CMS Excerpt on Controlled Substance Regulations & Interpretive Guidelines

CMS State Operations Manual states in 482.25(a)(3) that current and accurate records must be kept of the receipt and disposition of all scheduled drugs. Seems pretty straight forward. It goes on to give the interpretive guidelines that again are pretty straight forward. They will look for drug accountability procedures from entry into the hospital to administration to the patient or destruction/return to manufacturer. They want to see a policy that covers these procedures. They will look to see that all records can be traced and that those records are readily available.

They will hold the pharmacist responsible for determining that all drugs records are in order and maintained properly. How many of you Pharmacy Directors or Managers have a Buyer that handles the paperwork and would be hard pressed to walk a surveyor through portions of the accountability process? The interpretive guidelines also state “the hospital system is capable of readily identifying loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion.” What systems do you have in place and what would your answer be if a surveyor asked you how your facility minimizes that time frame? 

Review your current policies and procedures from a surveyor’s perspective and be prepared to demonstrate compliance and answer questions related to that compliance.

I don’t pretend we have all the answers. But the questions are certainly worth thinking about. –Arthur C. Clarke

Terri Vidals
Terri Vidals

Terri has been a pharmacist for over 30 years and is a drug diversion mitigation and monitoring subject matter expert. Her years of experience in various roles within hospital pharmacy have given her real-world insight into risk, compliance, and regulatory requirements, as well as best practices for medication and patient safety.

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