Regulatory Affairs: Regulatory Compliance Planning Is Critical

ASC leaders need teamwork, resources and a manageable process.

Regulatory compliance — what does that mean and how can I be compliant with something I am clueless about?

Ambulatory surgery centers (ASCs) and outpatient surgical hospitals are highly regulated healthcare facilities. But what exactly does “highly regulated” mean? What is really involved in regulatory compliance for these facilities? That is a much more complex question and one that many new ASC and outpatient leaders are facing today.

On multiple levels

There are also many federal, state and local statutes and regulations that govern day-to-day operations as well as how these facilities are paid.

Regulatory requirements can include the rules to apply and maintain a current state license to operate as a healthcare facility to complying with the “Conditions for Coverage” to participate in Medicare reimbursement.

Although state licensure and the CMS Conditions for Coverage have different rules and regulatory requirements, they both share a common goal of ensuring that the facility is equipped to appropriately care for patients. This includes every aspect of clinical and business operations.

Many healthcare facility leaders can focus on an area of specialty or niche, such as quality, infection prevention or patient safety, but in an outpatient facility these responsibilities fall to the administrator or leader. They are now expected to wear many hats including clinical staffing, sterile processing, infection prevention, quality and performance improvement as well as financial and business responsibilities.

New leaders will be facing these tasks for the first time — and all at once, which can be extremely overwhelming.

The good news is there are many resources available to assist leaders in navigating the regulatory compliance journey.

Connect the dots

Regulatory compliance is an exercise in connecting the dots throughout the organization. It includes governance through delegation by the governing body, quality management and improvement, emergency preparedness, infection prevention, credentialing, privileging and much more. In addition to the clinical and daily operations, it is no wonder the outpatient leaders are feeling the pain.

The good news is there are many resources available to assist leaders in navigating the regulatory compliance journey. The key is to understand the basics of regulatory compliance and then create a program that closes the loop of providing high-quality care, continually seeking opportunities to improve, communicating the findings throughout the organization and maintaining accurate documentation. Despite the many resources available, leaders may find themselves with too much information. The best approach is to determine your state, federal and accreditation requirements and create an action plan to address any areas of non-compliance. It is also helpful to divide the process into manageable projects, starting with governance, quality reporting, standards of patient care, and so on.

Organization and consistent storage of documents will assist to avoid re-work and using a team approach will foster ownership and accountability. The outpatient leader cannot complete all the tasks in a silo, but rather should be the coordinator of the information, oversee action plans and ensure the team is contributing to the regulatory compliance plans. OSM