Two workers inspect medical scanning equipment

Biggest Tip for Preparing for a Regulatory Visit? Always Be Ready


By Matt Solomon

Always be ready.

Because you never know the exact moment a regulator is going to walk through your hospital door, the best Healthcare Technology Management programs make operating on their A-game a priority. That’s simply the nature of our industry. We might have a general idea of when regulators, generally from The Joint Commission (TJC), will come for routine reviews as part of the reaccreditation process. For example, if we hosted regulators this year during the third quarter, so we might expect a return visit during that same window next year. Still, we can never be sure enough to mark a week or two in ink on our wall calendars.

At TKA, we share the mindset that maintaining a constant state of readiness is the higher goal. Of course, that sets you up for success in passing any inspection, but it also means your program is functioning at the most effective and efficient level for the safety of our hospital partner and its patients. As the saying goes, an ounce of prevention is worth a pound of cure.

Hospital administrators recognize TJC as the leader in healthcare accreditation. The commission also helps facilities ensure they’re complying with requirements from other state and federal agencies, including the Centers for Medicaid and Medicare Services (CMS). Granted, assessing the HTM program is only one piece of an exhaustive inspection where regulators look at the entire patient journey, including provider care.

Achieving TJC accreditation demonstrates to the community that your hospital embraces and maintains high standards of care. Whether your hospital has thousands or tens of thousands or more medical devices, biomedical services is an important part of the overall delivery of excellent patient care and a contributing factor to patient (and provider) satisfaction. Every piece of equipment that our biomeds maintain somehow touches a patient, which also makes patient safety paramount.

Managing an effective regulatory inspection

While a constant state of readiness is optimal for both patient satisfaction and safety, that also positions you for a successful regulatory visit. Going a step further, we recommend a few essential practices that create an experience where you can demonstrate your HTM program’s effectiveness and respond quickly to anything a regulator might uncover:


  1. Effective HTM starts at the top.

Every single day, your biomedical services department manager must be actively engaged and provide the appropriate oversight and guidance to staff members. That’s the only way to ensure all the proven plans, policies and procedures you’ve developed not only are in place – but followed, whether on the unit or in your biomed shop. Earning our ISO 9001 certification, which demonstrates that we adhere to best quality standards, has helped make that second nature for our TKA biomed teams.

  1. No job is ever done until the paperwork is finished.

We’re constantly on top of work orders, confirming TeamNet – our tailored  Computerized Management and Maintenance System – is updated. Expect your inspectors to stop here first to review your records and validate you’re meeting tracking standards for every piece of medical equipment in your hospital’s inventory. Proper maintenance history and documentation is a central part of regulatory compliance. You can expect a regulator to pick one piece of equipment and ask you to pull up every record for that device – and you better have current, accurate information at your fingertips.

Nearly every biomed can tell a story of how an inspector can ferret out the single past-due maintenance sticker across even a multi-building campus, usually on a low-priority device long reported as “could not locate.” In other cases, someone trying to be helpful might have used the wrong cleaning solution and a sticker fell off an up-to-day device. This reflects on the robustness of your CMMS and its accurate documentation, which can demonstrate that you’re already steps ahead of that inspector.

  1. Be prepared to act responsibly.

In reviewing your hospital operations, TJC inspectors use the commission’s self-developed SAFER (Survey Analysis for Evaluating Risk) Matrix to gauge how your equipment stacks up. This tool provides a visual representation of the potential for harm that a device might cause, as well as how limited or widespread that risk is. The takeaway for biomed teams is to prioritize addressing those items with the greater risk across the hospital.

Depending on the severity of the finding, gauged against the SAFE Matrix, the corrective action could be a simple process adjustment made on the spot. Or it might require a documented corrective plan, along with further proof of compliance and ongoing monitoring.

  1. Let your community know.

When your hospital receives your three-year TJC accreditation, be sure to share your success with your community, which includes current and prospective patients who might have a choice in where they receive care. In our industry, earning that accreditation is the equivalent of winning the Super Bowl, as it signifies we’re at the top of our game. Be sure your hospital tells this story of quality care and continuous improvement by prominently displaying the commission’s seal on your website and in your lobby or waiting rooms. You’ve worked hard to deliver and maintain this caliber of safe, effective patient care, so don’t keep it a secret.

Taking your HTM to inspection readiness

Without question, today’s medical technology is an integrated part of quality patient diagnosis and treatment today. Having your devices at a constant state of readiness is essential for maintaining quality patient care, and an HTM program that is humming can easily onboard new devices and decommission aging equipment. Our TKA team can help you develop an effective program that is always ready for patients and providers – with the added bonus of constantly being ready whenever your next inspection comes along.

Matt Solomon is TKA’s biomedical services manager at Children’s Health of Orange County (CHOC).




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