The purposes is to modify an existing rule to update incorporated application forms; remove duplicative language currently found in statute; and add references to align with our uniform licensure statute and rule.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

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

PURPOSE AND EFFECT: The purposes is to modify an existing rule to update incorporated application forms; remove duplicative language currently found in statute; and add references to align with our uniform licensure statute and rule.

SUMMARY: Rule 59A-7.021 is amended to delete provisions currently found in statute; update incorporated application forms; add references to align with our uniform licensing statute and rule; and delete duplicative language.

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. The Agency prepared a checklist for the rule to determine the necessity for a SERC.

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: 483.051, 483.101, 483.111, 483.172, 483.221, 483.23, 408.805, 408.806, 408.807, 408.812, 408.813 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: Monday, March 9, 2015, 2:00 p.m. – 3:00 p.m.

PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida 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 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: Dayle Mooney via e-mail: [e-mail] or by phone: [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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

(1) The application for licensure shall include the following information applicable to the laboratory operation:

(a) The application for an initial licensure, including initial, renewal, and changes of ownership and additions of specialty and subspecialty shall contain:

1. Name, mailing and street address of the laboratory.

2. Specialties and subspecialties performed.

3. A list of equipment.

4. The number of hours the director spends in the laboratory.

5. Names, mailing and street addresses of specimen collection stations, branch offices and other facilities representing the clinical laboratory.

6. Name and source of proficiency testing programs.

7. Annual volume of tests performed or anticipated to be performed.

8. Location and type of alternate-site testing in hospital facilities.

9. The name, address and employer or tax identification number of the laboratory licensee owner.

10. A current certificate of status or authorization pursuant to Chapter 607, 608, 617 or 620, F.S.

11. Such other information requested on the application, Health Care Licensing Application, Clinical Laboratories –

Non-waived, AHCA Form 3170-2004, July 2014, which is incorporated herein by reference. This form is available at http://flrules.org/Gateway/reference.asp?No=Ref-XXXXX or http://ahca.myflorida.com/HQAlicensureforms and from the Agency for Health Care Administration, 2727 Mahan Drive, MS 32, Tallahassee, Florida 32308. for licensure as specified in paragraph 59A-35.060(1)(aa), F.A.C.

(b)  The application for additions of specialty and subspecialty renewal licensure shall contain:

1. Name, mailing and street address of the laboratory.

2. Additional sSpecialties or and subspecialties to be performed.

3. Names, mailing and street addresses of specimen collection stations, branch offices and other facilities representing the clinical laboratory.

4. Annual volume of tests anticipated to be performed.

5. Location and type of alternate-site testing in hospital facilities.

6. The name and employer or tax identification number of the laboratory licensee owner.

7. Information requested on the application, Health Care Licensing Application, Clinical Laboratories – Non-Waived (Addition of Specialty, Subspecialty or Change in Specialty at Time Other than Licensure Renewal), AHCA Form 3170-2004D, July 2014, which is incorporated herein by reference. This form is available at http://flrules.org/Gateway/reference.asp?No=Ref-XXXXX or http://ahca.myflorida.com/HQAlicensureforms and from the Agency for Health Care Administration, 2727 Mahan Drive, MS 32, Tallahassee, Florida 32308. for licensure as specified in paragraph 59A-35.060(1)(aa), F.A.C.

(c) In addition to information required under paragraphs 59A-7.021(1)(a) and (b), F.A.C., accredited laboratories surveyed by an approved accreditation program in lieu of the agency, as specified in Rule 59A-7.033, F.A.C. and Chapter 408, Part II, F.S., must also submit:

1. Proof of enrollment in or current accreditation or licensure by an the approved accreditation program; and

2. Upon request, the most recent survey inspection reports from the accrediting organization. Proof of authorization for the approved accreditation program to submit to the agency such records or other information about the laboratory required for the agency to determine compliance with Chapter 59A-7, F.A.C. and Chapter 483, Part I, F.S.

(2) Payment of the licensure fee must accompany the application in order to be accepted. Applications submitted without payment will be returned to the applicant. If test volumes submitted in the application indicate the fee submitted is not the correct fee, the applicant will be notified by the Agency of any amount due. Applications where the correct fee is not timely submitted in response to the Agency’s notification will be withdrawn from review as required under Section 408.806(3)(b), F.S. Laboratories seeking initial licensure that claim accreditation and therefore a reduced fee, must provide proof that the clinical laboratory is accredited. Laboratories seeking licensure renewal must provide the most recent survey inspection reports from the accrediting organization as proof of accreditation. Surveys must have been completed by the accrediting organization within the past two years to be acceptable in accordance with Rule 59A-7.033, F.A.C. Accreditation reports must be for the laboratory. Proof that the facility in which the laboratory is located is accredited will not be accepted as proof that the clinical laboratory is accredited.

(3) Separate licensure shall be required for all laboratories maintained on separate premises, as defined under subsection 59A-7.020(27), F.A.C., including mobile laboratory units, even though operated under the same management. Separate licensure shall not be required for separate buildings on the same or adjoining grounds.

(4) Each license is valid only for the person or persons to whom it is issued and shall not be sold, assigned or transferred voluntarily or involuntarily. A license is not valid for any premises other than that for which it was originally issued. A laboratory must be re-licensed if a change of ownership, as defined in Section 408.803(5), F.S., occurs. Application for re-licensure must be made to the agency 60 days prior to the change of ownership and the effective date of the change must be included in the application. When a laboratory is leased by the owner to a second party for operation, said second party must apply to the agency 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 laboratory must be filed with the application.

(5) A license issued to any laboratory shall be revoked and reapplication denied by the agency in any case where the laboratory fails to sustain continued compliance with provisions of Chapter 483, Part I and Chapter 408, Part II, F.S., or rules promulgated thereunder.

(2)(6) A licensee shall notify the agency of a change of name, operation, relocation or impending closure of the laboratory prior to such change or closure. A licensee shall notify the agency by mail on company letterhead of a change of director or supervisor immediately upon learning of such change.

(7) Each license shall be returned to the agency immediately upon change of ownership or classification, suspension, revocation, or voluntary cessation of operations.

(3)(8) A license shall be valid for the period specified on the current license.

(a) In the event that specialties and subspecialties are added to an existing license, the expiration of the additional specialties/subspecialties shall be the expiration date of the current license.

(b) Continued operation of a clinical laboratory that has not submitted an application with or the application fee after the date of expiration of its license or after the date of sale in the event of a change of ownership shall be a criminal offense under Section 483.23, F.S., and may shall result in administrative action up to and including an administrative fine charged to the laboratory in the amount of $100.00 per day, each day constituting a separate violation as authorized under Section 483.221, F.S.

(4)(9) Laboratory services provided in a temporary testing location such as a patient’s home or health fair, is covered under the license or federal Certificate of Waiver in the case of laboratories doing waived testing only, of the designated primary site or home base using its address provided such services are not offered on a permanent basis. Mobile laboratory units shall be considered separate entities and shall require licensure under Chapter 483, Part I, F.S., for each unit.

(5)(10) Mobile laboratory units shall be considered separate entities and shall require licensure under Chapter 483, Part I, F.S., for each unit. Laboratories are prohibited from performing testing for which they are not authorized. The performance of unauthorized testing shall result in administrative action as authorized under Sections 483.221, 408.812, 408.813, 408.814, 408.815, 408.816, 408.817 and 408.831, F.S.

(11) All licensed facilities must authorize the agency to submit information requested or required by the federal Centers for Medicare and Medicaid Services to the Agency for the purpose of determining compliance with the Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder.

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 483.051, 483.101, 483.111, 483.172, 483.221, 483.23, 408.804, 408.805, 408.806, 408.807, 408.812, 408.813, 408.814, 408.815, 408.816, 408.817, 408.831 FS. History–New 11-20-94, Amended 7-4-95, 12-27-95, 3-25-03, 3-1-10, 12-29-10,________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dayle Mooney, Program Administrator

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 23, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 30, 2014