[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR84.55]



[Page 360-365]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 84_NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR 

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 or activities 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,



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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 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



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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 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



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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;

    (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



[[Page 364]]



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 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



[[Page 365]]



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; 70 

FR 24320, May 9, 2005]