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CMS Excerpt on Controlled Substance Regulations & Interpretive Guidelines

Rxpert Solutions > Controlled Substances > 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

Our References

Terri is absolutely phenomenal. She is an incredibly knowledgeable pharmacy resource. As the medication safety officer, the quality initiatives she implemented not only impacted the patients at our medical center but also reached into the community. Terri is a genuine professional who upholds accountability while creating community among her team members. She is a great listener to identify friction points and has actionable ideas to implement improvements.

T. Eagle. MBA, MLS(ASCP), CLS Lab Operations Manager

Terri is an expert at prospective risk identification -Failure, Mode and Effects Analysis (FMEA). Terri participated in CHPSO Patient Safety Safe Tables and was part of the Hospital Quality Institute’s Regional Quality and Patient Safety Leader Network.
She is an excellent public speaker and communicates well with public and professional audiences. I look forward to her continued work in medication safety.

Regional Quality Network at HQI

Terri has done a tremendous job with the controlled substance diversion program. She has had such a positive impact and has really made the hospital a safer place.

Tri-City Medical Center
Nurse Manager

We would not be where we are with the improvements we have made with opioid prescribing if it were not for Terri driving the process.

Tri-City Emergency Medical Group
Chief Physician

In addition to understanding the ins and outs of the [controlled substance use] process completely, she is very proactive in coming to me with provider issues that she detects. She truly balances the administrative duties and the regulatory components demand with a keen sense of what my practitioners do and what their needs are on the ground. Terri is instrumental in working with my department, balancing patient care, cooperation, ability, and integrity to get the job done.

UCSD Medical Center
Chief Anesthesiologist

Terri is knowledgeable and effective in pharmacy leadership. She has the ability to be able to anticipate and prepare for the future. Her ability to utilize resources effectively in this changing environment is a strong asset. She can adapt, evolve, mentor and still never say “no” when asked to assist. She exhibits great abilities to be flexible and is a “self starter”. She has a pleasant yet effective demeanor that commands results.

Candace Fong, Pharm D
System Director of Pharmacy and Medication Safety Common Spirit Health

Terri has always impressed me as being very smart. resourceful, creative, and easy to work with. Terri’s commitment to medication safety permeated our organization, raising the awareness of this important issue throughout all levels of the institution. Terri has always been engaged, cooperative, and generous with her time.

Cary Mells, MD
Chairman of the Department of Emergency Medicine Tri-City Medical Center

Terri has done more for the Pharmacy in her few months as Interim Pharmacy Director than any other Director has done during my 12 years here.

Anita Kennedy, MBA
VP of Ancillary Services Methodist Hospital

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Address: 950 Boardwalk Suite 305, San Marcos, CA 92078

  • 760.705.4078
  • tvidals@rxpert.solutions