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Advances in clinical chemistry and laboratory medicine [[electronic resource] /] / edited by Harald Renz and Rudolf Tauber
| Advances in clinical chemistry and laboratory medicine [[electronic resource] /] / edited by Harald Renz and Rudolf Tauber |
| Pubbl/distr/stampa | Berlin ; ; Boston, : De Gruyter, c2012 |
| Descrizione fisica | 1 online resource (164 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) |
RenzH (Harald)
TauberRudolf |
| Soggetto topico |
Clinical chemistry
Diagnosis, Laboratory |
| Soggetto non controllato |
Clinical Chemistry
Haematology Laboratory Diagnostics Laboratory Medicine Pathobiochemistry |
| ISBN |
1-283-85680-8
3-11-022464-X |
| Classificazione | YV 3300 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front matter -- Preface -- Table of Contents -- Authors Index -- 1 Plenary Articles -- 1.1 Proteomics strategies targeting biomarkers for cardiovascular disease / Scholten, Arjen / Heck, Albert J.R. -- 1.2 Influence of pre-examination aspects on result's validity - are ISO 15189 requirements sufficient and clear? / Šprongl, Luděk -- 1.3 Posttranslational modifications in tumor diagnosis / Nollau, Peter / Wagener, Christoph -- 1.4 Chronic inflammatory disease: a result of complex gene-environment interaction / Renz, Harald / Pfefferle, Petra Ina / Garn, Holger -- 2 Symposium Articles -- 2.1 Component-array technology diagnostics: a step forward in the study of the sensitization profile of allergic patients / Acedo Sanz, Juan Manuel -- 2.2 Pediatric metabolic syndrome: pathophysiology and molecular mechanisms / Chemin, Julie / Adeli, Khosrow -- 2.3 Urinary 8-hydroxydeoxyguanosine as a biomarker of microangiopathic complications in type 2 diabetic patients / Fattouh, Amr / Mahmoud, Nermine H. / Atef, Shereen H. / Gaber, Abd El Rahman -- 2.4 Biological variation data: the need for appraisal of the evidence base / Bartlett, William A. -- 2.5 Recovery ELISA - a newly-developed immunoassay for measurement of therapeutic antibodies and the target antigen during antibody therapy / Strohner, Pavel / Sarrach, Dieter / Reich, Jens G. / Staatz, Antonia / Schäfer, Astrid / Steiß, Jens-Oliver / Häupl, Thomas / Becher, Gunther -- 2.6 Genotypic prediction of HIV-1 tropism from plasma and peripheral blood mononuclear cells in the clinical routine laboratory / Paar, Christian / Geit, Maria / Stekel, Herbert / Berg, Jörg -- 2.7 Expression of a subset of microRNAs in clinically non-functioning pituitary adenomas correlates with tumor size / Butz, Henriett / Likó, István / Czirják, Sándor / Igaz, Péter / Korbonits, Márta / Rácz, Károly / Patócs, Attila -- 2.8 Serological markers of gastric pathology / Caleffi, Alberta -- 2.9 BNP as a biomarker of cardiac impairment in neonates with congenital heart diseases / Cantinotti, Massimiliano / Murzi, Bruno / Storti, Simona / Clerico, Aldo -- 2.10 Are 25-hydroxyvitamin D assays fit for purpose? / Carter, Graham D. -- 2.11 Update on multiple sclerosis / Cross, Anne H. -- 2.12 Microalbuminuria and urinary retinol binding protein as markers of subtle renal injury in visceral leishmaniasis: sensitivity, specificity and predictive values of the immunoturbidimetric technique / Elnojomi, Nuha A.A. / Musa, Ahmed M. / Younis, Brima M. / Elfaki, Mohammed E. / El-Hassan, Ahmed M. / Khalil, Eltahir A. -- 2.13 Occult hepatitis B virus infection: diagnosis and significance / Gerlich, Wolfram Hubert / Schüttler, Christian Gisbert / Glebe, Dieter -- 2.14 Unmet needs in chronic kidney disease testing / Jones, Graham -- 2.15 Towards a national chronic kidney disease testing program / Jones, Graham -- 2.16 Biochemistry and metabolism of vitamin D / Jones, Glenville -- 2.17 Diagnostics of thalassemia / Kaeslin, Martha / Brunner-Agten, Saskia / Huber, Andreas R. -- 2.18 The specific roles of assessors during accreditation / Huisman, Wim -- 2.19 Laboratory diagnosis of hereditary spherocytosis / King, May-Jean -- 2.20 Quantification of blood folate forms using stable-isotope dilution ultra performance liquid chromatography tandem mass spectrometry / Kirsch, Susanne H. / Herrmann, Wolfgang / Obeid, Rima -- 2.21 Evaluation of the new Marburg cerebrospinal fluid model with human spondylopathies / Kleine, Tilmann Otto / Löwer, Christa / Bien, Siegfried / Lehmitz, Reinhardt / Dorn-Beineke, Alexandra -- 2.22 E-learning experiences of national societies of clinical chemistry and laboratory medicine / Kocna, Petr -- 2.23 The experience of Médecins Sans Frontières in laboratory medicine in resource-limited settings / Kosack, Cara S. -- 2.24 Screening, identifying, and quantifying small molecules by hyphenated mass spectrometry in toxicology and drug monitoring - an update / Maurer, Hans H. -- 2.25 Analytical quality in the Latin America area / Migliarino, Gabriel Alejandro -- 2.26 Standardization in molecular diagnostics: definitions and uses of nucleic acid reference materials / Payne, Deborah A. / Rousseau, François / Mamotte, Cyril D.S. / Gancberg, David / Schaik, Ron H.N. van / Schimmel, Heinz / Pazzagli, Mario -- 2.27 Profiling of antiphospolipid antibodies - association with cerebrovascular events in APS / Roggenbuck, Dirk -- 2.28 Plasma levels of soluble CD30 and CD40L in pediatric patients after liver transplantation / Shevchenko, Olga P. / Tsirulnikova, Olga M. / Gichkun, Olga E. / Kurabekova, Rivada M. / Ammosov, Aleksandr A. / Gautier, Sergey V. -- 2.29 Diagnostic and prognostic value of presepsin (soluble CD14 subtype) in emergency patients with early sepsis using the new assay PATHFAST presepsin / Spanuth, Eberhard / Ebelt, Henning / Ivandic, Boris / Werdan, Karl -- 2.30 Diagnostic workup of primary aldosteronism / Stowasser, Michael -- 2.31 What should the clinical laboratory and the toxicologist-pharmacologist offer the poisoned patient? / Uges, Donald R.A. -- 2.32 Novel aspects of the von Willebrand factor - platelet glycoprotein IB interaction and signaling / Walter, Ulrich / Gambaryan, Stepan / Herterich, Sabine / Lohmann, Suzanne M. -- 2.33 Medical emergencies: what is the laboratory's role? / Young, Donald S. |
| Record Nr. | UNINA-9910786070203321 |
| Berlin ; ; Boston, : De Gruyter, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advances in clinical chemistry and laboratory medicine [[electronic resource] /] / edited by Harald Renz and Rudolf Tauber
| Advances in clinical chemistry and laboratory medicine [[electronic resource] /] / edited by Harald Renz and Rudolf Tauber |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Berlin ; ; Boston, : De Gruyter, c2012 |
| Descrizione fisica | 1 online resource (164 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) |
RenzH (Harald)
TauberRudolf |
| Soggetto topico |
Clinical chemistry
Diagnosis, Laboratory |
| Soggetto non controllato |
Clinical Chemistry
Haematology Laboratory Diagnostics Laboratory Medicine Pathobiochemistry |
| ISBN |
1-283-85680-8
3-11-022464-X |
| Classificazione | YV 3300 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front matter -- Preface -- Table of Contents -- Authors Index -- 1 Plenary Articles -- 1.1 Proteomics strategies targeting biomarkers for cardiovascular disease / Scholten, Arjen / Heck, Albert J.R. -- 1.2 Influence of pre-examination aspects on result's validity - are ISO 15189 requirements sufficient and clear? / Šprongl, Luděk -- 1.3 Posttranslational modifications in tumor diagnosis / Nollau, Peter / Wagener, Christoph -- 1.4 Chronic inflammatory disease: a result of complex gene-environment interaction / Renz, Harald / Pfefferle, Petra Ina / Garn, Holger -- 2 Symposium Articles -- 2.1 Component-array technology diagnostics: a step forward in the study of the sensitization profile of allergic patients / Acedo Sanz, Juan Manuel -- 2.2 Pediatric metabolic syndrome: pathophysiology and molecular mechanisms / Chemin, Julie / Adeli, Khosrow -- 2.3 Urinary 8-hydroxydeoxyguanosine as a biomarker of microangiopathic complications in type 2 diabetic patients / Fattouh, Amr / Mahmoud, Nermine H. / Atef, Shereen H. / Gaber, Abd El Rahman -- 2.4 Biological variation data: the need for appraisal of the evidence base / Bartlett, William A. -- 2.5 Recovery ELISA - a newly-developed immunoassay for measurement of therapeutic antibodies and the target antigen during antibody therapy / Strohner, Pavel / Sarrach, Dieter / Reich, Jens G. / Staatz, Antonia / Schäfer, Astrid / Steiß, Jens-Oliver / Häupl, Thomas / Becher, Gunther -- 2.6 Genotypic prediction of HIV-1 tropism from plasma and peripheral blood mononuclear cells in the clinical routine laboratory / Paar, Christian / Geit, Maria / Stekel, Herbert / Berg, Jörg -- 2.7 Expression of a subset of microRNAs in clinically non-functioning pituitary adenomas correlates with tumor size / Butz, Henriett / Likó, István / Czirják, Sándor / Igaz, Péter / Korbonits, Márta / Rácz, Károly / Patócs, Attila -- 2.8 Serological markers of gastric pathology / Caleffi, Alberta -- 2.9 BNP as a biomarker of cardiac impairment in neonates with congenital heart diseases / Cantinotti, Massimiliano / Murzi, Bruno / Storti, Simona / Clerico, Aldo -- 2.10 Are 25-hydroxyvitamin D assays fit for purpose? / Carter, Graham D. -- 2.11 Update on multiple sclerosis / Cross, Anne H. -- 2.12 Microalbuminuria and urinary retinol binding protein as markers of subtle renal injury in visceral leishmaniasis: sensitivity, specificity and predictive values of the immunoturbidimetric technique / Elnojomi, Nuha A.A. / Musa, Ahmed M. / Younis, Brima M. / Elfaki, Mohammed E. / El-Hassan, Ahmed M. / Khalil, Eltahir A. -- 2.13 Occult hepatitis B virus infection: diagnosis and significance / Gerlich, Wolfram Hubert / Schüttler, Christian Gisbert / Glebe, Dieter -- 2.14 Unmet needs in chronic kidney disease testing / Jones, Graham -- 2.15 Towards a national chronic kidney disease testing program / Jones, Graham -- 2.16 Biochemistry and metabolism of vitamin D / Jones, Glenville -- 2.17 Diagnostics of thalassemia / Kaeslin, Martha / Brunner-Agten, Saskia / Huber, Andreas R. -- 2.18 The specific roles of assessors during accreditation / Huisman, Wim -- 2.19 Laboratory diagnosis of hereditary spherocytosis / King, May-Jean -- 2.20 Quantification of blood folate forms using stable-isotope dilution ultra performance liquid chromatography tandem mass spectrometry / Kirsch, Susanne H. / Herrmann, Wolfgang / Obeid, Rima -- 2.21 Evaluation of the new Marburg cerebrospinal fluid model with human spondylopathies / Kleine, Tilmann Otto / Löwer, Christa / Bien, Siegfried / Lehmitz, Reinhardt / Dorn-Beineke, Alexandra -- 2.22 E-learning experiences of national societies of clinical chemistry and laboratory medicine / Kocna, Petr -- 2.23 The experience of Médecins Sans Frontières in laboratory medicine in resource-limited settings / Kosack, Cara S. -- 2.24 Screening, identifying, and quantifying small molecules by hyphenated mass spectrometry in toxicology and drug monitoring - an update / Maurer, Hans H. -- 2.25 Analytical quality in the Latin America area / Migliarino, Gabriel Alejandro -- 2.26 Standardization in molecular diagnostics: definitions and uses of nucleic acid reference materials / Payne, Deborah A. / Rousseau, François / Mamotte, Cyril D.S. / Gancberg, David / Schaik, Ron H.N. van / Schimmel, Heinz / Pazzagli, Mario -- 2.27 Profiling of antiphospolipid antibodies - association with cerebrovascular events in APS / Roggenbuck, Dirk -- 2.28 Plasma levels of soluble CD30 and CD40L in pediatric patients after liver transplantation / Shevchenko, Olga P. / Tsirulnikova, Olga M. / Gichkun, Olga E. / Kurabekova, Rivada M. / Ammosov, Aleksandr A. / Gautier, Sergey V. -- 2.29 Diagnostic and prognostic value of presepsin (soluble CD14 subtype) in emergency patients with early sepsis using the new assay PATHFAST presepsin / Spanuth, Eberhard / Ebelt, Henning / Ivandic, Boris / Werdan, Karl -- 2.30 Diagnostic workup of primary aldosteronism / Stowasser, Michael -- 2.31 What should the clinical laboratory and the toxicologist-pharmacologist offer the poisoned patient? / Uges, Donald R.A. -- 2.32 Novel aspects of the von Willebrand factor - platelet glycoprotein IB interaction and signaling / Walter, Ulrich / Gambaryan, Stepan / Herterich, Sabine / Lohmann, Suzanne M. -- 2.33 Medical emergencies: what is the laboratory's role? / Young, Donald S. |
| Record Nr. | UNINA-9910821630903321 |
| Berlin ; ; Boston, : De Gruyter, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Contemporary pediatrics / / edited by Öner Özdemir
| Contemporary pediatrics / / edited by Öner Özdemir |
| Pubbl/distr/stampa | IntechOpen, 2012 |
| Descrizione fisica | 1 online resource (436 pages) : illustrations |
| Disciplina | 618.9 |
| Soggetto topico | Pediatrics - Diagnosis |
| Soggetto non controllato | Haematology |
| ISBN | 953-51-6850-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910138446803321 |
| IntechOpen, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Euthanasia : Experiences and Insights of Belgian Doctors and Nurses
| Euthanasia : Experiences and Insights of Belgian Doctors and Nurses |
| Autore | Devos Timothy |
| Pubbl/distr/stampa | Springer Nature, 2021 |
| Descrizione fisica | 1 online resource (124 pages) |
| Soggetto topico |
Eutanàsia
Ètica mèdica Ètica en infermeria |
| Soggetto genere / forma | Llibres electrònics |
| Soggetto non controllato |
Palliative Medicine
Hematology Oncology Bioethics Nursing Ethics Psychiatry Palliative Care Internal Medicine Moral Philosophy and Applied Ethics Medical Ethics Critical views Therapeutic obstinacy Meaning of life Slippery slope Experiences from daily practice Open Access Haematology Nursing Medical ethics & professional conduct |
| ISBN | 3-030-56795-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- Foreword 1 -- Foreword 2 -- The Failure to Present "the Full Story" -- Range of Disciplines and Experiential Knowledge -- Issues Raised by Legalized Euthanasia -- Expansion and Normalization Through Giving Priority to Autonomy -- Suicide and Social Contagion -- Euthanasia is Incompatible with Palliative Care -- Loving Accompaniment Until Natural Death -- The "Mystery of Death" -- Conclusion -- Contents -- About the Authors -- About the Editor -- 1: The Slippery Slope Syndrome -- 1.1 The Decriminalization of Euthanasia -- 1.2 Ignorance About Palliative Care -- 1.3 The Trivialization of Euthanasia -- 1.4 A Perverted Sense of Duty -- 1.5 Suffering and Silence -- 1.6 The Economic Context -- 1.7 Euthanasia in the Psychiatric Context -- 1.8 After Euthanasia -- 1.9 The Euthanasia of Minors -- 1.10 The Euthanasia of Remorse -- References -- 2: The Doctor Turned into an Instrument -- 2.1 The Therapeutic Alliance -- 3: When Conscience Wavers. Some Reflections on the Normalization of Euthanasia in Belgium -- 3.1 The Embarrassment of the Law -- 3.2 Euthanasia: Medical Act or Transgression? -- 3.3 Euthanasia as Transgression -- 3.4 Between Law and Conscience: Euthanasia and Moral Integrity -- 3.5 Conclusion -- References -- 4: Euthanasia for Unbearable Psychological Suffering -- 4.1 What Does the Law Say? -- 4.2 A Lack of Prospect of Improvement of the Medical Situation -- 4.3 Incurable Disorder -- 4.4 Persistent and Unbearable Psychological Suffering -- 4.5 What Is Empathy? -- 4.6 Decision-Making Capacity -- 4.7 Conclusion -- 4.8 The Long and the Short of Mrs. Jeanine's Story -- References -- 5: People Facing the Question of Euthanasia: Patients, Family and Friends, Healthcare Workers -- 5.1 Personal Suffering -- 5.2 Physical Suffering -- 5.3 Psychological Suffering -- 5.4 Emotional and Relational Suffering.
5.5 Existential and Spiritual Suffering -- 5.6 How Can One Respond to a Request for Euthanasia? -- 5.7 The Reaction of Family and Friends to a Request for Euthanasia -- 5.8 How Can the Medical Staff Act or React to a Request for Euthanasia? -- References -- 6: Surrendering to or Inducing Death: Artificial Feeding as Paradigm -- 6.1 Framework of this Reflective Study -- 6.1.1 Case #1-Madame B. 73 Years Old -- 6.1.2 Case #2-Madame F. 90 Years Old -- 6.1.3 Case #3-Madame J. 68 Years Old -- 6.2 Why Use Feeding Tubes? What Criteria Prevailed? How Efficient Are they? How Did we Come to Adopt these Protocols? -- 6.3 First Approach of the Ethical Question -- 6.4 Distinguishing between Ordinary and Extraordinary -- 6.5 Three Levels of Ethical Judgment -- 6.6 Madame B. or the "Disproportioned Deemed Ordinary" -- 6.7 Madame F. or the "Proportionate Turned Doubtful (Optional) and Deemed Extraordinary" -- 6.8 Conclusion -- References -- 7: The Meaning of Suffering or the Meaning of Life Despite Suffering -- 7.1 Viktor Frankl: The Question of Meaning at the Heart of Medicine -- 7.2 How Can We Apply Viktor Frankl's Theories to Helping Patients? -- 7.2.1 First Pathway: Accomplishment Through Love -- 7.2.2 Second Pathway: Accomplishment Through a Meaningful Life -- 7.2.3 Third Pathway: Knowing How to Deal with Suffering -- 7.3 What Happens in a Country Where Euthanasia Has Been Decriminalised? -- References -- 8: Resisting -- 8.1 The Request for Euthanasia -- 8.2 Family Pressure -- 8.3 Explaining Euthanasia -- 8.4 The Trap of 'Integrated' Palliative Care -- 8.5 Sedation: Misunderstandings and Confusion -- 8.6 Palliative Care: A Hospital Paradigm -- 8.7 Contradiction and Ambiguity -- Reference -- 9: Behind the Scenes of Euthanasia -- 9.1 Distress of the Healthcare Worker -- 9.2 Euthanasia: A 'De-Humanising' Act. 9.3 When Conscience Competes Against Law and Bureaucracy -- 9.4 Euthanasia, a Stage in Accepting One's Illness -- 9.5 Euthanasia as a Wake-Up Call from Indifference -- 9.6 Sedation: Palliative Practise or Hypocrisy? -- 9.7 When Trust Meets Professional Integrity -- Correction to: When Conscience Wavers. Some Reflections on the Normalization of Euthanasia in Belgium -- Correction to: T. Devos (ed.), Euthanasia: Searching for the Full Story, https://doi.org/10.1007/978-3-030-56795-8 -- Postface -- Brief List of Health-Care Terms for the Non-specialist. |
| Altri titoli varianti | Euthanasia |
| Record Nr. | UNINA-9910473449503321 |
Devos Timothy
|
||
| Springer Nature, 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 | ||
| ||