Regulatory and Accreditation


Tissues: Regulation, Management and Monitoring (presented 12/6/2018)

Instruction Level: Intermediate

Learning Objectives:

-Define conditions when a CA state license or an FDA registration/license is required

-Discuss the AATB, TJC standards and how are they applied to hospital laboratory or physician office settings

-Identify several FDA human cells, tissue, and cellular and tissue-based product (HCT/P) categories of regulated tissue


It’s an Assessment NOT an Inquisition (presented 4/5/2018)

Instruction Level: Intermediate

Learning Objectives:

-Recognize the significant changes to the 31st edition of the BBTS Standards

-Understand ways to stay prepared for unannounced assessments

-Understand common nonconformances and how they may be prevented


Market Withdrawals and Lookback/Traceback (presented 8/17/2017)

Instruction Level: Basic

Learning Objectives:

-Review the types of blood component consignee notification letters; product under investigation, market withdrawals and recalls

-Explain the purpose of the requests and the actions that should be taken by the consignee

-Review the specific requirements for recipient tracing and notification for lookbacks/tracebacks

-Discuss How to Manage Recalls, Withdrawals, and Lookbacks/Tracebacks in the Transfusion Service


Transfusion Medicine Checklists and Challenges

(presented 4/6/2017)

Instruction Level: Intermediate

Learning Objectives:

-Understand the most common 2016 checklist deficiencies cited for the laboratory General, All Common, and Transfusion Medicine checklists

-Recognize current checklist challenge and ways to meet the various existing requirements

-Familiarize self with the new 2016 checklist updates

Last modified: Wednesday, January 9, 2019, 11:28 AM