A quality health service, as defined by the World Health Organization, ‘is one which organizes resources in the most effective way to meet the health needs of those most in need, for prevention and care, safely, without waste and within higher level requirements’. As health care standards improve globally, providing an optimal service that meets international standards and public expectations requires effective quality management. The process of quality improvement aims at defining, measuring and setting quality standards, and overcoming the associated challenges that include rising costs and skills shortages. The objective of this publication is to provide a framework for quality management systems (QMSs) to be implemented, managed and sustained holistically in nuclear medicine departments. It builds upon the IAEA’s QUANUM program, which has successfully been implemented in more than 80 countries worldwide.

• 1. INTRODUCTION
  • 1.1. Background
  • 1.2. Objective
  • 1.3. Scope
  • 1.4. Structure
  • 1.5. Clinical governance
• 2. RISK MANAGEMENT
  • 2.1. Education, training and continuing professional development
  • 2.2. Evidence based care and effectiveness
  • 2.3. Experience and involvement of patients, referrers and carers
  • 2.4. Staffing and staff management
  • 2.5. Indicators
  • 2.6. Internal reviews
  • 2.7. Audits
    • 2.7.1. Internal audits
    • 2.7.2. External audits
    • 2.7.3. The audit cycle
• 3. CULTURE OF QUALITY
  • 3.1. Fostering a culture of quality
  • 3.2. Engaging staff in implementing a quality programme in a culture of quality
  • 3.3. Leadership and responsibility for quality
  • 3.4. Quality committee
  • 3.5. Tasks in quality management for the quality committee
  • 3.6. Supporting senior management
• 4. MANAGEMENT AND STRUCTURE OF A QUALITY MANAGEMENT SYSTEM
  • 4.1. Quality manual
  • 4.2. Mission and vision
    • 4.2.1. Sample mission declaration
    • 4.2.2. Sample vision declaration
  • 4.3. Process identification and process map
  • 4.4. Short and long term strategic planning
  • 4.5. Documentation system and document control
    • 4.5.1. Developing the documentation system
    • 4.5.2. Implementation of the documentation system
    • 4.5.3. Issue and distribution of documents
    • 4.5.4. Control change of document
    • 4.5.5. Cancellation of a document
    • 4.5.6. Common problems
• 5. LICENSING AND COMPLIANCE
  • 5.1. Licensing
    • 5.1.1. Licence for the construction of radiological facilities
    • 5.1.2. Health authorizations
    • 5.1.3. Licences for radiopharmaceutical production
  • 5.2. Authorization for the use of radioactive materials and radiation protection
  • 5.3. Waste management
• 6. HUMAN RESOURCES MANAGEMENT
  • 6.1. Professional responsibility and authority
  • 6.2. Organizational chart
  • 6.3. Job description
  • 6.4. Personnel evaluation
  • 6.5. Personnel development
  • 6.6. Nms quality manager
• 7. RISK ASSESSMENT
  • 7.1. Retrospective (or reactive) risk analysis methods
  • 7.2. Prospective risk analysis methods
  • 7.3. Failure modes and effects analysis
  • 7.4. Fault tree analysis
  • 7.5. Incidents
    • 7.5.1. Incident prevention
    • 7.5.2. Incident management
    • 7.5.3. Incident reporting
• 8. STANDARD OPERATING PROCEDURES
  • 8.1. How to write a standard operating procedure
    • 8.1.1. Background, scope and purpose
    • 8.1.2. Responsibilities
    • 8.1.3. Procedure/steps
    • 8.1.4. Review and version control of SOPs
    • 8.1.5. References, associated documents and annexes
  • 8.2. Sops for clinical activity
  • 8.3. Procedural sops
  • 8.4. Sop for radionuclide therapy
  • 8.5. Sop for identification of patients
    • 8.5.1. Responsibility of staff for patient identification
    • 8.5.2. Approved patient identifiers
    • 8.5.3. Timing of patient identification
  • 8.6. Sop for traceability
  • 8.7. Formalization of coordination and interactions: ‘contracts’
  • 8.8. Sops for staff radiation protection and safety
  • 8.9. Sops for radiation protection of patients
  • 8.10. Sops for radiopharmacy
    • 8.10.1. Competences and training
    • 8.10.2. SOP(s) for purchase of products
    • 8.10.3. SOP for checking all materials delivered
    • 8.10.4. SOPs for storage of products
    • 8.10.5. Process SOPs
    • 8.10.6. Specific SOPs for particularly relevant cases
    • 8.10.7. Batch record
    • 8.10.8. SOP for routine microbiological monitoring
    • 8.10.9. SOP for QC of all radiopharmaceutical products
    • 8.10.10. SOP for terminal sterilization
    • 8.10.11. SOP for proper packaging and labelling
    • 8.10.12. Documentation and record of changes
    • 8.10.13. Traceability from single preparation dose back to prescription
    • 8.10.14. SOP for out of specification and recall of products — complaints
    • 8.10.15. Maintenance and QA/QC of radiopharmacy equipment
    • 8.10.16. SOPs for QA/QC of all radiopharmacy equipment
    • 8.10.17. Specific SOP for waste management
• 9. DETECTION AND MANAGEMENT OF NON-CONFORMANCES
  • 9.1. Management of non-conformance
  • 9.2. Categorization of non-conformance
    • 9.2.1. Example 1: Lack of uniformity
    • 9.2.2. Example 2: Dose activity mismatch
    • 9.2.3. Example 3: Modified scanner set-up
  • 9.3. Corrective and preventive actions
    • 9.3.1. Root cause analysis
    • 9.3.2. Examples of root cause analysis
• 10. MANAGEMENT OF EQUIPMENT AND OTHER MEDICAL DEVICES
  • 10.1. Generalities
  • 10.2. Equipment inventory
  • 10.3. Management of the equipment life cycle
  • 10.4. Maintenance and its evaluation
  • 10.5. The cycle of qa/qc
    • 10.5.1. Acceptance tests and commissioning
  • 10.6. Roles and responsibilities in equipment management
  • 10.7. End of service life and equipment disposal
  • 10.8. Provision and management of resources
    • 10.8.1. Purchase of equipment, products and services
    • 10.8.2. Selection, ordering and control of acquired radiopharmaceuticals, kits
• 11. MEASUREMENT, ASSESSMENT AND IMPROVEMENT IN QMS
  • 11.1. Definition of indicators and recording methods
  • 11.2. Sample parameter and indicator vaules
    • 11.2.1. Indicator Code: CLS-1 — Key area or process: Clinical activities
    • 11.2.2. Indicator Code: CLS-2 — Key area or process: Clinical activities
    • 11.2.3. Indicator Code: RPr-1 — Key area or process: Radiation protection
    • 11.2.4. Indicator Code: RP-01 — Key area or process: Radiopharmacy
    • 11.2.5. Indicator Code: RP-02 — Key area or process: Radiopharmacy
    • 11.2.6. Indicator Code: RP-03 — Key area or process: Radiopharmacy
    • 11.2.7. Indicator Code: IEq-1 — Key area or process: Nuclear medicine equipment
  • 11.3. Customer satisfaction
  • 11.4. Performing managerial review
• REFERENCES
• Annex I SAMPLE TABLE OF CONTENTS FOR A QUALITY MANUAL
• Annex II SAMPLE SOP FORM FOR DIAGNOSTIC PROCEDURES
• ANNEX III SAMPLE SOP FORM FOR THERAPY PROCEDURES
• ANNEX IV SAMPLE CLINICAL SOPS FOR DIAGNOSTICS WITH SINGLE PHOTON EMITTERS
• Annex V SAMPLE CLINICAL SOP FOR PET/CT
• Annex VI SAMPLE CLINICAL SOP FOR THERAPY
• Contributors to Drafting and Review