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Blood banking and regulation [[electronic resource] ] : procedures, problems, and alternatives / / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor
| Blood banking and regulation [[electronic resource] ] : procedures, problems, and alternatives / / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c1996 |
| Descrizione fisica | 1 online resource (137 p.) |
| Disciplina | 362.1/784/0973 |
| Altri autori (Persone) | DauerEdward A |
| Soggetto topico |
Blood banks - Safety regulations - United States
Blood - Transfusion - Safety regulations - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-19197-X
9786610191970 0-309-58950-9 0-585-15549-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456033603321 |
| Washington, D.C., : National Academy Press, c1996 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Blood banking and regulation [[electronic resource] ] : procedures, problems, and alternatives / / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor
| Blood banking and regulation [[electronic resource] ] : procedures, problems, and alternatives / / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c1996 |
| Descrizione fisica | 1 online resource (137 p.) |
| Disciplina | 362.1/784/0973 |
| Altri autori (Persone) | DauerEdward A |
| Soggetto topico |
Blood banks - Safety regulations - United States
Blood - Transfusion - Safety regulations - United States |
| ISBN |
0-309-17532-1
1-280-19197-X 9786610191970 0-309-58950-9 0-585-15549-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778666303321 |
| Washington, D.C., : National Academy Press, c1996 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Blood banking and regulation : procedures, problems, and alternatives / / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor
| Blood banking and regulation : procedures, problems, and alternatives / / Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c1996 |
| Descrizione fisica | 1 online resource (137 p.) |
| Disciplina | 362.1/784/0973 |
| Altri autori (Persone) | DauerEdward A |
| Soggetto topico |
Blood banks - Safety regulations - United States
Blood - Transfusion - Safety regulations - United States |
| ISBN |
9786610191970
9780309175326 0309175321 9781280191978 128019197X 9780309589505 0309589509 9780585155494 0585155496 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Blood Banking and Regulation: Procedures, Problems, and Alternatives -- Copyright -- Foreword -- Preface -- Contents -- I Overview of Regulatory and Policy-Making Procedures in Blood Banking -- FDA Policy and Regulation -- THE REGULATORY MANDATE -- REGULATORY MECHANISMS -- LEGAL AUTHORITIES -- REGULATION AND ENFORCEMENT AT FDA -- ENSURING BLOOD SAFETY AND AVAILABILITY IN THE FUTURE -- CDC Recommendations -- CDC'S MISSION -- EFFECTIVENESS OF CDC -- RESEARCH ON HIV -- HOW CDC AFFECTS POLICY -- FORMAL RECOMMENDATIONS -- Blood Banking's Policy Groups and Procedures -- THE TRADITION OF SELF-REGULATION -- STANDARD-SETTING ORGANIZATIONS -- AMERICAN ASSOCIATION OF BLOOD BANKS -- JOINT EFFORTS -- OTHER STANDARDS AND GUIDELINES -- Opportunities and Venues for Dialogue -- THE CHANGING CLIMATE IN BLOOD BANKING -- VENUES FOR DIALOGUE -- THE BLOOD PRODUCTS ADVISORY COMMITTEE -- OTHER VENUES FOR DIALOGUE -- THE VOICE OF BLOOD PRODUCT CONSUMERS -- ATTENDING TO THE DONOR -- REGULATORY DIFFICULTIES -- Discussion -- II Regulatory Enforcement And Compliance -- CBER Compliance Activity -- COORDINATION BETWEEN THE CENTERS AND THE FIELD -- OFFICE OF REGULATORY AFFAIRS -- INSPECTION CONSISTENCY -- INSPECTIONS AND ENFORCEMENT -- FDA Practice in the Field -- TRAINING FOR THE FIELD -- SOURCES OF CONSISTENCY -- Challenges and Questions About Compliance -- IMPROVEMENTS IN SAFETY -- QUESTIONS ABOUT ENFORCEMENT -- Evidence That Compliance Works -- Indirect Effects: "Bulletproofing -- Is Compliance Improving? -- REGULATION AND OTHER FORCES -- Discussion -- III Innovations and Alternatives in Regulation -- Regulatory Alternatives -- REGULATORY DIAGNOSIS AND MISMATCH -- MAXIMIZING EFFECTIVENESS AND EFFICIENCY -- PROPOSED ALTERNATIVES TO COMMAND-AND-CONTROL -- Specific Techniques -- ACUS STUDY AND RECOMMENDATIONS -- THE ADMINISTRATIVE PROCEDURE ACT -- THE ALTERNATIVE: NEGOTIATION.
RECENT DEVELOPMENTS AND THE FEDERAL ADVISORY COMMITTEE ACT (FACA) -- AUDITED SELF-REGULATION -- Negotiated Rule-Making -- REG-NEG"-DOES IT WORK? -- THE PUBLIC AT THE NEGOTIATION TABLE -- CONSENSUS -- DECISION-MAKING DYNAMICS -- BENEFITS OF COLLABORATION -- POLITICAL CONSENSUS -- REG-NEG OUTCOMES -- GETTING REG-NEG STARTED -- CHOOSING THE PROBLEM -- OTHER REQUISITES -- CONSTITUENCY PRESSURES -- ACCOUNTABILITY -- REG-NEG PROCESS -- QUESTIONS ABOUT REG-NEG -- Panel Discussion on Applications of Negotiated Rule-Making to Issues in Blood Banking -- Kathryn C. Zoon -- REGULATORY INITIATIVES AT FDA -- FDA IN THE FUTURE -- INITIATIVES AT CBER -- WILLINGNESS TO EXPLORE PILOTS -- Jay Epstein -- INITIATIVES IN BLOOD REGULATION -- PARTICIPATORY DECISION-MAKING -- PUBLIC MEETINGS -- NATIONAL PERFORMANCE REVIEW -- EXPERIMENTS IN REGULATION -- THE FORCES OF CHANGE -- THE ROLE OF THE RULE-MAKING PROCESS -- Toby Simon -- COMMENTS AND QUESTIONS -- General Discussion of Issues for Negotiated Rule-Making -- CRITERIA FOR SELECTING ISSUES -- CANDIDATES FOR REG-NEG -- IV Congressional Oversight and Regulatory Initiatives -- Congressional Oversight of Blood Safety Issues -- THE WORK OF THE SUBCOMMITTEE -- THE QUESTION OF COSTS -- DHHS Task Force on HIV and the Blood Supply -- THE TASK FORCE CHARGE -- BLOOD PRODUCTS ADVISORY COMMITTEE -- DECISION-MAKING -- COST AS A FACTOR -- THE PUBLIC VIEW -- V Postscript -- Investing in Regulatory Quality -- REQUISITES OF REGULATORY PROCEDURES -- PUBLIC PERCEPTIONS -- Appendixes -- A Negotiated Rule-Making Procedure -- Preamble -- 561. Purpose -- 562. Definitions -- 563. Determination of need for negotiated rulemaking committee -- 564. Publication of notice -- applications for membership on committees -- 565. Establishment of committee -- 566. Conduct of committee activity -- 567. Termination of committee. 568. Services, facilities, and payment of committee member expenses -- 569. Role of the Administrative Conference of the United States and other entities -- 570. Judicial review -- B Workshop Participants -- WORKSHOP ON RISK AND REGULATION -- WORKSHOP ON MANAGING THREATS TO THE BLOOD SUPPLY -- C Acronyms. |
| Record Nr. | UNINA-9910960557803321 |
| Washington, D.C., : National Academy Press, c1996 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Blood donors and the supply of blood and blood products [[electronic resource] /] / Frederick J. Manning, Linette Sparacino, editors
| Blood donors and the supply of blood and blood products [[electronic resource] /] / Frederick J. Manning, Linette Sparacino, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1996 |
| Descrizione fisica | xii, 119 p. : ill |
| Disciplina | 362.1/784/0973 |
| Altri autori (Persone) |
ManningFrederick J
SparacinoLinette R |
| Soggetto topico |
Blood banks - United States
Blood - Collection and preservation |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-19201-1
9786610192014 0-309-58962-2 0-585-15518-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456045903321 |
| Washington, D.C., : National Academy Press, 1996 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Blood donors and the supply of blood and blood products [[electronic resource] /] / Frederick J. Manning, Linette Sparacino, editors
| Blood donors and the supply of blood and blood products [[electronic resource] /] / Frederick J. Manning, Linette Sparacino, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1996 |
| Descrizione fisica | xii, 119 p. : ill |
| Disciplina | 362.1/784/0973 |
| Altri autori (Persone) |
ManningFrederick J
SparacinoLinette R |
| Soggetto topico |
Blood banks - United States
Blood - Collection and preservation |
| ISBN |
0-309-17528-3
1-280-19201-1 9786610192014 0-309-58962-2 0-585-15518-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778666003321 |
| Washington, D.C., : National Academy Press, 1996 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Blood donors and the supply of blood and blood products / / Frederick J. Manning, Linette Sparacino, editors
| Blood donors and the supply of blood and blood products / / Frederick J. Manning, Linette Sparacino, editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1996 |
| Descrizione fisica | xii, 119 p. : ill |
| Disciplina | 362.1/784/0973 |
| Altri autori (Persone) |
ManningFrederick J
SparacinoLinette R |
| Soggetto topico |
Blood banks - United States
Blood - Collection and preservation |
| ISBN |
9786610192014
9780309175289 0309175283 9781280192012 1280192011 9780309589628 0309589622 9780585155180 0585155186 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Blood Donors and the Supply of Blood and Blood Products -- Copyright -- PRESENTERS -- FOREWORD -- PREFACE -- Contents -- I CURRENT STATE OF THE BLOOD SUPPLY -- Longitudinal Studies of Blood Availability -- QUESTIONS AND COMMENTS -- Blood Supply Fluctuations -- QUESTIONS/COMMENTS -- When Should Physicians Transfuse? -- QUESTIONS/COMMENTS -- International Perspectives on Blood Availability -- QUESTIONS/COMMENTS -- II ENHANCING COLLECTIONS -- The Delaware Plan -- QUESTIONS/COMMENTS -- Markets and the Blood Supply -- QUESTIONS/COMMENTS -- Blood Donor Attitudes and Behavior -- QUESTIONS/COMMENTS -- III ENHANCING DISTRIBUTION -- American Red Cross Blood Distribution System -- QUESTIONS/COMMENTS -- Blood Resource Sharing Programs -- QUESTIONS/COMMENTS -- Exporting Blood from a Regional Blood Center -- QUESTIONS/COMMENTS -- Supply and Demand in Transfusion Services -- QUESTIONS/COMMENTS -- Logistic Problems and Perishables: The Kroger Company and Supermarket Seafood -- QUESTIONS/COMMENTS -- IV EXPANDING THE ALTERNATIVES -- Frozen Red Cell Technology -- QUESTIONS/COMMENTS -- Logistical Concerns in Prepositioning Frozen Blood -- QUESTIONS/COMMENTS -- Extended Liquid Storage of Red Blood Cells -- QUESTIONS/COMMENTS -- Overview of Blood Substitutes -- V CLOSING REMARKS -- Henrik H. Bendixen Chair, Forum on Blood Safety and Blood Availability -- Harvey Klein Workshop Moderator -- APPENDIXES -- A Acronyms -- B Workshop Participants. |
| Record Nr. | UNINA-9910962013403321 |
| Washington, D.C., : National Academy Press, 1996 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||