The complexities of healthcare, including the use of specialized services to support operations, have often required the use of clinical-based contractors to meet the needs of patients served by many healthcare organizations. These contracts can take the form of clinical staffing, specialized Practitioners, ancillary services, and others. As with organization-owned services, clinical contracts include regulatory requirements to maintain patient safety and quality, ensuring optimal service delivery. The Centers for Medicare and Medicaid Services (CMS) recognized that organizations were not effectively managing the contracted services rendered for their patients as outsourced resources became more prevalent. This led to the implementation of Conditions of Participation tailored to the need for clinical contract management. As healthcare becomes more expensive and specialized, many clinically based contracts will continue to expand, requiring more comprehensive management by leaders.
Healthcare organizations are being cited more frequently under leadership standards for lack of oversight and management by surveyors for infection control and physical environment findings. Oversight of clinical contracts is no exception. It is critical that organizational leaders, especially the Governing Body, take an active role in ensuring that clinical contracts are effectively managed and monitored to provide safe, high-quality care for patients. This would include approving contracts, reviewing services provided, implementing corrective actions to address deficiencies, and ensuring ongoing monitoring of performance improvement initiatives. Organizations should ensure that minutes of executive-level meetings, including the Governing Body, reflect the involvement of senior leadership to provide evidence for survey teams.
Additionally, organizations should maintain a list of all contracted services, including the scope and nature of each service. This list should specify the contractor’s responsibilities. Demographic data, such as contract start date and projected termination date, vendor information, vendor and organizational contact information, date of pending performance review, and performance measures, can provide a comprehensive resource for leaders and surveyors. It provides the organization with a single document for oversight and management of all clinical contracts. Our observations in the field indicate that some organizations often struggle to develop this resource. Several contracts may not be included due to clinical leaders’ lack of understanding of the importance of identifying and tracking all clinical contracts.
The Governing Body must ensure that all echelons of leaders in their organization are trained on the essentials of clinical contract oversight. This training should be included in onboarding and in ongoing training for clinical leaders. Training should include identifying leaders’ regulatory responsibilities for clinical contract oversight, procedures to follow when raising concerns about contracted clinical services, and their role in evaluating contractor performance. This training should be documented.
The organization must ensure that clinical contracts comply with all applicable laws and regulations. This includes verification that all training, licensing, infection control, environmental, and patient safety regulations are met and maintained. Leaders must understand these requirements, with the expectation that they have been communicated to the vendor and validated as compliant. The requirement to comply with applicable laws and regulations should be included in any clinical contract, with the stipulation that the organization retains the right to validate these requirements as needed.
Leaders should treat contracted clinical services as their own organic services with regard to regulatory requirements. For example, any organizational expectations regarding infection control practices must be communicated to the contracting authority for implementation into their practice. Organizations must also anticipate changes in regulatory requirements and verify that the contractor has implemented them. Organizations that fail to follow up on regulatory compliance validation by clinical contractors will be cited by survey teams. Remember, it is about ensuring the safe delivery of care for patients under your organization’s responsibility, regardless of whether they are contracted services.
Organizations must establish performance measures to determine whether contracted clinical services meet expectations for safety, efficiency, and effectiveness. These services are subject to the same requirements for evaluating services owned and operated by the organization. Therefore, existing performance measures may be applied to contracted services. All contracted clinic services must be evaluated for performance, with specific measures varying based on the complexity and risk of each contract.
The evaluation of clinical contracts must be incorporated into the organization’s existing Quality Assurance and Performance Improvement (QAPI) program. This provides an existing structure for monitoring performance, identifying opportunities for improvement, initiating and monitoring improvement efforts, and reporting activities to the Governing Body.
Organizations should ensure that success measures are meaningful and reflect sufficient oversight to ensure safe and effective care. Ideally, measures should be specific and measurable, not grounded solely in subjective criteria.
Data from these measures must be periodically reviewed and analyzed against established measures. This information must be reported through the organization’s structure, including the QAPI Committee and the Executive Committee, to the Medical Staff for review and input. Eventually, the data and input from the various committees must be reported to the Governing Body for their own review and guidance.
Ensuring organizational compliance in managing clinical contracts requires a deliberate, organized effort. Regulatory compliance does not end at execution. Organizations should consider the following initiatives:
For questions or to learn more, contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.
