Establish an Ambulatory Surgical Facility

Purpose: This procedure describes the steps necessary to establish a new ambulatory surgical facility in North Carolina. Pursuant to N.C. General Statute 131E-149 (PDF, 10 KB), the North Carolina Medical Care Commission has rulemaking authority for the licensure of this category. Rules in Title 10A of the North Carolina Administrative Code (10A NCAC 13C, PDF, 76 KB) apply.

Contacts: For questions regarding any part of this process, please contact the appropriate sections of the N.C. Division of Health Service Regulation:

Acute and Home Care Licensure and Certification Section 919-855-4620
Certificate of Need Section 919-855-3873
Construction Section 919-855-3893
Medical Facilities Planning Section 919-855-3865

Procedure Summary: In order to establish an ambulatory surgical facility in North Carolina, applicants first review the State Medical Facilities Plan to determine whether there is a demonstrated need for such a facility. The applicant must obtain a certificate of need. The applicant must get approval for the construction of the facility and then apply for and obtain a license and certification to treat Medicare or Medicaid patients. Licenses are then renewed every year.

Procedures:

  1. Review the State Medical Facilities Plan: Medical Facilities Planning Section
    1. Applicants can learn about the number of additional ambulatory surgery facilities needed by reviewing the annual State Medical Facilities Plan, which is published for each calendar year and specifies where in the state they are needed.
    2. Applicants can also find the Certificate of Need review schedule and deadline for submittal of applications for these facilities, if available, in the State Medical Facilities Plan. No one may develop a new ambulatory surgery facility without first obtaining a certificate of need. A certificate of need cannot be issued if the plan does not show a need for the facility.
  2. Obtain a Certificate of Need: Certificate of Need Section
    1. The applicant submits a certificate of need (CON) application for any new facility according to the review schedule outlined in the State Medical Facilities Plan. If the applicant is leasing the facility, both the prospective owner/lessor and the lessee of the facility must submit a joint application.
    2. The CON Section advertises a written public comment period and possibly a local public hearing. Written public comments on an application may be submitted during the first 30 days of the review period.
    3. If there is a public hearing, the CON Section conducts it no more than 20 days from the conclusion of the written comment period, at which time applicants are given an opportunity to respond to public comment on the application.
    4. A decision to approve or disapprove an application is made by the CON Section within 150 days of the beginning of the review period.
    5. A certificate of need is issued 35 days after the date of approval if a petition for a contested case hearing is not filed.
    6. After a certificate of need is issued, the applicant contacts the Construction Section and the Acute and Home Care Licensure and Certification Section about their respective requirements for the development of the project.
  3. Obtain construction approval: Construction Section
    1. The applicant sends one set of floor plans and specifications to the Construction Section.
    2. The Construction Section reviews the plans and writes the owner with requirements or review comments and instructions. Plans are generally reviewed in three stages: schematic, design development, and final working drawings.
    3. Owners and designers work closely with local building officials and fire prevention officials as well as the Construction Section to ensure the design is building code and licensure compliant and, if certification for Medicare is desired, certification compliant.
    4. At least two weeks before construction is complete, the applicant sends a letter to the Construction Section requesting a final construction inspection with project information and local approvals. The facility must be ready with all systems operational and all construction completed by the final construction inspection date. The Construction Section does not do punchlist inspections; they are the responsibility of the designer, contractor, and owner.
    5. The Construction Section inspects the facility and reviews the required final documentation. This inspection ensures that the building meets construction standards for licensure. The life safety code survey for Medicare/Medicaid certification may also be done at this time if the facility has received approval from the fiscal intermediary. (see step 5.b below)
    6. If minor deficiencies are found, the applicant submits a plan of correction.
    7. When all items are acceptable, the Construction Section sends a construction approval transmittal form (form 4086) to the Acute and Home Care Licensure and Certification Section.
  4. Obtain a license: Acute and Home Care Licensure and Certification Section
    1. Three months before the opening is scheduled, the applicant contacts the section for a license application and for a certification application packet. The applicant completes and returns all forms with the applicable fees (G.S. 131E-147, PDF, 11 KB).
    2. On request of the applicant, the section outlines the pre-opening services offered by the section. Availability of applicable licensing rules is outlined as well as a listing of similar operating facilities.The section’s staff are available to clarify or discuss any questions the facility may have concerning compliance with licensing rules.
    3. The section schedules an on-site, pre-opening licensure survey on a date that will coordinate with the Construction Section's projected approval for site occupancy.
    4. The section completes their inspection and issues a license if the facility is deemed acceptable for licensure.
  5. Obtain certification: Acute and Home Care Licensure and Certification Section
    1. The owner or representative contacts the Acute and Home Care Section within three months prior to being operational for a certification application packet. Certification is required before the facility can bill for Medicare or Medicaid services.
    2. The applicant completes and returns the application to the section. The application for Medicare is forwarded to the designated fiscal intermediary for approval. Once fiscal intermediary approval is received, coordination of the initial certification  survey by the Acute and Home Care Licensure and Certification Section staff and life safety code survey by the Construction Section staff are scheduled.
    3. After the Construction Section has determined that the facility meets the Life Safety Code requirements, the section conducts the initial certification survey within three weeks of request.
    4. Certification is completed if all programs are acceptable. The certification date will be one of the following: the last date of either the certification initial survey or the Life Safety Code survey or the last date of an acceptable plan of correction from either of these surveys.
    5. If the ambulatory surgical center is hospital-operated, the earliest date for Medicare participation must be the beginning of the hospital’s fiscal year.
    6. The section will assign the Center for Medicare & Medicaid Services Certification Number (CCN) and notifies the fiscal intermediary.