In this blog, experts offer the real scoop on audit readiness in healthcare. Learn the unfiltered truth about compliance audits and what audit etiquette means. Get essential tips on preparing for audits, the role of healthcare compliance auditors, and what to do (and what not do) during an audit.
Let’s say a regulator shows up at your door tomorrow. What’s the first thing your team scrambles to find? Is it evidence of task completion? Maybe a list of applicable regs? Updated policies? How about proof of communication to stakeholders? We saw a post this week asking for a current audit preparedness playbook because so many organizations think they’re ready, until they aren’t.
Here’s the raw, unfiltered truth; no organization is ever ready for an external auditor or inspector. Ever. If you were, no one would panic when the FDA shows up at the door unannounced, or the state shows up in your lobby. “The state showed up the other day, and I knew why they were coming so I wasn’t unprepared.”
The truth is you do your best, and you also expect the worst because they’re an auditor or inspector. Duh. It’s what they do.
It’s like when you hear a funny rattle in your car. You take it to the mechanic. You know he’s gonna find SOMETHING. That’s his job. If you didn’t hear the rattle, you wouldn’t have taken it to him. You’re just hoping it is a minor repair rather than a total overhaul. Same with your audit, your auditor, and the rattle in your compliance practices.
Auditing is a formal, independent way to investigate regulatory compliance of a system or process within an organization. In accordance with regulations or industry best practices, an auditor assesses the adherence, adequacy and absence of certain processes.
Once you know an audit is coming, use these five steps to prepare your organization.
Once you have these steps under control, preparation becomes a case of do’s and don’ts. In other words, audit etiquette.
Audit etiquette covers all the best practices required to facilitate smooth external audits. These vary slightly based on the health system’s existing compliance processes and experience facilitating them.
In most cases though, following these techniques for what to do and what to avoid will drive positive, less stressful outcomes.
Don’t guess. Say you don’t know or that you need to consult an SOP or defer to someone who is more suitable to answer the question. If you want to consult an SOP, describe the procedure in general terms with the auditor and then walk them through the details. Just saying “I have to consult my SOP” gives the impression that you aren’t trained.
Regulatory bodies will give a report prior to leaving the audit. Ensure you engage with the necessary teams to give sufficient responses and have a plan for any noted observations. The observations and responses in a report will generally be the first items looked at in the next audit. Make sure you stay on top of these action plans and complete the items you have committed to.
Also remember that auditors may be experts or novices based on the type and scope of the audit being performed. Do not assume you are the smartest person in the room when communicating with an auditor. Understand that the inherent authority of the auditor is dictated by the interested party they are advising. Their ability to influence a decision (that may have a significant impact on your organization) is the foundation of a desired outcome for you. That’s one reason why we recommend practicing good audit etiquette.
John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT, blog on LinkedIn as “The Q-Kids,” discussing everything related to clinical research education, inspiration, and professional connection.
Andrea has taught first grade in Willoughby, Ohio for 27 years in the same classroom that she attended school as a child. She earned a Bachelor of Science in elementary education with a minor in language arts from John Carroll University and a Master’s Degree in the Art of Teaching and Education from Marygrove College.
John builds and fixes quality departments, while currently thriving as the Administrator & Director of Quality, Risk Management and Compliance at River Vista, a behavioral hospital in Columbus, Ohio.
The Q-Kids – John R Nocero and Andrea L Bordonaro – are experts at everything quality, regulatory, education training and compliance and love sharing their knowledge on YouCompli.
Follow them on LinkedIn – for more quality content or send them a message – they’d love to hear from you.