1 Restraint and Seclusion Overview of Federal Laws and Policies (2003) Prepared by Gary Gross, Beth Mitchell, & Aaryce Hayes Advocacy, Incorporated 7800 Shoal Creek Boulevard, Suite 171-E, Austin, TX ,
2 Resources/Background Information Center for Medicare and Medicaid Services (formerly Health Care Financing Administration) sets standards for all health care providers that receive Medicare and Medicaid - Licensing and certification of providers is conducted primarily by state ( regulatory ) agencies; also conduct investigations - The web site for the CMS is
3 Resources/Background Information HHS Office of Inspector General Report on State abuse and neglect laws which describes the important components of a State system for identification, tracking, investigation and resolution of abuse incidents. - The report finds that up to 90 percent of persons with disabilities reside in facilities, such as group homes, residential schools, and supervised apartments, that do not receive Medicare or Medicaid funding, and thus are not covered by CMS standards - State systems and laws for protecting persons with disabilities from abuse or neglect can vary significantly from State to State. - The report might be used as a guide to assess the adequacy of your state laws on abuse and neglect, including R/S. - The report is available on line at:
4 Resources/Background Information U.S. General Accounting Office (GAO) Report on Restraint and Seclusion The GAO's October 1, 1999 report confirms that there is no adequate system of R/S reporting at the state level, making it impossible to determine the true level of deaths and injuries that result from R/S abuses, and preventing independent agency investigations. - GAO called on HCFA to issue regulations which: (1) establish strict standards on the use of R/S in all facilities and (2) require reporting to P&As regarding all deaths and serious injuries among those with mental illness or mental retardation indicating whether R/S was used for investigation by P&As. - Report is available on line at: Then go to search GAO archives ; then type the following phrase in the search box (report number) HEHS "
5 Resources/Background Information Joint Commission on Accreditation of Health Care Organizations (JCAHO) surveys its accredited hospitals every 3 years to ensure compliance with JCAHO standards - See
6 Federal Statutory & Regulatory Protections Regarding Restraint and Seclusion
7 Federal Regulations regarding Restraint and Seclusion CMS issued three sets of regulations prior to effective date of Children s Health Act, which presumably will be revised to conform to CHA; one set of regulations was issued after the CHA, and other new regulations, covering other health care providers, are in the works. CMS has issued interpretative guidelines and questions and answers on the application of the regulations. They are both available at
8 Regulations for Hospitals 42 CFR (f) (CoP s) Coverage - the regulations, which became effective August, 2, 1999 (pre-cha), apply to all Medicare- and Medicaid-participating hospitals, which include shortterm psychiatric, rehabilitation, long-term, children s and alcohol-drug treatment facilities. They are interim final regulations and may be amended. This rule does not apply to the psyh under 21 rules unless those services are being provided in a hospital setting. Conditions of Participation issued in the form of COPs i.e., requirements that hospitals must meet for participation in Medicaid and Medicare.
9 Regulations for Hospitals 42 CFR (f) (CoP s) Emergency use only In the context of behavioral management, the rule specifies that R/S may only be used in emergency situations if needed to ensure the patient s safety and less restrictive interventions have been determined to be ineffective. Can not use for discipline, staff convenience or as a substitute for active treatment, and no PRNs. Different standards for medical and surgical care - Consistent with the approach used by JCAHO, the rule establishes different standards on the use of R/S in the context of acute medical and surgical care (e.g., to ensure that an IV or feeding tube will not be removed). Time limitations Maximum duration of R/S orders are based on age: adults 4 hours; children and adolescents ages 9 to 17 2 hours; and children under 9 1 hour.
10 Regulations for Hospitals 42 CFR (f) (CoP s) Restraint and Seclusion includes: 1. Physical Restraint 2. Mechanical Restraint 3. Drug Used as a Restraint 4. Seclusion/Escort No use permitted for discipline, staff convenience or as a substitute for active treatment, and no PRNs.
11 PHYSICAL RESTRAINT (CoP s) Includes any manual method or mechanical device, material or equipment attached or adjacent to the patient s body that he or she cannot easily remove that restricts the patient s freedom of movement or normal access to one s body.
12 RESTRAINT (CoP s) Definition clarified all sorts of practices may constitute a physical restraint, the key consideration relating to how the material or practice is being used For example, tucking a patient's sheets in so tightly that he or she cannot move is restraining him or her. In that instance, a sheet is a restraint. Putting up side rails that inhibit the patient's ability to get out of bed when he or she wants to constitutes a restraint. Escorting the individual to an area
13 DRUG USED AS A RESTRAINT (CoP s) Is a medication used to control behavior or to restrict freedom of movement and is not a standard treatment for the patient s condition. A doctor orders a PRN medication for his patient in a detoxification program when he becomes violent. The medication is not a restraint because PRN medication is standard treatment to manage the violent behavior of individuals going through drug or alcohol withdraw
14 SECLUSION (CoP s) Any involuntary confinement to a room or area where one is physically prevented from leaving or assisting a person to an area (Escorting). It does not include confinement on a locked unit or ward, but does include separating an individual from others
15 Regulations for Hospitals 42 CFR (f) (CoP s) Who may issue order R/S may be ordered by either a physician or a licensed independent practitioner permitted by the State and hospital to order R/S without direct supervision. This will vary by state Assessments -- a physician or a licensed independent practitioner must see the patient and evaluate the need for the intervention within one hour after its initiation. Training - ongoing education and training required of all staff with direct patient contact; must cover safe and proper use of R/S and alternatives.
16 Regulations for Hospitals 42 CFR (f) (CoP s) Reporting -- hospitals must report to CMS any death: that occurs while a patient is in R/S, or where it is reasonable to assume that a death is a result of R/S. Under these regulations a hospital is permitted to make a subjective determination about cause of death when it occurs after R/S is discontinued; compare with psychiatric treatment facility regulations -- reporting of all deaths provided. CMS shares these reports with P&As. About 75 deaths have been reported to date nationwide.
17 General Provisions for Federally Funded Health Care Facilities (CHA) The Children s Health Act of 2000 (Public , Oct. 17, 2000) [Amends the Public Health Service Act, 42 U.S.C. 290aa, by adding sections ]
18 General Provisions for Federally Funded Health Care Facilities (CHA) Coverage The Act covers all public and private health care facilities which receive support from any program supported with funds appropriated to any Federal agency, including hospitals, nursing facilities, psychiatric facilities, and ICFs. When R/S Can Be Used R/S may only be imposed by a facility to ensure the physical safety of the resident or others and is not permitted for discipline, staff convenience or as a substitute for active treatment. Doesn t state anything about only in an emergency situation or PRN use Personal Escort is not considered a restraint Time-Out is not considered seclusion Allows medical immobilization, adaptive support and medical protective devices Orders - R/S may only be imposed upon the written order of a physician or other licensed independent practitioner permitted by the state and the facility to order such restraint or seclusion, that specifies the duration and circumstances under which the restraints are to be used.
19 General Provisions for Federally Funded Health Care Facilities (CHA) Regulations - HHS is required to issue regulations requiring facilities to: ensure adequate staffing levels, provide appropriate training for staff, and provide complete and accurate reporting on restraint-related deaths. Reporting - must, within seven days, "notify the appropriate agency, as determined by the Secretary [of HHS]," (which has not yet been done) of each death that occurs at each such facility while a patient is: restrained or in seclusion, occurring within 24 hours after the patient has been removed from restraints or seclusion, or where it is reasonable to assume that a patient s death is a result of such seclusion or restraint. Funding termination - A facility's failure to comply with any of the above provisions may result in its ineligibility for participation in federally supported programs.
20 Monitoring - Seclusion may only be used when a staff member is continuously face-to-face monitoring the resident. Special Provisions for Non-Medical Community- Based Facilities for Children (CHA) Coverage - Special provisions apply only to public and private non-medical, community-based facilities for children and youth (as defined in regulations to be issued by HHS) that receive support from programs funded under the Public Health Service Act. Even if other Federal Laws apply to a a facility, this Act must still be followed. Personal Restraint and Seclusion Only These interventions are permitted only in emergency circumstances (which is undefined) and to ensure the immediate physical safety of the resident or others. Escort not considered a restraint Time out not considered seclusion Allows medical immobilization, adaptive support and medical protective devices Mechanical and Chemical Restraints are Prohibited.
21 Special Provisions for Non-Medical Community- Based Facilities for Children (CHA) Certification of Staff - R/S may only be imposed by an individual trained and certified by a state-recognized body defined in regulations to be issued by HHS and pursuant to a process determined appropriate by the state and approved by HHS in the prevention and use of physical restraint and seclusion and in specified related skills. Interim Procedures - Until the state develops a training and certification process, R/S may only be imposed if the facility assures that a senior staff person, who is competent to conduct a face-toface assessment (as defined in regulations issued by HHS), assesses the well-being of the child subject to R/S. That individual must conduct the assessment within one hour after the initiation of R/S and continue to monitor the intervention for its duration.
22 Special Provisions for Non-Medical Community- Based Facilities for Children (CHA) Reporting - Within 24 hours, covered facilities are required to provide a notification to the appropriate State licensing or regulatory agency, as determined by HHS, regarding all deaths occurring at the facility, and regarding the use of seclusion and restraint (in accordance with regulations to be issued by HHS). Regulations - HHS is required to issue within six months regulations which require states that license covered facilities to develop (within a one year period) licensing rules and monitoring requirements concerning behavior management practice. The regulations also will establish standards on the qualifications of staff involved in R/S and their training and certification, and on reporting of deaths. Funding termination - States which fail to comply with the Act s requirements shall be ineligible for participation in programs funded under the Public Health Service Act.
23 Regulations for Psychiatric Residential Treatment Facilities for Persons under 21 (42 CFR Part 483) Coverage facility other than a hospital that provides psychiatric services for persons under the age of 21, in an inpatient setting. Effective date and comment deadline - These interim final regulations were issued in January 2001 and amended in May 2001; they became effective on May 22, Restraint and seclusion - Same definitions as hospital regulations, but a personal restraint does not include briefly holding without undue force a resident in order to calm or comfort him or her, or holding a resident s hand to safely escort a resident from one area to another. Emergency is defined unanticipated resident behavior that places the resident of others at serious threat of violence or injury if no intervention occurs and that calls for an emergency safety intervention No use permitted for discipline, staff convenience or as a substitute for active treatment, and no PRNs.
24 Regulations for Psychiatric Residential Treatment Facilities for Persons under 21 (42 CFR Part 483) Who can issue orders? Orders for R/S must be issued by a physician or other licensed practitioner permitted by the state and the facility to order R/S and trained in the use of emergency safety interventions. The original rule authorized only a board certified psychiatrist or a physician licensed to practice medicine with specialized training and experience in the diagnosis and treatment of mental diseases.
25 Regulations for Psychiatric Residential Treatment Facilities for Persons under 21 (42 CFR Part 483) Assessments - Within one hour of the R/S initiation, a face-to-face physical and psychological assessment must be conducted by a physician or other licensed practitioner trained in the use of emergency safety interventions and permitted by the state and the facility to assess the physical and psychological well being of residents. The original rule had required that this assessment be conducted by a physician or a clinically qualified registered nurse. Duration of R/S - R/S use must be limited in duration based on the age of patient (identical to the hospital rules), and must be documented in detail in the resident s record. Notification to residents - The facility must provide incoming residents and/or parents/guardians with contact information for the local P&A as part of a notification on the facility s policy on R/S use.
26 Regulations for Psychiatric Residential Treatment Facilities for Persons under 21 (42 CFR Part 483) Monitoring - Staff must be physically present to continually monitor residents in R/S. Debriefing - Within 24 hours after the use of R/S, staff involved in the intervention, supervisory staff, and the resident must engage in a debriefing to discuss the circumstances resulting in the use of R/S and strategies to be used to prevent future R/S. Training The facility must require staff to have ongoing education, training and demonstrated knowledge regarding events that may trigger emergencies, alternatives to R/S, and safe use of R/S, including responding to signs of physical distress; staff must demonstrate their competencies on a semiannual basis.
27 Regulations for Psychiatric Residential Treatment Facilities for Persons under 21 (42 CFR Part 483) Reporting Facilities are required to report, unless prohibited by state law, directly to P&As (and to State Medicaid agencies) ANY: resident death, serious injury to a resident (as defined in the regulations); or suicide attempt of a resident. Regardless of whether the incident related to R/S Timing and Contents The reports must be made by the close of the next business day and include the name of the resident; a description of the occurrence; and the name, address and phone number of the facility.
28 ICF/MR Regulations (42 CFR and ) No use permitted for discipline, staff convenience or as a substitute for active treatment, and no PRNs. One hour limit in time out room (but emergency seclusion is not permitted) as part of approved time-out program; requires constant direct visual observation by staff. Emergency use of restraints only is permitted; may not exceed 12 hours; must be used as part of an individual program plan, in emergency or for specific medical reasons. Drugs may only be used to control behavior if approved by an interdisciplinary team, as part of individual program plan and only if harmful effects of behavior outweigh the potential harmful effects of the drugs. Training requirements are not addressed.
29 Nursing Home Regulations (42 CFR ) Right to be free of physical or chemical restraints imposed for discipline or convenience, and involuntary seclusion. No standards on when R/S can be used No standards on training, length of use or procedures. All alleged violations of rights involving abuse or neglect are reported to facility administrator and other officials as required by state law. Facility must investigate and take corrective action.
30 Regulations for Hospitals 42 CFR (F) (COP s) In December of 2006, after 6 years of revision, the final rule was published on the conditions of participation for hospitals.
31 Links to Restraint Materials on the Web Press Articles - The Hartford Courant articles that revitalized the battle to regulate the use of restraint. Includes valuable data base tracking deaths from the use of restraint across the nation. - Article on the improper use of restraint in nursing homes in Louisiana.
32 Links to Restraint Materials on the Web Listservs, Interest Groups - West Virginia Mental Health Consumer Association has page with many links to restraint/seclusion items. - Detailed info on the dangers of positional asphyxia. - Principles enunciated by Dr. Peter R. Breggin, Center for the Study of Psychiatry and Psychology, for the elimination of the use of restraint. - A list serve dedicated to discussion of issues relating to the use of restraint. - Children Injured by Restraint and Aversives. Organization of families concerned with harm to children from use of restraint and aversive. - Website dedicated to exposing abuse in mental health hospitals.
33 Links to Restraint Materials on the Web Position Statements, Guidelines - NAMI position statement on the use of restraint and seclusion. - American Academy of Pediatrics position statement on the use of restraint on children. American Hospital Association (AHA) and the National Association of Psychiatric Health Systems guidelines on the use of restraint and seclusion. - JCAHO Restraint Use Taskforce principles. - National Association of State Mental Health Program Directors on the use of restraint and seclusion. - American Academy of Child and Adolescent Psychiatry Policy Statement on the Prevention and Management of Aggressive Behavior in Psychiatric Institutions with Special Reference to Seclusion and Restraint. - American Geriatrics Society position statement of the use of restraint.
34 Links to Restraint Materials on the Web Federal Regulations - CMS Interpretative Guidelines for Hospital Conditions of Participation for Patients' Rights. State Statutes, Regulations, Policies - Massachusetts Department of Education regulations on the use of restraint in schools. - Tennessee DMHRR policy on the use of restraint. - New York statue on use of emergency restraint in psychiatric facilities. Wisconsin licensing policy regarding the reporting of deaths.
35 Links to Restraint Materials on the Web Restraint Policies of Schools and other Institutions - Example of a restraint policy from a nursing home. - Restraint policy of Amarillo Independent school District. - Jefferson County Colorado Policy on the use of restraint in schools. int.htm - Worcestershire County Council Policy on the Use of Restraint in Schools. ctions/procedur.htm - Australian state policy on the use of restraints in schools.
36 Links to Restraint Materials on the Web Studies and Reports - New York Commission on Quality of Care study of restraint and seclusion practices in psychiatric facilities. - HCFA newsletter for its campaign to reduce the use of restraint in nursing homes. - Question and answer fact sheet prepared by Institute on Community Integration, University of Minnesota. - Article by Dick Sobesy on death in restraint. - Report of New York State Office of Mental Health taskforce to reduce use of restraint. - FDA fact sheet on use of physical restraint devices. - Article by Dr. Donald Milliken on deaths caused by the use of restraint.