Program Guidelines For Project Grants For Family Planning ServicesUnited States Department of Health and Human Services
Office of Public Health and Science
Office of Population Affairs
Office of Family Planning
4350 East West Highway, Suite 200
Bethesda, Maryland 20814
January 2001
Table of Contents
PART I . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.0 Introduction to the Program Guidelines . . . . . . . .1
1.1 Definitions. . . . . . . . . . . . . . . . . . . . . .1
2.0 The Law, Regulations, and Guidelines . . . . . . . . .2
3.0 The Application Process. . . . . . . . . . . . . . . .2
3.1 Eligibility . . . . . . . . . . . . . . . . . . .2
3.2 Needs Assessment . . . . . . . . . . . . . . . .3
3.3 The Application . . . . . . . . . . . . . . . . .3
3.4 Project Requirements . . . . . . . . . . . . . . .4
3.5 Notice of Grant Award . . . . . . . . . . . . . 5
4.0 Grant Administration. . . . . . . . . . . . . .. . . .5
5.0 Legal Issues . . . . . . . . . . . . . . . .. . . .5
5.1 Voluntary Participation . . . . . . . . . . . . .5
5.2 Confidentiality . . . . . . . . . . .. . .. . . .5
5.3 Conflict of Interest. . . . . . . . . . . . . . .6
5.4 Liability Coverage. . . . . . . . . . . . . . . .6
5.5 Human Subjects Clearance (Research) . . . . . . .6
6.0 Project Management . . . . . . . . . . . . . . . . . .6
6.1 Structure of the Grantee. . . . . . . . . . . . .6
6.2 Planning and Evaluation . . . . . . . . . . . . 7
6.3 Financial Management. . . . . . . . . . . . . . .7
6.4 Facilities and Accessibility of Services. . . . .9
6.5 Personnel . . . . . . . . . . . . . . . . . . . .9
6.6 Training and Technical Assistance . . . . . . . 10
6.7 Reporting Requirements . . . . . . . . . . . . . 10
6.8 Review and Approval of Informational
Educational Materials..........................10
6.9 Community Participation, Education, and
Project Promotion...............................11
6.10 Publications and Copyright. . . . . . . . . . . 12
6.11 Inventories or Discoveries . . . . . . . . . . 12
PART II. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.0 Client Services. . . . . . . . . . . . . . . . . . . 13
7.1 Service Plans and Protocols . . . . . . . . . . 13
7.2 Procedural Outline. . . . . . . . . . . . . . . 13
7.3 Emergencies . . . . . . . . . . . . . . . . . . 15
7.4 Referrals and Follow-Up . . . . . . . . . . . . 16
8.0 Required Services. . . . . . . . . . . . . . . . . . 16
8.1 Client Education . . . . . . . . . . . . . . . 17
8.2 Counseling. . . . . . . . . . . . . . . . . . . 18
8.3 History, Physical Assessment, And
Laboratory Testing..............................19
8.4 Fertility Regulation. . . . . . . . . . . . . . 23
8.5 Infertility Services. . . . . . . . . . . . . . 24
8.6 Pregnancy Diagnosis and Counseling. . . . . . . 24
8.7 Adolescent Services . . . . . . . . . . . . . . 25
8.8 Identification of Estrogen-Exposed Offspring . 26
9.0 Related Services. . . . . . . . . . . . . . . . . . 26
9.1 Gynecologist Services . . . . . . . . . . . . . 26
9.2 Sexuality Transmitted Diseases (STD)
and HIV/AIDS....................................26
9.3 Special Counseling . . . . . . . . . . . . . . .27
9.4 Genetic Information and Referral . . . . . . . .27
9.5 Health Promotion/Disease Prevention . . . . . . 27
9.6 Postpartum Care . . . . . . . . . . . . . . . . 27
10.0 Clinic Management. . . . . . . . . . . . . . . . . 27
10.1 Equipment and Supplies . . . . . . . . . . . . 27
10.2 Pharmaceuticals. . . . . . . . . . . . . . . . 28
10.3 Medical Records. . . . . . . . . . . . . . . . 28
10.4 Quality Assurance and Audit. . . . . . . . . . 30
Attachments
A. The Law: Title X Population Research and Voluntary
Family Planning Programs
B. Regulations: Grants for Family Planning Services under
Title X of the Public Health Service Act
C. Sterilization of Persons in Federally Assisted Family
Planning Projects
D. DHHS Regional Offices- Regional Program Consultants For
Family Planning
Resource Documents
PART I
1.0 Introduction to the Program Guidelines
This document, Program Guidelines for Project Grants for Family
Planning Services(Guidelines), has been developed by the Office
of Population Affairs (OPA), U.S. Department of Health and Human
Services (DHHS), to assist current and prospective grantees in
understanding and utilizing the family planning services grants
program authorized by Title X of the Public Health Service Act,
42 U.S.C. 300, et seq. The Office of Population Affairs also
provides more detailed guidance, updated clinical information
and clarification of specific program issues in the form of
periodic Program Instructions to the Regional Offices.
This document is organized into two parts. Part I (sections 1-6)
covers project management and administration, including the grant
application and award process. Part II (sections 7-11) covers
client services and clinic management.
Reference is made throughout the document to specific sections of
the Title X law and implementing regulations, which are contained
in Attachments A and B, respectively. (Reference to specific
sections of the regulations will appear in brackets, e.g.,
[45 CFR Part 74, Subpart C].) Federal sterilization regulations
are contained in Attachment C. The DHHS regional offices are
listed in Attachment D. Selected other materials that provide
additional guidance in specific areas are classified as Resource
Documents.
1.1 DEFINITIONS
Throughout this document, the word "must" indicates mandatory
program policy. "Should" indicates recommended program policy
relating to components of family planning and project management
that the project is urged to utilize in order to fulfill the intent
of Title X. The words "can" and "may" indicate suggestions for
consideration by individual projects.
The "grantee" is the entity that receives a Federal grant and assumes
legal and financial responsibility and accountability for the awarded
funds and for the performance of the activities approved for funding.
The "project" consists of those activities described in the grant
application and supported under the approved budget. Delegate/contract
agencies" are those entities that provide family planning services
with Title X funds under a negotiated, written agreement with a
grantee. "Service sites" are those locations where services actually
are provided by the grantee or delegate/contract agency.
2.0 The Law, Regulations, and Guidelines
To enable persons who want to obtain family planning care to have
access to such services, Congress enacted the Family Planning Services
and Population Research Act of 1970 (Public Law 91-572), which added
Title X, "Population Research and Voluntary Family Planning Programs"
to the Public Health Service Act. Section 1001 of the Act (as amended)
authorizes grants "to assist in the establishment and operation of
voluntary family planning projects which shall offer a broad range
of acceptable and effective family planning methods and services
(including natural family planning methods, infertility services,
and services for adolescents)" (see Attachment A). The mission of
Title X is to provide individuals the information and means to
exercise personal choice in determining the number and spacing of
their children.
The regulations governing Title X [42 CFR Part 59, Subpart A] set
out the requirements of the Secretary, Department of Health and
Human Services, for the provision of family planning services funded
under Title X and implement the statute as authorized under Section
1001 of the Public Health Service Act. Prospective applicants and
grantees should refer to the regulations (see Attachment B). This
document, Program Guidelines for Project Grants for Family Planning
Services, interprets the law and regulations in operational terms
and provides a general orientation to the Federal perspective on
family planning.
3.0 The Application Process
3.1 ELIGIBILITY
Any public or nonprofit private entity located in a state (which,
by definition, includes the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, the
U.S. Virgin Islands, American Samoa, the U.S. Outlying Islands
[Midway, Wake, et al.], the Marshall Islands, the Federated
States of Micronesia and the Republic of Palau) is eligible to
apply for a Title X family planning services project grant
[59.2, 59.3].
To promote the purposes of Section 1001 of the Act in the most
cost effective and efficient manner, grants will be made to public
and non-profit private entities to foster projects most responsive
to local needs. A non-profit private agency, institution, or
organization must furnish evidence of its non-profit status in
accordance with instructions accompanying the project grant
application form. Under the law, grants cannot be made to entities
that propose to offer only a single method or an unduly limited
number of family planning methods. A facility or entity offering
a single method can receive assistance under Title X by participating
as a delegate/contract agency in an approvable project that offers
a broad range of acceptable and effective medically approved family
planning methods and services [59.5(a)(1)].
3.2 NEEDS ASSESSMENT
An assessment of the need for family planning services must be
conducted prior to applying for a competitive grant award. The
needs assessment documents the need for family planning services
for persons in the service area and should include:
~ Description of the geographic area including a discussion of
potential geographic, topographic, and other related barriers
to service;
~ Demographic description of the service area including objective
data pertaining to individuals in need of family planning services,
maternal and infant morbidity/mortality rates, birth rates and
rates of unintended pregnancies by age groups, poverty status of
the populations to be served, cultural and linguistic barriers
to services, etc.;
~ Description of existing services and need for additional family
planning services to meet community/cultural needs;
~ Need indicators that include rates of STDs and HIV prevalence
(including perinatal infection rates) in the grantee area;
~ Identification and descriptions of linkages with other resources
related to reproductive health; and
~ Identification and discussion of high priority populations and
target areas.
Grantees should perform periodic reassessment of service needs.
Competitive grant applications must include a full and updated
needs assessment.
3.3 THE APPLICATION
The Department of Health and Human Services' Office of Population
Affairs administers the Title X Family Planning Program through the
DHHS Regional Offices. An annual announcement of the availability
of Title X service grant funds sets forth specific application
requirements and evaluation criteria. Applications must be submitted
to the Office of Grants Management for Family Planning Services on
the form required by the Department. The application forms are
available from the Office of Grants Management for Family Planning
Services. Assistance regarding programmatic aspects of proposal
preparation is available from the Regional Office. For assistance
with administrative and budgeting aspects of proposal preparation,
contact the Office of Grants Management for Family Planning Services.
Unless otherwise instructed, applicants are to respond to the standard
instructions contained in the application kit and to the PHS supplemental
instructions. An application must contain:
~ a needs assessment
~ a narrative description of the project and the manner in which the
applicant intends to conduct it in order to carry out the requirements
of the law and regulations;
~ a budget that includes an estimate of project income and costs, with
justification for the amount of grant funds requested [59.4(c)(2)]
and which is consistent with the terms of Section 1006 of the Act,
as implemented by regulation [59.7(b)];
~ a description of the standards and qualifications that will be
required for all personnel and facilities to be used by the project;
~ project objectives that are specific, realistic, and measurable; and
~ other pertinent information as required [59.4(c)(4)].
The application must address all points contained in section 59.7(a) of
the regulations, which are the criteria DHHS Regional Offices will use
to decide which family planning projects to fund and in what amount.
The application shall not include activities that cannot be funded under
Title X, such as abortion, fundraising, or lobbying activities.
3.4 PROJECT REQUIREMENTS
Projects must adhere to:
~ Section 59.5 and all other applicable provisions of the regulations,
which list the requirements to be met by each project supported
by Title X.
~ The applicable requirements of these Program Guidelines for Project
Grants for Family Planning Services.
~ Other Federal regulations which apply to grants made under Title X
[59.10]. For assistance in identifying other relevant regulations,
contact the Regional Office.
3.5 NOTICE OF GRANT AWARD
The notice of grant award will inform the grantee how long DHHS
intends to support the project without requiring it to recompete
for funds [59.8]. This period of funding is called the "project
period." The project will be funded in increments called "budget
periods." The budget period is normally twelve months, although
shorter or longer budget periods may be established for compelling
administrative or programmatic reasons.
4.0 Grant Administration
All grantees must comply with the applicable legislative,
regulatory and administrative requirements described in the
Public Health Service Grants Policy Statement. A copy of the
Public Health Service Grants Policy Statement may be obtained
from the Office of Grants Management for Family Planning Services.
5.0 Legal Issues
5.1 VOLUNTARY PARTICIPATION
Use by any individual of project services must be solely on a
voluntary basis. Individuals must not be subjected to coercion
to receive services or to use or not to use any particular method of
family planning. Acceptance of family planning services must not be
a prerequisite to eligibility for, or receipt of, any other service
or assistance from or participation in any other programs of
the applicant [59.5(a)(2)].
Project personnel must be informed that they may be subject to
prosecution under Federal law if they coerce or endeavor to coerce
any person to undergo an abortion or sterilization procedure.
5.2 CONFIDENTIALITY
Every project must assure client confidentiality and provide
safeguards for individuals against the invasion of personal privacy,
as required by the Privacy Act. No information obtained by the
project staff about individuals receiving services may be disclosed
without the individual's written consent, except as required by law
or as necessary to provide services to the individual, with
appropriate safeguards for confidentiality. Information may
otherwise be disclosed only in summary, statistical, or other
form that does not identify the individual [59.11].
5.3 CONFLICT OF INTEREST
Grantees must establish policies to prevent employees, consultants,
or members of governing or advisory bodies from using their
positions for purposes of private gain for themselves or for
others.
5.4 LIABILITY COVERAGE
Grantees and/or delegates/contractors should ensure the existence
of adequate liability coverage for all segments of the project
funded under the grant, including all individuals providing
services. Governing boards should obtain liability coverage
for their members.
5.5 HUMAN SUBJECTS CLEARANCE (RESEARCH)
Grantees considering clinical or sociological research using Title X
clients as subjects must adhere to the legal requirements governing
human subjects research at 45 CFR Part 46, as applicable. A copy of
these regulations may be obtained from the Regional Office. Grantees
must advise the Regional Office in writing of research projects
involving Title X clients or resources in any segment of the project.
6.0 Project Management
6.1 STRUCTURE OF THE GRANTEE
Family planning services under Title X grant authority may be
offered by grantees directly and/or by delegate/contract agencies
operating under the umbrella of the grantee. However, the grantee
is responsible for the quality, cost, accessibility, acceptability,
reporting, and performance of the grant-funded activities provided
by delegate/contract agencies. Grantees must therefore have a
negotiated, written agreement with each delegate/contract agency
and establish written standards and guidelines for all delegated
project activities consistent with the appropriate section(s) of
the Program Guidelines for Project Grants for Family Planning
Services, as well as other applicable requirements such as Subpart C
of 45 CFR Part 74, or Subpart C of 45 CFR Part 92. If a
delegate/contract agency wishes to subcontract any of its
responsibilities or services, a written negotiated agreement that
is consistent with Title X requirements and approved by the grantee
must be maintained by the delegate/contractor. Delegate/contract
agencies should be invited to participate in the establishment of
grantee standards and guidelines.
6.2 PLANNING AND EVALUATION
All projects receiving Title X funds must provide services of
high quality and be competently and efficiently administered.
To meet these requirements, each competitive application must
include a plan which identifies overall goals and specific
measurable objectives for the project period. The objectives
may be directed to all clients or to specific groups of clients
and must be consistent with Title X objectives. The plan must
include an evaluation component that addresses and defines
indicators by which the project intends to evaluate itself.
6.3 FINANCIAL MANAGEMENT
Grantees must maintain a financial management system that
meets the standards specified in Subpart C of 45 CFR Part 74
or Subpart C of 45 CFR Part 92, as applicable, as well as any
other requirements imposed by the Notice of Grant Award, and
which complies with Federal standards to safeguard the use of
funds. Documentation and records of all income and expenditures
must be maintained as required.
~ Charges, Billing, and Collections
A grantee is responsible for the implementation of policies
and procedures for charging, billing, and collecting funds
for the services provided by the project. The policies and
procedures should be approved by the governing authority or
board of the grantee and the Regional Office.
Clients must not be denied project services or be subjected
to any variation in quality of services because of the
inability to pay. Billing and collection procedures must
have the following characteristics:
(1) Charges must be based on a cost analysis of all
services provided by the project. At the time of
services, clients who are responsible for paying
any fee for their services must be given bills
directly. In cases where a third party is
responsible, bills must be submitted to that
party.
(2) A schedule of discounts must be developed and
implemented with sufficient proportional increments
so that inability to pay is never a barrier to
service. A schedule of discounts is required for
individuals with family incomes between 101% and 250%
of the Federal poverty level. Fees must be waived for
individuals with family incomes above this amount who,
as determined by the service site project director,
are unable, for good cause, to pay for family planning
services.
(3) Clients whose documented income is at or below 100%
of the Federal poverty level must not be charged,
although projects must bill all third parties
authorized or legally obligated to pay for services.
(4) Individual eligibility for a discount must be
documented in the client's financial record.
(5) Bills to third parties must show total charges
without applying any discount.
(6) Where reimbursement is available from Title XIX
or Title XX of the Social Security Act, a written
agreement with the Title XIX or the Title XX state
agency at either the grantee level or delegate/contract
agency level is required.
(7) Bills to clients must show total charges less any
allowable discounts.
(8) Eligibility for discounts for minors who receive
confidential services must be based on the income
of the minor.
(9) Reasonable efforts to collect charges without
jeopardizing client confidentiality must be made.
(10) A method for the "aging" of outstanding accounts
must be established.
(11) Voluntary donations from clients are permissible.
However, clients must not be pressured to make
donations, and donations must not be a prerequisite
to the provision of services or supplies. Donations
from clients do not waive the billing/charging
requirements set out above.
(12) Client income should be re-evaluated at least annually.
Effective financial management will assure the short and long term
viability of the project, including the efficient use of grant funds.
Technical assistance in achieving this objective is available from the
Regional Office. Title X projects offering services that are not
required by the statute, regulations or these Guidelines should
whenever possible seek other sources of funding for such services
before applying Title X funds to those activities.
~ Financial Audit
Audits of grantees and delegate/contract agencies must be conducted
in accordance with the provisions of 45 CFR Part 74, Subpart C, and
45 CFR Part 92, Subpart C, as applicable. The audits must be
conducted by auditors meeting established criteria for qualifications
and independence.
6.4 FACILITIES AND ACCESSIBILITY OF SERVICES
Facilities in which project services are provided should be
geographically accessible to the population served and should
be available at times convenient to those seeking services,
i.e., they should have evening and/or weekend hours in addition
to daytime hours. The facilities should be adequate to provide
the necessary services and should be designed to ensure comfort
and privacy for clients and to expedite the work of the staff.
Facilities must meet applicable standards established by the
Federal, state and local governments (e.g., local fire, building
and licensing codes).
Projects must comply with 45 CFR Part 84, which prohibits
discrimination on the basis of handicap in Federally assisted
programs and activities, and which requires, among other things,
that recipients of Federal funds operate their Federally assisted
programs so that, when viewed in their entirety, they are readily
accessible to people with disabilities. A copy of Part 84 may be
obtained from the Regional office. Projects must also comply with
any applicable provisions of the Americans With Disabilities Act
(Public Law 101-336).
Emergency situations may occur at any time. All projects must
therefore have written plans and procedures for the management
of emergencies.
6.5 PERSONNEL
Grantees and delegate/contract agencies are reminded of their
obligation to establish and maintain personnel policies that comply
with applicable Federal and state requirements, including Title VI
of the Civil Rights Act, Section 504 of the Rehabilitation Act of
1973, and Title I of the Americans With Disabilities Act. These
policies should include, but need not be limited to, staff
recruitment, selection, performance evaluation, promotion, termination,
compensation, benefits, and grievance procedures. Project staff
should be broadly representative of all significant elements of
the population to be served by the project, and should be sensitive
to and able to deal effectively with the cultural and other
characteristics of the client population [59.5 (b)(10)].
Grantees must also ensure that:
~ Projects are administered by a qualified project director;
~ The clinical care component of the project operates under
the responsibility of a medical director who is a licensed
and qualified physician with special training or experience
in family planning;
~ Protocols exist that provide all project personnel with
guidelines for client care;
~ Personnel records are kept confidential;
~ Licenses of applicants for positions requiring licensure
are verified prior to employment and that there is
documentation that licenses are kept current.
6.6 TRAINING AND TECHNICAL ASSISTANCE
Projects must provide for the orientation and in-service training
of all project personnel, including the staffs of delegate agencies
and service sites. All project personnel should participate in
continuing education related to their activities. Documentation of
continuing education should be maintained and used in evaluating the
scope and effectiveness of the staff training program.
Training through regional training centers is available to all
projects under the Title X program. In addition to training,
grantees may receive technical assistance for specific project
activities. Technical assistance is provided by contract from
the OPA and administered through the Regional Office. Information
on training and technical assistance is available from the Regional
Office.
6.7 REPORTING REQUIREMENTS
Grantees must:
(1) comply with the financial and other reporting
requirements of 45 CFR Part 74 or 45 CFR Part 92,
as applicable; and
(2) comply with other reporting requirements as
required by DHHS.
6.8 REVIEW AND APPROVAL OF INFORMATIONAL AND EDUCATIONAL
MATERIALS
An advisory committee of five to nine members (the size of the
committee can differ from these limits with written documentation
and approval from the Regional Office) who are broadly
representative of the community must review and approve all
informational and educational (I&E) materials developed or
made available under the project prior to their distribution
to assure that the materials are suitable for the population
and community for which they are intended and to assure their
consistency with the purposes of Title X. Oversight
responsibility for the I&E committee(s) rests with the
grantee. The grantee may delegate the I & E operations for
the review and approval of materials to delegate/contract
agencies.
The I&E committee(s) must:
~ Consider the educational and cultural backgrounds of
the individuals to whom the materials are addressed;
~ Consider the standards of the population or community
to be served with respect to such materials;
~ Review the content of the material to assure that the
information is factually correct;
~ Determine whether the material is suitable for the
population or community to which it is to be made
available; and
~ Establish a written record of its determinations [59.6].
The committee(s) may delegate responsibility for the review of
the factual, technical, and clinical accuracy to appropriate
project staff. However, final approval of the I& E material
rests with the committee(s).
6.9 COMMUNITY PARTICIPATION, EDUCATION, AND PROJECT
PROMOTION
Boards and advisory committees for family planning services
should be broadly representative of the population served.
~ Community Participation
Title X grantees and delegate/contract agencies must provide
an opportunity for participation in the development,
implementation, and evaluation of the project (1) by persons
broadly representative of all significant elements of the
population to be served, and (2) by persons in the community
knowledgeable about the community's needs for family planning
services [59.5(b)(10)].
The I& E advisory committee may serve the community
participation function if it meets the above requirements,
or a separate group may be identified. In either case, the
grantee project plan must include a plan for community
participation. The community participation committee must meet
annually or more often as appropriate.
~ Community Education
Each family planning project must provide for community
education programs [59.5(b)(3)]. This should be based
on an assessment of the needs of the community and should
contain an implementation and evaluation strategy.
Community education should serve to enhance community
understanding of the objectives of the project, make known
the availability of services to potential clients, and
encourage continued participation by persons to whom
family planning may be beneficial.
~ Project Promotion
To facilitate community awareness of and access to family
planning services, projects must establish and implement
planned activities whereby their services are made known
to the community [59.5(b)(3)]. Projects should review a
range of strategies and assess the availability of existing
resources and materials. Promotion activities should be
reviewed annually and be responsive to the changing needs
of the community. For more information, contact the
Regional Offices.
6.10 PUBLICATIONS AND COPYRIGHT
Unless otherwise stipulated, publications resulting from
activities conducted under the grant need not be submitted
to DHHS for prior approval. The word "publication" is defined
to include computer software. Grantees should ensure that
publications developed under Title X do not contain information
which is contrary to program requirements or to accepted clinical
practice. Federal grant support must be acknowledged in any
publication. Except as otherwise provided in the conditions of
the grant award, the author is free to arrange for copyright
without DHHS approval of publications, films, or similar
materials developed from work supported by DHHS. Restrictions
on motion picture film production are outlined in the Public
Health Service Grants Policy Statement. Any such copyrighted
materials shall be subject to a royalty-free, non-exclusive,
and irrevocable right of the Government to reproduce, publish,
or otherwise use such materials for Federal purposes and to
authorize others to do so [45 CFR 74.36][45 CFR 92.34 ].
6.11 INVENTIONS OR DISCOVERIES
Family planning projects must comply with Government-wide
regulations, 37 CFR Part 401, which apply to the rights to
inventions made under government grants, contracts and
cooperative agreements.
PART II
7.0 Client Services
Projects funded under Title X must provide clinical,
informational, educational, social and referral services
relating to family planning to clients who want such services.
All projects must offer a broad range of acceptable and
effective medically approved family planning methods and services
either on-site or by referral [59.5(a)(1)]. Projects should make
available to clients all methods of contraception approved by
the Federal Food and Drug Administration.
Part II of this document has been developed to assist grantees
in determining those services which will be provided to fulfill
the mission of Title X.
~ Projects must provide services stipulated in the law or
regulations, or which are required by these Guidelines
for the provision of high quality family planning services.
~ Projects may also provide those services that are intended
to promote the reproductive and general health care of the
family planning client population.
7.1 SERVICE PLANS AND PROTOCOLS
The service plan is the component of the grantee's project plan,
as set forth in the competitive application, which identifies
those services to be provided to clients under Title X by the
project. As part of the project plan, all grantees must assure
that delegate/contractors have written clinical protocols and
plans for client education, approved by the grantee and signed
by the service site Medical Director, which outline procedures
for the provision of each service offered and which are in
accordance with state laws. Clinical protocols must be consistent
with the requirements of these Guidelines.
Under exceptional circumstances, a waiver from a particular
requirement may be obtained from the Regional Office upon
written request from a grantee. In submitting a request for an
exception, the grantee must provide epidemiologic, clinical,
and other supportive data to justify the request and the
duration of the waiver.
7.2 PROCEDURAL OUTLINE
The services provided to family planning clients, and the
sequence in which they are provided, will depend upon the
type of visit and the nature of the service requested. However,
the following components must be offered to and documented on
all clients at the initial visit:
Education
~ Presentation of relevant information and educational
materials, based upon client needs and knowledge;
Counseling
~ Interactive process in which a client is assisted in
making an informed choice;
Informed Consent
~ Explanation of all procedures and obtaining a general
consent covering examination and treatment and, where
applicable, a method specific informed consent form;
History
~ Obtaining of a personal and family medical and social
history;
Examination
~ Performance of a physical examination and any necessary
clinical procedures, as indicated;
Laboratory Testing
~ Performance of routine and other indicated laboratory tests;
Follow-up & Referrals
~ Planned mechanism for client follow-up;
~ Performance of any necessary clinical procedures;
~ Provision of medications and/or supplies as needed; and
~ Provision of referrals as needed.
Return visits, with the exception of routine supply visits,
should include an assessment of the client's health status,
current complaints, and evaluation of birth control method,
as well as an opportunity to change methods. The following
components must be offered to and documented on all clients
at the return visit:
History
~ Updating a personal and family medical and social history;
Examination
~ Performance of a physical examination and any necessary
clinical procedures, as indicated;
Laboratory Testing
~ Performance of routine and other indicated laboratory tests;
Follow-up & Referrals
~ Planned mechanism for client follow-up;
~ Performance of any necessary clinical procedures;
~ Provision of medications and/or supplies as needed; and
~ Provision of referrals as needed.
7.3 EMERGENCIES
Emergency situations involving clients and/or staff may occur
at any time. All projects must therefore have written plans
for the management of on-site medical emergencies. At a minimum,
written protocols must address vaso-vagal reactions, anaphylaxis,
syncope, cardiac arrest, shock, hemorrhage, and respiratory
difficulties. Protocols must also be in place for emergencies
requiring transport, after-hours management of contraceptive
emergencies, and clinic emergencies. All project staff must
be familiar with these plans. Appropriate training, including
training in CPR, should be available to staff.
7.4 REFERRALS AND FOLLOW-UP
Grantees must assure that delegate/contract agencies provide
all family planning services listed in Section 8.0 under
"Required Services," either on-site or by referral. When
required services are to be provided by referral, the
grantee must establish formal arrangements with a referral
agency for the provision of services and reimbursement of
costs, as appropriate.
Agencies must have written policies/procedures for follow-up
on referrals that are made as a result of abnormal physical
examination or laboratory test findings. These policies must be
sensitive to clients' concerns for confidentiality and privacy.
For services determined to be necessary but which are beyond the
scope of the project, clients must be referred to other providers
for care. When a client is referred for non-family planning or
emergency clinical care, agencies must:
~ Make arrangements for the provision of pertinent client
information to the referral provider. Agencies must
obtain client's consent to such arrangements, except as
may be necessary to provide services to the patient or
as required by law, with appropriate safeguards for
confidentiality;
~ Advise client on their responsibility in complying with
the referral; and
~ Counsel client on the importance of such referral and
the agreed upon method of follow-up.
Efforts may be made to aid the client in identifying potential
resources for reimbursement of the referral provider, but
projects are not responsible for the cost of this care. Agencies
must maintain a current list of health care providers, local
health and human services departments, hospitals, voluntary
agencies, and health services projects supported by other
Federal programs to be used for referral purposes. Whenever
possible, clients should be given a choice of providers from
which to select.
8.0 Required Services
The services contained in this section must be provided by all
projects funded under Title X.
The client's written informed voluntary consent to receive
services must be obtained prior to the client receiving any
clinical services. In addition, if a client chooses a
prescription method of contraception, a method-specific
consent form must be obtained and updated routinely at
subsequent visits to reflect current information about
that method.
8.1 CLIENT EDUCATION
Grantees and/or delegate/contract agencies must have written
plans for client education that include goals and content
outlines to ensure consistency and accuracy of information
provided. Client education must be documented in the client
record. The education provided should be appropriate to the
client's age, level of knowledge, language, and socio-cultural
background and be presented in an unbiased manner. A
mechanism to determine that the information provided has
been understood should be established.
Education services must provide clients with the information
needed to:
~ Make informed decisions about family planning;
~ Use specific methods of contraception and identify
adverse effects;
~ Perform breast/testicular self examination;
~ Reduce risk of transmission of sexually transmitted
diseases and Human Immunodeficiency Virus (HIV);
~ Understand the range of available services and the
purpose and sequence of clinic procedures; and
~ Understand the importance of recommended screening
tests and other procedures involved in the family
planning visit.
Clients should be offered information about basic female and male
reproductive anatomy and physiology, and the value of fertility
regulation in maintaining individual and family health. Additional
education should include information on reproductive health and
health promotion/disease prevention, including nutrition, exercise,
smoking cessation, alcohol and drug abuse, domestic violence and
sexual abuse.
~ Method-Specific Informed Consent
Written informed consent, specific to the contraceptive method,
must be signed before a prescription contraceptive method is
provided. Prior to implementation, informed consent forms
should be approved by the service site Medical Director.
The consent forms must be written in a language understood by
the client or translated and witnessed by an interpreter. To
provide informed consent for contraception, the client must
receive information on the benefits and risks, effectiveness,
potential side effects, complications, discontinuation issues
and danger signs of the contraceptive method chosen. Specific
education and consent forms for the contraceptive method
provided must be part of the project's service plan.
The signed informed consent form must be a part of the client's
record. All consent forms should contain a statement that the
client has been counseled, provided with the appropriate
informational material, and understands the content of both.
The method-specific consent form should be renewed and updated
when there is a major change in the client's health status or a
change to a different prescriptive contraceptive method.
Federal sterilization regulations [42 CFR Part 50, Subpart B],
which address informed consent requirements, must be complied
with when a sterilization procedure is performed or arranged
for by the project (see Attachment C).
8.2 COUNSELING
The primary purpose of counseling in the family planning setting
is to assist clients in reaching an informed decision regarding
their reproductive health and the choice and continued use of
family planning methods and services. The counseling process
is designed to help clients resolve uncertainty, ambivalence,
and anxiety about reproductive issues and to enhance their
capacity to arrive at a decision that reflects their considered
self-interest.
The counseling process involves mutual sharing of information.
Persons who provide counseling should be knowledgeable, objective,
non-judgmental, sensitive to the rights and differences of clients
as individuals, culturally aware and able to create an environment
in which the client feels comfortable discussing personal
information. The counselor must be sufficiently knowledgeable
to provide accurate information regarding the benefits and risk,
safety, effectiveness, potential side effects, complications,
discontinuation issues and danger signs of the various contraceptive
methods. Additionally, the counselor should be knowledgeable
about the other services offered by the agency. Documentation of
counseling must be included in the client's record.
~ Method Counseling
Method counseling refers to an individualized dialogue with
a client that covers the following:
~ Results of physical exam and lab studies;
~ Effective use of contraceptive methods, including
natural family planning (NFP), and the benefit and
efficacy of the methods;
~ Possible side effects/complications;
~ How to discontinue the method selected and information
regarding back-up method use, including the use of
certain oral contraceptives as post-coital emergency
contraception;
~ Planned return schedule;
~ Emergency 24-hour telephone number;
~ Location where emergency services can be obtained;
and
~ Appropriate referral for additional services as
needed.
~ Sexually Transmitted Disease (STD) and HIV Counseling
All clients must receive thorough and accurate counseling on
STDs and HIV. STD/HIV counseling refers to an individualized
dialogue with a client in which there is discussion of personal
risks for STDs/HIV, and the steps to be taken by the individual
to reduce risk, if necessary. Persons found to have behaviors
which currently put them at risk for STD/HIV must be given advice
regarding risk reduction and must be advised whether clinical
evaluation is indicated. All projects must offer, at a minimum,
education about HIV infection and AIDS, information on risks and
infection prevention, and referral services. On an optional basis,
clinics may also provide HIV risk assessment, counseling and testing
by specially trained staff. When the project does not offer these
optional services, the project must provide the client with a list
of health care providers who can provide these services.
8.3 HISTORY, PHYSICAL ASSESSMENT, AND LABORATORY TESTING
~ History
At the initial comprehensive clinical visit, a complete medical
history must be obtained on all female and male clients.
Pertinent history must be updated at subsequent clinical visits.
The comprehensive medical history must address at least the
following areas:
~ Significant illnesses; hospitalizations; surgery; blood
transfusion or exposure to blood products; and chronic
or acute medical conditions;
~ Allergies;
~ Current use of prescription and over-the-counter
medications;
~ Extent of use of tobacco, alcohol, and other drugs;
~ Immunization and Rubella status;
~ Review of systems;
~ Pertinent history of immediate family members; and
~ Partner history
- injectable drug use
- multiple partners
- risk history for STDs and HIV
- bisexuality.
Histories of reproductive function in female clients must include
at least the following:
~ Contraceptive use past and current (including adverse
effects);
~ Menstrual history;
~ Sexual history;
~ Obstetrical history;
~ Gynecological conditions;
~ Sexually transmitted diseases, including HBV;
~ HIV;
~ Pap smear history (date of last Pap, any abnormal Pap,
treatment); and
~ In utero exposure to diethylstilbestrol (DES).
Histories of reproductive function in male clients must include
at least the following:
~ Sexual history;
~ Sexually transmitted diseases (including HBV);
~ HIV; and
~ Urological conditions.
~ Physical Assessment (female)
For many clients, family planning programs are their only
continuing source of health information and clinical care.
Therefore, an initial complete physical examination,
including height and weight, examination of the thyroid,
heart, lungs, extremities, breasts, abdomen, pelvis, and
rectum, should be performed.
While most client services will necessarily relate to
fertility regulation, family planning clinics must provide
and encourage clients to use health maintenance screening
procedures, initially and as indicated. Clinics must
provide and stress the importance of the following to
all clients:
~ Blood pressure evaluation;
~ Breast exam;
~ Pelvic examination which includes vulvar
evaluation and bimanual exam;
~ Pap smear;
~ Colo-rectal cancer screening in individuals
over 40; and
~ STD and HIVscreening, as indicated.
Following counseling about the importance of the above preventive
services, if a client chooses to decline or defer a service,
this should be documented in their record. Counseling must
include information about the possible health risks associated
with declining or delaying preventive screening tests or
procedures.
All physical examination and laboratory test requirements
stipulated in the prescribing information for specific
methods of contraception must be followed. Physical examination
and related prevention services should not be deferred beyond
3 months after the initial visit, and in no case may be
deferred beyond 6 months, unless if in the clinician's judgment
there is a compelling reason for extending the deferral. All
deferrals, including the reason(s) for deferral, must be
documented in the client record. Project protocols should
be developed accordingly.
~ Physical Assessment (male)
Family planning clinics also may be an important source of
reproductive health care for male clients. Physical
examination should be made available to male clients, including
height and weight, examination of the thyroid, heart, lungs,
breasts, abdomen, extremities, genitals and rectum.
Examination should also include palpation of the prostate, as
appropriate, and instructions in self-examination of the testes.
Clinics should stress the importance of the following to
male clients:
~ Blood pressure evaluation;
~ Colo-rectal cancer screening in individuals
over 40; and
~ STD and HIVscreening, as indicated.
~ Laboratory Testing
Specific laboratory tests are required for the provision of
specific methods of contraception. Laboratory tests can also
be important indicators of client health status and useful for
diagnostic purposes. Pregnancy testing must be provided onsite.
The following laboratory procedures must be provided to
clients if required in the provision of a contraceptive method,
and may be provided for the maintenance of health status and/or
diagnostic purposes, either on-site or by referral:
- Anemia assessment
- Gonorrhea and chlamydia test
- Vaginal wetmount
- Diabetes testing
- Cholesterol and lipids
- Hepatitis B testing
- Syphilis serology (VDRL, RPR)
- Rubella titer
- Urinalysis
- HIV testing
~ Notification of Abnormal Lab Results
A procedure which addresses client confidentiality must be
established to allow for client notification and adequate
follow-up of abnormal laboratory results.
~ Other Laboratory Services or Procedures
Other procedures and lab tests may be indicated for some
clients and may be provided on-site or by referral.
~ Revisits
Revisit schedules must be individualized based upon the
client's need for education, counseling, and clinical
care beyond that provided at the initial and annual visit.
Clients selecting hormonal contraceptives, intrauterine devices
(IUDs), cervical caps, or diaphragms for the first time should
be scheduled for a revisit as appropriate after initiation
of the method to reinforce its proper use, to check for possible
side effects, and to provide additional information or clarification.
A new or established client who chooses to continue a method
already in use need not return for this early revisit unless a
need for reevaluation is determined on the basis of the findings
at the initial visit.
8.4 FERTILITY REGULATION
~ Reversible Contraception
Currently, the reversible methods of contraception include
barrier methods (female and male), IUDs, fertility awareness
methods, natural family planning, and hormonal methods
(injectables, implants, orals). Certain oral contraceptive
regimens have been found by the Federal Food and Drug
Administration to be safe and effective for use as postcoital
emergency contraception when initiated within 72 hours after
unprotected intercourse. More than one method of contraception
can be used simultaneously by a client and may be particularly
indicated to minimize the risks of STDs/HIV and pregnancy.
Consistent and correct use of condoms should be encouraged
for all persons at risk for STDs/HIV.
~ Permanent Contraception
The counseling and consent process must assure that the
client's decision to undergo sterilization is completely
voluntary and made with full knowledge of the permanence,
risks, and benefits associated with female and male
sterilization procedures. Federal sterilization regulations,
which address informed consent requirements, must be complied
with when a sterilization procedure is performed or arranged
for by the project (see Attachment C).
8.5 INFERTILITY SERVICES
Grantees must make basic infertility services available to
women and men desiring such services. Infertility services
are categorized as follows:
Level I Includes initial infertility interview, education,
physical examination, counseling, and appropriate
referral.
Level II Includes such testing as semen analysis, assessment
of ovulatory function and postcoital testing.
Level III More sophisticated and complex than Level I
and Level II services.
Grantees must provide Level I infertility services as a minimum.
Level II infertility services may be offered in projects with
clinicians who have special training in infertility. Level III
services are considered to be beyond the scope of Title X program.
8.6 PREGNANCY DIAGNOSIS AND COUNSELING
Projects must provide pregnancy diagnosis and counseling to all
clients in need of this service. Pregnancy testing is one of
the most common reasons for a first visit to the family planning
facility. It is therefore important to use this occasion as an
entry point for providing education and counseling about family
planning.
Pregnancy cannot be accurately diagnosed and staged through
laboratory testing alone. Pregnancy diagnosis consists of a
history, pregnancy test, and physical assessment, including
pelvic examination. Projects should have available a pregnancy
test of high sensitivity. If the medical examination cannot be
performed in conjunction with the laboratory testing, the client
must be counseled as to the importance of receiving a physical
assessment as soon as possible, preferably within 15 days.
This can be done on-site, by a provider selected by the client,
or by a provider to which the client has been referred by the
project. For those clients with positive pregnancy test results
who elect to continue the pregnancy, referral for early
initiation of prenatal care should be made. Clients
planning to carry their pregnancies to term should be
given information about good health practices during early
pregnancy, especially those which serve to protect the fetus
during the first three months (e.g., good nutrition, avoidance
of smoking, drugs, and exposure to x-rays). For clients with
a negative pregnancy diagnosis, the cause of delayed menses
should be investigated. If ectopic pregnancy is suspected,
the client must be referred for immediate diagnosis and therapy.
Projects must offer pregnant women the opportunity to be
provided information and counseling regarding each of the
following options:
~ Prenatal care and delivery;
~ Infant care, foster care, or adoption; and
~ Pregnancy termination.
If requested to provide such information and counseling, provide
neutral, factual information and nondirective counseling on each
of the options, and referral upon request, except with respect to
any option(s) about which the pregnant woman indicates she does
not wish to receive such information and counseling [59.5(a)(5)].
Clients who are found not to be pregnant should be given
information about the availability of contraceptive and
infertility services, as appropriate.
8.7 ADOLESCENT SERVICES
Adolescent clients require skilled counseling and age-appropriate
information. Appointments should be available to them for
counseling and clinical services as soon as possible.
Adolescents seeking contraceptive services must be informed about
all methods of contraception. Abstinence as well as contraceptive
and safer sex practice options to reduce risks for STD/HIV
and pregnancy must be discussed with all adolescents. It is
important not to assume that adolescents are sexually active
simply because they have come for family planning services.
As the contraceptive needs of adolescents frequently change,
counseling should prepare them to use a variety of methods
effectively.
Adolescents must be assured that the counseling sessions are
confidential and, if follow-up is necessary, every attempt will
be made to assure the privacy of the individual. However,
counselors should encourage family participation in the
decision of minors to seek family planning services and
provide counseling to minors on resisting attempts to coerce
minors into engaging in sexual activities. Title X projects
may not require written consent of parents or guardians for
the provision of services to minors. Nor can the project
notify parents or guardians before or after a minor has
requested and received Title X family planning services.
8.8 IDENTIFICATION OF ESTROGEN-EXPOSED OFFSPRING
The children of women who received DES or similar hormones
during pregnancy may have abnormalities of their reproductive
systems or other fertility related risks. As part of the
medical history, clients born between 1940 and 1970 should
be asked if their mothers took estrogens during pregnancy.
Clients prenatally exposed to exogenous estrogens should
receive information/education and special screening either
on-site or by referral.
9.0 Related Services
The following related health services, which can improve
quality of care, may be offered if skilled personnel
and equipment are available.
9.1 GYNECOLOGIC SERVICES
Family planning programs should provide for the diagnosis
and treatment of minor gynecologic problems so as to avoid
fragmentation or lack of health care for clients with these
conditions. Problems such as vaginitis or urinary tract
infection may be amenable to on-the-spot diagnosis and
treatment, following microscopic examination of vaginal
secretions or urine. More complex procedures, such as
colposcopy, may be offered, provided that clinicians
performing these services have specialized training.
9.2 SEXUALLY TRANSMITTED DISEASES (STD) AND HIV/AIDS
The increasing incidence and prevalence of STDs, particularly
among adolescents, requires that family planning projects
increase their efforts to provide education and information
about the more common STDs and HIV/AIDS. Projects should
make available detection and treatment of the more common
STDs. At-risk clients should be urged to undergo examination
and treatment as indicated, either directly or by referral.
When treatment is provided on-site, appropriate follow-up
measures must be undertaken.
Gonorrhea and chlamydia tests must be available for clients
requesting IUD insertion. Tests for gonorrhea, syphilis,
chlamydia and HIV should be provided as indicated by client
request or evidence of increased risk for infection.
Grantees and/or delegate contract agencies must comply with
state and local STD reporting requirements.
9.3 SPECIAL COUNSELING
Clients should be offered appropriate counseling and referral
as indicated regarding future planned pregnancies, management
of a current pregnancy, and other individual concerns (e.g.,
substance use and abuse, sexual abuse, domestic violence,
genetic issues, nutrition, sexual concerns, etc.) as
indicated. Preconceptional counseling should be provided
if the client's history indicates a desired pregnancy in the future.
9.4 GENETIC INFORMATION AND REFERRAL
Basic information regarding genetic conditions should be offered
to family planning clients who request or are in need of such
services. Extensive genetic counseling and evaluation is beyond
the scope of the Title X program. Referral systems should be
in place for those who require further genetic counseling
and evaluation
9.5 HEALTH PROMOTION/DISEASE PREVENTION
Family planning programs should, whenever possible, provide or
coordinate access to services intended to promote health and
prevent disease. Programs are encouraged to assess the health
problems prevalent in the populations they serve and to develop
strategies to address them.
9.6 POSTPARTUM CARE
Family planning programs may provide postpartum care in
collaboration with local agencies or institutions which
provide prenatal and/or intrapartum care. If a family
planning program undertakes responsibility for postpartum
care, such care should be directed toward assessment of
the woman's physical health, initiation of contraception
if desired, and counseling and education related to
parenting, breast feeding, infant care, and family
adjustment.
10.0 Clinic Management
10.1 EQUIPMENT AND SUPPLIES
Equipment and supplies must be appropriate to the type
of care offered by the project. Projects are expected
to follow applicable Federal and state regulations
regarding infection control.
10.2 PHARMACEUTICALS
Agencies must be operated in accordance with Federal
and state laws relating to security and record keeping
for drugs and devices. The inventory, supply, and
provision of pharmaceuticals must be conducted in
accordance with state pharmacy laws and professional
practice regulations.
It is essential that each facility maintain an adequate
supply and variety of drugs and devices to effectively
manage the contraceptive needs of its clients. Projects
should also ensure access to other drugs or devices that
are necessary for the provision of other medical services
included within the scope of the Title X project.
10.3 MEDICAL RECORDS
Projects must establish a medical record for every client
who obtains clinical services. These records must be
maintained in accordance with accepted medical standards
and State laws with regard to record retention. Records
must be:
~ Complete, legible and accurate, including
documentation of telephone encounters of a
clinical nature;
~ Signed by the clinician and other appropriately
trained health professionals making entries,
including name, title and date;
~ Readily accessible;
~ Systematically organized to facilitate prompt
retrieval and compilation of information;
~ Confidential;
~ Safeguarded against loss or use by unauthorized
persons;
~ Secured by lock when not in use; and
~ Available upon request to the client.
~ Content of the Client Record
The client's medical record must contain sufficient
information to identify the client, indicate where and
how the client can be contacted, justify the clinical
impression or diagnosis, and warrant the treatment and
end results. The required content of the medical record
includes:
~ Personal data;
~ Medical history, physical exam, laboratory test
orders, results, and follow-up;
~ Treatment and special instructions;
~ Scheduled revisits;
~ Informed consents;
~ Refusal of services; and
~ Allergies and untoward reactions to drug(s)
recorded in a prominent and specific
location.
The record must also contain reports of clinical findings,
diagnostic and therapeutic orders, and documentation of
continuing care, referral, and follow-up. The record must
allow for entries by counseling and social service staff.
Projects should maintain a problem list at the front of
each chart listing identified problems to facilitate
continuing evaluation and follow-up. Client financial
information should be kept separate from the client medical
record. If included in the medical record, client financial
information should not be a barrier to client services.
~ Confidentiality and Release of Records
A confidentiality assurance statement must appear in the
client's record. The written consent of the client is
required for the release of personally identifiable information,
except as may be necessary to provide services to the client
or as required by law, with appropriate safeguards for
confidentiality [59.11]. HIV information should be handled
according to law, and kept separate whenever possible. When
information is requested, agencies should release only the
specific information requested. Information collected for
reporting purposes may be disclosed only in summary,
statistical, or other form which does not identify particular
individuals. Upon request, clients transferring to other
providers must be provided with a copy or summary of their
record to expedite continuity of care.
10.4 QUALITY ASSURANCE AND AUDIT
A quality assurance system must be in place that provides for
ongoing evaluation of project personnel and services. The
quality assurance system should include:
~ An established set of clinical, administrative and
programmatic standards by which conformity would
be maintained;
~ A tracking system to identify clients in need of
follow-up and/or continuing care;
~ Ongoing medical audits to determine conformity
with agency protocols;
~ Peer review procedures to evaluate individual clinician
performance, to provide feedback to providers, and to
initiate corrective action when deficiencies are noted;
~ Periodic review of medical protocols to insure
maintenance of current standards of care;
~ A process to elicit consumer feedback; and
~ Ongoing and systematic documentation of quality
assurance activities.
TITLE X
POPULATION RESEARCH AND
VOLUNTARY FAMILY PLANNING PROGRAMS
PROJECT GRANTS AND CONTRACTS FOR FAMILY PLANNING SERVICES
SEC. 1001 [300]
(a)The Secretary is authorized to make grants to and enter into contracts with
public or nonprofit private entities to assist in the establishment and operation
of voluntary family planning projects which shall offer a broad range of
acceptable and effective family planning methods and services (including
natural family planning methods, infertility services, and services for adolescents).
To the extent practicable, entities which receive grants or contracts under this
subsection shall encourage family [1] participation in projects assisted under
this subsection.
(b)In making grants and contracts under this section the Secretary shall take
into account the number of patients to be served, the extent to which family
planning services are needed locally, the relative need of the applicant, and its
capacity to make rapid and effective use of such assistance. Local and regional
entities shall be assured the right to apply for direct grants and contracts under
this section, and the Secretary shall by regulation fully provide for and protect
such right.
(c)The Secretary, at the request of a recipient of a grant under subsection
(a), may reduce the amount of such grant by the fair market value of any
supplies or equipment furnished the grant recipient by the Secretary. The
amount by which any such grant is so reduced shall be available for payment
by the Secretary of the costs incurred in furnishing the supplies or equipment
on which the reduction of such grant is based. Such amount shall be deemed as
part of the grant and shall be deemed to have been paid to the grant recipient.
(d)For the purpose of making grants and contracts under this section, there
are authorized to be appropriated $30,000,000 for the fiscal year ending June
30, 1971; $60,000,000 for the fiscal year ending June 30, 1972; $111,500,000
for the fiscal year ending June 30, 1973, $111,500,000 each for the fiscal years
ending June 30, 1974, and June 30, 1975; $115,000,000 for fiscal year 1976;
$115,000,000 for the fiscal year ending September 30, 1977;
$136,400,000 for the fiscal year ending September 30, 1978;
$200,000,000 for the fiscal year ending September 30, 1979;
$230,000,000 for the fiscal year ending September 30, 1980;
$264,500,000 for the fiscal year ending September 30, 1981;
$126,510,000 for the fiscal year ending September 30, 1982;
$139,200,000 for the fiscal year ending September 30, 1983;
$150,030,000 for the fiscal year ending September 30, 1984; and
$158,400,000 for the fiscal year ending September 30, 1985.
--------------------------
[1] So in law. See section 931(b)(I) of Public Law 97-35 (95 Stat. 570). Probably should be
"family".
FORMULA GRANTS TO STATES FOR FAMILY PLANNING SERVICES
SEC. 1002 [300a]
(a)The Secretary is authorized to make grants, from allotments made under
subsection (b), to State health authorities to assist in planning, establishing,
maintaining, coordinating, and evaluating family planning services. No grant
may be made to a State health authority under this section unless such authority
has submitted, and had approved by the Secretary, a State plan for a
coordinated and comprehensive program of family planning services.
(b)The sums appropriated to carry out the provisions of this section shall be
allotted to the States by the Secretary on the basis of the population and the
financial need of the respective States.
(c)For the purposes of this section, the term ''State'' includes the
Commonwealth of Puerto Rico, the Northern Mariana Islands, Guam,
American Samoa, the Virgin Islands, the District of Columbia, and the Trust
Territory of the Pacific Islands.
(d)For the purpose of making grants under this section, there are authorized to
be appropriated $10,000,000 for the fiscal year ending June 30, 1971;
$15,000,000 for the fiscal year ending June 30, 1972; and $20,000,000 for the
fiscal year ending June 30, 1973.
TRAINING GRANTS AND CONTRACTS;
AUTHORIZATION OF APPROPRIATIONS
SEC. 1003 [300a-1]
(a) The Secretary is authorized to make grants to public or nonprofit private
entities and to enter into contracts with public or private entities and individuals
to provide the training for personnel to carry out family planning service
programs described in section 1001 or 1002 of this title.
(b) For the purpose of making payments pursuant to grants and contracts
under this section, there are authorized to be appropriated $2,000,000 for the
fiscal year ending June 30, 1971; $3,000,000 for the fiscal year ending June 30,
1972; $4,000,000 for the fiscal year ending June 30, 1973; $3,000,000 each for
the fiscal years ending June 30, 1974 and June 30, 1975; $4,000,000 for fiscal
year ending 1976; $5,000,000 for the fiscal year ending September 30,
1977; $3,000,000 for the fiscal year ending September 30, 1978; $3,100,000
for the fiscal year ending September 30, 1979; $3,600,000 for the fiscal year
ending September 30, 1980; $4,100,000 for the fiscal year ending September
30, 1981; $2,920,000 for the fiscal year ending September 30, 1982;
$3,200,000 for the fiscal year ending September 30, 1983; $3,500,000 for
the fiscal year ending September 30, 1984; and $3,500,000 for the fiscal year
ending September 30, 1985.
RESEARCH
SEC. 1004 [300a-2]
The Secretary may -
(1) conduct, and
(2) make grants to public or nonprofit private entities and enter into contracts
with public or private entities and individuals for projects for, research in the
biomedical, contraceptive development, behavioral, and program
implementation fields related to family planning and population.
INFORMATIONAL AND EDUCATIONAL MATERIALS
SEC. 1005 [300a-3]
(a) The Secretary is authorized to make grants to public or nonprofit private
entities and to enter into contracts with public or private entities and individuals
to assist in developing and making available family planning and population
growth information (including educational materials) to all persons desiring
such information (or materials).
(b) For the purpose of making payments pursuant to grants and contracts
under this section, there are authorized to be appropriated $750,000 for the
fiscal year ending June 30, 1971; $1,000,000 for the fiscal year ending June 30,
1972; $1,250,000 for the fiscal year ending June 30, 1973; $909,000 each for
the fiscal years ending June 30, 1974, and June 30, 1975; $2,000,000 for fiscal
year 1976; $2,500,000 for the fiscal year ending September 30, 1977;
$600,000 for the fiscal year ending September 30, 1978; $700,000 for the fiscal
year ending September 30, 1979; $805,000 for the fiscal year ending
September 30, 1980; $926,000 for the fiscal year ending September 30, 1981;
$570,000 for the fiscal year ending September 30, 1982; $600,000 for the fiscal
year ending September 30, 1983; $670,000 for the fiscal year ending
September 30, 1984; and $700,000 for the fiscal year ending September 30,
1985.
REGULATIONS AND PAYMENTS
SEC. 1006 [300a-4]
(a)Grants and contracts made under this subchapter shall be made in
accordance with such regulations as the Secretary may promulgate. The
amount of any grant under any section of this title shall be determined by the
Secretary; except that no grant under any such section for any program or
project for a fiscal year beginning after June 30, 1975, may be made for less
than 90 per centum of its costs (as determined under regulations of the
Secretary) unless the grant is to be made for a program or project for which a
grant was made (under the same section) for the fiscal year ending June 30,
1975, for less than 90 per centum of its costs (as so determined), in
which case a grant under such section for that program or project for a fiscal
year beginning after that date may be made for a percentage which shall not be
less than the percentage of its costs for which the fiscal year 1975 grant was
made.
(b)Grants under this title shall be payable in such installments and subject to
such conditions as the Secretary may determine to be appropriate to assure that
such grants will be effectively utilized for the purposes for which made.
(c)A grant may be made or contract entered into under section 1001 or 1002
for a family planning service project or program only upon assurances
satisfactory to the Secretary that--
(1) priority will be given in such project or program to the furnishing of
such services to persons from low-income families; and
(2) no charge will be made in such project or program for services provided
to any person from a low-income family except to the extent that payment will
be made by a third party (including a government agency) which is authorized
or is under legal obligation to pay such charge.
For purposes of this subsection, the term ''low-income family'' shall be defined
by the Secretary in accordance with such criteria as he may prescribe so as to
insure that economic status shall not be a deterrent to participation in the
programs assisted under this title.
(d)(1) A grant may be made or a contract entered into under section 1001 or
1005 only upon assurances satisfactory to the Secretary that informational or
educational materials developed or made available under the grant or contract
will be suitable for the purposes of this title and for the population or
community to which they are to be made available, taking into account the
educational and cultural background of the individuals to whom such materials
are addressed and the standards of such population or community with respect
to such materials.
(2) In the case of any grant or contract under section 1001, such assurances
shall provide for the review and approval of the suitability of such materials,
prior to their distribution, by an advisory committee established by the grantee
or contractor in accordance with the Secretary's regulations. Such a committee
shall include individuals broadly representative of the population or community
to which the materials are to be made available.
VOLUNTARY PARTICIPATION
SEC. 1007 [300a-5]
The acceptance by any individual of family planning services or family
planning or population growth information (including educational materials)
provided through financial assistance under this title (whether by grant or
contract) shall be voluntary and shall not be a prerequisite to eligibility for or
receipt of any other service or assistance from, or to participation in, any other
program of the entity or individual that provided such service or information.
PROHIBITION OF ABORTION
SEC. 1008 [1] [300a-6]
None of the funds appropriated under this title shall be used in programs where
abortion is a method of family planning.
--------------------------
[1] Section 1009 was repealed by section 601(a)(1)(G) of Public Law 105-362 (112 Stat. 3285).
[Code of Federal Regulations]
[Title 42, Volume 1, Parts 1 to 399]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR59]
[Page 407-416]
TITLE 42--PUBLIC HEALTH
CHAPTER I--PUBLIC HEALTH SERVICE,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 59--GRANTS FOR FAMILY PLANNING SERVICES
Subpart A--Project Grants for Family Planning Services
Sec.
59.1 To what programs do these regulations apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning services grant?
59.4 How does one apply for a family planning services grant?
59.5 What requirements must be met by a family planning project?
59.6 What procedures apply to assure the suitability of informational
and educational material?
59.7 What criteria will the Department of Health and Human Services
use to decide which family planning services projects to fund
and in what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 What other HHS regulations apply to grants under this subpart?
59.11 Confidentiality.
59.12 Additional conditions.
Subpart B [Reserved]
Subpart C--Grants for Family Planning Service Training
59.201 Applicability.
59.202 Definitions.
59.203 Eligibility.
59.204 Application for a grant.
59.205 Project requirements.
59.206 Evaluation and grant award.
59.207 Payments.
59.208 Use of project funds.
59.209 Civil rights.
59.210 Inventions or discoveries.
59.211 Publications and copyright.
59.212 Grantee accountability.
59.213 [Reserved]
59.214 Additional conditions.
59.215 Applicability of 45 CFR part 74.
Subpart A--Project Grants for Family Planning Services
Authority: 42 U.S.C. 300a-4.
[[Page 408]]
Source: 65 FR 41278, July 3, 2000, unless otherwise noted.
Sec. 59.1 To what programs do these regulations apply?
The regulations of this subpart are applicable to the award of
grants under section 1001 of the Public Health Service Act (42 U.S.C.
300) to assist in the establishment and operation of voluntary family
planning projects. These projects shall consist of the educational,
comprehensive medical, and social services necessary to aid individuals
to determine freely the number and spacing of their children.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, 2000]
Sec. 59.2 Definitions.
As used in this subpart:
Act means the Public Health Service Act, as amended.
Family means a social unit composed of one person, or two or more
persons living together, as a household.
Low income family means a family whose total annual income does not
exceed 100 percent of the most recent Poverty Guidelines issued pursuant
to 42 U.S.C. 9902(2). ``Low-income family'' also includes members of
families whose annual family income exceeds this amount, but who, as
determined by the project director, are unable, for good reasons, to pay
for family planning services. For example, unemancipated minors who wish
to receive services on a confidential basis must be considered on the
basis of their own resources.
Nonprofit, as applied to any private agency, institution, or
organization, means that no part of the entity's net earnings benefit,
or may lawfully benefit, any private shareholder or individual.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human Services
to whom the authority involved has been delegated.
State includes, in addition to the several States, the District of
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana
Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlying
Islands (Midway, Wake, et al.), the Marshall Islands, the Federated
State of Micronesia and the Republic of Palau.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, 2000]
Sec. 59.3 Who is eligible to apply for a family planning services
grant?
Any public or nonprofit private entity in a State may apply for a
grant under this subpart.
Sec. 59.4 How does one apply for a family planning services grant?
(a) Application for a grant under this subpart shall be made on an
authorized form.
(b) An individual authorized to act for the applicant and to assume
on behalf of the applicant the obligations imposed by the terms and
conditions of the grant, including the regulations of this subpart, must
sign the application.
(c) The application shall contain--
(1) A description, satisfactory to the Secretary, of the project and
how it will meet the requirements of this subpart;
(2) A budget and justification of the amount of grant funds
requested;
(3) A description of the standards and qualifications which will be
required for all personnel and for all facilities to be used by the
project; and
(4) Such other pertinent information as the Secretary may require.
Sec. 59.5 What requirements must be met by a family planning project?
(a) Each project supported under this part must:
(1) Provide a broad range of acceptable and effective medically
approved family planning methods (including natural family planning
methods) and services (including infertility services and services for
adolescents). If an organization offers only a single method of family
planning, it may participate as part of a project as long as the entire
project offers a broad range of family planning services.
(2) Provide services without subjecting individuals to any coercion
to accept services or to employ or not to employ any particular methods
of family planning. Acceptance of services must be solely on a voluntary
basis and
[[Page 409]]
may not be made a prerequisite to eligibility for, or receipt of, any
other services, assistance from or participation in any other program of
the applicant.\1\
---------------------------------------------------------------------------
\1\ Section 205 of Pub. L. 94-63 states: ``Any (1) officer or
employee of the United States, (2) officer or employee of any State,
political subdivision of a State, or any other entity, which administers
or supervises the administration of any program receiving Federal
financial assistance, or (3) person who receives, under any program
receiving Federal assistance, compensation for services, who coerces or
endeavors to coerce any person to undergo an abortion or sterilization
procedure by threatening such person with the loss of, or
disqualification for the receipt of, any benefit or service under a
program receiving Federal financial assistance shall be fined not more
than $1,000 or imprisoned for not more than one year, or both.''
---------------------------------------------------------------------------
(3) Provide services in a manner which protects the dignity of the
individual.
(4) Provide services without regard to religion, race, color,
national origin, handicapping condition, age, sex, number of
pregnancies, or marital status.
(5) Not provide abortion as a method of family planning. A project
must:
(i) Offer pregnant women the opportunity to be provided information
and counseling regarding each of the following options:
(A) Prenatal care and delivery;
(B) Infant care, foster care, or adoption; and
(C) Pregnancy termination.
(ii) If requested to provide such information and counseling,
provide neutral, factual information and nondirective counseling on each
of the options, and referral upon request, except with respect to any
option(s) about which the pregnant woman indicates she does not wish to
receive such information and counseling.
(6) Provide that priority in the provision of services will be given
to persons from low-income families.
(7) Provide that no charge will be made for services provided to any
persons from a low-income family except to the extent that payment will
be made by a third party (including a government agency) which is
authorized to or is under legal obligation to pay this charge.
(8) Provide that charges will be made for services to persons other
than those from low-income families in accordance with a schedule of
discounts based on ability to pay, except that charges to persons from
families whose annual income exceeds 250 percent of the levels set forth
in the most recent Poverty Guidelines issued pursuant to 42 U.S.C.
9902(2) will be made in accordance with a schedule of fees designed to
recover the reasonable cost of providing services.
(9) If a third party (including a Government agency) is authorized
or legally obligated to pay for services, all reasonable efforts must be
made to obtain the third-party payment without application of any
discounts. Where the cost of services is to be reimbursed under title
XIX, XX, or XXI of the Social Security Act, a written agreement with the
title XIX, XX or XXI agency is required.
(10)(i) Provide that if an application relates to consolidation of
service areas or health resources or would otherwise affect the
operations of local or regional entities, the applicant must document
that these entities have been given, to the maximum feasible extent, an
opportunity to participate in the development of the application. Local
and regional entities include existing or potential subgrantees which
have previously provided or propose to provide family planning services
to the area proposed to be served by the applicant.
(ii) Provide an opportunity for maximum participation by existing or
potential subgrantees in the ongoing policy decisionmaking of the
project.
(11) Provide for an Advisory Committee as required by Sec. 59.6.
(b) In addition to the requirements of paragraph (a) of this
section, each project must meet each of the following requirements
unless the Secretary determines that the project has established good
cause for its omission. Each project must:
(1) Provide for medical services related to family planning
(including physician's consultation, examination prescription, and
continuing supervision, laboratory examination, contraceptive supplies)
and necessary referral
[[Page 410]]
to other medical facilities when medically indicated, and provide for
the effective usage of contraceptive devices and practices.
(2) Provide for social services related to family planning,
including counseling, referral to and from other social and medical
services agencies, and any ancillary services which may be necessary to
facilitate clinic attendance.
(3) Provide for informational and educational programs designed to--
(i) Achieve community understanding of the objectives of the
program;
(ii) Inform the community of the availability of services; and
(iii) Promote continued participation in the project by persons to
whom family planning services may be beneficial.
(4) Provide for orientation and in-service training for all project
personnel.
(5) Provide services without the imposition of any durational
residency requirement or requirement that the patient be referred by a
physician.
(6) Provide that family planning medical services will be performed
under the direction of a physician with special training or experience
in family planning.
(7) Provide that all services purchased for project participants
will be authorized by the project director or his designee on the
project staff.
(8) Provide for coordination and use of referral arrangements with
other providers of health care services, local health and welfare
departments, hospitals, voluntary agencies, and health services projects
supported by other federal programs.
(9) Provide that if family planning services are provided by
contract or other similar arrangements with actual providers of
services, services will be provided in accordance with a plan which
establishes rates and method of payment for medical care. These payments
must be made under agreements with a schedule of rates and payment
procedures maintained by the grantee. The grantee must be prepared to
substantiate, that these rates are reasonable and necessary.
(10) Provide, to the maximum feasible extent, an opportunity for
participation in the development, implementation, and evaluation of the
project by persons broadly representative of all significant elements of
the population to be served, and by others in the community
knowledgeable about the community's needs for family planning services.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, 2000]
Sec. 59.6 What procedures apply to assure the suitability of
informational and educational material?
(a) A grant under this section may be made only upon assurance
satisfactory to the Secretary that the project shall provide for the
review and approval of informational and educational materials developed
or made available under the project by an Advisory Committee prior to
their distribution, to assure that the materials are suitable for the
population or community to which they are to be made available and the
purposes of title X of the Act. The project shall not disseminate any
such materials which are not approved by the Advisory Committee.
(b) The Advisory Committee referred to in paragraph (a) of this
section shall be established as follows:
(1) Size. The Committee shall consist of no fewer than five but not
more than nine members, except that this provision may be waived by the
Secretary for good cause shown.
(2) Composition. The Committee shall include individuals broadly
representative (in terms of demographic factors such as race, color,
national origin, handicapped condition, sex, and age) of the population
or community for which the materials are intended.
(3) Function. In reviewing materials, the Advisory Committee shall:
(i) Consider the educational and cultural backgrounds of individuals
to whom the materials are addressed;
(ii) Consider the standards of the population or community to be
served with respect to such materials;
(iii) Review the content of the material to assure that the
information is factually correct;
(iv) Determine whether the material is suitable for the population
or community to which is to be made available; and
[[Page 411]]
(v) Establish a written record of its determinations.
Sec. 59.7 What criteria will the Department of Health and Human
Services use to decide which family planning services projects
to fund and in what amount?
(a) Within the limits of funds available for these purposes, the
Secretary may award grants for the establishment and operation of those
projects which will in the Department's judgment best promote the
purposes of section 1001 of the Act, taking into account:
(1) The number of patients, and, in particular, the number of low-
income patients to be served;
(2) The extent to which family planning services are needed locally;
(3) The relative need of the applicant;
(4) The capacity of the applicant to make rapid and effective use of
the federal assistance;
(5) The adequacy of the applicant's facilities and staff;
(6) The relative availability of non-federal resources within the
community to be served and the degree to which those resources are
committed to the project; and
(7) The degree to which the project plan adequately provides for the
requirements set forth in these regulations.
(b) The Secretary shall determine the amount of any award on the
basis of his estimate of the sum necessary for the performance of the
project. No grant may be made for less than 90 percent of the project's
costs, as so estimated, unless the grant is to be made for a project
which was supported, under section 1001, for less than 90 percent of its
costs in fiscal year 1975. In that case, the grant shall not be for less
than the percentage of costs covered by the grant in fiscal year 1975.
(c) No grant may be made for an amount equal to 100 percent for the
project's estimated costs.
Sec. 59.8 How is a grant awarded?
(a) The notice of grant award specifies how long HHS intends to
support the project without requiring the project to recompete for
funds. This period, called the project period, will usually be for three
to five years.
(b) Generally the grant will initially be for one year and
subsequent continuation awards will also be for one year at a time. A
grantee must submit a separate application to have the support continued
for each subsequent year. Decisions regarding continuation awards and
the funding level of such awards will be made after consideration of
such factors as the grantee's progress and management practices, and the
availability of funds. In all cases, continuation awards require a
determination by HHS that continued funding is in the best interest of
the government.
(c) Neither the approval of any application nor the award of any
grant commits or obligates the United States in any way to make any
additional, supplemental, continuation, or other award with respect to
any approved application or portion of an approved application.
Sec. 59.9 For what purpose may grant funds be used?
Any funds granted under this subpart shall be expended solely for
the purpose for which the funds were granted in accordance with the
approved application and budget, the regulations of this subpart, the
terms and conditions of the award, and the applicable cost principles
prescribed in 45 CFR Part 74 or Part 92, as applicable.
Sec. 59.10 What other HHS regulations apply to grants under this
subpart?
Attention is drawn to the following HHS Department-wide regulations
which apply to grants under this subpart. These include:
37 CFR Part 401--Rights to inventions made by nonprofit organizations
and small business firms under government grants, contracts, and
cooperative agreements
42 CFR Part 50, Subpart D--Public Health Service grant appeals procedure
45 CFR Part 16--Procedures of the Departmental Grant Appeals Board
45 CFR Part 74--Uniform administrative requirements for awards and
subawards to institutions of higher education, hospitals, other
nonprofit organizations, and commercial organizations; and certain
grants and agreements with states, local governments and Indian tribal
governments
45 CFR Part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and
[[Page 412]]
Human Services effectuation of Title VI of the Civil Rights Act of 1964
45 CFR Part 81--Practice and procedure for hearings under Part 80 of
this Title
45 CFR Part 84--Nondiscrimination on the basis of handicap in programs
and activities receiving or benefitting from Federal financial
assistance
45 CFR Part 91--Nondiscrimination on the basis of age in HHS programs or
activities receiving Federal financial assistance
45 CFR Part 92--Uniform administrative requirements for grants and
cooperative agreements to state and local governments
Sec. 59.11 Confidentiality.
All information as to personal facts and circumstances obtained by
the project staff about individuals receiving services must be held
confidential and must not be disclosed without the individual's
documented consent, except as may be necessary to provide services to
the patient or as required by law, with appropriate safeguards for
confidentiality. Otherwise, information may be disclosed only in
summary, statistical, or other form which does not identify particular
individuals.
Sec. 59.12 Additional conditions.
The Secretary may, with respect to any grant, impose additional
conditions prior to or at the time of any award, when in the
Department's judgment these conditions are necessary to assure or
protect advancement of the approved program, the interests of public
health, or the proper use of grant funds.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, 2000]
Subpart B [Reserved]
Subpart C--Grants for Family Planning Service Training
Authority: Sec. 6(c), 84 Stat. 1507, 42 U.S.C. 300a-4; sec. 6(c), 84
Stat. 1507, 42 U.S.C. 300a-1.
Source: 37 FR 7093, Apr. 8, 1972, unless otherwise noted.
Sec. 59.201 Applicability.
The regulations in this subpart are applicable to the award of
grants pursuant to section 1003 of the Public Health Service Act (42
U.S.C. 300a-1) to provide the training for personnel to carry out family
planning service programs described in sections 1001 and 1002 of the
Public Health Service Act (42 U.S.C. 300, 300a).
Sec. 59.202 Definitions.
As used in this subpart:
(a) Act means the Public Health Service Act.
(b) State means one of the 50 States, the District of Columbia,
Puerto Rico, Guam, the Virgin Islands, American Samoa, or the Trust
Territory of the Pacific Islands.
(c) Nonprofit private entity means a private entity no part of the
net earnings of which inures, or may lawfully inure, to the benefit of
any private shareholder or individual.
(d) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
(e) Training means job-specific skill development, the purpose of
which is to promote and improve the delivery of family planning
services.
Sec. 59.203 Eligibility.
(a) Eligible applicants. Any public or nonprofit private entity
located in a State is eligible to apply for a grant under this subpart.
(b) Eligible projects. Grants pursuant to section 1003 of the Act
and this subpart may be made to eligible applicants for the purpose of
providing programs, not to exceed three months in duration, for training
family planning or other health services delivery personnel in the
skills, knowledge, and attitudes necessary for the effective delivery of
family planning services: Provided, That the Secretary may in particular
cases approve support of a program whose duration is longer than three
months where he determines (1) that such program is consistent with the
purposes of this subpart and (2) that the program's objectives cannot be
accomplished within three months because of the unusually complex or
specialized nature of the training to be undertaken.
[37 FR 7093, Apr. 8, 1972, as amended at 40 FR 17991, Apr. 24, 1975]
[[Page 413]]
Sec. 59.204 Application for a grant.
(a) An application for a grant under this subpart shall be submitted
to the Secretary at such time and in such form and manner as the
Secretary may prescribe. \1\ The application shall contain a full and
adequate description of the project and of the manner in which the
applicant intends to conduct the project and carry out the requirements
of this subpart, and a budget and justification of the amount of grant
funds requested, and such other pertinent information as the Secretary
may require.
---------------------------------------------------------------------------
\1\ Applications and instructions may be obtained from the Program
Director, Family Planning Services, at the Regional Office of the
Department of Health and Human Services for the region in which the
project is to be conducted, or the Office of Family Planning, Office of
the Assistant Secretary for Health, Washington, DC 20201.
---------------------------------------------------------------------------
(b) The application shall be executed by an individual authorized to
act for the applicant and to assume for the applicant the obligations
imposed by the regulations of this subpart and any additional conditions
of the grant.
(Sec. 6(c), Public Health Service Act, 84 Stat. 1506 and 1507 (42 U.S.C.
300, 300a-1, and 300a-4))
[37 FR 7093, Apr. 8, 1972, as amended at 49 FR 38116, Sept. 27, 1984]
Sec. 59.205 Project requirements.
An approvable application must contain each of the following unless
the Secretary determines that the applicant has established good cause
for its omission:
(a) Assurances that:
(1) No portion of the Federal funds will be used to train personnel
for programs where abortion is a method of family planning.
(2) No portion of the Federal funds will be used to provide
professional training to any student as part of his education in pursuit
of an academic degree.
(3) No project personnel or trainees shall on the grounds of sex,
religion, or creed be excluded from participation in, be denied the
benefits of, or be subjected to discrimination under the project.
(b) Provision of a methodology to assess the particular training
(e.g., skills, attitudes, or knowledge) that prospective trainees in the
area to be served need to improve their delivery of family planning
services.
(c) Provision of a methodology to define the objectives of the
training program in light of the particular needs of trainees defined
pursuant to paragraph (b) of this section.
(d) Provision of a method for development of the training curriculum
and any attendant training materials and resources.
(e) Provision of a method for implementation of the needed training.
(f) Provision of an evaluation methodology, including the manner in
which such methodology will be employed, to measure the achievement of
the objectives of the training program.
(g) Provision of a method and criteria by which trainees will be
selected.
Sec. 59.206 Evaluation and grant award.
(a) Within the limits of funds available for such purpose, the
Secretary may award grants to assist in the establishment and operation
of those projects which will in his judgment best promote the purposes
of section 1003 of the Act, taking into account:
(1) The extent to which a training program will increase the
delivery of services to people, particularly low-income groups, with a
high percentage of unmet need for family planning services;
(2) The extent to which the training program promises to fulfill the
family planning services delivery needs of the area to be served, which
may include, among other things:
(i) Development of a capability within family planning service
projects to provide pre- and in-service training to their own staffs;
(ii) Improvement of the family planning services delivery skills of
family planning and health services personnel;
(iii) Improvement in the utilization and career development of
paraprofessional and paramedical manpower in family planning services;
(iv) Expansion of family planning services, particularly in rural
areas, through new or improved approaches to
[[Page 414]]
program planning and deployment of resources;
(3) The capacity of the applicant to make rapid and effective use of
such assistance;
(4) The administrative and management capability and competence of
the applicant;
(5) The competence of the project staff in relation to the services
to be provided; and
(6) The degree to which the project plan adequately provides for the
requirements set forth in Sec. 59.205.
(b) The amount of any award shall be determined by the Secretary on
the basis of his estimate of the sum necessary for all or a designated
portion of direct project costs plus an additional amount for indirect
costs, if any, which will be calculated by the Secretary either: (1) On
the basis of his estimate of the actual indirect costs reasonably
related to the project, or (2) on the basis of a percentage of all, or a
portion of, the estimated direct costs of the project when there are
reasonable assurances that the use of such percentage will not exceed
the approximate actual indirect costs. Such award may include an
estimated provisional amount for indirect costs or for designated direct
costs (such as travel or supply costs) subject to upward (within the
limits of available funds) as well as downward adjustments to actual
costs when the amount properly expended by the grantee for provisional
items has been determined by the Secretary.
(c) Allowability of costs shall be in conformance with the
applicable cost principles prescribed by Subpart Q of 35 CFR part 74.
(d) All grant awards shall be in writing, shall set forth the amount
of funds granted and the period for which support is recommended.
(e) Neither the approval of any project nor any grant award shall
commit or obligate the United States in any way to make any additional,
supplemental, continuation, or other award with respect to any approved
project or portion thereof. For continuation support, grantees must make
separate application annually at such times and in such form as the
Secretary may direct.
[37 FR 7093, Apr. 8, 1972, as amended at 38 FR 26199, Sept. 19, 1973]
Sec. 59.207 Payments.
The Secretary shall from time to time make payments to a grantee of
all or a portion of any grant award, either in advance or by way of
reimbursement for expenses incurred or to be incurred in the performance
of the project to the extent he determines such payments necessary to
promote prompt initiation and advancement of the approved project.
Sec. 59.208 Use of project funds.
(a) Any funds granted pursuant to this subpart as well as other
funds to be used in performance of the approved project shall be
expended solely for carrying out the approved project in accordance with
the statute, the regulations of this subpart, the terms and conditions
of the award, and, except as may otherwise be provided in this subpart,
the applicable cost principles prescribed by subpart Q of 45 CFR part
74.
(b) Prior approval by the Secretary of revision of the budget and
project plan is required whenever there is to be a significant change in
the scope or nature of project activities.
(c) The Secretary may approve the payment of grant funds to trainees
for:
(1) Return travel to the trainee's point of origin.
(2) Per diem during the training program, and during travel to and
from the program, at the prevailing institutional or governmental rate,
whichever is lower.
[37 FR 7093, Apr. 8, 1972, as amended at 38 FR 26199, Sept. 19, 1973]
Sec. 59.209 Civil rights.
Attention is called to the requirements of Title VI of the Civil
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in
particular section 601 of such Act which provides that no person in the
United States shall, on the grounds of race, color, or national origin
be excluded from participation in, be denied the benefits of, or be
subjected to discrimination under any program or activity receiving
Federal financial assistance. A regulation impelmenting such title VI,
which applies to grants made under this part, has been issued by the
Secretary of Health and Human Services with the
[[Page 415]]
approval of the President (45 CFR part 80).
Sec. 59.210 Inventions or discoveries.
Any grant award pursuant to Sec. 59.206 is subject to the
regulations of the Department of Health and Human Services as set forth
in 45 CFR parts 6 and 8, as amended. Such regulations shall apply to any
activity for which grant funds are in fact used whether within the scope
of the project as approved or otherwise. Appropriate measures shall be
taken by the grantee and by the Secretary to assure that no contracts,
assignments or other arrangements inconsistent with the grant obligation
are continued or entered into and that all personnel involved in the
supported activity are aware of and comply with such obligations.
Laboratory notes, related technical data, and information pertaining to
inventions and discoveries shall be maintained for such periods, and
filed with or otherwise made available to the Secretary, or those he may
designate at such times and in such manner, as he may determine
necessary to carry out such Department regulations.
Sec. 59.211 Publications and copyright.
Except as may otherwise be provided under the terms and conditions
of the award, the grantee may copyright without prior approval any
publications, films or similar materials developed or resulting from a
project supported by a grant under this part, subject, however, to a
royalty-free, nonexclusive, and irrevocable license or right in the
Government to reproduce, translate, publish, use, disseminate, and
dispose of such materials and to authorize others to do so.
Sec. 59.212 Grantee accountability.
(a) Accounting for grant award payments. All payments made by the
Secretary shall be recorded by the grantee in accounting records
separate from the records of all other grant funds, including funds
derived from other grant awards. With respect to each approved project
the grantee shall account for the sum total of all amounts paid by
presenting or otherwise making available evidence satisfactory to the
Secretary of expenditures for direct and indirect costs meeting the
requirements of this part: Provided, however, That when the amount
awarded for indirect costs was based on a predetermined fixed-percentage
of estimated direct costs, the amount allowed for indirect costs shall
be computed on the basis of such predetermined fixed-percentage rates
applied to the total, or a selected element thereof, of the reimbursable
direct costs incurred.
(b) [Reserved]
(c) Accounting for grant-related income--(1) Interest. Pursuant to
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C.
4213), a State will not be held accountable for interest earned on grant
funds, pending their disbursement for grant purposes. A State, as
defined in section 102 of the Intergovernmental Cooperation Act, means
any one of the several States, the District of Columbia, Puerto Rico,
any territory or possession of the United States, or any agency or
instrumentality of a State, but does not include the governments of the
political subdivisions of the State. All grantees other than a State, as
defined in this subsection, must return all interest earned on grant
funds to the Federal Government.
(d) Grant closeout--(1) Date of final accounting. A grantee shall
render, with respect to each approved project, a full account, as
provided herein, as of the date of the termination of grant support. The
Secretary may require other special and periodic accounting.
(2) Final settlement. There shall be payable to the Federal
Government as final settlement with respect to each approved project the
total sum of:
(i) Any amount not accounted for pursuant to paragraph (a) of this
section;
(ii) Any credits for earned interest pursuant to paragraph (c)(1) of
this section;
(iii) Any other amounts due pursuant to subparts F, M, and O of 45
CFR part 74.
Such total sum shall constitute a debt owed by the grantee to the
Federal Government and shall be recovered from the grantee or its
successors or
[[Page 416]]
assignees by setoff or other action as provided by law.
[36 FR 18465, Sept. 15, 1971, as amended at 38 FR 26199, Sept. 19, 1973]
Sec. 59.213 [Reserved]
Sec. 59.214 Additional conditions.
The Secretary may with respect to any grant award impose additional
conditions prior to or at the time of any award when in his judgment
such conditions are necessary to assure or protect advancement of the
approved project, the interests of public health, or the conservation of
grant funds.
Sec. 59.215 Applicability of 45 CFR part 74.
The provisions of 45 CFR part 74, establishing uniform
administrative requirements and cost principles, shall apply to all
grants under this subpart to State and local governments as those terms
are defined in subpart A of that part 74. The relevant provisions of the
following subparts of part 74 shall also apply to grants to all other
grantee organizations under this subpart.
45 CFR Part 74
Subpart:
A General.
B Cash Depositories.
C Bonding and Insurance.
D Retention and Custodial Requirements for Records.
F Grant-Related Income.
G Matching and Cost Sharing.
K Grant Payment Requirements.
L Budget Revision Procedures.
M Grant Closeout, Suspension, and Termination.
O Property.
Q Cost Principles.
[38 FR 26199, Sept. 19, 1973]
[Code of Federal Regulations]
[Title 42, Volume 1, Parts 1 to 399]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50]
[Page 171-176]
TITLE 42--PUBLIC HEALTH
CHAPTER I--PUBLIC HEALTH SERVICE,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 50--POLICIES OF GENERAL APPLICABILITY--Table of Contents
Subpart B--Sterilization of Persons in Federally Assisted Family Planning Projects
Sec. 50.201 Applicability.
The provisions of this subpart are applicable to programs or
projects for health services which are supported in whole or in part by
Federal financial assistance, whether by grant or contract, administered
by the Public Health Service.
Sec. 50.202 Definitions.
As used in this subpart:
Arrange for means to make arrangements (other than mere referral of
an individual to, or the mere making of an appointment for him or her
with, another health care provider) for the performance of a medical
procedure on an individual by a health care provider other than the
program or project.
Hysterectomy means a medical procedure or operation for the purpose
of removing the uterus.
Institutionalized individual means an individual who is (1)
involuntarily confined or detained, under a civil or criminal statute,
in a correctional or rehabilitative facility, including a mental
hospital or other facility for the care and treatment of mental illness,
or (2) confined, under a voluntary commitment, in a mental hospital or
other facility for the care and treatment of mental illness.
Mentally incompetent individual means an individual who has been
declared mentally incompetent by a Federal, State, or local court of
competent jurisdiction for any purpose unless he or she has been
declared competent for
[[Page 172]]
purposes which include the ability to consent to sterilization.
Public Health Service means the Office of the Assistant Secretary
for Health, Health Resources and Services Administration, National
Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse
and Mental Health Administration and all of their constituent agencies.
The Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
Sterilization means any medical procedure, treatment, or operation
for the purpose of rendering an individual permanently incapable of
reproducing.
[43 FR 52165, Nov. 8, 1978, as amended at 49 FR 38109, Sept. 27, 1984]
Sec. 50.203 Sterilization of a mentally competent individual aged 21 or
older.
Programs or projects to which this subpart applies shall perform or
arrange for the performance of sterilization of an individual only if
the following requirements have been met:
(a) The individual is at least 21 years old at the time consent is
obtained.
(b) The individual is not a mentally incompetent individual.
(c) The individual has voluntarily given his or her informed consent
in accordance with the procedures of Sec. 50.204 of this subpart.
(d) At least 30 days but not more than 180 days have passed between
the date of informed consent and the date of the sterilization, except
in the case of premature delivery or emergency abdominal surgery. An
individual may consent to be sterilized at the time of premature
delivery or emergency abdominal surgery, if at least 72 hours have
passed after he or she gave informed consent to sterilization. In the
case of premature delivery, the informed consent must have been given at
least 30 days before the expected date of delivery.
Sec. 50.204 Informed consent requirement.
Informed consent does not exist unless a consent form is completed
voluntarily and in accordance with all the requirements of this section
and Sec. 50.205 of this subpart.
(a) A person who obtains informed consent for a sterilization
procedure must offer to answer any questions the individual to be
sterilized may have concerning the procedure, provide a copy of the
consent form, and provide orally all of the following information or
advice to the individual who is to be sterilized:
(1) Advice that the individual is free to withhold or withdraw
consent to the procedure any time before the sterilization without
affecting his or her right to future care or treatment and without loss
or withdrawal of any federally funded program benefits to which the
individual might be otherwise entitled:
(2) A description of available alternative methods of family
planning and birth control;
(3) Advice that the sterilization procedure is considered to be
irreversible;
(4) A thorough explanation of the specific sterilization procedure
to be performed;
(5) A full description of the discomforts and risks that may
accompany or follow the performing of the procedure, including an
explanation of the type and possible effects of any anesthetic to be
used;
(6) A full description of the benefits or advantages that may be
expected as a result of the sterilization; and
(7) Advice that the sterilization will not be performed for at least
30 days except under the circumstances specified in Sec. 50.203(d) of
this subpart.
(b) An interpreter must be provided to assist the individual to be
sterilized if he or she does not understand the language used on the
consent form or the language used by the person obtaining the consent.
(c) Suitable arrangements must be made to insure that the
information specified in paragraph (a) of this section is effectively
communicated to any individual to be sterilized who is blind, deaf or
otherwise handicapped.
(d) A witness chosen by the individual to be sterilized may be
present when consent is obtained.
[[Page 173]]
(e) Informed consent may not be obtained while the individual to be
sterilized is:
(1) In labor or childbirth;
(2) Seeking to obtain or obtaining an abortion; or
(3) Under the influence of alcohol or other substances that affect
the individual's state of awareness.
(f) Any requirement of State and local law for obtaining consent,
except one of spousal consent, must be followed.
Sec. 50.205 Consent form requirements.
(a) Required consent form. The consent form appended to this subpart
or another consent form approved by the Secretary must be used.
(b) Required signatures. The consent form must be signed and dated
by:
(1) The individual to be sterilized; and
(2) The interpreter, if one is provided; and
(3) The person who obtains the consent; and
(4) The physician who will perform the sterilization procedure.
(c) Required certifications. (1) The person obtaining the consent
must certify by signing the consent form that:
(i) Before the individual to be sterilized signed the consent form,
he or she advised the individual to be sterilized that no Federal
benefits may be withdrawn because of the decision not to be sterilized,
(ii) He or she explained orally the requirements for informed
consent as set forth on the consent form, and
(iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized.
(2) The physician performing the sterilization must certify by
signing the consent form, that:
(i) Shortly before the performance of the sterilization, he or she
advised the individual to be sterilized that no Federal benefits may be
withdrawn because of the decision not to be sterilized,
(ii) He or she explained orally the requirements for informed
consent as set forth on the consent form, and
(iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized. Except in the case of premature
delivery or emergency abdominal surgery, the physician must further
certify that at least 30 days have passed between the date of the
individual's signature on the consent form and the date upon which the
sterilization was performed. If premature delivery occurs or emergency
abdominal surgery is required within the 30-day period, the physician
must certify that the sterilization was performed less than 30 days but
not less than 72 hours after the date of the individual's signature on
the consent form because of premature delivery or emergency abdominal
surgery, as applicable. In the case of premature delivery, the physician
must also state the expected date of delivery. In the case of emergency
abdominal surgery, the physician must describe the emergency.
(3) If an interpreter is provided, the interpreter must certify that
he or she translated the information and advice presented orally, read
the consent form and explained its contents and to the best of the
interpreter's knowledge and belief, the individual to be sterilized
understood what the interpreter told him or her.
Sec. 50.206 Sterilization of a mentally incompetent individual or of an
institutionalized individual.
Programs or projects to which this subpart applies shall not perform
or arrange for the performance of a sterilization of any mentally
incompetent individual or institutionalized individual.
Sec. 50.207 Sterilization by hysterectomy.
(a) Programs or projects to which this subpart applies shall not
perform or arrange for the performance of any hysterectomy solely for
the purpose of rendering an individual permanently incapable of
reproducing or where, if there is more than one purpose to the
procedure, the hysterectomy would not be performed but for the purpose
of rendering the individual permanently incapable of reproducing.
[[Page 174]]
(b) Except as provided in paragraph (c) of this section, programs or
projects to which this subpart applies may perform or arrange for the
performance of a hysterectomy not covered by paragraph (a) of this
section only if:
(1) The person who secures the authorization to perform the
hysterectomy has informed the individual and her representative, if any,
orally and in writing, that the hysterectomy will make her permanently
incapable of reproducing; and
(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 required 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 a 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]
Sec. 50.208 Program or project requirements.
(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.
Sec. 50.209 Use of Federal financial assistance.
(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.
(b) A program or project shall not use Federal financial assistance
for any sterilization or hysterectomy without first receiving
documentation showing that the requirements of this subpart have been
met. Documentation includes consent forms, and as applicable, either
acknowledgments of receipt of hysterectomy information or certification
of an exception for hysterectomies.
[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]
Sec. 50.210 Review of regulation.
The Secretary will request public comment on the operation of the
provisions of this subpart not later than 3 years after their effective
date.
Appendix to Subpart B of Part 50--Required Consent Form
Notice: YOUR DECISION AT ANY TIME NOT TO BE STERILIZED WILL NOT
RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED BY
PROGRAMS OR PROJECTS RECEIVING FEDERAL FUNDS.
Consent to Sterilization
I have asked for and received information about sterilization from
______________ (doctor or clinic). When I first asked for the
information, I was told that the decision to be sterilized is completely
up to me. I was told that I could decide not to be sterilized. If I
decide not to be sterilized, my decision will not affect my right to
future care or treatment. I will not lose any help or benefits from
programs receiving Federal funds, such as A.F.D.C. or medicaid that I am
now getting or for which I may become eligible.
I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND
NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME PREGNANT,
BEAR CHILDREN OR FATHER CHILDREN.
[[Page 175]]
I was told about those temporary methods of birth control that are
available and could be provided to me which will allow me to bear or
father a child in the future. I have rejected these alternatives and
chosen to be sterilized.
I understand that I will be sterilized by an operation known as a
______________. The discomforts, risks and benefits associated with the
operation have been explained to me. All my questions have been answered
to my satisfaction.
I understand that the operation will not be done until at least 30
days after I sign this form. I understand that I can change my mind at
any time and that my decision at any time not to be sterilized will not
result in the withholding of any benefits or medical services provided
by federally funded programs.
I am at least 21 years of age and was born on ____ (day), ____
(month), ____ (year).
I, ______________, hereby consent of my own free will to be
sterilized by ______________ by a method called ______________. My
consent expires 180 days from the date of my signature below.
I also consent to the release of this form and other medical records
about the operation to:
Representatives of the Department of Health and Human Services or
Employees of programs or projects funded by that Department but only
for determining if Federal laws were observed.
I have received a copy of this form.
Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)
You are requested to supply the following information, but it is not
required:
Race and ethnicity designation (please check)
Black (not of Hispanic origin)__________________________________________
Hispanic________________________________________________________________
Asian or Pacific Islander_______________________________________________
American Indian or Alaskan native_______________________________________
White (not of Hispanic origin)__________________________________________
Interpreter's Statement
If an interpreter is provided to assist the individual to be
sterilized:
I have translated the information and advice presented orally to the
individual to be sterilized by the person obtaining this consent. I have
also read him/her the consent form in ______________ language and
explained its contents to him/her. To the best of my knowledge and
belief he/she understood this explanation.
Interpreter_____________________________________________________________
Date____________________________________________________________________
State of Person Obtaining Consent
Before ______________ (name of individual), signed the consent form,
I explained to him/her the nature of the sterilization operation
______________, the fact that it is intended to be a final and
irreversible procedure and the discomforts, risks and benefits
associated with it.
I counseled the individual to be sterilized that alternative methods
of birth control are available which are temporary. I explained that
sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can
be withdrawn at any time and that he/she will not lose any health
services or any benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appears to
understand the nature and consequence of the procedure.
Signature of person obtaining consent___________________________________
Date____________________________________________________________________
Facility________________________________________________________________
Address_________________________________________________________________
Physician's Statement
Shortly before I performed a sterilization operation upon
______________ (name of individual to be sterilized), on __________
(date of sterilization), ______________ (operation), I explained to him/
her the nature of the sterilization operation ______________ (specify
type of operation), the fact that it is intended to be a final and
irreversible procedure and the discomforts, risks and benefits
associated with it.
I counseled the individual to be sterilized that alternative methods
of birth control are available which are temporary. I explained that
sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can
be withdrawn at any time and that he/she will not lose any health
services or benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appeared to
understand the nature and consequences of the procedure.
(Instructions for use of alternative final paragraphs: Use the first
paragraph below except in the case of premature delivery or emergency
abdominal surgery where the sterilization is performed less than 30 days
after the date of the individual's signature on the consent form. In
those cases, the second paragraph below must be used. Cross out the
paragraph which is not used.)
[[Page 176]]
(1) At least 30 days have passed between the date of the
individual's signature on this consent form and the date the
sterilization was performed.
(2) This sterilization was performed less than 30 days but more than
72 hours after the date of the individual's signature on this consent
form because of the following circumstances (check applicable box and
fill in information requested):
{time} Premature delivery
Individual's expected date of delivery:_________________________________
{time} Emergency abdominal surgery:
(Describe circumstances):_______________________________________________
Physician_______________________________________________________________
Date____________________________________________________________________
[43 FR 52165, Nov. 8, 1978, as amended at 58 FR 33343, June 17, 1993]
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