4. Condition for Coverage: Governing Body and ManagementThe 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:
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.
Standard: Contract Services(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Interpretive Guidelines: §416.41(a)
The ASCs may contract with third parties for provision of the ASC's services, including the ASC's environment. However, such a contract does not relieve the ASC's governing body from its responsibility to oversee the delivery of these ASC services. Given that many ASCs operate closely with a physician practice or clinic, or that some ASCs share space with other ASCs or other types of healthcare facilities operating at different times, use of a wide range of contract services may be common in ASCs. The ASC must assure that the contract services are provided safely and effectively. Contractor services must be included in the ASC's QAPI program.
For example:
Standard: Hospitalization (Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) The ASC must have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC.
(3) The ASC must -
- i. Have a written transfer agreement with a hospital that meets the requirements of paragraph (b)(2) of this section; or
- ii. Ensure that all physicians performing surgery in the ASC have admitting privileges at a hospital that meets the requirements of paragraph (b)(2) of this section.
Interpretive Guidelines: §416.41(b)
The ASC must be able to transfer a patient immediately to a local hospital when the patient experiences a medical emergency that the ASC is not capable of handling, or which requires emergency care extending well beyond the 24-hour time frame for ASC cases. (See §§416.44(c) and (d) for a discussion of the emergency care capabilities each ASC must have.)
An "effective procedure" for immediate emergency transfers includes:
- Written ASC policies and procedures that address the circumstances warranting emergency transfer, including who makes the transfer decision; the documentation that must accompany the transferred patient; and the procedure for accomplishing the transfer safely and expeditiously. There must be evidence that staff are aware of and can implement the ASC's policy immediately upon the development of a medical emergency.
- Provision of emergency care and initial stabilizing treatment within the ASC's capabilities until the patient is transferred. (See §§416.44(c) and (d).)
- Arrangement for immediate emergency transport of the patient. (It is acceptable if the ASC contacts the ambulance service via 911 to arrange emergency transport, unless State licensure requires additional arrangements.)
A transfer agreement is a written agreement, signed by authorized representatives of the ASC and the hospital, in which the hospital agrees to accept the transfer of the ASC's patients who need inpatient hospital care, including emergency care. Generally transfer agreements establish the respective responsibilities of each party to the agreement, such as the process for arranging a transfer, etc. A transfer agreement may have an expiration date, or it may have terms stating that it remains in effect until and unless one of the parties has terminated the transfer agreement. An ASC's transfer agreement must be reviewed to determine whether it is in force at the time of the survey.
If the ASC does not have a transfer agreement, then it must maintain documentation of the current admitting privileges of all physicians who perform surgery at the ASC at local hospitals that satisfy the regulatory requirements in §416.41(b)(2) . (Even if the ASC has a transfer agreement, such documentation would be a good idea. However, it is required under the regulations only if there is no transfer agreement.) If there is more than one local hospital that meets the regulatory requirement for an appropriate local transfer destination, the ASC may satisfy the requirement at §416.41(b)(3) when its operating physicians each have admitting privileges at one of the eligible hospitals; it is not necessary that they all have privileges in the same hospital. The physician who performed the surgery on the patient requiring an emergency transfer is expected to arrange the hospital admission of the patient, unless there is a compelling clinical reason to transfer the patient to a different local hospital where the physician does not have admitting privileges.
The existence of a transfer agreement or the possession of hospital admitting privileges by the ASC's operating physicians is not necessarily a guarantee that a hospital will accept a specific transfer, since the hospital may lack the capacity to provide the required service at the time an emergency transfer request is made. ASCs should have alternative plans to address such contingencies. While it is true that the local hospital, if it is a Medicare-participating hospital that has an emergency department, would be obligated under the Emergency Medical Treatment and Labor Act (EMTALA), once the patient arrives on the hospital's property, to provide a medical screening examination, as well as stabilizing treatment to an individual with an emergency medical condition, an ASC may not satisfy its transfer requirements by simply relying upon a hospital's EMTALA obligations. An ASC may call 911 to arrange emergency transport, but it must also take steps to arrange the admission of the patient at a local hospital
Standard: Disaster Preparedness Plan (Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Interpretive Guidelines: §416.41(c)
Disaster Preparedness Plan. The intent of this regulation is for an ASC to have in place a disaster preparedness plan to care for patients, staff and other individuals who are on the ASC's premises when a major disruptive event occurs. The governing body of the ASC is responsible for the development of this plan.
A wide range of events could occur, such as fire, flood, mass release of a biochemical hazard, electrical failure, failure of the water supply, failure of key equipment needed to sustain the operations of the ASC, etc. The ASC must take an all-hazards approach when developing its plan, identifying hazards that are specific to the operating environment of an ASC as well as hazards that may affect the community in which the ASC operates, including the ASC.
Comprehensive emergency management includes the following phases, which should be taken into account in the development of the ASC's disaster preparedness plan:
Hazard Identification: ASCs should make every effort to include any potential hazards that could affect the facility directly and indirectly for the particular area in which it is located. Indirect hazards could affect the community but not the ASC, and as a result interrupt necessary utilities, supplies, or staffing.
Hazard Mitigation: Hazard mitigation consists of those activities taken to eliminate or reduce the probability of the event, or reduce the event's severity or consequences, either prior to or following a disaster or emergency.
The emergency plan should include mitigation processes for patients, staff and others present in the facility at the time of the disaster or emergency. Mitigation details should address provision of needed care for the ASC's patients being prepared for procedures, undergoing procedures, or recovering from procedures, as well as how the ASC will educate staff in protecting themselves and others present in the ASC in the event of an emergency. Comprehensive hazard mitigation efforts, including staff education, will aid in reducing staffs' vulnerability to potential hazards. These activities precede any imminent or post-impact timeframe, and are considered part of the response.
Preparedness: Preparedness includes developing a plan to address how the ASC will meet the needs of patients, staff, and others present in the ASC if essential services break down as a result of a disaster. It will be the product of a review of the basic facility information, the hazard analysis, and an analysis of the ASC's ability to continue providing care and services during an emergency. It also includes training staff on their role in the emergency plan, testing the plan, and revising the plan as needed.
Response: Activities taken immediately before (for an impending threat), during and after a disaster/emergency event to address the immediate and short-term effects of the emergency.
Recovery: Activities and programs that are implemented during and after the ASC's response that are designed to return the ASC to its usual state or a "new normal."
Resources for providers and suppliers on effective healthcare emergency preparedness may be found on CMS' Web site at http://www.cms.hhs.gov/SurveyCertEmergPrep/03_HealthCareProviderGuidance.asp#TopOfPage
Coordination of the Plan. The regulation requires that the ASC must coordinate its disaster preparedness plan with State and local authorities that have responsibility for emergency management within the State. Coordination should take place in addressing threats that either extend beyond the premises of the ASC, e.g., floods, earthquakes, or biochemical releases, etc., or threats within the ASC that require response from a community agency, e.g., fire department.
Coordination assists in overall emergency management planning efforts within the area where the ASC is located, for example by ensuring that the facility's plans are consistent with the larger community approach to similar hazards. It also makes known to both the ASC and to the State and local authorities the assets and capabilities that each has available during an emergency.
The regulation does not require that ASCs be integrated into State and local emergency preparedness plans to address threats that extend beyond the premises of the ASC, since it will ultimately be the decision of the State and local officials whether and how they might utilize ASCs in a response to an emergency event. ASCs must, however, document that they have made efforts to communicate with their State and local emergency preparedness officials to inquire about potential coordination.
Testing, Evaluating, and Updating the Plan. At least once every year the ASC must conduct a drill to test the plan's effectiveness. A drill that is conducted in concert with State or local authorities would qualify as an annual test. While the drill does not have to test the response to every identified hazard, it is expected to test a significant portion of the plan. For example, a fire drill does not qualify on its own as a sufficient annual drill of the ASC's plan.
The ASC must prepare a written evaluation of each annual drill, identifying problems that arose as well as methods to address those problems. The disaster preparedness plan must be promptly updated to reflect the lessons learned from the drill and the needed changes identified in the evaluation.