Regulatory Changes Effective May 18, 2009 Revisions made to: –Governing Body and Management –Surgical Services –Quality Assessment and Performance Improvement (QAPI)
Regulatory Changes Additional Conditions for Coverage (CfCs) –Patient Rights –Infection Control –Patient Admission, Assessment and Discharge –Radiologic Services
Websites State Operations Manual Transmittal 56 Revised Appendix L, "Interpretive Guidelines for Ambulatory Surgery Centers" –www.cms.hhs.gov/transmittals/downloads/R56SOMA.pdfwww.cms.hhs.gov/transmittals/downloads/R56SOMA.pdf MDH Clinical Web Window –www.health.state.mn.us/divs/fpc/cww/cwwindex.htmlwww.health.state.mn.us/divs/fpc/cww/cwwindex.html
Survey Protocol Revisions Use of Infection Control Surveyor Worksheet Case Tracer Methodology Revised Surveyor Guidance
Medicare ASC Definition 42 CFR Distinct Entity Operates exclusively to provide surgical services to patients not requiring hospitalization expected stay does not exceed 24 hours Has an ASC supplier agreement Complies with ASC CfCs
Temporally Separation §416.2 CMS considers an ASC to be a distinct entity if it shares its space –So long as it is temporally separated –i.e., same physical premises used by the ASC and another entity, but they are not both open at the same time
Assessing Compliance – Governing Body (cont.) Review minutes or other evidence to ensure: Policies and procedures have been formally adopted Policies are implemented Monitoring internal compliance/reassessment of policies Data collected and submitted related to specific policies Ongoing oversight of and accountability of QAPI program (See §416.43)
Contract Services §416.41(a) Contract services must be provided in a safe and effective manner Contractor services must be included in the ASCs QAPI program ASC must maintain a list and personnel files of all contract services and personnel.
Hospitalization §416.41(b) ASC must : –Have a written transfer agreement with the nearest, most appropriate local hospital ; or –Ensure that every physician performing surgery at the ASC has admitting privileges at a local hospital
Disaster Preparedness §416.41(c) (1) The ASC must maintain a written disaster preparedness plan that provides for the emergency care of patients, staff, and others in the facility in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the ASC.
Disaster Preparedness (cont) (2) the ASC coordinates with the State and local authorities, as appropriate (3) the ASC conducts drills, at least annually, to test the plans effectiveness. The ASC must complete written evaluation of each drill.
Minnesota Department of Health Office of Emergency Preparedness thcare/index.html
Performance Improvement Project § (d)(1) Number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC services and operations § (d)(2) ASC must document the projects being conducted
Radiologic Services § (b) (1) The ASC must have procedures for obtaining radiological services from a Medicare approved facility to meet the needs of the patient. § (b) (2) Radiologic services must meet the hospital conditions of participation for radiologic services
Patient Rights § The ASC must inform the patient or the patients representative of the patients rights, and must protect and promote the exercise of such rights. Must provide verbal and written notice in advance of the date of the procedure.
Advance Directives §416.50(a)(2) The ASC must comply with the following requirements: (i) Provide the patient or, as appropriate, the patients representative in advance of the date of the procedure, with information concerning its policies on advance directives, including a description of applicable State health and safety laws and, if requested, official State advance directive forms
Advance Directive (cont.) §416.50(a)(2) (cont.) (ii) Inform the patient or, as appropriate, the patients representative of the patients rights to make informed decisions regarding the patients care (iii) Document in a prominent part of the patients current medical record, whether or not the individual has executed an advance directive
Grievances § (a) (3) (i) The ASC must establish a grievance procedure for documenting the existence, submission, investigation, and disposition of a patients written or verbal grievance to the ASC. (iv) Substantiated allegations of abuse, mistreatment, or neglect must be reported to the State authority.