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Inherited Hemoglobin Disorders / / edited by Anjana Munshi
| Inherited Hemoglobin Disorders / / edited by Anjana Munshi |
| Pubbl/distr/stampa | [Rijeka, Croatia] : , : IntechOpen, , 2015 |
| Descrizione fisica | 1 online resource (196 pages) : illustrations |
| Disciplina | 616.1 |
| Soggetto topico | Haematology |
| ISBN | 953-51-7261-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910317712503321 |
| [Rijeka, Croatia] : , : IntechOpen, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy : The JACIE Guide
| Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy : The JACIE Guide |
| Autore | Aljurf M. D (Mahmoud Deeb) |
| Pubbl/distr/stampa | Springer Nature, 2021 |
| Descrizione fisica | 1 online resource (189 pages) |
| Altri autori (Persone) |
SnowdenJohn A
HaydenPatrick (Consultant haematologist) OrchardKim H McGrathEoin |
| Soggetto topico |
Haematology
Oncology |
| Soggetto non controllato |
Hematology
Oncology Blood Transfusion Medicine Internal Medicine outcome analysis structural indicators process indicators Hematopoietic Stem Cell Transplantation Quality Management Audits Qualification and Validation Personnel Requirements Performance Measurement Tracking and Traceability Adverse Events Quality Management Plan Accreditation Data Management Training Risk Management JACIE Haematology |
| ISBN | 3-030-64492-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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. |
| Record Nr. | UNINA-9910473450803321 |
Aljurf M. D (Mahmoud Deeb)
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| Springer Nature, 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Soggetto topico
-
Haematology
(2)
- Oncology (1)