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 Duration 21 hours

Course Outline

Overview of Quality Assurance Auditing Within the Healthcare Sector

  • Definition and operational significance of quality assurance auditing
  • Categories of audits (internal, external, regulatory compliance, procedural)
  • Duties and scope of quality assurance auditors

Healthcare Quality Standards and Patient Safety

  • Foundational concepts in healthcare quality and patient safety
  • Governance requirements in the healthcare sector (e.g., JCAHO, CMS)
  • Primary quality criteria and frameworks (ISO 9001, Six Sigma, Lean)

Quality Management Systems (QMS)

  • Essential components of a QMS in the healthcare sector
  • Strategies for designing and deploying QMS
  • Processes for continuous operational improvement

Executive Leadership and Strategic Governance

  • Leadership principles within quality management structures
  • Strategic planning and organizational alignment
  • Change management protocols in healthcare settings

Audit Scheduling and Preparation

  • Planning a comprehensive audit program
  • Developing audit protocols and verification checklists
  • Resource distribution and timeline management

Execution of Audit Procedures

  • Data acquisition methods (interviews, site observations, record reviews)
  • Audit instrumentation and methodologies (flowcharts, data sheets, cause-and-effect diagrams)
  • Documentation and categorization of audit outcomes

Data Assessment and Interpretation

  • Statistical instruments for analytical assessment
  • Identification of underlying causes
  • Corrective and preventive action protocols (CAPA)

Reporting on Audit Outcomes

  • Drafting effective audit reports
  • Communicating results to relevant stakeholders
  • Monitoring and resolution of identified audit issues

Regulatory Adherence in Healthcare

  • Core statutes and standards (HIPAA, FDA, OSHA)
  • Techniques for compliance auditing
  • Management of non-compliance events

Ethical Considerations in Quality Auditing

  • Ethical standards and professional integrity
  • Conflicts of interest and data confidentiality
  • Ethical judgment in audit contexts

Preparation for Certification Examinations

  • Analysis of the CMQ/OE and ASQ examination structures
  • Recommendations and methods for effective study
  • Simulation questions and practice examinations

Conclusions and Recommended Actions

Requirements

  • Foundational knowledge of quality management principles and practices
  • Acquaintance with healthcare regulations and standards

Target Audience

  • Quality managers
  • Healthcare administrators
  • Professional auditors

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