Developing a Hybrid ASC/OBL Center: Unique Operational Considerations

The Hybrid Model – a combination of Ambulatory Surgery Centers (ASCs) and Office-Based Labs (OBLs) – is gaining popularity as a flexible and efficient approach to outpatient care. However, before embarking on the development of a Hybrid ASC/OBL center, operators must be aware of certain unique operational considerations to ensure compliance with federal regulations and state-specific rules. Let’s explore these considerations in detail.

Temporal Separation for Distinct Entities:

Under federal law, distinct entities, such as an ASC and OBL, may share space as long as they maintain temporal separation. According to CMS guidelines, a “distinct entity” must be “wholly separate and clearly distinguishable from any other healthcare facility or office-based physician practice,” either physically or temporally. To meet this requirement, most Hybrid ASC/OBL centers operate their ASC and OBL on different days. However, a small percentage of hybrids choose to operate both on the same day, necessitating stringent measures for temporal separation.

Ensuring Patient Safety and Privacy:

Hybrid centers operating both ASC and OBL services on the same day must ensure that all patients have exited the facility, including waiting rooms and recovery suites, before converting the space for the opposite type of use. This practice guarantees that the patients of each entity do not overlap, maintaining compliance with temporal separation regulations.

Separate Medical Records Maintenance:

To ensure compliance and patient privacy, an ASC and OBL involved in a hybrid model must maintain separate medical records. Even if a unified electronic medical records system is used to operate both entities, strong firewalls and safeguards should be in place to prevent access to the medical records of the respective ASC and OBL patients. Additionally, staff should have distinct logon credentials for each electronic medical records system to further ensure patient data segregation.

Clear Signage and Patient Education:

Clear and conspicuous signage in waiting areas is crucial to inform patients about the days and hours of ASC and OBL operations. Patients should be aware of the different care settings and understand that copays, coinsurance, and deductibles may vary depending on the type of service they receive.

State-Specific Regulations:

Operators must carefully assess state licensure, certificate of need requirements, and other rules and regulations applicable in the states where the Hybrid ASC/OBL center intends to operate. A number of states may not permit such hybrid arrangements, making it imperative to ensure full compliance with state-specific guidelines.

Conclusion: Developing a Hybrid ASC/OBL center offers numerous advantages in delivering comprehensive and convenient outpatient care. However, operators must navigate unique operational considerations to maintain compliance with federal and state regulations. By adhering to temporal separation requirements, ensuring patient safety and privacy, and providing clear patient education, operators can successfully establish and operate a Hybrid ASC/OBL center, enhancing patient experience and meeting the evolving demands of the healthcare landscape.