[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Rules and Regulations]
[Pages 53960-53963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27565]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AH72
Informed Consent for Patient Care
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: This document amends VA medical regulations concerning
informed consent for patient care. It describes the requirements for
obtaining and documenting informed consent. It also describes the types
of treatments or procedures for which the patient's or surrogate's
signature on a VA-authorized form is required and establishes a list
and priority of surrogates authorized to act on behalf of patients who
lack decision-making capacity. Further, it establishes an internal
decision-making process for patients who lack decision-making capacity
and who have no authorized surrogate. This is intended to protect
patient rights and ensure that the patient (or the patient's surrogate
or representative) receives sufficient information to make an informed
health-care decision.
DATES: Effective Date: November 17, 1997.
FOR FURTHER INFORMATION CONTACT: Ruth-Ann Phelps, Ph.D., Veterans
Health Administration, Patient Care Services (11B), 810 Vermont Avenue,
NW, Washington, DC 20420, (202) 273-8473.
SUPPLEMENTARY INFORMATION: In a document published in the Federal
Register on August 7, 1996 (61 FR 41108), we proposed to amend our
regulations concerning informed consent for patient care. Interested
parties were invited to submit written comments on or before October 7,
1996. We received comments from one commenter, the American Psychiatric
Association.
Comments
The commenter suggested that whenever the word ``patient'' appears
in the document, the phrase ``or patient surrogate'' should be added.
In response, we have added the words ``or surrogate'' wherever
appropriate. This is intended to clarify, consistent with the intent of
the proposal, that a surrogate may give informed consent on behalf of a
patient who lacks decision-making capacity.
With respect to requirements regarding the administration of
psychotropic medication to an involuntarily committed patient, the
commenter asserted that the prescribing of such medications should be
limited to psychiatrists, and further asserted that the multi-
disciplinary review committee constituted for purposes of review of the
decision to administer or continue the administration of such
medications should be required to include a psychiatrist. We do not
believe that psychotropic medication should be prescribed only by
psychiatrists. We believe that patients are adequately served as long
as the prescribing physician is privileged to prescribe such
medication. Also, we have added the requirement that the committee must
include a psychiatrist or a physician who has
[[Page 53961]]
psychopharmacology privileges. We believe this is adequate for the
types of determinations that need to be made.
With respect to the revocation of consent (including the revocation
of HIV testing consent), the commenter suggested that the regulations
should require that documentation immediately be added at the place in
the medical records that contained the earlier record of consent. No
changes are made based on this comment. We note that the regulations
provide that the informed consent process must be appropriately
documented in the medical record. This requires documentation for
revocations of consent, and we do not believe further instructions in
the regulations are necessary (see Sec. 17.32(d)).
The commenter suggested that consents regarding HIV testing
(required to be on VA form 10-012) be filed in the patient record. No
changes are made based on this comment. This already is required by
these regulations (see Sec. 17.32(g)(4)).
The proposal provided that HIV antibody testing must be
accomplished by pre-test and post-test counseling. The commenter
suggested that the counseling be at least equivalent to guidelines for
testing from the Centers for Disease Control and Prevention and other
Federal or State agencies which set HIV serologic testing policies. The
commenter further suggested that the form and language of such
counseling should be appropriate to the patient's or surrogate's
educational level as well as cognitive and emotional state. No changes
are made based on these comments. VA health-care professionals are
provided with guidance commensurate with the guidelines suggested by
the commenter. Further, there does not appear to be a need to
specifically address the educational level and cognitive and emotional
state of the patient or surrogate. This already is covered since the
final rule requires that health-care professionals explain consent
matters in language understandable to the patient or surrogate (see
Sec. 17.32(c)).
Paperwork Reduction Act
The collection of information contained in the notice of the
proposed rulemaking was submitted to the Office of Management and
Budget (OMB) for review in accordance with the Paperwork Reduction Act
(44 U.S.C. 3504(h)). The information collection subject to this
rulemaking concerns the disclosure requirements that non-VA physicians
contracting to perform services for VA must follow in conducting
informed consent procedures. The information provided is designed to
ensure that the patients (or in some cases, others) have sufficient
information to provide informed consent. Interested parties were
invited to submit comments on the collection of information. However,
no comments were received. OMB has approved this information collection
under control number 2900-0583.
VA is not authorized to impose a penalty on persons for failure to
comply with information collection requirements which do not display a
current OMB control number, if required.
Executive Order 12866
This final rule has been reviewed by OMB under Executive Order
12866.
Regulatory Flexibility Act
The Secretary hereby certifies that the adoption of this final rule
would not have a significant economic impact on a substantial number of
small entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. The adoption of the final rule would affect VA
beneficiaries but would not affect small businesses. Therefore,
pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial
and final regulatory flexibility analyses requirements of Secs. 603 and
604.
The Catalog of Federal Domestic Assistance Program numbers are
64.009, 64.010, 64.011.
Lists of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Foreign relations,
Government contracts, Grant programs-health, Grant programs-veterans,
Health care, Health facilities, Health professions, Health records,
Homeless, Medical and Dental schools, Medical devices, Medical
research, Mental health programs, Nursing home, Philippines, Reporting
and recordkeeping requirements, scholarships and fellowships, Travel
and transportation expenses, and Veterans.
Approved: September 5, 1997.
Hershel W. Gober,
Acting Secretary of Veterans Affairs.
In consideration of the foregoing, 38 CFR part 17 is amended as set
forth below:
PART 17--MEDICAL
1. The authority citation for part 17 continues to read as follows:
Authority: 38 U.S.C. 501, 1721, unless otherwise noted.
2. Section 17.32 is revised to read as follows:
Protection of Patient Rights
Sec. 17.32 Informed consent.
(a) Definitions:
Close Friend. Any person eighteen years or older who has shown care
and concern for the patient's welfare, who is familiar with the
patient's activities, health, religious beliefs and values, and who has
presented a signed written statement for the record that describes that
person's relationship to and familiarity with the patient.
Decision-making capacity. The ability to understand and appreciate
the nature and consequences of health-care treatment decisions.
Health-Care Agent. An individual named by the patient in a Durable
Power of Attorney for Health Care.
Legal Guardian. A person appointed by a court of appropriate
jurisdiction to make decisions for an individual who has been
judicially determined to be incompetent.
Practitioner. Any physician, dentist, or health-care professional
who has been granted specific clinical privileges to perform the
treatment or procedure involved. For the purpose of obtaining informed
consent for medical treatment, the term practitioner includes medical
and dental residents regardless of whether they have been granted
clinical privileges.
Signature consent. The patient's or surrogate's signature on a VA-
authorized consent form, e.g., a published numbered VA form (OF 522) or
comparable form approved by the local VA facility.
Special Guardian. A person appointed by a court of appropriate
jurisdiction for the specific purpose of making health-care decisions.
Surrogate. An individual, organization or other body authorized
under this section to give informed consent on behalf of a patient who
lacks decision-making capacity.
(b) Policy. Except as otherwise provided in this section, all
patient care furnished under title 38 U.S.C. shall be carried out only
with the full and informed consent of the patient or, in appropriate
cases, a representative thereof. In order to give informed consent, the
patient must have decision-making capacity and be able to communicate
decisions concerning health care. If the patient lacks decision-making
capacity or has been declared incompetent, consent must be obtained
from the patient's surrogate. Practitioners may provide necessary
medical care in emergency situations
[[Page 53962]]
without the patient's or surrogate's express consent when immediate
medical care is necessary to preserve life or prevent serious
impairment of the health of the patient or others and the patient is
unable to consent and the practitioner determines that the patient has
no surrogate or that waiting to obtain consent from the patient's
surrogate would increase the hazard to the life or health of the
patient or others. In such circumstances consent is implied.
(c) General requirements for informed consent. Informed consent is
the freely given consent that follows a careful explanation by the
practitioner to the patient or the patient's surrogate of the proposed
diagnostic or therapeutic procedure or course of treatment. The
practitioner, who has primary responsibility for the patient or who
will perform the particular procedure or provide the treatment, must
explain in language understandable to the patient or surrogate the
nature of a proposed procedure or treatment; the expected benefits;
reasonably foreseeable associated risks, complications or side effects;
reasonable and available alternatives; and anticipated results if
nothing is done. The patient or surrogate must be given the opportunity
to ask questions, to indicate comprehension of the information
provided, and to grant permission freely without coercion. The
practitioner must advise the patient or surrogate if the proposed
treatment is novel or unorthodox. The patient or surrogate may withhold
or revoke his or her consent at any time.
(d) Documentation of informed consent. (1) The informed consent
process must be appropriately documented in the medical record. In
addition, signature consent is required for all diagnostic and
therapeutic treatments or procedures that:
(i) Require the use of sedation;
(ii) Require anesthesia or narcotic analgesia;
(iii) Are considered to produce significant discomfort to the
patient;
(iv) Have a significant risk of complication or morbidity;
(v) Require injections of any substance into a joint space or body
cavity; or
(vi) Involve testing for Human Immunodeficiency Virus (HIV).
(2) The patient's or surrogate's signature on a VA-authorized
consent form must be witnessed. The witness' signature only attests to
the fact that he or she saw the patient or surrogate and the
practitioner sign the form. When the patient's or surrogate's signature
is indicated by an ``X'', two adults must witness the act of signing.
The signed form must be filed in the patient's medical record. A
properly executed OF 522 or other VA-authorized consent form is valid
for a period of 30 calendar days. If, however, the treatment plan
involves multiple treatments or procedures, it will not be necessary to
repeat the informed consent discussion and documentation so long as the
course of treatment proceeds as planned, even if treatment extends
beyond the 30-day period. If there is a change in the patient's
condition that might alter the diagnostic or therapeutic decision, the
consent is automatically rescinded.
(3) If it is impractical to consult with the surrogate in person,
informed consent may be obtained by mail, facsimile, or telephone. A
facsimile copy of a signed consent form is adequate to proceed with
treatment. However, the surrogate must agree to submit a signed consent
form to the practitioner. If consent is obtained by telephone, the
conversation must be audiotaped or witnessed by a second VA employee.
The name of the person giving consent and his or her authority to act
as surrogate must be adequately identified for the record.
(e) Surrogate consent. If the practitioner who has primary
responsibility for the patient determines that the patient lacks
decision-making capacity and is unlikely to regain it within a
reasonable period of time, informed consent must be obtained from the
patient's surrogate. Patients who are incapable of giving consent as a
matter of law, i.e., persons judicially determined to be incompetent
and minors not otherwise able to provide informed consent, will be
deemed to lack decision-making capacity for the purposes of this
section. If the patient is considered a minor in the state where the VA
facility is located and cannot consent to medical treatment, consent
must be obtained from the patient's parent or legal guardian. The
surrogate generally assumes the same rights and responsibilities as the
patient in the informed consent process. The surrogate's decision must
be based on his or her knowledge of what the patient would have wanted,
i.e., substituted judgment. If the patient's wishes are unknown, the
decision must be based on the patient's best interest. The following
persons are authorized to consent on behalf of patients who lack
decision-making capacity in the following order of priority:
(1) Health-care agent;
(2) Legal guardian or special guardian;
(3) Next-of-kin: a close relative of the patient eighteen years of
age or older, in the following priority: spouse, child, parent,
sibling, grandparent, or grandchild; or
(4) Close friend.
(f) Consent for patients without surrogates. (1) If none of the
surrogates listed in paragraph (e) of this section are available, the
practitioner may request Regional Counsel assistance to obtain a
special guardian for health care or follow the procedures outlined in
this paragraph (f).
(2) Facilities may use the following process to make treatment
decisions for patients who lack decision-making capacity and have no
surrogate. For treatments or procedures that involve minimal risk, the
practitioner must verify that no authorized surrogate can be located.
The practitioner must attempt to explain the nature and purpose of the
proposed treatment to the patient and enter this information in the
medical record. For procedures that require signature consent, the
practitioner must certify that the patient has no surrogate. The
attending physician and the Chief of Service (or his or her designee)
must indicate their approval of the treatment decision in writing. Any
decision to withhold or withdraw life-sustaining treatment for such
patients must be reviewed by a multi-disciplinary committee appointed
by the facility Director. The committee functions as the patient's
advocate and may not include members of the treatment team. The
committee must submit its findings and recommendations in a written
report to the Chief of Staff who must note his or her approval of the
report in writing. After reviewing the record, the facility Director
may concur with the decision to withhold or withdraw life support or
request further review by Regional Counsel.
(g) Special consent situations. In addition to the other
requirements of this section, additional protections are required in
the following situations.
(1) No patient will undergo any unusual or extremely hazardous
treatment or procedure, e.g., that which might result in irreversible
brain damage or sterilization, except as provided in this paragraph
(g). Before treatment is initiated, the patient or surrogate must be
given adequate opportunity to consult with independent specialists,
legal counsel or other interested parties of his or her choosing. The
patient's or surrogate's signature on a VA authorized consent form must
be witnessed by someone who is not affiliated with the VA health-care
facility, e.g., spouse, legal guardian, or patient advocate. If a
surrogate makes the treatment decision, a multi-
[[Page 53963]]
disciplinary committee, appointed by the facility Director, must review
that decision to ensure it is consistent with the patient's wishes or
in his or her best interest. The committee functions as the patient's
advocate and may not include members of the treatment team. The
committee must submit its findings and recommendations in a written
report to the facility Director. The Director may authorize treatment
consistent with the surrogate's decision or request that a special
guardian for health care be appointed to make the treatment decision.
(2) Administration of psychotropic medication to an involuntarily
committed patient against his or her will must meet the following
requirements. The patient or surrogate must be allowed to consult with
independent specialists, legal counsel or other interested parties
concerning the treatment with psychotropic medication. Any
recommendation to administer or continue medication against the
patient's or surrogate's will must be reviewed by a multi-disciplinary
committee appointed by the facility Director for this purpose. This
committee must include a psychiatrist or a physician who has
psychopharmacology privileges. The facility Director must concur with
the committee's recommendation to administer psychotropic medications
contrary to the patient's or surrogate's wishes. Continued therapy with
psychotropic medication must be reviewed every 30 days. The patient (or
a representative on the patient's behalf) may appeal the treatment
decision to a court of appropriate jurisdiction.
(3) If a proposed course of treatment or procedure involves
approved medical research in whole or in part, the patient or
representative shall be advised of this. Informed consent shall be
obtained specifically for the administration or performance of that
aspect of the treatment or procedure that involves research. Such
consent shall be in addition to that obtained for the administration or
performance of the nonresearch aspect of the treatment or procedure and
must meet the requirements for informed consent set forth in 38 CFR
Part 16, Protection of Human Subjects.
(4) Testing for Human Immunodeficiency Virus (HIV) must be
voluntary and must be conducted only with the prior informed and
(written) signature consent of the patient or surrogate. Patients who
consent to testing for HIV must sign VA form 10-012, ``Consent for HIV
Antibody Testing.'' This form must be filed in the patient's medical
record. Testing must be accompanied by pre-test and post-test
counseling.
(The information collection requirements in this section have been
approved by the Office of Management and Budget under control number
2900-0583)
(Authority: 38 U.S.C. 7331, 7332, 7333)
[FR Doc. 97-27565 Filed 10-16-97; 8:45 am]
BILLING CODE 8320-01-P