Standards for Cellular Therapy Services, 8th Edition

  • ID: 4464973
  • Book
  • 166 pages
  • AABB
1 of 4

The eighth edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.

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.
Note: Product cover images may vary from those shown
2 of 4

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

Note: Product cover images may vary from those shown
3 of 4

Loading
LOADING...

4 of 4
Note: Product cover images may vary from those shown
Adroll
adroll