The Agency is proposing to amend the rules governing multiphasic health testing centers licensure procedure to update and conform to current statutory provisions.

 

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 the rules governing multiphasic health testing centers licensure procedure to update and conform to current statutory provisions.

SUMMARY: Proposed changes include incorporating the most current application by reference, specifying the biennial licensure fee as adjusted in accordance with Section 408.805, F.S., and removing outdated procedures and references.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will 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 been prepared by the agency.

The Agency has determined that this will have an adverse impact on small business, however will not 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 been prepared by the agency.

Statement of estimated regulatory costs has been prepared for proposed rule revision in Rule 59A-6.020, F.A.C., and is available from the person to be contacted regarding this rule listed below. The following is a summary of the SERC:

For rule 59A-6.020, F.A.C., license fees are increased by the Consumer Price Index pursuant to Section 408.805(2), F.S. The biennial license fee will increase by $52.64. Accounting for currently licensed facilities and projected new licensees, the total regulatory increase for a 5 year period is $2,079.28.

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 been prepared by the agency.

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: 408.819, 483.291 FS.

LAW IMPLEMENTED: 408.033, 408.805, 483.285, 483.291, 483.30, 483.302 FS.

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: January 14, 2014, 10:00 a.m. – 11:00 a.m.

PLACE: Agency for Health Care Administration, Ft. Knox Bldg. 3, Conference Room D, 2727 Mahan Drive, 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 7 days before the workshop/meeting by contacting: Dayle Mooney at [e-mail]. 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: Dayle Mooney, Program Administrator, [phone], e-mail: [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.

(2) An applicant for licensure shall be designated by a distinctive name, and the name shall not be changed without first notifying the agency and receiving approval in writing for such change. The following documents shall accompany the initial 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.

(e) Curriculum vitae for the medical director.

(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.

(g) Evidence of registration from the Department of Health and Rehabilitative Services to provide HIV testing as stipulated in Rule 10D-93.076, F.A.C., if HIV specimens are collected for analysis.

(h) If a center performs waived testing as defined by Section 483.041, F.S. dipstick urinalysis and fecal occult blood tests, evidence of authorization under the federal Clinical Laboratory Improvement Amendments of 1988 or Chapter 483, Part I, F.S., where applicable, to perform such testing waived tests must be submitted.

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

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

(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 form, AHCA 3170-4001, Revised October 2013 Jan 94, incorporated by reference, which shall be provided by the agency, necessary in carrying out the purpose of this part. This form is 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/MCHQ/Corebill/index.shmtl.

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

(3) The license fee for the operation of a multiphasic health testing center as specified in Rule 59A-6.033, F.A.C. The license shall be valid until midnight on the 31st of December of the year issued.

(3)(4) Any center that fails to pay the proper fee or otherwise fails to qualify by the date of expiration of its license shall be delinquent, and its license shall be canceled without notice or further proceedings. Upon cancellation under this section, the center’s license shall be reinstated only upon application and qualification therefor as provided for initial applicants and upon payment of all delinquent fees.

(4)(5) 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.

(5)(6) Upon receipt of the completed initial application, the agency shall conduct a survey to determine compliance with the established rules and standards. The inspection shall be conducted on an annual basis thereafter.

(7) When a multiphasic health testing center is in compliance with rules, regulations and standards, a license which identifies the name and location of the multiphasic health testing center, will be issued. This license must be displayed in a conspicuous place on the center premises.

(6)(8) A separate license shall be required for each multiphasic health testing center when more than one (1) multiphasic health testing center, whether it be a fixed or mobile facility, is operated under the same ownership or management.

(9) A license issued to any multiphasic health testing center shall be revoked and reapplication denied by the agency in any case where the center fails to sustain continued compliance with provisions of Ch. 483, Part II, F.S., or these rules.

(7)(10) 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.

(11) Licenses issued shall be valid until the end of the current calendar year.

(12) These rules are applicable to both fixed and mobile multiphasic health testing centers.

Rulemaking Specific Authority 408.819, 483.291 FS. Law Implemented 408.033, 408.805, 483.285, 483.291, 483.30, 483.302 FS. History–New 3-20-94, Amended 5-1-96,___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dayle Mooney

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 9, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 10, 2013