Document Assessment

After your application and supplemental documentation have been processed and fees are paid, you will receive a Document Assessment Checklist. The Document Assessment Checklist is a tool provided for self-reporting policies and procedures and other documentation demonstrating compliance with the standards. The Document Assessment Checklist and the referenced policies, procedures and other documentation should be submitted within 120 days of receiving the Assessment. The Assessment requests policies, procedures and other documentation pertaining to:

Licensing and Compliance
• Pharmacy, pharmacists, technicians
• Code of conduct and compliance program
Management Processes
• Organizational structure mission statement, delegated processes
• Development and control of policies and procedures
• Scope of specialty pharmacy services
• Delegated services
• Job descriptions, hiring and credentialing procedures, training and skills assessment, performance and competency assessment
• Documentation, collection, and evaluation of pharmacy workload
Structure for Fiscal Management
Product Procurement, Receipt, Storage, Preparation, and Distribution
• Inventory control, supply chain, environmental conditions management, hazardous materials, recalls, mail order, and delivery
Confidentiality of Patient Information
• Access, information destruction, provision of privacy practice, physical layout for patient privacy
Information Systems and Security
Access to Evidence-Based References and Clinical-Decision Support
Privacy of Patient Information and Data Including HIPAA and HITECH Compliance

Contingency Plan

Comprehensive Benefits Investigation, Prior Authorization, and Benefits Coordination
Hub Coordination and Data Reporting
Patient Safety and REMs Compliance with Manufacturer and Payer Requirements
Provision of Financial Information

Patient Enrollment Process and Materials
Communication with Prescribers, Pharmacists, and Health Care Providers for Coordinated Patient Care and Collaboration
Comprehensive Patient Profile

• Demographics, medication history, DUR processes
• REMs requirements and lab documentation
Patient Consultation and Education
• Patient assessment
• DUR processes
• Education requirements and accommodations
• Communication and resources
Patient Pharmacy Case Management Services and Process
• Patient medication review, medication list
• Patient care plan and ongoing monitoring
• Pharmacist interventions
• Documentation
• Coordination with health care providers
Requirements for Patient Case Management Protocols (where provided)
• Alpha-1 antitrypsin deficiency
• Behavioral health
• Bleeding disorders
• Bone marrow transplantation
• Fertility and high-risk pregnancy
• Growth disorders
• Hematology
• Hereditary angioedema (HAE)
• Hypercholesterolemia
• Immune globulin therapy (IV or subcutaneous)
• Inflammatory conditions (includes rheumatology, dermatology, gastroenterology)
• Infusible oncology/hematology
• Osteoporosis
• Multiple sclerosis
• Oral oncology/hematology
• Pulmonary disorders (cystic fibrosis, pulmonary arterial hypertension)
• Renal failure
• Restricted distribution or orphan pharmaceutical-specific support programs
• Solid organ transplantation
Patient customization
Process for Delays in Therapy
Refill Protocol
Staff Competency and Professional Development

Collection and evaluation of quality related metrics including
• Adherence
• Persistence
• Pharmacist interventions and cost avoidance
• Call center performance
• Patient and healthcare provider satisfaction, and complaint handling
• Error rates and types of errors
• Outcomes based on quality improvement projects 
• Quality improvement training
• Data reporting accuracy