Quality Control

Establishing the Right Leadership and Staffing Standards

In Part 3 of this compliance series, learn about the leadership and committees required by CMS, as well as how to define your staffing standards

CMS sets clear standards for how we should structure the governance of our surgery centers and staff them, but those standards don’t offer clear direction on how to comply. Through my work, I document evidence of compliance through written policies, organizational charts, committee descriptions, committee meetings, job descriptions, staffing plans/assignments, competency assessments, and other records. In this article, I’ll define the CMS standards for governance and staffing and offer tips for compliance.

Organizational Structure

In the CMS definition of an ASC’s organizational structure (CMS 416.41), an ASC must have a designated Governing Body (GB) that exercises oversight for all activities in the facility. If an ASC has only one owner, that individual is the GB. To provide quality health care in a safe environment, the GB is responsible for establishing ASC policies, ensuring that the policies are implemented, monitoring internal compliance with policies, and periodically assessing those policies for any necessary revisions. The regulation particularly stresses the responsibility of the GB for direct oversight of the ASC’s quality assessment and performance improvement (QAPI) program (the quality of ASC healthcare services), the safety of the ASC environment, and development and maintenance of a disaster preparedness plan.

In addition to a GB, CMS requires organization of the medical staff through a Medical Advisory Committee (MAC), chaired by the Medical Director. This usually consists of officers and delegates from all services provided at the center (one or more surgeons from each specialty, anesthesiology, other health specialists and technicians) and chairpersons of standing committees appointed by the Medical Director.

MACs review a range of functions, including medical staff credentialing, corrective action, accreditation, infection control, performance improvement, tissue review, drugs and controlled substance inventory procedures, safety, and medical records. The MAC is the medical administrative liaison between the medical staff and the GB and makes recommendations related to governance to the GB. MACs meet at least quarterly and document their meeting minutes.

Since the GB and MAC are not qualified to directly oversee all aspects of management, CMS says they can delegate tasks. This is usually accomplished through a subcommittee structure, including, but not limited to, these groups:

Pharmacy and Therapeutics. This subcommittee approves all policies and procedures relating to pharmacy service within the facility, establishes criteria relative to the safe and effective use of pharmaceuticals, establishes and maintains a pharmaceutical formulary of drugs that may be used in the facility, reviews efforts aimed at cost containment, and reports drug shortages and recalls.

QAPI. The QAPI subcommittee works with the GB to develop a comprehensive program of performance improvement, quality assurance, risk management, and utilization review. It identifies standards for monitoring, documenting, and reporting quality improvement activities throughout the organization. Based on quality improvement findings, the QAPI subcommittee takes action, such as setting up or requiring educational programs and implementing corrective actions. It also reevaluates quality problems to determine whether or not corrective actions were effective. The QAPI subcommittee collects data in many areas, such as infection control, peer review, life safety, medical records, tissue, risk management, utilization review, quality assurance, and performance improvement studies.

Infection Control. This subcommittee focuses on creating awareness of infection control measures and helping staff develop the appropriate skills to function effectively. A nurse qualified in infection control standards heads the committee.

Peer Review. This group helps maintain a consistent standard of care at the ASC by assessing the clinical performance of its physicians. Members review an annual Peer Review Report and take action based on the findings when necessary. The group also maintains peer review documentation on all physicians in the facility, for reference and utilization in the appointment and reappointment process. All members of the medical staff are obligated to participate in the peer review process.

Safety. This subcommittee protects staff, patients, and visitors, as well as the facility’s property and assets. Headed by the ASC’s safety officer, the group helps develop fire and safety policies and protocols and identifies and corrects fire/safety/disaster code deficiencies in a timely manner. Members also develop fire and safety education programs for the staff.

Medical Records. This group ensures that the ASC’s medical records meet standards for completeness, accuracy, and confidentiality and creates policies to ensure compliance. It makes recommendations to physicians and facility personnel to improve the ASC’s medical records.

Tissue. Physicians in this group check whether a patient’s preoperative and postoperative (pathological) diagnosis justifies the surgery performed at the ASC. All staff members must comply with requests for information from the committee.

Special or Ad Hoc. The MAC can create subcommittees to perform other specified tasks. The MAC and medical director appoint members of these committees.

Staffing Standards

The CMS staffing standards (CMS 416.42) state, “Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC.”

A “safe manner” primarily means that physicians and other clinical staff must meet the CMS minimum staffing requirements (Figure 1). To ensure that everyone helps meet standards of care and supports the health and safety of patients and staff, CMS also defines the in-service education requirements for ASC staff (Figure 2). Finally, the facility must follow nationally recognized surgical standards of practice in all phases of a surgical procedure, beginning with preoperative preparation of the patient and ending with postoperative recovery and discharge. Those nationally recognized standards include federal and state laws, regulations, and guidelines governing surgical services, as well as standards and recommendations from major professional organizations (Figure 3).

Figure 1. Minimum Staffing for the ASC

Figure 2. Requirements

Figure 3. National Staffing Standards Specific to ASCs

In an ophthalmic ASC, standards cover not only physician staffing, but also staffing for the preoperative area, operating room, central sterile processing, and scrub technician requirements. By following these standards, centers meet the compliance standards evaluated during any CMS inspection. ■