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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results Appendix D Program Guidelines for Project Grants for Family Planning Services
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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)].
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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].
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results ! 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
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results ! 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
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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:
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results 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.
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