Regulatory compliance should never be a “check-the-box” exercise. While there are certainly minimum standards to meet, taking a more holistic approach affords organizations opportunities to improve care quality and safety. Andrew Resnick, MD, Chartis Chief Medical and Quality Officer, and Lisa Eddy, Partner and regulatory and compliance leader, discuss how and why chief medical officers (CMO) can seize inherent opportunities in regulatory compliance.
Lisa has more than 25 years of consulting experience specializing in Centers for Medicare & Medicaid Services (CMS) certification and accrediting agency regulatory compliance. She helps organizations achieve sustained regulatory excellence by developing and facilitating implementation strategies for performance improvement and patient safety programs.
Andrew is a nationally recognized expert in quality, patient safety, and high reliability. He helps organizations set and reach top performance goals through specific projects and transformational change. With more than 20 years of experience in healthcare, he has served as CMO and chief quality officer at leading health systems throughout the US. He is also active clinically as an associate surgeon at Brigham and Women’s Hospital and as a part-time lecturer at Harvard Medical School.
Chartis: Let’s start with discussing why regulatory compliance is so often a challenge if healthcare organizations know the rules and standards they must follow.
Lisa: People often don’t understand how regulations affect patient safety, preventable harm, and performance improvement. There’s a disconnect stemming from the idea that regulatory compliance is a cost of doing business—not an opportunity to improve care. What’s needed is a culture of compliance.
Andrew: Leaders play an important role in helping their staff perceive these regulations from the perspective of patient care. Compliance isn’t about checking boxes. The regulations are the minimum. Compliance should be about leveraging these minimal standards to enhance patient safety. For example, marking the surgical site is required, but as leaders implement site-marking policies, the focus should be on preventing any possibility of a wrong-site procedure. To do that, the team needs to understand the approach—not just make sure there’s an initial on the body somewhere.
Chartis: This brings us to the role of CMOs—why are they so important in terms of helping achieve regulatory compliance?
Lisa: Perhaps this as an alternative: CMOs are paramount. In fact, what I’ve seen is this: Oftentimes, when organizations get into trouble with The Joint Commission, DNV, or CMS, it’s because the regulatory work is siloed from the quality and operations work led by clinical leadership. In contrast, the CMO is front and center in the most successful organizations. The CMO is leading efforts for patient safety and quality, and ensuring that regulatory compliance is not an afterthought but integrated into this work.
The CMO rolls up their sleeves and problem-solves. For example, if an Emergency Department (ED) doesn’t meet Emergency Medical Treatment & Labor Act (EMTALA) requirements, a strategic CMO works directly with ED directors to better manage patient flow as well as hospitalists to ensure timely discharges. These changes not only improve patient care and patient throughput; they also enhance regulatory compliance.
The CMO is uniquely positioned to drive change because they have influence with the medical staff and are attuned to clinical workflows. The CMO can also collaborate with the Chief Nursing Officer (CNO) to ensure that regulatory compliance doesn’t unnecessarily overcomplicate clinical processes.
Andrew: On the point of collaboration, regardless of the reporting structure, there are multiple leaders CMOs should collaborate with, including the Regulatory Compliance Officer, Quality and Safety Directors, and physician leaders of relevant clinical specialties. A collaborative approach enables you to answer these 2 critical questions: What does this regulation mean to our specific organization? How can this regulation help us run our organization more effectively?
This also gets to one of the biggest challenges CMOs face trying to move the needle on regulatory compliance: CMOs typically have no direct authority over physicians.
It’s a tricky position that Chartis’ Chief Physician Executive Roger Ray, MD, has discussed previously. In lieu of authority, it’s all about building relationships and getting everyone on the same page.
Lisa: That’s right. But strategic CMOs take the time to understand the regulations and work directly with individual clinical departments to solve problems and address barriers. CMOs who do this collaboratively alongside the medical staff—not in an adversarial way—are the most successful.
Chartis: How are regulatory compliance and high reliability care related?
Lisa: Organizations need to weave accountability and responsibility into everything they do. They need to think about what regulations mean in terms of patient safety and preventable harm. They’re not just words on a page. They mean something at the point of care. When organizations realize this, they pivot from a reactive approach to a proactive approach that keeps patients safe.
Addressing problems immediately when they occur—instead of ignoring them and letting them increase until a regulator identifies a trend—is a much more sensible approach. Continuous improvement mitigates safety issues and decreases compliance findings. When we help organizations with regulatory adverse action, the findings often center on missed opportunities to correct these problems when they are first identified.
Andrew: The more an organization commits to high reliability care, the more regulatory compliance vulnerabilities lessen. Organizations that provide high reliability care don’t become overwhelmed when The Joint Commission comes on site. They already have the right policies, procedures, and culture in place. Everyone is doing what’s best for patients regardless of the regulation.
Chartis: In summary, what’s most important to turn regulatory compliance from checking the box to improving care quality and patient safety?
Andrew: These 3 things are most important:
-
Clinicians don’t respond well to “the regulator makes us do this.” CMOs must help others understand the intent behind regulatory compliance.
-
Regulatory compliance can’t happen in a silo. Establishing a culture of compliance allows you to address problems proactively and avoid harmful situations.
-
The CMO plays a key role in terms of identifying and solving problems, galvanizing staff, and designing policies that are executable, sustainable, and genuinely improve patient safety.
