Tennessee Ambulatory Surgery Center Regulations: TDH Licensing, CON Requirements, and Outpatient Surgical Treatment Center Standards
Tennessee outpatient surgical treatment centers (OSTCs) are licensed by the Tennessee Department of Health (TDH) under Tenn. Code Ann. Title 68, with detailed operational standards codified in Tenn. Comp. R. and Regs. Chapter 1200-08-06. Tennessee maintains a Certificate of Need program under Tenn. Code Ann. Title 68, Chapter 11, Part 16, which requires Tennessee Health Services and Regulatory Standards (HSRS) review and approval for new facility construction and certain changes in operational scope. Tennessee Medicare-certified ASCs must also comply with CMS Conditions for Coverage at 42 CFR Part 416. This guide covers the primary licensing requirements, CON obligations, staffing and anesthesia standards, discharge documentation requirements, and medical record retention obligations for Tennessee OSTC operators.
TDH Licensing and CON Requirements Under Tenn. Code Ann. Title 68
Tennessee outpatient surgical treatment centers must obtain a license from the Tennessee Department of Health before providing surgical services. The licensing framework for OSTCs is established under Tenn. Code Ann. § 68-11-201 et seq., which defines the categories of health care facilities requiring TDH licensure and authorizes TDH to set operational standards through rulemaking. The detailed standards governing physical plant, staffing, patient care, infection control, discharge planning, and medical records are codified in Tenn. Comp. R. and Regs. Chapter 1200-08-06. TDH conducts an initial inspection before issuing a license to confirm that the facility's design, staffing plan, and policies meet applicable rule requirements.
Tennessee's Certificate of Need program under Tenn. Code Ann. § 68-11-1601 et seq. requires Health Services and Regulatory Standards (HSRS) review and approval for the construction of new outpatient surgical treatment centers and for certain changes in the services or operating room capacity of licensed facilities. CON applications are reviewed by HSRS against the State Health Plan and applicable review criteria. The CON application must be approved before construction or renovation that adds or modifies surgical capacity begins. Tennessee providers planning a new OSTC or capacity expansion should engage CON counsel early to assess whether the proposed project constitutes a reviewable CON activity and to plan for the application and review timeline.
TDH surveys licensed outpatient surgical treatment centers on a periodic basis as part of the licensure renewal cycle and may conduct unannounced inspections at any time. Complaint-based surveys are initiated by the TDH Health Care Facilities Division when credible reports of patient safety concerns or standards violations are received. Deficiencies identified during TDH surveys require submission of a written Plan of Correction specifying corrective actions and completion dates for each cited deficiency. Patterns of uncorrected violations may result in civil monetary penalties or license action under Tenn. Code Ann. § 68-11-209. For Medicare-certified facilities, TDH may conduct certification surveys under contract with CMS in addition to state licensure surveys.
Tennessee outpatient surgical treatment centers seeking Medicare certification must comply with CMS Conditions for Coverage at 42 CFR Part 416 in addition to the state requirements under Tenn. Comp. R. and Regs. Chapter 1200-08-06. CMS-approved accrediting organizations including The Joint Commission, AAAHC, and AAAASF have deemed status authority for Tennessee ASCs, meaning accreditation by one of these bodies satisfies the CMS certification survey requirement. Accreditation does not replace the TDH state license, which must be maintained separately and renewed on the schedule established by TDH.
Staffing, Anesthesia, and CRNA Supervision
Tennessee outpatient surgical treatment centers must designate a physician medical director responsible for the clinical quality of services. Under Tenn. Comp. R. and Regs. Chapter 1200-08-06, the medical director must participate in credentialing and privileging of clinical staff, oversee the quality improvement program, and review adverse events and unplanned hospital transfers. TDH surveyors assess medical director engagement through review of quality improvement documentation, credentialing files, and adverse event records. Nominal compliance, where a physician holds the title without substantive clinical leadership involvement, is a documented survey citation area.
Registered nurse staffing requirements for Tennessee OSTCs under Tenn. Comp. R. and Regs. Chapter 1200-08-06 specify that a registered nurse (RN) must be present in each operating room during surgical procedures. Post-anesthesia care unit (PACU) staffing must include RNs with documented competency in post-anesthesia assessment and management of procedural sedation and general anesthesia complications. Patient discharge from the PACU requires a documented nursing assessment confirming that the patient meets established discharge criteria, typically scored using a validated instrument such as the Aldrete or Modified Aldrete Scoring System, and a physician order or standing order authorizing discharge.
Tennessee has submitted a CRNA supervision opt-out notification to CMS under 42 CFR 416.42(b)(2), allowing CRNAs to administer anesthesia in Tennessee Medicare-certified ASCs without mandatory physician supervision. Tennessee OSTC operators relying on the opt-out should confirm that their anesthesia service agreements and clinical policies reflect the applicable scope-of-practice framework for CRNAs under Tennessee nursing law. Anesthesia records must document the identity of the anesthesia provider, agents and doses administered, intraoperative patient vital signs, and the patient's condition at the conclusion of anesthesia.
Emergency preparedness requirements for Tennessee OSTCs under Tenn. Comp. R. and Regs. Chapter 1200-08-06 and CMS 42 CFR 416.54 require each facility to maintain a written emergency response plan. The plan must address fire, power failure, and medical emergencies beyond the facility's capability, and must include a current written transfer agreement with a hospital able to accept patients requiring a higher level of care. Transfer agreements must be reviewed and renewed at defined intervals. Documentation of emergency drills, transfer agreement renewals, and plan reviews must be maintained and available for TDH and CMS survey review.
Discharge Documentation and Medical Records Retention
Tennessee outpatient surgical treatment centers must provide each patient with written discharge instructions before or at discharge, consistent with Tenn. Comp. R. and Regs. Chapter 1200-08-06 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 relevant precautions, activity and dietary restrictions specific to the procedure performed, the scheduled follow-up appointment, and specific symptoms or complications that require provider contact or emergency evaluation. Instructions must be procedure-specific and provided in a language the patient can understand.
Tennessee requires outpatient surgical treatment centers to retain patient medical records for a minimum of 10 years from the date of service under Tenn. Code Ann. § 68-11-305. For minor patients, records must be retained until the patient reaches age 18, or for 10 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 10-year retention requirement. Electronic medical record systems must maintain records in a format that remains accessible and retrievable throughout the full retention period.
Patient rights for Tennessee OSTC patients are established under Tenn. Code Ann. § 68-11-1501 et seq. and Tenn. Comp. R. and Regs. Chapter 1200-08-06. Required patient rights protections include written notice of rights provided before or at admission, 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 TDH. Facilities must maintain a documented grievance process with defined timelines for acknowledgment and resolution, and records of all complaints filed and outcomes reached must be available for survey review.
Tennessee 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 the applicable deadlines results in a 2.0 percentage point reduction in the Medicare payment update for that payment year. Tennessee OSTCs must also maintain an internal quality improvement program meeting the requirements of Tenn. Comp. R. and Regs. Chapter 1200-08-06 and, for Medicare-certified facilities, the CMS QAPI condition at 42 CFR 416.43, with documented data collection, analysis, and improvement project tracking.
Does Tennessee require a Certificate of Need to open an outpatient surgical treatment center?
Yes. Tennessee maintains an active Certificate of Need program under Tenn. Code Ann. § 68-11-1601 et seq. that applies to outpatient surgical treatment centers. Providers must obtain HSRS CON approval before constructing a new OSTC or making certain changes to the services or surgical capacity of a licensed facility. CON applications are reviewed by HSRS against the State Health Plan and applicable review criteria. Providers should consult CON counsel before beginning any project planning, as the CON application must be approved before construction or qualifying service changes begin.
Has Tennessee opted out of the CMS CRNA supervision requirement?
Yes. Tennessee has submitted a CRNA supervision opt-out notification to CMS under 42 CFR 416.42(b)(2). Under this opt-out, CRNAs may administer anesthesia in Tennessee Medicare-certified ASCs without mandatory physician supervision. Tennessee OSTC operators relying on the opt-out should confirm that their anesthesia service arrangements and clinical policies reflect this framework and that CRNA credentials and scope-of-practice documentation are maintained in the credential file.
How long must Tennessee outpatient surgical treatment centers retain patient medical records?
Tennessee law under Tenn. Code Ann. § 68-11-305 requires outpatient surgical treatment centers to retain patient medical records for a minimum of 10 years from the date of service for adult patients. For minor patients, records must be retained until the patient reaches age 18, or for 10 years from the date of service, whichever is longer. All components of the medical record including discharge instructions, operative notes, anesthesia records, and PACU assessments are subject to this requirement and must remain accessible throughout the required retention period.
What discharge instruction content is required for Tennessee OSTC patients?
Tennessee outpatient surgical treatment centers must provide written discharge instructions before each patient's discharge covering the patient's clinical status at discharge, all prescribed medications 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 understands. 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.
