At Bluesight’s recent Diversion Symposium, former DEA Agent Susannah Herkert from Guidepost Solutions discussed the 10 areas she often sees her clients overlook when it comes to DEA compliance. Combining tools like ControlCheck with a comprehensive DEA binder and physical monitoring surveillance provides a complete program for preventing diversion. Below are the 10 highlighted areas Susannah recommends health systems focus on.
Understanding the Importance of Corresponding Responsibility
Corresponding responsibility is a critical aspect of DEA compliance often overlooked by healthcare facilities. This principle mandates that both the prescribing physician and the dispensing pharmacist share an equal obligation to ensure prescriptions for controlled substances are issued and filled for legitimate medical purposes. It’s not enough for a pharmacist to simply verify a DEA number; they must also critically assess the legitimacy of the prescription.
To effectively manage this responsibility, pharmacists should document every step taken to verify the prescription, including consulting Prescription Drug Monitoring Programs (PDMPs) and noting any red flags or anomalies. This proactive approach not only safeguards against diversion but also ensures compliance with DEA regulations, ultimately enhancing patient safety and trust in the healthcare system.
Ensuring Proper Access to Controlled Substances
Controlling access to controlled substances is another area where healthcare facilities frequently fall short. It’s essential to maintain an up-to-date list of individuals who have authorized access to these substances and ensure that this access is restricted to those who genuinely need it for their roles. Regular audits should be conducted to verify that only authorized personnel have access and that this access is appropriately documented and monitored.
Effective access control measures include implementing secure storage solutions, such as locked cabinets or automated dispensing machines (ADMs), and ensuring that these systems are regularly maintained and audited. Additionally, facilities should have protocols in place to immediately revoke access for any employee who leaves the organization or is found to be in violation of controlled substance policies, ensuring a robust and compliant system.
Managing the Registered Address for DEA Compliance
One of the more administrative but equally vital aspects of DEA compliance is ensuring that the registered address of each facility is accurate and appropriately listed. Each principal place of business where controlled substances are handled must have its own DEA registration. This means that any off-site locations, even those just across the street, must be separately registered if they store or dispense controlled substances.
Facilities must be diligent in maintaining accurate records of these registrations and ensuring that any changes in address or additional locations are promptly updated with the DEA. This not only helps in maintaining compliance but also facilitates smoother inspections and audits by the DEA, reducing the risk of hefty fines and penalties.
Maintaining Complete and Accurate Records
Complete and accurate record-keeping is the backbone of DEA compliance. Healthcare facilities must ensure that all records of controlled substances, from acquisition to dispensation, are meticulously maintained and readily retrievable. This includes keeping detailed logs of purchases, transfers, administrations, and disposals, and ensuring that all documentation is accurate and up-to-date.
Facilities should conduct regular internal audits to verify the accuracy of their records and ensure that any discrepancies are promptly addressed. By maintaining a culture of meticulous record-keeping, healthcare facilities can significantly reduce the risk of diversion and ensure they are always prepared for DEA inspections.
Fostering a Culture of Compliance
Creating a culture of compliance is essential for maintaining DEA standards. This involves fostering an environment where every staff member understands the importance of compliance and their role in maintaining it. Regular training sessions, clear communication, and a supportive leadership team can help instill this culture across the organization.
Healthcare facilities should establish dedicated compliance committees and encourage open dialogue about compliance issues. By making DEA compliance a shared responsibility and integrating it into the daily operations of the facility, organizations can ensure a higher level of adherence and create a safer environment for both patients and staff.
Implementing Effective Controls and Procedures
Effective controls and procedures are vital to safeguarding against diversion and theft of controlled substances. This includes implementing robust security measures like surveillance cameras, secure storage, and access controls. Additionally, facilities should use anti-diversion software to monitor and identify any suspicious activities or patterns that may indicate diversion.
Regular audits and inspections should be part of the routine to ensure that all controls are functioning as intended. When potential issues are identified, facilities must act swiftly to address them, whether through additional training, policy changes, or enhanced security measures. By maintaining a proactive approach to controls and procedures, healthcare facilities can significantly mitigate risks and ensure ongoing compliance with DEA regulations.
Training and Education
Ongoing training and education are crucial in maintaining DEA compliance. All staff members, from leadership to frontline workers, should receive comprehensive training on the importance of compliance, the specifics of DEA regulations, and their individual roles in maintaining these standards. This training should be updated regularly to reflect any changes in regulations or internal policies.
By investing in robust training programs, healthcare facilities can empower their staff to recognize and address compliance issues proactively. This not only helps in maintaining compliance but also fosters a culture of accountability and continuous improvement.
Regular Audits and Inspections
Conducting regular audits and inspections is essential for identifying and addressing compliance issues before they escalate. These audits should cover all aspects of controlled substance management, from record-keeping and storage to administration and disposal. By systematically reviewing these areas, facilities can ensure that they are consistently meeting DEA standards.
Audits should be both scheduled and random to provide a comprehensive view of the facility’s compliance status. Any findings from these audits should be promptly addressed, with corrective actions documented and implemented to prevent recurrence.
Addressing Diversion Incidents
When diversion incidents occur, it’s crucial for healthcare facilities to respond promptly and effectively. This involves conducting thorough investigations to determine the cause of the diversion, taking appropriate disciplinary actions, and implementing measures to prevent future incidents. Facilities should also report these incidents to the DEA as required, demonstrating their commitment to compliance and transparency.
By handling diversion incidents with diligence and transparency, healthcare facilities can maintain trust with regulatory bodies and the public, while also continually improving their internal controls and procedures.
Staying Informed and Adaptive
The landscape of DEA compliance is continually evolving, with new regulations and best practices emerging regularly. Healthcare facilities must stay informed about these changes and be ready to adapt their policies and procedures accordingly. This involves regularly reviewing DEA updates, participating in industry forums, and seeking advice from compliance experts when needed.
By staying informed and adaptive, healthcare facilities can ensure that they remain ahead of compliance challenges and continue to provide safe, high-quality care to their patients.
You can watch the recording of Susannah’s session here.