Tissue Banking/Human Allografts Flashcards
Which tissue is the most common type used for patients?
a. Freeze dried bone
b Cornea
c. skin
d. Heart Valve
Correct: Cornea
Corneal transplantation (CT) is the most frequently performed type of transplant worldwide. It restores visual function when impairment caused by corneal damage is deemed too severe to provide acceptable quality of life in the country where it is performed.
What statement below best describes the risk of transmitting infectious disease via allograft transplantation?
a. Irradiation of every allograft keeps infectious disease transmission low
b. Infectious disease transmission is common in allografts transplantation
c. Infectious disease transmission in allografts is low because every tissue donation is sterilized
d. Infectious disease transmission risk is low in allografts because of donor screening, disease testing and improved standards.
Correct: Infectious disease transmission risk is low in allografts because of donor screening, disease testing and improved standards.
Donor screening, first and foremost keeps the rate of viral transmission low. Remember that the donor screening for tissue donation involves a complete physical as well as extensive questioning of medical history. Add to that the viral marker testing, and the comprehensive nature of the standards, so both mean that the rate of transmission in allograft transplantation is rare.
In fact, the rare instances of disease transmission that do occur are largely due to human error in screening, testing, or processing (in the case of bacterial transmission)
Which of these procedures below would qualify as an autologous tissue transplant?
a. Pig valves implanted into a 42 year old woman
b. Patient skull bone flap moved during a surgical procedure
c. patient skull bone flap harvested, processed and implanted 3 days later.
d. Patient connective tissue removed and implanted during a single surgical procedure
Correct: patient skull bone flap harvested, processed and implanted 3 days later.
Holli Mason, MD. the author of the Harmening chapter , defines autologous tissue as that which is removed and then implanted at a later date. A procedure such as the patient whose bone skull flap is moved during one surgery is NOT defined as autologous tissue.
The distinction is important because “tissue” processing may mean that the facility has to register with the FDA, and there is oversight for “tissue” processing. Removing and implanting the patient’s skin, bone, etc., during one procedure falls under the umbrella of “treatment” and not true transplantation.
Which choice below represents organizations that have oversight over tissue banking?
a. FDA
b. FDA, AATB
c. FDA, AATB, AABB
d. CMS
Correct: FDA, AATB, AABB
FDA regulations concerning tissue banking are found in CFR Title 21 Part 1271. AABB and AATB have also written standards for tissue banking and the AATB has a certification process for tissue banks.
In addition, organizations such as JCAHO, and tissue specific groups such as those for eye and breast milk (listed in the additional resources for week 10) may have additional guidelines.
A tissue is harvested from a donor in a separate department and the local blood bank has agreed to store the tissue long term. Staff is trained to properly handle the tissue and charges to the other department to reflect the tech time needed to store the tissue. A tissue is dropped off but you’re not quite sure what the appropriate storage temperature for the tissue is. How would a tissue bank manager determine the proper storage condition for tissues received?
a. Consult the CFR
b. Consult the AABB
c. Consult the AATB
d. Consult the tissue vendor
Correct: Consult the tissue vendor
Tissue vendors are required to provide information on the proper storage conditions. The requirements will vary from tissue to tissue, and there are situations, such as bone tissue, in which the storage conditions vary depending on how the bone was processed (i.e. freeze dried, fresh, etc. ). Ideally the storage requirements for tissue stored in the blood bank should be clearly defined in an SOP but the SOP may or may not be available for blood bank staff.
A rural man who died with “chest numbness and back pain” in 1979, was reported by Houff and colleagues. His corneas were transplanted into an individual who died 6 weeks later, following development of headaches, eye pain, and respiratory failure. Studies on both donor and recipient revealed a rabies infection in both individuals. Had the clinical history of the deceased been more accurate, the transplant and subsequent second death could have been avoided.
Had this event occurred recently, the transplant facility would have been required to…
a. notify the FDA of the adverse event
b. notify the next of kin immediately following the death of the donor
c. perform a full autopsy on the donor
d. reharvest the tissue and save for up to 10 years
correct answer: notify the FDA of the adverse event
the remaining answers would not need to occur. The family may be notified once the complete investigation was performed, documented and reported but not immediately following the death of the donor.
In this case the donor was already deceased a full autopsy would not have been possible or necessary to determine the rabies status
it would not be customary to re harvest a tissue. Additionally it is not required.
CGTP as it relates to this week’s reading materials, stands for…
a. Current Good Tissue Practice
b. Controled General Tissue Practice
c. Current Good Transplant Practice
d. Corellated General Tissue Practice
ALL tissue banking and tissue banks are required to participate in Current Good Tissue Practice (CGTP) which is analogous to current good manufacturing practice (cGMP) in blood banking
GCTP is to tissue banking as X is to blood banking.
What is X?
a. cGMP
b. AABB
c. FDA
d. CAP
ALL tissue banking and tissue banks are required to participate in Current Good Tissue Practice (CGTP) which is analogous to current good manufacturing practice (cGMP) in blood banking
At what period of time did the FDA become more involved in oversight of tissue banking?
a. 1990’s
b. 2000’s
c. 1980;s
d. 1970’s
correct answer: 1900’s
What is AABB’s recommendation for a hospital’s tissue-dispensing model?
a. Dispersed tissue-dispensing model located within the transfusion service.
b. Centralized tissue-dispensing model located within the transfusion service.
c. Dispersed tissue-dispensing model with shared responsibility between the transfusion and surgical services.
d. Centralized tissue-dispersing model with shared responsibility between the transfusion and surgical services.
Answer B (Page 638)
