The Agency is proposing to amend Rule 59A-6.020, F.A.C., to implement changes to section 483.294, F.S., which was amended to remove the annual inspection requirement for multiphasic health testing centers.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-6.020Licensure Procedure

PURPOSE AND EFFECT: The Agency is proposing to amend Rule 59A-6.020, F.A.C., to implement changes to Section 483.294, F.S., which was amended to remove the annual inspection requirement for multiphasic health testing centers.

SUMMARY: Rule 59A-6.020, F.A.C., outlines the licensure procedure for multiphasic health testing centers. The proposed changes will update application forms incorporated by reference, align inspection requirements with s. 408.811, F.S., and clarify application requirements.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 408.033, 408.819, 483.291, F.S.

LAW IMPLEMENTED: 408.033, 408.805, 408.806, 408.809, 408.810, 408.811, 483.285, 483.291, 483.30, 483.302, F.S.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: Tuesday, April 23, 2019, 9:00 a.m. – 10:00 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room D, Tallahassee, FL 32308.

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Josei Ponce, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice). If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Josei Ponce at [phone] or email at: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-6.020 Licensure Procedure.

(1) A license from the agency is required to conduct, maintain or operate a multiphasic health testing center in this state, unless such center is exempt from licensure as specified in Section 483.285, F.S. The issuance of a multiphasic health testing center license shall be based upon compliance with Chapters 483, Part I, and 408, Part II, F.S., and Rule Chapters 59A-6 and 59A-35, F.A.C., as evidenced by a signed, complete and accurate Health Care Licensing Application, Multiphasic Health Testing Center, AHCA 3170-4001, April 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and an inspection as required in Sections 483.294 and 408.806(7), F.S. Applicants for renewal of a multiphasic health testing center license may submit the Health Care Licensing Online Application, Multiphasic Health Testing Center, AHCA Form 3170-4001OL, April 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. The application forms are available online at http://www/ahca.myflorida.com/HQAlicensureforms or, for online renewal submissions, at: http://apps.ahca.myflorida.com/SingleSignOnPortal.

(2) The following documents shall accompany the initial, change of ownershp, or renewal application:

(a) For a corporate applicant, a current certificate of status or authorization pursuant to Section 607.0128, F.S.

(b) Roster of personnel employed by the center including a listing of health care professionals performing fecal occult blood and dipstick urinalysis authorized in subsection 59A-6.022(15), F.A.C., which includes title, position held, and current certification number, if applicable.

(c) A statement of services offered including a list of equipment and test menu.

(d) Name and address of hospitals, providers of laboratory and electrocardiograph services, or other facilities or individuals providing services for the center.

(a) (e) Curriculum vitae for the medical director.

(b) (f) Evidence of certification by the American Board of Internal Medicine in Cardiology or the American Board of Radiology for the individual in the event such individual is designated by the medical director of a contract multiphasic health testing center to read and interpret electrocardiograms and x-rays.

(c) (g) Evidence of registration from the Department of Health to provide HIV testing as stipulated in Rule 64D-2.006, F.A.C., if HIV specimens are collected for analysis.

(d) (h) If a center performs waived testing as defined by Section 483.041, F.S., evidence of authorization under the federal Clinical Laboratory Improvement Amendments of 1988 to perform such testing must be submitted.

(e) (i) Evidence of current registration under Chapter 404, F.S., for all x-ray equipment.

(f) (j) Evidence of issuance of a current permit or exemption from such permitting pursuant to Section 381.0098, F.S.

(g) (k) Proof of liability insurance as defined in Section 624.605, F.S., shall be submitted at the time of application. The liability insurance policy shall contain the name and physical address of the facility and the dates of coverage and shall document that coverage is generally appropriate for the facility.

(l) Such other information requested on the Health Care Licensing Application, Multiphasic Health Testing Center, AHCA 3170-4001, July 2014, incorporated by reference. This form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-04588 and available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #32, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/HQAlicensureforms.

(m) The license fee shall be $652.64 per biennium and shall conform to the annual adjustment of Section 408.805, F.S.

(3) Each license is valid only for the person or entity to whom it is issued and may not be sold, assigned, or transferred voluntarily or involuntarily. A license is not valid for any premises or mobile facility other than that for which originally issued. A center must be relicensed if a change of ownership occurs. Application for relicensure must be made to the agency 60 days prior to the change of ownership. When a multiphasic health testing center is leased by the owner to a second party for operation, said second party must apply for a new license. A copy of the lease agreement or signed statement showing which party is to be held responsible for the organization, operation and maintenance of the multiphasic health testing center shall be filed with the application. A license shall be returned to the agency immediately upon change of ownership or classification, suspension, revocation, or voluntary cessation of operations.

(3) (4) Upon receipt of the completed initial application, the agency shall conduct a survey pursuant to Section 408.811, F.S. The inspection shall be conducted on a biennial an annual basis thereafter.

(5) A separate license shall be required for each multiphasic health testing center when more than one (1) multiphasic health testing center, is operated under the same ownership or management.

(6) A licensee shall notify the agency by certified mail of impending closure of a licensed center, thirty (30) days prior to such closure. The license shall be surrendered to the agency immediately following cessation of operations.

Rulemaking Authority 408.033, 408.819, 483.291 FS. Law Implemented 408.033, 408.805, 408.806, 408.809, 408.810, 408.811, 483.285, 483.291, 483.30, 483.302 FS. History–New 3-20-94, Amended 5-1-96, 9-28-14, ______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Josei Ponce

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Mary C. Mayhew

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 14, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 17, 2019