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New Hospital Condition of Participation
is Designed to Protect Patients' Rights
By Cami Gearhart
[August 1999]
On August 2, 1999, a new "Patients' Rights" Condition
of Participation ("CoP") becomes effective. All hospitals,
including psychiatric, rehabilitation, long-term, children's and
alcohol hospitals, must satisfy this CoP in order to be approved
for, or to continue participation in, the Medicare and Medicaid
programs. The rule requires hospitals to meet the following standards
for protecting patients' rights:
- Furnish notice to each patient (or patient's representative)
of the patient's rights, in advance of furnishing or discontinuing
care;
- Establish a grievance process for patients;
- Allow each patient to participate in the development/implementation
of his or her plan of care;
- Allow patients to formulate advance directives;
- Protect patients' personal safety, including "the right
to be free from all forms of abuse or harassment";
- Protect the confidentiality of, and access to, patient records;
- Provide freedom from restraints (both physical and pharmacological)
for medical care, unless certain standards are met; and
- Provide freedom from restraints or seclusion for behavior management,
unless certain standards are met.
All hospitals should review and update their policies in light
of this new CoP. A few of the new requirements appear to be more
stringent than the accreditation standards of the Joint Commission
on the Accreditation of Health Care Organizations ("JCAHO")
or the American Osteopathic Association ("AOA"). Even
though hospitals typically are deemed to meet CoP requirements as
long as they maintain accreditation, hospitals should consider taking
additional steps to satisfy those CoP requirements that are more
demanding than accreditation requirements.
At first glance, the new standards appear to be fairly vague. The
Health Care Financing Administration (" HCFA") declares
that it is granting flexibility to hospitals to develop their own
policies and procedures. HCFA also promises that additional guidelines
to explain this CoP will be published in HCFA's State Operations
Manual ("SOM").
The Patients' Rights CoP was first introduced in December 1997
as part of a comprehensive set of proposed new hospital conditions
of participation. In light of President Clinton's 1998 directive
to the Department of Health and Human Services ("DHHS")
to implement his Consumer Bill of Rights and Responsibilities, HCFA
decided to move ahead with implementation of this portion of the
1997 proposal. The final version of the Patients' Rights CoP is
very similar to the proposed version, although several standards
have been expanded.
Each of the new patient protection standards is discussed briefly
below.
1. Notice of Rights and Grievance Procedure
The new CoP requires hospitals to inform each patient "when
appropriate" of his or her rights in advance of furnishing
or discontinuing patient care. HCFA anticipates that a hospital
will provide a single "Notice of Patients' Rights" to
each patient (or his or her representative) at the time of admission
that lists all of the rights described in the new regulation.
HCFA acknowledges that in many situations an additional notification
of rights must occur later in the hospital stay.
In addition, this provision requires hospitals to develop a process
for prompt resolution of patient grievances. Apparently, this
grievance process needs to address only grievances related to
perceived violations of the patients' rights established by the
new CoP.
Each hospital should confirm that it has a grievance procedure
that addresses the patient rights established by the new CoP,
and conforms to the CoP's notice requirements. The CoP requirements
appear to be more stringent than JCAHO or AOA requirements.
2. Patient's Right to Participate in Plan of Care
The new regulation also requires that patients or their representatives
have the right to make informed decisions regarding their health
care. Under this standard, HCFA expects that hospitals will hold
physicians accountable for discussing all information regarding
treatment, experimental approaches and possible outcomes of care
with patients.
One aspect of a patient's right to participate in his or her
plan of care is the right to formulate an advance directive. The
regulation specifies that a patient must have the right to formulate
an advance directive in accordance with existing federal regulations.
3. Right to Privacy and Safety
The regulation also provides that a patient has a "right
to personal privacy." HCFA intends to publish interpretive
guidelines to more thoroughly explain its expectations under this
standard. HCFA acknowledges that this right does not mean that
each patient has a right to a private room. Instead, HCFA asserts
that if a patient is in a semiprivate room, the hospital should
provide privacy with steps such as pulling curtains closed for
exams.
In addition, the regulation provides that each patient "has
the right to be free from all forms of abuse or harassment."
HCFA acknowledges that commenters proposed narrowing this language,
but maintains that the standard is appropriate.
4. Confidentiality of Patient Records
The new CoP also declares that a patient has a right of confidentiality
of his or her clinical records, and a right of access to such
records within a reasonable time frame. This standard overlaps
with many state laws, and HCFA explains that it anticipates deferring
to more stringent state law requirements with respect to the confidentiality
of a patient's records, and the time frame in which a hospital
is required to furnish a patient with his or her records.
HCFA also outlines the access policy of the DHHS. Each hospital
might want to compare its current record access policies to pertinent
state law requirements, accreditation requirements and the DHHS
policy regarding exceptions to a patient's right of access to
his or her records.
5. Freedom from Restraints (Acute Medical and Surgical Care)
The most significant differences between the proposed and final
versions of the Patients' Rights CoP are found in the standards
regarding a hospital's ability to utilize seclusion and restraints
(both physical and pharmacological). For the final CoP, HCFA adopted
more detailed final standards that distinguish between restraints
for acute medical care and restraints for behavior management
involving psychiatric patients. The CoP imposes somewhat less
restrictive requirements on the use of restraints for acute medical
and surgical care. Restraints can be used only after other interventions
have been tried, and can be used only in accordance with the order
of a licensed independent practitioner who is permitted by state
law and hospital policies to order restraints.
6. Freedom from Restraints (Behavior Management)
Finally, the new CoP imposes its most detailed restrictions on
the use of seclusion or restraints for behavior management. The
CoP requires that practitioners' written orders authorizing seclusion
or restraints be time-limited (i.e., 4 hours for adults; 2 hours
for older children; 1 hour for children under 9), and the practitioner
cannot renew orders for more than 24 hours without seeing and
assessing the patient. The new CoP also requires that a patient
who is in a restraint or seclusion must be "continually"
monitored, and a patient who is in both a restraint and seclusion
must be monitored continually face-to-face or by video and audio
equipment. Staff must have ongoing education and training, and
the hospital must report to HCFA any death that occurs while a
patient is restrained or in seclusion.
Conclusion
HCFA will entertain comments only on the seclusion and restraint
standards of the new CoP. If you have further questions about the
application of the new CoP, or you would like to submit a comment
on the seclusion and restraint standards to HCFA, call Cami Gearhart
at (206) 628-7664 or your usual attorney Davis Wright Tremaine attorney.
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