CTBS Cheat Sheet 2026

The 30 highest-yield CTBS facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. A tissue bank receives a complaint that a processed bone allograft contained unexpected particulate matter. Under ISO 13485, this complaint must be: → Evaluated to determine if it constitutes a reportable event to FDA
2. When a cadaveric donor blood specimen is significantly hemolyzed, the tissue bank should: → Evaluate whether testing can proceed and document any potential impact on result validity
3. A tissue specialist processing Achilles tendon allografts notes it is the thickest tendon in the body. It inserts onto which anatomical structure? → The calcaneal tuberosity of the heel bone
4. In Certified Tissue Bank Specialist, what is the PRIMARY purpose of conducting regular safety drills and exercises? → To ensure personnel can respond effectively in emergencies
5. Nucleic acid testing (NAT) for tissue donors offers the primary advantage of: → Detecting HIV and HCV during the window period before antibody development
6. When a CTBS professional faces pressure to compromise professional standards, the BEST response is to: → Document the pressure and uphold professional standards
7. The FDA's 'same surgical procedure' exception under 21 CFR 1271.15(b) allows a physician to use HCT/Ps without full regulation if the tissue is: → Removed from and implanted into the same individual during the same surgical procedure
8. Which of the following is a contraindication to tissue donation due to risk of disease transmission? → Active systemic bacterial sepsis
9. What does the acronym 'UAGA' stand for in the context of tissue recovery? → Uniform Anatomical Gift Act
10. Under FDA 21 CFR 1271.85, which of the following laboratory tests is REQUIRED for all allogeneic tissue donors? → HIV-1/2 antibody and NAT testing
11. What is the most important professional competency for CTBS certification in storage and distribution? → Deep knowledge combined with practical application skills
12. How does the CTBS body of knowledge relate to daily professional practice? → It provides the foundational framework that guides decision-making and standard practices
13. What does a Certificate of Analysis (COA) for a processing reagent typically confirm? → The reagent meets specified quality criteria for identity, purity, and potency
14. What is the significance of maintaining a 'chain of custody' for donor tissue? → It provides a traceable record of tissue handling from donor to recipient
15. Which professional attribute is most valued in sterilization methods within the CTBS field? → Accountability and commitment to standards
16. Which of the following is a required element of labeling for a tissue allograft under 21 CFR 1271.370? → Donor identification number or alphanumeric code
17. A tissue bank's freezer alarm activates at -10°C during a power outage. The validated storage temperature for bone is -40°C or below. What must occur? → Quarantine the tissue and conduct a formal temperature excursion investigation
18. Which document typically outlines the compliance requirements for CTBS professionals? → Standards of practice and code of conduct
19. Which validation study is required to demonstrate that a processing method effectively inactivates enveloped and non-enveloped viruses in tissue? → Viral clearance validation study using surrogate viruses
20. Which regulatory body publishes the Good Tissue Practice (GTP) regulations applicable to human tissue establishments in the US? → FDA
21. Which of the following is a key element of an effective CAPA (Corrective and Preventive Action) system? → Root cause analysis followed by implementation and effectiveness verification
22. Which anatomical feature distinguishes cortical (compact) bone from cancellous (trabecular) bone at the microstructural level? → Cortical bone has Haversian systems (osteons); cancellous bone has a lattice of trabeculae
23. A tissue bank's distribution SOP requires two-person verification before releasing tissue. If only one person is available, the CORRECT action is to: → Hold the release until a second qualified person is available
24. When processing soft tissue allografts (e.g., tendons, ligaments), what is the primary function of low-dose gamma irradiation (< 20 kGy)? → To reduce bioburden without significantly compromising mechanical properties
25. Under AATB Standards, a tissue bank's corrective action process (CAPA) must include which key element to be considered complete? → Verification that the corrective action was effective in preventing recurrence
26. Which sterilization parameter is measured by a Biological Indicator (BI) containing Geobacillus stearothermophilus spores? → Steam sterilization efficacy
27. Which ISO standard specifically governs the development and validation of sterilization processes for medical devices and tissues? → ISO 11135 / ISO 11137
28. What action is required when a tissue bank identifies a distributed allograft that may pose a risk to recipients? → Initiate a formal recall and document all notification and retrieval activities
29. Under AATB standards, what must be documented when a tissue bank receives a customer complaint about an allograft? → The complaint details, investigation findings, and any corrective actions taken
30. Which anatomical plane divides the body into anterior (ventral) and posterior (dorsal) portions and is referenced when describing tissue layer orientation? → Coronal (frontal) plane