Hawaii Licensing Authority and CON Program
- The Hawaii Department of Health licenses ambulatory surgery centers under H.R.S. Chapter 323D and Hawaii Administrative Rules Title 11 governing health care facilities. Before beginning operations, ASCs must obtain a DOH health care facility license. DOH conducts initial licensing surveys and periodic unannounced surveys to assess ongoing compliance with licensing standards. Survey deficiencies are documented in writing and must be corrected through a written plan of correction submitted to DOH within the specified response window.
- Hawaii operates a Certificate of Need program administered by the Health Care Systems Branch of DOH under H.R.S. Chapter 323D. CON review is required before a person or organization establishes a new health care facility, makes a substantial capital expenditure in connection with a health care facility, or significantly changes the licensed capacity or services of a facility. Proposed ASC development or significant expansion in Hawaii requires a CON threshold analysis before initiating the project.
- Hawaii ASC licensing regulations require compliance with life safety code standards. Hawaii adopts NFPA 101 Life Safety Code requirements applicable to ambulatory health care occupancies. Physical plant surveys assess fire suppression systems, egress routes, emergency lighting, and operating suite conditions. New construction and renovation projects must comply with applicable FGI Guidelines for Design and Construction of Outpatient Facilities as adopted by Hawaii DOH and with state building code requirements.
- Hawaii DOH licensing requires ASC governing bodies to implement written policies covering patient rights, credentialing and privileging, infection control, quality assurance, emergency procedures, and personnel standards. Policies must be current, accessible to staff, and consistently implemented. Survey findings frequently cite outdated policies, inconsistencies between written policies and documented practice, or insufficient staff training documentation supporting the policies in place.
CMS Certification and ASCQR Program Requirements
- Hawaii ASCs participating in Medicare must demonstrate compliance with CMS Conditions for Coverage at 42 CFR Part 416. Two pathways are available: deemed status through accreditation by a CMS-recognized organization, or direct survey by CMS. The primary CMS-recognized accrediting organizations for ASCs are The Joint Commission, AAAHC, and AAAASF. Accredited facilities are considered to meet CMS Conditions for Coverage and are subject to unannounced accreditation surveys and potential CMS validation surveys.
- Hawaii ASCs enrolled in Medicare must comply with the ASC Quality Reporting (ASCQR) Program administered by CMS. ASCQR requires reporting of quality measures covering surgical infection prevention, patient safety practices, and patient experience. Non-submission by CMS-established deadlines results in an annual payment update reduction. ASCQR measure specifications and submission requirements are updated annually by CMS and should be confirmed through the CMS ASCQR Program website each year.
- CMS Conditions for Coverage for ASCs address governance, patient rights, QAPI, infection control, environment of care, anesthesia and pharmaceutical services, medical staff and nursing services, medical records, patient assessment, discharge planning, and emergency preparedness. Hawaii ASCs must maintain documentation demonstrating compliance with all applicable conditions in state licensure surveys and CMS certification surveys.
- CMS Conditions for Coverage at 42 CFR 416.54 require Hawaii ASCs to implement emergency preparedness programs that include a risk assessment specific to the facility's geographic location, written policies, a communication plan, and annual exercises to test the plan. Hawaii-specific natural hazards including earthquakes, tsunamis, and volcanic activity must be addressed in the facility's risk assessment. Emergency preparedness plans must be updated based on exercise findings and any changes in the facility's hazard profile.
Discharge Documentation and Language Access Requirements
- Hawaii DOH licensing standards and CMS Conditions for Coverage at 42 CFR 416.52 require that discharge planning include written instructions provided to the patient or responsible party before discharge. The medical record must document the written instructions provided, the name of the person who received them, and that the instructions were reviewed before the patient left the facility. Instructions must address medications, activity restrictions, wound care, dietary instructions where applicable, and the signs and symptoms requiring follow-up contact or emergency evaluation.
- Hawaii's population includes many patients for whom English is not a primary language. Hawaii ASCs serving patients with limited English proficiency are required to provide language access services under Title VI of the Civil Rights Act of 1964 and corresponding state requirements. Discharge instructions must be provided in a language the patient can understand. The medical record should document the language used and the interpreter services or translated materials provided.
- Hawaii ASC medical records must be complete, maintained securely, and retained for the periods specified in Hawaii Administrative Rules and applicable federal requirements. Records must include the operative report, anesthesia record, nursing notes, discharge instructions, and discharge summary for each patient. Hawaii DOH surveys assess medical records completeness and include review of discharge documentation as a standard survey component.
- Patients transferred from a Hawaii ASC to a hospital or other care setting must have transfer documentation in the medical record including the reason for transfer, the patient's condition at the time of transfer, and the contact made with the receiving facility. Transfer events must be tracked in the QAPI program, and recurring patterns in transfer causes should prompt review of clinical protocols and discharge planning practices.
QAPI Program Documentation and Infection Control Standards
- Hawaii DOH licensing standards and CMS Conditions for Coverage at 42 CFR 416.43 require Hawaii ASCs to maintain an active QAPI program that measures and tracks outcomes including adverse events, infection rates, unplanned transfers, patient complaints, and post-operative complications. The governing body must actively review QAPI findings and approve performance improvement plans. Survey deficiencies most commonly arise where data is collected but governing body documentation does not reflect review of findings or formal approval of improvement activities.
- Infection control documentation is a consistent focus of Hawaii DOH and CMS surveys. ASCs must maintain records of instrument sterilization monitoring, environmental cleaning logs, hand hygiene compliance monitoring, and staff training on infection prevention. Infection surveillance data, including records of post-operative infections reported to the facility, must be maintained as part of the QAPI program and made available for survey review.
- Discharge instruction completeness is an appropriate QAPI indicator for Hawaii ASCs. Tracking unplanned emergency department visits in the post-operative period, unscheduled calls to the practice, and patient complaints related to aftercare provides data for identifying instruction gaps. Medical record audits for documented written instruction provision and patient acknowledgment support both licensure compliance and quality improvement program objectives.
- Hawaii ASCs that accept Medicaid through the Hawaii Med-QUEST Division of the Department of Human Services are subject to Med-QUEST provider participation requirements in addition to state licensure standards. Med-QUEST provider agreements incorporate compliance with applicable quality and documentation standards. ASCs with Med-QUEST enrollment should confirm current participation requirements directly with the Department of Human Services.