59A-7.021: Laboratory Licensure - Qualifications, Licensure, Operation and Application
PURPOSE AND EFFECT: The agency is proposing to amend the rule that incorporates the laboratory licensure application and identifies information needed in laboratory applications.
SUMMARY: Revisions to laboratory applications that are incorporated by reference, requirements for accepting applications, requirements for notifications to the agency of laboratory changes, and the removal of language addressing licensure for Certificates of Exemption, as Certificates of Exemption licenses are no longer issued by the Agency, effective July 1, 2009, with revisions to Chapter 483, Part I, Florida Statutes.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 483.051 FS.
LAW IMPLEMENTED: 483.051, 483.091, 483.101, 483.101(1), 483.111, 483.172, 483.181, 483.221, 483.23, 408.303, 408.804, 408.805, 408.806, 408.807, 408.808, 408.809, 408.810, 408.812, 408.813, 408.814, 408.815, 408.816, 408.817, 408.831 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: December 9, 2009, 1:30 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida
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 5 days before the workshop/meeting by contacting: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, (850)487-3109. 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: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, (850)487-3109
THE FULL TEXT OF THE PROPOSED RULE IS:
59A-7.021 Laboratory Licensure – Qualifications, Licensure, Operation and Application.
(1) The application for initial licensure shall include the following information applicable to the laboratory operation:
(a) The application for an initial licensure, including changes of ownership and additions of specialty and subspecialty shall contain:
1. Name, mailing and street address of the laboratory.
2.(b) Specialties and subspecialties performed.
3.(c) A list of equipment.
4.(d) The number of hours the director spends in the laboratory.
5.(e) Names, mailing and street addresses of specimen collection stations, branch offices and other facilities representing the clinical laboratory.
6.(f) Name and source of proficiency testing programs.
7.(g) Annual volume of tests anticipated to be performed.
8.(h) Location and type of alternate-site testing in hospital facilities.
9.(i) The name, address and employer or tax employee identification number of the laboratory owner.
10.(j) For a corporate applicant, the application must include Aa current certificate of status or authorization pursuant to Chapter Section 607.0128, 608, 617 or 620, F.S.
11.(k) Such other information requested on AHCA Form 3170-2004B, 3000-4, Initial Clinical Laboratory Licensure Application, September, 2009, AHCA Form 3170-2004C, Change of Licensed Owner Application, September 2009, ACHA Form 3170-2004D, Addition of Specialty, Subspecialty or change in Specialty, September 2009, or AHCA Form 3110-1024, Health Care Licensing Application Addendum, October 2009, Nov 2002, necessary in carrying out the purpose of this part as stated in Section 483.021, F.S., and Sections 408.805, 408.806, 408.807, 408.810, and 408.813, F.S. as applicable to the laboratory operation. AHCA Forms 3170-2004B, 3170-2004C and 3170-2004D 3000-4, Initial Clinical Laboratory Licensure Application, Nov 2002, shall be obtained from the agency and is incorporated by reference herein and are available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/applications.shtml.
(b)(l) Notwithstanding the requirements of paragraphs (a) through (k) above Tthe application for renewal licensure shall contain the following information applicable to the laboratory operation:
1. Name, mailing and street address of the laboratory.
2. Specialties and subspecialties 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 performed.
5. Location and type of alternate-site testing in hospital facilities.
6. The name and employer or tax identification number of the laboratory owner.
7. Such other information requested on AHCA Form 3170-2004, Clinical Laboratory License Renewal Application, REV September 2009 Nov 2002, or AHCA Form 3110-1024, Health Care Licensing Application Addendum, October 2009, necessary in carrying out the purpose of this part as stated in Section 483.021, F.S. and Sections 408.805, 408.806, 408.807, 408.810, and 408.813, F.S., as applicable to the laboratory operation. AHCA Form 3170-2004, Clinical Laboratory License Renewal Application, REV September, 2009 Nov 2002, shall be obtained from the agency and is incorporated by reference herein and are available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/applications.shtml.
(c)(m) In addition to information required under paragraphs 59A-7.021(1)(a) and (b) through (l), 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., must also submit:
1. Proof of current accreditation or licensure by the approved accreditation program; and
2. 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 for the correct amount 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. Laboratories maintained on separate premises, operated under the same management and performing only waived tests shall be permitted to apply for a single certificate of exemption.
(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, F.S., and Chapter 408, Part II, F.S., or rules promulgated thereunder.
(6) A licensee shall notify the agency by certified mail of a change of name, operation, relocation or impending closure of the laboratory a minimum of thirty (30) days prior to such change or closure. A licensee shall notify the agency by certified 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.
(8) A license shall be valid for the period specified on the current license.
(a) In no event shall a license be issued for more than a 24 month period. 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 a completed application or the application required 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 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.
(9) Laboratories issued a licensure certificate of exemption must follow manufacturers’ instructions for performing tests and maintain documentation of same. The manufacturers’ instructions and documentation of tests performed must be maintained by the laboratory and available for review by the agency.
(9)(10) 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.
(11) A laboratory that is issued a licensure certificate and performs waived tests is subject to provisions of subsection 59A-7.021(9), F.A.C., for the waived tests.
(10)(12) Laboratories are prohibited from performing testing for which they are not authorized. The performance of unauthorized testing 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. Sections 408.812, 408.813, 408.814, 408.815, 408.816, 408.817 and 408.831, F.S.
(11)(13) 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 Health Care Financing Administration for the purpose of determining compliance with the Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder.
Rulemaking Specific Authority 483.051 FS. Law Implemented 483.051, 483.091, 483.101, 483.101(1), 483.111, 483.172, 483.181, 483.221, 483.23, 408.303, 408.804, 408.805, 408.806, 408.807, 408.808, 408.809, 408.810, 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,__________.