The Agency is proposing to repeal 59A-7, F.A.C., Clinical Laboratories, effective July 1, 2018 in response to Chapter 2018-24, Laws of Florida.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-7.019Application of Act - Exemption and Exclusions

59A-7.020Definitions

59A-7.021Laboratory Licensure - Qualifications, Licensure, Operation and Application

59A-7.022Laboratory Construction

59A-7.023Laboratory Safety and Sanitary Conditions

59A-7.024Clinical Laboratories, Collection Stations, Collection, Storage and Shipment of Specimens

59A-7.025Participation in Proficiency Testing

59A-7.026Approval of Proficiency Testing Programs

59A-7.027Proficiency Testing Programs by Specialty and Subspecialty

59A-7.028Patient Test Management

59A-7.029General Quality Control Requirements

59A-7.030Quality Control - Specialties and Subspecialties

59A-7.031Quality Assurance

59A-7.032Inspection of Laboratories

59A-7.033Acceptance of Accreditation Inspections

59A-7.034Alternate-Site Testing

59A-7.035Staffing Requirements

59A-7.036Fees

59A-7.037Rebates Prohibited - Penalties

PURPOSE AND EFFECT: The Agency is proposing to repeal Rule Chapter 59A-7, F.A.C., Clinical Laboratories, effective July 1, 2018 in response to Chapter 2018-24, Laws of Florida.

SUMMARY: The Agency proposes to repeal rules related to state licensure requirements for clinical laboratory effective July 1, 2018, in response to the repeal of Part I of Ch. 483, F.S. per Chapter 2018-24, Laws of Florida. The proposed change will remove language outside the Agency’s authority.

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:

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, 408.819, FS.

LAW IMPLEMENTED: 483.031, 483.035, 483.041, 483.051, 483.061, 483.191, 483.101, 483.106, 483.111, 483.172, 483.181, 483.191, 483.201, 483.221, 483.23, 400.235, 483.245, 408.805, 408.806, 408.807, 408.812, 408.813, 408.814, 408.816, 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: July 5, 2018, 2:00 p.m. to 3:00 p.m. ET.

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 via e-mail: [e-mail] or by phone: [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 IS: Josei Ponce via email: [e-mail] or by phone: [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-7.019 Application of Act – Exemption and Exclusions.

Rulemaking Authority 483.051 FS. Law Implemented 483.031, 483.041, 483.051 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.020 Definitions.

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, 7-19-17, Repealed 7-1-18.

 

59A-7.021 Laboratory Licensure – Qualifications, Licensure, Operation and Application.

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 483.051, 483.101, 483.111, 483.172, 483.221, 408.805, 408.806, 408.807, 408.812, 408.813 FS. History–New 11-20-94, Amended 7-4-95, 12-27-95, 3-25-03, 3-1-10, 12-29-10, 6-16-15, Repealed 7-1-18.

 

59A-7.022 Laboratory Construction.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.023 Laboratory Safety and Sanitary Conditions.

Rulemaking Authority 483.051 FS. Law Implemented 483.041, 483.051 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.024 Clinical Laboratories, Collection Stations, Collection, Storage and Shipment of Specimens.

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.106, 483.191, 483.201, 483.221, 483.23 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.025 Participation in Proficiency Testing.

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.201, 483.221 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.026 Approval of Proficiency Testing Programs.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.027 Proficiency Testing Programs by Specialty and Subspecialty.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.028 Patient Test Management.

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.181 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.029 General Quality Control Requirements for Non-waived Testing.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended 6-22-06, 2-27-17, Repealed 7-1-18.

 

59A-7.030 Special Requirements for Licensure: Specialties and Subspecialties.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended 12-27-95, 6-22-06, Repealed 7-1-18.

 

59A-7.031 Quality Assurance.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.032 Inspection of Laboratories.

Rulemaking Authority 483.051 FS. Law Implemented 483.061, 483.221 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.033 Acceptance of Accreditation Inspections.

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.061 FS. History–New 11-20-94, Repealed 7-1-18.

 

59A-7.034 Alternate-Site Testing.

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 408.806, 408.813, 408.814, 408.816, 483.051, 483.181, 483.201, 483.221, 483.23 FS. History–New 12-27-95, Amended 12-8-09, 12-29-10, 10-30-11, Repealed 7-1-18.

 

59A-7.035 Staffing Requirements.

Rulemaking Authority 483.051 FS. Law Implemented 483.035, 483.051, 483.111 FS. History–New 11-20-94, Amended 12-27-95, 7-27-09, 5-13-12, Repealed 7-1-18.

 

59A-7.036 Fees.

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.172 FS. History–New 11-20-94, Amended 3-25-03, Repealed 7-1-18.

 

59A-7.037 Rebates Prohibited – Penalties.

Rulemaking Authority 483.051 FS. Law Implemented 483.221, 483.245 FS. History–New 11-20-94, Amended 12-27-95, Repealed 7-1-18.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Josei Ponce

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 01, 2018