TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates: Clinic Site(s): Monitoring Staff:

CLINICAL SERVICES: The delegate agency provides family planning services to clients that are consistent with Title X regulations and with nationally recognized standards of care. MCH Nurse Consultants may review the following documents and medical records, interview staff, and direct observation of provision of clinic services to aid in compliance monitoring.

Policies/Procedures/Protocols IV. Medical Record Selection- Agency randomly selects 20 records for review II. Family planning clinical/medical standing orders, A. Income Levels policies, protocols, standards and procedures 1. Six (6) records must be for adolescent clients <18 yrs old III. Medical record charting forms (such as consent 2. Four (4) records must be for clients <100% of FPL, forms, medical history forms, etc.) and written policies for accepted medical record documentation 3. Four (4) records must be for clients 101 – 249% of FPL A. Information related to the medical oversight of the 4. Four (4) records must be for clients >250% of FPL program including midlevel provider agreements B. Type of Records (include lab results, CVR, client’s bill, 3rd party bill) IV. Written emergency procedures VIII. Initial comprehensive visit patients (3 records) V. Referral agreements and lists of referral agencies/organizations and physicians 1. Annual comprehensive visit patients (3 records) VI. Written policies for the use of interpreters 2. Pregnancy Tests/Positive & Negative (2 records – 1 each) VII. Educational material routinely given to clients 3. Emergency Contraception (1 record) B. Quality assurance and monitoring processes, 4. RN Visit (1 record) procedures, schedules and reports 5. Male Family Planning (2 records) II. Observation of Clinic Services & Pharmaceuticals 6. Problem Visit: 1. Direct observation client visit from intake to exit  Abnormal Pap/completion of testing/follow-up in prior year (2 records) 2. Examination of client record, bill and CVR  Method Problems (2 records) 3. Examination of pharmaceuticals & inventory  Vaginal Discharge (2 record) III. Delegate agency’s service plan & work plans  STI Testing (2 record)

The Clinical Services Review is based on the following Title X and other Federal grant requirements:  Title X Legislation and Title X Implementing Regulations, 42 CFR Part 59  Title X Program Guidelines for Family Planning Project Grants for Family Planning Services, 2001  OPA Program Instructions: 06-01; 05-01; 03-01;99-1; 98-1

SFY2012 FPP Clinical Services Review Tool 1 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates:

M Not I. Client Services References and Instructions Met Title X Statute Section 1001; Title X Comments / Required Action 1. Clinic meets the following criteria for a Title X delegate Guidelines: Sections 2.0, 6.5, 7.0 and agency: 8.7; 42 CFR 59.5 - (a)(1), (b)(2) and (b) (6).

a) Clinic provides clinical, informational, educational, Medical director is a physician holding a social and referral services relating to family current license to practice in Illinois with planning. training or experience in family planning and evidence of ongoing continuing b) Clinic care component operates under the education relevant to reproductive responsibility of a physician with experience or health. special training in family planning. Check current delegate agency services c) Clinic offers a broad range of acceptable/effective against the “Services Provided FDA approved methods onsite or by referral. Checklist” submitted annually by the (1) This must include natural family planning delegate agency. method. Check availability of emergency (2) Clinic provides family planning services to contraception: criteria for provision for adolescents. established and non-established client and ensure non-established client is established at ECP encounter – problem visit/initial visit status. No lower age cut-off allowed in Title X. Staff must query adolescent clients regarding the need for confidential services.

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M Not B. Service Plan and Protocol References and Instructions Met Comments / Required Action 1. Delegate agency’s service plan has been Title X Guidelines: Sections 6.5, 7.1 and successfully implemented. 10.4; Advanced Practice Nursing Act. a) Delegate agency provided the full range of The delegate agency’s service plan services as outlined in the service plan. outlines the clinical services provided at (1) If the delegate agency has an exemption for Title X clinics. Each service plan MUST providing a particular service please note in provide services stipulated in law or the comments section and verify IDHS FPP regulations and MAY include other approval and the duration of the waiver. services that promote reproductive health. Compare the available services b) Written clinical protocols are in place at each to the approved Services Provided service delivery site and are consistent with Title Checklist submitted by the Delegate X guidelines and nationally recognized standards Agency. for medical care. There are currently no clinical waivers. (1) Service site clinical protocols and plans for education are signed off by the site Medical Concerns about clinical protocols and Director and approved by IDHS FPP. education plans: request corrective action and provide a copy of the (2) Clinical protocols and plans are reviewed and problematic documents with the clinical updated annually. services review report. (3) Standing orders are current, reviewed, A front-page signature indicating updated and approved annually by the annual review of the policy manual medical director. contents is acceptable; however, the (4) The advanced practice nurse or physician contents must reflect appropriate assistant to physician relationship is updates. formalized. If standing orders are not current the agency must rectify the situation before the review is completed.

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M Not C. Procedural Outline References and Instructions Met 1. The following services are offered at the initial Comments / Required Action comprehensive visit and properly documented in the Title X Guidelines: Section 7.2 clients’ charts: a) Education. Observation of full initial client b) Counseling. encounter from intake process through exit conference. c) Informed consent. d) History. e) Examination. f) Laboratory testing. g) Follow up and referrals.

1. The following components, appropriate to the purpose of the visit, must be offered and documented Comments / Required Action Title X Guidelines: Section 7.2 on all clients’ charts: a) The following must be documented on all return Observation of various encounter types visits: from intake process through exit (1) History update. conference. (2) Examination: full or focused (3) Laboratory testing. (4) Follow-up and referrals. b) Client return visits (excluding routine supply visits) include as assessment of the client’s health status, current complaints, evaluation of contraceptive method and an opportunity to change methods.

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M Not D. Emergencies References and Instructions Met Comments / Required Action 1. Written protocols for medical emergencies are Title X Guidelines: Section 7.3 current and include the following situations:

a) Vaso-vagal reactions / Syncope (fainting). Emergency medications are readily a) Anaphylaxis (severe allergic reactions). available for use in the exam rooms. b) Cardiac arrest / Respiratory difficulties. c) Shock / Hemorrhage (uncontrolled bleeding). Check emergency kit maintenance d) Emergencies requiring EMS transport. Policy/Protocol and content list - identify e) After hours emergencies and management of frequency of content check for contraceptive emergencies. expiration dates, staff responsible and how documented.

2. Staff is prepared to manage clinic based Comments / Required Action Title X Guidelines: Section 7.3 emergencies IX. Staff members know their roles during an emergency. Interview staff X. Training for emergencies (including CPR) is available to staff.

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M Not E. Referrals and Follow-Up References and Instructions Met Comments / Required Action 1. Delegate agency has formal agreements with Title X Guidelines: Sections 7.4 and 8.0; referral agencies where necessary. 42 CFR 59.5(b)(8)

a) Agreements are necessary when: Agreements are necessary when (1) Required clinical services are provided clinical services are provided by referral by the referral agency. Agreements with agency, for example IUS/IUD. referral agencies include: (i) Description of the services provided. (ii) Cost reimbursement information. 2. Written policies/procedures are in place for follow- Title X Guidelines: Sections 7.4; 42 up on referrals made for abnormal findings. CFR 59.5(b)(8) Comments / Required Action Check Policy/Protocol/ Interview supervisory and direct service staff a) Follow-up policy is sensitive to client’s Identify tracking/follow-up Protocol concern for confidentiality and privacy. methods, responsible staff and required medical record documentation

1. Referrals for care beyond the scope of the project Title X Guidelines: Sections 7.4; 42 Comments / Required Action (e.g., non-family planning, emergency care, etc.) are CFR 59.5(b)(8) made consistent with Title X guidelines. a) Proper arrangements are made to provide Observation of various client encounter pertinent client information to the referral types. provider, with appropriate safeguards for confidentiality. b) Client's consent was obtained for referral arrangements (except as required by law). c) Documentation that client was advised of referral and counseled on their responsibility to comply with referral. Title X Guidelines: Sections 7.4; 42 Comments / Required Action 4. Delegate agency maintains a current referral list. CFR 59.5(b)(8) B. Referral list includes health care providers, Annual review and updating of service local DHS programs, local health departments, area resource list is required. hospitals, voluntary agencies, health services projects, and other Federal programs.

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M Not F. Required Services References and Instructions Met Comments / Required Action 1. Delegate agency provides consent forms Title X Guidelines: Sections 8.0 and 8.1 consistent with Title X requirements. XI. Written, informed, voluntary consent is obtained prior Language appropriate consent forms to services. must be written in a language b) Informed contraceptive method specific understood by the client or translated consent is appropriately obtained meaning: and witnessed by an interpreter. (1) If the client chooses a prescription method of contraception, a method-specific consent Check Policy/Protocol on translation form is obtained and updated with any services. change in prescriptive contraceptive methods. (2) Method consent forms are approved by the delegate agency medical director. (3) Method specific consent is updated when there is a major change in client’s health status. (4) Consent form is language appropriate. (5) Clients are provided information on: Observation of individual (a) Contraception benefits and risk. education/counseling session and (b) Effectiveness. review of handout materials with client. (c) Potential side effects. (d) Complications. (e) Discontinuation issues. (f) Danger signs of method chosen. c) All consent forms contain a statement that the client has been counseled and provided appropriate informational material and understands the content of both. d) Signed informed consent forms are maintained in the client’s medical record. e) Client has right to revoke written consent.

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M Not G. Client Education References and Instructions Met

1. Written plan for client education is current and Comments / Required Action consistent with Title X requirements. Title X Guidelines: Sections 7.1 and 8.1 An acceptable plan has: XII. Goals and content outlined to ensure consistency and Review policies, procedures and accuracy of information provided by staff and in educational materials. educational materials. If the delegate uses checklists to b) Signature approval of delegate Medical document required education Director components (such as family c) Client education requires: involvement, confidentiality, avoiding (1) Proper documentation of education in the sexual coercion) a detailed written chart. protocol for what is included in that (2) Presentation of education in an unbiased education should be reviewed. manner. Observation of client education (3) Presentation of education appropriate for sessions for various encounter types client’s age, knowledge, language and socio- and provide technical assistance as cultural background. necessary. Client is given an (4) A mechanism has been established to opportunity to ask questions. determine if the client understood the Language needs and cultural issues are information provided. 2. Education services offered allow client to make Title X Guidelines: Section 8.1; OPA 03- informed decisions and take positive health actions, Comments / Required Action 01 where appropriate.

a) Information needed to make informed decisions Prostrate and testicular health about family planning. education should accompany b) Information of the range of services, purpose and instructions on TSE. sequence of clinic procedures. c) Use of specific methods of contraception and Pre and interconception health adverse effects. promotion and disease prevention d) Instruction on BSE / TSE (Breast or testicular self topics include nutrition, exercise, exams smoking cessation, alcohol/drug abuse, domestic violence and sexual e) Actions to reduce transmission HIV and STIs. abuse. f) Importance of recommended tests and procedures. g) Pre and interconception health promotion. h) Health promotion/disease prevention (ie. nutrition, exercise, smoking cessation, ETOH/ drug abuse, domestic violence, sexual abuse) SFY2012 FPP Clinical Services Review Tool 8 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates:

M Not H. Counseling References and Instructions Met Comments / Required Action 1. Counseling services comply with Title X Title X Guidelines: Section 8.2 requirements.

a) Documentation of counseling is included in If the delegate uses checklists for client record. documenting required counseling XIII. Counselors are sufficiently knowledgeable to provide components, a detailed written protocol accurate information regarding the benefits and risk, for what is included in that counseling safety, effectiveness, potential side effects, complications, should be reviewed. discontinuation issues and danger signs of the various contraceptive methods. (1) Counselors should be objective, nonjudgmental, culturally aware and Observation of education and sensitive to individual differences of clients. counseling sessions. (2) Counselors should be knowledgeable about other services offered by the clinic.

2. Method counseling is provided when indicated Comments / Required Action Title X Guidelines: Section 8.2 and includes: a) Results of physical exam and lab studies. Observation of method counseling b) Effective use of contraceptive methods, sessions for various clinic encounters. benefits, and efficacy of the methods. XIV. Possible side effects and complications. XV. How to discontinue the method selected and information regarding back-up method to use. XVI. Planned return schedule. XVII. Emergency 24-hour telephone number. XVIII. Location where emergency services can be obtained. XIX. Appropriate referral for additional services, if needed.

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M Not H. Counseling (continued) Comments / Required Action References and Instructions Met

1. Project offers STI and HIV prevention education Title X Guidelines: Section 8.2 according to nationally recognized standards.

a) There is evidence that all clients receive STI and Information on HPV vaccine must be HIV prevention education. At a minimum, this provided to clients <27 years of age. includes: (1) Education about HIV infection and AIDS. Observation of education/counseling (2) Information on risks, infection prevention and sessions during various encounter referral services. types. (3) Discussion of personal risk and risk reduction steps. Check Policy/Protocol.

SFY2012 FPP Clinical Services Review Tool 10 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates:

M Not I. History, Physical Assessment and Lab Testing References and Instructions Met Comments / Required Action 1. Information related to client medical histories are Title X Guidelines: Section 8.3 consistent with Title X requirements. a) INITIAL comprehensive visit: Comprehensive A complete MEDICAL history is medical history must include: documented at the initial (1) Past medical comprehensive visit for both female (2) Allergies. and male clients and updated at (3) Current medications (including OTC subsequent clinical visits. medications). Past medical history includes Tobacco, alcohol, and drug use (both (4) significant illnesses, hospitalization, prescription and other drugs). surgery, blood transfusions or (5) Immunization and Rubella status. exposure to blood products, and (6) Review of systems. chronic or acute medical conditions. (7) Pertinent history of immediate family members. Partner history includes injectable (8) Partner history drug use, multiple partners, risk history for STIs and HIV, sex with men, b) FEMALE reproductive history must include sex with women, or both. the following: (1) Contraceptive use past and current Pap testing history includes date of last including adverse effects. Pap test and treatment of abnormal (2) Menstrual history. findings. (3) Sexual history. (4) Obstetrical/Gynecological history. XX. STI, including HBV. XXI. HIV Infection. XXII. Pap testing history. XXIII. In utero exposure to diethylstilbestrol (DES).

c) MALE reproductive history must include the following: a) Sexual history. b) STI, including HBV. c) HIV infection. d) Urological conditions.

SFY2012 FPP Clinical Services Review Tool 11 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates: I. History, Physical Assessment and Lab Testing M Not References and Instructions (continued) Met Comments / Required Action 2. Physical assessments are consistent with Title X Title X Guidelines: Section 8.3 and 9.6 requirements. a) INITIAL FEMALE physical assessment should Ensure that medical protocols and include: practice related to cervical cancer and 1) Height and weight. colorectal screening correspond with 2) Thyroid, heart, lung, extremities, breasts, current recommendations issued by abdomen, pelvis and rectum. professional groups. Review charts to 3) HIV screening on site or by referral. ensure practice follows protocol. 4) Clinic must stress the importance of and provide for health maintenance screening. (a) Blood pressure. STI screening protocols follow most (b) Breast exam. recent CDC STI guidelines. All women (c) Pelvic exam / Pap tests. <26 years old should be screened at (d) Colorectal CA screening. least annually for CT/GC. Screening at (e) STI screening. every visit or every 3 months is 5) When not provided, client deferral or decline of recommended. Screening clients 26 a health maintenance service is documented. years of age or older is limited by risk (a) Counseling includes information on criteria. Timeliness of treatment possible health risks associated with statistics are reviewed and technical declining or delaying preventive screening assistance is provided as necessary. tests or procedures. Partners of clients with positive CT/GC b) Requirements for female physical examination and tests should be tested and/or treated. laboratory tests stipulated in the prescribing information for a specific contraceptive method are Postpartum care if provided should followed. include assessment of the woman’s (1) Physical exam and preventative services are physical health, initiation of completed within 3 months of initial visit. contraception and postpartum (a) When services are deferred, reason for depression education and screening. deferral is documented. If time and staff skills permit include (b) In no case is the physical exam delayed counseling and education about beyond 6 months unless the clinician has parenting, breastfeeding, infant care documented a compelling reason. and family adjustment. (c) Protocols are in place to ensure deferrals are not lost to follow-up. c) INITIAL MALE physical assessment should include: XXIV. Height and weight. XXV. Thyroid, heart, lung, extremities, breasts, abdomen, genitals and rectum. XXVI. STI and HIV (onsite or by referral) testing, as indicated. XXVII. Blood pressure. XXVIII. Colorectal CA screening. SFY2012 FPP Clinical Services Review Tool 12 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates:

I. History, Physical Assessment and Lab Testing M Not References and Instructions (continued) Met Comments / Required Action 3. Laboratory Testing. Information related to client laboratory testing is consistent with Title X Title X Guidelines: Section 8.3 requirements. a) Delegate agency provides on site pregnancy testing. Check to ensure screening and testing is in accordance with current CLIA b) Delegate agency provides the following tests Certificate type. when required by the specific contraceptive method (FDA or prescribing recommendations). They may be provided for the maintenance of health status and/or diagnostic purposes either on-site or by referral. (1) Anemia assessment. (2) Gonorrhea and Chlamydia test. (3) Vaginal wet mount. (4) Diabetes testing. (5) Cholesterol and lipids. (6) Hepatitis B testing. (7) Syphilis serology (VDRL, RPR). (8) Rubella titer (9) Urinalysis (10) HIV testing a) Clients are notified of abnormal lab test results. (1) Notification procedure maintains client confidentiality. d) CLIA Certificate type 1. Revisits are individualized and based on client need Title X Guidelines: Section 8.3 as required by Title X. Comments / Required Action a) Revisit schedules must be based on client need for: (1) Education. (2) Counseling. (3) Clinical care beyond that provided at previous visit. b) First time users of hormonal methods, IUDs, diaphragms and cervical caps should be scheduled for an early revisit.

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M Not J. Pregnancy Diagnosis and Counseling References and Instructions Met Comments / Required Action 1. Delegate agency provides pregnancy diagnosis Title X Guidelines: Section 8.6; 42 CFR consistent with Title X regulations. 59.5 (a)(5) a) Pregnancy diagnosis and counseling is Review policies and charts, Observation provided to all clients in need of these services. of counseling session with clients b) Pregnancy diagnosis includes: having negative and positive pregnancy (1) History. screening/testing result. (2) Pregnancy testing. (3) Physical assessment including pelvic exam. Pregnancy testing for women < 26 (a) When exam not performed onsite, the years old should include a provider documented client was Chlamydia/Gonorrhea test. Please counseled of the importance of receiving provide technical assistance related to an exam within 15 days. policy changes and staff education. c) If ectopic pregnancy is suspected, the client is referred for immediate diagnosis and treatment.

2. Delegate agency provides pregnancy counseling Title X Guidelines: Section 8.6; 42 CFR Comments / Required Action consistent with Title X regulations. 59.5 (a)(5)

a) Clients with a positive pregnancy test: Review protocols, charts and referral (1) Pregnant clients are offered the information provided to clients. opportunity for options counseling to include: (a) Prenatal care and delivery. Good health practices during early (b) Infant care, foster care or adoption. pregnancy include good nutrition, and (c) Pregnancy termination. avoidance of smoking, drugs, alcohol (2) Options counseling is neutral, factual and x-rays. 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. (3) Clients electing to continue their pregnancy are: (a) Referred for early prenatal care and Family Case Management. (b) Provided information on good health practices during early pregnancy. b) Clients with a negative pregnancy test much be informed about contraception, infertility services and preconception health, as appropriate, and encouraged to schedule a comprehensive visit. SFY2012 FPP Clinical Services Review Tool 14 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates:

M Not K. Adolescent Services References and Instructions Met Comments / Required Action 1. Delegate agency provides contraceptives Title X Guidelines: Section 8.7; OPA services to adolescents consistent with Title X Program Instructions 06-01 and 99-1 regulations. a) Delegate agency complies with state Review policies, training logs and requirements regarding notification or charts. Observe adolescent education. reporting of child abuse, child molestation, Information provided is age-appropriate. sexual abuse, rape, or incest. Staff does not assume that adolescents b) Adolescents seeking contraceptive are sexually active simply because services are informed about all methods of family planning services are sought. contraception. Staff should not assume adolescents c) Adolescents are informed of the following: are seeking confidential services. (1) Abstinence. (2) Contraceptive options. Annual clinical staff continuing (3) Safer sex practices. education session on sexual coercion d) Counseling sessions and needed follow- resistance and Mandated Reporting. up are confidential. XXIX. Services provided are confidential and do not require written parental or guardian consent. f) There is no evidence that parents or guardians are notified before or after a minor has requested and received Title X services without the minors consent. g) Policies and procedures must be in place to provide counseling to minors on how to resist coercive attempts to engage in sexual activities.

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M Not L. Infertility Services Comments / Required Action References and Instructions Met (i) Delegat e agency provides Level I infertility services as Title X Guidelines: Section 8.5 required by Title X. a) Level I services include: Review protocol. Protocol must include (1) Initial infertility interview. the scope of infertility services provided (2) Education. and referral logistics. (3) Physical examination. (4) Counseling. (5) Referral. b) Delegate agency does NOT provide Level II or Level III infertility services.

M Not M. Identification of DES-Exposed Offspring References and Instructions Met 1. Clients exposed prenatally to DES receive Comments / Required Action Title X Guidelines: Section 8.3 and 8.8; information/education and special screening ACOG Recommendations for Cervical either on-site or by referral. Cancer Screening a) Clients born between 1940 and 1970 are Review protocol and charts. asked about DES exposure and their offspring. b) Clients exposed receive information/education and special screening either on-site or by referral.

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M Not N. Related Services References and Instructions Met Comments / Required Action 1. If optional services are offered, skilled Title X Guidelines: Section 9.0, 9.1 and personnel and equipment are available. 9.2 a) Delegate agency provides for diagnosis Review IDPH quarterly and 6 month and treatment of minor gynecologic problems GC/CT Screening and Timeliness to (e.g., Vaginitis, UTI). Treatment Reports with supervisory staff; provide consultation in relation to b) Delegate agency provides for detection IDHS/IDPH Performance Standards and treatment of the more common STIs and submitted Work Plan Activities and (e.g., GC, syphilis, chlamydia, HIV). Evaluation Methods. c) Delegate agency must comply with State and local STI reporting requirements. d) Gonorrhea and chlamydia tests are provided for clients requesting IUD insertions. e) When treatment for a) or b) is provided on-site, appropriate follow-up measures are undertaken. M Not O. Equipment and Supplies References and Instructions Met Comments / Required Action Title X Guidelines: Section 10.1

1. Equipment and supplies are appropriate to Observation of clinic flow for various the type of care offered by the project. encounter types. Interview direct service staff

M Not P. Infection Control Comments / Required Action References and Instructions Met

1. Clinic follows applicable Federal and state Observation of clinic flow for various regulations regarding infection control encounter types. Interview direct service staff

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M Not Q. Pharmaceuticals Comments / Required Action References and Instructions Met

1. Delegate agency meets Title X regulations as Title X Guidelines: Section 10.2 they relate to pharmaceuticals. Check to ensure formulary is updated XXX. Each delegate agency maintains an adequate supply annually. and variety of drugs and devices to effectively manage the contraceptive need of its clients. XXXI. Each delegate agency maintains the necessary drugs and devices for the provision of any other services Review Policy/Protocol. it includes within the scope of the Title X project. XXXII. Delegate agency complies with federal and Review pharmaceutical logs: Inventory, state laws relating to security and record keeping expiration dates; dispensing logs for drugs and devices. d) Inventory, supply, and dispensing of pharmaceuticals must be conducted in accordance with state pharmacy laws and professional practice regulations.

M Not R. Medical Records References and Instructions Met Comments / Required Action 1. Delegate agency meets Title X regulations as Title X Guidelines: Section 10.3 they relate to medical records.

SFY2012 FPP Clinical Services Review Tool 18 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates: XXXIII. A medical record is established for Ensure that medical charts area is each locked or completely inaccessible to client who obtains clinical services. clients. XXXIV. Medical records are retained in accordance with accepted medical standards and State laws. Records must be: (1) Complete, legible, and accurate. (Telephone encounters of a clinical nature are documented). (2) Signed by the clinician (name, title, date). (3) Readily accessible. (4) Systematically organized to facilitate prompt retrieval of information. (5) Confidential, safeguarded against loss or use by unauthorized persons. (6) Secured by lock when not in use. (7) Available to the client upon request.

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R. Medical Records (continued)

c) Sufficient information to identify the client, indicate contact information, justify clinical diagnosis, and warrant the treatment and end results. Required content includes: (1) Personal data. (2) Medical history, physical exam, clinical findings, diagnostic/laboratory orders, results, and treatment.. (3) Scheduled revisits. (4) Informed consents. (5) Refusal of services. (6) Allergies and drug reactions. (7) Problem list. (8) Medication list. (9) Medical record allows for entries by counseling and social service staff. d) Client financial information should be kept separate from chart or there is no evidence that client services are withheld because of a client’s financial status. e) Confidentiality and Release of Records: (1) A confidentiality assurance statement must appear in the client’s record. (2) HIV information is handled according to State law. (3) A written consent of the client is required for 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. XXXV. The delegate agency has a mechanism to expedite the transfer of medical records to other providers upon the client’s request.

SFY2012 FPP Clinical Services Review Tool 20 of 22 TOLL IDHS Family Planning Program Clinical Services Review Tool SFY2012 Delegate Agency: Review Dates: M Not S. Quality Assurance References and Instructions Met 1. Delegate agency quality assurance system in place Comments / Required Action that provides for ongoing evaluation of project Title X Guidelines: Section 10.4 personnel and services. XXXVI. The quality assurance system includes: Review QA system and reports. (1) Clinical policies have been adopted to Interview staff. ensure conformity within the program. (2) Annual review and update of medical The medical audit process should protocols. include an internal monthly review of a (3) Ongoing medical audits to determine reasonable number of client records and conformity with agency policies. the medical director or physician (4) Ongoing peer review procedures by the designee review of midlevel practitioner Medical Director to evaluate individual records. clinician performance. The results of an annual client (5) A tracking system to identify clients in satisfaction survey are used in program need of follow-up or continuing care. planning. (6) A process to elicit consumer feedback including an annual client satisfaction survey. Review delegate agency tracking of (7) Ongoing documentation of quality Ahlers and STI data to determine assurance activities. progress in achieving work plan goals (8) Assessing progress toward achieving and objectives. work plan objectives. Interview supervisory staff regarding (9) Regular staff meetings with minutes. Work Plan utilization to guide clinic practice over time. Ongoing peer review by Medical Director should include evaluation of both clinical skills and documentation practices. Re-certification in relevant practice area constitutes evidence of maintaining current skills.

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T. Clinical Review Summary

Medical chart and CVR audit findings:

Access security of access to Ahlers Data System by various staff members. Determine level of utilization of Ahlers Reports by staff and provide technical assistance as needed.

Staff present at initial interview:

Staff present at exit conference:

Significant changes in staff, leadership, services provided:

New/old issues:

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