Deck 22: Tissue Banking As Part of the Transfusion Service

Question 1

A bone flap is harvested by a physician for a patient at hospital X. The patient has an issue with hospital X and requests to go to hospital Y. The patient is transferred, but the physician wants to continue with the treatment. Which of the following scenarios is possible?

A) Hospital X would need to be registered with the FDA as a tissue vendor in order to transfer the bone flap to hospital Y.
B) The patient is allowed to take the bone flap with him to hospital Y because it is autologous.
C) The physician is licensed to practice at both hospitals, so he is allowed to transfer the bone flap.
D) There is no tissue with transfer from one hospital to the next, because the material being transferred is bone.

Answer 1

A

Question 2

What steps can be taken to minimize adverse events due to transplantation?

A) Ensuring contaminated tissues are not used for transplantation
B) Preventing improper handling that may contaminate or damage tissue
C) Demonstration of safety and effectiveness of tissue products
D) All of these

Answer 2

D

Question 3

According to the AABB, what is the function of the medical director with regard to tissue banks?

A) Must obtain special education and approves standard operating procedures
B) Investigates adverse outcomes and participates in look-back investigations
C) Communicates with the physicians using the procured tissue or end product
D) All of these

Answer 3

D

Question 4

What aspect of tissue banking is especially important during product recalls?

A) Accreditation of the tissue bank
B) Qualifications of the medical director
C) Traceability of the tissue to donor
D) Vendor validation

Question 5

At a minimum, all but which of the following must be included on the tissue receipt records?

A) Tissue Identification Number (TIN)
B) Expiration date (if applicable)
C) Condition of the tissue and who received it/inspected it upon arrival
D) Donor's birth date

Question 6

Records of tissue must be kept at least after expiration.

A) 2 years
B) 5 years
C) 10 years
D) indefinitely

Question 7

From which organization would a newly established tissue bank seek accreditation?

A) American Association of Tissue Banks
B) The Food and Drug Administration
C) The Joint Commission
D) Any of these

Question 8

Which of these organizations is NOT involved with tissue bank regulating?

A) American Association of Tissue Banks
B) American Society of Clinical Pathology
C) The Food and Drug Administration
D) The Joint Commission

Question 9

Which Joint Commission standard has to do with storage of tissues?

A) PC.17.10
B) PC.17.20
C) PC.17.30
D) All of the above

Question 10

The 21 in 21 CFR 1271 refers to:

A) the region from which the tissue was collected, thus falling under the general provisions of that area.
B) the title established for food and drugs in the Code of Federal Regulations.
C) the category of FDA laws that govern all blood bank regulation.
D) none of the above.

Question 11

Which statement about autologous is true?

A) Autologous tissue has a different outdate than allogeneic tissue.
B) Autologous tissue is not regulated by the AATB.
C) The medical director can have autologous tissue reassigned to an allogeneic donor if it is not used by the autologous donor.
D) Autologous tissue should have the same shelf-life as allogeneic tissue under the same storage.

Question 12

If your facility is a member of and accredited by the Eye Bank Associates of America, there is no need to be monitored by the FDA.

Question 13

The AABB Tissue Committee's recommended model for a centralized tissue bank includes:

A) allowing surgeons to maintain their own inventories.
B) validating vendor qualifications being handled by the purchasing department.
C) the infectious diseases department investigation of adverse events.
D) none of these.

Question 14

Which of the following does NOT describe an adverse event.

A) A patient contracts Creutzfeldt-Jakob disease a year after tissue transplantation.
B) An allograft is failing to function as expected and appears to be rejected.
C) An irregularity with the handling of a particular tissue is discovered in an FDA inspection 3 months after the tissue was processed.
D) An infection may have been caused by an improperly handled tissue for transplantation.

Question 15

Which of the following statements is false?

A) Bone can be sterilized and all living tissue removed prior to its use.
B) Bone must be HLA typed to the recipient prior to implantation.
C) ABO/RH is not relative to be bone transplantation.
D) Bone can be made into screws, chips, spacers, and wedges for patient use.

Question 16

Tissue receipt records do not require which of the following data?

A) Date of tissue collection of tissue
B) Name and address of tissue supplier
C) Description of tissue and quantity
D) Date of tissue received at the facility

Question 17

The Joint Commission's standard states that

A) hospitals are required to establish a specific tissue bank.
B) hospital tissue banks must be located within the blood bank.
C) oversight of the tissue bank must be assigned.
D) all of these must be followed.

Question 18

Donors for cornea transplants must be tested for all but which of the following diseases prior to transplant?

A) HIV-1 and -2
B) Hepatitis B
C) Hepatitis C
D) Chlamydia trachomatis

Question 19

Which of these steps is NOT part of the transplant adverse events investigation process?

A) All of the tissues that originated from that donor must be investigated.
B) Communications between tissue bank and supplier to initiate a recall.
C) Additional tissue is tracked down to prevent transmission of disease to other recipients.
D) Vendor validation of transport containers

Question 20

Which of the following is generally excluded from the tissue bank?

A) Corneas
B) Liver
C) Heart valves
D) Skin

Question 21

Which of these events are classified as adverse?

A) Infectious disease transmission.
B) Failure of the allograft to function as expected
C) Transmission of malignancy
D) All of these

Question 22

The following are of concern when selecting a qualified tissue vendor EXCEPT:

A) the transparency and willingness of the vendor to provide information.
B) the method of processing and disinfecting the tissue.
C) the supplier's medical director staying out of the communication loop.
D) the ability of the supplier to meet special needs.

Question 23

What must be considered when selecting a qualified tissue vendor?

A) Tissues supplied must be high in quality, safe and effective for the intended use.
B) The tissue must be readily available in a useful time frame
C) Cost of tissue must fall within budgetary guidelines and customary price range.
D) All of these

Question 24

Which of these occurrences might initiate a recall?

A) An error in tissue processing is discovered
B) FDA inspection uncovers an irregularity in tissue processing.
C) A doctor discovers a tissue handling problem.

Question 25

Upon periodic inspection of tissue products, a violation of an FDA labeling regulation is discovered. What class of recall would this initiate?

A) Class I
B) Class II
C) Class III
D) None

Question 26

The first step in qualifying any vendor is to:

A) determine the number of FDA recalls by this vendor.
B) have your medical director establish communication with the vendor's medical director.
C) order a sample tissue on which to perform quality checks.
D) verify the supplier's FDA registration.

Question 27

Who among the following is NOT usually part of the committee that selects tissue vendors?

A) Blood bank staff technologist
B) Head surgeon of transplant staff
C) Laboratory/ tissue bank medical director
D) Would care physician using tissues

Question 28

How is an adverse transplant event defined?

A) A negative change in the tissue recipient
B) The patient has a reaction to tissue implant
C) There is an unexpected outcome after tissue implant
D) All of these