OHFLAC Licensure Requirements
- The West Virginia Office of Health Facility Licensure and Certification licenses ambulatory surgery centers under W. Va. Code Chapter 16, Article 2D and the West Virginia Health Care Facility Licensure Rules codified in W. Va. C.S.R. 64-12. Facilities offering outpatient surgical services requiring anesthesia or sedation must obtain and maintain an OHFLAC license. The licensure process includes application submission, payment of applicable fees, and an initial on-site survey confirming compliance with state regulations before the facility begins seeing patients.
- OHFLAC conducts periodic on-site surveys of licensed ambulatory surgery centers to verify continued compliance with state requirements. Surveys evaluate physical plant and life safety code compliance, infection control program documentation and practices, sterilization and disinfection records, emergency preparedness protocols, governing body and medical staff credentialing documentation, QAPI program records, medical records practices, and discharge documentation. Facilities receiving deficiency citations must submit a written plan of correction addressing each finding within the timeframe specified in the deficiency notice.
- West Virginia requires licensed ambulatory surgery centers to maintain a governing body with documented responsibility for facility operations, quality oversight, and compliance with applicable laws and regulations. Governing body bylaws must specify the structure of the organization, the responsibilities of the medical director, the credentialing and privileging process applicable to all providers performing procedures at the facility, and the oversight structure for the quality program. Governing body activities, including credentialing approvals and quality program oversight, must be documented in meeting minutes.
- West Virginia's Certificate of Need program, administered through the West Virginia Health Care Authority, requires certain health facility development projects to obtain CON approval before proceeding. ASC operators contemplating new facility development or substantial expansion of services in West Virginia should consult with the Health Care Authority to determine whether the proposed project requires CON review. Proceeding with a CON-required project without approval is subject to regulatory and legal consequences.
- West Virginia ambulatory surgery centers must implement a quality assessment and performance improvement program meeting the requirements of OHFLAC regulations and, for CMS-certified facilities, 42 CFR Part 416 Subpart C. The QAPI program must track quality indicators appropriate to the facility's procedure types, analyze data to identify patterns and improvement opportunities, implement corrective actions, and evaluate whether those actions produce the intended improvement. QAPI documentation must be maintained and available for OHFLAC survey review.
Infection Control, Emergency Preparedness, and Clinical Standards
- West Virginia ambulatory surgery center regulations require a documented infection control program covering hand hygiene, sterilization and disinfection of instruments and equipment, surgical site infection prevention, environmental cleaning, and medical waste management. A designated staff member must be responsible for infection control program oversight, surveillance, and staff education. Written infection control policies must be reviewed at intervals specified in facility policy and updated to reflect current guidance, with revisions communicated to clinical staff.
- Sterilization processes in West Virginia ASCs must comply with manufacturer instructions for use for all sterilization equipment and adhere to the standards in ANSI/AAMI ST79 for steam sterilization. Facilities must maintain complete sterilization records including biological indicator logs, chemical indicator documentation, load content records, and equipment maintenance logs. These records are subject to review during OHFLAC surveys and accreditation surveys. Facilities must also have a documented recall procedure for instruments processed in failed sterilization loads.
- West Virginia ASC regulations require documented emergency protocols and available emergency equipment for the management of medical emergencies that may occur in the surgical setting. Required protocols include those for malignant hyperthermia, anaphylaxis, cardiac arrest, airway emergency, and fire. Emergency medications and equipment must be regularly inspected and documented as ready for use. Staff must receive emergency protocol training at hire and at periodic intervals as defined in facility policy, and fire drills must be conducted at the frequency required by applicable life safety standards.
- Discharge documentation requirements for West Virginia ASCs must satisfy both OHFLAC state licensure standards and, for CMS-certified facilities, 42 CFR 416.52. Each patient must receive written discharge instructions before leaving the facility, and the instructions must be documented in the medical record. Instructions must address wound care, activity restrictions by type and duration, all prescribed medications with dosing and schedule, warning signs that require contacting the surgeon's office or seeking emergency care, and the scheduled follow-up appointment. Patients who received general anesthesia or moderate sedation must be discharged to a responsible adult.
Quality Reporting, Documentation, and Accreditation
- West Virginia ASCs participating in Medicare are subject to the CMS Ambulatory Surgical Center Quality Reporting (ASCQR) program, which requires submission of quality measure data through the QualityNet portal. Facilities that do not satisfy ASCQR reporting requirements by applicable program deadlines face a reduction in their annual Medicare payment update per CMS policy. Administrators should verify current measure specifications and reporting deadlines through CMS ASCQR program resources each program year.
- Medical records in West Virginia ambulatory surgery centers must contain all elements required by OHFLAC regulations and, for CMS-certified facilities, 42 CFR 416.47. Required record elements include the history and physical examination, informed consent documentation, anesthesia record, operative report, intraoperative nursing documentation, post-anesthesia recovery assessment, discharge assessment, and the written discharge instructions provided to the patient. Records must be retained for the minimum period required by West Virginia law and CMS requirements, and storage and access policies must protect patient privacy consistent with HIPAA.
- West Virginia ASCs may obtain accreditation from national organizations recognized by CMS, including The Joint Commission, AAAHC, or AAAASF. CMS-recognized accreditation provides deemed status, meaning the facility is deemed to meet CMS Conditions for Coverage without a separate CMS survey. Accredited facilities are subject to unannounced accreditation surveys and must comply with accreditation standards in addition to OHFLAC licensure requirements. Facilities should maintain a current compliance calendar that tracks both OHFLAC and accreditation renewal and reporting obligations.
- Provider credentialing files in West Virginia ASCs must document verification of each provider's West Virginia medical license, federal DEA registration where applicable, malpractice insurance coverage, board certification status, and references or peer recommendations. Files must be reviewed and updated at intervals consistent with the facility's credentialing policy, typically every two years. The scope of clinical privileges granted to each provider must be documented and applied consistently in procedure scheduling. Facilities that grant privileges to locum tenens or independent contractors must apply the same credentialing process as for employed medical staff.