Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy : : The JACIE Guide.
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and...
Saved in:
| : | |
|---|---|
| TeilnehmendeR: | |
| Place / Publishing House: | Cham : : Springer International Publishing AG,, 2021. ©2021. |
| Year of Publication: | 2021 |
| Language: | English |
| Physical Description: | 1 online resource (189 pages) |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Table of Contents:
- Intro
- Introduction
- Contents
- Contributors
- Chapter 1: Quality and Standards for Haematopoietic Stem Cells Transplantation Programs
- Quality
- Standards
- Impact
- Conclusion
- References
- Chapter 2: Development of Organizational Quality Management System
- References
- Chapter 3: Document Development, Implementation, Review, Archive, and Disposal
- General
- Start
- Workflow
- Responsibilities
- Duplication of Requirements Between Different Quality Systems
- ICT Systems and Paper Documents
- Education and Document Management
- JACIE on Document Management
- Chapter 4: Audits
- General Concepts
- Definition and Purpose
- Scope
- Types of Audits
- Auditor Requirements
- How to Perform Internal Audit: The Steps of an Internal Audit
- Audit Calendar
- Audit Plan
- Conducting the Audit
- Closing
- Audit Report
- Actions
- Communication of the Result of Internal Audits
- References
- Chapter 5: Qualification and Validation
- Glossary
- Validation Process (Fig. 5.2)
- Example of Documents and Registration Forms for Validation
- Validation Master Plan (VMP)
- Validation Study
- References
- Chapter 6: Outcome Analysis
- What Is Outcome Analysis?
- Standards
- Collecting Data
- Establishing Outcome Analysis for Novel Applications
- Reviewing Data
- References
- Further Reading
- Chapter 7: Personnel Requirements Including Job Descriptions
- Introductıon
- Organisational Structure and Organisational Chart
- Key Personnel
- Personnel Competency
- Responsibility and Task Awareness
- Use of Effective Communication
- Job Descriptions
- Personnel File
- Conclusion
- References
- Chapter 8: Third-Party Agreements
- Gentlemen's Agreement
- Memoranda of Understanding (MoU) [1]
- Contract/Commercial Agreement (Fig. 8.2)
- Service-Level Agreements (SLAs)
- Technical Agreement.
- Third-Party Agreement
- Quick Checklist [2]
- Communication Is Critical [3] (Fig. 8.4)
- References
- Chapter 9: Performance Measurement
- Definitions for Healthcare Performance Measurement
- Measure Development Life Cycle
- Measure Development Process
- Bringing It All Together
- Performance Score
- Goals for Measure Development in SCT Program
- SCT Program Performance Measure
- Performance Measurement and KPI
- The Value of Dashboards for Metrics or KPI
- Dashboard Basics for Quality (Table 9.4)
- Challenges HCT Programs Can Embrace
- Examples of Quality KPI for Clinical SCT Program (Table 9.5)
- KPI Administrative Focus Areas
- Conclusion
- References
- Chapter 10: Tracking and Traceability
- Introduction
- Information Environment
- Donation Identification
- Combining Donation and Product Information
- References
- Chapter 11: Adverse Events and Corrective and Preventive Actions
- Definitions of What to Report
- Investigation, Analysis
- Corrective, Preventive Action
- Biological Product Deviations (BPD)
- References
- Chapter 12: Process Indicators
- Introduction, Definitions, and Example
- Process Definitions
- Process Controls
- Process Indicators
- Selection, Definition, and Range
- Persons Responsible for the Measure and Timing
- Indicator's Table
- Actions
- Other Indicators
- Indicators Within Time
- Communication
- References
- Chapter 13: Writing a Quality Management Plan
- Introduction
- QMP Structure
- HCT Programme Description
- Organizational Structure - Roles and Responsibilities
- Key Personnel - Qualifications, Training, and Competency
- Document Control
- Key Performance Data and Outcome Analysis
- Audits
- The Management of Products with Positive Microbial Culture Results
- The Management of Occurrences
- Traceability
- Business Continuity Policy.
- Qualification and Validation
- General Principles
- Quality Risk Management
- Obtaining Feedback
- Tools for Continuous Quality Improvement
- Other Aspects
- References
- Chapter 14: The Accreditation Process
- Why Seek Accreditation?
- Where to Start?
- Phases of the Accreditation Process
- Pre-inspection Phase
- Application Form
- Self-Assessment Standards Checklist
- Pre-inspection Documentation
- Inspection Phase
- Post-inspection Phase
- Plan the Post-accreditation Period
- Key Agents
- References
- Chapter 15: Data Management
- Data Management
- Conclusion
- References
- Chapter 16: Maintaining the Quality Management Program
- General
- The Setup of the Quality Manual
- Work Area
- Material and Supplies
- Hygiene
- Education
- Documentation
- Changes
- Validation
- Information and Communications Technology (ICT)
- Meetings
- Outcome
- Risk Assessments
- Audits
- Chapter 17: Training Programme
- Types of Education
- Orientation Training
- Initial Training
- Continuous Education
- Training Methods
- Theoretical Education
- Practical Training
- Rotation Training
- Conferences
- Case Training
- Online Training
- Standard Operating Procedure (SOP) Training
- Unplanned Training
- Trainer Qualifications
- Determination of Training Needs
- Documentation of Training
- Training Evaluation
- Conclusion
- References
- Chapter 18: Risk Management
- Defining Risk in Cell Therapy
- The Quality Risk Management Process
- Risk Assessment
- Risk Control
- Risk Review
- Risk Communication
- Stakeholders Involved in Risk Management
- Illustrative Examples of Specific Applications
- Related vs. Unrelated Donors
- Processing of Cell Therapy Products
- Patients
- Final Remarks
- References.
- Correction to: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
- Correction to:
- Index.