The purpose is to revise rules related to the ambulatory surgical centers standards and licensure. These revisions will update definitions, reword for clarity, update licensure fee amounts, correct rule and statutory references, update references ...

 

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

PURPOSE AND EFFECT: The purpose is to revise rules related to the ambulatory surgical centers standards and licensure. These revisions will update definitions, reword for clarity, update licensure fee amounts, correct rule and statutory references, update references to a form that has been revised and incorporated in rule, clarify who can administer anesthesia, and update rule references that are now found in the Florida Building Code.

SUMMARY: Rule 59A-5.002, F.A.C., is amended to reorder, delete, and add definitions. Rule 59A-5.003, F.A.C., is amended to incorporate a form revision, update fee, and update rule references that are now in Florida Building Code. Rule 59A-5.004, F.A.C., is amended to add references and align with language in Chapters 395 and 408, F.S. Rule 59A-5.005, F.A.C., is amended to specify the position of Administrator. Rule 59A-5.0085, F.A.C., is amended to expand the list of who can administer anesthesia in licensed ambulatory surgical centers. Rule 59A-5.012, F.A.C., is amended to specify a patient’s record, correct grammar, and strike language requiring original documents. Rule 59A-5.018, F.A.C., is amended to add references to the Florida Building Code and correct grammar.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will 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 this will have an adverse impact on small business, but will not 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 59A-5.003, F.A.C., and is available from the person listed below. The following is a summary of the SERC:

For proposed rule subsection 59A-5.003(7), 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 $179.82 per ambulatory surgical center. Based on the number of currently licensed ambulatory surgical centers the total impact over 5 years will be $197,442.36.

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: 395.1055, 408.819 FS.

LAW IMPLEMENTED: 395.001, 395.002, 395.003, 395.004, 395.009. 395.1055, 395.0161, 395.0191, 395.1011, 395.1065, 395.3025, 408.806, 408.809, 408.811 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: May 14, 2014, 4:00 p.m. – 5:00 p.m.

PLACE: Ft. Knox Bldg. 3, Conference Room D, 2727 Mahan Drive, Tallahassee, FL 32308

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Kim Stewart via e-mail: [e-mail] or by phone: [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 59A-5.002 follows. See Florida Administrative Code for present text.)

 

59A-5.002 Definitions.

In addition to definitions contained in Chapters 395, F.S. Part I and 408, F.S., Part II,  the following definitions shall apply specifically to ambulatory surgical centers.

(1) “Administrator” means a person who is delegated the responsibility of carrying out the policies and programs established by the governing body.

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

(3) “Anesthesiologist” means a person currently licensed to practice medicine or osteopathy pursuant to Chapter 458 or 459, F.S., and who has completed an approved residency in the field of anesthesiology.

(4) “Anesthesiologist Assistant” means a person currently licensed pursuant to Chapter 458 or 459, F.S. as an anesthesiologist assistant.

(5) “Center” means an ambulatory surgical center.

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

(7) “Dentist” means a person currently licensed to practice dentistry pursuant to Chapter 466, F.S.

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

(9) “Governing Body” 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) “Licensed Practical Nurse” means a person currently licensed as defined in Section 464.003(16), F.S.

(11) “Operating room” means a room used for the sole purpose of performing surgical procedures and meeting the requirements of Florida Building Code for ambulatory surgical centers.

(12) “Operating room technician” means a person with specialized training in operation room techniques and considered by the governing body qualified to serve as part of the operating room staff.

(13) “Organized Medical Staff” means a formal organization of physicians, dentists, podiatrists, or other health professionals, who are appointed by the governing body to attend patients within the ambulatory surgical center.

(14) “Patient” means a person admitted to the ambulatory surgical center.

(15) “Pharmacist” means a person currently licensed pursuant to Chapter 465, F.S.

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

(17) “Podiatrist” means a person currently licensed to practice podiatric medicine pursuant to Chapter 461, F.S.

(18) “Procedure Room” means a room designated for the performance of special procedures that do not require a restricted environment but may use sterile instruments or equipment.

(19) “Recovery Bed” means an accommodation with support services used for post-operative recovery in an ambulatory surgical center.

(20) “Registered Professional Nurse” means a person currently licensed as defined in Section 464.003(22), F.S.

Rulemaking Authority 395.1055, FS. Law Implemented 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) In addition to the licensure requirements contained in Chapters 395, F.S., Part I and 408, F.S., Part II, Section 395.003, F.S., all ambulatory surgical centers shall comply with the following:

(2) All persons requesting licensure for the operation of a ambulatory surgical center under the provisions of Chapter 395, F.S., on or after January 1, 1978, shall make application to the Agency for Health Care Administration, Office of Health Facility Regulation, Tallahassee, Florida on Health Care Licensing Application, Ambulatory Surgical Centers, AHCA Form 3130-2001 September 2013 May 95, which is hereby incorporated by reference, and available from the Agency for Health Care Administration. The ambulatory surgical center shall receive a regular license prior to the acceptance of patients for care or treatment. 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) Each ambulatory surgical center applying for a license shall be designated by a distinctive name, and the name shall not be changed without first notifying the Aagency and receiving approval in writing. Duplication of an existing ambulatory surgical center’s name is prohibited.

(4) In addition to the requirements found in Chapter 408, Part II, the The following documents shall accompany the initial application:

(a) Proof of fictitious name registration if applicable; The Affidavit of Compliance with Fictitious Name pursuant to Section 865.09, F.S.;

(b) Registration of Articles of Incorporation or similarly titled document registered by the applicant with the Florida Department of State in the State of Florida for the ambulatory surgical center; and

(c) The ambulatory surgical center’s Zoning Certificate or proof of compliance with zoning requirements.

(5) The following documents shall be available for inspection at the center by the Aagency area office at the initial licensure inspection:

(a) The governing body bylaws, rules and regulations, or other written organizational plan;

(b) Medical staff bylaws, rules and regulations;

(c) Roster of medical staff members;

(d) Nursing procedure manual;

(e) Roster of registered nurses and licensed practical nurses with current license numbers;

(f) The ambulatory surgical center’s fire plan; and

(g) The Comprehensive Emergency Management Plan pursuant to Rule 59A-5.018, F.A.C.

(6) In addition to the requirements found in Chapter 408, Part II, all applications for a change of ownership In the case of centers applying for first license after purchase, and previously licensed under other ownership, the licensure application shall include;

(a) A signed agreement with the Aagency to correct physical plant deficiencies listed in the most recent licensure inspection that conforms to Florida Building Code Rules 59A-5.020 through 59A-5.031, F.A.C., shall accompany the license application;

(b) A copy of the closing documents, which must include an effective date and the signatures of both the buyer and the seller;

(c) Registration of Articles of Incorporation or similarly titled document registered by the applicant with the Florida Department of State; in the State of Florida;

(d) Proof of fictitious name registration if applicable; The Affidavit of Compliance with Fictitious Name pursuant to Section 865.09, F.S.;

(e) Evidence of payment of, or arrangement to pay, any liability to the state pursuant to Section 395.003(3)(b)2., F.S.

(7) A license fee of $1,679.82 $1,500.00 for the operation of a an ambulatory surgical center as established by Chapter 395, F.S., shall accompany an application for an initial, renewal or change of ownership license. The license fee shall be made payable to the Agency for Health Care Administration. No license shall be issued without payment of the requisite fee, and, if the application for licensure is withdrawn, only that portion of the fee which is in excess of the agency’s actual costs for processing the application up to the point of withdrawal shall be refunded. Where licenses are denied, the license fee is not refundable.

(8) All permanent additions to the constructed center’s operating room capacity occurring after the issuance of the initial annual license shall require a new application for licensure.

(9) Each license shall specifically state the number of operating rooms, procedure rooms, and number of recovery beds in the center premise.

(10) Each license shall be returned to the agency immediately upon change in ownership or voluntary cessation of operations; or when license is suspended or revoked.

(10)(11) There shall not be multiple ambulatory surgical center licenses for a single ambulatory surgical center.

(11)(12) Each ambulatory surgical center licensed under Chapter 395, F.S., shall establish an internal risk management program pursuant to Chapter 59A-10, F.A.C., as a part of its administrative function.

(12)(13) Upon receipt of the required information in subsections (1) through (4) above, completed initial application, the Aagency shall conduct a licensure inspection a survey to determine substantial compliance with Chapter 395, F.S., Part I and Rules 59A-5.002  59A-5.001 through 59A-5.022, 59A-5.031, F.A.C.

(13)(14) When a an ambulatory surgical center is in substantial compliance with Chapters Chapter 395, F.S., Part I, 408, F.S., Part II and Rules 59A-5.002 59A-5.001 through 59A-5.022 59A-5.031, F.A.C., and has received all approvals required by law, the Aagency shall issue, a single license which identifies the licensee ambulatory surgical center and the name and location of the ambulatory surgical center. This license must be displayed in a conspicuous place.

(14)(15) Separate licenses shall not be required for separate buildings on the same grounds when used by the same ambulatory surgical center.

(15)(16) A license issued to a an ambulatory surgical center shall be revoked or denied by the Aagency in any case where the Aagency finds there has been substantial failure to comply with provisions of Chapter 395, F.S., Part I, or Chapter 59A-5, F.A.C.

(16)(17) A licensee shall notify the Aagency of impending closure of a an ambulatory surgical center not less than 30 days prior to such closure. The ambulatory surgical center shall be responsible for advising the Aagency as to the disposition of medical records.

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 Ambulatory Surgical Centers in order to ensure compliance with all licensure requirements in accordance with Section 395.0161, F.S.

(2) NON-ACCREDITED AMBULATORY SURGICAL CENTERS. Those ambulatory surgical Ccenters which are not accredited by an accrediting organization JCAHO or AAAHC shall be subject to a scheduled annual licensure inspection survey by the agency. The fee for conducting a an annual licensure inspection shall be $400.00.

(a) Within 10 days of the completion of the agency’s survey, the agency will mail a copy of the survey findings to the center. For those centers determined not in compliance with state licensure requirements, the notification shall include a statement of deficiencies.

(b) Within 10 days of receipt of a statement of deficiencies, the center must prepare and mail a plan of correction for review and approval to the agency. The plan of correction must address the action planned by the center to correct each deficiency, the individuals or entities responsible for implementing the corrective action, and the date by which each corrective action will be completed.

(c) The agency will conduct a follow-up visit to those centers with an approved plan of correction within 30 days of receipt by the agency of the approved plan of correction, or within 30 days of the completion date for deficiencies contained in the approved plan, or will review pertinent materials submitted by the center, to determine compliance with the approved plan of correction.

(d) The agency will work with ambulatory surgical centers to ensure compliance with standards of care through the implementation of acceptable plans of correction. Those centers which fail to implement approved plans of correction shall be subject to sanctions imposed under Section 395.1065, F.S.

(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 included in the survey report of the accrediting organization are determined by the agency to 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) Upon receipt of the accrediting organization’s survey report, the Aagency will review the findings to determine if the center is in substantial compliance with state licensure requirements.

(b) The Aagency shall notify the ambulatory surgical center within 60 days of the receipt of the accrediting organization’s survey report regarding the Aagency’s determination of the ambulatory surgical center’s compliance or non-compliance with state licensure requirements. For ambulatory surgical centers that are determined not to be in compliance with licensure requirements, the notification will include a statement of deficiencies.

(c) Ambulatory surgical centers determined by the agency not to be in substantial compliance with state licensure requirements shall submit a plan of correction to the agency within 10 days of receipt of the statement of deficiencies.

(d) The agency shall review the plan of correction in accordance with the procedures specified under paragraphs (2)(a) through (d).

(c)(e) Accredited Ambulatory surgical centers shall be subject to an annual licensure inspection under the following circumstances:

1. The ambulatory surgical center has been denied accreditation or has received a provisional or conditional accreditation from an accrediting organization on its most recent accreditation report survey, and has not submitted an acceptable plan of correction to the accrediting organization and the agency.

2. The ambulatory surgical center has received full accreditation, but has not authorized the release of the report to the Agency or has not ensured that the Aagency received the accrediting organization’s survey report prior to the Aagency’s scheduled inspection survey.

(d)(f) The fee for an annual licensure inspection shall be $400.00 for any accredited center subject to inspection pursuant to paragraph (c)(e).

(4) LIFE SAFETY INSPECTIONS. The agency shall conduct a scheduled annual life-safety inspection of all ambulatory surgical centers to ensure physical plant compliance with life safety codes pursuant to Rules 59A-5.020 through 59A-5.031, F.A.C., and requirements for disaster preparedness pursuant to Rule 59A-5.018, F.A.C., unless:

(a) The ambulatory surgical center was surveyed during an accreditation survey by a Florida certified life safety inspector, and found to be in compliance with life safety requirements by the accrediting organization, and;

(b) The report of that survey has been released to and received by the agency prior to the agency scheduling a life-safety inspection.

(4)(5) LIFE SAFETY INSPECTION FEE. A separate fee of $40.00 shall be assessed for a life-safety inspection, except when conducted as part of a licensure or a Centers for Medicare and Medicaid Services Health Care Financing Administration certification inspection.

(5)(6) VALIDATION INSPECTION. Each year, the Aagency shall conduct validation inspections on a minimum of five percent of those centers that have undergone an accreditation inspection from an accrediting organization, to determine ongoing compliance with state licensure requirements.

(a) Upon Within 10 days following the completion of a validation inspection survey, the Aagency will send mail a copy of its findings to the ambulatory surgical center. For those centers determined not to be in compliance with state licensure requirements the notification will include a statement of deficiencies.

(b) Ambulatory surgical centers found not in compliance based on a validation inspection shall submit a plan of correction as specified under paragraphs (2)(a) through (d).

(b)(c) If the Aagency determines, based on the results of validation inspection survey findings, that an accredited center is not in substantial compliance with state licensure requirements, the Aagency shall report its findings to the accrediting organization and shall conduct a full licensure inspection on that center during the following year.

(c)(d) The fee for conducting a licensure validation inspection shall be $400.00. A separate fee for a validation inspection survey will not be assessed when conducted in conjunction with a Centers for Medicare and Medicaid Services Health Care Financing Administration certification inspection.

(6)(7) COMPLAINT INVESTIGATIONS. The Aagency shall conduct investigations of complaints regarding violations of licensure, and life-safety standards in accordance with Sections 395.0161 and 408.811, F.S. Complaint investigations will be unannounced. An entrance conference shall be conducted upon arrival, by Aagency personnel investigating the complaint, to inform the center’s administrator about the nature of the complaint investigation and to answer questions from the center’s staff. An exit conference shall be provided at the conclusion of the on-site investigation to inform the center of the scope of the investigation and to receive any additional information that the center wishes to furnish.

(a) Upon receipt of a complaint, the Aagency shall review the complaint for allegations of non-compliance with licensure requirements compliance with licensure issues, and in addition, shall take the following actions:

1. Complaints involving any ambulatory surgical center shall be reviewed and sent to the appropriate 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. If allegations are more appropriately addressed by another state agency or entity, the complaint will be referred accordingly.

(b) Upon a determination that investigation of a complaint is warranted, the Aagency shall conduct an complete the complaint investigation within 90 days, unless there is an immediate threat to patient safety and well being, in which case an immediate investigation shall be undertaken.

(c) Upon conclusion of a complaint investigation by the agency, the agency shall notify the affected parties in writing within 10 days of its determination as to the validity of the complaint and any actions to be taken to resolve violations or sanctions imposed against the ambulatory surgical center.

(7)(8) CONFORMANCE WITH ACCREDITATION STANDARDS. In all ambulatory surgical centers where the Aagency does not conduct an annual licensure inspection, by reason of the ambulatory surgical center’s accreditation status, the ambulatory surgical center shall continue to conform to the standards of accreditation throughout the term of accreditation, or shall notify the Aagency of the areas of non-conformance. Where the Aagency is notified of non-conformance non-compliance, it shall take appropriate action as specified under subsection (3).

(8)(9) SANCTIONS. The Aagency shall impose penalties pursuant to Section 395.1065, F.S., on those ambulatory surgical centers which fail to submit an acceptable plan of correction or implement actions to correct deficiencies identified by the Aagency or an accrediting organization which are specified in an approved plan of correction or as identified as a result of a complaint investigation.

Rulemaking Authority 395.1055, 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 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 body in fulfilling its responsibility shall be organized under approved written bylaws, rules and regulations which shall:

(a) State the qualifications for governing 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 centers’ governing body 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 body.

(b) Provide for the designation of officers, their duties, and for the organization of the governing 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 body as a whole, the policies and activities of the ambulatory surgical centers and special committees established by the governing 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 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 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 body may suspend an organized medical staff member pending final determination of any reappointment or dismissal. The governing 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) Ensure that there is a written center facility agreement, with one or more acute care general hospitals licensed by the state, which will admit any patient referred who requires continuing care.

(l) Provide for a formal and official means of liaison among the medical staff, the governing body, and the administrator chief administrative officer to provide a channel for administrative advice.

(m) Specify the classification of services to be provided in the center facility and list authorized surgical procedures.

(2) Where a the physician-owner-operator serves as the licensee and governing body, the articles of incorporation or other written organizational plan shall describe the manner in which the licensee owner-operator executes the governing 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) SURGICAL DEPARTMENT. This department shall be organized under written policies and procedures relating to surgical staff privileges, anesthesia, functioning standards, staffing patterns and quality maintenance of the surgical suite.

(a) A qualified person designated by the administrator shall be responsible for the daily functioning and maintenance of the surgical suite.

(b) A surgery record shall be maintained on a current basis that contains at least the following information:

1. Patient’s name, patient number, pre-operative diagnosis, post-operative diagnosis, surgical procedure, anesthetic, and complications, if any; and

2. Name of each member of the surgical team, including the surgeon, first assistant, anesthesiologist, nurse anesthetist, anesthesiologist assistant, circulating nurse and operating room technician.

Patient’s name and facility patient number, pre-operative diagnosis, post-operative diagnosis, surgical procedure, surgeon, first assistant, anesthesiologist, nurse anesthetist, anesthetic, circulating nurse, O.R. technician, and complications, if any.

(c) Each center facility shall ensure, prior to any surgery being performed, that the original signed informed consent for the procedure, verification of the identity of patient, operative site, and operative procedure to be performed are in the patient’s medical record.

(d) A registered nurse shall serve as O.R. Circulating Nurse.

(d)(e) All infections of surgical cases shall be recorded and reported to the Infection Control Committee and a procedure shall exist for the investigation of such cases.

(e)(f) Emergency equipment shall be provided as needed commensurate with the services of the center facility, maintained in functional condition, and capable of providing at least the following services:

1. Inhalation and therapy;

2. Defibrillation;

3. Cardiac monitoring;

4. Suctioning;

5. Maintenance of patent patient airway.

(f)(g) 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:

1. Surgical asepsis: preparation, handling, and maintenance of sterile equipment and supplies.

2. Medical asepsis: patients, staff, equipment, traffic, and equipment flow patterns.

3. Sterilization and disinfection standards and controls; equipment and supplies.

4. Housekeeping.

(2) ANESTHESIA SERVICE. This service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.

(a) A qualified anesthesiologist, 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 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 alert or discharged.

(d) At least one registered professional nurse shall be in the recovery area during the patient’s recovery period.

(e) Prior to the administration of anesthesia, patients shall have a history and physical examination including laboratory analysis when indicated.

(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 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:

1. All operating room electrical and anesthesia equipment shall be inspected on no less than a semi-annual basis, and a written record of the results and corrective actions be maintained;

2. Flammable anesthetic agents shall not be employed in ambulatory surgical centers;

3. Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation monitor, with the exception of radiologic equipment and fixed lighting more than 5 feet above the floor;

4. Each anesthetic gas machine shall have pin-index system or equivalent safety system and a minimum oxygen flow safety device; and

5. All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use;

6. At a minimum Tthe following monitors shall be applied to all patients receiving conduction or general anesthesia:

a. Blood pressure cuff;

b. A continuous temperature device, readily available to measure the patient’s temperature;

c. Pulse Oximeter; and

d. Electrocardiogram.

e. An Inspired Oxygen Concentration Monitor and a Capnograph shall be applied to all patients receiving general anesthesia.

(3) NURSING SERVICE. This service shall be organized under written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.

(a) A qualified registered professional nurse designated by the administrator shall be responsible for coordinating and supervising all nursing services.

(b) There shall be a sufficient staffing pattern of registered professional nurses to provide quality nursing care to each surgical patient from admission through discharge. Such additional trained nursing service personnel shall be on duty as may be needed commensurate with the service of the center facility.

(c) A registered professional nurse shall serve as be the operating room circulating nurse for all surgical procedures performed in the center. A circulating nurse shall be present throughout the surgical procedure.

(d) A registered professional nurse shall be present in the recovery area at all times when a patient is present.

(e) A record shall be currently maintained of all nursing personnel and include regular and relief as well as full-time and part-time staff. The record shall include the current license number of each licensed person.

(f) A current job description delineating duties and responsibilities shall be maintained for each nursing service position.

(g) Written procedures in implementation of policies and to assure quality nursing care shall relate specifically to the functional activities of nursing service and include but not be limited to the following:

1. Patient admission;

2. Pre- and Post-Operative cCare;

3. Physician’s and Medical oOrders from physicians and other members of the organized medical staff;

4. Standing oOrders with required signatures;

5. Medications; storage and administration;

6. Treatments;

7. Surgical aAsepsis;

8. Medical aAsepsis;

9. Sterilization and dDisinfection;

10. Documentation: mMedical rRecords and center Facility rRecords;

11. Patient dDischarge;

12. Patient tTransfer;

13. Emergency mMeasures;

14. Isolation mMeasures;

15. Incident rReports;

16. Personnel oOrientation;

17. Inservice eEducation rRecord;

18. Equipment and sSupplies: availability and maintenance;

19. Visitors.

(4) LABORATORIES. Clinical Laboratory – Each ambulatory surgical center shall provide on the premises or by written agreement with a laboratory licensed under Chapter 483, F.S., and Chapter 59A-7, F.A.C., a clinical laboratory to provide those services commensurate with the ambulatory surgical center’s needs and which conform to the provisions of Chapter 483, F.S., and Chapter 59A-7, F.A.C.

(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) If radiological services are provided by center facility staff, the service shall be maintained free of hazards for patients and personnel.

(b) New installations of radiological equipment, and subsequent inspections for the identification of radiation hazards shall be made as specified in Chapter 64E-5, 10D-91, F.A.C.

(c) Personnel monitoring shall be maintained for each individual working in the area of radiation. Readings shall be on at least a monthly basis and reports kept on file and available for review.

1. Personnel – The ambulatory surgical center shall have a radiologist either full-time or part-time on a consulting basis, both to supervise the service and to discharge professional radiological services.

2. A technologist shall be on duty or on call at all times when there are patients within the center facility.

3. The use of all radiological apparatus shall be limited to personnel designated as qualified by the radiologist; and use of fluoroscopes shall be limited to 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 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 395.1055 FS. Law Implemented 395.001, 395.009, 395.1055, 395.1011, 464.012, 466.017, 483.051 FS. History–New 12-12-96, Amended__________.

 

59A-5.012 Medical Records.

(1) Each ambulatory surgical center shall establish processes to obtain, manage, and utilize information to enhance and improve individual and organizational performance in patient care, management, and support processes. Such processes shall:

(a) Be planned and designed to meet the center’s internal and external information needs;

(b) Provide for confidentiality, integrity and security;

(c) Provide education and training in information management principles to decision-makers and other center personnel who generate, collect, and analyze information; and

(d) Provide for information in a timely and accurate manner;

(2) Each center shall have a medical records service, patient information system or similarly titled unit with administrative responsibility for medical records.

(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 body.

(4) A current job description delineating duties and responsibilities shall be maintained for each medical records service position.

(5) The medical records service shall:

(a) Maintain a system of identification and filing to ensure the prompt location of a patient’s medical record. Patient records may be stored on electronic medium such as computer, microfilm or optical imaging;

(b) Maintain a current and complete medical record for every patient admitted to the ambulatory surgical center.

(c) All clinical information pertaining to the patient’s medical treatment shall be centralized in the patient’s medical record.

(d) Ensure that each medical record shall contain the original of the following, as appropriate to the service provided:

1. Identification data;

2. Chief complaint;

3. Present illness;

4. Past personal history;

5. Family medical history;

6. Physical examination report;

7. Provisional and pre-operative diagnosis;

8. Clinical laboratory reports;

9. Radiology, diagnostic imaging, and ancillary testing reports;

10. Consultation reports;

11. Medical and surgical treatment notes and reports;

12. The appropriate informed consent signed by the patient;

13. Record of medication and dosage administered;

14. Tissue reports;

15. Physician orders;

16. Physician and nurse progress notes;

17. Final diagnosis;

18. Discharge summary; and

19. Autopsy report, if appropriate.

(e) Ensure that:

1. Operative reports signed by the surgeon shall be recorded in the patient’s health record immediately following surgery or that an operative progress note is entered in the patient record to provide pertinent information; and

2. Postoperative information shall include vital signs, level of consciousness, medications, blood or blood components, complications and management of those events, identification of direct providers of care, discharge information from post-anesthesia care area.

(f) Index, and maintain on a current basis, all medical records according to surgical procedure and physician.

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) Each ambulatory surgical center shall develop and adopt a written comprehensive emergency management plan for emergency care during an internal or external disaster or emergency which it shall review and update annually.

(2) The emergency management plan shall be developed in conjunction with other agencies and providers of health care services within the local community pursuant to Section 252.32(2), F.S., and in accordance with the “Emergency Management Planning Criteria for Ambulatory Surgical Centers”, AHCA FORM 3130-2003 July 94, 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, at  http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/forms/ASC_CEMP_Reconstructed_122104.pdf:

The plan shall include:

(a) Provisions for internal and external disasters, and emergencies, pursuant to Section 252.34, F.S.;

(b) A description of the ambulatory surgical center’s role in a community wide comprehensive emergency management plan;

(c) Information about how the center plans to implement specific procedures outlined in its comprehensive emergency management plan;

(d) Precautionary measures, including voluntary cessation of center operations, to be taken by the center in preparation and response to warnings of inclement weather, including hurricanes and tornadoes, or other potential emergency conditions.

(e) Provisions for the management of patients, including the discharge or transfer of patients and staff to a hospital or subacute care facility, at the direction of the center’s administrator, in the event of an evacuation order, or when a determination is made by the Agency for Health Care Administration (ACHA) that the condition of the center facility is sufficient to render it a hazard to the health and safety of patients and staff, pursuant to Chapter 59A-5, F.A.C. Such provisions shall address the role and responsibility of the physician in the decision to move or relocate patients;

(f) Provisions for coordinating with hospitals that would receive patients to be transferred;

(g) Provisions for the management of staff, including the distribution and assignment of responsibilities and functions, and the assignment of staff to accompany patients to a hospital or subacute care facility;

(h) A provision that a verification check will be made to ensure patients transferred to a hospital arrive at the designated hospital;

(i) A provision that ensures that copies of medical records and orders accompany patients transferred to a hospital;

(j) Provisions for the management of patients who may be treated at the center during an internal or external disaster or emergencies, including control of patient information and medical records, individual identification of patients, transfer of patients to hospital(s) and treatment of mass casualties;

(k) Provisions for contacting relatives and necessary persons advising them of patient location changes. A procedure must also be established for responding to inquiries from patient families and the press;

(l) A provision for educating and training personnel in carrying out their responsibilities in accordance with the adopted plan;

(m) Identification of mutual aid agreements or statements of understanding for services; and

(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)(l) and 252.38(1)(e), F.S.

(a) The county emergency management agency has 60 days upon receipt of the plan, in which to review and approve the plan, or advise the ambulatory surgical center of necessary revisions. If the county emergency management agency advises the center of necessary revisions to the plan, those revisions shall be made as authorized by Section 395.1055(1)(c), F.S., and the plan shall be resubmitted to the county emergency management agency within 30 days of notification by the county emergency management agency.

(b) The county emergency management agency shall be the final administrative authority for emergency management plans developed by ambulatory surgical centers.

(4) The ambulatory surgical center shall test the implementation of the emergency management plan semiannually, either in response to an emergency or in a planned drill, and shall evaluate and document the center’s performance. This documentation must be on file at the center and available for inspection by the county emergency management agency and the Agency for Health Care Administration.

(5) The emergency management plan shall be available for immediate access by the staff.

(6) If a center evacuates during or after an emergency, the center shall not be reoccupied until a determination is made by the center’s administrator that the center can meet the needs of the patients. A center with significant structural damage shall not be reoccupied until approval is received from the Agency’s Agency for Health Care Administration’s Office of Plans and Construction that the center can be safely occupied as required by the Florida Building Code reoccupied, pursuant to. Rules 59A-5.020 through 59A-5.031, F.A.C.

(7) A center that must evacuate the premises due to a disaster or an emergency condition, shall report the evacuation to the Agency’s Agency for Health Care Administration’s local area health facility regulation office within 24 hours or as soon as practical. The names and destination of patients relocated shall be provided to the county emergency management agency or its designee having responsibility for tracking the population at large. The licensee shall inform the Agency’s Agency for Health Care Administration’s local area office of a contact person who will be available 24 hours a day, seven days a week, until the center is reoccupied.

Rulemaking Authority 395.1055, 408.819 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,__________.

 

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: April 1, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 4, 2013