This document discusses health care provider accreditation and compliance. It outlines the accreditation lifecycle which includes quality standards, compliance management, the accreditation process, and post-accreditation activities. It also identifies major compliance areas such as patient care, facility management, and information systems. Current issues with compliance include the difficulty tracking procedures, inefficient auditing, and tracking necessary actions. The accreditation process management allows planning and monitoring activities. Post-accreditation activities include surveillance preparation, complaint management, and tracking adverse decisions.
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Xybion Healthcare Regulatory Compliance
1. Health Care Provider Accreditation
Quality &
Standards
Compliance
Management
System
Accreditation
Process
Management
Post-
Accreditation
Response
Activities
Accreditation and Compliance Lifecycle
Major Compliance Areas
Current issues
• Requirements are Procedure – Dependent. Difficulty in tracking compliance and training
associated with the implementation of those procedures
• Inefficient planning, conducting and tracking of audit results associated with the
requirements and accreditation process.
• Tracking actions necessary to comply with standards
2. Health Care Provider Accreditation
Quality &
Standards
Compliance
Management
System
Major Compliance Areas
Standards
Continuity of Care
Patient Care/Education
Care of Patients
Management of Medication
Continuous Quality Improvement
Responsibility of Management
Facility Management & Safety
Human Resource Management
Information Management Systems
Policies &
Procedures –
Document Control
Framework
Training
Competency &
Certification
Framework
Compliance
Audits
HAI Workflow
Outbreak WF
CAPA Workflow
Flexible
Business
Process
Engine
Document
Management
3. Health Care Provider Accreditation
Accreditation
Process
Management
Major Compliance Areas
1. Management of Process –
Organization can plan and monitor accreditation
activities and status; Useful for Accreditation bodies.
2. Management of Follow-up Activities-
Plan, assign and track follow-up activities to prepare,
participate and respond to accreditation activities
3. Management of Corrective Actions
Track mitigation actions
4. Health Care Provider Accreditation
Post-
Accreditation
Response
Activities
Major Compliance Areas
1. Surveillance Preparation Management –
1. Organization will have “readiness” process to respond to
surveillance events – protect from surprise findings
2. Complaint Management
– External and internal complaints managed and mitigated
so accreditation affects are minimized
3. Adverse Decision Management
– Track decisions, communications and follow-up activities