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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
recommended, commonly accepted, not essential	May/Should
mandatory requirement	Must/Shall
an enclosure for 1 finished unit of transplantable tissue	Container
labeled receptacle containing tissue, may contain one or more containers and accompanying labeling materials.	Package
departure from procedure or normal practice	Deviation
a deviation from documented standards	Error
pre-approved departure from standards	Variance
an occurrence, not associated with a deviation, during stages of the deviation process that may affect 4 specific things: 1) Peformance 2) Bio compatibility (with recipient) 3) Freedom from transmissible pathogens 4) Tissue traceability	Accident
postmortem assessment	Physical Assessment
premortem exam	Physical Examination
permission given after adequate information concerning the donation, recovery and use of tissues is conveyed.	Authorization
information sufficient for donor/living donor/authorizing person to make a voluntary decision regarding the gift of tissues for TERT (transplantation, education, research and therapy)	adequate information
permission given by living donors -must be presented with scope, uses and risks/ benefits	informed consent
upon the death of the donor, the person, other than the donor, authorized by law to make an anatomical gift.	authorizing person
a person who is authorized to perform designated functions for which he/she is trained and qualified. -record of training (when/what) must be kept on file	responsible person
a responsible person who seeks authorization from an authorizing person or who makes notification concerning donation, recovery and use of gift(s)	donation coordinator
must be established, must be adequate for intended use, must be based on valid statistical rationale (such as FDA Guide to Inspection of Quality Systems)	sampling plans
a database established in accordance with law, consisting of legally valid documents of gift (s)	donor registry
conformance (of tissue or a process) to be pre-established specifications and/or standards. -applies to all people (staff), policies that describe a process (regulated work), the systems that contain that work (electronic systems, donor records, training records), packaging/containers/critical supplies.	quality
the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. (MwER)	quality policy
an undesirable effect or untoward complication in a recipient consequent to or reasonably related to tissue transplantation.	adverse outcomes
computerized systems that create source documents	electronic systems
Group of standard operating procedures (SOPs) detailing the specific policies of a tissue bank and the procedures used by the staff personnel to carny out the functions of the tissue bank.	SOPM
The ability of an employee to acceptably perform tasks for which he/she has been trained.	competency
The evaluation of the ability of an employee to acceptably perform tasks for which he/she has been trained.	competency assessment
the policies and environment required to meet standards of quality and safety, and to provide confidence that the processes and tissue consistently conform to quality requirements	quality assurance program
the process of establishing confidence that equipment, materials, reagents and ancillary systems are capable of consistently performing within established limits/ tolerances; establishes confidence that the process is effective and reproducible.	qualification
remedial action to eliminate a detected nonconformity	correction
action to eliminate the cause and present recurrence of a nonconformity or other undesirable situation; may be performed in conjunction with preventative action(s).	corrective action
action to eliminate the cause of a potential noncomformity or other undesirable situation	preventative action
a documented review of procedures, records, personal functions, equipment, materials, facilities, and/or supplies to evaluate adherence to the written SOPM , standards, applicable laws and regulations	audit
any written, printed, or graphic material used to identify tissue, cultures, blood specimens or other donor specimens	label
Any printed or written material, including labels, advertising, and/or accompanying information (eg. package insert, brochures, and pamphlets) related to the tissue.	labelling material
Specific tests defined by the QA program to be performed to monitor recovery, processing, preservation, and storage, tissue quality and test accuracy. These may include, but are not limited to, performance evaluations, inspection, testing, and controls used to determine the accuracy/viability of tissue banks equipment, operational procedures, and monitoring of supplies, reagents, equipment and facilities.	quality control
Activities performed to systematically observe and record data to characterize the environment to identify conditions, under which the potential may exist, for contamination or cross-contamination of tissue.	environmental monitoring
The limits that define a range of acceptable values that are established for each testing procedure which, when exceeded, require the implementation of corrective actions designed to produce results within the acceptable range in future tests.	tolerance limits
Any tests, samples, evaluations, monitoring, or measurements performed during processing or preservation that are designed to ensure conformance to specifications in the SOPM.	In-process controls
a system of checks and balances incorporated into SOP's introducing critical operations to prevent errors	Process controls
the transfer of infectious agents from one tissue to another (same or different donor)	cross-contamination
The process of establishing confidence that equipment, materials, reagents, and ancillary systems are capable of consistently performing within established limits and tolerances.	qualification
The confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.	verificaiton
confirmation through the provision of documented objected evidence that predefined specifications have been fulfilled and can be consistently reproduced.	validation
A finding that identifies non fulfillment of an accreditation requirement, a standard, policy, process, procedure or specification.	Non-conformity
Adjustment, clarification, and/or correction of practices and/or procedures that results in compliance with SOPM and/ or standards.	Resolution
a quality of tissue indicating handling according to standards and substantial freedoms from the potential for harmful effects to recipients	Safety
a decrease in the concentration of the donor's plasma proteins and circulating antigens or antibodies resulting from the transfusion of blood or blood products/components and/or infusion of fluids (colloids/crystalloids)	plasma dilution
(C)- the time interval from asystole to subjecting cardiac tissue to cold rinse (or transport) solution at recovery. (V)- the time interval from asystole to subjecting vascular tissue to transport solution and wet ice temperatures (temperature greater than 0 degrees Celsius, less than or equal to 10 degree Celsius) at recovery. MS,OA & S- reference "prep times"	warm ischemic time
Recovery activities must begin within 24 hours of asystole, if donor was cooled within 12 hours from TOD. If body was not cooled within 12 hours, recovery activities ,must begin within 15 hours of death. If body was cooled, then not cooled, total time not cooled must not exceed 15 hours. If body was not cooled at all past 15 hours from TOD, recoveries cannot continue.	Donor Cooling Rules
for the purpose of labeling, tissue provided for storage or transplantation	donated human tissue
the identification of tissue, reagents, supplies, materials and equipment as not suitable for use, or that has not yet been characterized as being suitable for use.	quarantine
the maintenance of tissue for future use.	storage
A condensed version of the donor testing and eligibility determination records. This can be combined with package insert.	summary of records
The written material accompanying an allograft or autograft baring further information about the tissue, directions for use, and any warnings.	package insert
Any unique combination of letters, numbers, and/or symbols assigned to tissue and linked to a donor, from which the complete history of each significant step can be traced.	tissue identification number
The ability to locate tissue during any steps of its donation, recovery, collection, or acquisition, processing, testing, storage, distribution or disposition. It implies the capacity to identify the medical facility receiving the tissue and, at the medical facility, the ability to identify the recipient.	traceability
human cells, tissues, or cellular or tissue-based products	HCTIPs
Any or all steps in the recovery, processing, storage, labeling, packaging or distribution of any human cell or tissue, and the screening and/ or testing of the donor.	manufacture
The processing of tissue using aseptic techniques where tissue, containers, and/or devices are handled in a controlled environment in which the air supply, materials, equipment and personnel are regulated to prevent microbial contamination of tissue.	aseptic processing
restricted work areas of low microbial and particulate content in which non-sterile materials are prepared	controlled areas
an additive that serves to minimize osmotic imbalances that occur with the progression of freezing fronts through a substance, and is intended ti limit the amount of cell damage caused by cell shrinkage and intracellular ice formation.	cryoprotectant
frozen with the addition of, or in a solution containing, a cryoprotectant agent such as glycerol or dimethylsulfoxide	cryopreserved
the removal of water from tissue	dehydration
the removal of water from tissue	desiccation
A process that reduces the number if viable microorganisms on tissue, but may not destroy all forms, such as spores and viruses.	disinfection
Tissue dehydrated for storage by conversion of the water content of frozen tissue to a gaseous state under vacuum that extracts moisture.	hydrophilized
Tissue produced from one donor at one time using one set of instruments and supplies. Also refers to a quantity of reagents, supplies, or containers that is processed or manufactured at one time and identified by a unique identification number.	Lot
The use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of tissue.	preservation
The probability of a single viable microorganism occuring on a product after sterilization 10^-3 one in a thousand; 10^-6 one in a million	Sterility Assurance Level (SAL)
A validated process used to render tissue free from viable microorganisms including spores.	Sterilization
a validated process whereby tissue within its final sterile barrier system (eg. package, container) is sterilized.	Terminal Sterilization
prevention of the introduction, transmission or spread of communicable disease agents	PITSCD
tissue that has been fully processed, enclosed in its final container, labeled, and released to distribution inventory	finished tissue
a labeled box, carton, receptacle, or wrapper containing tissue and may contain one or more containers and accompanying labeling materials.	package
any tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user (agency, institution, or organization) that receives tissue	consignee
a health care practitioners who performs transplantation procedures	end-users
a facility responsible for the receipt, maintenance and delivery of tissue for transplantation or research.	dispensing services
a filed correction or removal of distributed tissue initiated to reduce a risk to health posed by the tissue or to remedy a violation of regulatory requirements that may present a risk to health.	Recall
For distributed tissue, the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) without its physical removal to some other location.	field correction
the physical removal of distributed tissue from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.	removal
a room temperature, sterile isotonic solution such as tissue culture media on PlasmaLyte utilized to gently perfuse veins at recovery. This solution may also contain an antithrombotic agent.	perfusion solution (V)
the time interval from asystole to subjecting the vascular tissue to perfusion solution	Perfusion Time (V)
the time interval form asystole to subjecting vascular tissue to transport solution and wet ice	warm ischemic time (V)
the time interval from asystole to subjecting cardiac tissue to cold rinse (on transport) solution at recovery	warm ischemic time (C)
temps ranging from above freezing, 0 degree Celsius to 10 degree Celsius	wet ice temperatures
the time interval from subjecting cardiac tissue to cold rinse (or transport) solution at recovery to the beginning of disinfection.	cold ischemic time (C)
the time interval from subjecting VI to transport solution and wet ice temperatures at recovery to the beginning of disinfection.	cold ischemic time (V)
the time interval from asystole to subjecting tissue to disinfection solution. The sum of warm ischemic time and cold ischemic time.	total ischemic time (C, V)
the time interval between subjecting tissue to disinfection solution and transferring tissue to rinsing solutions in preparation for preservation	disinfection time (C, V)
Cardiac	C
Vascular	V
Musculoskeletal Tissue	MS
Birth Tissue	BT
tissue intended for transplantation into a genetically different person	allograft
A frequency of activity defined by each tissue bank as 12 months including reasonable tolerance limits (up to 3 months). Justification for the tolerance limits shall be documented by the tissue bank with consideration for the risk associated with the specific activity scheduled	annual
The distal segment of the abdominal aorta including the bifurcation and proximal segments of both the left and right common iliac arteries.	aortoiliac graft (c)
A segment of peripheral artery that is recovered, processed and preserved.	Arterial graft (V)
The recovery of tissue using methods that restrict or minimize contamination with microorganisms from the donor, environment, recovery personnel, and/or equipment.	Aseptic recovery
The reference time for cardiac death.	Asystole
A process that capture details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record.	audit trail
Tissue intended for implantation, transplantation or infusion into the living donor from whom it was recovered.	autograft (A)