Ambulatory Surgical Center Licensure

Hospital Licensing and Regulation‑ Florida Statutes, Chapter 395

Ambulatory Surgical Center Licensure‑ Florida Administrative Code, Chapter59A‑5

AHCA Licensure Packet

Florida Patient’s Bill of Rights and Responsibilities – Florida Statutes Chapter 381

Employment Screening – Florida Statutes Chapter 435

42 Code of Federal Regulations (CFR), Part 416 (Ambulatory Surgical Services)

State Regulatory Bodies

The state organization with the primary responsibility for licensing and regulating ambulatory surgical centers is the Agency For Health Care Administration (AHCA). Your initial contacts will be with officials from AHCA. Those officials will direct you to contact other state organizations when appropriate.

Beginning The Licensure Process

The first stage in the process of becoming licensed is to obtain a licensure packet from the Tallahassee office of Health Services and Facilities, Hospital and Outpatient Services, Health Facility Regulation, Agency for Health Care Administration (AHCA). Documents AHCA sends to those interested in obtaining state licensure and Medicare certification include a cover letter explaining the application process and applications for state licensure, Medicare certification, and Medicare provider status.

Copies of the regulations are located in this manual. Additional regulations referenced in Chapter 59A-5 (regulations for ambulatory surgical centers) may be obtained from your local law library.

Submitting The Application For Licensure

There are several areas that must be completed and documented before the state considers the application complete. These areas include submitting information about incorporation or providing proof of compliance with Fictitious Name Statute 865.09 and providing proof of compliance with zoning requirements. With these factors in mind, it is best to request the application for licensure several months before you expect the facility to open to allow time to complete the documentation that must accompany the state application. The state licensure and Medicare applications should be completed at least four months before the date you expect your surgery center to be open. The Medicare Provider application must be sent to the state, which sends it to the fiscal intermediary for Medicare in the State of Florida – Blue Cross Blue Shield – for processing. Blue Cross Blue Shield has 30 days in which to process the application. If the application is deemed incomplete, Blue Cross Blue Shield will return it to you for completion and resubmission. When the application is resubmitted the 30 day time clock starts again. Allow time for the possibility of resubmission of the provider application.

Special Procedures For New Facilities

The Office of Plans and Construction of AHCA will be involved in the approval of the facility construction documents as well as the on‑site inspection of actual construction. The architect will coordinate inspections for construction. (More information on this subject may be found in Section 2 of this manual.) The Health Services and Facilities staff at AHCA area offices will inspect for administrative and operational compliance to the rules. These inspections are governed by the rules contained in this manual and are coordinated with the facility’s administrative staff.

Administrative and Clinical Regulations, New Facilities

Once the building is ready for occupancy, your contractor and architect will work with the AHCA Office of Plans and Construction and the local building officials to receive approval to occupy the building. You must have major fixed equipment and a telephone installed for the inspection. The telephone connection is required for AHCA to test the monitoring of the fire alarm system.

Occupancy approval is required before center employees can begin to stock supplies and arrange equipment. Occupancy is granted by AHCA Office of Plans and Construction and the local building inspectors. The AHCA Health Services and Facilities section is notified when occupancy has been granted. Although AHCA offices may communicate this, it is wise for you to contact in writing the AHCA Health Services and Facilities section and tell them your building passed inspection. Give them a proposed time you would be ready for the policy and procedures inspection. AHCA announces the inspection date for the administrative and operational inspection. However, AHCA’s survey for Medicare certification is unannounced.

At the administrative and operational inspections, the inspectors will review documentation and files and tour the facility to ensure compliance with the rules as specified in FAC Chapter 59A‑5, FAC Chapter 59A‑10 and Florida Statutes Chapter 395.

Accreditation Through Deemed Status Organizations

The state and the Health Care Financing Administration (HCFA), which oversees the Medicare program, determined that the Joint Commission on the Accreditation of Heath Care Organizations (JCAHO) or Accreditation Association for Ambulatory Health Care (AAAHC) accreditation surveys provided equivalent review of the requirements to be licensed and Medicare certified. Those facilities that are accredited through JCAHO or AAAHC may have a validation inspection and/or a life safety inspection in years when a successful accreditation survey does not occur. Accreditation is important for payment and contracting reasons and now, with deemed status, accreditation will reduce the number of facility inspections.

Keeping current on accreditation standards, on time with re‑appointment of medical staff, and on schedule with committee meetings and reports should maintain conformance to the rules. Setting time for an annual review of all rules and standards compared to actual practices will assist in compliance. See Section 13 of this manual for more information on the accreditation process.

Description of Governing Rules

Hospital Licensing And Regulation, Chapter 395 Florida Statutes

Chapter 395, Florida Statutes provides the general policies, definitions and procedures governing ambulatory surgical centers in Florida. The statute grants the Agency for Health Care Administration (AHCA) authority to promulgate more specific rules and regulations which are embodied in Florida Administrative Code (FAC), Chapter 59A‑5.    

Ambulatory Surgical Center Licensure, Florida Administrative Code, Chapter 59A‑5

Using the rules found in FAC Chapter 59A‑5 to guide policy and procedure development can help the center organize for provision of patient services and inspections. Designing committee structure, outlining committee duties, and developing the flow of reports requires some planning since these areas are more difficult to change later. Whether preparing a new facility, renovation of an on‑going facility, or maintaining an existing facility, the rules found in FAC Chapter 59A‑5 for the type and number of employees and the time tables for measuring, relating, and approving reports should be reflected in policies and procedures and in minutes of committees, medical staff, and governing body.

The following rule section changed in 1998 to define the patient’s right to receive information about how to complain about quality of care to state agencies.

59A‑5.0065 Patient Rights

·        Mandates the development of policy to protect patient rights pursuant to Florida Statutes Chapter 381.026, 395.301 and 395.3025 and requires that Florida Patient’s Bill of Rights and Responsibilities be made available to patients. When a patient requests it, you must give them the address and telephone number of each state agency responsible for responding to patient complaints about a health care provider or health care facility. You must have a method, outlined in policies and procedures, to give patients the opportunity to receive information regarding their rights and how to file complaints.

(AHCA, by statute, must have printed and made continuously available a summary of Florida Patient’s Bill of Rights and Responsibilities. A copy of this example can be found in this section. A facility is not limited to the format.)