Regulatory scrutiny has tightened. This year, follow a series of four articles to prepare your ASC for full compliance

When I began working in ASC development, compliance, and management 38 years ago, there were only about 50 surgery centers in existence. Over time, more and more physicians working in the hospital setting became ASC owners, excited by the thought of fewer mandatory meetings, decreased turnover time, and more control of their surgical practice.

ASCs have largely delivered on their potential, but doctors escaping hospital bureaucracy often make regulatory compliance an afterthought. To ensure an ASC’s future success in a changing environment, there has to be a shift in priorities.

THE OLD WAY WORKED — FOR A WHILE

In the past, ASC partners would handle regulatory compliance by hiring an RN clinical director and trusting that he or she maintained compliance with all regulatory agencies. Many expected this to happen without adding cost or staffing hours to the budget. Required regulatory meetings were rare, physician involvement was sometimes nonexistent, infection control was inadequately addressed, and quality assurance was minimal.

How did ASCs survive with such a relaxed approach?

One thing on the side of the ASCs was their newness. It took CMS decades to alter its rule for the ASC model across all its specialties. There were standards in place, similar to today’s regulations, but those standards weren’t meticulously scrutinized during surveys.

Preparation and paperwork weren’t priorities because it was easier to wait until the next “unannounced” survey and write a plan of correction for anything that was neglected. It was painless. Surveys only lasted a few hours, rarely more than a day. The surveyors left and we didn’t see them for another few years. This worked for 30-plus years.

Today, everything has changed. ASCs are under much higher scrutiny to meet regulatory compliance; neglect and post-inspection plans of correction are no longer an option. In retrospect, we understand that hospitals have so many layers because they’ve been subjected to highly scrutinized regulatory oversight for many years. While we needed to move away from the hospital mentality toward patient care and efficiency, we could have benefited from learning how hospitals manage the scrutiny of compliance.

WHAT THE FUTURE LOOKS LIKE

The reality is that with more stringent regulatory oversight, the cost of doing business goes up.

Based on today’s compliance requirements, we have to employ higher-qualified staff (required by CMS), log more staff training hours (staff education requirements), pay more for employee health (meeting CMS requirements to meet CDC vaccination recommendations for healthcare workers), use more instrument sets (to meet the CMS requirement to follow Association for the Advancement of Medical Instrumentation [AAMI] sterilization standards), and invest in more expensive equipment (no more tabletop autoclaves!). All this comes in addition to decreased reimbursement and higher supply costs.

The pattern is clear: regulatory changes are shaping the ASC’s future. Owners cannot be bystanders any longer; the focus has to be on efficient compliance.

Based on my experience, many ASC owners know the regulatory bodies, such as CMS, but they’re not familiar with the standards and requirements their centers must meet. For example, you may not know that CMS requires your facility to meet a wide range of standards, including state licensing requirements (when applicable), OSHA and NFPA rules, nationally recognized standards (AORN, ASPAN, CDC, AAMI, etc.), and standards for civil rights, peer review, and credentialing.

Help is on the Way

Compliance isn’t a choice — it’s required — and your ASC can comply efficiently and sustainably in the future. It can be overwhelming, but like they say, you have to start somewhere. That’s where I come in.

I want to give back to the industry that has been so good to me in my career. In conjunction with The Ophthalmic ASC, my plan is to give you the keys to basic compliance. I’ll guide you, in quarterly articles, for the next year. By the end of the year, you will know what is required to keep your surgery center viable. ■