North Carolina Ambulatory Surgery Facility Regulations: DHSR Licensing Under G.S. 131E and CON Requirements
North Carolina ambulatory surgical facilities (ASFs) are licensed by the Division of Health Service Regulation (DHSR), a component of the NC Department of Health and Human Services (DHHS), under G.S. Chapter 131E. North Carolina maintains a Certificate of Need program that applies to ambulatory surgical facilities, requiring DHHS project review and approval before adding operating rooms or modifying services in CON-regulated categories. North Carolina ASCs that accept Medicare must also comply with CMS Conditions for Coverage at 42 CFR Part 416. This guide covers the primary licensing requirements, CON obligations, staffing standards, discharge documentation requirements, and record retention rules for North Carolina ASF operators.
DHSR Licensing and CON Requirements Under G.S. 131E
North Carolina ambulatory surgical facilities must obtain a license from DHSR before providing surgical services to patients. The licensing framework is established under G.S. 131E-75 through 131E-92, with operational standards codified in 10A NCAC 14C. DHSR conducts an initial inspection of the physical plant and reviews the facility's policies and staffing plan before issuing a license. A facility that provides ambulatory surgical services without a current DHSR license is subject to civil penalties and injunctive action under G.S. 131E-86.
North Carolina's CON program under G.S. 131A requires DHHS project review and approval before a provider may develop a new ambulatory surgical facility, add operating rooms to an existing facility, or change the service composition of a licensed ASF in a manner subject to CON review. CON applications are reviewed by the DHHS Certificate of Need Section against the State Medical Facilities Plan and applicable review criteria. CON approval timelines vary by project type and review cycle. Providers planning a new facility or capacity expansion should engage CON counsel early, as the CON application must be approved before construction begins.
DHSR conducts periodic licensure renewal inspections and may conduct unannounced surveys at any time. Complaint-based surveys are initiated when DHSR receives credible reports of patient safety concerns or standards violations from patients, employees, or others. Deficiencies identified during DHSR surveys require submission of a written Plan of Correction with defined corrective actions and completion dates. Patterns of uncorrected deficiencies may result in civil monetary penalties or license action under G.S. 131E-86. North Carolina ASFs accredited by The Joint Commission, AAAHC, or AAAASF may use their accreditation survey to satisfy the CMS certification survey requirement.
The 10A NCAC 14C rules establish minimum standards for North Carolina ASF physical plant design, infection control, medication management, documentation practices, and discharge planning. DHSR surveyors assess compliance with each standard during licensure inspections. Standards address requirements for operating room design and airflow, equipment sterilization and maintenance, PACU staffing and discharge criteria, medical record content and retention, and patient rights protections. Providers planning facility renovations must confirm whether the proposed changes require DHSR approval and whether a CON review is triggered under the applicable project thresholds.
Staffing, Anesthesia, and Patient Safety Standards
North Carolina ambulatory surgical facilities must designate a physician medical director responsible for the clinical quality of surgical and anesthesia services. The medical director's responsibilities under 10A NCAC 14C include oversight of credentialing and privileging, participation in quality improvement program activities, and review of adverse events and unplanned hospital transfers. DHSR surveyors review quality improvement minutes and credentialing files to assess whether the medical director role is fulfilled substantively. Facilities with multiple operating locations must have clear documentation of medical director accountability at each site.
A registered nurse (RN) must be present in each operating room throughout any surgical procedure at a North Carolina licensed ASF, consistent with 10A NCAC 14C and applicable nursing board rules under G.S. 90-171.20. Post-anesthesia care unit (PACU) staffing must include RNs with documented competency in post-anesthesia assessment and management of anesthesia complications. PACU discharge requires a physician order or standing order authorized by the medical director, supported by a documented nursing assessment confirming that the patient meets established discharge criteria using a validated scoring system.
North Carolina Medicare-certified ASCs are subject to the anesthesia requirements at 42 CFR 416.42, which require that anesthesia services be provided by or under the supervision of a qualified physician or by a CRNA supervised by a physician. North Carolina has not submitted a CRNA supervision opt-out notification to CMS, meaning North Carolina Medicare-certified ASCs must ensure that physician supervision of CRNA anesthesia services meets the 42 CFR 416.42 requirement. Anesthesia records must document the identity of the anesthesia provider, the type and dose of agents used, patient vital signs throughout the procedure, and the patient's condition at the conclusion of anesthesia.
Emergency preparedness obligations for North Carolina ASFs under 10A NCAC 14C and CMS 42 CFR 416.54 require each facility to maintain a written emergency response plan addressing fire, power failure, mass casualty events, and medical emergencies. The plan must include a current written transfer agreement with a hospital capable of accepting patients requiring inpatient care following complications. Transfer agreements must be reviewed and renewed at defined intervals, and the hospital named in the agreement must have the capability to provide the level of care likely to be required by ASF patients. Documentation of emergency drills, plan reviews, and transfer agreement renewals must be maintained and available for DHSR survey review.
Discharge Documentation and Medical Records Retention
North Carolina ambulatory surgical facilities must provide each patient with written discharge instructions before discharge under 10A NCAC 14C and, for Medicare-certified facilities, CMS 42 CFR 416.52. Required discharge instruction content includes the patient's clinical status at discharge, all medications prescribed with dosing instructions and precautions, activity restrictions specific to the procedure performed, follow-up appointment information, and symptoms or warning signs requiring provider contact or emergency care. Instructions must be procedure-specific and provided in a language the patient understands, consistent with federal language access obligations under Title VI of the Civil Rights Act.
North Carolina requires ambulatory surgical facilities to retain patient medical records for a minimum of 11 years from the date of service under G.S. 131E-95(b). This retention period is among the longer requirements in the country, and providers establishing records management policies should ensure their document retention schedules reflect the 11-year minimum for adult patients. For minor patients, G.S. 131E-95(b) requires retention until the patient reaches age 29, or for 11 years from the date of service, whichever is longer. Discharge instructions, operative reports, anesthesia records, PACU nursing assessments, and prescription records are all part of the complete medical record subject to the 11-year retention requirement.
Patient rights protections for North Carolina ASF patients are established under G.S. 131E-117 and 10A NCAC 14C. Patients must receive written notice of their rights before or at admission, including the right to receive information about the proposed procedure and alternatives, the right to give informed consent or refuse treatment, the right to privacy and confidentiality of medical information, and the right to file a complaint with DHSR. North Carolina law also requires that patients be provided a copy of their medical records upon request within a defined timeframe. Facilities must maintain a documented grievance process with defined response timelines and records of complaints filed and resolutions reached.
North Carolina Medicare-certified ASCs must participate in the CMS Ambulatory Surgical Center Quality Reporting (ASCQR) program and submit required quality measures through the National Healthcare Safety Network (NHSN) and the CMS web-based reporting system on the schedule established by CMS for each program year. Failure to submit ASCQR data by applicable deadlines results in a 2.0 percentage point reduction in the Medicare payment update for that year. North Carolina ASFs must also maintain an internal quality improvement program meeting the requirements of 10A NCAC 14C and, for Medicare-certified facilities, the CMS QAPI condition at 42 CFR 416.43, with quarterly data reviews and documented improvement projects.
Does North Carolina require a Certificate of Need to open an ambulatory surgical facility?
Yes. North Carolina maintains an active Certificate of Need program under G.S. 131A that applies to ambulatory surgical facilities. Providers must obtain DHHS CON approval before constructing a new ASF, adding operating rooms to an existing facility, or making service changes that constitute a reviewable project under the State Medical Facilities Plan. CON applications are evaluated by the DHHS Certificate of Need Section against need criteria and applicable review standards. Providers should consult CON counsel before beginning any project planning, as the CON application must be approved before construction or qualifying service changes begin.
How long must North Carolina ambulatory surgical facilities retain patient medical records?
North Carolina law under G.S. 131E-95(b) requires ambulatory surgical facilities to retain patient medical records for a minimum of 11 years from the date of service for adult patients. For minor patients, records must be retained until the patient reaches age 29, or for 11 years from the date of service, whichever is longer. This 11-year retention period applies to all components of the medical record, including discharge instructions, operative notes, anesthesia records, and PACU assessments, and should be reflected in the facility's document retention policy.
Has North Carolina opted out of the CMS CRNA supervision requirement?
No. North Carolina has not submitted a CRNA supervision opt-out notification to CMS under 42 CFR 416.42(b)(2). As a result, North Carolina Medicare-certified ASCs must ensure that CRNAs providing anesthesia services are supervised by a physician as required by 42 CFR 416.42. ASC operators should confirm that their anesthesia service agreements and operating policies reflect this supervision requirement and that documentation of physician supervision is maintained in the anesthesia record for each case.
What discharge instruction content is required for North Carolina ASF patients?
North Carolina ambulatory surgical facilities must provide written discharge instructions before each patient's discharge covering the patient's clinical status at discharge, all medications prescribed with dosing instructions and precautions, activity and dietary restrictions specific to the procedure, follow-up appointment information, and symptoms or complications requiring provider contact or emergency care. Instructions must be procedure-specific and provided in a language the patient can understand. For Medicare-certified facilities, 42 CFR 416.52 requires that a physician or authorized practitioner sign the discharge instructions.
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This blog provides general information about healthcare compliance and aftercare best practices. It does not constitute legal, medical, or regulatory advice. Consult qualified professionals for guidance specific to your practice.
