CTBS Exam 2022 Section F Tissue
Release
If a lab that performs organ donor testing performs the initial testing in duplicate or
triplicate? - answersthe tissue bank must obtain and review the results of all individual
tests performed.
If any one of those initial tests is reactive or positive, the tissue shall be determined not
suitable for transplantation.
WHO determines donor eligibility prior to release of tissue for transplantation? -
answersMedical Director or licensed physician designee
What needs to be Documented in donor records in regards to donor eligibility? -
answersEach donor record shall contain a disposition/release statement and signature
of both the Medical Director who is assuming responsibility for donor eligibility
determination and, if different, the individual(s) responsible for reviewing all technical
and quality control specifications.
What needs to be completed prior to the release of tissue for transplantation in final
review? - answersAll necessary information shall be complete and compiled in a
standardized format
PRIOR to final review and determination of donor eligibility and tissue acceptability for
transplantation
Who needs to review DRAI and determine eligibility of donor prior to tissue release? -
answersAlthough the DRAI interview may be preliminarily reviewed by technical staff to
evaluate acceptability for recovery, acquisition, collection, or processing,
tissue shall not be released for transplantation without determination of donor eligibility
by the Medical Director.
WHAT is contained in donor eligibility review record which is reviewed by Medical
Director or licensed physician designee? - answers1) acceptability of the authorization
or informed consent
2) suitability of the recovery site
delivery environment, or where collection took place
3) Pertinent info from the medical records generated at the time of death including:
any pathology, lab reports, physician summaries, and transfusion/infusion information
, 4)DRAI
5) Results of lab testing relevant to donor eligibility
6) any plasma dilution calculations used to determine the acceptability of the blood
sample used for testing
7) Culture results up to and through the completion of recovery or acquisition that are
pertinent.
(e.g., blood cultures, if performed; pre-sterilization/pre-disinfection cultures, if available)
8) applicable time limits for tissue recovery or acquisition
9) pertinent circumstantial and donor screening info relayed to tissue bank staff
10) results of PA or PE
11) Autopsy report, or a summary of findings, if performed
12) any other info gathered for the purposes of disease screening as required by
Standards and applicable laws or regulations
The determination of eligibility shall be based on ? - answersThe SOPM, these
Standards and applicable laws and regulations
In the case of pediatric donors who are 18months or less and have been breastfed
within the past 12 months? - answersthe birth mother's risk for transmissible disease
shall be EVAUATED for HIV, HBV, HCV and other infectious agents when indicated
For all donors 28 days of age or less? - answersthe infant and the birth mother shall
be screened for risk of RCDAD's and the mother's blood must be tested.
When third-party records are not available that can be used to establish a likely cause
of death, and if no autopsy was performed? - answersA certified copy of the death
certificate must be included in the donor record.
If it is not possible to obtain a certified copy, a verified copy of the death certificate must
be included in the donor record.
When third party records are available that can be used to establish a likely cause of
death, or if an autopsy was performed? - answersobtaining a certified copy or verified
copy of the death certificate is voluntary
If an autopsy was performed, the tissue bank's Medical Director? - answersShall review
the autopsy report or a summary of findings prior to the release of tissue to inventory
After dura mater has been recovered, a qualified pathologist shall perform an
examination of? - answersthe donor's brain
Release
If a lab that performs organ donor testing performs the initial testing in duplicate or
triplicate? - answersthe tissue bank must obtain and review the results of all individual
tests performed.
If any one of those initial tests is reactive or positive, the tissue shall be determined not
suitable for transplantation.
WHO determines donor eligibility prior to release of tissue for transplantation? -
answersMedical Director or licensed physician designee
What needs to be Documented in donor records in regards to donor eligibility? -
answersEach donor record shall contain a disposition/release statement and signature
of both the Medical Director who is assuming responsibility for donor eligibility
determination and, if different, the individual(s) responsible for reviewing all technical
and quality control specifications.
What needs to be completed prior to the release of tissue for transplantation in final
review? - answersAll necessary information shall be complete and compiled in a
standardized format
PRIOR to final review and determination of donor eligibility and tissue acceptability for
transplantation
Who needs to review DRAI and determine eligibility of donor prior to tissue release? -
answersAlthough the DRAI interview may be preliminarily reviewed by technical staff to
evaluate acceptability for recovery, acquisition, collection, or processing,
tissue shall not be released for transplantation without determination of donor eligibility
by the Medical Director.
WHAT is contained in donor eligibility review record which is reviewed by Medical
Director or licensed physician designee? - answers1) acceptability of the authorization
or informed consent
2) suitability of the recovery site
delivery environment, or where collection took place
3) Pertinent info from the medical records generated at the time of death including:
any pathology, lab reports, physician summaries, and transfusion/infusion information
, 4)DRAI
5) Results of lab testing relevant to donor eligibility
6) any plasma dilution calculations used to determine the acceptability of the blood
sample used for testing
7) Culture results up to and through the completion of recovery or acquisition that are
pertinent.
(e.g., blood cultures, if performed; pre-sterilization/pre-disinfection cultures, if available)
8) applicable time limits for tissue recovery or acquisition
9) pertinent circumstantial and donor screening info relayed to tissue bank staff
10) results of PA or PE
11) Autopsy report, or a summary of findings, if performed
12) any other info gathered for the purposes of disease screening as required by
Standards and applicable laws or regulations
The determination of eligibility shall be based on ? - answersThe SOPM, these
Standards and applicable laws and regulations
In the case of pediatric donors who are 18months or less and have been breastfed
within the past 12 months? - answersthe birth mother's risk for transmissible disease
shall be EVAUATED for HIV, HBV, HCV and other infectious agents when indicated
For all donors 28 days of age or less? - answersthe infant and the birth mother shall
be screened for risk of RCDAD's and the mother's blood must be tested.
When third-party records are not available that can be used to establish a likely cause
of death, and if no autopsy was performed? - answersA certified copy of the death
certificate must be included in the donor record.
If it is not possible to obtain a certified copy, a verified copy of the death certificate must
be included in the donor record.
When third party records are available that can be used to establish a likely cause of
death, or if an autopsy was performed? - answersobtaining a certified copy or verified
copy of the death certificate is voluntary
If an autopsy was performed, the tissue bank's Medical Director? - answersShall review
the autopsy report or a summary of findings prior to the release of tissue to inventory
After dura mater has been recovered, a qualified pathologist shall perform an
examination of? - answersthe donor's brain
