CTBS

Question 1

When was the AATB founded?

Answer 1

The American Association of Tissue Banks (AATB) was founded in 1976 as a voluntary, scientific, and educational not-for-profit organization to promote the exchange of information, methods, and procedures that would increase donation and provide safe, transplantable tissues of uniform high quality in quantities sufficient to meet national needs.

Question 2

What does AATB stand for?

Answer 2

American Association of Tissue Banks

Question 3

When were the first AATB guidelines published?

Answer 3

A book of “Proceedings” from the first annual meeting was published in 1978 that offered a detailed overview of current tissue banking practices and described the ethics of donation and transplantation.

Question 4

When was the first edition of AATB’s Standards for Tissue Banking published?

Answer 4

1984

Question 5

When was the voluntary accreditation program for tissue banks first launched?

Answer 5

1986

Question 6

GMPs

Answer 6

good manufacturing practices

Question 7

What is the strictest device classification?

Answer 7

Class III medical device manufacturer

Question 8

What is the Uniform Anatomical Gift Act?

Answer 8

The Uniform Anatomical Gift Act (UAGA or the Act) was passed in the US in 1968 and has since been revised in 1987 and in 2006. The Act sets a regulatory framework for the donation of organs, tissues, and other human body parts in the US. The UAGA helps regulate body donations to science, medicine, and education.

Question 9

What is the mission of the AATB?

Answer 9

A mission of the AATB is to establish and promulgate standards to provide tissue banks with performance requirements intended to prevent disease transmission and support quality measures that assist clinical performance of transplanted tissue. Furthermore, the AATB fosters education and research, and promotes quality and safety in cell and tissue banking and transplantation.

Question 10

These Standards establish performance requirements for informed consent or authorization, donor eligibility assessment through donor screening and testing, as well as for the recovery, processing, storage, packaging, labeling, and distribution of transplantable human tissue

Answer 10

(A) autologous tissue
(BT) birth tissue
(C) cardiac tissue
(CT) cellular tissue
(DM) dura mater
(LD) living donors
(MS) musculoskeletal tissue
(OA) osteoarticular graft
(R) reproductive tissue
(S) skin
(SB) living donor surgical bone for allogeneic use
(V) vascular tissue

Question 11

What 3 things are required to request a variance to the standards?

Answer 11

1) A request for variance or modification including the particular standard number(s) that applies to the request;
2) Justification of the alternative procedure(s), policy or process that assure(s) equivalency to the intent of Standards;
3) Supporting information such as worksheets, records, data, or other information (e.g., validation of the protocol to be used in the proposed variance, including the scientific data and quality assurance steps).

Question 12

ACCIDENT

Answer 12

Any occurrence, not associated with a deviation from standard operating procedures (SOPs), standards, or applicable laws and regulations, during donor screening or testing, or tissue recovery, collection or acquisition, 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.

Question 13

ACQUISITION (BT)

Answer 13

The point after delivery at which tissue is under the control of the tissue bank.

Question 14

ADEQUATE INFORMATION

Answer 14

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 D2.400 or D3.400, and such additional information as the donor, authorizing person, or living donor requests or which the donation coordinator reasonably believes the donor, authorizing person or living donor should know. When the donor is authorizing the gift of tissue, publicly available information concerning the scope and use of the gift shall be deemed adequate information.

Question 15

ADVERSE OUTCOME

Answer 15

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

Question 16

ALLOGENEIC

Answer 16

Used as an adjective to modify donation, tissue, donor or recipient when transplantation is intended for a genetically different person.

Question 17

ALLOGRAFT

Answer 17

Tissue intended for transplantation into a genetically different person.

Question 18

ANNUAL

Answer 18

A frequency of activity defined by each tissue bank as 12 months including reasonable tolerance limits (up to 3 months). Justification for the tolerance limits shall be documented by the tissue bank with consideration for the risk associated with the specific activity scheduled.

Question 19

ANONYMOUS DONOR (R)

Answer 19

A reproductive donor of tissue whose identity is unknown to the recipient (R)

Question 20

AORTOILIAC GRAFT (C)

Answer 20

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

Question 21

ARTERIAL GRAFT (V)

Answer 21

A segment of peripheral artery that is recovered, processed and preserved.

Question 22

ARTIFICIAL INSEMINATION (R)

Answer 22

The placement of semen within the reproductive tract of a recipient (R)

Question 23

ASEPTIC PROCESSING

Answer 23

The processing of tissue using aseptic techniques where tissue, containers and/or devices are handled in a controlled environment in which the air supply, materials, equipment and personnel are regulated to prevent microbial contamination of tissue.

Question 24

ASEPTIC RECOVERY

Answer 24

The recovery of tissue using methods that restrict or minimize contamination with microorganisms from the donor, environment, recovery personnel, and/or equipment.

Question 25

ASSISTED REPRODUCTIVE TECHNOLOGY PROCEDURE (R)

Answer 25

A medical procedure intended to result in conception, including, but not limited to, therapeutic insemination, in-vitro fertilization (including intracytoplasmic sperm injection), and gamete intrafallopian transfer.

Question 26

ASYSTOLE

Answer 26

The reference time for cardiac death. A documented pronounced time of death is used as asystole when life-saving procedures have been attempted and there were signs of, or documentation of, recent life (e.g., witnessed event, agonal respirations, pulseless electrical activity). If a death was not witnessed, asystole must be determined by the last time known alive. Asystole will be ‘cross clamp time’ if the tissue donor was also a solid organ donor.

Question 27

AUDIT

Answer 27

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.

Question 28

AUDIT TRAIL

Answer 28

A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the course of such details relating to the electronic record. (FDA Guidance for Industry, Computerized Systems Used in Clinical Investigations, May 2007)

Question 29

AUTHORIZATION

Answer 29

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

Question 30

AUTHORIZING PERSON

Answer 30

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

Question 31

AUTOGRAFT (A)

Answer 31

Tissue intended for implantation, transplantation or infusion into the living donor from whom it was recovered.

Question 32

AUTOLOGOUS

Answer 32

Used as an adjective to modify donation, tissue, donor or recipient when donation is intended only from him/herself and transplantation is intended only to him/herself.

Question 33

BATCH

Answer 33

A specific quantity of tissue produced according to a single processing protocol during the same processing cycle.

Question 34

BIOBURDEN

Answer 34

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

Question 35

BIRTH TISSUE (BT)

Answer 35

gestational tissue donated at the time of delivery of a living newborn. This includes placenta, Wharton’s jelly, amniotic fluid, chorionic membrane, amniotic membrane, placental/chorionic disc, umbilical veins, and umbilical cord tissue.

Question 36

BLOOD COMPONENT

Answer 36

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

Question 37

CARDIAC TISSUE (C)

Answer 37

Tissue type that includes, but is not limited to, valved conduits, non-valved conduits, aortoiliac grafts, and patch grafts.

Question 38

CELLULAR TISSUE (CT)

Answer 38

viable cells that are autologous or allogeneic, committed or uncommitted, and non-expanded.

Question 39

CERTIFIED COPY

Answer 39

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

Question 40

CLAIM

Answer 40

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

Question 41

CLIENT DEPOSITOR (R)

Answer 41

A person who consents to collection and/or storage of reproductive tissues for artificial insemination or assisted reproductive technology procedures for themself(ves) or a sexually intimate partner; not considered a reproductive tissue donor.

Question 42

COLD ISCHEMIC TIME (C)

Answer 42

The time interval from subjecting cardiac tissue to cold rinse (or transport) solution at recovery to the beginning of disinfection.

Question 43

COLD ISCHEMIC TIME (V)

Answer 43

The time interval from subjecting vascular tissue to transport solution and wet ice temperatures at recovery to the beginning of disinfection.

Question 44

COLLECTION (R)

Answer 44

The acquisition of reproductive tissue from a donor or client depositor by surgical or non-surgical procedures.

Question 45

COLLOID

Answer 45

A protein or polysaccharide solution that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment such as albumin, dextran, hetastarch, or certain blood components, such as plasma and platelets.

Question 46

COMPLAINT

Answer 46

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

Question 47

COMPETENCY

Answer 47

The ability of an employee to acceptably perform tasks for which he/she has been trained.

Question 48

COMPETENCY ASSESSMENT

Answer 48

The evaluation of the ability of an employee to acceptably perform tasks for which he/she has been trained.

Question 49

CONSIGNEE

Answer 49

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

Question 50

CONTAINER

Answer 50

An enclosure for one finished unit of transplantable tissue.

Question 51

CONTRACT SERVICES

Answer 51

Those functions pertaining to the recovery, screening, testing, processing, storage, and/or distribution of human tissue that another establishment agrees to perform.

Question 52

CONTROLLED AREAS

Answer 52

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

Question 53

CORRECTION

Answer 53

Related to conformity, remedial action to eliminate a detected nonconformity.

Question 54

CORRECTIVE ACTION

Answer 54

Action to eliminate the cause and prevent recurrence of a nonconformity or other undesirable situation; may be performed in conjunction with preventive action(s).

Question 55

CRITICAL

Answer 55

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

Question 56

CRITICAL AREAS

Answer 56

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

Question 57

CROSS-CONTAMINATION

Answer 57

The transfer of infectious agents from one tissue to another from either the same donor or a different donor.

Question 58

CRYOPRESERVED

Answer 58

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

Question 59

CRYOPROTECTANT

Answer 59

An additive that serves to minimize 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.

Question 60

CRYSTALLOID

Answer 60

A balanced salt and/or glucose solution used for electrolyte replacement or to increase intravascular volume, such as saline solution, Ringer’s lactate solution, or 5 percent dextrose in water, or total parenteral nutrition (TPN).

Question 61

DECONTAMINATION

Answer 61

Cleaning the environment, facilities, and/or surfaces (sanitation), or instruments, supplies, and equipment (sanitization), with intent to remove or reduce pathogenic microbes.

Question 62

DEHYDRATION

Answer 62

The removal of water from tissue. For example, dehydration methods may include chemical (alcohol), critical/supercritical drying, simple air drying, or drying in a dehydrator.

Question 63

DESICCATION

Answer 63

The removal of water from tissue. For example, desiccation methods may include chemical (alcohol), critical/supercritical drying, simple air drying, or drying in a desiccator.

Question 64

DEVIATION

Answer 64

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

Question 65

DIRECTED DONOR (R)

Answer 65

A reproductive tissue donor who is known to the recipient (R) but is not the recipient’s (R) sexually intimate partner.

Question 66

DISINFECTANT

Answer 66

An agent (e.g., heat or a chemical) capable of reducing the number of viable microorganisms. A disinfectant might not kill spores. Use of antimicrobials in tissue processing is included here.

Question 67

DISINFECTION

Answer 67

A process that reduces the number of viable microorganisms on tissue, but may not destroy all microbial forms, such as spores and viruses. Use of antimicrobials in tissue processing is included here.

Question 68

DISINFECTION TIME (C, V)

Answer 68

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

Question 69

DISPENSING SERVICE

Answer 69

A facility responsible for the receipt, maintenance and delivery to the ultimate user (e.g., transplanting surgeon, surgical center or research facility) of tissue for transplantation or research.

Question 70

DISPOSITION

Answer 70

The final destination of tissue, e.g., use for transplantation, therapy research, education, or discard; also, the final destination of critical supplies, reagents, materials or equipment that can affect the quality and/or safety of tissue, e.g., release for use or discard.

Question 71

DISTRIBUTION

Answer 71

A process that includes receipt of a request for tissue, selection of appropriate finished tissue, preparation for transport, any required inspections, and subsequent shipment and delivery of tissue to another tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user.

Question 72

DOCUMENT OF AUTHORIZATION

Answer 72

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, pursuant to law.

Question 73

DOCUMENT OF GIFT

Answer 73

The 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. It must be signed or otherwise recorded by the donor or person authorized under law to make a gift during the donor’s lifetime.

Question 74

DOCUMENT OF GIFT/AUTHORIZATION

Answer 74

Term used when the standard refers to both a document of gift and a document of authorization as defined above.

Question 75

DONATED HUMAN TISSUE

Answer 75

For the purposes of labeling, this is tissue provided for storage or transplantation, either allogeneic or autologous.

Question 76

DONATION COORDINATOR

Answer 76

A responsible person who seeks authorization from an authorizing person, or who makes notification concerning donation, recovery, and use of the gift, or in the case of a living donor a responsible person who seeks informed consent from a living donor, a birth mother, or a client depositor. For authorization purposes, this person may also be referred to as a ‘‘designated requestor.’’

Question 77

DONOR

Answer 77

A living or deceased individual whose body is the source of the tissue.

Question 78

DONOR ELIGIBILITY ASSESSMENT

Answer 78

The evaluation of all available information about a potential donor to determine whether the donor meets qualifications specified in the SOPM and Standards. See relevant medical records.

Question 79

DONOR RISK ASSESSMENT INTERVIEW (DRAI)

Answer 79

A documented dialogue in person or by telephone with an individual or individuals who would be knowledgeable of the donor’s relevant medical history and social behavior. For example this may be: the donor, if living; the next of kin; the nearest available relative; a member of the donor’s household; other individual with an affinity relationship (e.g., caretaker, friend, significant life partner); and/or the primary treating physician. Alternatively, a living donor may complete a written questionnaire. The relevant social history is elicited by questions regarding certain activities or behaviors that are considered to place such an individual at increased risk for a relevant communicable disease agent or disease (RCDAD).

Question 80

DONOR REFERRAL SOURCES

Answer 80

Entities such as hospitals, medical examiners, coroners and individual allied health care professionals who identify potential tissue donors and refer them, or their next of kin, to tissue banks.

Question 81

DONOR REGISTRY

Answer 81

A database established in accordance with law, consisting of legally valid documents of gift.

Question 82

DOSIMETRIC RELEASE

Answer 82

Tissue release based on dosimetry instead of sterility testing.

Question 83

DURA MATER (DM)

Answer 83

A type of soft tissue that includes the pachymeninx (thick, membranous) tissue covering the brain.

Question 84

DYNAMIC

Answer 84

Operational condition during aseptic processing where the controlled environment is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon [ISO 14644-1].

Question 85

ELECTRONIC SYSTEMS

Answer 85

Computerized systems that create source documents (electronic records).

Question 86

ELECTRONIC QUALITY MANAGEMENT SYSTEMS

Answer 86

Software used in the automation or monitoring of an organization’s quality system that may apply, but is not restricted, to the following: product design and development; supply and/or component acceptance; testing; manufacturing; labeling; packaging; distribution; handling of a complaint, CAPA, error, nonconformity; or any other aspect of the Quality Management Systems.

Question 87

EMBRYO (R)

Answer 87

Pre-implantation, reproductive tissue resulting from the combination of oocyte and sperm.

Question 88

EMBRYO BANK

Answer 88

A facility that performs cryopreservation or storage of embryos intended for use in creating pregnancy.

Question 89

EMBRYO CLIENT DEPOSITOR (R)

Answer 89

A woman and/or man who provides gametes or contracts with a gamete donor(s) responsible for creation of an embryo(s) intended for transfer (R).

Question 90

EMBRYO DONOR (R)

Answer 90

Embryo client depositor(s) who choose(s) to donate his/her (their) embryos. Ownership of the embryos is transferred to a new client depositor(s) who was (were) not gamete providers

Question 91

END-USER

Answer 91

A health care practitioner who performs transplantation procedures.

Question 92

ENVIRONMENTAL CONTROL

Answer 92

Activities performed to control the environment for the purpose of minimizing the potential for contamination or cross-contamination of tissue.

Question 93

ENVIRONMENTAL MONITORING

Answer 93

Activities performed to systematically observe and record data to characterize the environment to identify conditions under which the potential may exist for contamination or cross-contamination of tissue.

Question 94

EQUIPMENT QUALIFICATION STUDIES

Answer 94

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

Question 95

ERROR

Answer 95

A deviation from the SOPM, Standards, or applicable laws or regulations.

Question 96

ESTABLISH

Answer 96

Define, document and implement.

Question 97

FIELD CORRECTION

Answer 97

For distributed tissue, the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) without its physical removal to some other location. Reference 21 CFR Part 7, 7.3(h).

Question 98

FIELD NOTIFICATION

Answer 98

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

Question 99

FINISHED TISSUE

Answer 99

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

Question 100

GAMETE (R)

Answer 100

Mature human germ cell, whether an oocyte or sperm

Question 101

IMAGE(s)

Answer 101

A representation of the external form of an object, place or person in a photographic, digital, or videographic format.

Question 102

INFORMED CONSENT

Answer 102

Permission given by a living donor (LD) or client depositor who is presented with a description of the scope, use and any risks or benefits to her or him of the proposed donation, and who has been given the opportunity to ask questions and receive accurate answers. An LD who gives her or his informed consent to donation shall sign a record of the informed consent.

Question 103

IN-PROCESS CONTROLS

Answer 103

Any tests, samples, evaluations, monitoring, or measurements performed during processing or preservation that are designed to ensure conformance to specifications in the SOPM.

Question 104

IN-PROCESS MATERIAL

Answer 104

Any material that is used in the processing of tissue, including, but not limited to, incoming tissue, water, alcohol, acid, containers, and closures.

Question 105

LABEL

Answer 105

Any written, printed, or graphic material used to identify tissue, cultures, blood specimens or other donor specimens.

Question 106

LABELING MATERIAL

Answer 106

Any printed or written material, including labels, advertising, and/or accompanying information (e.g., package insert, brochures, and pamphlets), related to the tissue.

Question 107

LIVING DONOR (LD)

Answer 107

A person who consents to the recovery or collection of his or her tissue, where recovery or collection is to take place while she or he is alive. For all living donors, (LD) standards apply, then tissue-specific standards apply. A living donor is a type of donor and, unless otherwise specified, standards that apply to donors in general apply to living donors.

Question 108

LOT

Answer 108

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.

Question 109

LYOPHILIZED

Answer 109

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

Question 110

MANAGEMENT WITH EXECUTIVE RESPONSIBILITY

Answer 110

Those senior employees of a tissue bank who have the authority to establish or make changes to the tissue bank’s quality policy and quality system.

Question 111

MARKET WITHDRAWAL

Answer 111

A field 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 (e.g., normal stock rotation practices). Reference 21 CFR Part 7, 7.3(j).

Question 112

MAY

Answer 112

Used to indicate an acceptable method that is recognized but not essential.

Question 113

MICROORGANISM

Answer 113

A microscopic organism including bacteria and fungi; viruses, while sometimes included in this classification, are not included here.

Question 114

MUSCULOSKELETAL TISSUE (MS)

Answer 114

Tissue type that includes, but is not limited to, bone and cartilage, and soft tissue such as tendon, ligament, nerve, fascia, pericardium, peritoneal membrane, adipose, and dura mater.

Question 115

MUST

Answer 115

Used to indicate a mandatory requirement. The same as SHALL.

Question 116

NONCONFORMITY

Answer 116

A finding that identifies non-fulfillment of an accreditation requirement, a standard, policy, process, procedure, or specification.

Question 117

NON-TERMINAL IRRADIATION

Answer 117

Ionizing radiation used to reduce microbes prior to processing.

Question 118

NON-VALVED CONDUIT (C)

Answer 118

A length of cardiac outflow tract (aortic or pulmonic) from which the valve structure has been removed or intentionally rendered completely non-functional.

Question 119

NOTIFICATION (OF GIFT)

Answer 119

Provision and documentation of notice concerning an anatomical gift that was made by the donor during the donor’s lifetime

Question 120

OOCYTE DONOR (R)

Answer 120

A person who donates oocytes for use in assisted reproductive technology procedures. An oocyte donor can be further categorized as a directed donor or an anonymous donor but is not a client depositor.

Question 121

OSTEOARTICULAR GRAFT

Answer 121

A weight bearing allograft with intact articular surfaces, consisting of a joint with associated soft tissue and bone.

Question 122

PACKAGE

Answer 122

A labeled box, carton, receptacle, or wrapper containing tissue and may contain one or more containers and accompanying labeling materials.

Question 123

PACKAGE INSERT

Answer 123

The written material accompanying an allograft or autograft bearing further information about the tissue, directions for use, and any applicable warnings.

Question 124

PACKAGING SYSTEM

Answer 124

The combination of primary package, secondary package, and additional protective packaging, as deemed necessary.

Question 125

PATCH GRAFT (C)

Answer 125

A segment of cardiac allograft conduit to be used in cardiovascular repair, replacement, construction, or reconstruction.

Question 126

PERFUSION SOLUTION (V)

Answer 126

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).

Question 127

PERFUSION TIME (V)

Answer 127

The time interval from asystole to subjecting the vascular tissue to perfusion solution.

Question 128

PHYSICAL ASSESSMENT

Answer 128

A recent ante-mortem or postmortem documented evaluation of a deceased donor’s body that can identify evidence of: high-risk behavior and signs of HIV infection or hepatitis infection; other viral or bacterial infections; or, trauma to the potential recovery sites.

Question 129

PHYSICAL EXAMINATION

Answer 129

A recent documented evaluation of a living donor’s body to determine whether there is evidence of high risk behavior and that determines overall general health of the donor. After a donor risk assessment interview is completed and if any history is suspect, the physical examination should also encompass a directed examination (of a body part or region).

Question 130

PLASMA DILUTION

Answer 130

A decrease in the concentration of the donor’s plasma proteins and circulating antigens or antibodies resulting from the transfusion of blood or blood components and/or infusion of fluids, e.g., colloid(s) and/or crystalloid(s).

Question 131

POLICIES AND PROCEDURES MANUAL

Answer 131

See Standard Operating Procedures Manual (SOPM).

Question 132

POOLING

Answer 132

The physical contact or mixing of tissue from two or more donors in a single receptacle.

Question 133

PRE-STERILIZATION/PRE-DISINFECTION CULTURE

Answer 133

A culture of tissue obtained prior to exposure to antibiotics, disinfecting chemicals, or sterilizing agents.

Question 134

PRESERVATION

Answer 134

The use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of tissue.

Question 135

PREVENTIVE ACTION

Answer 135

Action to eliminate the cause of a potential nonconformity or other undesirable situation; may be performed in conjunction with corrective action(s).

Question 136

PRIMARY PACKAGE

Answer 136

Layer of packaging in direct contact with tissue.

Question 137

PROCEDURE

Answer 137

A series of steps, which when followed, is designed to result in a specific outcome.

Question 138

PROCESS CONTROLS

Answer 138

A system of checks and balances incorporated into standard operating procedures involving critical operations to prevent errors.

Question 139

PROCESS VALIDATION

Answer 139

Establishing by objective evidence that a process consistently produces a results meeting predetermined specifications.

Question 140

PROCESSING

Answer 140

Any activity performed on tissue other than donor screening, donor testing, tissue recovery, collection, or acquisition functions, storage, distribution or dispensing. It includes but is not limited to disinfecting, sterilizing, packaging, labeling, and testing tissue.

Question 141

PROFICIENCY TESTING

Answer 141

The evaluation of an individual laboratory’s performance against pre-established criteria by means of inter-laboratory comparisons. (Adapted from ISO/IEC 17043:2010 Conformity assessment - General requirements for proficiency testing)

Question 142

QUALIFICATION

Answer 142

The process of establishing confidence that equipment, materials, reagents, and ancillary systems are capable of consistently performing within established limits and tolerances. Process performance qualification is intended to establish confidence that the process is effective and reproducible.

Question 143

QUALITY

Answer 143

Conformance to pre-established specifications, attributes, requirements, regulations, and/or standards.

Question 144

QUALITY AGREEMENT

Answer 144

an agreement that establishes the quality specifications or standards that must be met for defined activities and delineates responsibilities of each entity involved. It may be a separate document or included as part of a written agreement/contract.

Question 145

QUALITY ASSURANCE (QA) PROGRAM

Answer 145

The policies and environment required to meet standards of quality and safety, and to provide confidence that the processes and tissue consistently conform to quality requirements.

Question 146

QUALITY CONTROL (QC)

Answer 146

Specific tests defined by the QA program to be performed to monitor recovery, processing, preservation and storage, tissue quality, and test accuracy. These may include but are not limited to, performance evaluations, inspection, testing, and controls used to determine the accuracy and reliability of the tissue bank’s equipment and operational procedures, as well as the monitoring of supplies, reagents, equipment, and facilities.

Question 147

QUALITY POLICY

Answer 147

The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

Question 148

QUALITY SYSTEM

Answer 148

The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Question 149

QUARANTINE

Answer 149

The identification of tissue, reagents, supplies, materials and equipment as not suitable for use, or that has not yet been characterized as being suitable for use.

Question 150

RECALL

Answer 150

A field 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.

Question 151

RECIPIENT

Answer 151

A person into whom tissue is transplanted.

Question 152

RECIPIENT (R)

Answer 152

A woman undergoing an assisted reproductive technology procedure. A recipient (R) can be an intended parent, a gestational carrier, or a gestational surrogate

Question 153

RECORD

Answer 153

Information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form.

Question 154

RECOVERY

Answer 154

Obtaining tissue other than reproductive tissue from a donor that is intended for use in human transplantation, therapy, research or education

Question 155

RECOVERY SITE

Answer 155

The immediate area or room where a tissue recovery takes place (e.g., dedicated tissue recovery site, healthcare facility operating room, autopsy suite).

Question 156

RELEVANT MEDICAL RECORDS

Answer 156

A collection of documents including a current donor risk assessment interview, a physical assessment/physical examination, laboratory test results (in addition to results of testing for required relevant communicable disease agents), relevant donor records, existing coroner and autopsy reports, a certified copy or verified copy of the death certificate (when applicable), as well as information obtained from any source or records which may pertain to donor eligibility regarding high risk behaviors, and clinical signs and symptoms for any relevant communicable disease agent or disease (RCDAD), and/or treatments related to medical conditions suggestive of such risk.

Question 157

REMOVAL

Answer 157

The physical removal of distributed tissue from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. Reference 21 CFR Part 806, 806.2(i).

Question 158

REPRODUCTIVE TISSUE (R)

Answer 158

Any tissue from the reproductive tract intended for use in assisted reproductive technology procedures. This includes, but is not limited to: oocytes, ovarian tissue, embryos, semen, spermatozoa, spermatids, testicular tissue, and epididymal tissue.

Question 159

REPRODUCTIVE TISSUE BANK (R)

Answer 159

A tissue bank that collects, processes, stores, and/or distributes human reproductive tissue for use in assisted reproductive technology procedures.

Question 160

RESOLUTION

Answer 160

Adjustment, clarification, and/or correction of practices and/or procedures that results in compliance with the SOPM and/or standards.

Question 161

RESPONSIBLE PERSON

Answer 161

A person who is authorized to perform designated functions for which he or she is trained and qualified.

Question 162

SAFETY

Answer 162

A quality of tissue indicating handling according to standards and substantial freedom from the potential for harmful effects to recipients.

Question 163

SATELLITE FACILITY

Answer 163

A facility operated or owned by the tissue bank and located in a physically separate location from its primary address, and where any tissue banking activities occur or where any tissue banking services are provided.

Question 164

SECONDARY PACKAGE

Answer 164

The barrier that surrounds the primary package (e.g., the tissue can be sterile tissue inside, aseptically processed tissue, recovered, or acquired tissue.)

Question 165

SEMEN (R)

Answer 165

The fluid of man’s reproductive system consisting of spermatozoa and secretions of accessory glands.

Question 166

SEMEN DONOR (R)

Answer 166

A man who donates semen for use in artificial insemination or assisted reproductive technology procedures where the recipient is not a sexually intimate partner. A semen donor can be further categorized as a directed donor or an anonymous donor but is not a client depositor.

Question 167

SERIES OF STANDARDS

Answer 167

A group of standards related to a particular topic presented as a capitalized heading (e.g., B2.000) followed by indented subsections (e.g., B2.100, B2.120, B2.121). The heading and everything indented under it are considered part of the series.

Question 168

SERVICES TO DONOR FAMILIES

Answer 168

A defined policy or support program describing tissue donation follow-up offered to the authorizing person (or party). This may include written communications regarding: potential uses of tissue; recovery outcome information; bereavement information and support; provision of a copy of the document of gift/authorization: and/or guidance describing how to contact the tissue bank if any questions arise regarding the donation. Frequency of follow-up and program maintenance is at the discretion of the tissue bank, however, periodic evaluation of services is required.

Question 169

SHALL

Answer 169

Used to indicate a mandatory standard, same as MUST.

Question 170

SHOULD

Answer 170

Used to indicate a recommendation; advisory, indicating a commonly accepted activity for which there may be effective alternatives.

Question 171

SIGNATURE

Answer 171

A record is signed when it has been authenticated or adopted by the signer by means in writing, or an electronic signature, symbol, sound, process or recording pursuant to applicable law.

Question 172

SKIN (S)

Answer 172

A membranous soft tissue type that includes, but is not limited to epidermis and dermis.

Question 173

SKIN PREP

Answer 173

The 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. Unless otherwise qualified/validated, the manufacturer’s written recommendations must be followed, including that the antiseptic solution should remain in place for the recommended contact time and be allowed to air dry completely before the surgical drapes are placed.

Question 174

STANDARD OPERATING PROCEDURES MANUAL (SOPM)

Answer 174

A group of standard operating procedures (SOPs) detailing the specific policies of a tissue bank and the procedures used by the staff/personnel to carry out the functions of the tissue bank.

Question 175

STANDARDS

Answer 175

AATB Standards for Tissue Banking

Question 176

STATIC

Answer 176

At-rest condition during aseptic processing where the controlled environment is complete with equipment installed and operating in a manner agreed upon, but with no personnel present [ISO 14644-1].

Question 177

STERILE

Answer 177

For tissue, the absence of detectable, viable, microorganisms (refer to ANSI/AAMI ST67:2011). For reagents, supplies, materials and equipment, free from viable microorganisms.

Question 178

STERILITY ASSURANCE LEVEL (SAL)

Answer 178

The probability of a single viable microorganism occurring on a product after sterilization (refer to ANSI/AAMI ST67:2003).

Question 179

STERILIZATION

Answer 179

A validated process used to render tissue free from viable microorganisms (refer to ANSI/AAMI ST67:2003) including spores.

Question 180

STOCK RECOVERY

Answer 180

Retrieval 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. Reference 21 CFR Part 7, 7.3(k).

Question 181

STORAGE

Answer 181

The maintenance of tissue for future use.

Question 182

STRUCTURAL SUPPORT

Answer 182

Those tissue grafts that contribute biomechanical strength to a surgical construct.

Question 183

SUMMARY OF RECORDS

Answer 183

A condensed version of the donor testing and eligibility determination records. This can be combined with the package insert.

Question 184

SURGICAL BONE (SB)

Answer 184

Any bone from a living donor for allogeneic use such as a femoral head removed during surgery.

Question 185

TERMINAL STERILIZATION

Answer 185

A validated process whereby tissue within its final sterile barrier system (e. g., package, container) is sterilized (refer to ANSI/AAMI ST67:2011).

Question 186

THIRD PARTY RECORDS

Answer 186

Records produced by an entity not involved in tissue recovery, acquisition, or donor screening. Examples of third party records include: hospital medical records; emergency medical services records; coroner/medical examiner records; prenatal records, and police reports.

Question 187

TISSUE

Answer 187

A functional group of cells. The term is used collectively in Standards to indicate both cells and tissue.

Question 188

TISSUE BANK

Answer 188

An entity that provides or engages in one or more services involving tissue from living or deceased persons for transplantation purposes. These services include obtaining authorization and/or informed consent, assessing donor eligibility, recovery, collection, acquisition, processing, storage, labeling, distribution and dispensing of tissue.

Question 189

TISSUE DISPENSING SERVICE

Answer 189

Any entity that receives, stores, and provides tissue directly to an end-user for transplantation. Tissue dispensing services may or may not be tissue banks, depending on what other functions they perform.

Question 190

TISSUE DISTRIBUTION INTERMEDIARY

Answer 190

An intermediary agent who acquires and stores tissue for further distribution and performs no other tissue banking functions.

Question 191

TISSUE IDENTIFICATION NUMBER

Answer 191

Any unique combination of letters, numbers, and/or symbols assigned to tissue and linked to a donor, from which the complete history of the recovery, collection or acquisition, processing, packaging, quarantine, labeling, storage, distribution and dispensing of tissue can be traced. Identical tissue processed under the criteria defined in ‘‘lot’’ may be assigned the same tissue identification number.

Question 192

TOLERANCE LIMITS

Answer 192

The limits that define a range of acceptable values that are established for each testing procedure which, when exceeded, require the implementation of corrective actions designed to produce results within the acceptable range in future tests.

Question 193

TOTAL ISCHEMIC TIME (C, V)

Answer 193

The time interval from asystole to subjecting tissue to disinfection solution. This is the sum of warm ischemic time and cold ischemic time.

Question 194

TRACEABILITY

Answer 194

The ability to locate tissue during any step of its donation, recovery, collection, or acquisition, processing, testing, storage, distribution or disposition. It implies the capacity to identify the medical facility receiving the tissue and, at the medical facility, the ability to identify the recipient.

Question 195

TRANSFER (R)

Answer 195

The placement of human reproductive tissue into a human recipient (R).

Question 196

TRANSPLANTATION

Answer 196

The transfer of an allograft or autograft to a recipient.

Question 197

TRANSPORT MEDIUM

Answer 197

Any microbiological medium capable of maintaining cellular viability during the transport of a culture from field to laboratory.

Question 198

TRANSPORT SYSTEM

Answer 198

The combination of the packaging system and the container utilized to transport tissue.

Question 199

VALIDATION

Answer 199

Confirmation through the provision of documented objective evidence that predefined specifications have been fulfilled and can be consistently reproduced.

Question 200

VALVED CONDUIT (C)

Answer 200

An allograft heart valve with an attached length of cardiac outflow tract (aortic or pulmonic).

Question 201

VARIANCE

Answer 201

A departure from Standards that is pre-approved by the AATB Board of Governors prior to implementation.

Question 202

VASCULAR TISSUE (V)

Answer 202

Tissue type that includes, but is not limited to arterial grafts and vein grafts.

Question 203

VEIN GRAFT (V)

Answer 203

A segment of vein that is recovered, processed and preserved.

Question 204

VERIFICATION

Answer 204

The confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Question 205

VERIFIED COPY

Answer 205

A copy of a death certificate without the raised seal but issued by an authorizing agency.

Question 206

VETERINARY USE

Answer 206

Treatment of a condition or disease in a non-human animal.

Question 207

WARM ISCHEMIC TIME (C)

Answer 207

The time interval from asystole to subjecting cardiac tissue to cold rinse (or transport) solution at recovery.

Question 208

WARM ISCHEMIC TIME (V)

Answer 208

The time interval from asystole to subjecting vascular tissue to transport solution and wet ice temperatures at recovery.

Question 209

WET ICE TEMPERATURES

Answer 209

Temperatures ranging from above freezing (0°C) to 10°C.

Question 210

WITNESS

Answer 210

An individual who signifies in writing, or in electronically recorded format, that he or she has observed the execution or verbal authorization of the document of gift/authorization or informed consent. The witness’ signification must be contemporaneous with execution and the witness must be identified by name, address and/or such other contact information as is relevant and feasible. A witness should not be an employee or agent of the tissue bank or requesting entity.

Question 211

AAMI

Answer 211

Association for the Advancement of Medical Instrumentation

Question 212

AATB

Answer 212

American Association of Tissue Banks

Question 213

ANSI

Answer 213

American National Standards Institute

Question 214

AORN

Answer 214

Association of periOperative Registered Nurses

Question 215

ASQ

Answer 215

American Society for Quality

Question 216

ASTM

Answer 216

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards

Question 217

CAP

Answer 217

College of American Pathologists

Question 218

CBER

Answer 218

Center for Biologics Evaluation and Research

Question 219

CDC

Answer 219

Centers for Disease Control and Prevention

Question 220

CFR

Answer 220

Code of Federal Regulations. Published by the Office of the Federal Register, National Archives and Records Administration, Washington, DC

Question 221

e.g.

Answer 221

exempli gratia; for example, such as; the list is not finite

Question 222

FDA

Answer 222

The United States Food and Drug Administration

Question 223

i.e.

Answer 223

id est; that is; indicates a finite list

Question 224

ISO

Answer 224

International Organization for Standardization

Question 225

USP

Answer 225

United States Pharmacopeia

Question 226

The purpose of a tissue bank shall be clearly

Answer 226

formulated and documented

Question 227

The tissue bank shall state whether it is a freestanding entity or part of an

Answer 227

institution

Question 228

The tissue bank shall have a BLANK that may consist of a Board of Trustees, Board of Governors, Board of Directors or a designated responsible individual in whom policy-making authority resides, unless otherwise provided by the institution of which it is a part.

Answer 228

Governing Body

Question 229

This Board or designated individual shall determine the BLANK to be pursued by the tissue bank.

Answer 229

scope of activities

Question 230

The Governing Body shall designate one or more senior employees as

Answer 230

management with executive responsibility

Question 231

Issues of liability, ethical considerations, fiduciary responsibility, and compliance with applicable laws and regulations, these Standards, and the tissue bank’s SOPM shall be the responsibility of the

Answer 231

Governing Body and management with executive responsibility.

Question 232

A tissue bank SHOULD establish and maintain a mechanism to access

Answer 232

medical, technical, and scientific advice as needed. Decisions SHALL be documented.

Question 233

Satellite facilities SHALL be operated in accordance with the

Answer 233

tissue bank’s SOPM

Question 234

What are some types of tissue banking activities or services?

Answer 234

1) donor referral;
2) authorization;
3) informed consent;
4) donor eligibility assessment;
5) recovery, collection, and/or acquisition;
6) post-delivery functions;
7) laboratory services (see exception at B1.600);
8) testing services;
9) processing;
10) storage;
11) tissue release;
12) distribution; and/or
13) consignment.

Question 235

Written agreements or contracts shall

Answer 235

indicate the nature of the relationships, division of tasks performed, division of issues of liability, specific responsibilities of each party and a summary of the protocols and procedures relating to the services provided. The tissue bank shall maintain a copy of each such agreement, which shall be made available for review if requested by AATB inspectors. Compliance with Standards by all parties shall be required and documented in a quality agreement.
A tissue bank that recovers tissue that is processed and/or distributed by another tissue bank shall be responsible for being in compliance with these Standards for all operations it performs. This includes, but is not limited to, the requirement to have a Medical Director; unless the tissue bank that recovers tissue and the tissue bank responsible for the processing and/or distribution of such tissue have a written agreement that defines the responsibilities of the processing tissue bank’s Medical Director to provide required oversight over donor screening and donor testing*, to follow applicable standards in Section D and Appendix II, and to share records (see D4.300). A tissue bank that recovers tissue is not required to audit its contracted tissue bank processor(s).

Question 236

A tissue bank that BLANK tissue recovered and/or distributed by another tissue bank shall be responsible for being in compliance with these Standards for all operations it performs. The tissue BLANK organization must bear the burden of proof, and document in writing, that operations performed by other organizations prior to the receipt of tissue for BLANK were performed in a manner consistent with these Standards as well as the BLANK tissue bank’s requirements.

Answer 236

processes, processing, processing, processing

Question 237

A tissue bank that BLANKS tissue recovered and/or processed by other tissue banks shall be responsible for being in compliance with AATB Standards for all operations it performs. The BLANK must also bear the burden of proof, and document in writing, that operations performed by other organizations prior to its receipt of tissue for BLANK were performed in a manner consistent with AATB Standards. Any records necessary to demonstrate compliance shall be readily accessible to the BLANK tissue bank.

Answer 237

distributes, distributor, distribution, distributing

Question 238

If an AATB-accredited tissue bank obtains from and processes tissue for a tissue bank not accredited by the AATB that is located outside of the United States (U.S.), do the the requirement for compliance with Standards apply to the foreign tissue bank if the processed tissues will not be distributed within, or to, the U.S?

Answer 238

No

Question 239

All tissues imported from entities that do not follow AATB Standards shall be appropriately BLANK throughout import, storage, processing, and export.

Answer 239

quarantined

Question 240

The AATB-accredited tissue bank must verify that the foreign tissue bank not accredited by the AATB complies with

Answer 240

regulations of the governmental authority having jurisdiction in their country for the functions they perform.

Question 241

How frequently does the accredited tissue bank have to verify (via audits and inspections) that that its contracted entities comply with AATB Standards, laws, and regulations?

Answer 241

at least biennially (once every 2 years)

Question 242

The tissue bank must ensure (and maintain documentation of activities obtained by either paper audit or on-site audit) that a laboratory performing donor infectious disease testing for the tissue bank is:

Answer 242

1) registered with the FDA as a tissue establishment and lists ‘testing’ as a function;
2) using the appropriate FDA-licensed, approved, or cleared donor screening tests;
3) following manufacturers’ instructions for these tests; 4) certified in accordance with the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493, or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services;
5) retaining donor infectious disease test run records for ten years; and
6) aware of the requirement of the tissue bank to comply with D4.240.

Question 243

Who shall ensure the establishment of the tissue bank’s policy and objectives for, and commitment to, quality, and shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization?

Answer 243

Management with executive responsibility

Question 244

What must a tissue bank have in place in the event of a merger, acquisition, or dissolution?

Answer 244

Contingency Plan

Question 245

The tissue bank shall have a Medical Director who maintains a valid medical license from any state or U.S. territory (or for international members, the physician must maintain an equivalent medical license). He/she should have training and experience in evaluating and determining donor eligibility particularly with regard to infectious diseases or use a Medical Advisory Committee or consultants to assist in those areas. Unless….

Answer 245

An AATB-accredited tissue bank recovering tissue for an AATB-accredited processing tissue bank may fulfill this requirement by securing a written agreement with the processing tissue bank that defines the responsibilities of the processing tissue bank’s Medical Director to provide required oversight over donor screening and donor testing operations conducted by the recovery tissue bank.

Question 246

Who is responsible for establishing donor eligibility criteria?

Answer 246

Medical Director overseeing the tissue bank

Question 247

Who establishes policies and procedures regarding adverse outcomes?

Answer 247

Medical Director overseeing the tissue bank

Question 248

Who is responsible for notifying appropriate parties of the availability of positive infectious disease test results, and for reporting positive test results when required?

Answer 248

Medical Director overseeing the tissue bank

Question 249

Who has the responsibility for assuring compliance with the SOPM regulatory requirements?

Answer 249

Quality assurance program personnel

Question 250

Who is responsible for managing audits?

Answer 250

Quality assurance personnel

Question 251

Who has the responsibility and authority to approve or reject tissue, as well as discontinue processing and/or release of tissue when deviations from SOPM warrants?

Answer 251

The individual responsible for the quality review

Question 252

Documentation must be made concurrent with each significant step and must include, but not be limited to:

Answer 252

1) information from the donor referral source;
2) donor eligibility assessment information;
3) record of informed consent, or document of gift/authorization;
4) donor physical assessment or physical examination, and donor identification;
5) tissue recovery or collection, transport, and processing;
6) quarantine and infectious disease testing;
7) in-process testing;
8) record review;
9) tissue labeling, storage, release, and distribution;
10) quality control; and
11) services to donor families.

Question 253

Records must include

Answer 253

the responsible party(ies) and must delineate the dates, times, and locations of subsequent procedures as well as the individuals performing them in order to facilitate traceability.

Question 254

Results of laboratory tests used to determine final release of tissue for transplantation (e.g., sterility testing and testing for residual water, ethylene oxide, residual calcium) shall be maintained by

Answer 254

the tissue bank that determines the suitability of the allograft for distribution (‘‘distributor’’).

Question 255

Records of the informed consent, documents of gift/authorization, and records pertaining to donor eligibility, recovery, collection, acquisition, processing, storage, date of distribution, QA, and identity of person/entity to whom distributed, shall be retained at least

Answer 255

10 years beyond the date of distribution, date of transplantation (if known), date of disposition, or date of expiration of the tissue (whichever is latest) or longer if required by applicable laws and regulations.

Question 256

Donor eligibility records of dura mater donors shall be retained

Answer 256

indefinitely

Question 257

Tissue banks that have their tissues processed by another agency must assure that processing and QC records are retained for at least

Answer 257

10 years.

Question 258

The reproductive tissue bank should maintain current donor and client depositor addresses until tissues are

Answer 258

used or destroyed.

Question 259

A tissue bank’s records management system shall identify tissue by use of

Answer 259

a unique identifier

Question 260

Laboratory and QC specimens related to a donor shall also be

Answer 260

traceable to the donor

Question 261

Revisions to paper records shall be made with a single line drawn through the altered text. The revision shall be initialed and dated by the individual making the revision. Additions to a completed record shall be initialed and dated by the individual making the additions.
Records additionally shall include the following information:

Answer 261

1) ABO/Rh, if available;
2) date/time of asystole;
3) date/time of recovery of the heart (time when subjected to cold rinse solution);
4) date/time of subjection of cardiac tissue to disinfection solution;
5) start and stop times when tissue was subjected to disinfection solution; and
6) date/time: a) when preservation began; and b) when placed in final container.

3) date/time vascular tissues subjected to perfusion solution;
4) date/time vascular tissues placed in transport solution and subjected to wet ice temperatures;
5) date/time of subjection of vascular tissue to disinfection solution;
6) start and stop times when tissue was subjected to disinfection solution; and
7) date/time (a) when preservation began and (b) when placed in final container.

Question 262

What records need to be maintained for reproductive tissue?

Answer 262

Donor records shall include documentation of informed consent, relevant medical records, results of all laboratory screening tests, and outcome of prior assisted reproductive technology procedures (if known) including number of successful pregnancies and any reports that would affect the donor’s eligibility. Records shall also include personal attributes of the donor such as: height, weight, eye color, hair color, complexion, racial group, and/or body type.

Question 263

Monetary compensation or other valuable consideration, including goods or services, shall not be offered to a donor, authorizing person, the donor’s estate, or any other third party acting on behalf of the donor, except in the following instances:

Answer 263

1) the tissue bank may reimburse responsible third parties for costs directly associated with a donation; or 2) the tissue bank may reimburse living donors for costs associated with an acceptable donation, including compensation for restoration of lost earnings when directly attributable to donation, if and as authorized by law.

Question 264

(R) The reproductive tissue bank may provide monetary compensation to donors of reproductive tissue if

Answer 264

the compensation is compliant with professional standards of practice.

Question 265

A policy shall be established requiring the donor always be treated with

Answer 265

A policy shall be established requiring the donor always be treated with

Question 266

This authorization shall be expressed in a document of gift/authorization, the original or a copy of which shall be maintained in the donor’s record at the tissue bank responsible for

Answer 266

recovery, as well as in the donor’s record at the tissue bank whose Medical Director is responsible for the donor eligibility determination.

Question 267

True or False: In cases where a donor has executed a document of gift it may be acted upon (permits recovery) provided it meets applicable laws and regulations.

Answer 267

True

Question 268

When a document of authorization is used it must contain the following signatures and related information:

Answer 268

1) the authorizing person’s signature and: name, mailing address (NOTE: If requested by the authorizing person, only an email address may be documented as the address but, in such cases, the authorizing person should permit its use and should be informed that if the email address changes or if email communication is blocked, there may be no effective forwarding or receipt of information.); phone number, and relationship to the donor;

2) the donation coordinator’s signature and the date, identity of their organization, the signature of each witness if witnessing is required by law or regulation, documentation that the Core Elements were used, and a statement granting authorization for tissue recovery

Question 269

Legal authorization can be obtained using different methods. When authorization is obtained:

Answer 269

In person, by telephone, by facsimile, or using electronic transmission (e-mail)

Question 270

What are the Core Elements?

Answer 270

1) the name of the Donor;
2) the name, mailing address, and telephone number of the authorizing person, and his/her relationship to the donor
3) an explanation that the tissue is a gift, and that neither the donor’s estate nor the authorizing person will receive monetary compensation or valuable consideration for it;
4) a description of the general types of tissue to be recovered;
5) a description of the permitted use(s) of the recovered tissues (i.e., transplant, therapy, research, or education);
6) an explanation that recovery of tissue requires the following actions, and the document of gift/authorization thus specifically authorizes: a) access to, and required disclosure of, the Donor’s medical and other relevant records; b) testing and reporting for transmissible diseases; c) the removal of specimens which may include, but are not limited to blood or tissue samples for the purposes of biopsy or other testing necessary for determination of donor eligibility; d) the release to the tissue bank of any and all records and reports of a Medical Examiner, Coroner or Pathologist (e.g., autopsy report); and e) such other requirements as may be applicable for the specific donation or tissue bank, such as transport of the donor’s body, archiving of samples, photographic or other imaging, etc.
7) contact information for the organization represented by the donation coordinator; and
8) any additional information required by laws or regulations.
9) Any explanation required by law, such as an explanation that multiple organizations (nonprofit and/or for profit) may be involved in facilitating the gift(s) and/or reference to the possibility that tissue may be distributed internationally, must be included.

Question 271

The following information should be provided to an authorizing person:

Answer 271

1) a general description of the recovery e.g., timing, relocation of donor if applicable, contact information, etc.;
2) an explanation that costs directly related to the evaluation, recovery, preservation, and placement of the tissues will not be charged to the family;
3) an explanation regarding the impact the donation process may have on burial arrangements and on appearance of the donor’s body; and
4) an explanation that the document of authorization is available.

Question 272

When is it required to obtain blood from the birth mother?

Answer 272

When a donor is 28 days of age or less

Question 273

Is the authorizing person able to revoke or amend the gift made by the donor?

Answer 273

No

Question 274

In cases where the gift is authorized by a donor’s own document of gift (i.e., first person consent), including a document of gift recorded in a donor registry…

Answer 274

law mandates notification, such notification shall be made pursuant to law.

Question 275

Prior to transport of the donor’s body or recovery, the donation coordinator should attempt to notify the person who would have been an authorizing person had no gift been made during the life of the donor or the person who is authorized to make arrangements for final disposition. The information to be provided in the notification should contain, at a minimum…

Answer 275

the Core Elements of authorization

Question 276

The donation coordinator should inquire during the notification whether the notified person is aware of any revocation or refusal made by

Answer 276

the donor

Question 277

Recovery may proceed only after…

Answer 277

good faith efforts to notify an appropriate person of the gift fail to result in actual notification within a time frame compatible with the successful recovery of the tissue, and the attempt to notify shall be documented.

Question 278

Donor eligibility criteria shall be established by

Answer 278

the Medical Director of the tissue establishment responsible for the determination of donor eligibility (ref. Section 1271.50) and shall not conflict with these Standards.

Question 279

Is documentation of a physical exam and DRAI required for an autologous donor?

Answer 279

No

Question 280

True or False: The health status of the infant(s) shall be assessed in regard to information that could affect the quality or safety of the birth tissue for transplantation.

Answer 280

True

Question 281

Heart donors shall also be evaluated for the risk of

Answer 281

Chagas’ Disease

Question 282

Potential skin donors shall be evaluated on an individual basis by chart review and visual assessment for size, current medical status, and…

Answer 282

skin condition

Question 283

What is the age limit for autologous tissue donation?

Answer 283

No age limit

Question 284

What is the age limit for the birth mother for birth tissue donation?

Answer 284

There is no age limit for the birth mother, however, policies and procedures shall be written regarding gestational age limits.

Question 285

Semen donors shall be younger than…years of age to minimize the risk of genetic anomalies except with the written agreement of the user physician

Answer 285

40

Question 286

Oocyte donors shall be younger than… years, unless an exception has been made by the Medical Director with documented agreement of the user physician.

Answer 286

35

Question 287

Prior to the recovery of tissue from a deceased donor, a physical…

Answer 287

assessment shall be performed by a responsible person.

Question 288

Tissue shall be rejected if the recent ante-mortem or postmortem physical assessment identifies evidence of:

Answer 288

high risk behavior and signs of HIV infection or hepatitis infection; other viral or bacterial infections; or, signs of trauma or infection to the body where recovery of tissue is planned.

Question 289

If any of the following signs are observed or noted in any other available record, and are deemed to be an indication of these risks, then the tissue shall be rejected:

Answer 289

1) physical evidence for risk of sexually transmitted diseases such as genital ulcerative disease, herpes simplex, chancroid (genital lesions);
2) physical evidence for risk of, or evidence of, syphilis (genital lesions, rash, skin lesion [non-genital]);
3) for a male donor, physical evidence consistent with anal intercourse including perianal condyloma (insertion trauma, perianal lesions);
4) physical evidence of non-medical percutaneous drug use such as needle tracks (and/or non-medical injection sites), including examination of tattoos (which may be covering needle tracks);
5) disseminated lymphadenopathy (enlarged lymph nodes);
6) unexplained oral thrush (white spots in the mouth);
7) blue or purple spots consistent with Kaposi’s sarcoma (blue/purple [gray/black] spots/lesions);
8) physical evidence of recent tattooing, ear piercing, or body piercing (tattoos/piercings should be described);
9) unexplained jaundice, hepatomegaly, or icterus.

Note: Hepatomegaly may not be apparent in a physical assessment unless an autopsy is performed (enlarged liver, jaundice, icterus);

10) physical evidence of sepsis, such as unexplained generalized rash/generalized petechiae, or fever (rash); 11) large scab consistent with recent smallpox immunization (scab);
12) eczema vaccinatum (lesion,scab); 13) generalized vesicular rash, generalized vaccinia (rash); 14) severely necrotic lesion consistent with vaccinia necrosum (lesion); and/or 15) corneal scarring consistent with vaccinial keratitis (abnormal ocular finding, scarring).

Question 290

a physical examination of the birth mother must be performed during admission for delivery or within

Answer 290

14 days prior to delivery.

Question 291

A physical examination must be performed on all anonymous and directed semen and oocyte donors. A repeat physical examination shall be performed on anonymous semen donors at least every

Answer 291

A physical examination must be performed on all anonymous and directed semen and oocyte donors. A repeat physical examination shall be performed on anonymous semen donors at least every

Question 292

A physical examination shall be performed by the Medical Director or licensed physician designee, or by a physician involved with the individual’s medical care, or designee as permitted by law prior to…

Answer 292

the donation of tissue from a potential living donor

Question 293

A physical assessment shall be performed by a responsible person prior to…

Answer 293

recovery of tissue from a deceased donor

Question 294

A documented dialogue (DRAI) shall be conducted with the

Answer 294

donor (if living) or the deceased donor’s next of kin, the nearest available relative, a member of the donor’s household, other individual with an affinity relationship (caretaker, friend, significant life partner) and/or the primary treating physician

Question 295

For all donors one month (28 days) of age or less, the infant and the birth mother shall be screened for

Answer 295

risk of relevant communicable disease agents and diseases (RCDADs) and the birth mother’s blood must be tested

Question 296

The tissue bank shall have a policy for obtaining information from the patient’s physician as to whether the autologous donor is at high risk for

Answer 296

viral hepatitis or HIV infection.

Question 297

The donor risk assessment interview of the birth mother shall be obtained, or previous donor risk assessment interview information verified, no more than BLANK days prior to delivery. If this interview is performed after delivery it must be completed within BLANK days of delivery.

Answer 297

14

Question 298

Prior to tissue donation, a preliminary review of readily available relevant medical records shall be conducted by a trained individual. This review shall include but may not be limited to:

Answer 298

Prior to tissue donation, a preliminary review of readily available relevant medical records shall be conducted by a trained individual. This review shall include but may not be limited to:

Question 299

(A) Except for skin, autologous donation should not be undertaken when the autologous donor has, or is being treated for, bacteremia or other significant bacterial infection that can be associated with bacteremia, unless

Answer 299

such tissue will be secondarily sterilized prior to transplantation or treated in such a manner to minimize microbial contamination.

Question 300

Infectious disease testing of donor blood specimens shall be performed for each tissue donor on a specimen collected at the time of donation or within

Answer 300

7 days prior to or after donation

Question 301

If the donor is one month (28 days) of age or less, a blood specimen from the birth mother must be collected within

Answer 301

7 days prior to or after tissue donation and tested instead of a specimen from the infant donor

Question 302

For anonymous and directed oocyte donors, the blood specimen must be collected within

Answer 302

30 days prior to oocyte collection, or within 7 days post donation.

Question 303

Samples for infectious disease testing of anonymous and directed semen donors must be obtained within

Answer 303

7 days of initial semen collection

Question 304

Tissue from a donor who is older than 12 years of age shall be determined to be not suitable for transplantation if blood loss is known or suspected to have occurred and there has been transfusion/infusion of more than

Answer 304

2,000 milliliters (mL) of blood (e.g., whole blood, or red blood cells) or colloids within 48 hours; or more than 2,000 mL of crystalloids within one hour; or any combination thereof, prior to asystole or the collection of a blood specimen, whichever occurred earlier unless: 1) a pre-transfusion or pre-infusion blood specimen from the tissue donor is available for infectious disease testing; or 2) an algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donorto ensure that there has not been plasma dilution sufficient to affect test results.

Question 305

Tissue from a donor who is 12 years of age or less who has been transfused or infused at all, shall be determined to be not suitable for transplantation unless

Answer 305

a pre-transfusion or pre-infusion blood specimen from the tissue donor is available for infectious disease testing, or an algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results.

Question 306

Testing used for donor eligibility shall be performed by laboratories that are registered with

Answer 306

FDA as a tissue establishment for testing and are either certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493, or that have met equivalent requirements as determined by the Centers for Medicare and Medicaid Services.

Question 307

Results of initial infectious disease and/or confirmatory testing shall be used as one component of determining

Answer 307

donor eligibility

Question 308

If a laboratory that performs organ donor testing performs the initial testing in duplicate or triplicate, the tissue bank must obtain and review the results of

Answer 308

all individual tests performed

Question 309

All tissue from donors who test repeatedly reactive on a required screening test shall be

Answer 309

quarantined and shall not be used for transplantation.

Question 310

Donor sample testing shall be performed, and test results interpreted according to the

Answer 310

manufacturer’s instructions in the package insert for the particular infectious disease marker.

Question 311

Excluding autologous, embryo donor, and client depositor tissue, all human tissue intended for transplantation shall be from donors who are tested and found to be negative for:

Answer 311

1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti- HIV-1 and anti-HIV-2);
2) nucleic acid test (NAT) for HIV-1; 3) hepatitis B surface antigen (HBsAg);
4) nucleic acid test (NAT) for the hepatitis B virus (HBV); 5) total antibodies to hepatitis B core antigen (anti-HBc—total, meaning IgG and IgM);
6) antibodies to the hepatitis C virus(anti-HCV);
7) nucleic acid test (NAT) for HCV;
8) syphilis (a non-treponemal or treponemal-specific assay may be performed).

Question 312

Donors of viable leukocyte-rich tissue (e.g., semen, certain (CT)) shall also be tested and found to be negative for antibodies to

Answer 312

human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II).

Question 313

For tissue establishments located within the United States (U.S.), all living donors, excluding autologous donors, shall be tested and found to be negative for

Answer 313

WNV NAT when recovery, collection, or acquisition occurs from June 1st through October 31st every year.

For tissue establishments located outside the U.S. importing tissues to the U.S., all living donors, excluding autologous donors, shall be tested year-round and found to be negative for WNV NAT.
In addition to the infectious disease tests listed above, all anonymous and directed semen and oocyte donors shall undergo testing for Neisseria gonorrhea and Chlamydia trachomatis. If the reproductive tissue is collected by a method that ensures freedom from contamination of the tissue by infectious disease organisms that may be present in the genitourinary tract, then these tests are not required.
All donated semen from anonymous donors shall be frozen and quarantined for at least 6 months. After such time and prior to release of semen, the donor shall be retested for anti-HIV-1, HIV-1 NAT, antiHIV-2, HBsAg, anti-HBc, HBV NAT, anti-HCV, HCV NAT, antiHTLV-I, anti-HTLV-II, syphilis, and for anti-CMV.

Question 314

Oocyte donor tissue is not subject to

Answer 314

quarantine and the donor is not subject to repeat testing.

Question 315

“Appropriate measures” meansv

Answer 315

using available resources to accomplish the testing. If the client depositor cannot be tested due to death or inability to locate the person, directed or anonymous donation of the embryos can still be completed.

Question 316

Positive test results shall be

Answer 316

reported to state and/or local health department(s) as required by law or regulation, the donor (if living), and/or the authorizing person (if donor is deceased)

Question 317

A policy shall be established to collect and preserve serum, plasma, or hematopoietic tissue samples from donors for an appropriate duration after the

Answer 317

recovery, collection, or acquisition date as/if prescribed by a quality, safety, and legal risk assessment conducted by the tissue bank to mitigate the establishment’s specific risk exposure.

Question 318

Prior to enrollment of a donor in the sperm donor program, his semen shall be tested for sperm quality and found acceptable for such parameters as

Answer 318

sperm motility, concentration, and post-thaw motility. Donors shall be excluded unless the specimen meets criteria set by the Medical Director and, when appropriate, the Medical Advisory Committee.

Question 319

True or False: If any tissue bank determines a donor to be ineligible, this determination must be communicated in writing to the tissue bank that recovered tissues, and the tissue bank that recovered tissues must share this information with all establishments that are known to have recovered tissues, or to have received recovered tissues, from the same donor.

Answer 319

True

Question 320

Are tests performed after tissue has been disinfected or subjected to processing considered relevant donor records to the tissue bank that recovered? Would these results be shared with the tissue banks who received recovered tissues?

Answer 320

No

Question 321

Detailed records of the tissue donation shall be maintained that include information regarding

Answer 321

relevant packaging, transportation, and, when applicable, donor reconstruction steps.

Question 322

All critical supplies, reagents, materials, and equipment approved for use for recovery, collection, or acquisition shall be identified and specifications (e.g., sterile where applicable) shall be

Answer 322

documented

Question 323

What needs to be recorded in regards to reagents, supplies, and materials?

Answer 323

the type, quantity, manufacturer, lot number, date of receipt, and expiration date or manufacturing date (as applicable)

Question 324

Do tissue banks need to maintain records on supplies?

Answer 324

The tissue bank shall maintain records of all supplies, reagents, materials, and equipment from receipt through period of time used. All reagents, supplies, materials and equipment shall be used and stored in accordance with manufacturers’ instructions, unless qualified/validated for intended use or storage.

Question 325

Do sterilization steps need to be documented?

Answer 325

Yes

Question 326

True or False: Newer stock rotation items should be used first and not used if expired or quality has been compromised.

Answer 326

False

Question 327

What is the importance of using unique donor identifiers?

Answer 327

Donor identifiers allow for tracing of the tissue from the donor and to final disposition of each tissue with confidentiality.

Question 328

What are some ways to verify the identity of a patient?

Answer 328

hospital wristband, medical examiner number, driver’s license, or government issued identification with photograph

Question 329

Who is responsible for verifying a patient’s identity for autologous and surgical bone recovery?

Answer 329

Identification of the donor shall be the responsibility of the hospital staff involved with the recovery.

Question 330

Who is responsible for verifying a patient’s identity for birth tissue recovery?

Answer 330

Identification of the birth mother shall be the responsibility of the hospital staff, or the tissue bank staff member involved with acquisition.

Question 331

Recovery, collection, or acquisition shall be performed using what kind of technique?

Answer 331

aseptic or clean techniques appropriate to the specific tissue type and intended use. Tissue must be labeled using a donor identifier and a description according to the SOPM.

Question 332

If recovery is to be delayed for a deceased donor, the donor’s body should be

Answer 332

refrigerated/cooled as specified in the tissue-specific standards.

Question 333

Recovery from one donor shall be the exclusive activity taking place at one time at a recovery site to prevent…

Answer 333

cross-contamination or mix-ups

Question 334

True or False: Two tissue recoveries can occur simultaneously in the same room.

Answer 334

False

Question 335

Tissue recovery shall not occur after

Answer 335

embalming procedures have begun (i.e., injection of embalming fluid, application of drying agents either internally or topically).

Question 336

Is pooling allowed in tissue banking?

Answer 336

No. Pooling tissue from multiple donors shall not occur during recovery, collection, acquisition or storage

Question 337

Cardiac tissue and vascular tissue recovery and processing time limits (i.e., warm and cold ischemic time, disinfection time, and the perfusion time [specific to vascular tissues]) shall be established by

Answer 337

each individual tissue bank; however, the upper time limits for initiation of recovery of specific tissue types shall not be exceeded.

Question 338

Warm ischemic time (C, V) shall not exceed

Answer 338

24 hours from asystole if the donor’s body was cooled (e.g., application of sufficient amounts of wet ice or a cooling blanket, cold weather conditions) or refrigerated within 12 hours of asystole. The time limit shall not exceed 15 hours if the donor’s body was not cooled or refrigerated. If the donor’s body is cooled for a period of time then not cooled for a period of time, the time period the donor’s body is not cooled cannot exceed 15 cumulative hours.

Question 339

Perfusion time shall not exceed

Answer 339

12 hours from asystole

Question 340

The skin prep shall begin within

Answer 340

24 hours of asystole provided the donor’s body was cooled (e.g., application of sufficient amounts of wet ice or a cooling blanket, cold weather conditions) or refrigerated within 12 hours of asystole. The skin prep shall begin within 15 hours of death if the deceased donor’s body has not been cooled or refrigerated. If the donor’s body is cooled for a period of time then not cooled for a period of time, the time period the donor’s body is not cooled cannot exceed 15 cumulative hours.

Question 341

Prior to recovery, the recovery site must be evaluated for suitability using pre-established criteria designed to control…

Answer 341

contamination and cross-contamination

Question 342

All tissue shall be recovered in an aseptic or clean fashion using standard surgical preparation with

Answer 342

sterile packs, instrumentation, and technique.

Question 343

The recovery site evaluation must be documented, however, if the recovery site is an operating room in a heath care facility…

Answer 343

no documented site evaluation is required.

Question 344

What are the Recovery Site Suitability Parameters?

Answer 344

1) size/space;
2) lighting;
3) plumbing and drainage for the intended use;
4) the physical state of the facility (i.e., state of repair);
5) ventilation;
6) cleanliness of room and furniture surfaces;
7) pests;
8) traffic;
9) location;
10) other activities occurring simultaneously;
11) sources of contamination; and
12) the ability to appropriately dispose of biohazardous waste and handle contaminated equipment.

Question 345

All working surfaces (e.g., back table, Mayo stand, recovery table) used during recovery must be decontaminated using a

Answer 345

bactericidal/antimicrobial agent. All cleansing and disinfecting events performed by tissue bank personnel shall be documented.

Question 346

Technician gowning, gloving, and movement shall be accomplished with the same diligence as used routinely for

Answer 346

operative procedures. Aseptic technique shall be followed.

Question 347

What shall be worn during the time of the surgical scrub?

Answer 347

A head cover, eye shields and mask shall be worn at the time of scrub, and a Sterile gown and gloves shall be donned after the scrub/wash.

Question 348

Cleansing, preparing (i.e., skin prep), and draping the skin shall be accomplished with the same diligence as used routinely for operative procedures. Unless otherwise qualified/validated, agents used shall be

Answer 348

antimicrobial skin preparation products, as specified in the SOPM, and shall be used in accordance with manufacturers’ guidelines/instructions.

Question 349

What kind of specific tissue recovery operations control contamination and cross- contamination?

Answer 349

Some examples include: sequencing of the tissue recovery, use of well-defined zone recovery techniques, and isolation draping in the presence of trauma. Areas of skin that have abrasions or puncture wounds should be avoided. All tissue shall be recovered using aseptic technique.

Question 350

What tissues require cultures to be obtained at recovery?

Answer 350

MS, OA, S, SB

Question 351

True or False: If the birth tissue delivery location is an operating room or a designated delivery room in a specialized health care facility, no documented site evaluation is required, however, any other location of delivery must meet the requirements at D5.500 and D5.510. Such an evaluation must be documented.

Answer 351

True

Question 352

Are birth tissue cultures obtained before or after acquisition?

Answer 352

If performed, the technique used to obtain cultures prior to acquisition shall be appropriate and performed according to written instructions

Question 353

Recovery records for allogeneic tissue shall include, but not be limited to:

Answer 353

1) name, and address of the recovery agency;
2) date, time and staff involved in all significant steps performed during the recovery (documentation shall be as per C1.100);
3) location and assessment of the suitability of the recovery site;
4) documentation of the physical assessment or physical examination;
5) documentation of any errors, accidents, or deviations that occurred;
6) donor name, age, and sex;
7) the type, lot number, manufacturer, and expiration date of critical reagents, supplies and materials, and the identification of equipment, used to recover, rinse, and/or transport tissue; and
8) specific tissue recovered; and
9) other available relevant medical records.

Question 354

The following information regarding autologous tissue recovery shall be documented:

Answer 354

1) name and address of the institution in which the autologous tissue was recovered;
2) date and time the autologous tissue was recovered; 3) name of the physician recovering the autologous tissue;
4) donor name, age, sex, and hospital medical record number and/or social security number; and
5) type of tissue recovered.
Details of the delivery and post-delivery time period through acquisition shall be documented in the donor’s record. These records shall include, but not be limited to the: 1) birth mother’s name;
2) infant donor’s gestational age;
3) name and address of the health care facility and the identification of the delivery environment/location;
4) date and time of the delivery;
5) the physician or other authorized practitioner involved with the delivery, or designee as permitted by law;
6) information to allow tracking of critical reagents, supplies and materials provided by the tissue bank;
7) specific tissue(s) acquired;
8) other available relevant medical records; and
9) documentation of any errors, accidents, or deviations that occurred.

Question 355

Immediately following recovery of each individual tissue at the recovery site, how should the recovered tissue be packaged?

Answer 355

individually and aseptically wrapped or enclosed and shall be immediately labeled with the unique donor identifier and the description according to the SOPM. Tissue shall be maintained at defined environmental temperatures until the time of transport to the processing center. Maintenance of such temperatures shall be documented. The receptacle/transport package must be designed to prevent contamination of the contents and allow for aseptic presentation of the tissue at the time of processing.

Question 356

The package shall be labeled immediately with definitive autologous donor identifying information such as the patient’s name, hospital registration number, security number, birth date, etc., and shall be prominently labeled…

Answer 356

“FOR AUTOLOGOUS USE ONLY.’’

Question 357

What kind of solution should recovered cardiac tissue be rinsed and packaged in?

Answer 357

Recovered cardiac tissue shall be rinsed and packaged in an isotonic, sterile solution such as normal saline, lactated Ringer’s solution, PlasmaLyte®, transplant organ perfusate (e.g., Belzer’s UW solution, Collin’s solution) or tissue culture media, immediately following recovery. The volume of the transport solution should be adequate to cover the entire heart, including the vessels and valves. The type, lot number, manufacturer, and expiration date shall be documented.

Question 358

Immediately following recovery, vascular tissue shall be gently flushed and packaged in…

Answer 358

an isotonic sterile solution such as tissue culture media. Normal saline solution should not be used. The type, lot number, manufacturer, and expiration date of all reagents used for recovery and packaging shall be documented.

Question 359

Recovered skin tissue shall be packaged in…

Answer 359

a sterile solution immediately following recovery or packaged by another method that maintains the integrity of the tissue for its intended use (e.g., decellularized dermis). If in solution, the volume of transport solution must be adequate to cover the entire skin. The type, lot number, manufacturer, and expiration date(s) shall be documented.

Question 360

Transportation temperatures do not require verification if the packaging and transport conditions have been

Answer 360

validated to maintain the required environmental conditions, including temperatures.

Question 361

The receptacle/transport package for tissue transport must indicate…

Answer 361

'’DONATED HUMAN TISSUE’’ is enclosed and must include the name and address of the originating agency and processing center (if different).

Question 362

All human tissue processed or shipped prior to determination of donor eligibility must be

Answer 362

under quarantine, accompanied by records assuring identification of the donor and indicating that the tissue has not been determined to be suitable for transplantation (e.g., ‘‘Quarantine’’; “Donor Eligibility Has Not Been Completed’’; and ‘‘Not Suitable for Transplant in its Current Form’’)

Question 363

When wet ice temperatures would be injurious to the tissue recovered (A, LD, CT), it may be transported at appropriate temperatures and within time limits that maintain the

Answer 363

quality of the tissue for its intended use.

Question 364

The transport package (C, V) shall be transported at wet ice temperatures. Time of acceptance of the tissue into the processing center shall be documented. Cardiac tissue and vascular tissue shall be received at the processing location within sufficient time following recovery to allow for the start of

Answer 364

disinfection within the established cold ischemic time limit.

Question 365

The recovered MS tissue shall be wrapped in an aseptic fashion with at least one

Answer 365

moisture barrier and shall be transported at wet ice temperatures or colder

Question 366

The maximum time that recovered tissue shall remain at wet ice temperatures, prior to either processing or freezing, shall be no longer than a time limit established by

Answer 366

a validated procedure that maintains tissue quality

Question 367

If the tissue is to be cryopreserved, the skin transport package shall be transported at what temperature?

Answer 367

wet ice temperatures or packaged by another method that maintains the quality of the tissue for its intended use.

Question 368

Unless there is a specific request from a medical examiner, pathologist, or a funeral home, the surgical incision(s) shall be

Answer 368

closed in an aesthetic fashion and the deceased donor’s body prepared for the next portion of the recovery or for transportation to an appropriate facility

Question 369

Reconstruction should employ techniques consistent with what guidelines?

Answer 369

funeral home guidelines and/or medical examiner or pathologist requests. Documentation of donor reconstruction (if applicable) and disposition of the donor’s body shall be maintained in the donor’s record.

Question 370

Storage, including temporary storage, of recovered, acquired, or collected tissue shall be in conformance with storage temperature and monitoring expectations provided by the tissue bank that will

Answer 370

process the tissue.

Question 371

Adequate controls must exist to prevent

Answer 371

mix-ups, contamination, cross-contamination, and ensure tissue is identified as acceptable or unacceptable during all stages of recovery, receipt, storage, processing and distribution.

Question 372

If physical segregation is deemed unnecessary, justification must be established, and must include a risk assessment and use of a validated electronic system. Considerations for the risk assessment shall include:

Answer 372

1) potential severity of impact if controls fail to prevent mix-up, contamination or cross-contamination;
2) probability of failure to occur;
3) likelihood of identifying a failure before it reaches a customer;
4) existing controls to prevent failure; and
5) back-up plan for failure of validated electronic system.
The SOPM must address when the segregation of tissue during storage is indicated and how it will be appropriately segregated to avoid contamination, cross-contamination and mix-ups.

Question 373

Considerations for assessment of risk include, where applicable:

Answer 373

1) donor infectious disease test results are unavailable or this testing will not be performed;
2) the intended use of the tissue is primarily for transplantation or is restricted to research or education; 3) autologous tissue is segregated from allogeneic tissue;
4) the donor has been determined to be ineligible;
5) the ability of packaging and labeling to withstand storage temperatures, and/or
6) the ability to decontaminate storage equipment or the storage area should an accident occur.

Appropriate segregation must include considerations above and storage must be in clearly defined and labeled areas (shelves or compartments) of the storage equipment or storage area

Question 374

Freezers and refrigerators used for storing tissue shall be regularly maintained, calibrated, and monitored according to written

Answer 374

QC procedures

Question 375

Approval or rejection of the receipt of tissue into the processing or storage facility must be documented. The receipt and movement into storage, to immediate processing or to removal, shall be documented, including, at a minimum:

Answer 375

1) the condition of the transport package;
2) confirmation each tissue is labeled with a tissue identification number, or other traceable unique identifier;
3) evidence proper environmental conditions were maintained (e.g., presence/absence of ice/coolant). Refer to H3.300;
4) the date and time of receipt and movement; and
5) personnel involved.

Question 376

Except for reproductive tissue, each unit of tissue shall be assigned a tissue identification number, which shall serve to

Answer 376

relate the tissue to the donor from whom it was recovered or acquired and the associated records at any phase (e.g., quarantined, unprocessed, processed inventory) of the operation. Tissue units shall be assigned the same tissue identification number only if they are identical and processed as a lot.

Question 377

Can a unique identifier for reproductive tissue include the directed donor’s or client depositor’s name?

Answer 377

Yes

Question 378

For donors and client depositors giving multiple specimens, do tissue banks use the same unique identifier for all collection dates?

Answer 378

No, for donors and client depositors giving multiple specimens, a secondary code shall be used to distinguish between dates of collection. The reproductive tissue bank that collects and processes the reproductive tissue shall be identified by name, code, or other identifier on the final container.

Question 379

Is pooling from multiple donors during processing, preservation, or storage allowed?

Answer 379

No

Question 380

If autologous tissue is not to be processed, it should be retained in its

Answer 380

original wrapping.

Question 381

(C, V) Processing shall include a disinfection period followed by

Answer 381

rinsing, packaging, and preservation

Question 382

What is required in a tissue evaluation that describes the attributes of each allograft?

Answer 382

A standardized evaluation and classification system is required that describes the attributes of each allograft. A detailed description of the condition of the allograft shall be recorded in the permanent donor processing records. The allograft evaluation system shall be made available to the implanting surgeon. (C, V, OA)

Question 383

Except for reproductive tissue, when tissues are exposed to the environment during processing, these activities shall be consistent with the requirements of

Answer 383

aseptic processing.

Question 384

Without a subsequent validated microbial inactivation process, aseptic processing shall be performed in a

Answer 384

a certified and qualified bacteriologically and climate-controlled environment.

Question 385

Adequate processing environmental control is defined by justifying and documenting the following:

Answer 385

1) type and frequency of environmental monitoring;
2) when the samples are to be taken (e.g., during or at the conclusion of operations);
3) sampling locations and number of sites to be sampled;
4) sample duration;
5) sample size (e.g., surface area, air volume);
6) action and alert levels for test results; and
7) potential corrective actions when alert and/or action levels are exceeded

Question 386

All critical supplies, reagents, materials, and equipment approved for use for processing and preservation shall be identified and specifications (e.g., sterile where applicable) documented. It is expected that the tissue bank has the ability to link all supplies, reagents, materials, and equipment to

Answer 386

tissue processed over the period of time they were in use.

Question 387

All non-disposable surgical instruments and mechanical/electrical equipment used in tissue processing shall be

Answer 387

cleaned, decontaminated, and, where applicable sterilized, between use for tissue from different donors according to written procedures.

Question 388

A record shall be made of all reagents, supplies, and materials following receipt including, as applicable, the…

Answer 388

the type, quantity, manufacturer, lot number, date of receipt, and expiration date or manufacturing date (as applicable).

Question 389

For non-disposable surgical instruments and mechanical/electrical equipment deemed critical, written procedures must be prepared and methods shall be

Answer 389

validated, to prevent contamination or cross-contamination during processing. Adequate controls must exist to prevent mix-ups between acceptable and unacceptable items.

Question 390

Reagents, supplies, and materials with expiration dates or production dates shall be stored in a manner to facilitate

Answer 390

inventory rotation. Items not bearing an expiration or production date shall be labeled with the date of acquisition and stored in a manner to facilitate inventory rotation. Older items should be used first and not used if expired or quality is compromised.

Question 391

The container shall…

Answer 391

maintain its integrity, withstand sterilization and storage conditions, not produce toxic residues during storage, and maintain tissue quality through the labeled expiration date. Containers shall not interfere with the effective use of appropriate agents applied to sterilize or disinfect the tissue.

Question 392

If ethylene oxide is used to sterilize processing or packaging components that come in contact with the allografts (e.g., disinfection jars or packaging pouches), residues of

Answer 392

ethylene oxide, ethylene glycol, and ethylene chlorohydrin should be evaluated.

Question 393

(C, V) Final packaging containers shall be adequate for use at defined storage temperatures and documented to remain stable and impervious to microbial particles under normal environmental conditions at the specified temperature and throughout the recommended

Answer 393

thawing regimen.

Question 394

Containers shall be stored under quarantine until the containers have been

Answer 394

tested, sampled, or examined, as appropriate, and released for use. Containers not meeting specifications shall not be used.

Question 395

Time limits and/or other valid process control end points or limits for the completion of each phase of processing and preservation shall be

Answer 395

established and validated with reference to tissue quality. Additionally, a time limit and temperature for pre-processing quarantine storage that address tissue quality must be established and justified.

Question 396

(C, V) Disinfection of cardiac and vascular tissue shall be accomplished via a time specific, validated process (disinfection time). The total ischemic time shall not exceed

Answer 396

48 hours

Question 397

(R) After collection, analysis shall be performed within an appropriate time period, and processing, if performed, shall be initiated within a time period appropriate for retention of functional quality, as specified in the

Answer 397

SOPM

Question 398

(S) When preservation of cellular viability is desired, processing of skin shall be initiated within

Answer 398

10 days of recovery, provided the skin is placed in tissue storage media that is replaced at least every 72 hours.

Question 399

If the media for skin preservation is not changed, processing shall be initiated within

Answer 399

96 hours of recovery

Question 400

(C, V, OA, S) To prevent drying and possible cellular and extracellular matrix deterioration, the tissue shall be kept moist at all times during processing using a

Answer 400

sterile solution/medium. If drying does not impact quality for intended use (e.g., decellularized dermis), the requirement to prevent drying is not applicable.

Question 401

When applicable, the type, amount, concentration, and method of incorporation/addition of all media, cryoprotectants, and any other additives used in processing shall be specified in the

Answer 401

SOPM. This information about the allograft shall be made available to the implanting/transplanting physician, upon request.

Question 402

Process control procedures shall be designed to assure that tissue has the intended…

Answer 402

identity, characteristics, and quality

Question 403

The tissue bank shall determine when, which, and how controls are to be performed

Answer 403

e.g…. residual moisture testing, microbial cultures of tissue, solutions, packaging, equipment, pH measurements, or post thaw sperm quality). Sampling for in-process controls shall be designed to be representative of the materials to be evaluated.

Question 404

True or False: Tissue dimensions do not matter because each recipient is a different height and weight.

Answer 404

False. Tissue banks that process tissue shall include in their SOPM a description of the final types of tissue, any specifically required or specifically prohibited dimensions or characteristics, and the means used to assess these characteristics. At or near the end of processing, tissue shall be evaluated according to these procedures to determine whether it is in conformance with the SOPM. Relevant tissue dimensions or characteristics shall be recorded. All tissue deemed to be out of conformance shall not be released for transplantation.

Question 405

Tissue measurement shall be performed and documented and must include the…

Answer 405

quantity or other characteristics of the tissue expressed as applicable (e.g. volume, weight, dimensions, cell density, number of viable cells or a combination of these).

Question 406

(C) Allograft heart valve grafts shall be inspected, evaluated, and sized by internal valve annulus diameter, and recorded in…

Answer 406

millimeters (mm)

Question 407

The length of the aortic conduit, main pulmonary artery, and the left and right pulmonary arteries shall be recorded in…

Answer 407

millimeters (mm) or centimeters (cm).

Question 408

(V) Vascular tissue grafts shall be inspected, evaluated, and sized by diameter and recorded in

Answer 408

millimeters (mm)

Question 409

The length of the vascular segment shall be recorded in…

Answer 409

centimeters (cm)c

Question 410

(MS) Unless bone is treated by a validated process to reduce minerals, representative samples of each lot shall be tested for…

Answer 410

residual calcium by a standard method

Question 411

Residual calcium content for bone labeled as demineralized shall not exceed

Answer 411

8% by a standard method.

Question 412

For bone that has been subjected to a demineralization process with a residual calcium content target that exceeds 8% when tested, the tissue must not be labeled as….

Answer 412

demineralized and should be labeled as partially demineralized to describe the extent of demineralization.

Question 413

Records of in-house laboratory testing shall include, at a minimum:

Answer 413

1) sample source and quantity;
2) tissue identification number;
3) test date and identification of the person performing the test;
4) assay methods;
5) calculations, graphs, and charts, if used;
6) test results as well as interpretation of results;
7) testing or standardization of reference standards, reagents, or standard solutions; and
8) record review by an individual other than the operator generating the records to ensure compliance with Standards.

Question 414

Each lyophilization cycle shall be monitored and recorded for

Answer 414

shelf temperature, condenser temperature, and vacuum

Question 415

Residual moisture measurement shall not exceed

Answer 415

a limit linked to tissue quality

Question 416

If a residual moisture limit has been established for finished tissue, the container shall maintain the limit for the duration of the

Answer 416

expiration period

Question 417

Except for reproductive tissue, tissue to be cryopreserved must be frozen at a controlled and monitored, predetermined rate with compensation for

Answer 417

heat of crystallization/latent heat of fusion to a predetermined end-point

Question 418

What information must be maintained about cryopreserved tissue?

Answer 418

Documentation of the concentrations of cryoprotectant and nutrient or isotonic solutions in the cryopreservative solution shall be maintained. When applicable, procedures for cryopreservation shall be established and the method controlled to maintain tissue quality.

Question 419

Procedures for cryopreservation of reproductive tissue shall be established and documented. If a controlled rate chamber is being utilized, the thermal profile for each

Answer 419

cryopreservation cycle shall be logged with the specimen records.

Question 420

Upon termination of the freezing program, the cryopreserved tissue shall immediately be placed in

Answer 420

storage. Temperature fluctuation and cycling should be avoided.

Question 421

Procedures for the preservation of tissue by chemical means shall be validated and documented. When chemical preservation has been used, what kind of document shall indicate so?

Answer 421

package insertc

Question 422

Individual processing facilities shall establish, validate, and document disinfection or sterilization regimens and microbial surveillance methods. The SOPM shall establish a list of organisms that necessitate discard, sterilization and/or disinfection of tissue. The list shall be based upon not only the category type of tissue but also the

Answer 422

method by which the tissue was processed (e.g., cryopreserved MS tissues that cannot be sterilized and can only be disinfected and rendered culture negative).

Question 423

What organisms for C, V, CT tissue are considered to be pathogenic, highly virulent microorganisms that shall result in tissue discard unless treated with a disinfection or sterilization process validated to eliminate the infectivity of such organisms? (C, V, CT)

Answer 423

1) Clostridium;
2) fungi (yeasts, molds); and
3) Streptococcus pyogenes (group A strep.).

Question 424

What organisms for MS, OA tissue are considered to be pathogenic, highly virulent microorganisms that shall result in tissue discard unless treated with a disinfection or sterilization process validated to eliminate the infectivity of such organisms?

Answer 424

(MS, OA)
1) Clostridium; and
2) Streptococcus pyogenes (group A strep.).

Question 425

What organisms for Skin tissue are considered to be pathogenic, highly virulent microorganisms that shall result in tissue discard unless treated with a disinfection or sterilization process validated to eliminate the infectivity of such organisms? (S)

Answer 425

1) Clostridium;
2) Enterococcus sp.;
3) fungi (yeasts, molds);
4) gram negative bacilli;
5) Staphylococcus aureus; and
6) Streptococcus pyogenes (group A strep.).

Question 426

What is used to reduce or eliminate bioburden?

Answer 426

Non-terminal irradiation. A dose is selected to reduce or eliminate bioburden. The selected dose shall be justified and any claims made must be supported by data. The type of irradiation shall be indicated on the container label or package insert of all tissue exposed to non-terminal irradiation.

Question 427

What are the most common sources of ionizing radiation?

Answer 427

Cobalt 60, electon beam, and X-ray

Question 428

Identification of the irradiation source, the dosimetry, and completed certificate of irradiation shall be documented in the

Answer 428

processing record

Question 429

What shall the sterilization dose be capable of achieving?

Answer 429

The sterility assurance level (SAL)

Question 430

The type of irradiation shall be indicated on the

Answer 430

container label or package insert of all tissue exposed to irradiation.

Question 431

What size/weight category is “very small” tissue?

Answer 431

<100 mg

Question 432

What size/weight category is “small” tissue?

Answer 432

<10 grams

Question 433

What size/weight category is “medium” tissue?

Answer 433

10-100 grams

Question 434

What size/weight category is “large” tissue?

Answer 434

> 100 grams

Question 435

What is the residual level in parts per million of Ethylene oxide in very small tissue (<100 mg)?

Answer 435

2,500 ppm

Question 436

What is the residual level in parts per million of Ethylene oxide in small tissue (<10 g)?

Answer 436

250 ppm

Question 437

What is the residual level in parts per million of Ethylene oxide in medium tissue (10-100 g)?

Answer 437

100 ppm

Question 438

What is the residual level in parts per million of Ethylene oxide in large tissue (>100 g)?

Answer 438

25 ppm

Question 439

What is the residual level in parts per million of Ethylene Chlorohydrin in very small tissue (<100 mg)?

Answer 439

2500 ppm

Question 440

What is the residual level in parts per million of Ethylene Chlorohydrin in small tissue (<10 g)?

Answer 440

250 ppm

Question 441

What is the residual level in parts per million of Ethylene Chlorohydrin in medium tissue (10-100 g)?

Answer 441

100 ppm

Question 442

What is the residual level in parts per million of Ethylene Chlorohydrin in large tissue (>100 g)?

Answer 442

25 ppm

Question 443

What is the residual level in parts per million of Ethylene Glycol in very small tissue (<100 mg)?

Answer 443

5000 ppm

Question 444

What is the residual level in parts per million of Ethylene Glycol in small tissue (<10 g)?

Answer 444

5000 ppm

Question 445

What is the residual level in parts per million of Ethylene Glycol in medium tissue (10-100 g)?

Answer 445

2000 ppm

Question 446

What is the residual level in parts per million of Ethylene Glycol in large tissue (>100 g)?

Answer 446

500 ppm

Question 447

What may be used as disinfectants of bone in a validated processing procedure? (MS)

Answer 447

Iodophors, ethanol, and other solvent/detergent combinations. In any instance where a chemical disinfectant or antibiotic agent is used, the container label or the package insert shall identify presence of possible trace residuals.

Question 448

What other agents may be used as disinfection agents? (BT, MS)

Answer 448

Other agents such as heat, ultraviolet radiation, or exposure to antibiotics may be used as disinfection agents. Procedures for processing with such agents shall be documented and validated to ensure consistency in tissue processing.

Question 449

Processing and preservation records shall include the following:

Answer 449

1) processing dates and responsible processing personnel;
2) tissue identification number(s) and type(s) of tissue being processed;
3) tissue measurements (e.g., weight, dimensions, volume), as appropriate;
4) expiration, where applicable;
5) type and quantity of tissue sampled for in-process controls;
6) final disposition of each tissue obtained and/or processed; and
7) the type, lot number, manufacturer (unless recorded in other records), and expiration date, where applicable, of critical reagents, supplies and materials, and the identification of critical equipment, used to process and/or preserve tissue.

Question 450

Human tissue shall be quarantined until the tissue is either determined to be

Answer 450

suitable for processing, transplantation or another appropriate disposition is accomplished.

Question 451

All tissue shall be quarantined until the following criteria for donor eligibility are satisfied

Answer 451

1) all required infectious disease testing has been completed, reviewed by the responsible person, and found to be negative or non-reactive; and
2) donor screening has been completed, reviewed by the responsible person, and determined to indicate freedom from risk factors for and clinical evidence of HIV, hepatitis B, and/or hepatitis C infection.

Question 452

Tissue shall be quarantined at any phase of the operation when its release could affect the…

Answer 452

safety, effectiveness, or quality of the tissue, and subsequently, the health of the recipient.

Question 453

What tissue shall be quarantined?

Answer 453

1) tissue that is pending completion of processing, packaging, preservation, or labeling and final-release-approval signature;
2) tissue recovered, collected, or acquired from donors not meeting established donor eligibility criteria, including unacceptable test results;
3) tissue involved in a recall pending investigation, documentation, and resolution;
4) tissue failing to meet technical or quality assurance specifications;
5) tissue pending discard as medical waste; and
6) tissue returned by a consignee, pending evaluation.

Question 454

Quarantine records for tissue quarantined post-release shall indicate

Answer 454

the reason for quarantine and the final disposition of the tissue. Release dates or disposal dates shall be indicated as well.

Question 455

Each tissue bank shall establish acceptable temperature-range limits for the storage of tissue before and after processing in accordance with

Answer 455

with these Standards, applicable laws and regulations and in consideration of tissue quality and the packaging system for the tissue.

Question 456

(A) Storage temperatures and conditions shall be the same as for comparable

Answer 456

allogeneic tissue. Any exception shall require written approval of the Medical Director of the tissue bank.
(MS, OA)

Question 457

Processed frozen or cryopreserved musculoskeletal tissues shall be stored at temperatures of

Answer 457

-40°C or colder.

Question 458

Temporary storage of processed frozen or cryopreserved musculoskeletal tissue between -20°C and -40°C is limited to

Answer 458

six months total.

Question 459

(C, V) Cryopreserved cardiac tissue and vascular tissue allografts shall be maintained at temperatures of

Answer 459

-100°C or colder

Question 460

(R) Reproductive tissues shall be stored

Answer 460

either in liquid nitrogen or in the vapor phase of liquid nitrogen.

Question 461

(S) Frozen or cryopreserved skin shall be stored at ultra-low

Answer 461

-40°C or colder temperatures.

Question 462

What temperature should Lyophilized, dehydrated, or desiccated tissue be stored at?

Answer 462

ambient temperature or colder.

Question 463

What shall be utilized to document temperatures and to alert staff when temperatures have strayed outside acceptable limits?

Answer 463

A temperature monitoring system

Question 464

If storage utilizes liquid nitrogen, what shall be monitored and documented at an interval specified in the SOPM?

Answer 464

either liquid nitrogen levels or temperature

Question 465

What is the storage temperature for birth tissue?

Answer 465

Established by the tissue bank

Question 466

What types of storage conditions are used for birth tissue?

Answer 466

Frozen, refrigerated, cryopreserved, lyophilized, dehydrated, desiccated

Question 467

What types of storage conditions are used for cardiac and vascular tissue?

Answer 467

Frozen, cryopreserved

Question 468

What is the storage temperature for cardiac and vascular?

Answer 468

-100°C or colder

Question 469

What types of storage conditions are used for cellular tissue (CT)?

Answer 469

Refrigerated, Frozen, cryopreserved

Question 470

What is the storage temperature for frozen or cryopreserved cellular tissue?

Answer 470

Established by the tissue bank

Question 471

What is the storage temperature for refrigerated cellular tissue?

Answer 471

Above freezing (0°C) to 10°C

Question 472

What types of storage conditions are used for musculoskeletal tissue (MS) and osteoarticular graft (OA)?

Answer 472

Refrigerated, Frozen, cryopreserved (temporary storage for 6 months or less), Frozen, cryopreserved (long term storage), Lyophilized, dehydrated, desiccated

Question 473

What is the storage temperature for refrigerated MS tissue?

Answer 473

Above freezing (0°C) to 10°C

Question 474

What is the storage temperature for frozen or cryopreserved (temporary storage for 6 months or less) MS tissue?

Answer 474

-20°C or colder to -40°C (this is warmer than -40°C but colder than -20°C)

Question 475

What is the storage temperature for frozen or cryopreserved (long term storage) MS tissue?

Answer 475

40°C or colder

Question 476

What is the storage temperature for lyophilized, dehydrated, or desiccated MS tissue?

Answer 476

Ambient

Question 477

What is the storage temperature for reproductive tissue?

Answer 477

LN2 (Liquid or Vapor Phase)

Question 478

What types of storage conditions are used for Reproductive tissue (R)?

Answer 478

Frozen, cryopreserved

Question 479

What types of storage conditions are used for Skin (S)?

Answer 479

Refrigerated, Frozen, cryopreserved, Lyophilized, dehydrated, desiccated

Question 480

What is the storage temperature for refrigerated skin?

Answer 480

Above freezing (0°C) to 10°C

Question 481

What is the storage temperature for frozen and cryopreserved skin?

Answer 481

-40°C or colder

Question 482

What is the storage temperature for lyophilized, dehydrated, and desiccated skin?

Answer 482

Ambient

Question 483

Is ambient temperature monitoring required for lyophilized, dehydrated, or desiccated tissue?

Answer 483

No

Question 484

Policies and procedures shall be developed for the emergency transfer of tissue to designated alternative storage facilities and for alternative monitoring methods in the event of

Answer 484

mechanical failure or loss of coolant. These shall include specification of tolerance limits or temperatures and time limits after which the initiation of the emergency transfer is required. Actions to be taken when limits have been exceeded shall also be specified in the SOPM.

Question 485

The maximum storage period for tissue shall be appropriate to

Answer 485

the type of tissue, method of preservation, required storage temperature, packaging, and processing, as well as to its intended application.

Question 486

Who shall be informed of any expiration dates?

Answer 486

The implanting physician

Question 487

(A) Autologous skin that has not been processed or preserved should be stored refrigerated for no longer than

Answer 487

14 days

Question 488

Each donor record shall contain a disposition/release statement and signature of both

Answer 488

the Medical Director or licensed physician designee who is assuming responsibility for donor eligibility determination and, if different, the individual(s) responsible for reviewing all technical and quality control specifications. If processing was performed, there shall be documentation of a review by designated personnel of all technical and quality control specifications. An SOPM shall clearly define the responsibilities of each reviewer.

Question 489

Although the donor risk assessment interview may be preliminarily reviewed by technical staff to evaluate acceptability for recovery, acquisition, collection, or processing, tissue shall not be released for transplantation without determination of donor eligibility by

Answer 489

the Medical Director or licensed physician designee.

Question 490

The donor eligibility review shall include, but is not limited to these records:

Answer 490

1) acceptability of the authorization or informed consent;
2) suitability of the recovery site, delivery environment, or where collection took place;
3) pertinent information from the medical records generated at the time of death, including any pathology and laboratory reports, physician summaries, and transfusion/infusion information;
4) the donor risk assessment interview; 5) all results of laboratory testing relevant to donor eligibility;
6) any plasma dilution calculations used to determine the acceptability of the blood sample used for testing;
7) all relevant culture results up to and through the completion of recovery (e.g., blood cultures, if performed; pre-sterilization/pre-disinfection cultures, if available);
8) applicable time limits for tissue recovery;
9) pertinent circumstantial and donor screening information relayed to tissue bank staff; 10) results of the physical assessment or physical examination;
11) the autopsy report, or a summary of findings, if an autopsy was performed; and
12) any other information gathered for the purposes of disease screening as required by Standards and applicable laws or regulations.

Question 491

The birth mother’s risk for transmissible disease shall be evaluated for HIV, HBV, HCV and other infectious agents when indicated in the case of pediatric donors who…

Answer 491

have been breastfed within the past 12 months and/or are 18 months of age or less

Question 492

The infant and the birth mother shall be screened for risk of relevant communicable disease agents and diseases (RCDAD) and the mother’s blood must be tested for all donors who are how old?

Answer 492

For all donors one month (28 days) of age or less

Question 493

When no third party records are available that can be used to establish a likely cause of death, and if no autopsy was performed, what must be included in the donor record?

Answer 493

a certified copy of the death certificate. If it is not possible to obtain a certified copy, a verified copy of the death certificate must be included in the donor record.

Question 494

Is a certified or verified copy of the death certificate required when third party records are available that can be used to establish a likely cause of death, or if an autopsy was performed?

Answer 494

No, it is voluntary

Question 495

If it is determined that an autopsy was not performed due to infectious disease risk or, if an autopsy was performed, if any special precautions were taken that would suggest risk of a communicable disease in the donor…

Answer 495

this information should be considered

Question 496

In the case of suspected Sudden Unexpected Infant Death (SUID), should an autopsy be performed?

Answer 496

Yes, an autopsy should be performed and results reviewed to confirm the cause of death.

Question 497

What shall happen after the dura matter has been recovered?

Answer 497

After the dura mater has been recovered, a qualified pathologist shall perform an examination of the donor’s brain. Following fresh examination, the brain should be fixed and sliced, gross examination of the entire brain should be conducted (including multiple cross sections), and multiple specimens of tissue should be obtained (from different parts of the brain, e.g., frontal and occipital lobes) for histological examination. The gross and histologic findings must be assessed for any evidence suggestive of transmissible spongiform encephalopathy (TSE).

Question 498

Tissue shall not be distributed from a donor who, or a donor whose birth mother, has engaged in behaviors defined as…

Answer 498

high risk for transmission of relevant communicable disease agents or diseases (RCDADs). This information shall be obtained via a donor risk assessment interview, physical assessment or physical examination, and by review of other available relevant medical records.

Question 499

The Medical Director or licensed physician designee shall not determine an allogeneic donor eligible with any of the following findings:

Answer 499

1) evidence of significant active infection at the time of donation for relevant communicable disease agents or diseases (RCDADs). These include, but are not limited to: septicemia, viral disease (e.g., HIV, viral hepatitis, West Nile virus, rabies, Ebola virus disease, Zika virus infection, etc.), human transmissible spongiform encephalopathies, untreated syphilis, clinically active tuberculosis, leprosy (Hansen’s disease) or systemic mycosis; and/or 2) risk factors for relevant communicable disease agents or diseases (RCDADs) as specified in Appendix II. (R) Semen donors shall not exhibit an infectious skin disease that creates a risk of contamination of the semen. For all reproductive tissue donors, there shall not be evidence of infection within the past twelve months with Chlamydia trachomatis and/or Neisseria gonorrhea unless the reproductive tissues are collected by a method that ensures freedom from contamination of the tissue by infectious disease organisms that may be present in the genitourinary tract.

Question 500

In addition to the infectious disease risk review, the Medical Director shall establish criteria and evaluate tissue donors for conditions that may adversely affect the safety or utility of the specific types of tissue processed and/or distributed by the tissue bank. Such conditions include, but are not limited to

Answer 500

1) history of autoimmune diseases;
2) current or prior diagnosis of malignancy and the evaluation shall include the type of malignancy, clinical course, and treatment prior to acceptance;
3) ingestion of, or exposure to, toxic substances;
4) genetic, metabolic, traumatic, or infectious diseases that may adversely affect the quality of specific tissues;
5) previous surgery; and
6) diseases of unknown etiology.

Question 501

Disposition of allogeneic tissue shall be based upon the interpretation of all infectious disease test results and shall be as follows:

Answer 501

1) Human tissue shall be determined not to be suitable for transplantation if from a donor whose specimen has tested repeatedly reactive on an FDA-licensed, approved, or cleared donor screening test for anti-HIV-1, anti- HIV-2, HBsAg, antiHBc, or anti-HCV. When a birth mother’s specimen is used for testing, these same rules apply. 2) Viable leukocyte-rich tissue (e.g., semen) shall be determined not to be suitable for transplantation if from a donor whose specimen has tested repeatedly reactive (RR) on an FDA-licensed, approved, or cleared donor screening test for anti-HTLV-I or anti-HTLV-II. The eligibility of other human tissue for transplantation from donors whose specimens test RR for anti-HTLV-I or anti-HTLV-IIshall be determined by the Medical Director. Note: Law and/or regulation, including, where applicable, foreign laws and/ or regulations, may differ in regard to a RR HTLV antibody test result and how this impacts the suitability of the donor’s tissues for transplantation. 3) Human tissue shall be determined not to be suitable for transplantation if from a donor whose specimen had a final test result of positive, repeat reactive, or repeatedly reactive on a screening test using a NAT assay. When a birth mother’s specimen is used for testing, these same rules apply. 4) If a laboratory that performs organ donor testing performs the initial testing in duplicate or triplicate, the tissue bank must obtain and review the results of all individual tests performed. If any one of those initial tests is reactive or positive, the tissue shall be determined not suitable for transplantation. 5) Tissue from a donor reactive for syphilis using an FDA-licensed, cleared, or approved non-treponemal screening assay may be used for transplantation only if the sample is found to be negative using an FDA-licensed, cleared or appro

Question 502

Tissue from an anonymous semen donor who tests reactive for an active, acute infection with cytomegalovirus (CMV)…

Answer 502

shall not be deemed suitable for use. Tissue from an anonymous semen donor determined to be in a latent CMV status may be acceptable.

Question 503

What must be noted in the processing records in order for tissue to be released for transplantation?

Answer 503

Tissue may be released for transplantation only with notation in processing records by responsible persons that tissue produced meets technical specifications set forth in the SOPM (e.g., dimensions, quality) and that processing was performed according to the SOPM. There must be a signature by technical staff indicating that all technical elements were reviewed.

Question 504

For contractual processing arrangements, tissue shall be released for transplantation by the distributing tissue bank only with a signature and written disposition/release statement or equivalent documentation from the processing center indicating that all quality measures were reviewed and determined to be acceptable according to the written SOPM. The written disposition/release statement or equivalent documentation shall indicate that the following conditions, at a minimum, have been met:

Answer 504

1) review of tissue processed for consistency with specific tissue requirements; 2) review of all processing and packaging bacteriologic testing results for completeness and acceptability; 3) review for completeness and acceptability of any test or environmental testing results generated; 4) review of all lot numbers and expiration dates recorded for verification of completeness and that all were within acceptable ranges (e.g., recovery kits, culture media, processing solutions); 5) review of all processing records for completeness and accuracy, and verification that tissue was processed in accordance with the SOPM and met defined specifications; 6) review and comparison of tissue obtained and units produced from each tissue for verification that the disposition of each tissue recovered, acquired, or collected is traceable; 7) verification that all (if any) error and accident reports potentially related to the safety or quality of the tissue to be released are resolved and corrections made where appropriate; 8) verification that all processing was accomplished within time limits specified in the SOPM and within applicable technical specifications in the SOPM (e.g., acceptable residual moisture, irradiation exposure limits, temperatures, and freezing curves); and
9) if tissue was recovered or collected by another entity, verification that the shipment was acceptable when it arrived at the processing center (e.g., with respect to temperature and time limits). (A) If autologous tissue is processed, the autograft may be released for clinical use only upon notation in processing records by technicians or their supervisor that processing was performed according to the SOPM. There must be a signature by technical staff indicating that all technical elements were reviewed.

Question 505

Except for reproductive tissue, tissue shall not be released for transplantation without a signed disposition/release statement from the responsible person(s) at the site of distribution, indicating that, at some time prior to release, all quality measures were performed and found acceptable according to the written SOPM. The written disposition/release statement or equivalent documentation shall indicate that the following conditions, at a minimum, have been met:

Answer 505

1) review of tissue processed for consistency with specific tissue requirements;
2) review and comparison of tissue obtained and grafts produced from tissue for verification that the Disposition of tissue recovered is traceable;
3) verification that all (if any) error and accident reports, potentially related to the safety or quality of the tissue from each donor, are resolved and corrections made where appropriate;
4) verification that all processing was accomplished within time limits specified in the SOPM and within applicable technical specifications in the SOPM (e.g., acceptable residual moisture, irradiation exposure limits, temperatures, and freezing curves);
5) if tissue was recovered by another entity, verification of the acceptability of the shipment upon arrival at the processing center (e.g., with respect to temperature and time limits);
6) verification that the Medical Director or licensed physician designee has made a decision regarding donor eligibility and that all directives of the Medical Director regarding the donor were implemented; and
7) verification that final labeling of tissue was performed in accordance with SOPM and Standards.

Question 506

(R) Reproductive tissue shall not be released for clinical use without a signed, written disposition/release statement of the person responsible for authorizing release, at the site of processing, indicating that all quality measures were reviewed and found acceptable according to the written SOPM. This includes, but is not limited to:

Answer 506

1) review of donor age and of tissue processed for consistency with specific tissue requirements;
2) record and verification that all lot numbers and expiration dates were complete and that all were within acceptable ranges (e.g., cryopreservation media);
3) review of all processing records for completeness and accuracy and verification that the tissue was processed in accordance with the SOPM and meets defined technical specifications;
4) review of tissue obtained and specimens produced from each collection for verification that the disposition of each tissue specimen is traceable;
5) verification of resolution of all error or accident reports (if any) potentially related to the safety or quality of the tissue;
6) verification that all processing was accomplished within time limits specified in the SOPM and within applicable technical specifications in the SOPM (e.g., ejaculate volume, sperm motility, concentration, morphology, and post-thaw motility);
7) if reproductive tissue was collected by another entity, verification of the time of receipt at the reproductive tissue bank and condition of the sample upon receipt; and
8) verification that the Medical Director has made a decision regarding donor eligibility and that all directives of the Medical Director regarding the donor were implemented.

Question 507

Pre-established release criteria based on tissue utility must be developed. If tissue other than reproductive tissue is distributed or dispensed for transplantation, there shall be in each instance, documentation of:

Answer 507

1) donor eligibility and tissue processing information available at the time of release. All donor eligibility requirements in F1.100 must be met with the exception of a review of the autopsy report (if applicable) and pending culture results;
2) Medical Director or licensed physician designee review of all relevant information present;
3) approval of the release by the Medical Director or licensed physician designee;
4) a written statement issued to the end-user physician indicating what information required by the SOPM and/or these Standards is available and what information is not available for review, and when it is expected that the information will be available; and
5) a statement from the end-user physician indicating his/her understanding that the tissue is being released using available information.

Question 508

Relevant final results shall be forwarded promptly

Answer 508

to the end-user physician upon completion of testing. Documentation of the release based on tissue utility shall be maintained in the donor record. These records shall be maintained together or summarized in a log.

Question 509

(R) Release of reproductive tissue may be considered in the special cases of:

Answer 509

1) reproductive tissues from client depositors known to be reactive on tests for antiHIV-1, anti-HIV-2, anti-HCV, HBsAg, or any other test, excluding CMV, without subsequent negative confirmative testing as approved by the Medical Director; or
2) reproductive tissues from client depositors that have not been tested or do not meet current Standards; or
3) directed donors who have completed all required testing and screening according to Standard but:
a) had reactive test results; or
b) are determined ineligible according to screening criteria. In the case of release for one of the three circumstances listed above, the following documentation is required (refer to G3.210 and G3.220 for labeling requirements):
1) a written statement signed by a responsible person at the reproductive tissue bank disclosing the deviation(s) from Standards and description of potential risks to the recipient; and
2) acknowledgement from the medical provider indicating he/she:
a) has received the written statement from the reproductive tissue bank and acknowledges the deviation(s) from Standards;
b) has had ample opportunity to discuss the implication(s) with a responsible person at the reproductive tissue bank and other medical authorities;
c) agrees to fully explain the implication(s) to the recipient and provide her ample opportunity to ask questions and consult with experts of her choice; and
d) will document informed consent from the recipient.

Question 510

If donor reproductive tissue is to be released before completion of the donor eligibility assessment, the tissue must be kept in

Answer 510

quarantine during shipment. The labeling must include a statement that the donor eligibility assessment, has not yet been completed. It must also include a statement indicating the reproductive tissue must not be transplanted or transferred until the donor eligibility assessment, is complete.

Question 511

Tissue failing any portion of the review process shall be maintained in quarantine pending

Answer 511

resolution or disposal and shall not be released for transplantation. Unexplained discrepancies or deviations from specifications shall be fully investigated and documented.

Question 512

If a donor is deemed ineligible as a result of donor eligibility assessment or disease screening procedures, the finding shall be specifically stated in the donor record and in the release/disposition decision statement, and this determination must be described and communicated in writing in a timely manner to the tissue bank that recovered tissue. If the tissue is to be made available for nonclinical purposes from a donor who has been determined to be ineligible based on the results of required testing and/or screening, it must be labeled:

Answer 512

1) ‘‘For Nonclinical Use Only’’; and 2) with the biohazard legend. (SB) Permanent and temporary deferrals of living surgical bone donors and the reason(s) for such deferral shall be documented in the donor record.

Question 513

True or False: A list of labels used shall be maintained, as well as an example of every label that is utilized by the tissue bank.

Answer 513

True

Question 514

Who is required to communicate changes regarding labels?

Answer 514

Dates of use (start and discontinuance) shall be recorded. Changes pertaining to labels and communicating changes shall be expected from tissue banks that supply labels to other tissue banks and tissue distribution intermediaries.

Question 515

Labels shall be designed and qualified to be…

Answer 515

legible, indelible, and affixed firmly to the container under anticipated storage conditions for length of use. All labeling claims shall be clear, accurate, substantiated, and not misleading.

Question 516

There shall be SOPs established and followed to ensure that approved labels, labeling, and packaging materials are used for tissue. Tissue labeling shall be documented at each step e.g.,

Answer 516

unprocessed, in-process quarantined, rejected, released.

Question 517

If a sampling plan is used, it must follow a statistically valid method, such as ANSI/ASQ Z1.4:

Answer 517

Sampling Procedures and Tables for Inspection by Attributes

Question 518

True or False: The storage area for labels and labeling materials shall be clearly identified. Access should be restricted to authorized personnel only. This is not applicable to labels included in tissue recovery packs.

Answer 518

True

Question 519

As each type of label is removed from inventory, one label shall be retained for the

Answer 519

archives and the surplus labels shall be discarded. The label list and the SOPM shall be updated accordingly.

Question 520

Except for autologous tissue and reproductive tissue, container labels shall include:

Answer 520

1) the tissue identification number;
2) descriptive name of the tissue and other information necessary for selection or use (e.g., size, right/left, medial/lateral, anterior/posterior);
3) expiration date (if applicable), including the month, day, and year or, if only the month and year are used, the expiration date must be clearly described in labeling as occurring at the beginning or the end of the month;
4) storage conditions, including recommended storage temperature and/or storage temperature range;
5) quantity or other characteristics of tissue expressed as applicable (e.g., volume, weight, dimensions, cell density, number of viable cells or a combination of these);
6) a reference to the package insert.

Question 521

The following information shall be included on the container label unless space limitations require use of a corresponding insert:

Answer 521

1) disinfection or sterilization procedure utilized (if applicable);
2) preservative (if utilized) and/or method of preservation (if applicable);
3) potential residues of processing agents/solutions (e.g., antibiotics, ethanol, ethylene oxide, dimethylsulfoxide); and
4) name(s) and address(es) of tissue bank(s) responsible for determining donor eligibility, processing and distribution. Should more than two tissue banks be involved, the name of all tissue banks are required but the address is only required for the tissue bank determining donor eligibility.

Question 522

(A) The following information shall be included on the container label for autologous tissue unless space limitations require use of a corresponding insert:

Answer 522

1) the donor classification statement ‘‘AUTOLOGOUS DONOR’’; 2) definitive autologous donor identifying information such as the patient’s hospital identification number, social security number, birth date, etc.; 3) alabel or attached tag ‘‘FOR AUTOLOGOUS USE ONLY’’; and 4) if infectious disease testing or donor screening is not complete or has not been performed, a label indicating ‘‘NOT EVALUATED FOR INFECTIOUS SUBSTANCES’’ is required; or 5) if infectious disease testing was performed and any results were positive, or if donor screening was performed and risk factors identified, then labeling with a ‘‘BIOHAZARD’’ label is required.

Question 523

(R) Cryocontainers (e.g., vials, straws or ampules) shall be labeled so as to identify:

Answer 523

1) donor or client depositor unique identifier and/or other code that can be used by the reproductive tissue bank to identify the date the specimen was cryopreserved and the stage of development at cryopreservation, where applicable; and
2) name, initials, or other code that can be used to identify the reproductive tissue bank at which the specimen was processed.

Question 524

A summary of records is not required if

Answer 524

donor eligibility determination is not required (i.e., autologous tissue and certain types of reproductive tissue).

Question 525

A summary of records is required when donor eligibility assessment has been completed and shall include:

Answer 525

1) a statement that the tissue was prepared from a donor determined to be eligible based on the results of screening and testing. All results of relevant communicable disease tests performed on specimens from the donor and used for release of tissue shall be listed. Relevant tests include those tests that are required (see D4.230). For example, the CMV test result used must be listed for reproductive tissue. If a test for anti-HTLV I and/or anti-HTLV II was performed it must be reported;
2) the name and address of the establishment that made the donor eligibility assessment; and
3) a statement that the communicable disease testing was performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).

Question 526

(R) A statement noting the reason for the determination of ineligibility in the case of tissue from a directed donor who is ineligible based on screening and/or testing. The summary of records may be included in the package insert. The package insert shall contain the following information:

Answer 526

1) a statement limiting use to specific health professionals (e.g., physicians, dentists, and/ or podiatrists);
2) a statement that the tissue is intended for use in one patient, on a single occasion only, or as is applicable for reproductive tissue;
3) known contraindications (if any) to the use of the tissue;
4) warnings and list of known possible significant adverse reactions;
5) a statement that adverse outcomes potentially attributable to the tissue must be reported promptly to the tissue supplier;
6) presence of known sensitizing agents (if any);
7) a statement that indicates that the tissue may transmit infectious agents;
8) a statement, if applicable, that the tissue may not be sterilized or re-sterilized.
9) dosage information (if applicable);
10) description of how the tissue was supplied (e.g., frozen, lyophilized, irradiated, demineralized or partially demineralized, see E2.612); 11) type of antibiotics present (if applicable);
12) concentration of preservative(s) and/or cryoprotectant(s) in final package solution (if applicable);
13) instructions for opening the package and/or container;
14) instructions for preparation of tissue for transplantation;
15) expiration time of tissue following reconstitution (upon preparation for use);
16) instructions indicating that once a container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded;
17) acceptable storage conditions and tolerance limits;
18) special instructions required for the particular tissue, when applicable (e.g., ‘‘DO NOT FREEZE,’’ “DO NOT X-RAY,” “DO NOT IRRADIATE”);
19) a statement that it is the responsibility of the tissue dispensing service, tissue distribution intermediary, and/or end-user clinician to maintain tissue intended for transplantation in appropriate storage condi

Question 527

(C, V) Inserts for cardiac tissue and vascular tissue shall contain the following additional information:

Answer 527

1) warning against using a graft if there is evidence that the container has broken or the contents have thawed;
2) statement that the end-user may not subject the tissue to sterilization (e.g., DO NOT STERILIZE the allograft by any method. Exposure of the allograft and the packaging to irradiation, steam, ethylene oxide, or other chemical sterilants will render the allograft unfit for use);
3) donor age (and blood type, if available);
4) date of dissection or preservation;
5) tissue warm ischemic time;
6) tissue cold ischemic time;
7) graft sizes (e.g., diameter and length);
8) graft physical descriptions and evaluations, including description of imperfections and evaluation criteria;
9) the type of cryoprotectant (if applicable) and clear statement regarding the possibility of residuals;
10) a description of the temperature-sensitive nature of the grafts; and
11) instructions for preparation of tissue for use.
Center-specific protocols shall be established for control of proper thawing, removal of cryoprotectant, and restoration of isotonic balance within the cryopreserved tissue. These protocols shall be provided with each cardiovascular allograft distributed for transplantation.

Question 528

Reproductive tissue in the following categories require additional information in package inserts as listed below:

Answer 528

1) If the intended recipient is the sexually intimate partner of the gamete provider(s): 1) If the intended recipient is the sexually intimate partner of the gamete provider(s):

Note: a Summary of records is not required for this category.
a) For all reproductive tissue, include the statement: ‘‘For use by Sexually Intimate Partner Only.’’
b) For all reproductive client depositors who were not tested or screened using all parameters required for either a semen or egg donor, including the required tests and time limits for donor testing, include the statements:
1. ‘‘Not evaluated for Infectious Substances’’; and
2. ‘‘WARNING: Advise Recipient of Communicable Disease Risks.’’
c) For all reproductive client depositors who have reactive or positive test results:
1. biohazard symbol; and
2. ‘‘WARNING: Reactive test results for (insert name of test).’’
Reproductive tissue in the following categories require additional information in package inserts as listed below:

2) If the intended recipient is NOT the sexually intimate partner of either gamete provider, the following labeling is required in addition to a summary of records: 2) If the intended recipient is NOT the sexually intimate partner of either gamete provider, the following labeling is required in addition to a summary of records:
a) Directed donors (semen, oocyte, and/or embryo) with reactive test results: 1. biohazard symbol; 2. ‘‘WARNING: Reactive test results for (insert name of test)’’; and 3. ‘‘WARNING: Advise Recipient of Communicable Disease Risks.’’ b) Directed donors (semen, oocyte, and/or embryo) determined to be ineligible based upon risk factors for or clinical evidence of relevant communicable disease agents or diseases, including the physical examination: 1. biohazard symbol; and 2. “WARNING: Advise Recipient of Communicable Disease Risks.’’
Reproductive tissue in the following categories require additional information in package inserts as listed below:

If the intended recipient is NOT the sexually intimate partner of either gamete provider, and the tissue is from anonymous or directed embryo donors in cases where the gamete provider(s) was (were) not initially tested as donors, but were re-tested following 6-month quarantine, include the statement: 3) If the intended recipient is NOT the sexually intimate partner of either gamete provider, and the tissue is from anonymous or directed embryo donors in cases where the gamete provider(s) was (were) not initially tested as donors, but were re-tested following 6-month quarantine, include the statement: ‘‘Advise recipient that screening and testing of the donor(s) were not performed at the time of cryopreservation of the reproductive tissue, but have been performed subsequently.’’ (Note: A summary of records is not required for this category, however, a summary of the test results must be included.)
Reproductive tissue in the following categories require additional information in package inserts as listed below:
4) If the intended recipient is NOT the sexually intimate partner of a gamete provider who initially cryopreserved reproductive tissue as a client depositor but was subsequently screened and tested as a directed donor in cases where additional collections are unavailable, include the statement: 4) If the intended recipient is NOT the sexually intimate partner of a gamete provider who initially cryopreserved reproductive tissue as a client depositor but was subsequently screened and tested as a directed donor in cases where additional collections are unavailable, include the statement: “Advise recipient that screening and testing of the donor(s) were not performed at the time of cryopreservation of the reproductive tissue, but have been performed subsequently.”
Reproductive tissue in the following categories require additional information in package inserts as listed below:

5) Reproductive tissue intended for research: 5) Reproductive tissue intended for research: a) Client depositor reproductive tissue when gamete provider(s) were not tested or screened using all parameters required for either a semen or egg donor, including the required tests and time limits for donor testing, or donor (anonymous or directed) tissue has not completed 6- month quarantine release requirement: 1. ‘‘For Non-Clinical Use Only’’; and 2. ‘‘Not evaluated for Infectious Substances.’’ b) Anonymous donor tissue that has completed 6-month quarantine release requirement: 1. ‘‘For Non-Clinical Use Only.’’ c) Client depositor or donor (anonymous or directed) tissue from gamete provider(s) who had reactive test results OR have been determined to be ineligible: 1. biohazard label; 2. ‘‘For Non-Clinical Use Only’’; and 3. if applicable, ‘‘WARNING: Reactive test results for (insert name of test).’’

Question 529

The transport package label shall include the following information:

Answer 529

1) name, address and telephone number of the distribution facility;
2) name and address of the destination;
3) unless the shipment contains reproductive tissue, prominent identification of contents as ‘‘DONATED HUMAN TISSUE.’’;
4) recommended storage conditions;
5) validated expiration date/time of the transport package when the storage temperature must be controlled;
6) type and quantity (when the quantity is applicable) of refrigerant or other hazardous materials enclosed in the transport package; and
7) any special handling instructions, when applicable (e.g., “DO NOT FREEZE,” “DO NOT X-RAY,” “DO NOT IRRADIATE”).

Question 530

Labels for international shipments shall contain all of the information required for domestic shipments; however, information may be modified to meet requirements of the federal government and those of the

Answer 530

receiving country.

Question 531

Provision of tissue for transplantation shall be restricted to

Answer 531

hospitals, free-standing medical facilities, tissue banks, tissue dispensing services, and end-users (e.g., physicians, dentists, podiatrists or other medical professionals) for use in recipients with the veterinary use exception that follows.

Question 532

Human tissue for transplantation shall not be offered, distributed or dispensed for veterinary use unless

Answer 532

such use is specifically granted in a document of gift/authorization or in a record of informed consent.

Question 533

(R) Reproductive tissue shall be released for use by the client depositor or the client depositor’s

Answer 533

sexually intimate partner only

Question 534

A client depositor who requests that his/her reproductive tissue be distributed to a recipient, who is not the client depositor or who is not the sexually intimate partner of the client depositor, shall be treated as a

Answer 534

directed donor(s). All directed donor(s) must be fully tested and screened in a manner consistent with donor protocols and these Standards.

Question 535

True or False: There is a limit to the number of offspring allowed by a gamete donor through a given a reproductive tissue bank.

Answer 535

(R) A written policy addressing limitation of the number of offspring by a gamete donor shall be established. The policy shall include the upper limits deemed acceptable to the reproductive tissue bank and shall describe the methods that will be used to comply

Question 536

True or False: When a tissue bank distributes tissue obtained from another tissue bank or tissue distribution intermediary, all accompanying original labeling materials or other enclosures shall be distributed with the tissue.

Answer 536

True

Question 537

Donor risk assessment, tissue-related information, and tissue processing details shall be made available to the end-user upon request, except

Answer 537

such information that may infringe upon the confidentiality of donor information.

Question 538

Records shall be maintained by the tissue bank that distributes tissue (including unfinished or as yet unreleased tissue) to other entities. These records shall be designed to permit tissue to be traced from the donor to a consignee or end-user, and from a consignee or end-user back to the donor. Tissue distribution records shall include:

Answer 538

1) date of order placement;
2) name and address of consignee;
3) name of individual placing the order;
4) type and quantity of tissue ordered;
5) information pertaining to tissue shipped including:
a) identification number(s) of tissue(s);
b) collection and/or expiration date of tissue;
c) date of shipment;
d) type of refrigerant, and quantity of refrigerant when applicable, in the shipment;
e) mode of transportation and/or courier; and
f) name of the staff member filling the order.
6) identifying information, if available, about the intended recipient.

Question 539

The tissue bank shall establish recipient…

Answer 539

follow-up data collection protocols, and procedures to evaluate information received.

Question 540

All requests for human tissue intended for research use shall be submitted in writing. The request shall indicate the type of tissue requested and how it will be used as well as

Answer 540

the name, address and affiliation of the principal investigator accepting responsibility for receipt of the tissue.

Question 541

Any specifically required solutions not readily available to the end-user that are needed to prepare the tissue for use shall

Answer 541

be made available to the utilizing facility.

Question 542

A tissue bank shall establish a policy authorizing or prohibiting the return of tissue in its

Answer 542

original, unopened container.