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
Table of Contents
- 1.0 Introduction to the Program Guidelines
- 1.1 Definitions
- 2.0 The Law, Regulations, and Guidelines
- 3.0 The Application Process
- 3.1 Eligibility
- 3.2 Needs Assessment
- 3.3 The Application
- 3.4 Project Requirements
- 3.5 Notice of Grant Award
- 4.0 Grant Administration
- 5.0 Legal Issues
- 5.1 Voluntary Participation
- 5.2 Confidentiality
- 5.3 Conflict of Interest
- 5.4 Liability Coverage
- 5.5 Human Subjects Clearance (Research)
- 6.0 Project Management
- 6.1 Structure of the Grantee
- 6.2 Planning and Evaluation
- 6.3 Financial Management
- 6.4 Facilities and Accessibility of Services
- 6.5 Personnel
- 6.6 Training and Technical Assistance
- 6.7 Reporting Requirements
- 6.8 Review and Approval of InformationalEducational Materials
- 6.9 Community Participation, Education, and Project Promotion
- 6.10 Publications and Copyright
- 6.11 Inventories or Discoveries
- 7.0 Client Services
- 7.1 Service Plans and Protocols
- 7.2 Procedural Outline
- 7.3 Emergencies
- 7.4 Referrals and Follow-Up
- 8.0 Required Services
- 8.1 Client Education
- 8.2 Counseling
- 8.3 History, Physical Assessment, And Laboratory Testing
- 8.4 Fertility Regulation
- 8.5 Infertility Services
- 8.6 Pregnancy Diagnosis and Counseling
- 8.7 Adolescent Services
- 8.8 Identification of Estrogen-Exposed Offspring
- 9.0 Related Services
- 9.1 Gynecologist Services
- 9.2 Sexuality Transmitted Diseases (STD) and HIV/AIDS
- 9.3 Special Counseling
- 9.4 Genetic Information and Referral
- 9.5 Health Promotion/Disease Prevention
- 9.6 Postpartum Care
- 10.0 Clinic Management
- 10.1 Equipment and Supplies
- 10.2 Pharmaceuticals
- 10.3 Medical Records
- 10.4 Quality Assurance and Audit
- 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
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.
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
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.
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:
- 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.
- 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.
- 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.
- Individual eligibility for a discount must be documented in the client's financial record.
- Bills to third parties must show total charges without applying any discount.
- 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.
- Bills to clients must show total charges less any allowable discounts.
- Eligibility for discounts for minors who receive confidential services must be based on the income of the minor.
- Reasonable efforts to collect charges without jeopardizing client confidentiality must be made.
- A method for the "aging" of outstanding accounts must be established.
- 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.
- 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.
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.
6.5 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
- 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.
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:
- Presentation of relevant information and educational materials, based upon client needs and knowledge;
- Interactive process in which a client is assisted in making an informed choice;
- Explanation of all procedures and obtaining a general consent covering examination and treatment and, where applicable, a method specific informed consent form;
- Obtaining of a personal and family medical and social history;
- Performance of a physical examination and any necessary clinical procedures, as indicated;
- 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:
- Updating a personal and family medical and social history;
- Performance of a physical examination and any necessary clinical procedures, as indicated;
- 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.
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).
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 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
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;
- 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
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;
- 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.
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
- 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.
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
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.
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.
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 aclinical 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;
- 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