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The Secretary means the Secretary of or advice to the individual who is Health and Human Services and any sterilized: other officer or employee of the De- (1) Advice that the individual 3 partment of Health and Human Serv. to withhold or withdraw consent z ices to whom the authority involved procedure any time before the s has been delegated.

lization without affecting his or: Sterilization means any medical pro- right to future care or treatme? cedure, treatment, or operation for the without loss or withdrawal of any." purpose of rendering an individual per- erally funded program benefit manently incapable of reproducing. which the individual might be esta (43 FR 52165, Nov. 8, 1978, as amended at 49

wise entitled: FR 38109, Sept. 27, 1984)

(2) A description of available 17

native methods of family planning $50.203 Sterilization of a mentally birth control;

competent individual aged 21 or (3) Advice that the sterilizatios; older.

cedure is considered to be irreve... Programs or projects to which this (4) A thorough explanation of subpart applies shall perform or ar- specific sterilization procedure to range for the performance of steriliza- performed; tion of an individual only if the follow

(5) A full description of the disc.. ing requirements have been met:

forts and risks that may accompany (a) The individual is at least 21 years

follow the performing of the procee old at the time consent is obtained. (b) The individual is not a mentally

including an explanation of the te

and possible effects of any aneste incompetent individual.

to be used; (c) The individual has voluntarily given his or her informed consent in

(6) A full description of the bene.

or advantages that may be expected accordance with the procedures of

a result of the sterilization; and $50.204 of this subpart.

(7) Advice that the sterilization L (d) At least 30 days but not more than 180 days have passed between the

not be performed for at least 30 date of informed consent and the date

except under the circumstances spel of the sterilization, except in the case

fied in $ 50.203(d) of this subpart. of premature delivery or emergency ab

(b) An interpreter must be provid dominal surgery. An individual may

to assist the individual to be sterius

if he or she does not understand consent to be sterilized at the time of premature delivery or emergency ab

language used on the consent fort 3 dominal surgery, if at least 72 hours

the language used by the person have passed after he or she gave in

taining the consent. formed consent to sterilization. In the

(c) Suitable arrangements must case of premature delivery, the in

made to insure that the informat... formed consent must have been given

specified in paragraph (a) of this si at least 30 days before the expected

tion is effectively communicated * date of delivery.

any individual to be sterilized who »

blind, deaf or otherwise handicapped. 850.204 Informed consent require- (d) A witness chosen by the indist ment.

ual to be sterilized may be presel Informed consent does not exist un

when consent is obtained. less a consent form is completed volun

(e) Informed consent may not be of tarily and in accordance with all the tained while the individual to be ste

lized is: requirements of this section and $50.205 of this subpart.

(1) In labor or childbirth; (a) A person who obtains informed (2) Seeking to obtain or obtaining sa consent for a sterilization procedure abortion; or must offer to answer any questions the (3) Under the influence of alcohol a individual to be sterilized may have other substare concerning the procedure, provide a vidual's sté copy of the consent form, and provide (f) Any orally all of the following information local law

that affect the indi: of spousal consent, must be fol- mature delivery occurs or emergency d.

abdominal surgery is required within

the 30-day period, the physician must 205 Consent form requirements.

certify that the sterilization was per) Required consent form. The consent formed less than 30 days but not less in appended to this subpart or an- than 72 hours after the date of the indier consent form approved by the vidual's signature on the consent form retary must be used.

because of premature delivery or emer») Required signatures. The consent gency abdominal surgery, as applican must be signed and dated by: ble. In the case of premature delivery, b) The individual to be sterilized; the physician must also state the ex

pected date of delivery. In the case of :) The interpreter, if one is provided; emergency abdominal surgery, the phy

sician must describe the emergency. 3) The person who obtains the con- (3) If an interpreter is provided, the it; and

interpreter must certify that he or she 1) The physician who will perform translated the information and advice sterilization procedure.

presented orally, read the consent form c) Required certifications. (1) The per- and explained its contents and to the i obtaining the consent must certify best of the interpreter's knowledge and signing the consent form that:

belief, the individual to be sterilized .i) Before the individual to be steri- understood what the interpreter told sed signed the consent form, he or she him or her. vised the individual to be sterilized at no Federal benefits may be with- 850.206 Sterilization of a mentally inawn because of the decision not to be competent individual or of an insti.

tutionalized individual. erilized, (ii) He or she explained orally the re- Programs or projects to which this uirements for informed consent as set subpart applies shall not perform or arrth on the consent form, and

range for the performance of a steri(iii) To the best of his or her knowl- lization of any mentally incompetent 'lge and belief, the individual to be individual or institutionalized individerilized appeared mentally com- ual. etent and knowingly and voluntarily onsented to be sterilized.

850.207 Sterilization by hysterectomy. (2) The physician performing the (a) Programs or projects to which Cerilization must certify by signing this subpart applies shall not perform ne consent form, that:

or arrange for the performance of any (i) Shortly before the performance of hysterectomy solely for the purpose of he sterilization, he or she advised the rendering an individual permanently ndividual to be sterilized that no Fed- incapable of reproducing or where, if -ral benefits may be withdrawn be- there is more than one purpose to the

ause of the decision not to be steri- procedure, the hysterectomy would not ized,

be performed but for the purpose of (ii) He or she explained orally the re- rendering the individual permanently quirements for informed consent as set incapable of reproducing. forth on the consent form, and

(b) Except as provided in paragraph (iii) To the best of his or her knowl- (c) of this section, programs or projects edge and belief, the individual to be to which this subpart applies may persterilized appeared mentally com- form or arrange for the performance of petent and knowingly and voluntarily a hysterectomy not covered by paraconsented to be sterilized. Except in graph (a) of this section only if: the case of premature delivery or emer- (1) The person who secures the augency abdominal surgery, the physi- thorization

perform the cian must further certify that at least hysterectomy has informed the individ30 days have passed between the date of ual and her representative, if any, oralthe individual's peonature on the con- ly and in writing, that the sent forma

n which the hysterectomy will make her permasteriliza:

11 pre- nently incapable of reproducing; and

to

а

(2) The individual or her representative, if any, has signed a written acknowledgment of receipt of that information.

(c)(1) A program or project is not require to follow the procedures of paragraph (b) of this section if either of the following circumstances exists:

(i) The individual is already sterile at the time of the hysterectomy.

(ii) The individual requires hysterectomy because of a life-threatening emergency in which the physician determines that prior acknowledgment is not possible.

(2) If the procedures of paragraph (b) of this section are not followed because one or more of the circumstances of paragraph (c)(1) exist, the physician who performs the hysterectomy must certify in writing:

(i) That the woman was already sterile, stating the cause of that sterility;

or

(ii) That the hysterectomy was performed under a life-threatening emergency situation in which he or she determined prior acknowledgment was not possible. He or she must also include a description of the nature of the emergency. (43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982)

(b) A program or project shall not a Federal financial assistance for < sterilization or hysterectomy with first receiving documentation shot that the requirements of this subz have been met. Documentation cludes consent forms, and as app ble, either acknowledgments of IKE. of hysterectomy information or cerca cation of an exception hysterectomies. (43 FR 52165, Nov. 8, 1978, as amended : FR 33701, Aug. 4, 1982) $50.210 Review of regulation.

The Secretary will request pet comment on the operation of the pro sions of this subpart not later tha years after their effective date. APPENDIX TO SUBPART B OF PART 54

REQUIRED CONSENT FORM NOTICE: YOUR DECISION AT ANY TIL NOT TO BE STERILIZED WILL NOT BE SULT IN THE WITHDRAWAL OR WTS HOLDING OF ANY BENEFITS PROVIIS BY PROGRAMS OR PROJECTS RECEIV FEDERAL FUNDS.

CONSENT TO STERILIZATION I have asked for and received informat" about sterilization from tor or clinic). When I first asked for the formation, I was told that the decision to sterilized is completely up to me. I was so that I could decide not to be sterilized. I decide not to be sterilized, my decision " not affect my right to future care or tres ment. I will not lose any help or beneza from programs receiving Federal funds, sock as A.F.D.C. or medicaid that I am now FE ting or for which I may become eligible.

I UNDERSTAND THAT THE STERILIZA TION MUST BE CONSIDERED PERMA NENT AND NOT REVERSIBLE. I HAVE DE CIDED THAT I DO NOT WANT TO BECOM PREGNANT, BEAR CHILDREN OR FATHE: CHILDREN.

I was told about those temporary method of birth control that are available and cous be provided to me which will allow me w bear or father a child in the future. I have me jected these alternatives and chosen to be sterilized.

I understand that I will be sterilized by operation known as a comforts, risks and benefits associated File the operation have been explained to me. Ali my questions have been answered to my sal isfaction.

I understand that the or done until at least form. I understan

850.208 Program or project require

ments. (a) A program or project must, with respect to any sterilization procedure or hysterectomy it performs or arranges, meet all requirements of this subpart.

(b) The program or project shall maintain sufficient records and documentation to assure compliance with these regulations, and must retain such data for at least 3 years.

(c) The program or project shall submit other reports as required and when requested by the Secretary.

The dis

850.209 Use of Federal financial assist

ance. (a) Federal financial assistance adminstered by the Public Health Service may not be used for expenditures for sterilization procedures unless the consent form appended to this section or another form approved by the Secretary is used.

lic Health Service, HHS

Pt. 50, App. to Subpt. B

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d at any time and that my decision at services or any benefits provided by Federal

time not to be sterilized will not result funds. he withholding of any benefits or medical To the best of my knowledge and belief the vices provided by federally funded pro- individual to be sterilized is at least 21 years ms.

old and appears mentally competent. He/She am at least 21 years of age and was born knowingly and voluntarily requested to be (day),

(month), - (year). sterilized and appears to understand the na

hereby consent of my own ture and consequence of the procedure. fe will to be sterilized by

by nethod called

My consent

Signature of person obtaining consent vires 180 days from the date of my signa

Date e below.

Facility also consent to the release of this form

Address 1 other medical records about the oper

PHYSICIAN'S STATEMENT on to: Representatives of the Department of Shortly before I performed a sterilization alth and Human Services or

operation upon

(name of indiEmployees of programs or projects funded vidual to be sterilized), on

(date of that Department but only for determin- sterilization),

(operation), I exg if Federal laws were observed.

plained to him her the nature of the steriI have received a copy of this form.

lization operation

(specify type

of operation), the fact that it is intended to gnature ute:

be a final and irreversible procedure and the Tonth, day, year)

discomforts, risks and benefits associated

with it. You are requested to supply the following I counseled the individual to be sterilized .formation, but it is not required:

that alternative methods of birth control are ace and ethnicity designation (please

available which are temporary. I explained check)

that sterilization is different because it is lack (not of Hispanic origin)

permanent. Lispanic

I informed the individual to be sterilized sian or Pacific Islander

that his

her consent can be withdrawn at any merican Indian or Alaskan native

time and that he/she will not lose any health Vhite (not of Hispanic origin)

services or benefits provided by Federal

funds. INTERPRETER'S STATEMENT

To the best of my knowledge and belief the

individual to be sterilized is at least 21 years If an interpreter is provided to assist the ndividual to be sterilized:

old and appears mentally competent. He/She · I have translated the information and ad

knowingly and voluntarily requested to be

sterilized and appeared to understand the navice presented orally to the individual to be

ture and consequences of the procedure. sterilized by the person obtaining this consent. I have also read him/her the consent

(Instructions for use of alternative final paraform in language and explained

graphs: Use the first paragraph below except its contents to him/her. To the best of my

in the case of premature delivery or emerknowledge and belief he/she understood this

gency abdominal surgery where the sterilizaexplanation.

tion is performed less than 30 days after the

date of the individual's signature on the conInterpreter

sent form. In those cases, the second paraDate

graph below must be used. Cross out the

paragraph which is not used.) STATE OF PERSON OBTAINING CONSENT

(1) At least 30 days have passed between Before

(name of individual), the date of the individual's signature on this signed the consent form, I explained to him

consent form and the date the sterilization her the nature of the sterilization operation was performed.

-, the fact that it is intended to (2) This sterilization was performed less be a final and irreversible procedure and the

than 30 days but more than 72 hours after the discomforts, risks and benefits associated date of the individual's signature on this with it.

consent form because of the following cirI counseled the individual to be sterilized cumstances (check applicable box and fill in that alternative methods of birth control are information requested): available which are temporary. I explained Premature delivery that sterilization is different because it is

Individual's expected date of delivery: permanent.

Emergency abdominal surgery: I informed the individual to be sterilized

(Describe circumstances): that his/her consent can be withdrawn at any time and that he/she will not lose any health Physician

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Date

abortion in programs or projects (43 FR 52165, Nov. 8, 1978, as amended at 58 which this subpart applies except FR 33343, June 17, 1993)

circumstances described in $50.38

$50.306. Subpart C-Abortions and Related Medical Services in Federally 61598, Oct. 26, 1979)

(43 FR 4570, Feb. 2, 1978, as amended si Assisted Programs of the Public Health Service

$50.304 Life of the mother would >

endangered AUTHORITY: Sec. 118, Pub. L. 96-86, Oct. 12, 1979, unless otherwise noted.

Federal financial participation

available in expenditures for an ste SOURCE: 43 FR 4570, Feb. 2, 1978, unless otherwise noted.

tion when a physician has found, and 5

certified in writing to the program: $50.801 Applicability.

project, that on the basis of hists The provisions of this subpart are ap

professional judgment, the life of plicable to programs or projects for

mother would be endangered if >> health services which are supported in

fetus were carried to term. The cert" whole or in part by Federal financial

cation must contain the name and sa assistance, whether by grant or con

dress of the patient. tract, appropriated to the Department (Sec. 101, Pub. L. 95,205, 91 Stat. 1461. Dez! of Health and Human Services and ad- 1977) ministered by the Public Health Service.

(43 FR 13868, July 21, 1978) $50.302 Definitions.

$ 50.305 (Reserved) As used in this subpart: (a) Law en- 850.306 Rape and incest. forcement agency means an agency, or any part thereof, charged under appli

Federal financial participation cable law with enforcement of the gen

available in expenditures for medica eral penal statutes of the United

procedures performed upon a victim : States, or of any State or local juris

rape or incest if the program or projet diction.

has received signed documentatic (b) Medical procedures performed upon

from a law enforcement agency or pak a victim of rape or incest means any

lic health service stating: medical service, including an abortion,

(a) That the person upon whom the performed for the purpose of prevent

medical procedure was performed ing or terminating a pregnancy arising reported to have been the victim of & out of an incident of rape or incest.

incident of rape or incest; (c) Physician means a doctor of medi- (b) The date on which the incide: cine or osteopathy legally authorized occurred; to practice medicine and surgery by (c) The date on which the report a the State in which he or she practices. made, which must have been within 5

(d) Public health service means: (1) An agency of the United States or of a

days of the date on which the incider:

occurred; State or local government, that provides health or medical services; and

(d) The name and address of the vie (2) A rural health clinic, as defined

tim and the name and address of the under section 1(d)(aa)(2) of Pub. L. 95–

from the victim); and

person making the report (if different 210, 91 Stat. 1485; except that any agency or facility whose principal function

(e) That the report included the si is the performance of abortions is spe

nature of the person who reported the cifically excluded from this definition.

incident. 850.303 General rule.

Federal financial participation 18 alse

available in expenditures for abortions Federal financial participation is not available for the performance of an

for victims of rape or Incest under the circur

ribed in $50.84

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