The purpose is to modify existing rules to delete definitions defined in statute; update references to an outdated form which has been revised and incorporated in rule; update licensure fee reference; and add references to align with our uniform ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-9.019Definitions

59A-9.020Licensure Procedures

59A-9.021Investigations and License and Validation Inspections

PURPOSE AND EFFECT: The purpose is to modify existing rules to delete definitions defined in statute; update references to an outdated form which has been revised and incorporated in rule; update licensure fee reference; and add references to align with our uniform licensure statute and rule.

SUMMARY: Rule 59A-9.019, F.A.C., is amended to delete definitions clearly defined in statute. Rule 59A-9.020, F.A.C., is amended to add references and align with our uniform licensing statute and rule (Chapter 408, Part II, F.S., and Chapter 59A-35, F.A.C.) and update references to the abortion clinic licensure application form. Rule 59A-9.021, F.A.C., is amended to add references and align with our uniform licensing statute and rule and delete subsection (3) as it is duplicative of fees stated in Rule 59A-9.020, F.A.C.

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 been prepared by the Agency.

A statement of estimated regulatory costs has been prepared for proposed rule revisions in Rule 59A-9.020 and is available from the person listed below. The following is a summary of the SERC:

For proposed rule subsection 59A-9.020(2), F.A.C., license fees are increased by the Consumer Price Index pursuant to Section 408.805(2), F.S. The biennial licensure fee will increase by $45.05. Based on the number of currently licensed facilities, the total impact over 5 years will be $7,433.25. There is no projected growth in licensees.

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 been prepared by the agency for Rule 59A-9.020, F.A.C. For rules listed where no SERC was prepared, the Agency prepared a checklist for each 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: 390.012, 408.033, 408.819 FS.

LAW IMPLEMENTED: 381.0012, 382, 390.011, 390.012, 390.013, 390.014, 390.015, 390.016, 390.017, 390.018, 390.019, 390.021, 408.805, 408.033 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: September 23, 2014, 10:00 a.m. – 11:00 a.m.

PLACE: Agency for Health Care Administration, Ft. Knox Bldg. 3, Conference Room D, 2727 Mahan Drive, 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: Kim Stewart via e-mail at [e-mail] or by phone at [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: Kim Stewart via e-mail at [e-mail] or by phone at [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-9.019 Definitions.

The following definitions shall apply specifically to abortion clinics.

(1) “Abortion” means the termination of human pregnancy with the intention other than to produce a live birth or to remove a dead fetus.

(2) “Abortion Clinic” or “Clinic” means a facility, institution, or place in which abortions are performed other than a hospital or a physician’s office which is not used primarily for the performance of abortions.

(1)(3) “Anesthesiologist” means a person currently licensed to practice medicine or osteopathy pursuant to Chapter 458 or 459, F.S., and certified by the American Board of Anesthesiology.

(4) “Advanced Registered Nurse Practitioner, (ARNP)” means a person currently licensed pursuant to Chapter 464, F.S.

(5) “Agency” means the Agency for Health Care Administration.

(2)(6) “Certified Registered Nurse Anesthetist, (CRNA)” means a person currently licensed pursuant to Chapter 464, F.S., and certified by the Council on Certification of Nurse Anesthetists.

(3)(7) “Clinical staff” means the individuals employed full or part time by an abortion clinic who are licensed or certified to provide care prior to, during, or after an abortion.

(8) “Department” means the Department of Health.

(4)(9) “F.A.C.” means the Florida Administrative Code.

(5)(10) “Facility” means those objects, including physical plant, equipment, and supplies necessary for providing required services.

(11) “Hospital” means a facility licensed under Chapter 395, F.S.

(12) “License” means the certificate issued by the agency for the operation of the facility. This document constitutes the authority to receive patients and to perform the services included within the scope of this rule and as specified on the license.

(6)(13) “Licensed” means that person or facility to which the term is applied has a current or valid license, certificate or registration issued by the State of Florida to follow his profession or vocation within the State of Florida, and when applied to a health care facility means that the facility has a current license issued by the agency.

(14) “Licensee” means the person who has been granted a license to operate an abortion clinic and who has ultimate authority and responsibility for the operation, management, control, conduct, and functioning of the abortion clinic.

(7)(15) “Licensure” means the process of obtaining official or legal permission to operate an abortion clinic.

(16) “Licensed Practical Nurse, (L.P.N.)” means a person currently licensed as an L.P.N. pursuant to Chapter 464, F.S.

(8)(17) “Medical Director” means a physician licensed under Chapter 458 or 459, F.S., and who has admitting privileges at a licensed hospital in this state or has a transfer agreement with a licensed hospital within reasonable proximity of the abortion clinic.

(9)(18) “Patient” means any woman receiving services in an abortion clinic.

(10)(19) “Person” means any individual, firm, partnership, corporation, or association.

(20) “Physician Assistant, (P.A.)” means a person currently licensed as a P.A. pursuant to Chapter 458 or 459, F.S.

(21) “Physician” means a person currently licensed to practice medicine or osteopathy pursuant to Chapter 458 or 459, F.S.

(11)(22) “Premises” means those buildings, beds, and facilities of the clinic and all other buildings, beds, and facilities for the performance of abortions located in such reasonable proximity to the main address of the licensee and appear to the public to be under the domain and the control of the licensee.

(12)(23) “Reasonable proximity” means a distance not to exceed thirty (30) minutes transport time by emergency vehicle.

(13)(24) “Registered Professional Nurse, (R.N.)” means a person currently licensed as a R.N. pursuant to Chapter 464, F.S.

(14)(25) “Trimester” means a 12-week period of pregnancy.

(a) First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period).

(b) Second Trimester. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation.

(c) Third Trimester. That portion of pregnancy beginning with the 25th week of gestation.

(15)(26) “Volunteer” means a person who is not employed by the facility who interacts with patients on behalf of the abortion clinic.

Rulemaking Specific Authority 390.012, FS. Law Implemented 390.011, 390.012, 390.013 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.019, Amended 8-24-94, 9-25-06,___________.

 

59A-9.020 Licensure Procedures.

(1) All persons planning the operation of an abortion clinic under the provisions of Chapters 408 and Chapter 390, F.S., shall make application for a license to the Agency on the Health Care Licensing Application, Abortion Clinic, AHCA Form 3130-1000, July 2014, which is for Health Care Administration, Office of Health Facility Regulation, Tallahassee, Florida, on Agency Form 3130-1000-revised July, 2005, “Abortion Clinic Licensure Application”, hereby incorporated by reference., The form which can be obtained at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida, 32308 or on the agency website at: http://ahca.myflorida.com/HQAlicensureforms. http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/abortion.shtml, and must receive a license prior to the acceptance of patients for care and treatment. The application shall be made under oath and shall contain such information as the agency reasonably requires, which may include evidence of the applicant’s ability to comply with applicable laws and rules. 

(2) The licensure A license fee of $545.05 $250 shall accompany the application for a license or a license renewal. The licensure license fee shall be made payable to the agency and is not refundable. The licensure fee will be established as prescribed by Sections 408.805 and 390.014, F.S.

(3) Each license shall be valid only for the persons or entity to whom it is issued and shall not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor shall a license be valid for any premises other than for which it was orginally issued.

(4) A current license shall be posted in a conspicuous place within the licensed premises where it can be viewed by patients.

(5) A license, unless sooner suspended or revoked, shall automatically expire two years one year from the date of issuance, and shall be renewable biennially annually upon application for renewal and payment of the fee prescribed by these rules, provided that the applicant and abortion clinic meet the requirements established under Chapters 408 and Chapter 390, F.S., and Chapters 59A-35 and Chapter 59A-9, F.A.C. Application for renewal of a license shall be made not less than 60 days prior to expiration of a license. on agency Form 3130-1000-revised July 2005, available from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop 31,2727 Mahan Drive, Tallahassee, Florida 32308. The application is also available on-line at the agency website at: http://ahca.myflorida.com/MCHQ/ Health_Facility_Regulation/Hospital_Outpatient/abortion.shtml.

(6) Where the agency finds that there has been a failure to comply with the requirements established under this part or in rules promulgated hereunder, the agency is authorized to deny, modify, suspend, or revoke a license.

Rulemaking Specific Authority 390.012, 408.033, 408.819 FS. Law Implemented 20.42(2)(a), 390.011, 390.012, 390.014, 390.015, 390.016, 390.017, 390.018, 390.019, 390.021, 408.033, 408.805 FS. History–New 6-13-90, Amended 4-17-91, 10-9-91, Formerly 10D-72.020, Amended 8-24-94, 9-25-06,__________.

 

59A-9.021 Investigations and License and Validation Inspections.

(1) The agency has the right to enter an abortion clinic to make or cause to be made such inspections and investigations as are necessary to:

(a) Assure compliance with the licensure requirements and standards as specified in statute and rule;

(b) Respond to complaints; and

(c) Protect the public health and safety.

(2) The agency shall conduct an annual unannounced licensure inspection of all abortion clinics.

(3) The fee for the renewal license shall be $250.

(3)(4) Representatives of the agency shall have the right to enter upon the premises of any facility licensed, or applying for license, pursuant to this Chapter, at any reasonable time in order to determine the state of compliance with the provisions of Chapters 408 and Chapter 390, F.S., and Chapters 59A-35 and 59A-9, F.A.C. these rules, providing that such entry and inspection shall be made with the least possible disruption to clinic activities and in a manner considerate of the privacy and confidentiality of any patient who is present therein. All inspections shall be unannounced.

Rulemaking Specific Authority 390.012, 408.819 FS. Law Implemented 381.0012, 382, 390.011, 390.012, 390.014, 390.019 FS. History–New 6-13-90, Amended 4-17-91, 10-9-91, Formerly 10D-72.021, Amended 9-25-06,___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kim Stewart via e-mail at [e-mail] or by phone at [phone]

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek, Secretary, Agency for Health Care Administration

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 3, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 12, 2013