March 2020 ASTCT Monthly Self-Directed Learning Quiz

On behalf of the ASTCT Committee on Education, we are pleased to continue our monthly self-directed learning quiz "Basic Principles and Practices of Hematopoietic Cell Transplantation and Cell Therapy – Question and Answer Approach” for fellows in training, highlighting HCT and cell therapy topics. Answers to each question appear with evidence-based “non-exhaustive” peer-review commentary. Our aim is to provide you with a credible and freely available educational resource. Questions generated and reviewed by Syed Abutalib, MD, Amrita Krishnan, MD, and William A. Wood, MD.

Question Title

* 1.
FACT-JACIE International Standard for Hematopoietic Cellular Therapy

SEVENTH EDITION 7.0¹

Emphasis on Apheresis Collection Facility Standards

In aggregate, how many Sections are part of “Apheresis Collection Facility Standards”?

A. 10

B. 11

C. 12

D. 13

Question Title

* 2. FACT-JACIE Standard - C1 → General: Which of the following statements about this Section is CORRECT

A. The apheresis standards do not apply to storage, and distribution activities of the cellular product

B. The Apheresis Collection Facility should use cell processing facilities that meet FACT-JACIE Standards

C. Compliance with governmental regulations ensures that the FACT-JACIE standards have been properly met.

D. The Apheresis Collection Facility shall have an Apheresis Collection Facility Director, an Apheresis Collection Facility Medical Director, a Quality Manager, and a minimum of one (1) additional designated staff member.

Question Title

* 3. FACT-JACIE Standard – C2 → Apheresis Collection Facility: Which of the following statements about this Section is FALSE?

A. Storage areas for cellular therapy products must be designated and controlled to prevent mix-ups and contamination regardless of the duration of the storage

B. There should be a mechanism to monitor the flow of supplies and reagents within the collection facility.

C. There shall be a designated area for collection with appropriate location.

D. There is a designated and standardized amount of space necessary to provide a safe environment for collection

Question Title

* 4. FACT-JACIE Standard - C3 → Personnel: Which of the following statements about Apheresis Collection Facility Director is CORRECT?

A. There shall be an Apheresis Collection Facility Director with a medical degree or degree in a relevant science, with four (4) years of postgraduate training and experience in cellular therapy product collection procedures at a minimum.

B. The Apheresis Collection Facility Director shall have performed or supervised a minimum of three (3) cellular therapy product apheresis collection procedures in the twelve (12) months preceding initial accreditation

C. The Apheresis Collection Facility Director shall participate in a minimum of ten (10) hours of educational activities related to cellular therapy annually.

D. All of the above are correct statements

Question Title

* 5. FACT-JACIE Standard - C3 → Personnel: Which of the following statements about the Apheresis Collection Facility Medical Director is CORRECT?

A. There shall be an Apheresis Collection Facility Medical Director who is a licensed Hematologist

B. The Medical Director shall be licensed in other jurisdictions in which satellite Apheresis Collection Facilities are located.

C. The Apheresis Collection Facility Medical Director shall be responsible for the medical care of donors undergoing apheresis

D. The Apheresis Collection Facility Medical Director is responsible for the initial selection of the donor

Question Title

* 1. FACT-JACIE International Standard for Hematopoietic Cellular Therapy SEVENTH EDITION 7.01 Emphasis on Apheresis Collection Facility Standards In aggregate, how many Sections are part of “Apheresis Collection Facility Standards”?

Question Title

* 2. FACT-JACIE Standard - C1 → General: Which of the following statements about this Section is CORRECT

Question Title

* 3. FACT-JACIE Standard – C2 → Apheresis Collection Facility: Which of the following statements about this Section is FALSE?

Question Title

* 4. FACT-JACIE Standard - C3 → Personnel: Which of the following statements about Apheresis Collection Facility Director is CORRECT?

Question Title

* 5. FACT-JACIE Standard - C3 → Personnel: Which of the following statements about the Apheresis Collection Facility Medical Director is CORRECT?

* 1.
FACT-JACIE International Standard for Hematopoietic Cellular Therapy

SEVENTH EDITION 7.0¹

Emphasis on Apheresis Collection Facility Standards

In aggregate, how many Sections are part of “Apheresis Collection Facility Standards”?