[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR84.55]

[Page 344-348]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 84--NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS AND ACTIVITIES 
RECEIVING FEDERAL FINANCIAL ASSISTANCE--Table of Contents
 
             Subpart F--Health, Welfare, and Social Services
 
Sec. 84.55  Procedures relating to health care for handicapped infants.

    (a) Infant Care Review Committees. The Department encourages each 
recipient health care provider that provides health care services to 
infants in programs receiving Federal financial assistance to establish 
an Infant Care Review Committee (ICRC) to assist the provider in 
delivering health care and related services to infants and in complying 
with this part. The purpose of the committee is to assist the health 
care provider in the development of standards, policies and procedures 
for providing treatment to handicapped infants and in making decisions 
concerning medically beneficial treatment in specific cases. While the 
Department recognizes the value of ICRC's in assuring appropriate 
medical care to infants, such committees are not required by this 
section. An ICRC should be composed of individuals representing a broad 
range of perspectives, and should include a practicing physician, a 
representative of a disability organization, a practicing nurse, and 
other individuals. A suggested model ICRC is set forth in paragraph (f) 
of this section.
    (b) Posting of informational notice. (1) Each recipient health care 
provider that provides health care services to infants in programs or 
activities receiving Federal financial assistance shall post and keep 
posted in appropriate places an informational notice.
    (2) The notice must be posted at location(s) where nurses and other 
medical professionals who are engaged in providing health care and 
related services to infants will see it. To the extent it does not 
impair accomplishment of the requirement that copies of the notice be 
posted where such personnel will see it, the notice need not be posted 
in area(s) where parents of infant patients will see it.
    (3) Each health care provider for which the content of the following 
notice (identified as Notice A) is truthful may use Notice A. For the 
content of the notice to be truthful: (i) The provider must have a 
policy consistent with that stated in the notice; (ii) the provider must 
have a procedure for review of treatment deliberations and decisions to 
which the notice applies, such as (but not limited to) an Infant Care 
Review Committee; and (iii) the statements concerning the identity of 
callers and retaliation are truthful.

                                Notice A:

               PRINCIPLES OF TREATMENT OF DISABLED INFANTS

    It is the policy of this hospital, consistent with Federal law, 
that, nourishment and medically beneficial treatment (as determined with 
respect for reasonable medical judgments) should not be withheld from 
handicapped infants solely on the basis of their present or anticipated 
mental or physical impairments.
    This Federal law, section 504 of the Rehabilitation Act of 1973, 
prohibits discrimination on the basis of handicap in programs or 
activities receiving Federal financial assistance. For further 
information, or to report suspected noncompliance, call:
    [Identify designated hospital contact point and telephone number] or
    [Identify appropriate child protective services agency and telephone 
number] or
    U.S. Department of Health and Human Services (HHS): 800-368-1019 
(Toll-free; available 24 hours a day; TDD capability).

The identity of callers will be held confidential. Retaliation by this 
hospital against any person for providing information about possible 
noncompliance is prohibited by this hospital and Federal regulations.

    (4) Health care providers other than those described in paragraph 
(b)(3) of this section must post the following notice (identified as 
Notice B):

                                Notice B:

               PRINCIPLES OF TREATMENT OF DISABLED INFANTS

    Federal law prohibits discrimination on the basis of handicap. Under 
this law, nourishment and medically beneficial treatment (as determined 
with respect for reasonable

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medical judgments) should not be withheld from handicapped infants 
solely on the basis of their present or anticipated mental or physical 
impairments.
    This Federal law, section 504 of the Rehabilitation Act of 1973, 
applies to programs or activities receiving Federal financial 
assistance. For further information, or to report suspected 
noncompliance, call:
    [Identify appropriate child protective services agency and telephone 
number] or
    U.S. Department of Health and Human Services (HHS): 800-368-1019 
(Toll-free; available 24 hours a day: TDD capability)

The identity of callers will be held confidential. Federal regulations 
prohibit retaliation by this hospital against any person who provides 
information about possible violations.

    (5) The notice may be no smaller than 5 by 7 inches, and the type 
size no smaller than that generally used for similar internal 
communications to staff. The recipient must insert the specified 
information on the notice it selects. Recipient hospitals in Washington, 
DC, must list 863-0100 as the telephone number for HHS. No other 
alterations may be made to the notice. Copies of the notices may be 
obtained from the Department of Health and Human Services upon request, 
or the recipient may produce its own notices in conformance with the 
specified wording.
    (c) Responsibilities of recipient state child protective services 
agencies. (1) Within 60 days of the effective date of this section, each 
recipient state child protective services agency shall establish and 
maintain in written form methods of administration and procedures to 
assure that the agency utilizes its full authority pursuant to state law 
to prevent instances of unlawful medical neglect of handicapped infants. 
These methods of administration and procedures shall include:
    (i) A requirement that health care providers report on a timely 
basis to the state agency circumstances which they determine to 
constitute known or suspected instances of unlawful medical neglect of 
handicapped infants;
    (ii) A method by which the state agency can receive reports of 
suspected unlawful medical neglect of handicapped infants from health 
care providers, other individuals, and the Department on a timely basis;
    (iii) Immediate review of reports of suspected unlawful medical 
neglect of handicapped infants and, where appropriate, on-site 
investigation of such reports;
    (iv) Provision of child protective services to such medically 
neglected handicapped infants, including, where appropriate, seeking a 
timely court order to compel the provision of necessary nourishment and 
medical treatment; and
    (v) Timely notification to the responsible Department official of 
each report of suspected unlawful medical neglect involving the 
withholding, solely on the basis of present or anticipated physical or 
mental impairments, of treatment or nourishment from a handicapped 
infant who, in spite of such impairments, will medically benefit from 
the treatment or nourishment, the steps taken by the state agency to 
investigate such report, and the state agency's final disposition of 
such report.
    (2) Whenever a hospital at which an infant who is the subject of a 
report of suspected unlawful medical neglect is being treated has an 
Infant Care Review Committee (ICRC) the Department encourages the state 
child protective services agency to consult with the ICRC in carrying 
out the state agency's authorities under its state law and methods of 
administration. In developing its methods of administration and 
procedures, the Department encourages child protective services agencies 
to adopt guidelines for investigations similar to those of the 
Department regarding the involvement of ICRC's.
    (d) Expedited access to records. Access to pertinent records and 
facilities of a recipient pursuant to 45 CFR 80.6(c) (made applicable to 
this part by 45 CFR 84.61) shall not be limited to normal business hours 
when, in the judgment of the responsible Department official, immediate 
access is necessary to protect the life or health of a handicapped 
individual.
    (e) Expedited action to effect compliance. The requirement of 45 CFR 
80.8(d)(3) pertaining to notice to recipients prior to the initiation of 
action to effect compliance (made applicable to this part by 45 CFR 
84.61) shall not

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apply when, in the judgment of the responsible Department official, 
immediate action to effect compliance is necessary to protect the life 
or health of a handicapped individual. In such cases the recipient will, 
as soon as practicable, be given oral or written notice of its failure 
to comply, of the action to be taken to effect compliance, and its 
continuing opportunity to comply voluntarily.
    (f) Model Infant Care Review Committee. Recipient health care 
providers wishing to establish Infant Care Review Committees should 
consider adoption of the following model. This model is advisory. 
Recipient health care providers are not required to establish a review 
committee or, if one is established, to adhere to this model. In seeking 
to determine compliance with this part, as it relates to health care for 
handicapped infants, by health care providers that have an ICRC 
established and operated substantially in accordance with this model, 
the Department will, to the extent possible, consult with the ICRC.
    (1) Establishment and purpose. (i) The hospital establishes an 
Infant Care Review Committee (ICRC) or joins with one or more other 
hospitals to create a joint ICRC. The establishing document will state 
that the ICRC is for the purpose of facilitating the development and 
implementation of standards, policies and procedures designed to assure 
that, while respecting reasonable medical judgments, treatment and 
nourishment not be withheld, solely on the basis of present or 
anticipated physical or mental impairments, from handicapped infants 
who, in spite of such impairments, will benefit medically from the 
treatment or nourishment.
    (ii) The activities of the ICRC will be guided by the following 
principles:
    (A) The interpretative guidelines of the Department relating to the 
applicability of this part to health care for handicapped infants.
    (B) As stated in the ``Principles of Treatment of Disabled Infants'' 
of the coalition of major medical and disability organizations, 
including the American Academy of Pediatrics, National Association of 
Children's Hospitals and Related Institutions, Association for Retarded 
Citizens, Down's Syndrome Congress, Spina Bifida Association, and 
others:

    When medical care is clearly beneficial, it should always be 
provided. When appropriate medical care is not available, arrangements 
should be made to transfer the infant to an appropriate medical 
facility. Consideration such as anticipated or actual limited potential 
of an individual and present or future lack of available community 
resources are irrelevant and must not determine the decisions concerning 
medical care. The individual's medical condition should be the sole 
focus of the decision. These are very strict standards.
    It is ethically and legally justified to withhold medical or 
surgical procedures which are clearly futile and will only prolong the 
act of dying. However, supportive care should be provided, including 
sustenance as medically indicated and relief of pain and suffering. The 
needs of the dying person should be respected. The family also should be 
supported in its grieving.
    In cases where it is uncertain whether medical treatment will be 
beneficial, a person's disability must not be the basis for a decision 
to withhold treatment. At all times during the process when decisions 
are being made about the benefit or futility of medical treatment, the 
person should be cared for in the medically most appropriate ways. When 
doubt exists at any time about whether to treat, a presumption always 
should be in favor of treatment.

    (C) As stated by the President's Commission for the Study of Ethical 
Problems in Medicine and Biomedical and Behavioral Research:

    This [standard for providing medically beneficial treatment] is a 
very strict standard in that it excludes consideration of the negative 
effects of an impaired child's life on other persons, including parents, 
siblings, and society. Although abiding by this standard may be 
difficult in specific cases, it is all too easy to undervalue the lives 
of handicapped infants; the Commission finds it imperative to counteract 
this by treating them no less vigorously than their healthy peers or 
than older children with similar handicaps would be treated.

    (iii) The ICRC will carry out its purposes by:
    (A) Recommending institutional policies concerning the withholding 
or withdrawal of medical or surgical treatments to infants, including 
guidelines for ICRC action for specific categories of life-threatening 
conditions affecting infants;

[[Page 347]]

    (B) Providing advice in specific cases when decisions are being 
considered to withhold or withdraw from infant life-sustaining medical 
or surgical treatment; and
    (C) Reviewing retrospectively on a regular basis infant medical 
records in situations in which life-sustaining medical or surgical 
treatment has been withheld or withdrawn.
    (2) Organization and staffing. The ICRC will consist of at least 7 
members and include the following:
    (i) A practicing physician (e.g., a pediatrician, a neonatologist, 
or a pediatric surgeon),
    (ii) A practicing nurse,
    (iii) A hospital administrator,
    (iv) A representative of the legal profession,
    (v) A representative of a disability group, or a developmental 
disability expert,
    (vi) A lay community member, and
    (vii) A member of a facility's organized medical staff, who shall 
serve as chairperson.

In connection with review of specific cases, one member of the ICRC 
shall be designated to act as ``special advocate'' for the infant, as 
provided in paragraph (f)(3)(ii)(E) of the section. The hospital will 
provide staff support for the ICRC, including legal counsel. The ICRC 
will meet on a regular basis, or as required below in connection with 
review of specific cases. It shall adopt or recommend to the appropriate 
hospital official or body such administrative policies as terms of 
office and quorum requirements. The ICRC will recommend procedures to 
ensure that both hospital personnel and patient families are fully 
informed of the existence and functions of the ICRC and its availability 
on a 24-hour basis.
    (3) Operation of ICRC--(i) Prospective policy development. (A) The 
ICRC will develop and recommend for adoption by the hospital 
institutional policies concerning the withholding or withdrawal of 
medical treatment for infants with life-threatening conditions. These 
will include guidelines for management of specific types of cases or 
diagnoses, for example, Down's syndrome and spina bifida, and procedures 
to be followed in such recurring circumstances as, for example, brain 
death and parental refusal to consent to life-saving treatment. The 
hospital, upon recommendation of the ICRC, may require attending 
physicians to notify the ICRC of the presence in the facility of an 
infant with a diagnosis specified by the ICRC, e.g., Down's syndrome and 
spina bifida.
    (B) In recommending these policies and guidelines, the ICRC will 
consult with medical and other authorities on issues involving disabled 
individuals, e.g., neonatologists, pediatric surgeons, county and city 
agencies which provide services for the disabled, and disability 
advocacy organizations. It will also consult with appropriate committees 
of the medical staff, to ensure that the ICRC policies and guidelines 
build on existing staff by-laws, rules and regulations concerning 
consultations and staff membership requirements. The ICRC will also 
inform and educate hospital staff on the policies and guidelines it 
develops.
    (ii) Review of specific cases. In addition to regularly scheduled 
meetings, interim ICRC meetings will take place under specified 
circumstances to permit review of individual cases. The hospital will, 
to the extent possible, require in each case that life-sustaining 
treatment be continued, until the ICRC can review the case and provide 
advice.
    (A) Interim ICRC meetings will be convened within 24 hours (or less 
if indicated) when there is disagreement between the family of an infant 
and the infant's physician as to the withholding or withdrawal of 
treatment, when a preliminary decision to withhold or withdraw life-
sustaining treatment has been made in certain categories of cases 
identified by the ICRC, when there is disagreement between members of 
the hospital's medical and/or nursing staffs, or when otherwise 
appropriate.
    (B) Such interim ICRC meetings will take place upon the request of 
any member of the ICRC or hospital staff or parent or guardian of the 
infant. The ICRC will have procedures to preserve the confidentiality of 
the identity of persons making such requests, and such persons shall be 
protected from reprisal. When appropriate, the ICRC or a designated 
member will inform the

[[Page 348]]

requesting individual of the ICRC's recommendation.
    (C) The ICRC may provide for telephone and other forms of review 
when the timing and nature of the case, as identified in policies 
developed by the ICRC, make the convening of an interim meeting 
impracticable.
    (D) Interim meetings will be open to the affected parties. The ICRC 
will ensure that the interests of the parents, the physician, and the 
child are fully considered; that family members have been fully informed 
of the patient's condition and prognosis; that they have been provided 
with a listing which describes the services furnished by parent support 
groups and public and private agencies in the geographic vicinity to 
infants with conditions such as that before the ICRC; and that the ICRC 
will facilitate their access to such services and groups.
    (E) To ensure a comprehensive evaluation of all options and factors 
pertinent to the committee's deliberations, the chairperson will 
designate one member of the ICRC to act, in connection with that 
specific case, as special advocate for the infant. The special advocate 
will seek to ensure that all considerations in favor of the provision of 
life-sustaining treatment are fully evaluated and considered by the 
ICRC.
    (F) In cases in which there is disagreement on treatment between a 
physician and an infant's family, and the family wishes to continue 
life-sustaining treatment, the family's wishes will be carried out, for 
as long as the family wishes, unless such treatment is medically 
contraindicated. When there is physician/family disagreement and the 
family refuses consent to life-sustaining treatment, and the ICRC, after 
due deliberation, agrees with the family, the ICRC will recommend that 
the treatment be withheld. When there is physician/family disagreement 
and the family refuses consent, but the ICRC disagrees with the family, 
the ICRC will recommend to the hospital board or appropriate official 
that the case be referred immediately to an appropriate court or child 
protective agency, and every effort shall be made to continue treatment, 
preserve the status quo, and prevent worsening of the infant's condition 
until such time as the court or agency renders a decision or takes other 
appropriate action. The ICRC will also follow this procedure in cases in 
which the family and physician agree that life-sustaining treatment 
should be withheld or withdrawn, but the ICRC disagrees.
    (iii) Retrospective record review. The ICRC, at its regularly-
scheduled meeting, will review all records involving withholding or 
termination of medical or surgical treatment to infants consistent with 
hospital policies developed by the ICRC, unless the case was previously 
before the ICRC pursuant to paragraph (f)(3)(ii) of this section. If the 
ICRC finds that a deviation was made from the institutional policies in 
a given case, it shall conduct a review and report the findings to 
appropriate hospital personnel for appropriate action.
    (4) Records. The ICRC will maintain records of all of its 
deliberations and summary descriptions of specific cases considered and 
the disposition of those cases. Such records will be kept in accordance 
with institutional policies on confidentiality of medical information. 
They will be made available to appropriate government agencies, or upon 
court order, or as otherwise required by law.
    Note: The mandatory provisions set forth in paragraphs (b)--(e) 
inclusive of this section are subject to an injunction prohibiting their 
enforcement. In Bowen v. American Hospital Association, ------ U.S. ----
--, 106 S. Ct. 2101 (1986), the Supreme Court upheld the action of a 
United States District Court, 585 F. Supp. 541 (S.D.N.Y. 1984), 
declaring invalid and enjoining enforcement of provisions under this 
section, promulgated January 12, 1984.

(Information collection requirements contained in paragraph (c) have 
been approved by the Office of Management and Budget under control 
number 0990-0114)

[49 FR 1651, Jan. 12, 1984, as amended at 52 FR 3012, Jan. 30, 1987]