Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy : : The JACIE Guide.
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Place / Publishing House: | Cham : : Springer International Publishing AG,, 2021. ©2021. |
Year of Publication: | 2021 |
Edition: | 1st ed. |
Language: | English |
Online Access: | |
Physical Description: | 1 online resource (189 pages) |
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020 | |z 9783030644918 | ||
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035 | |a (OCoLC)1240210401 | ||
040 | |a MiAaPQ |b eng |e rda |e pn |c MiAaPQ |d MiAaPQ | ||
050 | 4 | |a RC633-647 | |
100 | 1 | |a Aljurf, Mahmoud. | |
245 | 1 | 0 | |a Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy : |b The JACIE Guide. |
250 | |a 1st ed. | ||
264 | 1 | |a Cham : |b Springer International Publishing AG, |c 2021. | |
264 | 4 | |c ©2021. | |
300 | |a 1 online resource (189 pages) | ||
336 | |a text |b txt |2 rdacontent | ||
337 | |a computer |b c |2 rdamedia | ||
338 | |a online resource |b cr |2 rdacarrier | ||
505 | 0 | |a 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. | |
505 | 8 | |a 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. | |
505 | 8 | |a 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. | |
505 | 8 | |a Correction to: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy -- Correction to: -- Index. | |
588 | |a Description based on publisher supplied metadata and other sources. | ||
590 | |a Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries. | ||
655 | 4 | |a Electronic books. | |
700 | 1 | |a Snowden, John A. | |
700 | 1 | |a Hayden, Patrick. | |
700 | 1 | |a Orchard, Kim H. | |
700 | 1 | |a McGrath, Eoin. | |
776 | 0 | 8 | |i Print version: |a Aljurf, Mahmoud |t Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy |d Cham : Springer International Publishing AG,c2021 |z 9783030644918 |
797 | 2 | |a ProQuest (Firm) | |
856 | 4 | 0 | |u https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=6483075 |z Click to View |