Compliance
Reduce Risks and Liabilities with Pharmacy Regulatory Compliance Solutions
Identify risks ahead of time and implement mitigation strategies to keep your organization survey-ready and compliant with healthcare regulations.
Does Your Organization Have Problems With:
Complex and ever-changing regulations
Unauthorized or illegal distribution, transfer, or use of controlled substances
Maintaining accreditation standards
Don't let these issues affect your organization. Atomic Healthcare Solutions is here to help you identify regulatory gaps, develop solutions, and empower you to achieve growth & compliance.
Simple Solutions. Atomic Results.™
Comprehensive Strategies for Your Business
The diversion of controlled substances (CS) poses significant risks to patient safety, individuals involved in diversion, and organizational liability. To address these risks, healthcare entities must establish comprehensive measures that comply with federal and state laws and proactively prevent, detect, investigate, and report CS diversion incidents. This includes implementing strict inventory controls, conducting thorough monitoring and audits, providing comprehensive staff training, and having clear procedures for investigating and reporting suspected diversion activities. With the help of Atomic Healthcare Solutions, you can prioritize proactive diversion prevention and detection strategies to mitigate risks, safeguard patient safety, protect your workforce, and uphold integrity in medication management practices.
Streamline the accreditation process and ensure your organization meets all necessary standards for quality and safety. We support you in obtaining and maintaining licensure and certification from various regulatory bodies including the Centers for Medicare and Medicaid Services (CMS), ensuring compliance with state regulations governing healthcare facility licensing, staffing, infection control, patient safety, and quality of care.
In preparing for The Joint Commission (TJC) accreditation, we can also help you conduct mock surveys, gap analyses, and readiness assessments to identify areas needing improvement and develop action plans for achieving compliance.
Atomic Healthcare Solutions also guides healthcare facilities in complying with Resource Conservation and Recovery Act (RCRA) regulations governing the management of hazardous waste generated within their operations. This includes identifying, segregating, labeling, and properly disposing of hazardous pharmaceuticals, chemicals, and other waste materials in accordance with RCRA guidelines.
Ensure your sterile compounding practices adhere to the latest regulations and best practices, including the USP 797 and USP 800 established by the United States Pharmacopeia to establish the safety and quality of sterile compounded medications and ensure the safe handling of hazardous drugs to minimize risks of contamination and exposure. Our sterile compounding services involve a thorough assessment of your current practices to keep your pharmacy in regulatory compliance. We also conduct prevention/mock audits to identify potential deviations from regulatory standards or best practices before they occur. Our remediation strategies involve thorough root cause analysis, identifying the underlying factors contributing to the issue, and implementing corrective actions and systematic plans to address identified instances of non-compliance, such as deviations in aseptic technique or environmental monitoring.
As part of our commitment to help you maintain state-of-the-art compounding facilities, Atomic Healthcare Solutions also employs expert construction project management and assessments to ensure the integrity and compliance of your physical infrastructure. From initial design and construction to ongoing maintenance and assessments, we ensure you adhere to rigorous standards and regulations governing sterile compounding environments.
Service Offerings
Identify vulnerabilities and improve practices to prevent, identify, investigate, and escalate potential controlled substance diversion.
Ensure your controlled substance diversion program meets auditing and investigation best practices.
Identify gaps, develop remediation plans, and optimize construction, quality assurance, and compliance for sterile compounding under USP 797 standards.
Identify gaps, develop remediation plans, assess and manage risks, and conduct employee surveillance and safety programs.
Evaluate your pharmaceutical waste management program for compliance and identify areas for improvement.
Identify gaps and optimize quality assurance programs for non-sterile compounding under USP 795 standards.
Prepare your pharmacy for successful Joint Commission and DNV surveys.
Assess, plan, and implement strategies to comply with Institute for Safe Medication Practices (ISMP) best practices.
Prepare your pharmacy for a successful CMS Medication Management survey.
Evaluate your current MERP and ensure it's survey-ready and effective in minimizing medication errors.
Prepare your pharmacy for a successful GACH survey with a focus on medication management, antimicrobial stewardship, and leadership.
Navigate the complexities of permit renewal with our guidance and support for regulatory compliance.
Navigate the complexities of obtaining and maintaining pharmacy permits and licenses.
Develop plans to address non-compliance identified by regulatory bodies.
Equip new pharmacy leaders with the knowledge and skills to navigate regulatory requirements and ensure survey preparedness.