Are Your Medications Secure?
on 8/20/2019 10:00:00 AM
You're preparing for survey and the question arises; Are the medications in your care area "secure"? Understanding what it means for a medication to be considered secured is the first step in the process. Absent State regulations to the contrary, CMS has clearly defined the issue. Most accrediting agencies adhere to the CMS definition.
CMS requires that all drugs and biologicals must be kept in a secure area and locked when appropriate. Per CMS, a secure area means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. For example, if medications are kept in a private office or other area where patients and visitors are not allowed without the supervision or presence of a health care professional (for example, ambulatory infusion), they are considered secure. Areas restricted to authorized personnel only would generally be considered secure areas.
If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, a hospital is expected to evaluate its current medication control policies and procedures and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained.
There are certain areas in a hospital that are considered inherently secure: Generally labor and delivery suites and critical care units are staffed and actively providing patient care around the clock, and, therefore, considered secure. However, hospital policies and procedures are expected to ensure that these areas are secure, with entry and exit limited to appropriate staff, patients and visitors.
The operating room suite is considered secure when the suite is staffed and staff are actively providing patient care. When the suite is not in use (e.g., weekends, holidays and after hours), it would not be considered secure. A hospital may choose to lock the entire suite, lock non-mobile carts containing drugs and biologicals, place mobile carts in a locked room, or otherwise lock drugs and biologicals in a secure area. If an individual operating room is not in use, the hospital is expected to lock non-mobile carts and ensure mobile carts are in a locked room.
Due to their mobility, mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing drugs or biologicals (hereafter, all referred to as "carts") must be locked in a secure area when not in use. Hospital policies and procedures are expected to address the security and monitoring of carts, locked or unlocked, containing drugs and biologicals in all patient care areas to ensure their safe storage and to ensure patient safety.
Medication automated distribution units with security features, such as logon and password or biometric identification, are considered to be locked since they can only be accessed by authorized personnel who are permitted access to the medications. Such units must be stored in a secure area.
All Schedule II, III, IV and V drugs must be kept locked within a secure area. A secure area means the drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Automated medication distribution units with logon and password/biometric identification are considered to be locked since they can only be accessed by authorized personnel who are permitted access to Schedule II - V medications. Mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing Schedule II, III, IV and V drugs must be locked within a secure area.
Armed with a clear understanding of what "secure" means, the next step is to assess your care area. Pay attention to access into medication storage areas, location of crash carts, location of treatment carts that contain medications, and medication preparation areas.
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About the Author
Richard Curtis RN, MS, HACP
RN, MS, HACP
Richard (Rick) Curtis is the Chief Executive Officer for CIHQ. Rick is nationally recognized as an expert on the Medicare Conditions of Participation and the CMS Certification & Survey Process. As CEO, he successfully guided CIHQ in becoming the nation's 4th CMS approved deeming authority for acute care hospitals.
Rick's clinical background is in critical care nursing with a focus in cardiovascular and trauma service lines. He has held both clinical and executive management level positions in Quality, Risk, Education, Infection Control, and Regulatory Compliance.
Rick is a regular speaker at numerous state and national conferences on the federal regulations and accreditation standards, and is host of CIHQ's popular monthly webinars addressing key compliance challenges in today's environment.
Rick is nationally certified in healthcare accreditation, and serves as Chair of the Board of Examiners for the Healthcare Accreditation Certification Program (HACP). Rick has a degree in Nursing with a Master's Degree in Health Services Administration.