CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
Samples of Contract agencies that require written agreements -
correct answer ✅1. Donor referral
2. Authorization
3. Informed consent
4. Donor eligibility assessment
5. Recovery, collection, and/or acquisition
6. Post-delivery functions
7. Laboratory services
8. Testing services
9. Processing
10. Storage
11. Tissue release
12. Distribution
13. Consignment
How often do Tissue Banks audit Contracted Services -
correct answer ✅Every two years
,CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
What are the requirements for laboratories (contracted or non-
contracted) performing donor infectious disease testing -
correct answer ✅1. Registered with the FDA
2. Use appropriate FDA-licensed, approved, or cleared donor
screening tests
3. Follow test kits manufacturer's instructions
4. CLIA certified (clinical laboratory improvement amendment)
5. Retain test results for a minimum of 10 years
6. Comply with Tissue Bank's requirements
Who is responsible for establishing the quality policy of a Tissue
Bank -
correct answer ✅Management with Executive Responsibility
What is the frequency of the quality assurance program internal
audit/review -
correct answer ✅Annual
What are the responsibilities of the Tissue Bank's Medical Director?
-
correct answer ✅1. Establishing Donor Eligibility Criteria (i.e. age)
2. Establish policies and procedures regarding Adverse outcomes
,CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
3. Responsible for notifying appropriate parties of positive
infectious disease test results
How long is AATB accreditation valid for? -
correct answer ✅3 years (Tissue Bank will need to renew after 3
years)
- Apply - 12 months before expiration
- Inspect - within 90 days of application
- Evaluate
- Review
Who is the father of vascular and transplant surgery? -
correct answer ✅Alexis Carrel
What was the first recognized Tissue Bank? -
correct answer ✅U.S. Navy Tissue Bank
When was AATB established? -
correct answer ✅1976
, CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
What should a record management system contain? -
correct answer ✅- Information from donor referral sources
- Donor eligibility assessment
- Record of informed consent or doc of Gift/Authorization
- Donor physical assessment/examination and donor ID
- Tissue recovery/collection, transport and processing
- Quarantine and infectious disease testing
- In-process testing
- Record review
- Tissue labeling, storage, release and distribution
- QC
- Services to donor families
What is the retention policy for records in Record Management? -
correct answer ✅Minimum 10 years beyond longest date known
All donor records shall be maintained 10 years beyond distribution,
transplantation, expiration or disposition except for Dura Mater,
records shall be maintained indefinitely
Questions & Answers (Grade A+)
Samples of Contract agencies that require written agreements -
correct answer ✅1. Donor referral
2. Authorization
3. Informed consent
4. Donor eligibility assessment
5. Recovery, collection, and/or acquisition
6. Post-delivery functions
7. Laboratory services
8. Testing services
9. Processing
10. Storage
11. Tissue release
12. Distribution
13. Consignment
How often do Tissue Banks audit Contracted Services -
correct answer ✅Every two years
,CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
What are the requirements for laboratories (contracted or non-
contracted) performing donor infectious disease testing -
correct answer ✅1. Registered with the FDA
2. Use appropriate FDA-licensed, approved, or cleared donor
screening tests
3. Follow test kits manufacturer's instructions
4. CLIA certified (clinical laboratory improvement amendment)
5. Retain test results for a minimum of 10 years
6. Comply with Tissue Bank's requirements
Who is responsible for establishing the quality policy of a Tissue
Bank -
correct answer ✅Management with Executive Responsibility
What is the frequency of the quality assurance program internal
audit/review -
correct answer ✅Annual
What are the responsibilities of the Tissue Bank's Medical Director?
-
correct answer ✅1. Establishing Donor Eligibility Criteria (i.e. age)
2. Establish policies and procedures regarding Adverse outcomes
,CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
3. Responsible for notifying appropriate parties of positive
infectious disease test results
How long is AATB accreditation valid for? -
correct answer ✅3 years (Tissue Bank will need to renew after 3
years)
- Apply - 12 months before expiration
- Inspect - within 90 days of application
- Evaluate
- Review
Who is the father of vascular and transplant surgery? -
correct answer ✅Alexis Carrel
What was the first recognized Tissue Bank? -
correct answer ✅U.S. Navy Tissue Bank
When was AATB established? -
correct answer ✅1976
, CTBS (14th Edition AATB) Exam
Questions & Answers (Grade A+)
What should a record management system contain? -
correct answer ✅- Information from donor referral sources
- Donor eligibility assessment
- Record of informed consent or doc of Gift/Authorization
- Donor physical assessment/examination and donor ID
- Tissue recovery/collection, transport and processing
- Quarantine and infectious disease testing
- In-process testing
- Record review
- Tissue labeling, storage, release and distribution
- QC
- Services to donor families
What is the retention policy for records in Record Management? -
correct answer ✅Minimum 10 years beyond longest date known
All donor records shall be maintained 10 years beyond distribution,
transplantation, expiration or disposition except for Dura Mater,
records shall be maintained indefinitely