Program Guidelines for Project Grants for Family Planning Services

United 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,
nonjudgmental, 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.