For a complete copy of the report, go to http://oig.hhs.gov/oei/reports/oei-09-04-00350.pdf.)You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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