The Agency proposes to amend the rule to clarify the definition of an Exclusive Use Laboratory.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.: RULE TITLE:

59A-7.020  Definitions

PURPOSE AND EFFECT: The Agency proposes to amend the rule to clarify the definition of an Exclusive Use Laboratory.

SUMMARY: Definitions related to clinical laboratory licensure.

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.

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: 483.051, FS.

LAW IMPLEMENTED: 483.035, 483.041, 483.051, 483.191, 483.245 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: May 2, 2017 at 10:00 a.m. to 12:00 p.m. ET

PLACE: Agency for Health Care Administration, Conference Room C, 2727 Mahan Drive, Building #3, 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: Zachary Masters, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone] or by e-mail 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).. 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: Zachary Masters at [phone] or email at: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-7.020 Definitions.

(1) through (10) No changes.

(11) Exclusive Use Laboratory – a clinical laboratory where operated by one or more of the following is legally responsible for all aspects of the provider operation and which is operated exclusively in connection with the diagnosis and treatment of their own patients:

(a) Physician licensed under Chapters 458 or 459, F.S.;

(b) Chiropractor licensed under Chapter 460, F.S.;

(c) Podiatrist licensed under Chapter 461, F.S.;

(d) Naturopathist licensed under Chapter 462, F.S.; or

(e) Dentist licensed under Chapter 466, F.S.

(12) through (32) No changes.

Rulemaking Authority 483.051 FS. Law Implemented 483.035, 483.041, 483.051, 483.191, 483.245 FS. History–New 11-20-94, Amended 8-13-95, 12-27-95, 6-22-06, 3-31-10,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Zachary Masters

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Justin M. Senior

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 03/28/2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 05/25/2016