Ctbs Exam Sample Questions

Front 1

Cryopreserved cardiac and vascular tissue must be maintained at what storage temperatures?

Back 1

-100*C or colder

Front 2

The minimal dose of irradiation for terminal sterilization is:

Back 2

must be validated and supported by data. SAL (Security assurance level) must be selected & dose must achieve SAL.

Front 3

Maximum residual calcium content of demineralized bone shall not exceed...

Back 3

8% calcium residuals "by a standard method"

Front 4

Laboratories performing serology testing must have what certification?

Back 4

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

Front 5

The time period to be examined for plasma dilution for blood, blood products and colloids is...

Back 5

48 Hours
(Crystalloids: 1 Hour)

Front 6

Archived serum must be maintained for how many years after Recovery/Collection date?

Back 6

10 years
(Additional standards for (DM) & (R))

Front 7

(C) tissue may be recovered from donors up to what age?

Back 7

Medical Director &/or Medical Advisory Committee determine age criteria for donor suitability.

Front 8

When a body is refrigerated 13 hour after death, (MS) recovery must commence in how many hours after death?

Back 8

Skin prep within 15 hours.
(MS, OA, S = same post-mortem time limits)

Front 9

What are the 7 required infectious disease tests?

Back 9

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))

Front 10

(MS) tissue must be processed in what class environment?

Back 10

"bacteriologically and climate controlled environment"
(same for S, OA, A)

Front 11

Another term for freeze dried tissue is...

Back 11

Lyophilized
(lyo = dispersion, dissolution)

Front 12

History of autoimmune diseases shall be handled in what manner?

Back 12

Eval for suitability by Medical Director according to SOPM.

Front 13

A reactive screening test where the confirmatory test is negative is acceptable for which test?

Back 13

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)

Front 14

Lyophilized (MS) tissue can be stored for how many years?

Back 14

5 years from processing date.

Front 15

The maximum storage time for refrigerated fresh skin (not processed or preserved is...

Back 15

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)

Front 16

Osteoblasts are cells that...

Back 16

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.

Front 17

Who formed the first tissue banks in the US in the late 1940s?

Back 17

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.

Front 18

The critical volume of infused blood/fluids in an adult donor with blood loss requiring evaluation of potential hemodilution is...

Back 18

Older than 12 years: 2000mL blood/colloids/crystalloids

Front 19

Frozen MS tissue kept for greater than 6 months must be stored at or below what temperature?

Back 19

-40*C or colder

Front 20

Which of the following histories of cancers always excludes donation of skin?

Back 20

Melanoma

Front 21

Within what time interval must the body be refrigerated to allow commencement of MS recovery at 24 hours?

Back 21

12 Hours

Front 22

Persons who have lived with another person with HepB or clinically active HepC rules out donation for what time interval?

Back 22

12 months

Front 23

White cell counts can be elevated for which of the following reasons?

Back 23

infection, neurological, disease of bone marrow

Front 24

Identify the common source(s) of ionizing radiation.

Back 24

Cobalt 60, electron beam, Xray

Front 25

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)?

Back 25

10 years (or longer if required by law)

exceptions:
(DM) - indefinitely; (R) - until tissues are used or destroyed

Front 26

The maximum time that MS tissue shall remain on wet ice prior to processing or freezing is ...

Back 26

No longer than 72 hours.

Front 27

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?

Back 27

2500

Front 28

Potential donors who have traded sex for drugs or money are excluded from donation for what period following the last incident at risk?

Back 28

5 years

Front 29

The cruciate ligament connects the ...

Back 29

Anterior and Posterior C.L. form an "X" connecting tibial head to intercondyloid femoral notch.

Front 30

The greater trocanter is located on the ...

Back 30

medial to femoral head (lesser trochanter is inferior to femoral head, medial to head/greater trochanter)

Front 31

An anatomical structure located medially is ...

Back 31

Toward the median plane/ midline.

Front 32

The achilles tendon connects to what bone?

Back 32

Thickest tendon in the human body. Gastrocnemius & Soleus connect to CALCANEUS.

Front 33

The stratum corneum and lucidum are parts of what tissue?

Back 33

Skin

Front 34

Which of the following organisms found on skin cultures result in the destruction of the tissue?

Back 34

Staph aureus, Strep pyogenes (group A strep), Enterococcus, gram neg bacilli, clostridium, & fungi (yeasts, molds).

Front 35

What is the UAGA hierarchy for granting consent?

Back 35

donor, spouse, adult child, parent, sibling, other relative or adult with special concern, guardian, other person with authority for final disposition

Front 36

Compensation for donation is acceptable...

Back 36

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)

Front 37

Prior to recovery of tissues the area of excision shall be ...

Back 37

clean, prep, drape

Front 38

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...

Back 38

Eligible for donation; IV drug use 5 years

Front 39

During transport to the processing facility the outer container must contain...

Back 39

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.

Front 40

Split thickness skin is generally recovered at what thickness?

Back 40

0.012 - 0.018
(FTSG at 0.018 - 0.035)

Front 41

The Director of the Tissue Bank shall review all SOPs every...

Back 41

Annually
(reviewing SOPs for donor suitability and adverse outcomes)

Front 42

Techniques for preserving MS tissue include...

Back 42

frozen, cryopreservation, lyophilization

Front 43

Packaging of CV tissue must be done in what class environment?

Back 43

IO5 (Grade A Class 100)

Front 44

Pre-sterilization cultures of OA tissue must be...

Back 44

negative for Clostridium, Strep pyogenes (group A strep), or any other virulent microorganism, unless treated with validated disinfection/ sterilization process.

Front 45

To prevent additional ischemia and possible cellular damage, cardiac tissue shall be processed by methods that maintain the tissue and solutions between what temperatures?

Back 45

0-10*C

Front 46

During skin processing it is allowable for the tissue or solutions to be above 10*C for no longer than what duration of time?

Back 46

2 hours

Front 47

Package inserts shall contain the following:

Back 47

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

Front 48

Which of the following precludes the use of skin if found in the final culture results?

Back 48

1. (like C,V,CT) fungi (yeast/mold), clostridium, strep pyogenes (Group A strep)
or 2. (S only) staph aureus, enterococcus, gram neg bacilli)

Front 49

How often must QA staff perform audits of major tissue banking operations?

Back 49

At Least Annually

Front 50

SOP manuals must be made available to applicable staff at what intervals?

Back 50

At all times.

Front 51

Employee review of SOPM must be maintained for what time period following employment termination?

Back 51

16 years, or as required by law/regulation (whichever is longer)

Front 52

Archived SOPs shall be maintained for what time period after discontinuation?

Back 52

16 years

Front 53

Persons with a recent history of encephalitis or meningitis ...

Back 53

Active viral or unknown etiology unacceptable

Front 54

Allograft heart valve grafts internal annulus shall be sized...

Back 54

in mm

Front 55

In the anatomical position, the palms of the hands face...

Back 55

Anterior

Front 56

The use of bi and tri-cortical wedges is commonly associated with what type of surgery?

Back 56

spinal fusions (cortical = structural/ weight-bearing)

Front 57

The most common BTB allograft is fashioned from the....

Back 57

Patellar tendon: patella to tibial tuberosity.

Front 58

Another name for spongy bone is...

Back 58

Cancellous (vs. cortical)

Front 59

Upper age for MS recovery is...

Back 59

Determined by Medical Director and/or tissue bank Medical Advisory Committee.

Front 60

The Ross procedure is associated with what surgical specialty?

Back 60

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).

Front 61

Which of the following practices is not governed by cGTP final rule?

Back 61

21CFR Part 1270 cGTP final rule Subpart D

Front 62

The presence of HbsAb in a serologic panel means...

Back 62

Hep B surface antibody

Front 63

Processing of OA tissue must be accomplished within what time frame?

Back 63

5 days (must be kept in solution at wet ice temperatures throughout)

Front 64

The current requirement for exclusion of donors from the UK d/t high risk for CJD is...

Back 64

3 cumulative months in UK 1980-1996 OR transfusion 1980-present.

Front 65

Donors with a history of what type of transplant shall be declined for donation?

Back 65

live cell xenograft or human dura mater

Front 66

Which valve regulates blood flow between the right Atrium and right Ventricle?

Back 66

Tricuspid

Front 67

The acetabulum is associated with which joint?

Back 67

Femoral head meets pelvis at acetabulum (socket).

Front 68

The olecranon process is found on which bone?

Back 68

Ulnar process, forms the outer bump of the elbow, fits into the fossa of the humerus when the arm is extended.

Hint 68

https://o.quizlet.com/fhHVToCl9QEgbK9og4EUqg_m.jpg

Front 69

The presence of an amateur tattoo precludes donation for how long?

Back 69

N/A (12 months if shared instruments)

Front 70

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.

Back 70

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

Front 71

Which of the following levels of air filtration provides the greatest reduction in airborne particles?

Back 71

Class 1/ISO 3
(Maximum particles is Class 100K/ISO8)

Front 72

The Reduviid bug is the vector for which parasitic infection that has been linked to CV allografts?

Back 72

Triatomine bugs are a type of reduviid bug that can carry the parasite Trypanosoma cruzi that causes Chagas disease.

Front 73

Vector

Back 73

Any agent (person, animal or microorganism) that carries and transmits an infectious pathogen into another living organism.

Front 74

When determining the effect of plasma dilution on a sample, donors under what age must always have an algorithm applied if transfused or infused?

Back 74

Less than 12 years

Front 75

AATB History

Back 75

Founded in 1976. First Standards 1984. Voluntary accreditation 1986.

Front 76

JCAHO

Back 76

Joint Commision on Accreditation of Hospitals Organization

Front 77

Consequences of failing to comply with Standards...

Back 77

AATB Board of Governors majority, corrective action in accordance with bylaws. Accreditation may be rescinded.

Front 78

Define: Critical

Back 78

Classification of a supply, reagent, material, or equipment that can affect the quality and/or safety of tissue.

Front 79

Define: Cellular Tissue (CT)

Back 79

Cells that are autologous or allogenic, committed or uncommitted, and non-expanded.

Front 80

Define: Perfusion Solution (V)

**corrected definition

Back 80

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).

Front 81

Define: Skin Prep

Back 81

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.

Front 82

The time period to be examined for plasma dilution for crystalloids is...

Back 82

1 Hour

(Blood, blood product, and colloid: 48 Hours)

Front 83

What is serum?

Back 83

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)

Front 84

What is plasma?

Back 84

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)

Front 85

Archived samples retained for 10 years, what is the additional standard for DM?

Back 85

Samples from DM donors shall be archived "for the appropriate duration".

Front 86

What is the age criteria for (A) donation?

Back 86

No age limit for autologous tissue donation.

(General standard: Medical Director &/or Medical Advisory Committee determine age criteria for donor suitability.)

Front 87

Classification: Clean Room Standards

Back 87

ISO 1- ISO 9 (9=Room air)
AKA grade A - Grade D
Based on number/size of particles in certain area.

Front 88

Lyophilize aka...

Back 88

Freeze-dry (dehydrated)

Front 89

History of toxic substance ingestion/exposure shall be handled in what manner?

Back 89

Eval for suitability by Medical Director according to SOPM.

Front 90

Storage temperatures for refrigerated tissue?

Back 90

Above freezing (0*C) to 10*C.

Front 91

Storage temperature for lyophilized/dehydrated tissue?

Back 91

Ambient - does not require temperature monitoring.

Front 92

What commonly transplanted tissues can be lyophilized?

Back 92

MS, S

Front 93

What commonly transplanted tissues can be stored at refrigerated temperatures?

Back 93

CT, MS, S

Front 94

What commonly transplanted tissues can be stored at frozen/cryopreserved temperatures?

Back 94

All (except fresh grafts)

Front 95

Temperature for frozen/cryopreserved CT?

Back 95

Established by Tissue Bank.

Front 96

Temperature for frozen/cryopreserved (C) & (V) tissue?

Back 96

-100*C or colder.

Front 97

Temperature for frozen/cryopreserved (S) tissue?

Back 97

-40*C or colder.

Front 98

Temperature for frozen/cryopreserved (MS) tissue?

Back 98

-20*C to -40*C (temporary storage, less than 6 months)

-40*C or colder (long term storage)

Front 99

Temperature for frozen/cryopreserved (R) tissue?

Back 99

LN2 (Liquid or vapor phase)

Front 100

Examples of Colloids (re. Plasma Dilution)

Back 100

plasma, albumin, platelets, cryoprecipitate, dextran, hetastarch, hespan

Front 101

Examples of Blood Products (re. Plasma Dilution)

Back 101

whole blood, PRBC

Front 102

Examples of Crystalloids (re. Plasma Dilution)

Back 102

NS, ringer's lactate, NaCl, TPN, dextrose in H20, IV meds

Front 103

Parasitic infections

Back 103

Chagas, Leishmaniasis, Malaria (all protozoan)

Front 104

Normal flora

Back 104

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.

Front 105

Anterior

Back 105

Front

Front 106

Lateral

Back 106

Away from the midline

Front 107

Medial

Back 107

Toward the midline

Front 108

Lactated ringers

Back 108

Crystalloid

Front 109

Market Withdrawl

Back 109

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)

Front 110

Recall

Back 110

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.

Front 111

Removal

Back 111

The physical removal of distributed tissue from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

Front 112

Stock Recovery

Back 112

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.

Front 113

AAMI

Back 113

Association for the Advancement of Medical Instrumentation

Front 114

Accident

Back 114

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.

Front 115

Adequate Information

Back 115

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.

Front 116

Adverse Outcome

Back 116

an undesirable effect or untoward complication in a recipient consequent to or reasonably related to tissue transplantation.

Front 117

ANSI

Back 117

American National Standards Institute

Front 118

AORN

Back 118

Association of periOperative Registered Nurses

Front 119

AI Graft

Back 119

distal segment of the abdominal aorta including the bifurcation and proximal segments of both the left and right common iliac arteries

Front 120

Aseptic processing

Back 120

the processing of tissue using methods to prevent, restrict or minimize contamination with microorganisms from the environment, processing personnel, and/or equipment

Front 121

Required to screen for 7 RCDADs

Back 121

HIV, HepA, HepB, Syphillis, WNV, TSE, Vaccinia

Front 122

Leukocytes

Back 122

Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil

Front 123

Ischemia

Back 123

inaequate blood supply

Front 124

Audit

Back 124

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.

Front 125

Cellular Tissue (CT)

Back 125

Cells that are autologous or allogenic, committed or uncommitted, and non-expanded.

Front 126

Authorization

Back 126

Permission given after adequate information concerning donation, recovery, and use of tissues is conveyed.

Front 127

Authorizing Person

Back 127

Upon death of donor, the person other than the donor authorized by law to make an anatomical gift.

Front 128

Batch

Back 128

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)

Front 129

Lot

Back 129

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)

Front 130

Bioburden

Back 130

The number of contaminating organisms found on a given amount of material.

Front 131

Blood Component

Back 131

Any part of a single-donor unit of blood separated by physical or mechanical means.

Front 132

CBER

Back 132

Center for Biologics Evaluation and Research

Front 133

CDC

Back 133

Centers for Disease Control and Prevention

Front 134

Certified Copy

Back 134

Relating to a death certificate, an original, authenticated form produced by a governing authority

Front 135

CFR

Back 135

Code of Federal Regulations, published by the Office of the Federal Register, National Archives and Records Administration

Front 136

Claim

Back 136

Any written or oral communication alleging the quality, durability, reliability, infectious disease risk, or performance of tissue.

Front 137

Clean Room

Back 137

A room in which the concentration of airborne particles is monitored and controlled to defined specification limits.

Front 138

Correction

Back 138

The repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of distributed tissue without its physical removal to some other location.

Front 139

Critical

Back 139

classification of a supply, reagent, material, or equipment that can affect the quality and/or safety of tissue.

Front 140

Colloid

Back 140

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)

Front 141

Complaint

Back 141

Any written or oral communication concerning dissatisfaction with the identity, quality, packaging, durability, reliability, safety, effectiveness, or performance of tissue.

Front 142

Competency

Back 142

The ability of an employee to acceptably perform tasks for which they've been trained.

Front 143

Competency Assessment

Back 143

The evaluation of the ability of an employee to acceptably perform tasks for which they've been trained.

Front 144

Consignee

Back 144

Any tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user (individual, agency, institution, or organization) that receives finished tissue.

Front 145

Container

Back 145

Enclosure for one finished unit of transplantable tissue (vs. Package)

Front 146

Package

Back 146

A labeled carton, receptacle, or wrapper, containing one or more containers and accompanying labeling material. (vs. container)

Front 147

Contract Services

Back 147

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.

Front 148

Controlled areas

Back 148

restricted work areas of low microbial and particulate content in which non-sterile materials are prepared.

Front 149

Critical Areas

Back 149

Restricted work areas where cells, tissue, containers, and/or closures are exposed to the environment.

Front 150

Cross-Contamination

Back 150

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.

Front 151

Cryopreserved

Back 151

Tissue frozen with the addition of, or in a solution containing, a cryoprotectant agent such as glycerol or dimethylsulfoxide.

Front 152

Cryoprotectant

Back 152

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.

Front 153

Crystalloid

Back 153

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)

Front 154

Deviation

Back 154

An event that is a departure from a procedure or normal practice.

Front 155

Disinfectant

Back 155

An agent that reduces the number of viable cellular microorganisms. Use of antibiotics in tissue processing is considered a disinfectant.

Front 156

Disinfection Time (C)(V)

Back 156

Time interval between subjecting tissue to disinfection solution and transferring tissue to rinsing solutions in preparation for preservation.

Front 157

Dispensing Service

Back 157

A facility responsible for the receipt, maintenance and delivery to the ultimate user (eg transplant surgeon) of tissue for transplantation or research.

Front 158

Disposition

Back 158

the final destination of tissue, including use for transplantation, research, or discard

Front 159

Distribution

Back 159

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.

Front 160

Document of Authorization

Back 160

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.

Front 161

Document of Gift

Back 161

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.

Front 162

Field Notification

Back 162

The provision of additional information pertaining to safety, quality, identification, function, and/or use of distributed tissue.

Front 163

Donor Suitability Assessment

Back 163

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.

Front 164

Dosimetric Release

Back 164

Tissue release based on dosimetry instead of sterility testing (ionizing radiation dose)

Front 165

Dura Mater

Back 165

soft tissue, includes pachymeninx (thick, membranous) covering of brain.

Front 166

Electronic systems

Back 166

Computerized systems that create source documents (electronic records)

Front 167

End-User

Back 167

A health care practitioner who performs transplantation procedures

Front 168

Equipment Qualification Studies

Back 168

Protocols designed to adequately evaluate, prior to use, whether pieces of equipment will perform to expectations, and normally function within the required tolerance limits.

Front 169

Error

Back 169

Departure from SOPM, standards, or applicable laws or regulations.

Front 170

Establish(ed)

Back 170

define, document, implement

Front 171

FDA

Back 171

US Food and Drug Administration

Front 172

Finished Tissue

Back 172

Tissue that has been fully processed, enclosed in its final container, labeled, and released to distribution inventory.

Front 173

Freeze Dried/Lyophilized

Back 173

Tissue dehydrated for storage by conversion of the water content of frozen tissue to a gaseous state under vacuum that extracts moisture.

Front 174

In-Process Controls

Back 174

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.

Front 175

In-Process Material

Back 175

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.