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284 Cards in this Set
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Cryopreserved cardiac and vascular tissue must be maintained at what storage temperatures?
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-100*C or colder
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The minimal dose of irradiation for terminal sterilization is:
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must be validated and supported by data. SAL (Security assurance level) must be selected & dose must achieve SAL.
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Maximum residual calcium content of demineralized bone shall not exceed...
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8% calcium residuals "by a standard method"
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Laboratories performing serology testing must have what certification?
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CLIA (Clinical Laboratory Improvement Amendments)
Labs must be registered with FDA as tissue establishment for testing AND either CLIA certified or meet equivilent requirements per Centers for Medicare & Medicaid Services. D4.353 |
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The time period to be examined for plasma dilution for blood, blood products and colloids is...
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48 Hours
(Crystalloids: 1 Hour) |
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Archived serum must be maintained for how many years after Recovery/Collection date?
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10 years
(Additional standards for (DM) & (R)) |
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(C) tissue may be recovered from donors up to what age?
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Medical Director &/or Medical Advisory Committee determine age criteria for donor suitability.
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When a body is refrigerated 13 hour after death, (MS) recovery must commence in how many hours after death?
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Skin prep within 15 hours.
(MS, OA, S = same post-mortem time limits) |
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What are the 7 required infectious disease tests?
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1.antiHIV1/2 (antibodies)
2.NAT HIV1 (nucleic acid) 3.HBsAg (Hep B Surface Antigen) 4.antiHBc-Total (IgG & IgM - total antibodies to core antigen) 5.antiHCV 6.HCV NAT 7.Syphillis (non-treponemal or treponemal-specific assay) (Standards for all tissue except (A, R)) |
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(MS) tissue must be processed in what class environment?
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"bacteriologically and climate controlled environment"
(same for S, OA, A) |
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Another term for freeze dried tissue is...
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Lyophilized
(lyo = dispersion, dissolution) |
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History of autoimmune diseases shall be handled in what manner?
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Eval for suitability by Medical Director according to SOPM.
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A reactive screening test where the confirmatory test is negative is acceptable for which test?
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Syphillis - If initial NON-treponemal assay is reactive but the confirmatory treponemal-SPECIFIC assay is negative, then tissue is transplantable.
(If initial test is treponemal-SPECIFIC, and it's positive, then no transplantation regardless of repeat test results) |
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Lyophilized (MS) tissue can be stored for how many years?
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5 years from processing date.
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The maximum storage time for refrigerated fresh skin (not processed or preserved is...
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14 Days.
(if its going to be frozen/cryopreserved, then 10 days with media changes every 72 hours; no media change then 96 hours only) |
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Osteoblasts are cells that...
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Osteoblast ("bone" "germinate") are cells with single nuclei that synthesize bone. However, in the process of bone formation, osteoblasts function in groups of connected cells. Individual cells cannot make bone, and the group of organized osteoblasts together with the bone made by a unit of cells is usually called the osteon.
Osteoblasts are specialized, terminally differentiated products of mesenchymal stem cells. They synthesize very dense, crosslinked collagen, and several additional specialized proteins in much smaller quantities, including osteocalcin and osteopontin, which comprise the organic matrix of bone. In organized groups of connected cells, osteoblasts produce a calcium and phosphate-based mineral that is deposited, in a highly regulated manner, into the organic matrix forming a very strong and dense mineralized tissue - the mineralized matrix. This is further discussed in "Mineralization of bone" below. The mineralized skeleton is the main support for the bodies of air breathing vertebrates. It also is an important store of minerals for physiological homeostasis including both acid-base balance and calcium or phosphate maintenance. |
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Who formed the first tissue banks in the US in the late 1940s?
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History of Tissue Transplantation
1900s - Successful transplantation of bone, soft tissue and corneas began. 1949 - The establishment of the U.S. Navy Tissue Bank gave the nation its first bone and tissue processing and storage facility. 1970s -The rapid development of transplant medicine, combined with factors including general population growth and expansion of the elderly population caused an increased demand for donated tissues and organs. 1986 - There were more than 300 bone banks in operation. 1993 - The Food and Drug Administration (FDA) initiated regulation of all U.S. Tissue Banks. 1997-2005 - Additional regulations were announced including the required registration with the FDA of all tissue banking establishments and tissue donor suitability criteria. The FDA enforced the comprehensive Good Tissue Practices. This regulation which binds all agencies that recover, process, store, label, package, distribute, screen or test human tissue resulted in greater safety assurances industry wide. Today - It is estimated that over one million allograft tissue transplants are performed annually. |
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The critical volume of infused blood/fluids in an adult donor with blood loss requiring evaluation of potential hemodilution is...
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Older than 12 years: 2000mL blood/colloids/crystalloids
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Frozen MS tissue kept for greater than 6 months must be stored at or below what temperature?
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-40*C or colder
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Which of the following histories of cancers always excludes donation of skin?
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Melanoma
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Within what time interval must the body be refrigerated to allow commencement of MS recovery at 24 hours?
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12 Hours
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Persons who have lived with another person with HepB or clinically active HepC rules out donation for what time interval?
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12 months
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White cell counts can be elevated for which of the following reasons?
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infection, neurological, disease of bone marrow
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Identify the common source(s) of ionizing radiation.
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Cobalt 60, electron beam, Xray
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How long must donor processing records be retained after date of distribution, date of implantation (if known), date of disposition, or date of expiration (whichever is latest)?
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10 years (or longer if required by law)
exceptions: (DM) - indefinitely; (R) - until tissues are used or destroyed |
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The maximum time that MS tissue shall remain on wet ice prior to processing or freezing is ...
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No longer than 72 hours.
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A very small piece of tissue (<100mg) shall have no more than how many parts per million of residual ethylene glycol following terminal sterilization with ethylene oxide?
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2500
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Potential donors who have traded sex for drugs or money are excluded from donation for what period following the last incident at risk?
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5 years
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The cruciate ligament connects the ...
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Anterior and Posterior C.L. form an "X" connecting tibial head to intercondyloid femoral notch.
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The greater trocanter is located on the ...
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medial to femoral head (lesser trochanter is inferior to femoral head, medial to head/greater trochanter)
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An anatomical structure located medially is ...
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Toward the median plane/ midline.
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The achilles tendon connects to what bone?
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Thickest tendon in the human body. Gastrocnemius & Soleus connect to CALCANEUS.
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The stratum corneum and lucidum are parts of what tissue?
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Skin
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Which of the following organisms found on skin cultures result in the destruction of the tissue?
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Staph aureus, Strep pyogenes (group A strep), Enterococcus, gram neg bacilli, clostridium, & fungi (yeasts, molds).
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What is the UAGA hierarchy for granting consent?
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donor, spouse, adult child, parent, sibling, other relative or adult with special concern, guardian, other person with authority for final disposition
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Compensation for donation is acceptable...
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1. tissue bank reimburse responsible 3rd parties for costs directly associated with donation
2. tissue bank reimburse living donors ex. restoration of lost earnings (if authorized by law) (R) monetary compensation to donors if compliant with current ASRM Guidelines for Gamete and Embryo Donation -Donors and their families shouldn't be held responsible for expenses related to allogenic tissue recovery -compensation includes monetary and other (incl. goods, services) |
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Prior to recovery of tissues the area of excision shall be ...
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clean, prep, drape
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A man killed in a traffic accident was reported as having used IV drugs as recently as 2005 but his family relates that he has been clean since then and has attended a rehab program. The man is...
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Eligible for donation; IV drug use 5 years
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During transport to the processing facility the outer container must contain...
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Must contain: TIN, expiration, descriptive name, name/address of TB, storage conditions, disinfection/sterilization procedure, preservative, qty/other characteristics, potential residues, reference to package insert.
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Split thickness skin is generally recovered at what thickness?
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0.012 - 0.018
(FTSG at 0.018 - 0.035) |
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The Director of the Tissue Bank shall review all SOPs every...
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Annually
(reviewing SOPs for donor suitability and adverse outcomes) |
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Techniques for preserving MS tissue include...
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frozen, cryopreservation, lyophilization
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Packaging of CV tissue must be done in what class environment?
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IO5 (Grade A Class 100)
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Pre-sterilization cultures of OA tissue must be...
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negative for Clostridium, Strep pyogenes (group A strep), or any other virulent microorganism, unless treated with validated disinfection/ sterilization process.
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To prevent additional ischemia and possible cellular damage, cardiac tissue shall be processed by methods that maintain the tissue and solutions between what temperatures?
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0-10*C
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During skin processing it is allowable for the tissue or solutions to be above 10*C for no longer than what duration of time?
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2 hours
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Package inserts shall contain the following:
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limited to health professionals, intended for 1 patient and 1 occasion, known contraindications, warnings & adverse reactions, sensitizing agents, may transmit infectious agents, cannot re-sterilize, dosage info, how supplied (frozen, lyophilized), antibiotics, concentration of preservative/ cryoprotectant, opening & preparation instructions, storage conditions,
"donated human tissue", effective date |
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Which of the following precludes the use of skin if found in the final culture results?
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1. (like C,V,CT) fungi (yeast/mold), clostridium, strep pyogenes (Group A strep)
or 2. (S only) staph aureus, enterococcus, gram neg bacilli) |
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How often must QA staff perform audits of major tissue banking operations?
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At Least Annually
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SOP manuals must be made available to applicable staff at what intervals?
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At all times.
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Employee review of SOPM must be maintained for what time period following employment termination?
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16 years, or as required by law/regulation (whichever is longer)
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Archived SOPs shall be maintained for what time period after discontinuation?
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16 years
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Persons with a recent history of encephalitis or meningitis ...
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Active viral or unknown etiology unacceptable
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Allograft heart valve grafts internal annulus shall be sized...
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in mm
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In the anatomical position, the palms of the hands face...
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Anterior
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The use of bi and tri-cortical wedges is commonly associated with what type of surgery?
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spinal fusions (cortical = structural/ weight-bearing)
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The most common BTB allograft is fashioned from the....
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Patellar tendon: patella to tibial tuberosity.
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Another name for spongy bone is...
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Cancellous (vs. cortical)
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Upper age for MS recovery is...
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Determined by Medical Director and/or tissue bank Medical Advisory Committee.
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The Ross procedure is associated with what surgical specialty?
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Replace diseased aortic valve with autograft pulmonary valve. Then transplant allograft pulmonary valve.
Advantages: Freedom from thromboembolism without the need for anticoagulation, The valve grows as the patient grows (i.e. children), Favourable hemodynamics, No foreign material present in the valve. Disadvantages: Single valve disease (aortic) treated with a two valve procedure (aortic and pulmonary). |
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Which of the following practices is not governed by cGTP final rule?
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21CFR Part 1270 cGTP final rule Subpart D
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The presence of HbsAb in a serologic panel means...
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Hep B surface antibody
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Processing of OA tissue must be accomplished within what time frame?
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5 days (must be kept in solution at wet ice temperatures throughout)
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The current requirement for exclusion of donors from the UK d/t high risk for CJD is...
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3 cumulative months in UK 1980-1996 OR transfusion 1980-present.
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Donors with a history of what type of transplant shall be declined for donation?
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live cell xenograft or human dura mater
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Which valve regulates blood flow between the right Atrium and right Ventricle?
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Tricuspid
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The acetabulum is associated with which joint?
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Femoral head meets pelvis at acetabulum (socket).
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The olecranon process is found on which bone?
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Ulnar process, forms the outer bump of the elbow, fits into the fossa of the humerus when the arm is extended.
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https://o.quizlet.com/fhHVToCl9QEgbK9og4EUqg_m.jpg
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The presence of an amateur tattoo precludes donation for how long?
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N/A (12 months if shared instruments)
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Who must consent for donation in the following scenario: The donor is divorced and has an adult child who lives at home with deceased. Donor also has a parent still alive.
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adult child (before parent or sibling)
donor, spouse, adult child, parent, adult sibling, another adult related or special care, guardian, other person with authority for final disposition |
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Which of the following levels of air filtration provides the greatest reduction in airborne particles?
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Class 1/ISO 3
(Maximum particles is Class 100K/ISO8) |
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The Reduviid bug is the vector for which parasitic infection that has been linked to CV allografts?
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Triatomine bugs are a type of reduviid bug that can carry the parasite Trypanosoma cruzi that causes Chagas disease.
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Vector
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Any agent (person, animal or microorganism) that carries and transmits an infectious pathogen into another living organism.
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When determining the effect of plasma dilution on a sample, donors under what age must always have an algorithm applied if transfused or infused?
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Less than 12 years
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AATB History
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Founded in 1976. First Standards 1984. Voluntary accreditation 1986.
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JCAHO
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Joint Commision on Accreditation of Hospitals Organization
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Consequences of failing to comply with Standards...
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AATB Board of Governors majority, corrective action in accordance with bylaws. Accreditation may be rescinded.
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Define: Critical
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Classification of a supply, reagent, material, or equipment that can affect the quality and/or safety of tissue.
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Define: Cellular Tissue (CT)
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Cells that are autologous or allogenic, committed or uncommitted, and non-expanded.
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Define: Perfusion Solution (V)
**corrected definition |
A room temperature, sterile isotonic solution such as tissue culture media or Plasmalyte utilized to gently perfuse veins at recovery. This solution may also contain an antithrombotic agent (i.e., sodium, heparin).
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Define: Skin Prep
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The application of antiseptic solution to decomtaminate the skin. This is a continuous process that is performed without delay between steps; it does not include shaving hair, although this can be done if preferred. The manufacturer's written recommendations must be followed, including that the antiseptic agent should remain in place for the full time.
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The time period to be examined for plasma dilution for crystalloids is...
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1 Hour
(Blood, blood product, and colloid: 48 Hours) |
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What is serum?
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PLASMA MINUS FIBRINOGEN & CLOTTING FACTORS
Blood is centrifuged to remove cellular components (no WBC or RBC). Coagulated blood yields serum. Serum includes all proteins not used in blood clotting (coagulation) and all the electrolytes, antibodies, antigens, hormones, and any exogenous substances (e.g., drugs and microorganisms). Red-top tube. (vs. plasma, anti-coagulated blood w/fibrinogen & clotting factors) |
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What is plasma?
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WITH FIBRINOGEN & CLOTTING FACTORS
Blood is centrifuged to remove cellular components (no WBC or RBC). Anti-coagulated blood yields plasma containing fibrinogen and clotting factors, plus serum components. Lavender tube - treated w/EDTA (anti-coagulant) (vs. serum, coagulated blood minus fibrinogen & clotting factors) |
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Archived samples retained for 10 years, what is the additional standard for DM?
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Samples from DM donors shall be archived "for the appropriate duration".
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What is the age criteria for (A) donation?
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No age limit for autologous tissue donation.
(General standard: Medical Director &/or Medical Advisory Committee determine age criteria for donor suitability.) |
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Classification: Clean Room Standards
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ISO 1- ISO 9 (9=Room air)
AKA grade A - Grade D Based on number/size of particles in certain area. |
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Lyophilize aka...
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Freeze-dry (dehydrated)
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History of toxic substance ingestion/exposure shall be handled in what manner?
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Eval for suitability by Medical Director according to SOPM.
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Storage temperatures for refrigerated tissue?
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Above freezing (0*C) to 10*C.
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Storage temperature for lyophilized/dehydrated tissue?
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Ambient - does not require temperature monitoring.
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What commonly transplanted tissues can be lyophilized?
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MS, S
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What commonly transplanted tissues can be stored at refrigerated temperatures?
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CT, MS, S
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What commonly transplanted tissues can be stored at frozen/cryopreserved temperatures?
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All (except fresh grafts)
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Temperature for frozen/cryopreserved CT?
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Established by Tissue Bank.
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Temperature for frozen/cryopreserved (C) & (V) tissue?
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-100*C or colder.
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Temperature for frozen/cryopreserved (S) tissue?
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-40*C or colder.
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Temperature for frozen/cryopreserved (MS) tissue?
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-20*C to -40*C (temporary storage, less than 6 months)
-40*C or colder (long term storage) |
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Temperature for frozen/cryopreserved (R) tissue?
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LN2 (Liquid or vapor phase)
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Examples of Colloids (re. Plasma Dilution)
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plasma, albumin, platelets, cryoprecipitate, dextran, hetastarch, hespan
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Examples of Blood Products (re. Plasma Dilution)
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whole blood, PRBC
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Examples of Crystalloids (re. Plasma Dilution)
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NS, ringer's lactate, NaCl, TPN, dextrose in H20, IV meds
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Parasitic infections
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Chagas, Leishmaniasis, Malaria (all protozoan)
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Normal flora
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The human microbiota is the aggregate of microorganisms, a microbiome that resides on the skin, in glands, mucosa, conjuctiva, GI tract. Include bacteria, fungi, archaea.
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Anterior
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Front
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Lateral
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Away from the midline
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Medial
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Toward the midline
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Lactated ringers
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Crystalloid
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Market Withdrawl
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a correction or removal of distributed tissue that involves a minor violation that would not be subject to legal action by the FDA or that involves no violation (eg. normal stock rotation)
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Recall
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A 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.
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Removal
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The physical removal of distributed tissue from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
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Stock Recovery
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A correction or removal of tissue that has not left the direct control of the tissue bank (manufacturer), i.e., the tissue is located on the premises owned, or under the control of, the tissue bank (manufacturer), and no portion of the affected tissue has been released for use.
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AAMI
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Association for the Advancement of Medical Instrumentation
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Accident
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any occurrence, not associated with a deviation from SOPs, standards, or applicable laws and regulations, during donor screening or testing, or tissue recovery or collection, processing, quarantining, labeling, storage, distribution, or dispensing that may affect the performance, biocompatibility, or freedom from transmissible pathogens of the tissue or the ability to trace tissue to the donor.
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Adequate Information
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information sufficient for the donor, the Authorizing person, or the living donor to make a voluntary decision regarding the gift of tissues for transplantation, therapy, research, and/or education. the parameters of what constitutes Adequate information must include "core elements" contained in standards, and such additional information as the person requests or which the donation coordinator reasonably believes the person should know. when donor is authorizing the gift of tissue, publicly available information concerning the scope and use of the gift shall be deemed adequate info.
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Adverse Outcome
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an undesirable effect or untoward complication in a recipient consequent to or reasonably related to tissue transplantation.
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ANSI
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American National Standards Institute
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AORN
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Association of periOperative Registered Nurses
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AI Graft
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distal segment of the abdominal aorta including the bifurcation and proximal segments of both the left and right common iliac arteries
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Aseptic processing
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the processing of tissue using methods to prevent, restrict or minimize contamination with microorganisms from the environment, processing personnel, and/or equipment
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Required to screen for 7 RCDADs
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HIV, HepA, HepB, Syphillis, WNV, TSE, Vaccinia
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Leukocytes
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Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil
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Ischemia
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inaequate blood supply
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Audit
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A documented review of procedures, records, personnel functions, equipment, materials, facilities, and/or suppliers to evaluate adherence to the written SOPM, standards, applicable laws, and regulations.
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Cellular Tissue (CT)
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Cells that are autologous or allogenic, committed or uncommitted, and non-expanded.
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Authorization
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Permission given after adequate information concerning donation, recovery, and use of tissues is conveyed.
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Authorizing Person
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Upon death of donor, the person other than the donor authorized by law to make an anatomical gift.
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Batch
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A specific quantity of tissue that is intended to have a uniform character and quality, within specific limits, which is produced according to a single processing protocol during the same processing cycle, precluding mixing of tissue from two or more donors. (vs. lot)
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Lot
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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. (vs. batch)
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Bioburden
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The number of contaminating organisms found on a given amount of material.
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Blood Component
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Any part of a single-donor unit of blood separated by physical or mechanical means.
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CBER
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Center for Biologics Evaluation and Research
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CDC
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Centers for Disease Control and Prevention
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Certified Copy
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Relating to a death certificate, an original, authenticated form produced by a governing authority
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CFR
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Code of Federal Regulations, published by the Office of the Federal Register, National Archives and Records Administration
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Claim
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Any written or oral communication alleging the quality, durability, reliability, infectious disease risk, or performance of tissue.
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Clean Room
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A room in which the concentration of airborne particles is monitored and controlled to defined specification limits.
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Correction
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The repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of distributed tissue without its physical removal to some other location.
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Critical
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classification of a supply, reagent, material, or equipment that can affect the quality and/or safety of tissue.
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Colloid
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Protein or polysaccharide solution that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment (includes albumin, dextran, hetastarch, plasma, platelets)
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Complaint
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Any written or oral communication concerning dissatisfaction with the identity, quality, packaging, durability, reliability, safety, effectiveness, or performance of tissue.
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Competency
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The ability of an employee to acceptably perform tasks for which they've been trained.
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Competency Assessment
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The evaluation of the ability of an employee to acceptably perform tasks for which they've been trained.
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Consignee
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Any tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user (individual, agency, institution, or organization) that receives finished tissue.
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Container
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Enclosure for one finished unit of transplantable tissue (vs. Package)
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Package
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A labeled carton, receptacle, or wrapper, containing one or more containers and accompanying labeling material. (vs. container)
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Contract Services
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Those functions pertaining to the recovery, screening, testing, processing, storage, and/or distrubution of human tissue that another establishment agrees to perform for a tissue establishment.
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Controlled areas
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restricted work areas of low microbial and particulate content in which non-sterile materials are prepared.
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Critical Areas
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Restricted work areas where cells, tissue, containers, and/or closures are exposed to the environment.
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Cross-Contamination
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The transfer of infectious agents from tissue to other tissue from the same donor or from one donor's tissue to another donor's tissue.
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Cryopreserved
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Tissue frozen with the addition of, or in a solution containing, a cryoprotectant agent such as glycerol or dimethylsulfoxide.
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Cryoprotectant
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Additive that serves to miniize osmotic imbalances that occur with the progression of freezing fronts through a substance, and is intended to limit the amount of cell damage caused by cell shrinkage and intracellular ice formation.
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Crystalloid
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A balanced salt and/or glucose solution used for electrolyte replacement or to increase intravascular volume (including saline solution, Ringer's lactate, 5% dextrose in water, or TPN)
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Deviation
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An event that is a departure from a procedure or normal practice.
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Disinfectant
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An agent that reduces the number of viable cellular microorganisms. Use of antibiotics in tissue processing is considered a disinfectant.
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Disinfection Time (C)(V)
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Time interval between subjecting tissue to disinfection solution and transferring tissue to rinsing solutions in preparation for preservation.
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Dispensing Service
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A facility responsible for the receipt, maintenance and delivery to the ultimate user (eg transplant surgeon) of tissue for transplantation or research.
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Disposition
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the final destination of tissue, including use for transplantation, research, or discard
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Distribution
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a process that includes receipt of a request for tissue, selection and inspection of appropriate tissue, and inspection and subsequent shipment and delivery of tissue to another tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user.
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Document of Authorization
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Legal record of the gift of tissue, permitting and defining the scope of the postmortem recovery and use of tissues for transplantation, therapy, research and/or education. Signed or otherwise recorded by the Authorizing Person, persuant to law.
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Document of Gift
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Donor's legal record of the gift of tissue permitting and defining the scope of the postmortem recovery and use of tissues for transplantation, therapy, research and/or education. must be signed or otherwise recorded by the donor or person authorized under law to make a gift during the donor's lifetime.
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Field Notification
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The provision of additional information pertaining to safety, quality, identification, function, and/or use of distributed tissue.
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Donor Suitability Assessment
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The evaluation of all available information about a potential donor to determine whether the donor meets qualifications specified in the SOPM and standards. Includes but not limited to medical, social, sexual histories, lab tests, physical assessment/examination, and autopsy findings.
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Dosimetric Release
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Tissue release based on dosimetry instead of sterility testing (ionizing radiation dose)
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Dura Mater
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soft tissue, includes pachymeninx (thick, membranous) covering of brain.
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Electronic systems
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Computerized systems that create source documents (electronic records)
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End-User
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A health care practitioner who performs transplantation procedures
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Equipment Qualification Studies
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Protocols designed to adequately evaluate, prior to use, whether pieces of equipment will perform to expectations, and normally function within the required tolerance limits.
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Error
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Departure from SOPM, standards, or applicable laws or regulations.
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Establish(ed)
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define, document, implement
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FDA
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US Food and Drug Administration
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Finished Tissue
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Tissue that has been fully processed, enclosed in its final container, labeled, and released to distribution inventory.
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Freeze Dried/Lyophilized
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Tissue dehydrated for storage by conversion of the water content of frozen tissue to a gaseous state under vacuum that extracts moisture.
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In-Process Controls
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Any tests, samples, evaluations, monitoring, or measurements performed during processing or preservations that are designed to evaluate the processing or preservation procedure of the tissue subjected to processing or preservation for conformance to specifications in the SOPM.
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In-Process Material
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Any material that is used in the processing of tissue, including but not limited to incoming tissue, water, alcohol, acid, containers, and closures.
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ISO
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International Organization for Standardization. (standards for Everythingggg)
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Label
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Any written, printed, or graphic material used to identify tissue, cultures, blood specimens, or other donor specimens.
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Labeling Material
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Any printed or written material, including labels, advertising, and/or accompanying information (eg package insert, brochures, and pamphlets) related to the tissue.
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Management with Executive Responsibility
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Those senior employees of a tissue bank who have the authority to establish or make changes to the tissue bank's quality policy an quality system.
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Microorganisms
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Microscopic organisms (eg bacteria and fungi); viruses are not included in this classification for AATB.
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Non-Terminal Irradiation
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Ionizing radiation to reduce microbes prior to processing.
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Non-Valved Conduit
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A length of cardiac outflow tract (aortic or pulmonic) from which the valve structure has been removed or intentionally rendered completely non-functional.
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OA Graft
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Large, weight-bearing graft with intact articular surfaces, consisting of a joint with associated soft tissue and bone.
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Package Insert
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The written material accompanying tissue allograft or autograft bearing further information about the tissue, directions for use, and any applicable warnings. (Insert is a "labeling material" but not a "label")
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Patch Graft
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A segment of cardiac allograft conduit to be used in cardiovascular repair, replacement, construction, or reconstruction.
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Perfusion Time
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Time interval from asystole to subjecting the vascular tissue to perfusion solution.
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Physical Assessment
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A recent ante-mortem or postmortem documented evaluation of a deceased donor's body.
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Physical Examination
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A recent documented evaluation of a living donor's body.
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Pooling
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The physical contact or mixing of tissue from two or more donors in a single receptacle.
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Pre-Sterilization/Pre-Disinfection Culture
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A culture obtained prior to exposing the tissue to antibiotics, disinfecting chemicals, or sterilizing agents.
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Preservation
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The use of chemical agents, alterations in environmental conditions, or other means during processing to prevent or retard biological or physical deterioration of tissue.
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Procedure
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A series of steps, which when followed, is designed to result in a specific outcome.
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Process Controls
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A system of checks and balances incorporated into standard operating procedures involving critical operations to prevent errors.
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Process Validation Studies
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The process of demonstrating that a specific process or procedure will consistently produce expected results within predetermined specifications.
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Processing
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Any activity performed on tissue other than screening, tesing, recovery/collection, storage, or distribution.
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Proficiency
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An evaluation of laboratory methods and test results that assesses the quality of standard operating procedures, equipment, supplies, reagents, and the skill of the personnel performing the testing.
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Qualification
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Process of establishing confidence that equipment, reagents, and ancillary systems are capable of consistently operating within established limits and tolerances. Process performance qualification is intended to establish confidence that the process is effective and reproducible.
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Quality
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Conformance of tissue or a process with pre established specifications or standards
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QA Program
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Policies and environment required to meed standards of quality and safety, and provide confidence that the process and tissue consistently conform to quality requirements.
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QC
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Specific tests defined by QA Program to be performed to monitor recovery, processing, preservation and storage, tissue quality, and test accuracy. Includes performance evaluations, inspection, testing and controls used to determine the accuracy and reliability of equipment and operational procedures, and monitoring of supplies, reagents, equipment, and facilities
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Quality Policy
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Overall intentions and direction of an organization with respect to quality, as established by Management with Executive Responsibility.
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Quality System
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The organizational structure responsibilities, procedures, processes, and resources for implementing quality management.
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Quarantine
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Identification of human tissue as not suitable for transplantation, including tissue that hasn't yet been characterized as suitable for transplantation. Quarantine includes the storage of such tissue in an area clearly identified for such use, or other procedures, such as automated designation, to prevent the release of the tissue for transplantation.
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Record
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Information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in a perceivable form.
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Recovery Site
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The immediate area or room where a tissue recovery takes place.
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Relevant Medical Records
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A collection of documents including a current DRAI, physical assessment/exam, lab tests, autopsy reports, and information from any source pertaining to donor suitability.
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Resolution
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Adjustment, clarification, and/or correction of practices and/or procedures that results in compliance with the SOPM and/or standards.
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Responsible Person
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A person who is authorized to perform designated functions for which they are trained and qualified.
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Safety
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A quality of tissue indicating handling according to standards and substantial freedom from the potential for harmful effects to recipients.
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Satellite Facility
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An establishment in a physically separate location where any activities occur that contribute to recovery, transport, processing, storage, packaging, labeling, or distribution of tissue under the management or direct supervision of the same corporate entity or its employees
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Services to Donor Families
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Defined policy or program describing tissue donation follow-up that is offered to the Authorizing Person. May include written communications, outcome information, bereavement support, etc. Frequency and program maintenance at bank's discretion.
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SAL Security Assurance Level
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Probability of a single viable microorganism occurring on a product after sterilization (ANSI/AAMI)
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Skin Prep
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Application of antiseptic solution to decontaminate the skin. This is a continuous process that is performed without delay between steps; it does not include shaving hair, although this can be done if preferred. Manufacturer's written recommendations must be followed, including that the antiseptic agent should remain in place for the full time.
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Structural Support
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Grafts contributing biomechanical strength to a surgical construct (vs. non-structural: cord blood, nerve, amniotic fluid)
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Summary of Records
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Condensed version of the donor testing and suitability determination records. Can be combined with package insert. (Insert is a Labeling Material, not a Label)
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Terminal Sterilization
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Validated process whereby tissue within its primary package is sterilized.
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Third Party Records
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Records produced by an entity not involved in tissue recovery or donor screening. Examples include hospital records, EMS, autopsy report)
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Tissue Bank
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Entity that provides or engages in one or more services involving tissue from living or deceased individuals for transplantation purposes. These services include assessing donor suitability, recovery, processing, storage, labeling, and distribution of tissue.
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Tissue Dispensing Service
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Any entity that receives, stores, and provides tissue to end-user for transplantation. May or may not be banks, depending on what other functions they perform.
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Tissue Distribution Intermediary
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An intermediary agent who acquires and stores tissue for further distribution and performs no other tissue banking functions.
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TIN Tissue Identification Number
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Trace to donor. Identical tissue processed as a "lot" (1 donor, 1 time, 1 set of instruments) may be assigned the same TIN.
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Tolerance Limits
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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.
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Total Ischemic Time
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Time interval from asystole to subjecting tissue to disinfection solution (warm ischemic time + cold ischemic time)
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Traceability
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Ability to locate tissue during any step of its donation, collection/recovery, processing, testing, storage, distribution, or disposition. It implies the capacity to identify the medical facility receiving the tissue & recipient.
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Transport Medium
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Microbiological medium capable of maintaining cellular viability during the transport of a culture from field to laboratory.
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Validation
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Process of establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce the predetermined outcome.
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Valved Conduit
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Allograft Heart valve with an attached length of caridac outflow tract (aortic or pulmonic)
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Variance
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Departure from standards that is pre-approved by the AATB Board of Governors prior to implementation.
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Verification
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Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
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Warm Ischemic Time
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Time interval from asystole to subjecting:
Cardiac tissue to cold rinse (or transport solution) Vein to transport solution AND wet ice temperature |
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Wet Ice Temperatures
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Above freezing (0*C) - 10*C
Does not include 0* |
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Witness
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Observed the execution or authorization of the Authorization/consent. Should not be an employee or agent of the tissue bank or requesting entity.
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Disinfection
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Chemical agents: iodophors, ethanol, other solvent/detergent combinations. Other disinfection agents: heat, UV radiation, antibiotics.
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Chemicals not to be used in Disinfection
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mercurials, quaternary compounds, formaldehyde, beta propilactone, chloroform, glutaraldehyde (except for ear drums and ear ossicles).
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Types of Corrections/Removals
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Recall, Market Withdrawal, Stock Recovery
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Polyarteritis Nodosa
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Autoimmune; systemic vasculitis. Small aneurysms like rosary beads.
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Rheumatoid Arthritis
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Synovial membrane inflammation. Erosion of joint surface and joint deformity.
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Systemic Lupus
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Erythematosus; butterfly rash, apoptosis.
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Sarcoidosis
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Autoimmune; lungs and lymph nodes. Abnormal collection of inflammatory cells (granuloma) => nodules.
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Bacteria
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Unicellular. Lack organelles and nucleus.
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Iatrogenic
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Illness caused by medical examination or treatment.
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Endemic
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Disease which permanently exists in a particular region or population.
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Epidemic
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Outbreak affecting many at the same time; may spread through several communities.
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Pandemic
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Worldwide epidemic.
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Dementia
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Alzheimer's is a type of dementia
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Endocarditis
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Endocardium inflammation. Usually involves valves. Valves don't have dedicated blood supply - blunted immune ability/response. Infective vs. non-infective. Characterized by lesions ("vegetations"); may form granulamatous tissue/calcify or fibrose. Rheumatic fever can lead to infective endocarditis. Lupus can lead to non-infective endocarditis.
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IgM
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Immediate
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IgG
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Gradual
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Marfan's Syndrome
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Genetic; long limbs, disorder of connective tissue. Mild -> severe. Can affect aorta & valves.
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Mycoses
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Fungal infection. Usually starts in lungs or on skin.
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NAT
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Nucleic Acid Testing. Detects DNA or RNA of virus. Detectable before antibody production. Shortens viral window period; not relying on seroconversion.
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Leishmaniasis
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Parasite - protozoan. Spread by sandflies. Causes skin lesions & sometimes visceral lesions.
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Malaria
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Vector: Mosquito. Protozoa: plasmodium. Symptoms 10-15 days post-bite. Parasites -> liver. Can cause seizure, coma, death.
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Viral Window Period
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Between inoculation (when antigen enters blood) & serology detectibility.
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Seroconversion
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When the antibody becomes detectible (d/t immune response); #antibodies>antigens; antibodies detectible and antigens not.
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Semilunar Valves
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Aortic and Pulmonic
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Mitral
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Bicuspid
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History of Bacterial endocarditis, Rheumatic fever, viral or idiopathic cardiomyopathy
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R/O cardiac donation
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Function of bone
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Maintain mineral balance, activate immune system (leukocytes in red marrow), produce RBC, produces platelets. Protection, movement.
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3 main components of bone
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Organic matrix, mineral, osteogenic cells (osteoblasts, clasts, cytes)
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Osteocyte
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mature cells within bone
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Osteoblast
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Produces new bone
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Osteoclast
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removes and remodels bone
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adduction vs abduction
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Adduction is toward the midline
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Spongy Bone
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cancellous bone, trabecular bone. honeycombe. strength without weight. within compact bone.
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oteogenesis
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bone repair - new bone formation (vs osteoconduction, osteoinduction)
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Osteoconduction
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bone repair - framework for depositing bone (vs. osteogenesis, osteoinduction)
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Osteoinduction
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Bone repair - induces cells to differentiate into bone cell lines (vs. osteogenesis, osteoinduction)
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Bone repair
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hemaoma, fibrocartilaginous callus, bony callus, remodeling
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bone remodeling
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lifelong process: removing old bone, replacing with new bone. Creeping substitution.
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# bones in the human skeleton
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during infancy, # increases as ossification occurs. during adolescence, # decreases as bones fuse.
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tendon vs ligament
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tendon is muscle-bone; ligament is bone-bone
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anaplastic
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indication of malignancy
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erythema
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redness
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burns - 2nd - 4th degree
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2nd: dermis doesn't regenerate
3rd: heals from contraction (epithelization from margin) to subQ tissue 4th: deeper than dermis (back of hands, ears esp.) |
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lab findings for hepatitis:
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elevated ALT, ALP, AST, CGT, Bilirubin, aminotransferase
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contracture
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shortening/hardening of muscles/other soft tissues leading to rigidity and deformity
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ELISA
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enzyme-linked immunosorbent assay
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origins of plasma dilution
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1986 organ donor, then 1991: 6 recipients with HIV. other history, early 1990s - donors from Soviet Union. December 1993: Emergency Interim Rule (Med Soc and Dilution algorithm, English)
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Emergency Interim Rule
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December 1993, Soviet Union donors and 1991 6 recipients with HIV after 1986 organ donor
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idiopathic
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unknown etiology
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atypical scenarios in which dilution calculation may be warranted
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autologous transfustion, obese donor, no blood loss with massive transfusion, weight <45kg or >100kg
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Wolff's law
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bone in a healthy person or animal will adapt to the loads under which it is placed.
Theory developed by the German anatomist and surgeon Julius Wolff (1836-1902) in the 19th century |
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Vitrification
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Water hardens like glass with no crystal formation during freezing with cryoprotectant.
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