(1) Definitions:
    (a) Appropriate Resources – those service providers who provide most effectively and efficiently the specific services needed by the geriatric patient.
    (b) Geriatric Outpatient Clinic – a site in a nursing home treatment room for the provision of health care to geriatric patients on an outpatient basis which is staffed by a registered nurse or by a physician’s assistant or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physical assistant or a physician.
    (c) Geriatric Patient – any patient who is 60 years of age or older.
    (d) Pre-established Protocols – a statement prepared by or with the responsible or attending physician and/or physician assistant and advanced practice registered nurse (APRN) defining the extent and limits of the medical services provided by the nurse. Such protocols are to be reviewed at periods not to exceed one year, to be dated and signed by the physician, and to be kept readily available.
    (e) Responsible Physician – the licensed physician delegated by the supervising physician as responsible for the services rendered by the registered nurse, physician’s assistant, advanced practice registered nurse (APRN) or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physician assistant or a physician in the absence of the supervising physician.
    (f) Routine Health Care – preventive care, detection of health problems, referral for medical care, and management of chronic illness within medical prescriptions.
    (g) Substantive Change – a change in the patient’s condition indicating the need for change in treatment and/or medication orders.
    (h) Supervising Physician – the licensed physician assuming responsibility and legal liability for the services rendered by the registered nurse, physician’s assistant, advanced practice registered nurse (APRN) or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physician assistant or a physician. (Sections 458.135(2)(e), 459.151(2), (3), F.S.)
    (i) Treatment Room – the room or suite of rooms set aside for the examination and care of patients.
    (2) Applications.
    (a) The nursing home licensee must submit a letter to the Agency for Health Care Administration, Long-Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308, stating intent to establish a geriatric outpatient clinic in compliance with Florida Statutes Chapter 400, and this rule. Such notice may also be provided at the time of initial licensure or licensure renewal. This letter must be sent at least sixty (60) days prior to the anticipated date of the establishment of the clinic.
    (b) The licensee must be compliant with Chapter 400, Part II, Florida Statutes Chapter 408, Part II this rule chapter and Florida Building Code during an inspection by the Agency.
    (c) Receipt of the letter of notification stating compliance shall constitute authority to operate a geriatric outpatient clinic within the facility.
    (d) Application for renewal of authority to operate a geriatric outpatient clinic must be submitted in the manner described above at the same time the application for the nursing home licensure renewal is submitted.
    (e) Suspension or revocation of the nursing home license automatically suspends or revokes authority to operate the geriatric outpatient clinic.
    (3) Treatment Rooms and Access Areas.
    (a) Plant maintenance and housekeeping must be in accordance with Fl. Admin. Code R. 59A-4.122
    (b) Every nursing home licensee conducting a geriatric outpatient clinic must:
    1. Use an existing treatment room exclusively for the examination and treatment of patients.
    2. Store supplies and equipment in such a manner that safeguards patients and staff from hazards.
    3. Have a waiting area which does not interfere with regular in-patient functions.
    4. Provide clinic patients with the most direct route to and from the treatment room.
    (4) Administration.
    (a) The business and administrative management of the geriatric outpatient clinic must be under the management control of the nursing home administrator. This must include, maintenance of the following written records;
    1. An accident and incident record, containing a clear description of each accident and any other incident hazardous or deviant behavior of a patient or staff member with names of individuals involved, description of medical and other services provided, by whom such services were provided and the steps taken to prevent recurrence.
    2. Personnel records for each clinic employee and/or contractual provider. Employees of a geriatric outpatient clinic must have a Level 2 background screening as required in Section 408.809 and Florida Statutes Chapter 435 These records must be kept updated and include current Florida license and certificate numbers. The original application for the position, references furnished and an annual performance evaluation must be included.
    3. A record of personnel policies, including statement of policies affecting personnel and a job description for each person providing clinic services.
    4. Clinic Schedule.
    5. Compliance with the requirements of Title VI of the Civil Rights Act of 1964, § 2000, effective date July 2, 1964, is incorporated herein by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-06377 and http://www.gpo.gov/fdsys/pkg/USCODE-2008-title42/html/USCODE-2008-title42-chap21-subchapV.htm.
    (b) The provision of health services through geriatric outpatient clinics must be under the direct management control of the registered nurse, physician’s assistant or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physician assistant or physician, providing those services. The licensee must oversee the provision of health services to ensure all health services are provided to protect the health, safety and well-being of the patients. The licensee must also:
    1. Maintain the confidentiality of clinical records for each patient as required in this rule, Section 400.022(m) and 400.0222, F.S., Title 42 Code of Federal Regulation § 483.10, effective October 1, 2003, Title 45 Code of Federal Regulation Chapters 160, 162 and 164 with an effective date of August 14, 2002, which is incorporated by reference and available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl.
    2. Develop and periodically review the written policies and protocols governing patient care, including emergency procedures.
    3. Develop and periodically review the patient referral system.
    4. Administer and handle drugs and biological as required in this rule, Chapter 400 Part II, F.S., Title 42 C.F.R. §§ 483.25(1) and 483.25(m), effective October 1, 2014 and incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-25.xml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06378; and 42 C.F.R. § 483.60, effective October 1, 2014, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-60.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06379.
    5. Maintain an individual and cumulative clinic census record.
    6. Coordinate patient care with the attending physician and other community health and social agencies and/or facilities.
    7. Maintain a safe and sanitary clinic environment.
    (5) Fiscal Management.
    (a) There must be a recognized system of accounting used to accurately reflect business details of the clinic operation, documentation of all transactions and services kept separate from the nursing home’s fiscal records.
    (b) A reasonable fee, based on cost of operation and services, may be charged for clinic services rendered.
    (c) Personnel involved in operating and/or providing clinic services must not:
    1. Pay any commission, bonus, rebate or gratuity to any organization, agency, physician, employee or other person for referral of any patients to the clinic.
    2. Request or accept any remuneration, rebate, gift, benefit, or advantage of any form from any vendor or other supplier because of the purchase, rental, or loan, of equipment, supplies or services for the resident and/or patient.
    (6) Personnel Policies.
    (a) Staff in the geriatric outpatient nurse clinic must be governed by the personnel standards in this rule, Florida Statutes § 400.141, Title 42 Code of Federal Regulation § 483.75, effective October 1, 2014, and incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-75.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06382, 42 C.F.R. § 483.30, effective October 1, 2014, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-30.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06383.
    (b) Staff in the geriatric outpatient clinic must be qualified and sufficient in numbers to perform the necessary services.
    (c) Services of this clinic must not reduce the minimum staffing standards for in-patient care.
    (d) Staff in the geriatric outpatient clinic may be regularly employed or serve on a contractual basis.
    (7) Personnel Functions and Responsibilities.
    (a) The registered nurse, advanced practice registered nurse (APRN), physician assistant or a licensed practical nurse under the direct supervision of a registered nurse, APRN, physician assistant or physician staffing the geriatric outpatient clinic must:
    (b) Be responsible for eliciting and recording a health history, observation and assessment nursing diagnosis, counseling and health teaching of patients and the maintenance of health and prevention of illness.
    (c) Provide treatment for the medical aspects of care according to pre-established protocols or physician’s orders.
    (d) Note findings and activities on the clinical record.
    (e) Provide progress reports to the attending physicians about patients under the physician’s care when there is a substantive change in the patient’s condition, there are deviations from the plan of care, or at least every sixty (60) days.
    (8) Patient Eligibility Criteria.
    (a) Acceptance of patients and discharge policies must include the following:
    (b) Patients must be accepted for clinic services on self-referral for nursing care, or upon a plan of treatment established by the patient’s attending physician.
    (c) Patients with an attending physician will be held responsible for providing the clinic with a written medical plan of treatment reviewed and signed by their physician.
    (d) When services are to be terminated, the patient must be notified of the date of termination and the reason for termination which shall be documented in the patient’s clinical record. A plan shall be developed for a referral made for any continuing care required.
    (9) Patient’s Rights.
    (a) The nursing home licensee must adopt, implement and make public a statement of the rights and responsibilities of the clinic patients and must treat such patients in accordance with the provisions of the statement. This statement must be conspicuously posted and available to clinic patients in pamphlet form. The statement must ensure each patient the following:
    1. The right to have private communication with any person of his or her choice.
    2. The right to present grievances on behalf of himself, herself, or others to the facility’s staff or administrator, to government officials, or to any person without fear of reprisal, and to join with other patients or individuals to work for improvements in patient care.
    3. The right to be fully informed in writing, prior to or at the time of admission and during his or her attendance, of fees and services not covered under Title XVIII or Title XIX of the Social Security Act or other third party reimbursement agents.
    4. The right to be adequately informed of his or her medical condition and proposed treatment unless otherwise indicated in the written medical plan of treatment by the physician, and to participate in the planning of all medical treatment, including the right to refuse medication and treatment, unless otherwise indicated in the written medical plan of treatment by the physician, and to know the consequences of such actions.
    5. The right to receive adequate and appropriate health care consistent with established and recognized practice standards within the community and with the rules promulgated by the Agency.
    6. The right to have privacy in treatment and in caring for personal needs and confidentiality of personal and medical records.
    7. The right to be treated courteously, fairly, and with the fullest measure of dignity and to receive a written statement of the services provided by the nursing home licensee.
    (b) Any violation of the patient’s rights set forth in this section shall constitute grounds for action by the Agency under the provisions of Florida Statutes § 400.102
    (10) The scope of services of the Geriatric Outpatient Clinic must include:
    (a) Observation of signs and symptoms.
    (b) Assessment of health status/progress.
    (c) Nursing diagnosis and plan of care.
    (d) Nursing care of patients and counseling to maintain health and prevent disease, including diet counseling.
    (e) Health instruction to control progression of disease and/or disability and self-care measures.
    (f) Administration of medication and treatment as prescribed by a person licensed in this state to prescribe such medications and treatment.
    (g) Provision of progress reports to the attending physician.
    (h) Referral for additional services as needed.
    (i) Follow-up on a regular basis by communication with the patient, the patient’s physician, and other agencies or persons to which referrals were made.
    (j) When staffed by an APRN or physician’s assistant, additional services may be provided dependent upon their respective certification authority. (Sections 458.347 and 459.022, F.S.)
    (11) Clinical Records.
    (a) The clinic must maintain a clinical record for every patient receiving health services that contain the following:
    1. Identification data including name, address, telephone number, date of birth, sex, social security number, clinic case number if used, next of kin or guardian and telephone number, name and telephone number of patient’s attending physician.
    2. Assessment of problems.
    3. A health care plan including diagnoses, type, and frequency of services and when receiving medications and medical treatments, the medical treatment plan and dated signature of the physician or designee licensed in this state to prescribe such medications and treatments.
    4. Clinical notes, signed and dated by staff providing service.
    a. Progress notes with changes in the patient’s condition.
    b. Services rendered with progress reports.
    c. Observations.
    d. Instructions to the patient and family.
    e. Referrals made.
    f. Consultation reports.
    g. Case conferences.
    h. Reports to physicians.
    i. Termination summary which must include:
    (I) Date of first and last visit.
    (II) Total number of visits by discipline.
    (III) Reason for termination of service.
    (IV) Evaluation of achievements of previously established goals at time of termination.
    (V) Condition of patient on discharge.
    j. Clinical records must be confidential. Information may be released by the nurse, APRN or physician’s assistant responsible for clinical services only in accordance with state and federal regulations related to patient records and confidentiality.
    (12) Medications. The clinic shall have policies and procedures for the administration of medications by health care professionals acting within the scope of practice defined by the Department of Health, chapter 464, part I, F.S. and Fl. Admin. Code R. 64B9-15.002, which must include the following:
    (a) All prescriptions for medications must be noted on the patient record, and include the date, drug, dosage, frequency, method or site of administration, and the authorized health care professional’s signature.
    (b) All verbal orders for medication or medication changes must be taken by the clinic registered nurse, APRN or physician’s assistant. Such must be in writing and signed by the authorized health care professional within eight (8) days and added to the patient’s record.
    (c) The clinic registered nurse, APRN or physician’s assistant must record and sign for each medication administrated by drug, dosage, method, time and site on patient’s record.
    (d) An emergency plan for reversal of drug reaction to include the nursing licensee’s pro re nata (P.R.N.) or “”as needed”” standing orders for medications available in the emergency drug kit.
    (e) If there is not a separate emergency drug kit in the clinic, the nursing home licensee’s emergency drug kit must be immediately accessible for use in the outpatient clinic.
    (f) A drug storage system which includes:
    1. Prescribed medications for individual outpatients may be retained in the clinic. These medications must be stored separately from those of the nursing home in-patients for preventive measures and the treatment of minor illnesses.
    2. Multi-dose containers must be limited to medications or biologicals commonly prescribed for preventive measures and the treatment of minor illnesses.
    3. A list must be kept of patients receiving medication from multi-dose medication containers.
Rulemaking Authority 400.141, 400.23 FS. Law Implemented Florida Statutes § 400.141. History-New 4-27-78, Formerly 10D-29.71, 10D-29.071, 59A-4.071, Amended 2-6-97, 12-21-15.