Licensure, Application Process, General Requirements, Certificates of Exemption and Exempt Status, Medical or Clinic Director, Survey Requirements and Process
AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing
RULE NOS.:RULE TITLES:
59A-33.002Licensure, Application Process, General Requirements
59A-33.006Certificates of Exemption and Exempt Status
59A-33.008Medical or Clinic Director
59A-33.012Survey Requirements and Process
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. 40, No. 194, October 6, 2014 issue of the Florida Administrative Register.
The following sections of the proposed rule should be changed to read:
59A-33.002 Licensure, Application Process, General Requirements.
(1) The applicant or 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 X, F.S., on the Health Care Licensing Application, Health Care Clinics, AHCA Form 3110-0013, July 2014, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and available from the Agency for Health Care Administration website at: http://ahca.myflorida.com/HQAlicensureforms.
(2) 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) Proof of financial ability to operate. Proof of financial ability to operate must be demonstrated for initial licensure and change of ownership applications as required in Section 408.810(8), F.S. and Rule 59A-35.062, F.A.C.; and
(e) Accreditation. Each clinic engaged in magnetic resonance imaging (“MRI”) services shall provide documentation that it 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 within 1 year after licensure or one year after beginning MRI services to patients or placing a new magnet for an existing MRI. This period may be extended in accordance with Section 400.9935(7)(a), F.S. Clinics that are accredited by the Accreditation Association for Ambulatory Health Care prior to July 1, 2013, shall be accredited by an approved accreditating organization on or before July 1, 2014; and
(f) Background Screening. Applicants must submit evidence of compliance with level 2 background screening requirements as required in Section 400.991, F.S. and Section 408.809, F.S., and
(g) Medical/Clinic Director Attestation, AHCA Form 3110-1028 (Sept 2014), incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and available from the Agency for Health Care Administration website at: http://ahca.myflorida.com/HQAlicensureforms.
Rulemaking Authority 400.991(1), 400.991(7)(d), 400.995(3), 400.9925, 408.809, 408.810(8), 408.819 FS. Law Implemented 400.9925, 400.991(1)(a), (4), (7)(d), 408.806, 408.809, 408.810(8), 435.04 FS. History–New 8-28-06, Amended__________.
59A-33.006 Certificates of Exemption and Exempt Status.
(1) through (2) No change.
(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. In such case, the health care clinic must file with the Agency a license application under ss. 400.990-400.995, F.S. 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 ss. 400.990-400.995, F.S. the Act.
(4) through (10) No change.
Rulemaking Authority 400.9925 FS. Law Implemented 400.9905(4), 400.9925, 400.9935(2), (9) FS. History–New 8-28-06, Amended________.
59A-33.008 Medical or Clinic Director.
(1) through (2) No change.
(3) 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 ss. 400.990-400.995, F.S. 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.
Rulemaking 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 8-28-06, Amended________.
59A-33.012 Inspection Requirements and Process.
(1) through new (2) No change.
(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.
(b) Copy of medical or clinic director’s written agreement with the health care clinic assuming the responsibilities for the statutory activities in Sections 400.9935(1)(a)-(i), F.S. If the medical or clinic director signs the Medical/Clinic Director Attestation, AHCA Form 3110-1028 (Sept 2014), incorporated by reference referenced in Rule 59A-33.002, F.A.C., 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.
New (3)(d) through (3)(s) No change.
Rulemaking Authority 400.9925, 408.806, 408.811, 408.819 FS. Law Implemented 120.542, 120.60(6), 400.9905(5), 400.9915(3), 400.993(6), 400.9935(1)(a)-(i), 400.9935(3), 400.995(1), (6), (8), 408.806, 408.811 FS. History–New 8-28-06, Amended________.
The following changes have been made to Health Care Licensing Application, Health Care Clinics, AHCA Form 3110-0013, July 2014:
Page 4
The definition of “nonimmigrant’ in the form has been removed and replaced with a reference to 8 U.S.C. §1101.
