Definitions, Licensure Procedure, Validation, Licensure, & Life Safety Inspections and Complaint Investigations, Governing Body, Departments and Services, Medical Records, Comprehensive Emergency Management Plan
AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing
RULE NOS.:RULE TITLES:
59A-5.002Definitions
59A-5.003Licensure Procedure
59A-5.004Validation, Licensure, & Life Safety Inspections and Complaint Investigations
59A-5.005Governing Body
59A-5.0085Departments and Services
59A-5.012Medical Records
59A-5.018Comprehensive Emergency Management Plan
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 76, April 18, 2014 issue of the Florida Administrative Register.
The following sections of the proposed rule will be changed to read:
59A-5.002 Definitions.
(1) “Administrator” means a person who is delegated the responsibility of carrying out the policies and programs established by the governing board.
(2) through (8) No change.
(9) “Governing board” means an individual owner, partnership, corporation or other legally established authority in whom the ultimate authority and responsibility for management of the ambulatory surgical center is vested.
(10) No change.
(11) “Operating room” means a room designated and equipped for performing surgical operations that requires a restricted environment.
(12) No change.
(13) “Medical Staff” means a formal organization of physicians, dentists, podiatrists, or other health professionals, who are appointed by the governing board to attend patients within the ambulatory surgical center.
(14) through (20) No change.
Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 395.002 FS. History–New 6-14-78, Formerly 10D-30.02, Amended 2-3-88, 5-5-92, Formerly 10D-30.002, Amended 11-13-95,__________.
59A-5.003 Licensure Procedure.
(1) No change.
(2) All persons requesting licensure for the operation of a center under the provisions of Chapter 395, F.S shall make application to the Agency on Health Care Licensing Application, Ambulatory Surgical Centers, AHCA Form 3130-2001 July 2014 September 2013, which is incorporated by reference. The form is available at: http//www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 31, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/HQAlicensureforms. The center must obtain a standard license prior to the acceptance of patients for care or treatment.
(3) through (4)(b) No change.
(c) The ambulatory surgical center’s Zoning Certificate or proof of compliance with zoning requirements.
(5) No change.
(5)(a) The governing board body bylaws, rules and regulations, or other written organizational plan;
(b) through (e) No change.
(f) The ambulatory surgical center’s fire plan; and
(g) through (9) No change.
(10) There shall not be multiple ambulatory surgical center licenses for the same premises a single ambulatory surgical center.
(11) through (16) No change.
Rulemaking Authority 395.1055, 408.819 FS. Law Implemented 395.001, 395.003, 395.004, 395.0161, 395.1055, 408.806, 408.809, 408.811 FS. History–New 6-14-78, Formerly 10D-30.03, Amended 2-3-88, Formerly 10D-30.003, Amended 11-13-95, ___________.
59A-5.004 Validation, Licensure, & Life Safety Inspections and Complaint Investigations.
(1) INSPECTIONS. The Agency for Health Care Administration shall conduct periodic inspections of aAmbulatory sSurgical cCenters in order to ensure compliance with all licensure requirements in accordance with Section 395.0161, F.S.
(2) through (2)(d) No change.
(3) ACCREDITED AMBULATORY SURGICAL CENTERS. The Aagency shall accept the survey report of an accrediting organization in lieu of an annual licensure inspection for accredited centers and for centers seeking accreditation pursuant to Section 395.0161, F.S., provided that the standards used by included in the survey report of the accrediting organization are determined by the Aagency to incorporate comparable document that the ambulatory surgical center is in substantial compliance with state licensure requirements, found in Chapters 395 and 408, F.S., and Chapters 59A-5 and 59A-35, F.A.C., and the center does not meet the criteria specified under subparagraphs (c)(e)1. and 2.
(a) through (6)(a) No change.
1. Complaints involving any ambulatory surgical center shall be reviewed and sent to the appropriate Agency agency’s local area health facility regulation office for investigation, if it is determined that the allegations could constitute a violation of state licensure or and federal certification;
2. through (8) No change.
Rulemaking Authority 395.1055, 395.0161, 408.819 FS. Law Implemented 126.60, 395.001, 395.003, 395.0161, 395.1065, 408.811 FS. History–New 6-14-78, Formerly 10D-30.04, 10D-30.004, Amended 11-13-95,__________.
59A-5.005 Governing Board Body.
(1) The ambulatory surgical center’s organization shall have an effective governing authority responsible for the legal and ethical conduct of the ambulatory surgical center. The governing board body in fulfilling its responsibility shall be organized under approved written bylaws, rules and regulations which shall:
(a) State the qualifications for governing board body membership, and the method of selecting members as well as the terms of appointment or election of members, officers and chairmen of committees. Where legally permissible, physicians who are members of the organized medical staff shall be eligible for, and should be included in, full membership of the ambulatory surgical center’s’ governing board bodies and its their action committees in the same manner as are other knowledgeable and effective individuals. Also, any other member of the organized medical staff shall be considered eligible for membership of the governing board body.
(b) Provide for the designation of officers, their duties, and for the organization of the governing board body into essential committees with the number and type consistent with the size and scope of the ambulatory surgical center’s activities.
(c) Coordinate through an executive committee or the governing board body as a whole, the policies and activities of the ambulatory surgical centers and special committees established by the governing board body.
(d) Specify the frequency of meetings, at regular stated intervals, with a majority of the members constituting a quorum and with the requirement that minutes be recorded and made available to all members of the governing board body.
(e) Establish the a position of administrator, the incumbent of which shall be responsible for operation and maintenance of the ambulatory surgical center as a functioning institution, and define the methods established by the governing board body for holding such designated person responsible.
(f) Provide for the appointment, reappointment, or dismissal of members of the organized medical staff through a credentialing credential committee or its equivalent and a procedure for hearing and appeal. No action on appointment, reappointment or dismissal shall be taken without prior referral to the credentialing medical credential committee for their recommendation, provided that the governing board body may suspend an organized medical staff member pending final determination of any reappointment or dismissal. The governing board body shall only appoint members of the organized medical staff as recommended by the credentialing credentials medical committee.
(g) Provide for the approval of the bylaws, rules and regulations of the organized medical staff.
(h) Require that every patient shall be admitted by and remain under the care of a member of the organized medical staff.
(i) Require that all medications, treatments and procedures shall be administered upon specific orders of a member of the organized medical staff.
(j) Require that all attending organized medical staff members, podiatrists and dentists who do not have admitting privileges at an acute care general hospital document, shall have a written agreement with from a physician who has staff privileges with one or more acute care general hospitals licensed by the state to accept any patient who requires continuing care; or
(k) No change.
(l) Provide for a formal and official means of liaison among the medical staff, the governing board body, and the administrator chief administrative officer to provide a channel for administrative advice.
(m) No change.
(2) Where a the physician-owner-operator serves as the licensee and governing board body, the articles of incorporation or other written organizational plan shall describe the manner in which the licensee owner-operator executes the governing board body responsibility.
Rulemaking Authority 395.1055 FS. Law Implemented 395.003, 393.0191, 395.1055 FS. History–New 6-14-78, Amended 3-3-80, Formerly 10D-30.05, 10D-30.005, Amended 11-13-95,__________.
59A-5.0085 Departments and Services.
(1) through (1)(a) No change.
(b) A surgery record shall be maintained on a current basis that contains at least the following information:
(b)1. through (c) No change.
(d) All infections of surgical cases shall be recorded and reported to the governing board or its designee Infection Control Committee and a procedure shall exist for the investigation of such cases.
(e) Emergency equipment shall be provided as needed commensurate with the services of the center facility, maintained in functional condition, and capable of providing and maintaining cardiorespiratory fuctioning. at least the following services:
1. Inhalation and therapy;
2. Defibrillation;
3. Cardiac monitoring;
4. Suctioning;
5. Maintenance of patient airway.
(f) Written procedures in implementation of policies shall relate specifically to the functional activities of the surgical suite and include but not be limited to the following:
(f)1. through (2) No change.
(2)(a) An A qualified anesthesiologist, credentialed and privileged physician, or certified registered nurse anesthetist, certified pursuant to Section 464.012, F.S., shall be responsible for coordinating and supervising all anesthesia services the functions, equipment and supplies of the service.
(b) All anesthesia shall be administered by an anesthesiologist, or by a credentialed and privileged physician, certified registered nurse anesthetist, under the on-site medical direction of a licensed physician, or anesthesiologist assistant, except for local anesthesia administered by a podiatrist, and except for local anesthesia administered by a dentist, and such other anesthesia administered by a dentist in accordance with Section 466.017, F.S., and Chapter 64B5-14 59Q-14, F.A.C.
(c) An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist, shall be in the ambulatory surgical center during the anesthesia and post-anesthesia recovery period until all patients are cleared for discharge alert or discharged.
(d) through (e) No change.
(f) Written policies and procedures relative to the administration of anesthesia shall be developed by the anesthesia service, approved by the medical staff and the governing board body, and be reviewed annually, dated at time of each review, revised as necessary, and enforced.
(g) Anesthetic safety regulations shall be developed, posted and enforced. Such regulations shall include at least the following requirements:
(g)1. through (3) No change.
(3)(a) A qualified registered professional nurse designated by the administrator shall be responsible for coordinating and supervising all nursing services.
(b) No change.
(c) A registered professional nurse shall be assigned as the operating room circulating nurse for one patient at a time for the duration of the sugical procedure for any procedure performed in the center.
(d) through (g)2. No change.
3. Physician’s and Medical oOrders from physicians and other members of the medical staff;
4. through 17. No change.
18. Equipment and sSupplies: availability and maintenance; and
19. through (4) No change.
(5) RADIOLOGICAL SERVICES. Each ambulatory surgical center shall provide within the institution, or through arrangement, diagnostic radiological services commensurate with the needs of the ambulatory surgical center.
(a) No change.
(b) New installations of radiological equipment, and subsequent inspections for the identification of radiation hazards shall be made as required by specified in Chapter 64E-5, 10D-91, F.A.C.
(c) no change.
(c)1. Personnel – The ambulatory surgical center shall have a licensed practitioner, as defined in Section 468.301(11), F.S., radiologist either full-time or part-time on a consulting basis, both to supervise the service and to discharge professional radiological services.
(c)2. No change.
(c)3. The use of all radiological apparatus shall be limited to appropriately licensed personnel designated as qualified by the radiologist; and use of fluoroscopes shall be limited to appropriately licensed, credentialed and privileged personnel physicians.
(d) If provided under arrangement with an outside provider, the radiological services must be directed by a qualified radiologist and meet the standards as required by specified in Chapter 64E-5, 10D-91, F.A.C.
(6) HOUSEKEEPING SERVICE. The Housekeeping Service shall be organized under effective written policies and procedures relating to personnel, equipment, materials, maintenance, and cleaning of all areas of the ambulatory surgical center. A qualified person designated by the administrator shall be responsible for all procedures. Policies and procedures shall include but not be limited to the following areas:
(a) Operating room suite;
(b) Recovery and pre-operative;
(c) Clean and soiled utilities;
(d) Operating room clean-up;
(e) Operating room materials preparation;
(f) Storage and dispensing;
(g) Laboratory, X-ray and procedure rooms Physical examination;
(h) Isolation units, linen and equipment;
(i) Staff lounges;
(j) Admitting and bBusiness areas;
(k) Separation, handling, and storage of clean and soiled linen.
(l) Identification, separation, handling, and storage of biomedical waste.
Rulemaking Authority and Law Implemented no change to proposed.
59A-5.012 Medical Records.
(1) through (2) No change.
(3) The administrator shall appoint in writing a qualified person responsible for the mMedical rRecords sService. This person shall meet the qualifications established for this position, in writing, by the governing board body.
(4) through (5)(f) No change.
Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055, 395.3025 FS. History–New 6-14-78, Formerly 10D-30.12, 10D-30.012, Amended 11-13-95,__________.
59A-5.018 Comprehensive Emergency Management Plan.
(1) through (2) No change.
(2)(a) Provisions for internal and external disasters, and emergencies, pursuant to Section 252.34, F.S.;
(b) through (m) No change.
(n) Provisions for coordination with designated agencies, including the local Red Cross, and the county emergency management agency pursuant to Section 252.311, F.S.
(3) The plan, including appendices, as required by the “Emergency Management Planning Criteria for Ambulatory Surgical Centers”, shall be submitted annually to the county emergency management agency for review and approval. A fee may be charged for the review of the plan as authorized by Sections 252.35(2)(m)(l) and 252.38(1)(e), F.S.
(a) through (7) No change.
Rulemaking Authority 395.1055, FS. Law Implemented 395.001, 395.1055, 252.35, 252.38 FS. History–New 6-14-78, Formerly 10D-30.18, 10D-30.018, Amended 12-28-94,__________.
The following sections of the Application Checklist of the Health Care Licensing Application, Ambulatory Surgical Center, AHCA Form 3130-2001, September 2013, should be changed to read:
Pg. 1-3, Footer:
The form revision date was updated change the revision date from “September 2013” to “July 2014”.
Pg. 1
The Agency logo has been updated.
The following sections of the Health Care Licensing Application, Ambulatory Surgical Center, AHCA Form 3130-2001, September 2013, should be changed to read:
Pg. 1-8, Footer:
The form revision date was updated to change the revision date from “September 2013” to “July 2014”.
Pg. 1
The Agency logo has been updated.
On Pg. 8, Section 11.
The section title has been changed from “Affidavit” to “Attestation”.
The statements in this section have been replaced with the following:
I, ___________________, under penalty of perjury, attest as follows:
(1) Pursuant to Section 837.06, Florida Statutes, I have not knowingly made a false statement with the intent to mislead the Agency in the performance of its official duty.
(2) Pursuant to Section 408.815, Florida Statutes, I acknowledge that false representation of a material fact in the license application or omission of any material fact from the license application by a controlling interest may be used by the Agency for denying and revoking a license or change of ownership application.
(3) Pursuant to Section 408.806, Florida Statutes, the applicant is in compliance with the provisions of Section 408.806 and Chapter 435, Florida Statutes.
(4) Pursuant to Sections 408.809 and 435.05, Florida Statutes, every employee of the applicant required to be screened has attested, subject to penalty of perjury, to meeting the requirements for qualifying for employment pursuant to Chapter 408, Part II, and Chapter 435, Florida Statutes, and has agreed to inform the employer immediately if arrested for any of the disqualifying offenses while employed by the employer.
(5) Pursuant to Section 435.05, Florida Statutes, the applicant has conducted a level 2 background screening through the Agency on every employee required to be screened under Chapter 408, Part II, or Chapter 435, Florida Statutes, as a condition of employment and continued employment and that every such employee has satisfied the level 2 background screening standards or obtained an exemption from disqualification from employment.
