Definitions, Licensure, Application Process, General Requirements, Initial License Applications Applicability, Renewal License Applications, Change of Ownership License Applications, Certificates of Expemption and Exempt Status, AHCA Forms ...

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

RULE NO: RULE TITLE
59A-33.001: Definitions
59A-33.002: Licensure, Application Process, General Requirements
59A-33.003: Initial License Applications Applicability
59A-33.004: Renewal License Applications
59A-33.005: Change of Ownership License Applications
59A-33.006: Certificates of Expemption and Exempt Status
59A-33.007: AHCA Forms Availability, Information and Website
59A-33.008: Medical or Clinic Director
59A-33.009: Financial Instability
59A-33.010: Cessation of Business, Billing and Medical Records Retention, Suspended and Revoked Licenses
59A-33.011: Magnetic Resonance Imaging Exemption for Chief Financial Officer
59A-33.012: Survey Requirements and Process
59A-33.013: Medical and Clinic Directorships Maximum Number of Clinics

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol.32,No.02, January 13, 2006 issue of the Florida Administrative Weekly.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE CHANGES IS: Roger Bell, Unit Manager of the Health Care Clinic Unit, 2727 Mahan Drive, Mail Stop #53, Tallahassee, Florida 32308-5704, [phone], Suncom 278-1365, e-mail: [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE WITH CODED CHANGES IS:

 

59A-33.001 Definitions.

In addition to definitions contained in Chapter 400, Part XIII, 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 Chapter 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 Part XIII, Chapter 400, 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.

Specific Authority 400.9925 FS. Law Implemented 400.991(1), 400.9925, 400.9905(4)(g), (5) FS. History–New ________.

 

59A-33.002 Licensure, Application Process, General Requirements.

(1) The licensee or prospective licensee shall make application for an initial, change of ownership, or renewal license to operate a health care clinic and shall provide all of the information required by this rule and Chapter 400, Part XIII, F.S. on AHCA Form 3110-0013B, Application for Health Care Clinic Licensure June 2004, and AHCA Form 3110-0013A, Instruction for Completing the Application for Health Care Clinic Licensure June 2004 incorporated by reference. 

The following shall be included with the application:

(a) License Fee.  A nonrefundable $2,000 application fee payable to AHCA; and

(b) Fictitious Name.  When an applicant intends to operate under a fictitious name, a copy of an Affidavit of Compliance with Fictitious Name pursuant to Section 865.09, F.S., or a copy of a registration form from the Division of Corporations, Secretary of State, showing registration of the applicant’s fictitious name; and

(c) Evidence of Incorporation.  When an applicant is a corporation or other entity, a copy of the registration of the applicant entity on file with the Division of Corporations, Secretary of State, State of Florida; and

(d) Financial Projections.  Proof of financial ability to operate for the first year of licensure.  This proof shall include evidence that the applicant has sufficient assets, credit, and projected revenues to cover liabilities and expenses.  The applicant must submit a projected income and expense statement and projected balance sheet that have been prepared according to generally accepted accounting principals and signed by a certified public accountant.  As a convenience, the applicant may submit the required information on AHCA Form 3110-001C, June 2005, Schedule 2, Projected Income and Expense, incorporated by reference, and AHCA Form 3110-001D, Schedule 3, Projected Balance Sheet, June 2005, incorporated by reference.  As an alternative, and not in addition to providing a projected income and expense statement and projected balance sheet, the applicant may submit a surety bond in the amount of $500,000 payable to the Agency for Health Care Administration.  For a Surety Bond the applicant must submit AHCA Form 3110-1103E, Health Care Clinic Surety Bond, June 2005, incorporated by reference; and

(e) Background Screening. All information required by this paragraph (e) to enable the Agency to evaluate and determine compliance with the Act regarding background screening.  This information must include the identification of all individuals who must be the subject of Level 2 background screening under standards established in Chapter 435, F.S., and in Section 400.991(7)(d), F.S., as  required on AHCA Form 3110-0013B, June 2005, Application for Health Care Clinic Licensure, adopted by reference. 

1. Individuals required to meet background screening requirements include individuals owning or controlling, directly or indirectly, 510% or more of an ownership interest in the health care clinic; the medical or clinic director, or similarly titled person responsible for the day to day operation of the health care clinic; the financial officer or similarly titled individual responsible for the financial operation of the health care clinic,; and all licensed health care practitioners employed by or under contract to the health care clinic that have been issued a license, registration or certification by the Florida Department of Health. 

2. For each individual not previously screened within the last 5 years, who passed background screening in accordance with the Act in such previous background screening, the applicant for licensure shall submit an original completed applicant (meaning that individual) fingerprint card (blue and white card) from any authorized agency or law enforcement office in the United States plus the applicable processing fee established by the Florida Department of Law Enforcement (FDLE); provided however, an individual who owns an interest in a health care clinic, where but such ownership interest is less than a 10% interest, may shall not be required to submit a fingerprint card.  This latter proviso shall not preclude the Agency from determining through means other than through the examination of fingerprints, whether any such individual has a criminal record that precludes issuance of a health care clinic license to the applicant for licensure.

3.  Within thirty (30) days of Upon receipt by the Agency of the results of background Level 2 screening by FDLE and by the Federal Bureau of Investigation (FBI), the Agency will notify the applicant in writing if the determination is other than compliant (“HCC-OK”).  Within twenty-one (21) days of such notice by the Agency to the licensure applicant, with the Agency’s accompanying request for additional information, tThe applicant shall provide the following additional information to the Agency as requested within 30 days of the notice to enable the Agency to make a final determination regarding whether a disqualifying criminal record exists for any such individual that would preclude issuance of the license to the applicant.  The Agency will notify the applicant for the license in writing of a final disqualifying criminal record and the right to formally contest the determination.   

4.  Any applicant that fails to provide requested criminal or other necessary information within twenty-one (21) thirty (30) days after the notice to the applicant of the need for such information regarding any particular individual, or that otherwise fails to respond to the notice in a manner that resolves the problem in determining the disqualifying nature of the criminal record of a particular individual, shall be subject to having the applicant’s pending license application withdrawn to denial or revocation of an existing license revoked for such failure. 

5. Individuals directly or indirectly owning or controlling 510% or more of an interest in a health care clinic means the natural persons owning or controlling stock, directly or indirectly, in the applicant entity or owning or controlling 510% or more interest in a company or companies directly or indirectly related to the applicant entity through inter-company ownership or control.  For example:  When a parent company or companies own 100% of the outstanding stock or controls the applicant entity,  any individual owning or controlling a 510% or more interest in the parent company is required to undergo Level 2 background screening in accordance with the Act. 

6.  Any individual employed by or under contract with a health care clinic who is required to pass Level 2 background screening must submit an applicant fingerprint card and processing fee of $47 to the Agency within 10 days of becoming affiliated with a health care clinic in accordance with paragraph (1)(e), unless submitted with an initial, change of ownership or renewal application.  This requirement shall be a continuous obligation of the healthcare clinic. All applicants for a license or current licensees must comply in a timely manner.  For persons who have previously completed and met Level 2 background screening requirements and for such other persons subject to background screening, the health care clinic must file a supplemental application on AHCA Form 3110-0013B, June 2005, Application for Health Care Clinic Licensure, incorporated by reference, by following the instructions for meeting background screening requirements when adding personnel to the health care clinic.  Failure of the health care clinic to submit fingerprint cards and related fees in a timely manner as required by this paragraph shall subject the health care clinic to the penalties of Section 400.995 (1), F.S.

6.7.  No license will be issued to any health care clinic until all of the required background screening responses from FDLE the Florida Department of Law Enforcement and from the FBI have been received by the Agency and the individuals screened have been determined cleared in accordance with the Act and consistent with this rule. Documentation that resolves background screening issues is required documentation pursuant to Section 400.991(4), F.S.  A license that is granted, notwithstanding the existence of a pending criminal charge against an individual whose criminal case will not be resolved within the time specified in this rule, and which criminal charge may result in the establishment of a criminal record that would have precluded licensure if established prior to issuance of the license, shall be subject to periodic review by the Agency specifically as to the disposition of that individual’s criminal charge.  The licensee promptly shall promptly notify the Agency of such disposition upon learning of it.

(2) All health care clinics deemed to be unlicensed under this rule are specifically subject to a fine for unlicensed activity in accordance with Section 400.995(5), F.S. and all other remedies provided by law.  The Agency may deny, suspend, revoke and refuse to renew a license or application for any reason set forth in Section 408.831, F.S.  In the event the Agency denies an application for renewal and seeks sanctions, the Agency shall issue a provisional license that shall enable the health care clinic to operate during the sanction proceedings.  The provisional license shall terminate on the date the license is revoked by final order, the date the sanctioning proceeding terminates, or the date the final order grants the health care clinic a standard license. 

(2)(3)  All forms and these rules may be obtained by contacting the Agency as shown in Rule 59A-33.007, F.A.C.

Specific Authority 400.991(1), 400.991(7)(d), 400.995(3), 400.9925 FS. Law Implemented 400.9925, 400.991(1)(a), (4), (7)(d), 435.04 FS. History–New ________.

 

59A-33.003 Initial License Applications Applicability.

(1)  Licensure is required for all entities meeting the definition of “health care clinic” per Section 400.9905(4), F.S., that are not otherwise exempt under Section 400.9905(4)(a)-(j)(i), F.S.

(2)  Any business that meets the definition of a health care clinic must submit an application in accordance with Rule 59A-33.002, F.A.C., within 5 days of becoming a health care clinic pursuant to Section 400.9935(2), F.S.  An application for licensure is required for health care clinics that have a current certificate of exemption or have self-determined they have exempt status, but do not qualify for an exemption under Section 400.9905 (4), F.S. 

(3) A change of ownership application that is not received before the ownership change has been completed is considered an initial license application.

Special Provisions.  Submission of applications must be in accordance with Rule 59A-33.002, F.A.C., General Provisions.

Specific Authority 400.9925 FS. Law Implemented 400.991, 400.992, 400.9935(9) FS. History–New ________.

 

59A-33.004 Renewal License Applications.

(1)  At least 90 days prior to the expiration of the license, all licensed health care clinics must submit a complete renewal application on AHCA Form 3110-0013B, Application for Health Care Clinic Licensure June 2005, in accordance with AHCA Form 3110-0013A, Instruction for Completing the Application for Health Care Clinic Licensure June 2005 and check the renewal box.  These forms are hereby adopted by reference.  All information required by the form and instructions must be submitted. All forms and these rules may be obtained by contacting the Agency in accordance with Rule 59A-33.007, F.A.C.

(2)  Timeliness of the renewal application will be determined on the basis of receipt by the Agency.  In the event an application is submitted less than 90 days before license expiration, an administrative fine of one-half of the license fee shall be assessed. An application for renewal submitted to the Agency after the expiration date will be processed as an initial application.

(3)  A health care clinic is deemed to be unlicensed after the license has expired.  The health care clinic is then subject to a fine for unlicensed operation in accordance with Section 400.995(5), F.S.

(2)(4) Special Provisions.  Submission of the renewal application must be in accordance with Rule 59A-33.002, F.A.C. Proof of financial ability to operate shall not be required for a renewal application unless the Agency determines that there is evidence of financial instability. If the Agency and notifies the health care clinic in writing of such evidence of instability, the clinic will be required to demonstrate proof of financial ability to operate in order to meet the licensure requirements of the Act comply with. (See Rule 59A-33.009, F.A.C., relating to financial instability).

(3)(5) An unannounced onsite inspection and survey will be conducted by the Agency prior to license expiration.  All requirements for licensure under these rules and the Act must be met during the survey.

(4)(6)  Each health care clinic providing magnetic resonance imaging services must provide proof of required accreditation under Section 400.9935(9), F.S., with the license renewal application.  This requirement is met with a copy of a letter or certificate indicating the effective date of the accreditation.

Specific Authority 400.9925 FS. Law Implemented 400.991(4), (8), (9), 400.991 (1) 400.9935(5), (11)(a), 400.995(1), (5) FS. History– New ________.

 

59A-33.005 Change of Ownership License Applications.

(1) Applications for change (”CHOW”) of health care clinic ownership are subject to the following standards.

(a) A health care clinic license cannot be sold, assigned, encumbered, pledged as security, leased or otherwise transferred, directly or indirectly.  A health care clinic license is good only for the location and owners originally approved by the Agency. 

(b)  An application for change of ownership of a health care clinic is required pursuant to Section 400.992(4), F.S., when 45 percent or more of the ownership, voting shares, or controlling interest of a health care clinic is transferred or assigned, or when the maximum aggregate percentage is achieved cumulatively within a 2-year period.  The standards and applications under Rule 59A-33.002, F.A.C., shall apply to applications for change of ownership.

(c)  When such a changeing the of ownership of a health care clinic occurs or is contemplated to occur as described in paragraph (b), an application for change of ownership must be submitted to the Agency at least 60 days before the effective date of the change. A change of ownership prior to submitting this required application in a timely manner and operation as a health care clinc is considered operating in violation of the Act and the clinic shall be fined $5,000 in accordance with Section 400.995 F.S.

(d) When changing the ownership of a health care clinic, the transferee must submit an application for a license and check the change of ownership box on AHCA Form 3110-0013B, June 2005, Application for Health Care Clinic Licensure with accompanying instructions.  This form is adopted herein by reference.  The form and these rules may be obtained by contacting the Agency in accordance with Rule 59A-33.007, F.A.C.

(e) When a health care clinic changes ownership according to the criteria set forth in this rule and the Act and operates before an change of ownership application is filed, it is in violation of Section 400.993(1), F.S., and the Agency shall issue a notice of intent to assess the assess a statutory fine of $5,000.

(f)(e)  When a health care clinic changes ownership and operates after an application is filed, but before the new change-of-ownership license is effective, the Agency shall issue a notice of intent to fine assess the applicant a fine of up to $5,000 pursuant to Section 400.995(1), F.S.

(g)(f) A change of ownership application requires compliance with Rule 59A-33.002, F.A.C., which includes, but is not limited to, the licensure applicant’s submission of proof of financial ability to operate and of applicant fingerprint cards for all persons required to meet to submit to comply with level 2 background screening requirements within the past 5 years in accordance with AHCA Form 3110-0013B, June 2005, titled Application for Health Care Clinic Licensure.

Specific Authority 400.9925 FS. Law Implemented 400.991(7)(d), 400.992(4)-(5), 400.9925(1)-(5, 400.993(2), 400.995(1), (6), (7) FS.  History–New ________.

 

59A-33.006 Certificates of Exemption and Exempt Status.

(1) Facilities and entities exempt from health care clinic license requirements are set forth in Section 400.9905(4), F.S.  A facility is not required to have, but may voluntarily apply for a certificate of exemption.

(2)  Facilities that claim an exemption, either by filing an application for an certificate of exemption with the Agency and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times the facility is in operation. 

(3)  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 becomes a health care clinic.  In such case, the health care clinic must file with the Agency a license application under the Act within 5 days of becoming a health care clinic and shall be subject to all provisions of the Act 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 the Act. 

(4) A facility becomes a health care “clinic” as defined in Section 400.9905(4), F.S., when it does not qualify for an exemption, provides healthcare services to individuals and bills third party payers for those services.

(5) Change of Exempt Status.  When exempt status changes are discovered, the Agency will notify a facility or entity applying for, obtaining or self-determining exempt status, that the exempt status is no longer valid, giving the grounds therefore, the date of the change, when known, and the statutory and rule provisions applicable.  The Agency shall give the facility or entity notice of unlawful health care clinic operation, the statutory and rule requirements of becoming a health care clinic and sanctions for operating without a valid license for the owners, medical or clinic directors and the location.  The Agency shall also provide information to the facility or entity believed to be operating without exempt status of the licensing procedures and the Agency filings necessary to meet licensure requirements. 

(6)  The applicant for a certificate of exemption must affirm, without reservation, the exemption sought pursuant to Section 400.9905(4), F.S., and the qualifying requirements for obtaining and maintaining an exempt status; the current existence of applicable exemption-qualifying health care practitioner licenses; qualified ownership, qualified certifications or registration of the facility or owners; federal employer identification number; services provided; proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; plus other satisfactory proof required by form adopted by this rule.

(7) The fee for issuance of a certificate of exemption shall be $100 and submitted to the Agency with the application.

(8) Within 30 calendar days after application receipt, the Agency shall determine whether the application is complete. If the application is deemed incomplete, the Agency shall request in writing from the applicant specific information necessary for the application to be deemed complete.  Only one such request will be made by the Agency. If the applicant does not provide the specific additional information required by the statute and rule in writing to the Agency within 21 calendar days of receipt of the Agency’s request, the application will be deemed incomplete and the certificate of exemption shall be  withdrawn from further consideration denied.  The applicant’s response must be received by the Agency no later than 5:00 P.M., E.S.T., on or before the omissions due date.  An application for a certificate of exemption from health care clinic licensure shall be granted or denied by the Agency within 90 days of receipt of a fully completed application on AHCA Form 3110-0014, which is incorporated by reference and may be obtained in accordance with Rule 59A-33.007, F.A.C.

(9) The Agency shall may rely upon the address given on the application as the official address to which correspondence may be sent.  It is the duty of the applicant to notify the Agency in writing at least 10 days in advance of any change of the current mailing address by contacting the Agency according to Rule 59A-33.007, F.A.C.

(10)  Certificates of exemption are not moveable or transferable, directly or indirectly.  They are valid only for the applicant, qualifying owners, licenses, registrations, certifications and services provided under specific statutory exemptions and are valid only to the specific exemption claimed and granted.  In order for a certificate of exemption to be valid the applicant must apply for and receive a new certificate of exemption for changes of location and any qualifying statutory or rule requirement of an exemption.

Specific Authority 400.9925 FS. Law Implemented 400.9905(4), 400.9935(2), (9) FS. History–New ________.

 

59A-33.007 AHCA Forms Availability, Information and Website.

All forms and corresponding instructions, copies of these rules, the Health Care Clinic Act and other information necessary for licensure and exemption that are incorporated by reference into this chapter, F.A.C., may be obtained from the Health Care Clinic Unit website: http://www.fdhc.state.fl.us/MCHQ/ Health_Facility_Regulation/HealthCareClinic/index.shtml or may be obtained by written request addressed to: AHCA, Health Care Clinic Unit, 2727 Mahan Drive, MS #53, Tallahassee, FL 32308 or by telephone at [phone] for mailing or inquiry. 

Specific Authority 400.9925 FS. Law Implemented 120.54 FS. History–New ________.

 

59A-33.008 Medical or Clinic Director.

(1)  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 400.9905(5), F.S.  The health care clinic responsibilities under Section 400.9935(1)(a)-(g), F.S., cannot be met without an active, appointed medical or clinic director.  Failure of an appointed medical or clinic director to substantially comply with health care clinic responsibilities under Rule 59A-33.012, F.A.C., and Sections 400.9935(1)(a)-(g), F.S., shall be grounds for the revocation or suspension of the license and assessment of a fine pursuant to Section 400.995(1), F.S. 

(2)  By statutory definition in Section 400.9905(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. 

(3)  The Agency shall may issue an emergency order suspending the license of any health care clinic operated or maintained without a medical or clinic director as required by the Act and this rule for such period of time as the health care clinic is without a medical or clinic director.  The Agency shall assess a civil fine of up to $5,000 for operating or maintaining a health care clinic without a medical or clinic director.  Each day of operation following receipt of Agency notice is considered a separate offense.  Operation and maintenance of a health care clinic without a medical or clinic director shall be grounds for revocation of the license in addition to the assessment of fines pursuant to Section 400.995(1), F.S.

(4)  All health care clinics must notify the Agency of the resignation, abandonment and appointment of a medical or clinic director on AHCA Form AHCA Form 3110-0014 June 05, which is adopted by reference, by delivering the original form to the Agency at the address set forth in Rule 59A-33.007, F.A.C.  Such application must be filed with the Agency within 10 days of the resignation or abandonment of a medical or clinic director.  The health care clinic must also file an application with the Agency within 10 days of the appointment of a new medical or clinic director.  The form shall require the date the medical or clinic director of record ceased to be the director and the date the successor began as director.  The incoming medical or clinic director and a representative of the owner of the health care clinic shall sign the form and attest to its accuracy.  The form shall include an acknowledgement that the new medical or clinic director has accepted the responsibilities of Section 400.9935(1), F.S., by signing the form.  A copy of the form may be obtained from the Agency at the address shown in Rule 59A-33.007, F.A.C.  All appointed medical or clinic directors must comply with Section 400.9905(5), F.S., at the time of appointment and throughout the appointment period.  There is no fee for this form.

(4)  The Unless otherwise exempted by law, an application for a change in the medical or clinic director shall be accompanied by a fingerprint card of the new medical or clinic director together with the required and a processing fee for background screening of that individual of $47 per card.

Specific Authority 400.9925(1), (2) FS. Law Implemented 120.542, 120.60(6), 400.9905(5), 400.9915(3), 400.993, 400.9935(1)(a)-(g), 400.9935(3), 400.995(1), (6) FS.  History–New ________.

 

59A-33.009 Financial Instability. 

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 with Part XIII, Ch. 400, 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, an accumulation of 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. 

(2) The licensee shall submit to the Agency a written plan of correction to resolve specific financial problems that the Agency has identified as evidence of financial instability.  Should the financial instability not be resolved within 90 days of the original notice, the licensee shall be subject to disciplinary action, fine, suspension or revocation of the license. 

Specific Authority 400.9925 FS. Law Implemented 400.992(3) FS. History–New ________.

 

59A-33.010 Cessation of Business, Billing and Medical Records Retention, Suspended and Revoked Licenses.

(1)  The medical or clinic director serves as the medical records owner while the health care clinic is in operation.  After The licensee is the records owner of billing and medical records after the cessation or change of ownership of the business,. tThe treating health care practitioner creating the record is the medical records owner in accordance with ss. 456.057, 456.0575, 456.58, F.S., and the rules promulgated thereunder unless there is a written agreement between the practitioner and health care clinic to the contrary.

(2) Each original license shall be returned to the Agency at the address shown in Rule 59A-33-007, F.A.C., within 10 days after a change of ownership in accordance with Rule 59A-33.005, F.A.C., or cessation of operations, suspension or revocation of the license by the Agency.  Agency staff shall may enter the premises of the health care clinic at reasonable times to remove a license after final action of the Agency suspending or revoking the license or when the health care clinic has changed ownership in accordance with Rule 59A-33.005, F.A.C., or relocated without notice to the agency.  Operating a health care clinic while a license is suspended or revoked constitutes shall be deemed unlicensed operation of a clinic and subjects the clinic, owners and medical or clinic director, individulally, to the criminal sanctions, and the clinic to per-day fines for operating without a license. 

(3) All financial books and medical records, including but not limited to, patient files and billing records, shall be retained by the health care clinic owners in a secure location for a period of at least five (5) years from the last date on the record.  The licensee shall notify the Agency in writing within 10 days of closure giving the Agency the name, street address and telephone number of the custodian and street address of the location of financial and medical records.

(4)  When a change of ownership occurs, the new medical or clinic director will serve as the records owner in accordance with the practice act of the director.  Within 10 days of any change of location or change of records custodian, the health care clinic owners shall provide to the Agency in writing, information as required by subsection (3).  Records shall be retained for at least five (5) years from the last date on the record.

Specific Authority 400.9925 FS. Law Implemented 400.991, 400.993, 400.994, 400.995 FS. History–New ________.

 

59A-33.011 Magnetic Resonance Imaging Exemption for Chief Financial Officer.

(1)  The statutory authorization threshold to utilize a chief financial officer (“CFO”) in lieu of a medical or clinic director to supervise health care clinic activities under Section 400.9935(1)(g), F.S., is partially met when less than 15% of the total scans for the previous quarter (3 months) of operation are reimbursed from automobile personal injury protection insurance (“PIP”). 

(2)  Calendar quarters shall begin on the first of January, April, July and October.  For health care clinics applying for and obtaining initial licenses, a partial quarter shall count as a full quarter of operations for purposes of qualifying for this CFO exemption to Section 400.9935(1)(g), F.S.

(3)  In calculating total scans, a single scan means one patient study.  The records of total scans must be maintained by the health care clinic and made available to an authorized employee of the Agency upon request.  The records for each quarter in which the exemption is claimed must be tallied separately and demonstrate the total number of scans billed to PIP insurance divided by the total scans for the quarter.  Upon request of the Agency, the health care clinic shall demonstrate how the figures were determined and the methodology utilized. 

(4)  The exemption from the required utilization of a medical or clinic director for Section 400.9935(1)(g), F.S., activities applies only to a health care clinic that is fully accredited by the Joint Commission on Accreditation of Healthcare Organizations and the American College of Radiology or dually accredited by the Accreditation Association for Ambulatory Health Care and the American College of Radiology.

(5) Each CFO claiming qualifications for the exemption, shall within 30 days of the health care clinic meeting the threshold for the previous quarter for utilization, affirm to the Agency in writing at the address shown in Rule 59A-33.007, F.A.C., that the CFO meets the minimum qualifications for appointment, the MRI health care clinic has been appropriately accredited and the health care clinic has met the minimum scan threshold for the previous three months as set forth in Section 400.9935(1)(g), F.S.

(6)  The health care clinic shall maintain the records reflecting qualification for the CFO exemption, including the individual qualifications of the person acting as the CFO as set forth in Section 400.9935(1)(g), F.S., for 3 years.

(7)  For purposes of determining whether a clinic has obtained required accreditation within one year of licensing, a temporary or provisional license is considered “licensed” within the meaning of Section 400.9935(11)(a), F.S.

Specific Authority 400.9925 FS. Law Implemented 400.9905(3), 400.9935(11)(a), (g). FS. History–New ________.

 

59A-33.012 Survey Requirements and Process. 

(1)  The survey process is an onsite inspection and review of the health care clinic facility or administrative office, by authorized Agency employees to determine the health care clinic’s compliance with the minimum standards established by the Act, its statutory references and rules regulating the operation and licensure of health care clinics.  Surveys will be conducted as part of the review process for initial, renewal, change of ownership and complaint investigations and may be unannounced.  The purpose of the survey is to verify information provided on an application as well as inspect, review, interview, document and determine that the minimum health care delivery system attributes for a health care clinic, as required by the Act and these rules are in place and operational or will be operational after commencing business.

(2) A survey will be conducted for:

(a) Initial applications for licensure; and

(b) Applications for renewal licenses; and

(c) Applications for a change of ownership.

(d) Complaints filed with the Agency.

(3) The surveyor will request the health care clinic to demonstrate how it is meeting or will meet the minimum requirements for licensure.  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.  Other key personnel required include the financial director, a representative of management or ownership and persons responsible for patient records and billing.

(4) At the entrance conference, each surveyor will identify himself or herself and will discuss the survey process and what is expected of the health care clinic during the survey.  At the exit conference, surveyors will inform health care clinic representatives of the findings of the survey. When deficiencies are found, the surveyor will discuss them with the persons then in attendance and discuss the criteria for determining the level of sanctions in accordance with Section 400.995(1)(a)-(d), F.S.  The field office shall inform the health care clinic in writing of its recommendations and shall require a plan of correction to be prepared and delivered to the field office within 10 days of receipt to correct deficiencies when minimum health care delivery system requirements have not been met.  Implementation and Agency verification of a successful plan of correction does not prohibit the field office from recommending sanctions. Sanctions shall include the assessment of fines, suspension, moratorium, emergency order of suspension and revocation.

(5) To facilitate a licensure survey, the health care clinic shall should have the following materials readily available for review at the time of the survey:. When the survey is unannounced, the materials should be made available to the surveyor upon request.

(a) The professional license or facsimile of the license for the medical or clinic director.

(b) Copy of medical or clinic director’s written agreement with the health care clinic assuming the responsibilities for the statutory activities in Section 400.9935(1)(a)-(g), F.S. If the medical or clinic director signs the application or change of medical or clinic director form, acknowledging these responsibilities as specified in Section 400.9935, F.S., this requirement is met.

(c) Written policies, protocols, guidelines and procedures used or to be used by the facility staff in day-to-day operations.  This includes, but is not limited to 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.

(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

(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.

(h) Personnel files.

(i) Logs, charts or notes demonstrating day-to-day oversight of health care clinic activities by the medical or clinic director.

(j) Copies of professional licenses issued by the respective boards and the Department of Health under the several practice acts.

(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.

(m) Deion of means by which the health care clinic conducts a systematic review of billings that ensures billings 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.(l) 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 (1) Medicaid file, if certified as a Medicaid provider, plus the five (5) billing records that correspond with the five patient records.

(n) List of services provided or a general deor of scope, level and complexity of care for services provided.

(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.

(p) An organizational flow chart with lines of authority and names of key individuals and positions.

(q) An all-inclusive and up to date listing of original signatures and initials of all persons entering information 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.

(r)  Log of all natural person required and who have been screened under Level 2 criteria of Chapter 435, Section 400.991, F.S.

(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 400.9935(1)(a)-(g), F.S.  Such documentation shall be made available to authorized agency personnel upon request.

Specific Authority 400.9925 FS. Law Implemented 120.542, 120.60(6), 400.9905(5), 400.9915(3), 400.995(1), (6), (8) FS. History–New _________.

 

59A-33.013  Medical and Clinic Directorships Maximum Number of Clinics.

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 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.

Specific Authority 400.9925(2) FS. Law Implemented 400.9925(2) FS. History–New ________.