2026 CTBS STUDY GUIDE (14TH
EDITION AATB) QUESTIONS ANS
ANSWERS WITH COMPLETE
SOLUTIONS 100% CORRECT RATED A+
||UPDATED 2026
Contract Agencies Requiring Written Agreements
Question: According to tissue banking standards, which 13 types of contract
agencies or outsourced services are strictly required to have formal, written
agreements in place?
Answer:
1. Donor referral sources
2. Authorization providers
3. Informed consent facilitators
4. Donor eligibility assessment services
5. Recovery, collection, and/or acquisition agencies
6. Post-delivery function providers
7. Laboratory services
8. Testing services
9. Processing facilities
10.Storage providers
11.Tissue release authorities
12.Distribution entities
13.Consignment intermediaries
Audit Frequency for Contracted Services
,Question: How frequently must a certified tissue bank conduct audits of its
contracted services to ensure compliance with quality standards and standard
operating procedures?
Answer: Every two years (biennially).
Infectious Disease Testing Laboratory Requirements
Question: What are the 6 mandatory compliance and regulatory requirements for
any laboratory (whether contracted or internal) that performs donor infectious
disease testing?
Answer:
1. FDA Registration: Must be explicitly registered with the Food and Drug
Administration (FDA).
2. Approved Test Kits: Must utilize appropriate FDA-licensed, approved, or
cleared donor screening tests.
3. Manufacturer Adherence: Must strictly follow the test kit manufacturer's
specific instructions.
4. CLIA Certification: Must hold a valid Clinical Laboratory Improvement
Amendments (CLIA) certification.
5. Record Retention: Must securely retain all donor test results for a minimum
of 10 years.
6. Tissue Bank Compliance: Must fully comply with all individual
requirements established by the partnering Tissue Bank.
Who is responsible for establishing the quality policy of a Tissue Bank
Management with Executive Responsibility
,What is the frequency of the quality assurance program internal audit/review
Annual
What are the responsibilities of the Tissue Bank's Medical Director?
1. Establishing Donor Eligibility Criteria (i.e. age)
2. Establish policies and procedures regarding Adverse outcomes
3. Responsible for notifying appropriate parties of positive infectious disease test
results
How long is AATB accreditation valid for?
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?
Alexis Carrel
What was the first recognized Tissue Bank?
U.S. Navy Tissue Bank
, When was AATB established?
1976
What should a record management system contain?
- 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?
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
EDITION AATB) QUESTIONS ANS
ANSWERS WITH COMPLETE
SOLUTIONS 100% CORRECT RATED A+
||UPDATED 2026
Contract Agencies Requiring Written Agreements
Question: According to tissue banking standards, which 13 types of contract
agencies or outsourced services are strictly required to have formal, written
agreements in place?
Answer:
1. Donor referral sources
2. Authorization providers
3. Informed consent facilitators
4. Donor eligibility assessment services
5. Recovery, collection, and/or acquisition agencies
6. Post-delivery function providers
7. Laboratory services
8. Testing services
9. Processing facilities
10.Storage providers
11.Tissue release authorities
12.Distribution entities
13.Consignment intermediaries
Audit Frequency for Contracted Services
,Question: How frequently must a certified tissue bank conduct audits of its
contracted services to ensure compliance with quality standards and standard
operating procedures?
Answer: Every two years (biennially).
Infectious Disease Testing Laboratory Requirements
Question: What are the 6 mandatory compliance and regulatory requirements for
any laboratory (whether contracted or internal) that performs donor infectious
disease testing?
Answer:
1. FDA Registration: Must be explicitly registered with the Food and Drug
Administration (FDA).
2. Approved Test Kits: Must utilize appropriate FDA-licensed, approved, or
cleared donor screening tests.
3. Manufacturer Adherence: Must strictly follow the test kit manufacturer's
specific instructions.
4. CLIA Certification: Must hold a valid Clinical Laboratory Improvement
Amendments (CLIA) certification.
5. Record Retention: Must securely retain all donor test results for a minimum
of 10 years.
6. Tissue Bank Compliance: Must fully comply with all individual
requirements established by the partnering Tissue Bank.
Who is responsible for establishing the quality policy of a Tissue Bank
Management with Executive Responsibility
,What is the frequency of the quality assurance program internal audit/review
Annual
What are the responsibilities of the Tissue Bank's Medical Director?
1. Establishing Donor Eligibility Criteria (i.e. age)
2. Establish policies and procedures regarding Adverse outcomes
3. Responsible for notifying appropriate parties of positive infectious disease test
results
How long is AATB accreditation valid for?
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?
Alexis Carrel
What was the first recognized Tissue Bank?
U.S. Navy Tissue Bank
, When was AATB established?
1976
What should a record management system contain?
- 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?
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
