Healthcare Compliance Services

Healthcare Compliance Services

In today’s highly regulated healthcare landscape, maintaining compliance is not just a requirement—it is essential for operational success, patient safety, and financial stability. Healthcare providers face continuous scrutiny from regulatory agencies, accreditation bodies, and insurers, making it critical to proactively manage compliance risks. By contracting with an experienced healthcare compliance consulting firm like ProPharma, providers gain access to specialized expertise, strategic guidance, and tailored solutions that safeguard their organization from costly penalties and reputational harm.

Proactive Risk Mitigation & Regulatory Readiness: Regulatory requirements are complex and constantly evolving. Partnering with a compliance consulting firm ensures that healthcare providers stay ahead of changes, reducing the risk of violations. From Joint Commission survey readiness to pharmacy auditing and facility inspections, a dedicated consulting partner helps identify potential compliance gaps before they escalate into critical issues.
Operational Efficiency & Cost Savings: Non-compliance can result in severe financial penalties, loss of accreditation, and increased operational costs due to inefficiencies or corrective actions. A compliance consulting firm streamlines compliance processes, improves documentation accuracy, and optimizes workflows to enhance overall efficiency while minimizing unnecessary expenditures.
Improved Patient Safety & Quality of Care: Compliance is intrinsically linked to patient care quality and safety. A consulting firm helps healthcare providers uphold best practices in medication management, infection control, credentialing, and provider site standards—ensuring patients receive safe and effective care while reducing liability risks.
Seamless Survey Preparation & Audit Support: Regulatory surveys and audits can be stressful and resource-intensive. A compliance consulting firm provides comprehensive Joint Commission survey support, pharmacy audits, and facility inspections to ensure organizations are fully prepared. By conducting mock surveys, readiness assessments, and corrective action planning, consulting firms help healthcare providers navigate regulatory evaluations with ease.

Partnering with a healthcare compliance consulting firm is an investment in long-term success, integrity, and sustainability of a healthcare organization. ProPharma’s expertise in Joint Commission survey support, pharmacy auditing, and facility and provider site audits ensure that healthcare providers remain compliant, efficient, and focused on delivering high-quality patient care.

Joint Commission Survey Support Services

Ensuring continuous compliance with Joint Commission standards is critical for healthcare organizations.

Pre-Survey Readiness Assessment

• Identify gaps in compliance with Joint Commission standards, including Environment of Care (EOC), Life Safety, Medication Management, and Infection Control.
• Provide a risk-based analysis of potential non-compliance areas.
• Develop a corrective action plan with specific timelines and responsibilities.

Documentation and Policy Review

• Audit and review policies, procedures, and protocols for alignment with Joint Commission standards.
• Ensure all required documentation, logs, and records (e.g., credentialing, patient safety, infection control) are up to date.
• Assist in policy development where gaps are identified.
• Provide guidance on document control and retention best practices.

Mock Accreditation & Survey Readiness

• Conduct mock surveys to prepare for Joint Commission, AAAHC, or other accreditation inspections.
• Provide survey readiness training for staff and leadership.
• Assist in developing survey response strategies and documentation preparation.
• Identify common deficiencies and mitigation strategies before formal inspections.

Post-Survey Corrective Action & Response

• Develop and implement corrective action plans for survey findings.
• Assist with Joint Commission Evidence of Standards Compliance (ESC) and Plan of Correction (POC) responses
• Conduct follow-up audits to verify corrective actions are effective.
• Provide ongoing monitoring support to maintain compliance year-round.

Continuous Compliance Monitoring & Support

• We offer annual or quarterly compliance check-ins to maintain readiness.
• Develop a Joint Commission compliance calendar for ongoing assessments.
• Provide access to regulatory updates and best practices.
• Support performance improvement initiatives and compliance benchmarking.

503A USP <797> Pharmacy Auditing & Compliance

Ensuring compliance with USP <797> and state and federal regulations is essential for 503A compounding pharmacies. ProPharma offers specialized contract-based auditing services to help pharmacies meet and maintain compliance, mitigate regulatory risks, and enhance patient safety.

USP <797> Gap Assessment & Compliance Audits

• Conduct in-depth audits to assess compliance with USP <797> standards.
• Identify deficiencies in aseptic techniques, facilities, training, and documentation.
• Provide a detailed gap analysis report with corrective action recommendations.
• Assess compliance with state Board of Pharmacy regulations and FDA oversight. Develop comprehensive CAPA plans to address compliance deficiencies.
• Provide post-audit follow-ups to ensure effective remediation.

Environmental Monitoring & Cleanroom Compliance Review

• Evaluate cleanroom design, airflow classification (ISO 5, 7, 8), and engineering controls.
• Review HEPA filter integrity, differential pressure, air exchanges, and segregated compounding areas.
• Assess environmental monitoring programs, including viable/non-viable particle counts and surface/air sampling.

Personnel Training & Competency Assessment

• Provide hands-on training in aseptic technique, gowning, and garbing.
• Conduct gloved fingertip sampling and media-fill testing to assess competency.
• Review documentation and retraining protocols to maintain compliance.
• Offer corrective training plans for personnel who fail competency tests.

Sterile Compounding Process Audits

• Audit compounding workflows and aseptic manipulations.
• Ensure proper beyond-use dating (BUD) and sterility testing compliance.
• Review batch documentation, formulation records, and sterility assurance levels.
• Verify proper storage, labeling, and transport conditions for compounded sterile preparations (CSPs).

State & FDA Compliance Readiness

• Evaluate state Board of Pharmacy compliance for sterile compounding regulations.
• Provide support for FDA 483 responses and warning letter remediation.
• Conduct mock FDA inspections and regulatory preparedness assessments.

Facility & Provider Site Visits/Audits

Ensuring compliance with federal, state, and accreditation standards is essential for healthcare facilities and providers. ProPharma offers specialized contract-based auditing services to help organizations maintain compliance, enhance patient safety, and improve operational efficiency.

Regulatory Compliance Audits

• Conduct comprehensive audits to assess compliance with federal (CMS, OSHA, HIPAA) and state regulations.
• Assess compliance with licensure and accreditation requirements (e.g., Joint Commission, AAAHC, DNV, CARF).
• Review adherence to Medicare and Medicaid Conditions of Participation (CoPs).
• Identify gaps and risks related to clinical operations, patient safety, and documentation.

Provider Site Visit Evaluations

• Conduct on-site and virtual provider assessments to verify compliance with payer requirements.
• Ensure provider sites meet credentialing and re-credentialing requirements for health plans and networks.
• Evaluate the physical environment, equipment, staffing levels, and infection control measures.
• Assess compliance with state health department regulations for provider practices.

Clinical Quality & Patient Safety Audits

• Evaluate adherence to patient safety protocols and quality assurance programs.
• Assess compliance with infection prevention and control standards.
• Review adverse event reporting processes and root cause analysis (RCA) procedures.
• Verify compliance with medication management and controlled substance handling.

Corrective Action Plans & Follow-Up Audits

• Develop and implement corrective action plans (CAPAs) for identified deficiencies.
• Conduct re-audits to verify corrective actions have been implemented.
• Provide ongoing compliance monitoring to ensure continued adherence to standards.