Agency for Health Care Administration

Transcription

1 Page 1 of 69 ST - U Initial Comments Title Initial Comments Statute or Rule Type Memo Tag These guidelines are meant solely to provide guidance to surveyors in the survey process. ST - U Definitions Title Definitions Statute or Rule FS; 59A FAC Type Memo Tag Definitions.- (1) "Agency" means the Agency for Health Care Administration. (2) "Applicant" means an individual owner, corporation, partnership, firm, business, association, or other entity that owns or controls, directly or indirectly, 5 percent or more of an interest in the clinic and that applies for a clinic license. (3) "Chief financial officer" means an individual who has at least a minimum of a bachelor's degree from an accredited university in accounting or finance, or a related field, and who is the person responsible for the preparation of a clinic's billing. (4) "Clinic" means an entity where health care services are provided to individuals and which tenders charges for reimbursement for such services, including a mobile clinic and a portable equipment provider. As used in this part, the term does not include and the licensure requirements of this part do

2 Page 2 of 69 not apply to: (a) Entities licensed or registered by the state under chapter 395; entities licensed or registered by the state and providing only health care services within the scope of services authorized under their respective licenses under ss , chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, part I of chapter 483, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 405, subpart U; providers certified under 42 C.F.R. part 485, subpart B or subpart H; or any entity that provides neonatal or pediatric hospital-based health care services or other health care services by licensed practitioners solely within a hospital licensed under chapter 395. (b) Entities that own, directly or indirectly, entities licensed or registered by the state pursuant to chapter 395; entities that own, directly or indirectly, entities licensed or registered by the state and providing only health care services within the scope of services authorized pursuant to their respective licenses under ss , chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, part I of chapter 483, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 405, subpart U; providers certified under 42 C.F.R. part 485, subpart B or subpart H; or any entity that provides neonatal or pediatric hospital-based health care services by licensed practitioners solely within a hospital licensed under chapter 395. (c) Entities that are owned, directly or indirectly, by an entity licensed or registered by the state pursuant to chapter 395; entities that are owned, directly or indirectly, by an entity licensed or registered by the state and providing only health care services within the scope of services authorized pursuant to their respective licenses under ss , chapter 390, chapter 394, chapter 397, this chapter except part X,

3 Page 3 of 69 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, part I of chapter 483, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 405, subpart U; providers certified under 42 C.F.R. part 485, subpart B or subpart H; or any entity that provides neonatal or pediatric hospital-based health care services by licensed practitioners solely within a hospital under chapter 395. (d) Entities that are under common ownership, directly or indirectly, with an entity licensed or registered by the state pursuant to chapter 395; entities that are under common ownership, directly or indirectly, with an entity licensed or registered by the state and providing only health care services within the scope of services authorized pursuant to their respective licenses under ss , chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, part I of chapter 483, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 405, subpart U; providers certified under 42 C.F.R. part 485, subpart B or subpart H; or any entity that provides neonatal or pediatric hospital-based health care services by licensed practitioners solely within a hospital licensed under chapter 395. (e) An entity that is exempt from federal taxation under 26 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan under 26 U.S.C. s. 409 that has a board of trustees at least two-thirds of which are Florida-licensed health care practitioners and provides only physical therapy services under physician orders, any community college or university clinic, and any entity owned or operated by the federal or state government, including agencies, subdivisions, or municipalities thereof. (f) A sole proprietorship, group practice, partnership, or corporation that provides health care services by physicians covered by s , that is directly supervised by one or

4 Page 4 of 69 more of such physicians, and that is wholly owned by one or more of those physicians or by a physician and the spouse, parent, child, or sibling of that physician. (g) A sole proprietorship, group practice, partnership, or corporation that provides health care services by licensed health care practitioners under chapter 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, chapter 490, chapter 491, or part I, part III, part X, part XIII, or part XIV of chapter 468, or s , and that is wholly owned by one or more licensed health care practitioners, or the licensed health care practitioners set forth in this paragraph and the spouse, parent, child, or sibling of a licensed health care practitioner if one of the owners who is a licensed health care practitioner is supervising the business activities and is legally responsible for the entity's compliance with all federal and state laws. However, a health care practitioner may not supervise services beyond the scope of the practitioner's license, except that, for the purposes of this part, a clinic owned by a licensee in s (3)(b) which provides only services authorized pursuant to s (3)(b) may be supervised by a licensee specified in s (3)(b). (h) Clinical facilities affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows. (i) Entities that provide only oncology or radiation therapy services by physicians licensed under chapter 458 or chapter 459 or entities that provide oncology or radiation therapy services by physicians licensed under chapter 458 or chapter 459 which are owned by a corporation whose shares are publicly traded on a recognized stock exchange. (j) Clinical facilities affiliated with a college of chiropractic accredited by the Council on Chiropractic Education at which training is provided for chiropractic students. (k) Entities that provide licensed practitioners to staff

5 Page 5 of 69 emergency departments or to deliver anesthesia services in facilities licensed under chapter 395 and that derive at least 90 percent of their gross annual revenues from the provision of such services. Entities claiming an exemption from licensure under this paragraph must provide documentation demonstrating compliance. (l) Orthotic, prosthetic, pediatric cardiology, or perinatology clinical facilities or anesthesia clinical facilities that are not otherwise exempt under paragraph (a) or paragraph (k) and that are a publicly traded corporation or are wholly owned, directly or indirectly, by a publicly traded corporation. As used in this paragraph, a publicly traded corporation is a corporation that issues securities traded on an exchange registered with the United States Securities and Exchange Commission as a national securities exchange. (m) Entities that are owned by a corporation that has $250 million or more in total annual sales of health care services provided by licensed health care practitioners where one or more of the persons responsible for the operations of the entity is a health care practitioner who is licensed in this state and who is responsible for supervising the business activities of the entity and is responsible for the entity's compliance with state law for purposes of this part. (n) Entities that employ 50 or more licensed health care practitioners licensed under chapter 458 or chapter 459 where the billing for medical services is under a single tax identification number. The application for exemption under this subsection shall contain information that includes: the name, residence, and business address and phone number of the entity that owns the practice; a complete list of the names and contact information of all the officers and directors of the corporation; the name, residence address, business address, and medical license number of each licensed Florida health care practitioner employed by the entity; the corporate tax identification number of the entity seeking an exemption; a

6 Page 6 of 69 listing of health care services to be provided by the entity at the health care clinics owned or operated by the entity and a certified statement prepared by an independent certified public accountant which states that the entity and the health care clinics owned or operated by the entity have not received payment for health care services under personal injury protection insurance coverage for the preceding year. If the agency determines that an entity which is exempt under this subsection has received payments for medical services under personal injury protection insurance coverage, the agency may deny or revoke the exemption from licensure under this subsection. Notwithstanding this subsection, an entity shall be deemed a clinic and must be licensed under this part in order to receive reimbursement under the Florida Motor Vehicle No-Fault Law, ss , unless exempted under s (5)(h). (5) "Medical director" means a physician who is employed or under contract with a clinic and who maintains a full and unencumbered physician license in accordance with chapter 458, chapter 459, chapter 460, or chapter 461. However, if the clinic does not provide services pursuant to the respective physician practices acts listed in this subsection, it may appoint a Florida-licensed health care practitioner who does not provide services pursuant to the respective physician practices acts listed in this subsection to serve as a clinic director who is responsible for the clinic's activities. A health care practitioner may not serve as the clinic director if the services provided at the clinic are beyond the scope of that practitioner's license, except that a licensee specified in s (3)(b) who provides only services authorized pursuant to s (3)(b) may serve as clinic director of an entity providing services as specified in s (3)(b). (6) "Mobile clinic" means a movable or detached self-contained health care unit within or from which direct

7 Page 7 of 69 health care services are provided to individuals and which otherwise meets the definition of a clinic in subsection (4). (7) "Portable equipment provider" means an entity that contracts with or employs persons to provide portable equipment to multiple locations performing treatment or diagnostic testing of individuals, that bills third-party payors for those services, and that otherwise meets the definition of a clinic in subsection (4). 59A Definitions. In addition to definitions contained in Chapter 400, Part X, F.S., the following definitions shall apply specifically to health care clinics. (1) "Licensee" means an individual, general partner of a limited partnership, general partnership, joint venture, limited liability company, limited liability partnership, unincorporated association, corporation or any other business relationship or entity that owns or controls a health care clinic or is the lessee of the health care clinic having the right of possession of the health care clinic location or mobile unit. (2) "Physician" means a person currently licensed to practice medicine, osteopathy, chiropractic, or podiatry pursuant to Chapters 458, 459, 460 or 461, F.S., respectively. (3) "Unencumbered license" means a license issued by the respective health practitioner board of the Department of Health that permits a physician to perform all duties authorized under a license without restriction. (4) "The Health Care Clinic Act" or "Act" means Chapter 400, Part X, F.S. (5) "F.S." means Florida Statutes. (6) "F.A.C." means Florida Administrative Code. (7) "Licensed medical provider" means a licensed health care practitioner.

8 Page 8 of 69 ST - U License Required; Mobile Clinics Title License Required; Mobile Clinics Statute or Rule (1)(b), F.S (1)(b), F.S. Each mobile clinic must obtain a separate health care clinic license and must provide to the agency, at least quarterly, its projected street location to enable the agency to locate and inspect such clinic. A portable equipment provider must obtain a health care clinic license for a single administrative office and is not required to submit quarterly projected street locations. Mobile clinics should be licensed at an administrative office with postal street address, and cannot provide direct health care services to individuals at their own facilities without first obtaining a health care clinic license for the address. A mobile clinic is self-contained and the client enters the unit. The unit may be either mobile (can be moved from place to place) or is detached from the clinic where the services are being provided. A trailer detached from a fixed location clinic is considered "mobile" under the definition. Per definition: (7) "Portable equipment provider" means an entity that contracts with or employs persons to provide portable equipment to multiple locations performing treatment or diagnostic testing of individuals, that bills third-party payors for those services, and that otherwise meets the definition of a clinic in subsection (4). ST - U License Required; Change of Exempt Status Title License Required; Change of Exempt Status Statute or Rule 59A (3), F.A.C. 59A (3), F.A.C. When a change to the exempt status occurs to an exempt facility or entity that causes it to no longer qualify for an exemption, any exempt status claimed or reflected in a certificate of exemption ceases on the date the facility or entity no longer qualifies for a certificate of exemption. In such case, the health care clinic must file with the Agency a license application under Sections , F.S., within 5 If the final closing/sale of the clinic has been completed and exempt status no longer applies, application must be submitted within 5 days after the closing/sale. If no application has been submitted and the clinic is in operation, see Z827 for citation. Facilities that have a certificate of exemption or self-determined that their facility is exempt, or a facility that provides services in which remuneration is by cash, check, or credit card, not third party payments, (seek third party insurance reimbursement), and who become a business that meets the definition of a health care clinic must submit an application within 5 days of meeting the definition. If the facility fails to meet the 5 day standard they are to be

9 Page 9 of 69 days of becoming a health care clinic and shall be subject to all provisions applicable to unlicensed health care clinics. Failure to timely file an application for licensure within 5 days of becoming a health care clinic will render the health care clinic unlicensed and subject the owners, medical or clinic directors and the health care clinic to sanctions under Sections , F.S.. considered an unlicensed facility. The surveyor can confirm the 5 day period is met by record review of documentation demonstrating the application was mailed or faxed to the Heath Care Clinic Unit within the five (calendar) day period. 59A (l), FAC For health care clinics that are in operation at the time of the survey, the surveyor will select a sample of at least five (5) patient medical records from the previous 6 months of operation with at least one Medicaid file, if certified as a Medicaid provider, plus the five (5) billing records that correspond with the five patient records; ST - U Notice of Insurance Fraud Display Title Notice of Insurance Fraud Display Statute or Rule (9), F.S (9), F.S. In addition to the requirements of part II of chapter 408, the clinic shall display a sign in a conspicuous location within the clinic readily visible to all patients indicating that, pursuant to s , the Department of Financial Services may pay rewards of up to $25,000 to persons providing information leading to the arrest and conviction of persons committing crimes investigated by the Division of Insurance Fraud arising from violations of s , s , s , s , or s The Notice of Insurance Fraud should be displayed in a public area within the clinic, such as the reception area or the front desk, at eye level where it is visible to all patients prior to entering an examination room. ST - U Level 2 Background Screening Required Title Level 2 Background Screening Required Statute or Rule (5)(a-b), F.S.

10 Page 10 of (5), F.S. (a) As used in this subsection, the term "applicant" means individuals owning or controlling, directly or indirectly, 5 percent or more of an interest in a clinic; the medical or clinic director, or a similarly titled person who is responsible for the day-to-day operation of the licensed clinic; the financial officer or similarly titled individual who is responsible for the financial operation of the clinic; and licensed health care practitioners at the clinic. (b) The agency shall require level 2 background screening for applicants and personnel as required in s (1)(e) pursuant to chapter 435 and s Individuals who are required to be screened for Level II Standards: 1. Individuals owning or controlling 5 percent or more of an interest in a clinic; 2. The medical or clinic director, or a similarly titled person who is responsible for the day-to-day operation of the licensed clinic; 3. The financial officer or similarly titled individual who is responsible for the financial operation of the clinic; and 4. Licensed health care practitioners at the clinic. Note: Surveyors may encounter, during the survey record review, telemedicine providers who interpret diagnostic tests, i.e. MRI, CT, X-Ray, EKG, EEG, Pulmonary Function, who are not classified as "practitioners at the clinic" and would not be required to undergo level II background screening even though the providers may be under global billing agreements with the health care clinic. If the telemedicine providers work, even only occasionally, in the physical facility of the clinic they are then required to be level II screened. Clinic shall maintain a log of all natural persons required and who have been screened under Level II criteria. See U-308, Clinic Responsibilities ST - U Proof of Financial Ability to Operate Title Proof of Financial Ability to Operate Statute or Rule 59A (1), F.A.C. 59A (1), F.A.C. When evidence of financial instability of a health care clinic is substantiated, the Agency will notify the health care clinic in writing that satisfactory proof of financial ability to comply Upon Agency request, clinic must provide the following documentation: - Checks and drafts returned due to insufficient funds - Delinquent bills for such items as personnel salaries, drugs, lease, mortgage, utilities or other operational costs - Appointment of a receiver

11 Page 11 of 69 with Chapter 400, Part X, F.S., must be provided. (1) Evidence of financial instability of a health care clinic shall, without limitation, include issuance of checks and drafts for which there are insufficient funds, delinquent bills for such items as personnel salaries, drugs, lease, mortgage, utilities or other operational costs, appointment of a receiver, a voluntary or involuntary petition for bankruptcy, a voluntary arrangement with creditors, health care clinic closure, discontinuance of health care clinic business for more than 60 consecutive days or insolvency. - A voluntary or involuntary petition for bankruptcy - A voluntary arrangement with creditors - Health care clinic closure - Discontinuance of health care clinic business for more than 60 consecutive days or insolvency. ST - U M.R.I. Accreditation Title M.R.I. Accreditation Statute or Rule (7)(a), F.S (7)(a), F.S. Each clinic engaged in magnetic resonance imaging services must be accredited by a national accrediting organization that is approved by the Centers for Medicare and Medicaid Services for magnetic resonance imaging and advanced diagnostic imaging services within 1 year after licensure. A clinic that is accredited or that is within the original 1-year period after licensure and replaces its core magnetic resonance imaging equipment shall be given 1 year after the date on which the equipment is replaced to attain accreditation. However, a clinic may request a single, 6-month extension if it provides evidence to the agency establishing that, for good cause shown, such clinic cannot be accredited within 1 year after licensure, and that such accreditation will be completed within the 6-month extension. After obtaining accreditation as required by this subsection, each such clinic must maintain accreditation as a condition of renewal of its license. A clinic that files a change of ownership application must comply with Review documentation of accreditation status.

12 Page 12 of 69 the original accreditation timeframe requirements of the transferor. The agency shall deny a change of ownership application if the clinic is not in compliance with the accreditation requirements. When a clinic adds, replaces, or modifies magnetic resonance imaging equipment and the accrediting agency requires new accreditation, the clinic must be accredited within 1 year after the date of the addition, replacement, or modification but may request a single, 6-month extension if the clinic provides evidence of good cause to the agency. ST - U Right Of Inspection; Provider On Site Title Right Of Inspection; Provider On Site Statute or Rule (7)(d), F.S (7)(d), F.S. If a provider is not available when an inspection is attempted, the application shall be denied. In the event a surveyor finds a facility closed on the day of inspection, the surveyor should attempt to contact the owner, manager, financial officer, or medical/clinic director by telephone and allow an opportunity to open the facility for surveyor inspection prior to a recommendation for denial of licensure. If telephone contact is unsuccessful, call the Health Care Clinic Unit to determine hours of operation. Any recommendation for denial should be submitted to the Field Office supervisor for consultation with the Health Care Clinic Unit for approval ST - U Medical Director Required Title Medical Director Required Statute or Rule (1), F.S., 59A (1) (1), F.S. See U0430 re: Administrative Action for no medical or clinic director

13 Page 13 of 69 Each clinic shall appoint a medical director or clinic director who shall agree in writing to accept legal responsibility for the following activities on behalf of the clinic. 59A (1), F.A.C. A licensed health care clinic may not operate or be maintained without the day-to-day supervision of a single medical or clinic director as defined in Section (5), F.S. ST - U Medical Director Required; Written Agreement Title Medical Director Required; Written Agreement Statute or Rule 59A (3)(b), FAC; (2), FS 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (b) Copy of medical or clinic director's written agreement with the health care clinic assuming the responsibilities for the statutory activities in Sections (1)(a)-(i), F.S. If the medical or clinic director signs the Medical/Clinic Director Attestation, AHCA Form , incorporated by reference in Rule 59A , F.A.C., acknowledging these responsibilities as specified in Section , F.S., this requirement is met; (2), F.S. Any contract to serve as a medical director or a clinic director entered into or renewed by a physician or a licensed health care practitioner in violation of this part is void as contrary to public policy. This subsection shall apply to contracts entered

14 Page 14 of 69 into or renewed on or after March 1, ST - U Medical Director; Qualifications Title Medical Director; Qualifications Statute or Rule (5) FS; 59A (2) &.012(3)a 59A (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (a) The professional license or facsimile of the license for the medical or clinic director; Medical or Clinic Director should present DOH license to practice. License must be current (not expired) (5), F.S. "Medical director" means a physician who is employed or under contract with a clinic and who maintains a full and unencumbered physician license in accordance with chapter 458, chapter 459, chapter 460, or chapter 461. However, if the clinic does not provide services pursuant to the respective physician practices acts listed in this subsection, it may appoint a Florida-licensed health care practitioner who does not provide services pursuant to the respective physician practices acts listed in this subsection to serve as a clinic director who is responsible for the clinic ' s activities. A health care practitioner may not serve as the clinic director if the services provided at the clinic are beyond the scope of that practitioner's license, except that a licensee specified in s (3)(b) who provides only services authorized pursuant to s (3)(b) may serve as clinic director of an entity providing services as specified in s (3)(b). 59A , F.A.C.

15 Page 15 of 69 (2) By statutory definition in Section (5), F.S., a medical director is a health care practitioner that holds an active and unencumbered Florida physician ' s license in accordance with Chapters 458 (medical physician), 459 (osteopathic physician), 460 (chiropractic physician) or 461 (podiatric physician), F.S. A suspended or non-renewed license is considered an encumbered license, as is a license that restricts the license holder from performing health care services in a manner or under supervision different from a license holder without board or Department of Health restrictions. ST - U Medical Director; On Site for Survey Title Medical Director; On Site for Survey Statute or Rule 59A (2), F.A.C. 59A (2), F.A.C. (2) The medical or clinic director must attend the survey entrance conference and be available when the survey is conducted for the surveyor to determine compliance with minimum standards and requirements for licensure. Other key personnel required include the financial director, a representative of management or ownership and persons responsible for patient records and billing. Flexibility is left to the surveyor in determining "persons required to be present" for licensure survey, as a result of required person travel time and availability, (i.e.: physicians conducting surgical procedures off site). On "Initial", (announced) surveys the surveyor should require all required persons to be present. For unannounced re-licensure and complaint surveys the surveyor may use personal judgment in permitting contact with required facility personnel by telephone. Persons who may be required to be present for licensure survey: 1. Medical or Clinic Director 2. Owner or Manager 3. Financial Director 4. Records/Billing Personnel

16 Page 16 of 69 ST - U Medical Director; Max Number of Clinics Title Medical Director; Max Number of Clinics Statute or Rule 59A , F.A.C. 59A , F.A.C. A medical or clinic director may not serve in that capacity for more than a maximum of five health care clinics with a cumulative total of more than 200 employees and persons under contract with the health care clinic at any given time. A medical or clinic director may not supervise a health care clinic more than 200 miles from any other health care clinic supervised by the same medical or clinic director. Review copy of application to verify number of clinics for medical director and their locations. ST - U Clinic Responsibilities-Sign Identify Med Dir Title Clinic Responsibilities-Sign Identify Med Dir Statute or Rule (1)(a), F.S (1), F.S. The medical director or the clinic director shall: (a) Have signs identifying the medical director or clinic director posted in a conspicuous location within the clinic readily visible to all patients. A sign identifying the Medical or Clinic Director should be displayed in a public area within the clinic, such as the reception area or the front desk, at eye level where it is visible to all patients prior to entering an examination room.

17 Page 17 of 69 ST - U Clinic Responsibilities-Organizational Chart Title Clinic Responsibilities-Organizational Chart Statute or Rule 59A (3)(p), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: Clinic should have an organizational chart identifying Medical Director, Officers/Managers, and other key individuals in order of authority. (p) An organizational flow chart with lines of authority and names of key individuals and positions; ST - U Clinic Responsiblities-Log of Level 2 Bkgd Ck Title Clinic Responsiblities-Log of Level 2 Bkgd Ck Statute or Rule 59A (3)(r), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: Clinic must present a log of persons screened for Level II standards. Log must include persons required to be screened by statute. See U-0175, Background Screening Required (r) Log of all natural persons required and who have been screened under Level 2 criteria of Chapter 435 and Section , F.S.;

18 Page 18 of 69 ST - U Clinic Responsibilities-Licensed Staff Title Clinic Responsibilities-Licensed Staff Statute or Rule (1)(b) FS; 59A (3)(j) , F.S. (1) The medical director or the clinic director shall: (b) Ensure that all practitioners providing health care services or supplies to patients maintain a current active and unencumbered Florida license. Clinic shall have a copy of DOH licenses on file for all health care practitioners. Licenses must be current (not expired). 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (j) Copies of professional licenses issued by the respective boards and the Department of Health under the several practice acts; ST - U Clinic Responsibilities-Staff Operations Title Clinic Responsibilities-Staff Operations Statute or Rule 59A (3)(c), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the Clinic should have policies, procedures, protocols and guidelines for daily operations at the clinic. Policies/procedures should be available for staff use.

19 Page 19 of 69 time of the survey: (c) Written policies, protocols, guidelines and procedures used or to be used by the facility staff in day-to-day operations. This includes protocols for physician assistants and advanced registered nurse practitioners plus a copy of the supervision form submitted to the Department of Health by the physician supervisor Clinic should have copy of the supervision form submitted to DOH by the physician supervisor on file for all PAs and ARNPs on staff. ST - U Clinic Responsibilities-Patient Contracts Rvw Title Clinic Responsibilities-Patient Contracts Rvw Statute or Rule (1)(c), F.S , F.S. (1) The medical director or the clinic director shall: (c) Review any patient referral contracts or agreements executed by the clinic. ST - U Clinic Responsibilities-Patient Contracts Rvw Title Clinic Responsibilities-Patient Contracts Rvw Statute or Rule 59A (3)(k), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey:

20 Page 20 of 69 (k) Any patient referral contracts or agreements of the health care clinic that are in writing and a disclosure to the surveyor of any such agreements that are not in writing including the names of the parties to the agreement, the date and the essential terms of agreement; ST - U Clinic Responsibilities-Patient Referrals Title Clinic Responsibilities-Patient Referrals Statute or Rule (1)(h), F.S , F.S. (1) The medical director or the clinic director shall: (h) Not refer a patient to the clinic if the clinic performs magnetic resonance imaging, static radiographs, computed tomography, or positron emission tomography. The term "refer a patient" means the referral of one or more patients of the medical or clinical director or a member of the medical or clinical director's group practice to the clinic for magnetic resonance imaging, static radiographs, computed tomography, or positron emission tomography. A medical director who is found to violate this paragraph commits a felony of the third degree, punishable as provided in s , s , or s The medical director of a licensed clinic may not refer his/her patient or the patient of any other physician from his/her (group) practice to the licensed clinic for the following diagnostic tests/scans: Magnetic Resonance Imaging (MRI) Static Radiographs Computed Tomography (CT) Positron Emission Tomography (PET) There must be two clinics involved to substantiate a violation: a licensed clinic and a separate (group) practice that the medical director is a member of and from which a patient referral is made. A medical director may not refer any patient to the licensed clinic for designated tests/scans at which he or she serves as the medical director when that patient is from his/her private (group) practice. Violation of this provision is a mandatory report to the Department of Health, MQA Consumer Services. An internal referral of the medical director for a patient of the licensed clinic is not a violation. Surveyor Questions for the Medical Director: 1. Are you also a member of a separate (group) practice? If NO, there is no violation. If YES, go to question Have you referred any patient of yours or a patient of the group practice to this clinic for MRI, X-RAY, CT or

21 Page 21 of 69 PET scan. If NO, there is no violation. If YES, document referrals using principles of documentation and follow recommended guidelines for discipline and outside referral. ST - U Clinic Responsibilities-Publish Fee Schedules This section of statute is not to be confused with , F.S. known as the Patient Self-Referral Act. Title Clinic Responsibilities-Publish Fee Schedules Statute or Rule (1)(i); ; (30), FS , F.S. (1) The medical director or the clinic director shall: (i) Ensure that the clinic publishes a schedule of charges for the medical services offered to patients. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the urgent care center and must include, but is not limited to, the 50 services most frequently provided by the clinic. The schedule may group services by three price levels, listing services in each price level. The posting may be a sign that must be at least 15 square feet in size or through an electronic messaging board that is at least 3 square feet in size. The failure of a clinic to publish and post a schedule of charges as required by this section shall result in a fine of not more than $1,000, per day, until the schedule is published and posted , F.S. (30) "Urgent care center" means a facility or clinic that provides immediate but not emergent ambulatory medical care Verify whether clinic meets definition as "Urgent Care Center" ( (30), F.S.) upon statutory definitions. Initial Survey: Clinic must be in compliance with TAG in order to pass survey. Clinic shall identify the 50 most frequently provided services and post on Schedule of Services and Prices in patients' waiting room. Complaint, CHOW (when requested by central office) and Renewal surveys: If fee schedule is appropriately published and posted, survey should sample billings to verify published fee schedule is still accurate. Use POC for corrections. If uncorrected, statement of deficiency may recommend a discretionary fine of up to $1,000. For period of time clinic complies with clinic responsibility, there is no fine. When survey substantiates clinic fails or failed to publish and post the fee schedule, survey should recommend fine of $1,000 per day for each day of substantiated non-compliance until compliance is met. *A Plan of Correction will not prevent fine if there is no posted and published sign in patient or client reception area. Contact central office for technical assistance. *A timely completed Plan of Correction will eliminate fine until January 1, After that date, the statutory fine will be imposed regardless of corrective action.

22 Page 22 of 69 to patients. The term includes an offsite emergency department of a hospital that is presented to the general public in any manner as a department where immediate and not only emergent medical care is provided. The term also includes: (a) An offsite facility of a facility licensed under this chapter, or a joint venture between a facility licensed under this chapter and a provider licensed under chapter 458 or chapter 459, that does not require a patient to make an appointment and is presented to the general public in any manner as a facility where immediate but not emergent medical care is provided. (b) A clinic organization that is licensed under part X of chapter 400, maintains three or more locations using the same or a similar name, does not require a patient to make an appointment, and holds itself out to the general public in any manner as a facility or clinic where immediate but not emergent medical care is provided Urgent care centers; publishing and posting schedule of charges; penalties.- (1) An urgent care center must publish and post a schedule of charges for the medical services offered to patients. (2) The schedule of charges must describe the medical services in language comprehensible to a layperson. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area and must include, but is not limited to, the 50 services most frequently provided. The schedule may group services by three price levels, listing services in each price level. The posting may be a sign, which must be at least 15 square feet in size, or may be through an electronic messaging board. If an urgent care center is affiliated with a facility licensed under this chapter, the schedule must include text that notifies the insured patients whether the charges for

23 Page 23 of 69 medical services received at the center will be the same as, or more than, charges for medical services received at the affiliated hospital. The text notifying the patient of the schedule of charges shall be in a font size equal to or greater than the font size used for prices and must be in a contrasting color. The text that notifies the insured patients whether the charges for medical services received at the center will be the same as, or more than, charges for medical services received at the affiliated hospital shall be included in all media and Internet advertisements for the center and in language comprehensible to a layperson. (3) The posted text describing the medical services must fill at least 12 square feet of the posting. A center may use an electronic device or messaging board to post the schedule of charges. Such a device must be at least 3 square feet, and patients must be able to access the schedule during all hours of operation of the urgent care center. (4) An urgent care center that is operated and used exclusively for employees and the dependents of employees of the business that owns or contracts for the urgent care center is exempt from this section. (5) The failure of an urgent care center to publish and post a schedule of charges as required by this section shall result in a fine of not more than $1,000, per day, until the schedule is published and posted. ST - U Clinic Responsibilities - Personnel File Title Clinic Responsibilities - Personnel File Statute or Rule 59A (3)(h) 59A (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey:

24 Page 24 of 69 (h) Personnel files; ST - U Clinic Responsibilities-Level of Care Title Clinic Responsibilities-Level of Care Statute or Rule (1)(d), 59A (3)(j) , F.S. (1) The medical director or the clinic director shall: (d) Ensure that all health care practitioners at the clinic have active appropriate certification or licensure for the level of care being provided. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (j) Copies of professional licenses issued by the respective boards and the Department of Health under the several practice acts; ST - U Clinic Responsibilities-Services Provided Title Clinic Responsibilities-Services Provided Statute or Rule 59A (3)(n), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the Services being provided at the clinic should match those services listed on the licensure application.

25 Page 25 of 69 time of the survey: (n) List of services provided or a general descriptor of scope, level and complexity of care for services provided; ST - U Clinic Responsibilities-Clinic Records Owner Title Clinic Responsibilities-Clinic Records Owner Statute or Rule (1)(e), F.S , F.S. (1) The medical director or the clinic director shall: (e) Serve as the clinic records owner as defined in s For undisclosed change of ownership (CHOW) and closure only, request a copy of the written agreement regarding medical record ownership. ST - U Clinic Responsibilities-Clinic Records System Title Clinic Responsibilities-Clinic Records System Statute or Rule 59A (3)(d), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (d) Any policies, procedures, guidelines, checklists and/or means that are used in the systematic creation and maintenance of the health care clinic's medical record system; Clinic shall demonstrate the means by which medical records are created and maintained, which may include but not be limited to, policies, procedures, guidelines, and/or checklists.

26 Page 26 of 69 ST - U Clinic Resp-Records, Surgery, Adv Incidents Title Clinic Resp-Records, Surgery, Adv Incidents Statute or Rule (1)(f), F.S., 59A (3)(e-g) , F.S. (1) The medical director or the clinic director shall: (f) Ensure compliance with the recordkeeping, office surgery, and adverse incident reporting requirements of chapter 456, the respective practice acts, and rules adopted under this part and part II of chapter A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (e) Any policies, procedures, guidelines, checklists that demonstrate compliance with the medical records retention, disposition, reproduction, and disclosure requirements of the medical or clinic director's practice act; (f) Any policies, procedures, guidelines, checklists that demonstrate compliance with the office surgery requirements of the practice acts for services performed at the facility; (g) Any policies, procedures, guidelines, checklists that demonstrate compliance with adverse incident reporting requirements and injury disclosure; Clinic shall demonstrate compliance with the medical records retention, disposition, reproduction, and disclosure requirements of the medical or clinic director's practice act. This may include but not be limited to methods and techniques used, policies, procedures, guidelines, and checklists. Clinic shall demonstrate compliance with the office surgery requirements of the practice acts for services performed at the facility. Clinic must demonstrate compliance with adverse incident reporting requirements and injury disclosure.

27 Page 27 of 69 ST - U Clinic Reponsibilities-Systematic Bill Rvw Title Clinic Reponsibilities-Systematic Bill Rvw Statute or Rule (1)(g), F.S., 59A (3)(m) , F.S. (1) The medical director or the clinic director shall: (g) Conduct systematic reviews of clinic billings to ensure that the billings are not fraudulent or unlawful. Upon discovery of an unlawful charge, the medical director or clinic director shall take immediate corrective action. If the clinic performs only the technical component of magnetic resonance imaging, static radiographs, computed tomography, or positron emission tomography, and provides the professional interpretation of such services, in a fixed facility that is accredited by a national accrediting organization that is approved by the Centers for Medicare and Medicaid Services for magnetic resonance imaging and advanced diagnostic imaging services and if, in the preceding quarter, the percentage of scans performed by that clinic which was billed to all personal injury protection insurance carriers was less than 15 percent, the chief financial officer of the clinic may, in a written acknowledgment provided to the agency, assume the responsibility for the conduct of the systematic reviews of clinic billings to ensure that the billings are not fraudulent or unlawful. Clinic must present a description of systematic review including: 1. Sample(s) reviewed by the medical director or clinic director at least once every 30 days. Sample size is not specified in statute/rule. 2. Record maintained (for at least 3 years) identifying the medical records reviewed and when/what corrective action taken for fraudulent or unlawful billings. 3. A log of systematic reviews shall be kept and maintained in a discrete file at the health care clinic for review on request of the Agency during the retention period. 59A (l), FAC For health care clinics that are in operation at the time of the survey, the surveyor will select a sample of at least five (5) patient medical records from the previous 6 months of operation with at least one Medicaid file, if certified as a Medicaid provider, plus the five (5) billing records that correspond with the five patient records; 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (m) Description of means by which the health care clinic conducts a systematic review of billings that ensures billings

28 Page 28 of 69 are not fraudulent or unlawful. A sample must be reviewed by the medical director or clinic director at least once every 30 days and a record maintained by the health care clinic for at least three years identifying the records reviewed and when and what action was taken to correct fraudulent or unlawful billings. A log of systematic reviews shall be kept and maintained in a discrete file at the health care clinic for review on request of the Agency during the retention period; ST - U Clinic Responsibilities-Record Sign Off Title Clinic Responsibilities-Record Sign Off Statute or Rule 59A (3)(q), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (q) An all-inclusive and up to date listing of original signatures and initials of all persons entering information on billing and patient records, the printed name and medical designation, if any, such as PA, RN, MD, etc. The log shall be kept and concurrently maintained at the health care clinic. Information required by this rule shall be stored and maintained by the health care clinic for a period of 5 years. All-inclusive and up to date listing of original signatures and initials of all persons entering information on billing and patient records, including the printed name and medical designation, if any, such as PA, RN, MD, etc. The log shall be kept and concurrently maintained at the health care clinic. Information shall be stored and maintained by the health care clinic for a period of 5 years. ST - U Clinic Responsibilities-Equipment Certified Title Clinic Responsibilities-Equipment Certified Statute or Rule 59A (3)(o), F.A.C.

29 Page 29 of 69 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (o) Current diagnostic and treatment equipment records showing equipment certification when such equipment must have regulatory certification. This requirement is met with presentation of a current maintenance agreement; Current diagnostic and treatment equipment records showing equipment certification when such equipment must have regulatory certification. This requirement is met with presentation of a current maintenance agreement. ST - U Clinic Responsibilities-Med Dir Oversight Title Clinic Responsibilities-Med Dir Oversight Statute or Rule 59A (3)(i), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey: (i) Logs, charts or notes demonstrating day-to-day oversight of health care clinic activities by the medical or clinic director; Clinic shall provide a description or manner of review demonstrating the oversight of daily clinic activities by the medical or clinic director which may include but not be limited to logs, charts or notes. Review may be weekly, bi-weekly, etc. but should document that daily activities have been reviewed. ST - U Clinic Responsibilities-Compliance by Med Dir Title Clinic Responsibilities-Compliance by Med Dir Statute or Rule 59A (3)(s), F.A.C. 59A , F.A.C. (3) To facilitate a licensure survey, the health care clinic shall The clinic shall have documentation for the past two years (or from the date of licensure, whichever is earlier) that demonstrates actions taken by the medical or clinic director to perform the functions, duties, and clinic

30 Page 30 of 69 have the following materials readily available for review at the time of the survey: (s) Documentation for the past two years or from the date of licensure, whichever is earlier, demonstrating in writing compliance, when, and what action was taken by the medical or clinic director to perform the functions, duties and clinic responsibilities under Sections (1)(a)-(i), F.S. Such documentation shall be made available to authorized agency personnel upon request. responsibilities. Documentation must be in writing and include dates and specific action taken by medical director to maintain compliance with clinic reponsiblities. Documentation shall be made available to the authorized agency personnel upon request. ST - U Violation of This Part; Lic Deny, Revoc, Fine Title Violation of This Part; Lic Deny, Revoc, Fine Statute or Rule (1)-(2), F.S , F.S. (1) In addition to the requirements of part II of chapter 408, the agency may deny the application for a license renewal, revoke and suspend the license, and impose administrative fines of up to $5,000 per violation for violations of the requirements of this part or rules of the agency. In determining if a penalty is to be imposed and in fixing the amount of the fine, the agency shall consider the following factors: (a) The gravity of the violation, including the probability that death or serious physical or emotional harm to a patient will result or has resulted, the severity of the action or potential harm, and the extent to which the provisions of the applicable laws or rules were violated. (b) Actions taken by the owner, medical director, or clinic director to correct violations. (c) Any previous violations. (d) The financial benefit to the clinic of committing or continuing the violation.

31 Page 31 of 69 (2) Each day of continuing violation after the date fixed for termination of the violation, as ordered by the agency, constitutes an additional, separate, and distinct violation. ST - U No Medical Director; Emergency Suspension Title No Medical Director; Emergency Suspension Statute or Rule (1), F.S., 59A (3) (1), F.S. Failure by a clinic to employ a qualified medical director or clinic director constitutes a ground for emergency suspension of the license by the agency pursuant to s A (3), F.A.C. The Agency shall issue an emergency order suspending the license of any health care clinic operated or maintained without a medical or clinic director as required by Sections , F.S., and this rule for such period of time as the health care clinic is without a medical or clinic director. ST - U False Application; 3rd Degree Felony Title False Application; 3rd Degree Felony Statute or Rule (4), F.S (4), F.S. (a) Regardless of whether notification is provided by the

32 Page 32 of 69 agency under s , a person commits a felony of the third degree, punishable as provided in s , s , or s , if the person knowingly: 1. Establishes, owns, operates, manages, or maintains an unlicensed clinic required to be licensed under this part or part II of chapter 408; or 2. Offers or advertises services that require licensure as a clinic under this part or part II of chapter 408 without a license. (b) If the agency provides notification under s of, or if a person is arrested for, a violation of subparagraph (a)1. or subparagraph (a)2., each day during which a violation of subparagraph (a)1. or subparagraph (a)2. occurs constitutes a separate offense. (c) A person convicted of a second or subsequent violation of subparagraph (a)1. or subparagraph (a)2. commits a felony of the second degree, punishable as provided in s , s , or s If the agency provides notification of, or if a person is arrested for, a violation of this paragraph, each day that this paragraph is violated thereafter constitutes a separate offense. For purposes of this paragraph, the term "convicted" means a determination of guilt which is the result of a trial or the entry of a plea of guilty or nolo contendere, regardless of whether adjudication is withheld. (d) In addition to the requirements of part II of chapter 408, a health care provider who is aware of the operation of an unlicensed clinic shall report the clinic to the agency. The agency shall report to the provider's licensing board a failure to report a clinic that the provider knows or has reasonable cause to suspect is unlicensed. (e) A person commits a felony of the third degree, punishable

33 Page 33 of 69 as provided in s , s , or s , if the person knowingly: 1. Files a false or misleading license application or license renewal application or files false or misleading information related to such application or agency rule; or 2. Fails to report information to the agency as required by s (3). ST - U Licensed Provider/ Unlicensed Clinc;$5000/day Title Licensed Provider/ Unlicensed Clinc;$5000/day Statute or Rule (4), F.S (4), F.S. Any licensed clinic whose owner, medical director, or clinic director concurrently operates an unlicensed clinic shall be subject to an administrative fine of $5,000 per day. ST - U Injunctions Title Injunctions Statute or Rule (1)(2), F.S (1)(2), F.S. (1) In addition to the other powers provided by this part, authorizing statutes, and applicable rules, the agency may institute injunction proceedings in a court of competent jurisdiction to: (a) Restrain or prevent the establishment or operation of a

34 Page 34 of 69 provider that does not have a license or is in violation of any provision of this part, authorizing statutes, or applicable rules. The agency may also institute injunction proceedings in a court of competent jurisdiction when a violation of this part, authorizing statutes, or applicable rules constitutes an emergency affecting the immediate health and safety of a client. (b) Enforce the provisions of this part, authorizing statutes, or any minimum standard, rule, or order issued or entered into pursuant thereto when the attempt by the agency to correct a violation through administrative sanctions has failed or when the violation materially affects the health, safety, or welfare of clients or involves any operation of an unlicensed provider. (c) Terminate the operation of a provider when a violation of any provision of this part, authorizing statutes, or any standard or rule adopted pursuant thereto exists that materially affects the health, safety, or welfare of a client. Such injunctive relief may be temporary or permanent. (2) If action is necessary to protect clients of providers from immediate, life-threatening situations, the court may allow a temporary injunction without bond upon proper proofs being made. If it appears by competent evidence or a sworn, substantiated affidavit that a temporary injunction should be issued, the court, pending the determination on final hearing, shall enjoin the operation of the provider. ST - UZ800 - Applicability; Definitions Title Applicability; Definitions Statute or Rule ; 59A ; 59A (1)

35 Page 35 of Applicability.- The provisions of this part apply to the provision of services that require licensure as defined in this part and to the following entities licensed, registered, or certified by the agency, as described in chapters 112, 383, 390, 394, 395, 400, 429, 440, 483, and 765: (1) Laboratories authorized to perform testing under the Drug-Free Workplace Act, as provided under ss and (2) Birth centers, as provided under chapter 383. (3) Abortion clinics, as provided under chapter 390. (4) Crisis stabilization units, as provided under parts I and IV of chapter 394. (5) Short-term residential treatment facilities, as provided under parts I and IV of chapter 394. (6) Residential treatment facilities, as provided under part IV of chapter 394. (7) Residential treatment centers for children and adolescents, as provided under part IV of chapter 394. (8) Hospitals, as provided under part I of chapter 395. (9) Ambulatory surgical centers, as provided under part I of chapter 395. (10) Mobile surgical facilities, as provided under part I of chapter 395. (11) Health care risk managers, as provided under part I of chapter 395. (12) Nursing homes, as provided under part II of chapter 400. (13) Assisted living facilities, as provided under part I of chapter 429. (14) Home health agencies, as provided under part III of chapter 400. (15) Nurse registries, as provided under part III of chapter 400. (16) Companion services or homemaker services providers, as

36 Page 36 of 69 provided under part III of chapter 400. (17) Adult day care centers, as provided under part III of chapter 429. (18) Hospices, as provided under part IV of chapter 400. (19) Adult family-care homes, as provided under part II of chapter 429. (20) Homes for special services, as provided under part V of chapter 400. (21) Transitional living facilities, as provided under part V of chapter 400. (22) Prescribed pediatric extended care centers, as provided under part VI of chapter 400. (23) Home medical equipment providers, as provided under part VII of chapter 400. (24) Intermediate care facilities for persons with developmental disabilities, as provided under part VIII of chapter 400. (25) Health care services pools, as provided under part IX of chapter 400. (26) Health care clinics, as provided under part X of chapter 400. (27) Clinical laboratories, as provided under part I of chapter 483. (28) Multiphasic health testing centers, as provided under part II of chapter 483. (29) Organ, tissue, and eye procurement organizations, as provided under part V of chapter Definitions.-As used in this part, the term: (1) "Agency" means the Agency for Health Care Administration, which is the licensing agency under this part. (2) "Applicant" means an individual, corporation, partnership, firm, association, or governmental entity that submits an application for a license to the agency.

37 Page 37 of 69 (3) "Authorizing statute" means the statute authorizing the licensed operation of a provider listed in s and includes chapters 112, 383, 390, 394, 395, 400, 429, 440, 483, and 765. (4) "Certification" means certification as a Medicare or Medicaid provider of the services that require licensure, or certification pursuant to the federal Clinical Laboratory Improvement Amendment (CLIA). (5) "Change of ownership" means: (a) An event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number; or (b) An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange. A change solely in the management company or board of directors is not a change of ownership. (6) "Client" means any person receiving services from a provider listed in s (7) "Controlling interest" means: (a) The applicant or licensee; (b) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the applicant or licensee; or (c) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the management company or other entity, related or unrelated, with which the applicant or licensee contracts to manage the provider. The term does not include a voluntary board member. (8) "License" means any permit, registration, certificate, or license issued by the agency.

38 Page 38 of 69 (9) "Licensee" means an individual, corporation, partnership, firm, association, governmental entity, or other entity that is issued a permit, registration, certificate, or license by the agency. The licensee is legally responsible for all aspects of the provider operation. (10) "Moratorium" means a prohibition on the acceptance of new clients. (11) "Provider" means any activity, service, agency, or facility regulated by the agency and listed in s (12) "Services that require licensure" means those services, including residential services, that require a valid license before those services may be provided in accordance with authorizing statutes and agency rules. (13) "Voluntary board member" means a board member or officer of a not-for-profit corporation or organization who serves solely in a voluntary capacity, does not receive any remuneration for his or her services on the board of directors, and has no financial interest in the corporation or organization. 59A Definitions. (1) "Address of record" means the location that is printed on the license and is the address at which the provider is licensed to operate. In the event a license displays multiple locations including branch offices, satellite offices, or off-site locations, the address of record is the main or principle office address. (2) "Agency notification" or "Agency request" means the Agency sends notification by: (a) Mail or personal delivery to the address of record for a licensee or applicant, (b) Mail to an alternative mailing address if requested by the licensee or applicant, or (c) Electronic mail if an electronic mail address has been provided. (3) "Days" means calendar days.

39 Page 39 of 69 (4) "Management company" means an entity retained by a licensee to administer or direct the operation of a provider. This does not include an entity that serves solely as a lender or lien holder. 59A Background Screening. (1) Definitions: (a) "Arrest Report" means the detailed narrative written by the arresting law enforcement officer explaining the circumstances of the arrest. (b) "Disposition" means the sentencing or other final settlement of a criminal case which shall include, regardless of adjudication, a plea of nolo contendere or guilty, or a conviction by a judge or jury. (c) "Disqualifying Offense" means any criminal offense prohibited in Section or (5), F.S. (d) "Exemption from Disqualification" means an exemption granted by the Agency following a review of the Application for Exemption, AHCA Form , May 2015, hereby incorporated by reference, and available at < 5>, and an informal teleconference, during which the individual must present clear and convincing evidence to support a reasonable belief that he or she has been rehabilitated and does not present a danger to the health, safety, and welfare of the patient or individual as described in Section , F.S. (e) "FBI" means the Federal Bureau of Investigation. (f) "FDLE" means the Florida Department of Law Enforcement. (g) "Level 2 Screening" means an assessment of the criminal history record obtained through a fingerprint search through the FDLE and FBI to determine whether screened individuals have any disqualifying offenses pursuant to Section or (5), F.S. An analysis and review of court dispositions

40 Page 40 of 69 and arrest reports may be required to make a final determination. (h) "Livescan Service Provider" means an entity that scans fingerprints electronically and submits them to FDLE. ST - UZ802 - License of Application Denial; Revocation Title License of Application Denial; Revocation Statute or Rule FS License or application denial; revocation.- (1) In addition to the grounds provided in authorizing statutes, grounds that may be used by the agency for denying and revoking a license or change of ownership application include any of the following actions by a controlling interest: (a) False representation of a material fact in the license application or omission of any material fact from the application. (b) An intentional or negligent act materially affecting the health or safety of a client of the provider. (c) A violation of this part, authorizing statutes, or applicable rules. (d) A demonstrated pattern of deficient performance. (e) The applicant, licensee, or controlling interest has been or is currently excluded, suspended, or terminated from participation in the state Medicaid program, the Medicaid program of any other state, or the Medicare program. (2) If a licensee lawfully continues to operate while a denial or revocation is pending in litigation, the licensee must continue to meet all other requirements of this part, authorizing statutes, and applicable rules and file subsequent renewal applications for licensure and pay all licensure fees. The provisions of ss (1) and (3)(c) do not apply to renewal applications filed during the time period in which the litigation

41 Page 41 of 69 of the denial or revocation is pending until that litigation is final. (3) An action under s or denial of the license of the transferor may be grounds for denial of a change of ownership application of the transferee. (4) Unless an applicant is determined by the agency to satisfy the provisions of subsection (5) for the action in question, the agency shall deny an application for a license or license renewal based upon any of the following actions of an applicant, a controlling interest of the applicant, or any entity in which a controlling interest of the applicant was an owner or officer when the following actions occurred: (a) A conviction or a plea of guilty or nolo contendere to, regardless of adjudication, a felony under chapter 409, chapter 817, chapter 893, 21 U.S.C. ss , or 42 U.S.C. ss , Medicaid fraud, Medicare fraud, or insurance fraud, unless the sentence and any subsequent period of probation for such convictions or plea ended more than 15 years before the date of the application; or (b) Termination for cause from the Medicare program or a state Medicaid program, unless the applicant has been in good standing with the Medicare program or a state Medicaid program for the most recent 5 years and the termination occurred at least 20 years before the date of the application. ST - UZ803 - License Required; Display Title License Required; Display Statute or Rule , F.S License required; display.- (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency - Check to see that the license is for the facility and location where it is displayed. Contact the appropriate licensure unit if there are questions about the license. - If applicable, check to make sure the category of testing being done is reflected on the license, the ownership given on the face of the license is accurate, that the location of the facility is the address printed on the license, and that the

42 Page 42 of 69 a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. (3) Any person who knowingly alters, defaces, or falsifies a license certificate issued by the agency, or causes or procures any person to commit such an offense, commits a misdemeanor of the second degree, punishable as provided in s or s Any licensee or provider who displays an altered, defaced, or falsified license certificate is subject to the penalties set forth in s and an administrative fine of $1,000 for each day of illegal display. license is properly displayed. Look at Z0827 Unlicensed Activity , F.S. as unlicensed activity should be cited if there has been a change of ownership, or for clinical laboratories, testing outside of the specialty/subspecialties printed on the license are being performed. - Regarding Nursing Homes, refer to (2) which states: Separate licenses shall be required for facilities maintained in separate premises, even though operated under the same management. However, a separate license shall not be required for separate buildings on the same grounds. - Regarding Labs, refer to 59A-7.021(3) which states: Separate licensure shall be required for all laboratories maintained on separate premises, as defined under subsection 59A-7.020(27), F.A.C., including mobile laboratory units, even though operated under the same management. Separate licensure shall not be required for separate buildings on the same or adjoining grounds. ST - UZ806 - Change of Address Title Change of Address Statute or Rule 59A (2-5), FAC (2) Any request to amend a license must be received by the Agency in advance of the requested effective date as detailed below. Requests to amend a license are not authorized until the license is issued. (a) Requests to change the address of record must be received by the Agency 60 to 120 days in advance of the requested effective date for the following provider types: 1. Birth Centers, as provided under Chapter 383, F.S.; 2. Abortion Clinics, as provided under Chapter 390, F.S.; 3. Crisis Stabilization Units, as provided under Parts I and IV of Chapter 394, F.S.; - The licensure unit handles change of address, but surveyors may find that the provider has moved and therefore could cite this.

43 Page 43 of Short Term Residential Treatment Units, as provided under Parts I and IV of Chapter 394, F.S. 5. Residential Treatment Facilities, as provided under Part IV of Chapter 394, F.S.; 6. Residential Treatment Centers for Children and Adolescents, as provided under Part IV of Chapter 394, F.S.; 7. Hospitals, as provided under Part I of Chapter 395, F.S.; 8. Ambulatory Surgical Centers, as provided under Part I of Chapter 395, F.S.; 9. Nursing Homes, as provided under Part II of Chapter 400, F.S.; 10. Hospices, as provided under Part IV of Chapter 400, F.S.; 11. Homes for Special Services as provided under Part V of Chapter 400, F.S.; 12. Transitional Living Facilities, as provided under Part V of Chapter 400, F.S.; 13. Prescribed Pediatric Extended Care Centers, as provided under Part VI of Chapter 400, F.S.; 14. Intermediate Care Facilities for the Developmentally Disabled, as provided under Part VIII of Chapter 400, F.S.; 15. Assisted Living Facilities, as provided under Part I of Chapter 429, F.S.; 16. Adult Family-Care Homes, as provided under Part II of Chapter 429, F.S.; 17. Adult Day Care Centers, as provided under Part III of Chapter 429, F.S. (b) Requests to change the address of record must be received by the Agency 21 to 120 days in advance of the requested effective date for the following provider types: 1. Drug Free Workplace Laboratories as provided under Sections and , F.S.; 2. Mobile Surgical Facilities, as provided under Part I of Chapter 395, F.S.; 3. Health Care Risk Managers, as provided under Part I of Chapter 395, F.S.;

44 Page 44 of Home Health Agencies, as provided under Part III of Chapter 400, F.S.; 5. Nurse Registries, as provided under Part III of Chapter 400, F.S.; 6. Companion Services or Homemaker Services Providers, as provided under Part III of Chapter 400, F.S.; 7. Home Medical Equipment Providers, as provided under Part VII of Chapter 400, F.S.; 8. Health Care Services Pools, as provided under Part IX of Chapter 400, F.S.; 9. Health Care Clinics, as provided under Part X of Chapter 400, F.S., including certificate of exemption; 10. Clinical Laboratories, as provided under Part I of Chapter 483, F.S.; 11. Multiphasic Health Testing Centers, as provided under Part II of Chapter 483, F.S.; 12. Organ and Tissue Procurement Agencies, as provided under Chapter 381, F.S. (c) All other requests to amend a license including but not limited to services, licensed capacity, and other specifications which are required to be displayed on the license by authorizing statutes or applicable rules must be received by the Agency 60 to 120 days in advance of the requested effective date. This deadline does not apply to a request to amend hospital emergency services defined in Section (2), F.S. (3) Failure to submit a timely request shall result in a $500 fine. (4) A licensee is not authorized to operate in a new location until a license is obtained which specifies the new location. Failure to amend a license prior to a change of the address of record constitutes unlicensed activity. (5) The licensee shall return the license certificate to the Agency upon the rendition of a final order revoking, cancelling or denying a license, and upon the voluntary discontinuance of operation.

45 Page 45 of 69 ST - UZ809 - Proof of Financial Ability to Operate Title Proof of Financial Ability to Operate Statute or Rule 59A (3)(e)&(7); (7) &.810(8) 59A (3)(e) FAC Proof of Financial Ability to Operate. "Financial instability" means the provider cannot meet its financial obligations. Evidence such as the issuance of bad checks, an accumulation of delinquent bills, or inability to meet current payroll needs shall constitute prima facie evidence that the ownership of the provider lacks the financial ability to operate. Evidence shall also include the Medicare or Medicaid program's indications or determination of financial instability or fraudulent handling of government funds by the provider (7) FS Definitions. "Controlling interest" means: (a) The applicant or licensee; (b) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the applicant or licensee; or (c) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the management company or other entity, related or unrelated, with which the applicant or licensee contracts to manage the provider. The term does not include a voluntary board member FS (8) Upon application for initial licensure or change of ownership licensure, the applicant shall furnish satisfactory proof of the applicant's financial ability to operate in - This standard would be used by surveyors if evidence of financial instability is found and the licensee or any controlling interest in the licensee withholds information from the surveyor. - The financial schedules and documentation of correction of the financial instability are submitted to the AHCA Home Care Unit in the state office and reviewed by AHCA state office financial reviewers in the Financial Analysis Unit. Further administrative action may be taken by the state office. - This standard applies to the following provider types: Nursing Home Facilities, as specified in Part II, Chapter 400, F.S.; Assisted Living Facilities, as specified in Part I, Chapter 429, F.S.; Home Health Agencies, as specified in Part III, Chapter 400, F.S.; Hospices, as specified in Part IV, Chapter 400, F.S.; Adult Day Care Centers, as specified in Part III, Chapter 429, F.S.; Prescribed Pediatric Extended Care Centers, as specified in Part VI, Chapter 400, F.S.; Home Medical Equipment Providers, as specified in Part VII, Chapter 400, F.S.; Intermediate Care Facilities for the Developmentally Disabled, as specified in Part VIII, Chapter 400, F.S.; Health Care Clinics, as specified in Part X, Chapter 400, F.S.; - The standard applies to Nurse Registries as specified in 59A (7) which states: - An application for renewal of a license shall not be required to provide proof of financial ability to operate, unless the applicant has demonstrated financial instability at any time, pursuant to Section , F.S., in which case AHCA shall require the applicant for renewal to provide proof of financial ability to operate by submitting information as described in 59A (7)(b), F.A.C. and documentation of correction of the financial instability, to include evidence of the payment in full of any bad checks, delinquent bills or liens and all associated fees, costs, and changes related to the instability. If complete payment cannot be made, evidence must be submitted of partial payment along with a plan for payment of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal, state, or district court, an accepted plan of repayment must be provided. If the licensed nurse registry has demonstrated financial instability as outlined above at any time the AHCA will request proof of financial ability to operate. - None of the Hospital Unit Programs nor the Lab Unit Programs would have this requirement. 59A is not applicable to Abortion Clinics.

46 Page 46 of 69 accordance with the requirements of this part, authorizing statutes, and applicable rules. The agency shall establish standards for this purpose, including information concerning the applicant's controlling interests. The agency shall also establish documentation requirements, to be completed by each applicant, that show anticipated provider revenues and expenditures, the basis for financing the anticipated cash-flow requirements of the provider, and an applicant's access to contingency financing. A current certificate of authority, pursuant to chapter 651, may be provided as proof of financial ability to operate. The agency may require a licensee to provide proof of financial ability to operate at any time if there is evidence of financial instability, including, but not limited to, unpaid expenses necessary for the basic operations of the provider. 59A FS (7) An applicant for renewal of a license shall not be required to provide proof of financial ability to operate, unless the licensee or applicant has demonstrated financial instability. If an applicant or licensee has shown signs of financial instability, as provided in Section (9), F.S., at any time, the Agency may require the applicant or licensee to provide proof of financial ability to operate by submission of: (a) AHCA Form , July 2009, Proof of Financial Ability Form, that includes a balance sheet and income and expense statement for the next 2 years of operation which provide evidence of having sufficient assets, credit, and projected revenues to cover liabilities and expenses, and (b) Documentation of correction of the financial instability, including but not limited to, evidence of the payment of any bad checks, delinquent bills or liens. If complete payment cannot be made, evidence must be submitted of partial payment along with a plan for payment of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal or state court, an accepted plan of repayment must be provided.

47 Page 47 of 69 ST - UZ812 - Change of Ownership Title Change of Ownership Statute or Rule (5); FS (5) FS "Change of ownership" means: (a) An event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number; or (b) An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange. A change solely in the management company or board of directors is not a change of ownership. - This tag may be cited for unreported changes of ownership Change of ownership.-whenever a change of ownership occurs: (1) The transferor shall notify the agency in writing at least 60 days before the anticipated date of the change of ownership. (2) The transferee shall make application to the agency for a license within the timeframes required in s (3) The transferor shall be responsible and liable for: (a) The lawful operation of the provider and the welfare of the clients served until the date the transferee is licensed by the agency. (b) Any and all penalties imposed against the transferor for violations occurring before the date of change of ownership. (4) Any restriction on licensure, including a conditional

48 Page 48 of 69 license existing at the time of a change of ownership, shall remain in effect until the agency determines that the grounds for the restriction are corrected. (5) The transferee shall maintain records of the transferor as required in this part, authorizing statutes, and applicable rules, including: (a) All client records. (b) Inspection reports. (c) All records required to be maintained pursuant to s , if applicable. ST - UZ813 - Results of Screening & Notification In File Title Results of Screening & Notification In File Statute or Rule 59A (3)(c), FAC 59A (3) Results of Screening and Notification. (c) The eligibility results of employee screening and the signed Attestation referenced in subsection 59A (2), F.A.C., must be in the employee's personnel file, maintained by the provider. ST - UZ814 - Background Screening Clearinghouse Title Background Screening Clearinghouse Statute or Rule (2)(b-d), FS (2) Care Provider Background Screening Clearinghouse.- (b) Until such time as the fingerprints are enrolled in the Review employee files for verification that any break in service was less than 90 days or a new screening was completed.

49 Page 49 of 69 national retained print arrest notification program at the Federal Bureau of Investigation, an employee with a break in service of more than 90 days from a position that requires screening by a specified agency must submit to a national screening if the person returns to a position that requires screening by a specified agency. (c) An employer of persons subject to screening by a specified agency must register with the clearinghouse and maintain the employment status of all employees within the clearinghouse. Initial employment status and any changes in status must be reported within 10 business days. (d) An employer must register with and initiate all criminal history checks through the clearinghouse before referring an employee or potential employee for electronic fingerprint submission to the Department of Law Enforcement. The registration must include the employee's full first name, middle initial, and last name; social security number; date of birth; mailing address; sex; and race. Individuals, persons, applicants, and controlling interests that cannot legally obtain a social security number must provide an individual taxpayer identification number. Verify that the facility has an updated employee roster listed in the clearinghouse. ST - UZ815 - Background Screening; prohibited offenses Title Background Screening; prohibited offenses Statute or Rule ; (2); FS Background screening; prohibited offenses.- (1) Level 2 background screening pursuant to chapter 435 must be conducted through the agency on each of the following persons, who are considered employees for the purposes of conducting screening under chapter 435: (a) The licensee, if an individual. (b) The administrator or a similarly titled person who is - Employees and independent contractors hired or contracted before August 1, 2010, must be screened according to the schedule in (5), F.S. included in this standard. - Persons already hired or under contract before August 1, 2010 would have received level 1 screening. - Employees and contractors who do not meet the background screening requirements cannot be retained in a direct care capacity, unless an exemption from disqualification has been approved by AHCA or the Department of Health (when a licensed or certified health care professional or certified nursing assistant). - The employee or contractor with a disqualifying offense must have a copy of an exemption [granted by either DOH

50 Page 50 of 69 responsible for the day-to-day operation of the provider. (c) The financial officer or similarly titled individual who is responsible for the financial operation of the licensee or provider. (d) Any person who is a controlling interest if the agency has reason to believe that such person has been convicted of any offense prohibited by s For each controlling interest who has been convicted of any such offense, the licensee shall submit to the agency a description and explanation of the conviction at the time of license application. (e) Any person, as required by authorizing statutes, seeking employment with a licensee or provider who is expected to, or whose responsibilities may require him or her to, provide personal care or services directly to clients or have access to client funds, personal property, or living areas; and any person, as required by authorizing statutes, contracting with a licensee or provider whose responsibilities require him or her to provide personal care or personal services directly to clients. Evidence of contractor screening may be retained by the contractor's employer or the licensee. (3) All fingerprints must be provided in electronic format. Screening results shall be reviewed by the agency with respect to the offenses specified in s and this section, and the qualifying or disqualifying status of the person named in the request shall be maintained in a database. The qualifying or disqualifying status of the person named in the request shall be posted on a secure website for retrieval by the licensee or designated agent on the licensee's behalf. or AHCA] in their personnel file before the employee or contractor can be hired. - There is a new staggered schedule: (a) Individuals for whom the last screening was conducted on or before December 31, 2004, must be rescreened by July 31, (b) Individuals for whom the last screening conducted was between January 1, 2005, and December 31, 2008, must be rescreened by July 31, (c) Individuals for whom the last screening conducted was between January 1, 2009, through July 31, 2011, must be rescreened by July 31, An employer may hire an employee to a position that requires background screening before the employee completes the screening process for training and orientation purposes. However, the employee may not have direct contact with vulnerable persons until the screening process is completed and the employee demonstrates that he or she exhibits no behaviors that warrant the denial or termination of employment. - Individuals may be provisionally employed in positions requiring background screening. They may be in training or orientation, but may NOT have access to residents/patients until the background screening process is completed. - An employer of persons subject to screening by a specified agency must register with the clearinghouse and maintain the employment status of all employees within the clearinghouse. Initial employment status and any changes in status must be reported within 10 business days. - If an individual is in the Clearinghouse and are working then they must be on that provider's employee roster within 10 days of their hire date. The same for once a person is no longer working for that provider. If they are in the Clearinghouse then their status in the employee roster must be updated within 10 days of a change. Surveyor Probes: - Level 2 includes FDLE and FBI screening. - Staff who do not have access to client property, funds, or living areas or who do not have contact with clients are not required to be screened. - If an employee or contractor's responsibility requires him or her to have contact with clients, a Level 2 background screening is required. - Was the employee or contractor hired on or after August 1, 2010? - Does the licensee have evidence of contractor and employee screening? (4) In addition to the offenses listed in s , all persons required to undergo background screening pursuant to this part or authorizing statutes must not have an arrest awaiting final disposition for, must not have been found guilty of, regardless of adjudication, or entered a plea of nolo contendere or guilty

51 Page 51 of 69 to, and must not have been adjudicated delinquent and the record not have been sealed or expunged for any of the following offenses or any similar offense of another jurisdiction: (a) Any authorizing statutes, if the offense was a felony. (b) This chapter, if the offense was a felony. (c) Section , relating to Medicaid provider fraud. (d) Section , relating to Medicaid fraud. (e) Section , relating to domestic violence. (f) Section , relating to attempts, solicitation, and conspiracy to commit an offense listed in this subsection. (g) Section , relating to fraudulent acts through mail, wire, radio, electromagnetic, photoelectronic, or photooptical systems. (h) Section , relating to false and fraudulent insurance claims. (i) Section , relating to obtaining goods by using a false or expired credit card or other credit device, if the offense was a felony. (j) Section , relating to fraudulently obtaining goods or services from a health care provider. (k) Section , relating to patient brokering. (l) Section , relating to criminal use of personal identification information. (m) Section , relating to obtaining a credit card through fraudulent means. (n) Section , relating to fraudulent use of credit cards, if the offense was a felony. (o) Section , relating to forgery. (p) Section , relating to uttering forged instruments. (q) Section , relating to forging bank bills, checks, drafts, or promissory notes. (r) Section , relating to uttering forged bank bills, checks, drafts, or promissory notes. (s) Section , relating to fraud in obtaining medicinal

52 Page 52 of 69 drugs. (t) Section , relating to the sale, manufacture, delivery, or possession with the intent to sell, manufacture, or deliver any counterfeit controlled substance, if the offense was a felony. (u) Section , relating to racketeering and collection of unlawful debts. (v) Section , relating to the Florida Money Laundering Act. If, upon rescreening, a person who is currently employed or contracted with a licensee as of June 30, 2014, and was screened and qualified under ss and , has a disqualifying offense that was not a disqualifying offense at the time of the last screening, but is a current disqualifying offense and was committed before the last screening, he or she may apply for an exemption from the appropriate licensing agency and, if agreed to by the employer, may continue to perform his or her duties until the licensing agency renders a decision on the application for exemption if the person is eligible to apply for an exemption and the exemption request is received by the agency no later than 30 days after receipt of the rescreening results by the person. (5) A person who serves as a controlling interest of, is employed by, or contracts with a licensee on July 31, 2010, who has been screened and qualified according to standards specified in s or s must be rescreened by July 31, 2015, in compliance with the following schedule. If, upon rescreening, such person has a disqualifying offense that was not a disqualifying offense at the time of the last screening, but is a current disqualifying offense and was committed before the last screening, he or she may apply for an exemption from the appropriate licensing agency and, if agreed to by the employer, may continue to perform his or her duties until the licensing agency renders a decision on the application for

53 Page 53 of 69 exemption if the person is eligible to apply for an exemption and the exemption request is received by the agency within 30 days after receipt of the rescreening results by the person. The rescreening schedule shall be: (a) Individuals for whom the last screening was conducted on or before December 31, 2004, must be rescreened by July 31, (b) Individuals for whom the last screening conducted was between January 1, 2005, and December 31, 2008, must be rescreened by July 31, (c) Individuals for whom the last screening conducted was between January 1, 2009, through July 31, 2011, must be rescreened by July 31, (6) The costs associated with obtaining the required screening must be borne by the licensee or the person subject to screening. Licensees may reimburse persons for these costs. The Department of Law Enforcement shall charge the agency for screening pursuant to s (3). The agency shall establish a schedule of fees to cover the costs of screening. (7)(a) As provided in chapter 435, the agency may grant an exemption from disqualification to a person who is subject to this section and who: 1. Does not have an active professional license or certification from the Department of Health; or 2. Has an active professional license or certification from the Department of Health but is not providing a service within the scope of that license or certification. (b) As provided in chapter 435, the appropriate regulatory board within the Department of Health, or the department itself if there is no board, may grant an exemption from disqualification to a person who is subject to this section and who has received a professional license or certification from the Department of Health or a regulatory board within that

54 Page 54 of 69 department and that person is providing a service within the scope of his or her licensed or certified practice. (8) The agency and the Department of Health may adopt rules pursuant to ss (1) and to implement this section, chapter 435, and authorizing statutes requiring background screening and to implement and adopt criteria relating to retaining fingerprints pursuant to s (2). (9) There is no reemployment assistance or other monetary liability on the part of, and no cause of action for damages arising against, an employer that, upon notice of a disqualifying offense listed under chapter 435 or this section, terminates the person against whom the report was issued, whether or not that person has filed for an exemption with the Department of Health or the agency Exclusion from employment.- (1) If an employer or agency has reasonable cause to believe that grounds exist for the denial or termination of employment of any employee as a result of background screening, it shall notify the employee in writing, stating the specific record that indicates noncompliance with the standards in this chapter. It is the responsibility of the affected employee to contest his or her disqualification or to request exemption from disqualification. The only basis for contesting the disqualification is proof of mistaken identity. (2)(a) An employer may not hire, select, or otherwise allow an employee to have contact with any vulnerable person that would place the employee in a role that requires background screening until the screening process is completed and demonstrates the absence of any grounds for the denial or termination of employment. If the screening process shows any grounds for the denial or termination of employment, the employer may not hire, select, or otherwise allow the

55 Page 55 of 69 employee to have contact with any vulnerable person that would place the employee in a role that requires background screening unless the employee is granted an exemption for the disqualification by the agency as provided under s (b) If an employer becomes aware that an employee has been arrested for a disqualifying offense, the employer must remove the employee from contact with any vulnerable person that places the employee in a role that requires background screening until the arrest is resolved in a way that the employer determines that the employee is still eligible for employment under this chapter. (c) The employer must terminate the employment of any of its personnel found to be in noncompliance with the minimum standards of this chapter or place the employee in a position for which background screening is not required unless the employee is granted an exemption from disqualification pursuant to s (d) An employer may hire an employee to a position that requires background screening before the employee completes the screening process for training and orientation purposes. However, the employee may not have direct contact with vulnerable persons until the screening process is completed and the employee demonstrates that he or she exhibits no behaviors that warrant the denial or termination of employment. (3) Any employee who refuses to cooperate in such screening or refuses to timely submit the information necessary to complete the screening, including fingerprints if required, must be disqualified for employment in such position or, if employed, must be dismissed. (4) There is no reemployment assistance or other monetary liability on the part of, and no cause of action for damages against, an employer that, upon notice of a conviction or arrest for a disqualifying offense listed under this chapter, terminates the person against whom the report was issued or who was

56 Page 56 of 69 arrested, regardless of whether or not that person has filed for an exemption pursuant to this chapter Definitions.-For the purposes of this chapter, the term: (2) "Employee" means any person required by law to be screened pursuant to this chapter, including, but not limited to, persons who are contractors, licensees, or volunteers. ST - UZ816 - Background Screening-Compliance Attestation Title Background Screening-Compliance Attestation Statute or Rule (2)(a-c) FS (2) Every 5 years following his or her licensure, employment, or entry into a contract in a capacity that under subsection (1) would require level 2 background screening under chapter 435, each such person must submit to level 2 background rescreening as a condition of retaining such license or continuing in such employment or contractual status. For any such rescreening, the agency shall request the Department of Law Enforcement to forward the person's fingerprints to the Federal Bureau of Investigation for a national criminal history record check unless the person's fingerprints are enrolled in the Federal Bureau of Investigation's national retained print arrest notification program. If the fingerprints of such a person are not retained by the Department of Law Enforcement under s (2)(g) and (h), the person must submit fingerprints electronically to the Department of Law Enforcement for state processing, and the Department of Law Enforcement shall forward the fingerprints to the Federal Bureau of Investigation for a national criminal history record check. The fingerprints shall be retained by the Department of Law Enforcement under s (2)(g) and (h) and enrolled in the national retained print arrest notification program when the Department - Is AHCA Recommended Form , September 2013, Affidavit of Compliance with Background Screening Requirements, in the employee's personnel file? - Or, does the employee have a similar document attesting under penalty of perjury that they are in compliance with Chapter 435, F.S.

57 Page 57 of 69 of Law Enforcement begins participation in the program. The cost of the state and national criminal history records checks required by level 2 screening may be borne by the licensee or the person fingerprinted. Until a specified agency is fully implemented in the clearinghouse created under s , the agency may accept as satisfying the requirements of this section proof of compliance with level 2 screening standards submitted within the previous 5 years to meet any provider or professional licensure requirements of the agency, the Department of Health, the Department of Elderly Affairs, the Agency for Persons with Disabilities, the Department of Children and Families, or the Department of Financial Services for an applicant for a certificate of authority or provisional certificate of authority to operate a continuing care retirement community under chapter 651, provided that: (a) The screening standards and disqualifying offenses for the prior screening are equivalent to those specified in s and this section; (b) The person subject to screening has not had a break in service from a position that requires level 2 screening for more than 90 days; and (c) Such proof is accompanied, under penalty of perjury, by an attestation of compliance with chapter 435 and this section using forms provided by the agency. ST - UZ817 - Minimum Licensure Requirement - Inform AHCA Title Minimum Licensure Requirement - Inform AHCA Statute or Rule (3-4) FS; 59A (1) FAC Minimum licensure requirements.-in addition to the licensure requirements specified in this part, authorizing statutes, and applicable rules, each applicant and licensee must comply with the requirements of this section in order to obtain - Refer to s , F.S. regarding the Exemptions for this regulation. - Regarding Nursing Homes, note that the closing of a nursing facility ( (4)(a)) must comply with (1), F.S. instead which states: (1) Whenever a licensee voluntarily discontinues operation, and during the period when it is preparing for such

58 Page 58 of 69 and maintain a license. (3) Unless otherwise specified in this part, authorizing statutes, or applicable rules, any information required to be reported to the agency must be submitted within 21 calendar days after the report period or effective date of the information, whichever is earlier, including, but not limited to, any change of: (a) Information contained in the most recent application for licensure. (b) Required insurance or bonds. discontinuance, it shall inform the agency not less than 90 days prior to the discontinuance of operation. The licensee also shall inform the resident or the next of kin, legal representative, or agency acting on behalf of the resident of the fact, and the proposed time, of such discontinuance and give at least 90 days' notice so that suitable arrangements may be made for the transfer and care of the resident. In the event any resident has no such person to represent him or her, the licensee shall be responsible for securing a suitable transfer of the resident before the discontinuance of operation. The agency shall be responsible for arranging for the transfer of those residents requiring transfer who are receiving assistance under the Medicaid program. (4) Whenever a licensee discontinues operation of a provider: (a) The licensee must inform the agency not less than 30 days prior to the discontinuance of operation and inform clients of such discontinuance as required by authorizing statutes. Immediately upon discontinuance of operation by a provider, the licensee shall surrender the license to the agency and the license shall be canceled. (b) The licensee shall remain responsible for retaining and appropriately distributing all records within the timeframes prescribed in authorizing statutes and applicable rules. In addition, the licensee or, in the event of death or dissolution of a licensee, the estate or agent of the licensee shall: 1. Make arrangements to forward records for each client to one of the following, based upon the client's choice: the client or the client's legal representative, the client's attending physician, or the health care provider where the client currently receives services; or 2. Cause a notice to be published in the newspaper of greatest general circulation in the county in which the provider was located that advises clients of the discontinuance of the provider operation. The notice must inform clients that they may obtain copies of their records and specify the name, address, and telephone number of the person from whom the

59 Page 59 of 69 copies of records may be obtained. The notice must appear at least once a week for 4 consecutive weeks. 59A Minimum Licensure Requirements. Provider location. A licensee must maintain proper authority for operation of the provider at the address of record. If such authority is denied, revoked or otherwise terminated by the local zoning or code enforcement authority, the Agency may deny or revoke an application or license, or impose sanctions. ST - UZ818 - Minimum Licensure Requirements Title Minimum Licensure Requirements Statute or Rule (5) FS Minimum licensure requirements. In addition to the licensure requirements specified in this part, authorizing statutes, and applicable rules, each applicant and licensee must comply with the requirements of this section in order to obtain and maintain a license. - Refer to s , F.S. regarding the Exemptions for this regulation. (5)(a) On or before the first day services are provided to a client, a licensee must inform the client and his or her immediate family or representative, if appropriate, of the right to report: 1. Complaints. The statewide toll-free telephone number for reporting complaints to the agency must be provided to clients in a manner that is clearly legible and must include the words: "To report a complaint regarding the services you receive, please call toll-free (phone number)." 2. Abusive, neglectful, or exploitative practices. The statewide toll-free telephone number for the central abuse hotline must be provided to clients in a manner that is clearly legible and must include the words: "To report abuse, neglect, or

60 Page 60 of 69 exploitation, please call toll-free (phone number)." 3. Medicaid fraud. An agency-written description of Medicaid fraud and the statewide toll-free telephone number for the central Medicaid fraud hotline must be provided to clients in a manner that is clearly legible and must include the words: "To report suspected Medicaid fraud, please call toll-free (phone number)." The agency shall publish a minimum of a 90-day advance notice of a change in the toll-free telephone numbers. (b) Each licensee shall establish appropriate policies and procedures for providing such notice to clients. ST - UZ819 - Minimum Licensure Req - Financial Viability Title Minimum Licensure Req - Financial Viability Statute or Rule (9) FS FS (9) A controlling interest may not withhold from the agency any evidence of financial instability, including, but not limited to, checks returned due to insufficient funds, delinquent accounts, nonpayment of withholding taxes, unpaid utility expenses, nonpayment for essential services, or adverse court action concerning the financial viability of the provider or any other provider licensed under this part that is under the control of the controlling interest. A controlling interest shall notify the agency within 10 days after a court action to initiate bankruptcy, foreclosure, or eviction proceedings concerning the provider in which the controlling interest is a petitioner or defendant. Any person who violates this subsection commits a misdemeanor of the second degree, punishable as provided in s or s Each day of continuing violation is a separate offense. - Refer to s , F.S. regarding the Exemptions for this regulation.

61 Page 61 of 69 ST - UZ821 - Reporting Requirements; Electronic Submission Title Reporting Requirements; Electronic Submission Statute or Rule 59A , FAC 59A Reporting Requirements; Electronic Submission. (1) During the two year licensure period, any change or expiration of any information that is required to be reported under Chapter 408, Part II, F.S., or authorizing statutes for the provider type as specified in Section (3), F.S., during the license application process must be reported to the Agency within 21 days of occurrence of the change, including: (a) Insurance coverage renewal, (b) Bond renewal, (c) Change of administrator or the similarly titled person who is responsible for the day-to-day operation of the provider, (d) Annual sanitation inspections, (e) Fire inspections, (f) Approval of revisions to emergency management plans. (2) Electronic submission of information. (a) The following required information must be reported through the Agency's Internet site at 1. Nursing homes: a. Semi-annual staffing ratios required pursuant to Section (1)(o), F.S. and Rule 59A-4.103, F.A.C. b. Adverse incident reports required pursuant to Sections (7) and (8), F.S. and Rule 59A-4.123, F.A.C. c. Liability claim reports required pursuant to Section (10), F.S. and Rule 59A-4.123, F.A.C. 2. Assisted living facilities: a. Adverse incident reports required pursuant to Sections (3) and (4), F.S. and Rule 58A , F.A.C. - Regarding 59A (1)(f), this does not apply to Home Care Unit programs since there is a different process through the Department of Health in chapter 400 Part III & IV, F.S. - Regarding 59A (2), this only applies to nursing homes and assisted living facilities. 59A FAC does not apply to Abortion Clinics

62 Page 62 of 69 b. Liability claim reports required pursuant to Section (5), F.S. and Rule 58A , F.A.C. (b) The licensee must retain the receipt issued from the Internet site indicating that their transaction was accepted. (c) If the Agency's Internet site is temporarily out of service, the required reports may be submitted by mail or facsimile as follows: 1. Semi-annual staffing ratios and liability claim reports are sent to the Agency for Health Care Administration, Central Systems Management Unit, 2727 Mahan Drive, MS #47, Tallahassee, FL or facsimile to (850) Adverse incident reports are sent to the Agency for Health Care Administration, Florida Center for Health Information and Policy Analysis, 2727 Mahan Drive, MS #16, Tallahassee, FL or facsimile to (850) ST - UZ824 - Right of Inspection; Inspection Reports Title Right of Inspection; Inspection Reports Statute or Rule FS; 59A FAC Right of inspection; copies; inspection reports; plan for correction of deficiencies.- (1) An authorized officer or employee of the agency may make or cause to be made any inspection or investigation deemed necessary by the agency to determine the state of compliance with this part, authorizing statutes, and applicable rules. The right of inspection extends to any business that the agency has reason to believe is being operated as a provider without a license, but inspection of any business suspected of being operated without the appropriate license may not be made without the permission of the owner or person in charge unless a warrant is first obtained from a circuit court. Any application for a license issued under this part, authorizing

63 Page 63 of 69 statutes, or applicable rules constitutes permission for an appropriate inspection to verify the information submitted on or in connection with the application. (a) All inspections shall be unannounced, except as specified in s (b) Inspections for relicensure shall be conducted biennially unless otherwise specified by authorizing statutes or applicable rules. (2) Inspections conducted in conjunction with certification, comparable licensure requirements, or a recognized or approved accreditation organization may be accepted in lieu of a complete licensure inspection. However, a licensure inspection may also be conducted to review any licensure requirements that are not also requirements for certification. (3) The agency shall have access to and the licensee shall provide, or if requested send, copies of all provider records required during an inspection or other review at no cost to the agency, including records requested during an offsite review. (4) A deficiency must be corrected within 30 calendar days after the provider is notified of inspection results unless an alternative timeframe is required or approved by the agency. (5) The agency may require an applicant or licensee to submit a plan of correction for deficiencies. If required, the plan of correction must be filed with the agency within 10 calendar days after notification unless an alternative timeframe is required. (6)(a) Each licensee shall maintain as public information, available upon request, records of all inspection reports pertaining to that provider that have been filed by the agency unless those reports are exempt from or contain information

64 Page 64 of 69 that is exempt from s (1) and s. 24(a), Art. I of the State Constitution or is otherwise made confidential by law. Effective October 1, 2006, copies of such reports shall be retained in the records of the provider for at least 3 years following the date the reports are filed and issued, regardless of a change of ownership. (b) A licensee shall, upon the request of any person who has completed a written application with intent to be admitted by such provider, any person who is a client of such provider, or any relative, spouse, or guardian of any such person, furnish to the requester a copy of the last inspection report pertaining to the licensed provider that was issued by the agency or by an accrediting organization if such report is used in lieu of a licensure inspection. 59A Inspections. (1) When regulatory violations are identified by the Agency: (a) Deficiencies must be corrected within 30 days of the date the Agency sends the deficiency notice to the provider, unless an alternative timeframe is required or approved by the Agency. (b) The Agency may conduct an unannounced follow-up inspection or off-site review to verify correction of deficiencies at any time. (2) If an inspection is completed through off-site record review, any records requested by the Agency in conjunction with the review, must be received within 7 days of request and provided at no cost to the Agency. Each licensee shall maintain the records including medical and treatment records of a client and provide access to the Agency. (3) Providers that are exempt from Agency inspections due to accreditation oversight as prescribed in authorizing statutes must provide: (a) Documentation from the accrediting agency including the

65 Page 65 of 69 name of the accrediting agency, the beginning and expiration dates of the provider's accreditation, accreditation status and type must be submitted at the time of license application, or within 21 days of accreditation. (b) Documentation of each accreditation inspection including the accreditation organization's report of findings, the provider's response and the final determination must be submitted within 21 days of final determination or the provider is no longer exempt from Agency inspection. ST - UZ827 - Unlicensed Activity Title Unlicensed Activity Statute or Rule FS Unlicensed activity.- (1) A person or entity may not offer or advertise services that require licensure as defined by this part, authorizing statutes, or applicable rules to the public without obtaining a valid license from the agency. A licenseholder may not advertise or hold out to the public that he or she holds a license for other than that for which he or she actually holds the license. (2) The operation or maintenance of an unlicensed provider or the performance of any services that require licensure without proper licensure is a violation of this part and authorizing statutes. Unlicensed activity constitutes harm that materially affects the health, safety, and welfare of clients. The agency or any state attorney may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of the unlicensed provider or the performance of any services in violation of this part and authorizing statutes, until compliance with this part, authorizing statutes, and agency rules has been demonstrated to the satisfaction of the agency. - This tag can be cited in conjunction with Z0803 License Required; Display, F.S. - License required when the provider is offering services not authorized and printed on the face of the license, when the licensed owner is not operating and it is being operated by another entity that is not licensed to operate. - It may also be cited if the Agency has notified the provider to cease unlicensed activity and the provider continues to operate.

66 Page 66 of 69 (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (4) Any person or entity that fails to cease operation after agency notification may be fined $1,000 for each day of noncompliance. (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. (6) In addition to granting injunctive relief pursuant to subsection (2), if the agency determines that a person or entity is operating or maintaining a provider without obtaining a license and determines that a condition exists that poses a threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the same actions and fines imposed against a licensee as specified in this part, authorizing statutes, and agency rules. (7) Any person aware of the operation of an unlicensed provider must report that provider to the agency. ST - UZ828 - Administrative Fines; Violations Title Administrative Fines; Violations Statute or Rule (3) FS

67 Page 67 of 69 (3) The agency may impose an administrative fine for a violation that is not designated as a class I, class II, class III, or class IV violation. Unless otherwise specified by law, the amount of the fine may not exceed $500 for each violation. Unclassified violations include: (a) Violating any term or condition of a license. (b) Violating any provision of this part, authorizing statutes, or applicable rules. (c) Exceeding licensed capacity. (d) Providing services beyond the scope of the license. (e) Violating a moratorium imposed pursuant to s ST - UZ829 - Moratorium; Emergency Suspension Title Moratorium; Emergency Suspension Statute or Rule FS Moratorium; emergency suspension.- (1) The agency may impose an immediate moratorium or emergency suspension as defined in s on any provider if the agency determines that any condition related to the provider or licensee presents a threat to the health, safety, or welfare of a client. (2) A provider or licensee, the license of which is denied or revoked, may be subject to immediate imposition of a moratorium or emergency suspension to run concurrently with licensure denial, revocation, or injunction. (3) A moratorium or emergency suspension remains in effect after a change of ownership, unless the agency has determined that the conditions that created the moratorium, emergency suspension, or denial of licensure have been corrected.

68 Page 68 of 69 (4) When a moratorium or emergency suspension is placed on a provider or licensee, notice of the action shall be posted and visible to the public at the location of the provider until the action is lifted. ST - UZ830 - Emergency Management Planning Title Emergency Management Planning Statute or Rule FS Emergency management planning; emergency operations; inactive license.- (1) A licensee required by authorizing statutes to have an emergency operations plan must designate a safety liaison to serve as the primary contact for emergency operations. (2) An entity subject to this part may temporarily exceed its licensed capacity to act as a receiving provider in accordance with an approved emergency operations plan for up to 15 days. While in an overcapacity status, each provider must furnish or arrange for appropriate care and services to all clients. In addition, the agency may approve requests for overcapacity in excess of 15 days, which approvals may be based upon satisfactory justification and need as provided by the receiving and sending providers. (3)(a) An inactive license may be issued to a licensee subject to this section when the provider is located in a geographic area in which a state of emergency was declared by the Governor if the provider: 1. Suffered damage to its operation during the state of emergency. 2. Is currently licensed. 3. Does not have a provisional license. 4. Will be temporarily unable to provide services but is reasonably expected to resume services within 12 months. - Four of the Home Care programs have major state laws that have extensive emergency management requirements - home health agencies, hospices, nurse registries and home medical equipment providers - and their associated regulation sets have specific standards FS does not apply to Abortion Clinics

69 Page 69 of 69 (b) An inactive license may be issued for a period not to exceed 12 months but may be renewed by the agency for up to 12 additional months upon demonstration to the agency of progress toward reopening. A request by a licensee for an inactive license or to extend the previously approved inactive period must be submitted in writing to the agency, accompanied by written justification for the inactive license, which states the beginning and ending dates of inactivity and includes a plan for the transfer of any clients to other providers and appropriate licensure fees. Upon agency approval, the licensee shall notify clients of any necessary discharge or transfer as required by authorizing statutes or applicable rules. The beginning of the inactive licensure period shall be the date the provider ceases operations. The end of the inactive period shall become the license expiration date, and all licensure fees must be current, must be paid in full, and may be prorated. Reactivation of an inactive license requires the prior approval by the agency of a renewal application, including payment of licensure fees and agency inspections indicating compliance with all requirements of this part and applicable rules and statutes. (4) The agency may adopt rules relating to emergency management planning, communications, and operations. Licensees providing residential or inpatient services must utilize an online database approved by the agency to report information to the agency regarding the provider's emergency status, planning, or operations.