HCFA Hospital Condition of
Participation: Patients' Rights
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Date: October 15, 1999 DSL-BQA
99-063
To: Hospitals HOSP 27
From: Susan Schroeder, Director, Bureau of Quality Assurance
Attached is a copy of the Condition of Participation: Patients’ Rights that became
effective for all hospitals participating in the Medicare program on August 2, 1999. This
Condition of Participation is found in the Code of Federal
Regulations (exit DHFS) at 42 CFR 482.13. The Health Care Financing Administration (HCFA)
information on the background of this regulation and responses to comments made prior to
July 2, 1999 can be found at the website:
http://www.access.gpo.gov/su_docs/aces/aces140.html
(exit DHFS)
[address updated 12/03]
The Wisconsin Bureau of Quality Assurance (BQA) has requested Interpretive Guidelines,
and made suggestions to HCFA about questions that need clarification. BQA will forward to
hospitals any clarifying information as soon as we receive it.
In the absence of Interpretive Guidelines, hospitals are advised to familiarize
themselves with the regulation and to attempt in good faith to comply with the regulation.
At 42 CFR 482.13(e), under the standard for restraint for acute medical and surgical
care, the regulation refers to "other licensed independent practitioner permitted by
the State and hospital to order a restraint." In Wisconsin, the only independent
practitioner besides a physician who may be credentialed by a hospital to order restraints
for acute medical and surgical care is an Advanced Practice Nurse Prescriber, that is, an
advanced practice nurse who has been granted a certificate to issue prescription orders
under Wisconsin State Statutes, Section 441.16(2).
At 42 CFR 482.13(f)(3)(ii)(C), under the standard for seclusion and restraint for
behavior management, the regulation permits seclusion or restraint only "in
accordance with the order of a physician or other licensed independent practitioner
permitted by the State and hospital to order seclusion or restraint." In Wisconsin,
only certain physicians may order restraints for persons receiving inpatient hospital
services for mental illness, developmental disabilities, alcoholism or drug dependency.
Only certain physicians and licensed psychologists may order seclusion. Under Wisconsin
State Statutes, Section 51.61(1)(i):
The treatment director shall specifically designate physicians who are authorized to
order isolation or restraint, and shall specifically designate licensed psychologists who
are authorized to order isolation. In the instance where the treatment director is not a
physician, the medical director shall make the designation.
At 42 CFR 482.13(f)(3)(ii)(C), the standard for seclusion and restraint for behavior
management requires that "[a] physician or other licensed independent practitioner
must see and evaluate the need for restraint or seclusion within 1 hour after the
initiation of this intervention." Wis. Stats. s. 51.61 only limits the classes of
providers who may order restraint or seclusion, not those who may "evaluate
the need for restraint or seclusion." Accordingly, in Wisconsin a face-to-face
evaluation by an advanced practice nurse prescriber would satisfy this requirement, in
light of the statutory authority of advanced practice nurse prescribers to "issue
prescription order" for certain "devices…[I]ntended to affect the structure
or function of the body of persons…" Sections 441.16 and 450.01(6)(c ),
Wis.Stats. [Please see BQA memo 01-046 re
the remainder of this paragraph - the rest of this memo remains in effect:] The requirement for evaluation within 1 hour after initiation of restraint or
seclusion for patients who have been admitted for treatment of mental illness may also be
met by a licensed psychologist who is listed or eligible to be listed in the national
register of health services providers in psychology or who is certified by the American
board of professional psychology and who has been granted hospital staff privileges to
treat patients, in accordance with Section 50.36(3g)(b), Wis. Stats.
As noted above, BQA will distribute any official clarifications from HCFA as soon as
they are received. For further information, please contact Beth Stellberg, Chief, Health
Services Section (replaced by Cremear Mims)or Helen Brewster,
ACSW, (608) 243-2089.
Hospital Patient Rights
For the reasons set forth, Standard: Notice of rights. in the preamble, 42 CFR chapter
IV, part 482 is amended as follows: PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS 1.
The authority citation for part 482, continues to read as follows: Authority: Secs. 1102
and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), unless otherwise noted.
Subpart B--Administration 2. Section 482.13 is added to subpart B to read as follows:
Sec. 482.13 Condition of participation: Patients' rights. A hospital must protect
and promote each patient's rights.
(a) Standard: Notice of rights.
(1) A hospital must inform each patient, or when appropriate, the patient's
representative (as allowed under State law), of the patient's rights, in advance of
furnishing or discontinuing patient care whenever possible.
(2) The hospital must establish a process for prompt resolution of patient grievances
and must inform each patient whom to contact to file a grievance. The hospital's governing
body must approve and be responsible for the effective operation of the grievance process
and must review and resolve grievances, unless it delegates the responsibility in writing
to a grievance committee. The grievance process must include a mechanism for timely
referral of patient concerns regarding quality of care or premature discharge to the
appropriate Utilization and Quality Control Peer Review Organization. At a minimum:
(i) The hospital must establish a clearly explained procedure for the submission of a
patient's written or verbal grievance to the hospital.
(ii) The grievance process must specify time frames for review of the grievance and the
provision of a response.
(iii) In its resolution of the grievance, the hospital must provide the patient with
written notice of its decision that contains the name of the hospital contact person, the
steps taken on behalf of the patient to investigate the grievance, the results of the
grievance process, and the date of completion.
(b)Standard: Exercise of rights.
(1) The patient has the right to participate in the development and implementation of
his or her plan of care.
(2) The patient or his or her representative (as allowed under State law) has the right
to make informed decisions regarding his or her care. The patient's rights include being
informed of his or her health status, being involved in care planning and treatment, and
being able to request or refuse treatment. This right must not be construed as a mechanism
to demand the provision of treatment or services deemed medically unnecessary or
inappropriate.
(3) The patient has the right to formulate advance directives and to have hospital
staff and practitioners who provide care in the hospital comply with these directives, in
accordance with Sec. 489.100 of this part (Definition), Sec. 489.102 of this part
(Requirements for providers), and Sec. 489.104 of this part (Effective dates).
(4) The patient has the right to have a family member or representative of his or her
choice and his or her own physician notified promptly of his or her admission to the
hospital.
(c ) Standard: Privacy and safety.
(1) The patient has the right to personal privacy.
(2) The patient has the right to receive care in a safe setting.
(3) The patient has the right to be free from all forms of abuse or harassment.
(d) Standard: Confidentiality of patient records.
(1) The patient has the right to the confidentiality of his or her clinical records.
(2) The patient has the right to access information contained in his or her clinical
records within a reasonable time frame. The hospital must not frustrate the legitimate
efforts of individuals to gain access to their own medical records and must actively seek
to meet these requests as quickly as its recordkeeping system permits.
(e) Standard: Restraint for acute medical and surgical care.
(1) The patient has the right to be free from restraints of any form that are not
medically necessary or are used as a means of coercion, discipline, convenience, or
retaliation by staff. The term "restraint" includes either a physical restraint
or a drug that is being used as a restraint. A physical restraint is any manual method or
physical or mechanical device, material, or equipment attached or adjacent to the
patient's body that he or she cannot easily remove that restricts freedom of movement or
normal access to one's body. A drug used as a restraint is a medication used to control
behavior or to restrict the patient's freedom of movement and is not a standard treatment
for the patient's medical or psychiatric condition.
(2) A restraint can only be used if needed to improve the patient's well-being and less
restrictive interventions have been determined to be ineffective.
(3) The use of a restraint must be—
(i) Selected only when other less restrictive measures have been found to be
ineffective to protect the patient or others from harm;
(ii) In accordance with the order of a physician or other licensed independent
practitioner permitted by the State and hospital to order a restraint. This order
must—
(A) Never be written as a standing or on an as needed basis (that is, PRN); and
(B) Be followed by consultation with the patient's treating physician, as soon as
possible, if the restraint is not ordered by the patient's treating physician;
(iii) In accordance with a written modification to the patient's plan of care;
(iv) Implemented in the least restrictive manner possible;
(v) In accordance with safe and appropriate restraining techniques; and
(vi) Ended at the earliest possible time.
(4) The condition of the restrained patient must be continually assessed, monitored,
and reevaluated.
(5) All staff who have direct patient contact must have ongoing education and training
in the proper and safe use of restraints.
(f) Standard: Seclusion and restraint for behavior management.
(1) The patient has the right to be free from seclusion and restraints, of any form,
imposed as a means of coercion, discipline, convenience, or retaliation by staff. The term
"restraint" includes either a physical restraint or a drug that is being used as
a restraint. A physical restraint is any manual method or physical or mechanical device,
material, or equipment attached or adjacent to the patient's body that he or she cannot
easily remove that restricts freedom of movement or normal access to one's body. A drug
used as a restraint is a medication used to control behavior or to restrict the patient's
freedom of movement and is not a standard treatment for the patient's medical or
psychiatric condition. Seclusion is the involuntary confinement of a person in a room or
an area where the person is physically prevented from leaving.
(2) Seclusion or a restraint can only be used in emergency situations if needed to
ensure the patient's physical safety and less restrictive interventions have been
determined to be ineffective.
(3) The use of a restraint or seclusion must be—
(i) Selected only when less restrictive measures have been found to be ineffective to
protect the patient or others from harm;
(ii) In accordance with the order of a physician or other licensed independent
practitioner permitted by the State and hospital to order seclusion or restraint. The
following requirements will be superseded by existing State laws that are more
restrictive:
Orders for the use of seclusion or a restraint must never be written as a standing
order or on an as needed basis (that is, PRN).
(A) The treating physician must be consulted as soon as possible, if the restraint or
seclusion is not ordered by the patient's treating physician.
(B) A physician or other licensed independent practitioner must see and evaluate the
need for restraint or seclusion within 1 hour after the initiation of this intervention.
(C) Each written order for a physical restraint or seclusion is limited to 4 hours for
adults; 2 hours for children and adolescents ages 9 to 17; or 1 hour for patients under 9.
The original order may only be renewed in accordance with these limits for up to a total
of 24 hours. After the original order expires, a physician or licensed independent
practitioner (if allowed under State law) must see and assess the patient before issuing a
new order.
(iii) In accordance with a written modification to the patient's plan of care;
(iv) Implemented in the least restrictive manner possible;
(v) In accordance with safe appropriate restraining techniques; and
(vi) Ended at the earliest possible time.
(4) A restraint and seclusion may not be used simultaneously unless the patient
is—
(i) Continually monitored face-to-face by an assigned staff member; or
(ii) Continually monitored by staff using both video and audio equipment. This
monitoring must be in close proximity the patient.
(5) The condition of the patient who is in a restraint or in seclusion must continually
be assessed, monitored, and reevaluated.
(6) All staff who have direct patient contact must have ongoing education and training
in the proper and safe use of seclusion and restraint application and techniques and
alternative methods for handling behavior, symptoms, and situations that traditionally
have been treated through the use of restraints or seclusion.
(7) The hospital must report to HCFA any death that occurs while a patient is
restrained or in seclusion, or where it is reasonable to assume that a patient's death is
a result of restraint or seclusion.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare Hospital
Insurance; Program No. 93.778, Medical Assistance Program) Dated: May 24, 1999.Nancy-Ann
Min DeParle,Administrator, Health Care Financing Administration. Approved: June 9,
1999 - Donna E. Shalala, Secretary.[FR Doc. 99-16543 Filed 6-24-99; 4:29 pm]
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