AATB 14th Edition Standards
Exam with 100% Correct
Answers
What type of efficacy monitoring is required for steam, ethylene oxide, and vaporized
hydrogen peroxide sterilization? - Answer- Weekly use of PCD
What type of efficacy monitoring is required for irradiation sterilization? - Answer-
Bioburden testing, dose audits, and dose mapping.
Equipment/instrument cleaning, decontamination, sterilization, qualification, calibration,
and maintenance records must be maintained for how long after creation? - Answer- 10
years
What can cardiac valve allografts be used for? - Answer- congenital heart defects and
endocarditis
What is the saphenous vein most commonly used for? - Answer- peripheral vascular
bypass
What must the QA program include? - Answer- 1.) designating and maintaining quality
control functions
2.) process validation studies
3.) equipment qualification studies
4.) purchasing controls
5.) procedures for corrective and preventative action
6.) reviewing donor screening, informed consent or authorization, recovery, and
processing records
7.) approving processing and relevant medical records prior to tissue release
8.) auditing
9.) documenting formal conclusions of all incidents
10.) maintaining documentation
11.) evaluating training and competency of personnel
12.) labeling controls
13.) establishing a process for sharing information with other tissue banks
,What qualification, verification, and validation requirements does a tissue bank have? -
Answer- 1.) to develop, document, and implement protocols for significant components
of facilities, processes, equipment, reagents, labels, containers, packaging materials,
electronic systems, and donor eligibility criteria
2.) to perform process validations for processes whose results cannot be fully verified
by subsequent inspection and test
3.) to assess process changes and perform revalidation
4.) to evaluate parameters tested and determine the adequacy of the study
What are acceptable methods to demonstrate validation? - Answer- 1.) studies
conducting challenges that can potentially affect tissue quality, and studies
demonstrating consistency when repeated lot to lot
2.) identification of an established procedure or process known to be effective, and
implementation without modification
When was the AATB founded? - Answer- 1976
What must tissue banks wanting a variance from current standards provide? - Answer-
1.) a request for variance including the particular standards number
2.) justification for the alternative that assures equivalency
3.) supporting information
What responsibilities does the Governing Body have? - Answer- 1.) determine the
scope of activities pursued by the TB
2.) designates employees as management with executive responsibility
3.) issues with liability, compliance, ethical considerations etc.
(T/F) TB shall have written agreements or contracts with individuals or organizations
that perform tissue banking activities/services. - Answer- True
The tissue bank must ensure that a laboratory performing donor infectious disease
testing for the TB is: - Answer- 1.) registered with the FDA and lists "testing" as a
function
2.) using appropriate donor screening tests
3.) following manufacturers instructions for tests
4.) CLIA certified or met equivalent requirements
5.) retaining donor infectious disease test results for 10 years
6.) aware of the archived sample standard
What are the responsibilites of a Medical Director? - Answer- 1.) establish, review, and
approve all medical policies/procedures
2.) establish donor eligibility criteria and make determinations
3.) establish procedures regarding adverse outcomes
4.) notifying of positive infectious disease results and reporting
, What is included in a donor record management system? (11) - Answer- 1.) donor
referral source info
2.) donor eligibility assesment
3.) informed consent or document of gift/authorization
4.) physical assessment/examination, and donor identification
5.) recovery or collection, transport, processing
6.) quarantine and infectious disease testing
7.) in-process testing
8.) record review
9.) labeling, storage, release, distribution
10.) quality control
11.) services to donor families
How long must records of informed consent, documents of gift/authorization, and
records pertaining to eligibility, recovery, processing, storage, distribution, and QA be
retained? - Answer- 10 years
How must revisions to paper records be made? - Answer- Single line drawn through
altered text, then initialed and dated by individual making the revision
What must cardiac records include? - Answer- 1.) ABO/Rh
2.) date/time of asystole
3.) date/time subjected to cold rinse solution
4.) date/time subjected to disinfection solution
5.) start/stop times for disinfection solution
6.) date/time when preservation began, and placed in final container
What must vascular records include? - Answer- 1.) ABO/Rh
2.) date/time asystole
3.) date/time subjected to perfusion solution
4.) date/time subjected to transport solution and wet ice temps
5.) date/time subjection to disinfection solution
6.) start/stop times for disinfection solutions
7.) date/time when preservation began, and placed in final container
Monetary compensation shall not be offered to a donor or authorizing person unless: -
Answer- 1.) reimbursing third parties for costs associated directly with donation
2.) reimbursing living donors for costs associated with a donation
What must written requests for tissue for research include? - Answer- the type of tissue
requested, how it will be used, and the name/address/affiliation of the principal
investigator responsible for receipt
What must be obtained from a donor or authorizing person to acquire tissues? -
Answer- Authorization
Exam with 100% Correct
Answers
What type of efficacy monitoring is required for steam, ethylene oxide, and vaporized
hydrogen peroxide sterilization? - Answer- Weekly use of PCD
What type of efficacy monitoring is required for irradiation sterilization? - Answer-
Bioburden testing, dose audits, and dose mapping.
Equipment/instrument cleaning, decontamination, sterilization, qualification, calibration,
and maintenance records must be maintained for how long after creation? - Answer- 10
years
What can cardiac valve allografts be used for? - Answer- congenital heart defects and
endocarditis
What is the saphenous vein most commonly used for? - Answer- peripheral vascular
bypass
What must the QA program include? - Answer- 1.) designating and maintaining quality
control functions
2.) process validation studies
3.) equipment qualification studies
4.) purchasing controls
5.) procedures for corrective and preventative action
6.) reviewing donor screening, informed consent or authorization, recovery, and
processing records
7.) approving processing and relevant medical records prior to tissue release
8.) auditing
9.) documenting formal conclusions of all incidents
10.) maintaining documentation
11.) evaluating training and competency of personnel
12.) labeling controls
13.) establishing a process for sharing information with other tissue banks
,What qualification, verification, and validation requirements does a tissue bank have? -
Answer- 1.) to develop, document, and implement protocols for significant components
of facilities, processes, equipment, reagents, labels, containers, packaging materials,
electronic systems, and donor eligibility criteria
2.) to perform process validations for processes whose results cannot be fully verified
by subsequent inspection and test
3.) to assess process changes and perform revalidation
4.) to evaluate parameters tested and determine the adequacy of the study
What are acceptable methods to demonstrate validation? - Answer- 1.) studies
conducting challenges that can potentially affect tissue quality, and studies
demonstrating consistency when repeated lot to lot
2.) identification of an established procedure or process known to be effective, and
implementation without modification
When was the AATB founded? - Answer- 1976
What must tissue banks wanting a variance from current standards provide? - Answer-
1.) a request for variance including the particular standards number
2.) justification for the alternative that assures equivalency
3.) supporting information
What responsibilities does the Governing Body have? - Answer- 1.) determine the
scope of activities pursued by the TB
2.) designates employees as management with executive responsibility
3.) issues with liability, compliance, ethical considerations etc.
(T/F) TB shall have written agreements or contracts with individuals or organizations
that perform tissue banking activities/services. - Answer- True
The tissue bank must ensure that a laboratory performing donor infectious disease
testing for the TB is: - Answer- 1.) registered with the FDA and lists "testing" as a
function
2.) using appropriate donor screening tests
3.) following manufacturers instructions for tests
4.) CLIA certified or met equivalent requirements
5.) retaining donor infectious disease test results for 10 years
6.) aware of the archived sample standard
What are the responsibilites of a Medical Director? - Answer- 1.) establish, review, and
approve all medical policies/procedures
2.) establish donor eligibility criteria and make determinations
3.) establish procedures regarding adverse outcomes
4.) notifying of positive infectious disease results and reporting
, What is included in a donor record management system? (11) - Answer- 1.) donor
referral source info
2.) donor eligibility assesment
3.) informed consent or document of gift/authorization
4.) physical assessment/examination, and donor identification
5.) recovery or collection, transport, processing
6.) quarantine and infectious disease testing
7.) in-process testing
8.) record review
9.) labeling, storage, release, distribution
10.) quality control
11.) services to donor families
How long must records of informed consent, documents of gift/authorization, and
records pertaining to eligibility, recovery, processing, storage, distribution, and QA be
retained? - Answer- 10 years
How must revisions to paper records be made? - Answer- Single line drawn through
altered text, then initialed and dated by individual making the revision
What must cardiac records include? - Answer- 1.) ABO/Rh
2.) date/time of asystole
3.) date/time subjected to cold rinse solution
4.) date/time subjected to disinfection solution
5.) start/stop times for disinfection solution
6.) date/time when preservation began, and placed in final container
What must vascular records include? - Answer- 1.) ABO/Rh
2.) date/time asystole
3.) date/time subjected to perfusion solution
4.) date/time subjected to transport solution and wet ice temps
5.) date/time subjection to disinfection solution
6.) start/stop times for disinfection solutions
7.) date/time when preservation began, and placed in final container
Monetary compensation shall not be offered to a donor or authorizing person unless: -
Answer- 1.) reimbursing third parties for costs associated directly with donation
2.) reimbursing living donors for costs associated with a donation
What must written requests for tissue for research include? - Answer- the type of tissue
requested, how it will be used, and the name/address/affiliation of the principal
investigator responsible for receipt
What must be obtained from a donor or authorizing person to acquire tissues? -
Answer- Authorization
