How much does compliance cost?

How much does compliance cost?

How much compliance costs is tricky to calculate, but there are multiple examples of organizations who have paid millions of dollars in fines from regulatory agencies, and/or medical malpractice lawsuits.

Of course, there are many other ways facilities lose money because of poor practices, lack of oversight and expertise. What are some steps you can take to make your patients safer and greatly reduce your liability and costs?

For those of you who saw me speak at the Massachusetts Association of Ambulatory Surgery Centers’ 8th Annual Northeast Conference on October 21st, you know that medication management is complex and there is a lot of oversight. How many organizations oversee medication management? The list is lengthy and grows larger every day. What organizations provide oversight? It includes entities like the Centers for Medicare and Medicaid Services (CMS), state departments of health, U.S. Food and Drug Administration (FDA), U.S. Pharmacopeia (USP), U.S. Drug Enforcement Administration (DEA) and accrediting agencies like the Accreditation Association for Ambulatory Healthcare (AAAHC), The Joint Commission (JC) and Quad A. Do you have someone in your facility who is expert in all these regulations and standards? How do they stay ahead of all the changes?

Lack of compliance can impact many different aspects of your facility. The affected areas could include patient safety, safe injection practices, infection control and medication management (both controlled and non-controlled medications). The consequences can range from a “simple” deficiency leading to a quick plan of correction (this still has many hidden costs), all the way to multi-million-dollar fines/litigation or even having your operation being shut down. How much would it cost to shut down your facility for a few days or weeks? Yes, this is the disaster scenario but if you have a plan, you are more likely to avoid the worst-case situation.

Just a few years ago, the University of Michigan Hospital was fined $4.3 million dollars for violating provisions of the controlled substances act. Among their findings, the DEA noted that the hospital committed “recordkeeping violations, some of which included failing to maintain complete and accurate records of certain controlled substances that it received, sold, delivered or otherwise disposed of, and failing to notify DEA in a timely manner regarding certain instances of thefts or significant losses of controlled substances”.

Do you know what provisions of the controlled substances act apply to your facility? Except for selling medication, all the items above apply to most ambulatory surgery centers. Are you fully compliant? Do you have $4.3 million dollars sitting around just in case the DEA determines you are not fully compliant? Although I am trying to inject some humor into this topic to make a point, this is a very serious situation. Compliance is not hard or expensive, but it requires expertise. Who in your facility is expert in all aspects of managing controlled substances?

In what ways do facilities manage this risk?

  1. Some facilities erroneously believe that the risk is either non-existent or minimal and do nothing further.
  2. Some facilities believe they have the expertise in-house and try to take this on themselves. Often with disastrous results.
  3. Some facilities decide to hire help, but they fail to find someone who is expert. This can be more of a liability than an asset because it gives the facility a false sense of security.
  4. Some facilities are proactive, see the big picture and hire an expert to assess their processes and guide them with clarity.

Which type of facility are you? Hopefully you’re in the fourth category and have a lot of support from someone who is a leader in their area of expertise!

Are you working with an expert to help minimize your risks? At OctariusRx, we provide an exceptional level of guidance and help you sleep soundly at night. We guide you in all aspects of medication management and help you improve patient safety, reduce costs, and ensure regulatory compliance. If you’re not currently working with someone, or if you’re working with someone who is merely checking a box, reach out to us and we will help you develop a plan for full compliance.

The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centerssenior care facilities and pharmacies. We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.

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