Standards for Cellular Therapy Services, 8th Edition - Print and Portal - Product Image

Standards for Cellular Therapy Services, 8th Edition - Print and Portal

  • ID: 4464974
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This combination provides two ways to access the 8th edition of Standards for Cellular Therapy Services: print and digital. The 8th edition of Standards for Cellular Therapy Services, effective July 1, 2017, details the latest standards of practice for accredited cellular therapy facilities.

Product Features:

A multi-user license is available for this product at a discounted rate. The Standards Portal allows users to customize their profile based on the activities for which they are accredited and can be rearranged at any time. Standards that do not apply to a user’s profile will appear grayed out to ensure that purchasers are aware of the standards that apply to their facility and those that do not.

The Standards Portal is also fully searchable by key word, chapter, or standard number, allowing users to navigate quickly to the most relevant standards to them at that time. Guidance is provided on how to implement a standard, why it was created, or why a change was made from this edition to the last. Any relevant documentation that would assist users in implementing the standard in question is provided.

New Benefits to Users:

All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the CT Standards (not including any guidance) is printable at any time to ensure that users can take the CT Standards on the go.

Any interim or emergent standards will appear seamlessly in the portal once effective and highlighted.

By purchasing the Standards for Cellular Therapy Services, 8th edition (“Standards”) through the Standards Portal (“Portal”), users acknowledge and agree that they will access the Standards solely for their own personal and/or professional use and not distribute, copy or provide access to the Standards for use by any third parties. Furthermore, users will securely maintain their login and password for the Portal. In the event that the researcher or its authorized agents discover that users have not complied with these Terms and Conditions of Use, they understand that they will lose all rights to access the Standards and will not be entitled to any refund.

Significant changes to the 8th edition include:

  • The 8th edition has expanded requirements for proficiency testing to ensure that the standards can be complied with outside of the United States where access to an external proficiency testing is limited.
  • Standard 5.8, #6 requires all accredited laboratories to have implemented ISBT 128 labeling for all products by July 1, 2018, one year after the effective date of this edition.
  • Standards for donor suitability and eligibility have been separated into two distinct sections in the standards (5.12.1 and 5.12.2 respectively) and their sections expanded.
  • New standard 5.12.2.11 requires that all facilities have policies, processes and procedures in place to address all relevant emerging infectious diseases and that action is taken with regard to donor screening and testing processes.
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PREFACE

INTRODUCTION

1. ORGANIZATION
1.0 Organization
1.1 Executive Management
1.2 Quality
1.3 Emergency Operation Plans
1.4 Communication of Concerns
1.5 Customer Focus
1.6 Human Subjects Research

2. RESOURCES
2.0 Resources
2.1 Human Resources
2.2 Access to Ancillary and Direct Patient Care Services

3. EQUIPMENT
3.0 Equipment
3.1 Elements of Control
3.2 Qualification of Equipment
3.3 Equipment Monitoring and Maintenance
3.4 Equipment Traceability
3.5 Information Systems

4. AGREEMENTS
4.0 Agreements
4.1 Agreement Review
4.2 Changes to Agreements
4.3 Agreements Relating to Cellular Therapy Products
4.4 Educational and Promotional Materials
4.5 Donor Informed Consent
4.6 Authorization for Cadaveric Donors
4.7 Patient Informed Consent
4.8 Obtaining Materials, Services, and Cellular Therapy Products
4.9 Donor Informed Consent or Authorization
4.10 Patient Informed Consent

5. PROCESS CONTROL
5.0 Process Control
5.1 General Elements
5.2 Process and Procedure Development and Change
5.3 Quality Control
5.4 Materials Management
5.5 Methods and Operational Controls
5.6 Product Identification and Traceability
5.7 Labels, Labeling, and Labeling Controls
5.8 Transport and Shipping
5.9 Inspection and Testing
5.10 Storage and Preservation
5.11 Donor Evaluation
5.12 Medical Management and Emergency Care of Donors
5.13 Procurement
5.14 Procurement Endpoints
5.15 Packaging
5.16 Processing
5.17 Storage of Noncryopreserved Products
5.18 Cryopreservation
5.19 Expiration Dates and Stability of Products
5.20 Discard and Disposal
5.21 Evaluation to Make a Product Available for Distribution
5.22 Distribution
5.23 Product Issue
5.24 Clinical Program
5.25 Medical Orders for Administration
5.26 Medical Orders for Clinical Care
5.27 Preparation of the Patient for Administration of Cellular Therapy Products
5.28 Receipt of the Product and Storage
5.29 Administration
5.30 Postadministration Monitoring
5.8.1A Requirements for Labeling of Cellular Therapy Products
5.8.1B Requirements for Labeling Shipping Containers
5.9.5A Labeling and Packaging Requirements Upon Shipping of Cellular Therapy Products
5.12A General Requirements for Cellular Therapy Product Donors  
5.12B Clinical Evaluation and Laboratory Testing of Living Allogeneic Donors
5.12C Clinical Evaluation and Laboratory Testing of Autologous Donors
5.12D Clinical Evaluation and Laboratory Testing of Mothers of Cord Blood Donors
5.12E Clinical Evaluation and Laboratory Testing of Cadaveric Donors
5.17A Processing Tests for Cellular Therapy Products other than HPC, Cord Blood
5.17B Processing Tests for HPC, Cord Blood Products

6. DOCUMENTS AND RECORDS
6.0 Documents and Records
6.1 Document Control
6.2 Record Control
6.3 Electronic Records

7. DEVIATIONS, NONCONFORMING PRODUCTS OR SERVICES, AND ADVERSE EVENTS
7.0 Deviations, Nonconforming Products or Services and Adverse Events
7.1 Deviations
7.2 Control of Nonconforming Products or Services
7.3 Adverse Events
7.4 Reporting

8. INTERNAL AND EXTERNAL ASSESSMENTS
8.0 Internal and External Assessments
8.1 Internal Assessments
8.2 External Assessments
8.3 Management of Assessment Results
8.4 Proficiency Testing
8.5 Monitoring Clinical Activities

9. PROCESS IMPROVEMENT
9.0 Process Improvement
9.1 Corrective Action
9.2 Preventive Action
9.3 Performance Improvement

10. SAFETY AND FACILITIES
10.0 Safety and Facilities
10.1 Safety
10.2 Facilities
10.3 General Operational Controls

GLOSSARY

CROSSWALK BETWEEN THE SEVENTH AND EIGHTH EDITIONS OF CT STANDARDS

INDEX

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