4. Governing Body and Management

§416.41 Condition for Coverage: Governing Body and Management
The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC’s total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that the facility policies and programs are administered so as to provide quality healthcare in a safe environment, and develops and maintains a disaster preparedness plan.
Interpretive Guidelines: §416.41
The ASC must have a designated governing body that exercises oversight for all ASC activities. The governing body is responsible for establishing the ASC’s policies, making sure that the policies are implemented, and monitoring internal compliance with the ASC’s policies as well as assessing those policies periodically to determine whether they need revision. The regulation particularly stresses the responsibility of the governing body for:
• direct oversight of the ASC’s quality assessment and performance improvement (QAPI) program (see 72 FR 50472, August 31, 2007) and 73 FR 68714, November 18, 2008
• the quality of the ASC’s healthcare services
• the safety of the ASC’s environment; and
• development and maintenance of a disaster preparedness plan.
In the case of an ASC that has one owner, that individual constitutes the governing body.
Although the governing body may delegate day-to-day operational responsibilities to administrative, medical, or other personnel, the ASC’s governing body retains the ultimate responsibility for the overall operations of the ASC and quality of its services. The regulation also emphasizes the governing body’s responsibilities in the areas of QAPI and disaster preparedness. Delegations of governing body authority should be documented in writing.
The governing body is responsible for creating a safe environment where ASC patients can receive quality healthcare services. This means the governing body is not only responsible for adopting formal policies and procedures that govern all operations within the ASC, but also that it must take actions to ensure that these policies are implemented. Through its direct oversight and accountability for the ASC’s QAPI program, it is expected that the ASC is better able to improve care being furnished to its patients. (See 72 FR 51472, August 31, 2007.) When QAPI citations are made related to 42 CFR 416.43, particularly Standard (e), the citation at 42 CFR 416.41should also be considered.
If condition-level deficiencies are cited related to multiple other ASC CfCs, with the result that the ASC does not provide quality healthcare or a safe environment, then it is also likely that the ASC is not complying with the governing body CfC.
Survey Procedures: §416.41
• Ask the ASC for information about its governing body. If there are questions about who constitutes the ASC’s governing body, it may help to review the information the ASC reported in Section 6 of its CMS Form 855B application, identifying those individuals with ownership interest or managing control of the ASC.
• Ask the ASC how frequently the governing body meets and what are the typical items on its meeting agendas.
• Has the governing body delegated operational responsibility to a manager?
• Ask for an organizational chart of the ASC management. Ask who performs the following functions:
• Human Resources
• Medical staff credentialing and granting of privileges
• Management of surgical services
• Management of nursing services
• Management of pharmaceutical services
• Management of laboratory (if applicable) and radiologic services
• Management of the ASC’s physical plan
• Medical records maintenance
• Infection control
• Quality Assurance and Performance Improvement.
• Ask to see meeting minutes or other evidence that the ASC’s policies and procedures have been formally adopted by the governing body.
• Ask to see meeting minutes or other evidence of how the governing body assures that its policies are implemented, and of how the governing body monitors internal compliance with and reassesses the ASC’s policies. For example, is there any evidence of data collected and submitted to the governing body related to specific ASC policies?
• Ask to see meeting minutes or other evidence of how the governing body exercises ongoing oversight of and accountability for the ASC’s QA/PI program. See the discussion of §416.43 for more detail on the regulatory requirements related to QA/PI.
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