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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 78757
512-454-4816, bmitchell@advocacyinc.org
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 www.cms.gov


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:
www.hhs.gov/progorg/oas/reports/region1/10002502.htm
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: http://www.access.gpo.gov Then


go to “search GAO archives”; then type the following phrase in the
search box (report number) “HEHS-99-176"
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 www.jcaho.org
Federal Statutory & Regulatory
Protections Regarding Restraint
and Seclusion
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 www.hcfa.gov/quality/4b.htm.]
Regulations for Hospitals
42 CFR 482.13(f) (CoP’s)
 Coverage - the regulations, which became effective
August, 2, 1999 (pre-CHA), apply to all Medicare- and
Medicaid-participating hospitals, which include short-
term 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.
Regulations for Hospitals
42 CFR 482.13(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.
Regulations for Hospitals
42 CFR 482.13(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.
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.
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


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
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
Regulations for Hospitals
42 CFR 482.13(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.
Regulations for Hospitals
42 CFR 482.13(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.
General Provisions for Federally Funded
Health Care Facilities (CHA)

 The Children’s Health Act of 2000 (Public


106-310, Oct. 17, 2000) [Amends the
Public Health Service Act, 42 U.S.C.
290aa, by adding sections 591-595]
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.
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.
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.

 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)
 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-to-
face 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.
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.
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, 2001.

 “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.
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.
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.
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.
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.
ICF/MR Regulations
(42 CFR.483.420 and 483.450)
 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.
Nursing Home Regulations
(42 CFR 483.13)

 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.
Regulations for Hospitals
42 CFR 482.13(F) (COP’s)
 In December of 2006, after 6 years of
revision, the final rule was published on
the conditions of participation for
hospitals.
Links to Restraint Materials on the Web

Press Articles
 http://courant.ctnow.com/projects/restraint/ - 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.
 http://www.aradvocate.com/News119.html - Article on
the improper use of restraint in nursing homes in
Louisiana.
Links to Restraint Materials on the Web

Listservs, Interest Groups


 http://www.contac.org - West Virginia Mental Health Consumer Association
has page with many links to restraint/seclusion items.
 http://www.angelfire.com/co/CharlyDMiller/panewz.html - Detailed info on
the dangers of positional asphyxia.
 http://www.breggin.com/jcah.html - Principles enunciated by Dr. Peter R.
Breggin, Center for the Study of Psychiatry and Psychology, for the
elimination of the use of restraint.
 http://groups.yahoo.com/group/RESTRAINT_INFO - A list serve dedicated
to discussion of issues relating to the use of restraint.
 http://users.1st.net/cibra/ - Children Injured by Restraint and Aversives.
Organization of families concerned with harm to children from use of
restraint and aversive.
 http://www.stopabuse.net - Website dedicated to exposing abuse in
mental health hospitals.
Links to Restraint Materials on the Web
Position Statements, Guidelines
 http://www.nami.org/update/unitedrestraint.html - NAMI position statement on the
use of restraint and seclusion.
 http://www.aap.org/policy/re9713.html - American Academy of Pediatrics position
statement on the use of restraint on children.
 http://www.accreditinfo.com/howto/acutecare/restraintguidelines.cfm American
Hospital Association (AHA) and the National Association of Psychiatric Health Systems
guidelines on the use of restraint and seclusion.
 http://www.jcaho.org/lwapps/online/rstprcpl.html - JCAHO Restraint Use Taskforce
principles.
 http://www.nasmhpd.org/posses1.htm - National Association of State Mental Health
Program Directors on the use of restraint and seclusion.
 http://www.aacap.org/publications/policy/Ps44.htm - 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.
 http://www.americangeriatrics.org/products/positionpapers/restrain.shtml - American
Geriatrics Society position statement of the use of restraint.
Links to Restraint Materials on the Web
Federal Regulations
 http://www.cms.hhs.gov/cop/2b.asp - CMS Interpretative Guidelines
for Hospital Conditions of Participation for Patients' Rights.

State Statutes, Regulations, Policies


 http://www.doe.mass.edu/lawsregs/603cmr46.html - Massachusetts
Department of Education regulations on the use of restraint in
schools.
 http://www.taba.org/restraint.htm - Tennessee DMHRR policy on
the use of restraint.
 http://www.cqc.state.ny.us/chap334.htm - New York statue on use
of emergency restraint in psychiatric facilities.
 http://www.dhfs.state.wi.us/rl_DSL/Publications/00074a.htm
Wisconsin licensing policy regarding the reporting of deaths.
Links to Restraint Materials on the Web

Restraint Policies of Schools and other Institutions


 http://www.acsu.buffalo.edu/~drstall/restrain.html - Example of a
restraint policy from a nursing home.
 http://www.amarillo.isd.tenet.edu/speced/physrest.html - Restraint
policy of Amarillo Independent school District.
 http://204.98.1.2/isu/conduct_code/punish.html - Jefferson County
Colorado Policy on the use of restraint in schools.
 http://www.worcestershire.gov.uk/educontent/education_info/restra
int.htm - Worcestershire County Council Policy on the Use of
Restraint in Schools.
 http://education.qld.gov.au/corporate/doem/studeman/sm05000/se
ctions/procedur.htm - Australian state policy on the use of restraints
in schools .
Links to Restraint Materials on the Web

Studies and Reports


 http://www.cqc.state.ny.us/pubvoice.htm - New York Commission on
Quality of Care study of restraint and seclusion practices in psychiatric
facilities.
 http://www.hcfa.gov/publications/newsletters/restraint/ - HCFA newsletter
for its campaign to reduce the use of restraint in nursing homes.
 http://ici2.umn.edu/multistate/tip_sheets/physrest.htm - Question and
answer fact sheet prepared by Institute on Community Integration,
University of Minnesota.
 http://www.quasar.ualberta.ca/ddc/parent/restraint.html - Article by Dick
Sobesy on death in restraint.
 http://www.omh.state.ny.us/omhweb/omhq/q0600/restraint.htm - Report
of New York State Office of Mental Health taskforce to reduce use of
restraint.
 http://www.fda.gov/opacom/backgrounders/safeuse.html - FDA fact sheet
on use of physical restraint devices.
 http://www.cma.ca/cmaj/vol158/issue12/1611.htm - Article by Dr. Donald
Milliken on deaths caused by the use of restraint.

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