New York Hospital Assessed $15,000 Civil Penalty for Recordkeeping Violations of the Controlled Substances Act
A New York hospital recently agreed to pay a $15,000 civil penalty related to violations of the Controlled Substances Act. The violations were revealed during a March 2019 Drug Enforcement Administration (DEA) inspection of the hospital’s Narcotic Treatment Program (NTP). Diversion investigators noted multiple recordkeeping violations related to the hospital’s relocation of its NTP in October 2018. Investigators found that the facility had failed to conduct the required initial inventory of methadone at the new location and the NTP also omitted material information on multiple forms required by DEA. The omitted material information is used to order and track controlled substances. The quantity of packages ordered, date the containers were received, and the correct supplier are examples of the omitted information.
The lack of an initial inventory, combined with incomplete forms, made it difficult to determine whether diversion was occurring at the NTP. Diversion occurs when controlled substances are transferred from legitimate distribution channels to illegitimate distribution channels.
The hospital created a new position for a registered nurse to oversee controlled substance dispensing at the NTP and is implementing a policy to enhance its compliance with the CSA recordkeeping requirements.
Compliance Perspective
Failure to implement, enforce, and monitor a system of ordering and tracking of controlled substances may be considered a violation of the federal Controlled Substances Act (CSA) and provision of substandard quality of care, in violation of state and federal regulations.
Discussion Points:
- Review policies and procedures regarding obtaining, securing, dispensing, and monitoring of controlled substances.
- Train staff regarding the importance of obtaining and presenting to the pharmacy the required signed medication orders for controlled substances. Notably, the DEA has ruled that a chart order in a resident’s medical record is not considered a valid prescription.
- Periodically audit the changes in medication orders to determine if CSA requirements are being observed regarding prescriptions for Schedule II-V controlled substances.
