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

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-6.020:Licensure Procedure

PURPOSE AND EFFECT: The Agency is proposing to amend the rules governing multiphasic health testing centers licensure procedures to update and conform to current statutory provisions.

SUBJECT AREA TO BE ADDRESSED: Multiphasic health testing centers licensure procedure standards.

RULEMAKING AUTHORITY: 483.291 FS.

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

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: Friday, June 28, 2013, 10:00 a.m. − 11:00 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, FL 32308-5407

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, 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).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Dayle Mooney, Health Services & Facilities Consultant, [phone], email: [e-mail]

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT 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 testingwaived 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 the application for licensure as specified in paragraph 59A-35.060(1)(bb), F.A.C.form, AHCA 3170-4001, Jan 94, incorporated by reference, which shall be provided by the agency, necessary in carrying out the purpose of this part.

(m) The license fee shall be $643.00 per biennium and shall conform to the annual adjustment of Section 408.805, F.S.

(3) The license fee of $643.00 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.

RulemakingSpecific Authority 483.291 FS. Law Implemented 483.285, 483.291, 483.30, 483.302 FS. History–New 3-20-94, Amended 5-1-96, _______.