Blood banking and regulation : procedures, problems, and alternatives

Blood banking and regulation procedures, problems, and alternatives

Bibliographic Details
Corporate Author: Forum on Blood Safety and Blood Availability (-)
Other Authors: Dauer, Edward A. (-)
Format: eBook
Language:Inglés
Published: Washington, D.C. : National Academy Press c1996.
Edition:1st ed
Subjects:
Blood banks > Safety regulations > United States.
Blood > Transfusion > Safety regulations > United States.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820332206719
Table of Contents:
  • 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.

Similar Items