CTBS CERTIFICATION SCRIPT 2026
QUESTIONS WITH SOLUTIONS GRADED A+
◍ DISINFECTANT.
Answer: 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.
◍ 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..
Answer: aseptic processing
◍ what test is required for HV donors.
Answer: Chagas
◍ TISSUE IDENTIFICATION NUMBER.
Answer: 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.
◍ BLOOD COMPONENT.
Answer: Any part of a single-donor unit of blood separated by physical or
mechanical means.
◍ A validated process used to render a product (e.g., tissue) within its final
sterile barrier system (e.g., package, container) sterile..
Answer: Terminal Sterilization
◍ AUDIT.
Answer: A documented review of procedures, records, personnel functions,
, equipment, materials, facilities, and/or suppliers to evaluate adherence to the
SOPM, standards, applicable laws and regulations.
◍ QUALITY AGREEMENT.
Answer: 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.
◍ Container labels should include all of the following.
Answer: Tissue identification number, descriptive name, expiration date,
storage conditions, quantity of tissue, disinfection/sterilization procedure
used, preservation method, potential residuals, reference to package insert,
name and address of tissue bank
◍ POOLING.
Answer: The physical contact or mixing of tissue from two or more donors
in a single receptacle.
◍ ASEPTIC PROCESSING.
Answer: 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.
◍ DECONTAMINATION.
Answer: Cleaning the environment, facilities, and/or surfaces (sanitation), or
instruments, supplies, and equipment (sanitization), with intent to remove or
reduce pathogenic microbes.
◍ PROCESS VALIDATION.
Answer: Establishing by objective evidence that the output of a process
consistently meets predetermined specification.
◍ DISPOSITION.
Answer: 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.
◍ NOTIFICATION (OF GIFT).
Answer: Provision and documentation of notice concerning an anatomical
gift that was made by the donor during the donor's lifetime.
◍ ACQUISITION (BT).
Answer: The point after delivery at which tissue is under the control of the
tissue bank.
◍ What does AAMI stand for?.
Answer: Association for the Advancement of Medical Instrumentation
◍ 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% Dextrose in water, or total parenteral nutrition (TPN)..
Answer: Crystalloid
◍ ANNUAL.
Answer: 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.
◍ The combination of the packaging system and the container utilized to
transport tissue..
Answer: Transport System
◍ Enough information for a person to make a voluntary decision. Must include
the core elements..
Answer: Adequate information
◍ INFORMED CONSENT.
Answer: 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.
◍ ESTABLISH.
Answer: Define, document and implement.
◍ DOCUMENT OF AUTHORIZATION.
Answer: 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.
◍ TRANSPORT SYSTEM.
Answer: The combination of the packaging system and the container utilized
to transport tissue.
◍ AUTOLOGOUS.
Answer: 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.
◍ The time interval from subjecting cardiac tissue to cold rinse (or transport)
solution at recovery to the beginning of disinfection.
Answer: Cold Ischemic Time (C)
◍ The status of an HCT/P upon verifying and documenting that the HCT/P
meets the release criteria on the basis of a review of manufacturing and
tracking records pertaining to the HCT/P, documented by a responsible
person with the date when the determination that the HCT/P is available for
distribution has been made..
Answer: available for distribution
◍ DONOR.
Answer: A living or deceased individual who is the source of tissue.
◍ Allograft heart valve grafts shall be evaluated and sized by.
Answer: Internal valve annulus diameter, and recorded in millimeters (mm)
QUESTIONS WITH SOLUTIONS GRADED A+
◍ DISINFECTANT.
Answer: 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.
◍ 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..
Answer: aseptic processing
◍ what test is required for HV donors.
Answer: Chagas
◍ TISSUE IDENTIFICATION NUMBER.
Answer: 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.
◍ BLOOD COMPONENT.
Answer: Any part of a single-donor unit of blood separated by physical or
mechanical means.
◍ A validated process used to render a product (e.g., tissue) within its final
sterile barrier system (e.g., package, container) sterile..
Answer: Terminal Sterilization
◍ AUDIT.
Answer: A documented review of procedures, records, personnel functions,
, equipment, materials, facilities, and/or suppliers to evaluate adherence to the
SOPM, standards, applicable laws and regulations.
◍ QUALITY AGREEMENT.
Answer: 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.
◍ Container labels should include all of the following.
Answer: Tissue identification number, descriptive name, expiration date,
storage conditions, quantity of tissue, disinfection/sterilization procedure
used, preservation method, potential residuals, reference to package insert,
name and address of tissue bank
◍ POOLING.
Answer: The physical contact or mixing of tissue from two or more donors
in a single receptacle.
◍ ASEPTIC PROCESSING.
Answer: 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.
◍ DECONTAMINATION.
Answer: Cleaning the environment, facilities, and/or surfaces (sanitation), or
instruments, supplies, and equipment (sanitization), with intent to remove or
reduce pathogenic microbes.
◍ PROCESS VALIDATION.
Answer: Establishing by objective evidence that the output of a process
consistently meets predetermined specification.
◍ DISPOSITION.
Answer: 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.
◍ NOTIFICATION (OF GIFT).
Answer: Provision and documentation of notice concerning an anatomical
gift that was made by the donor during the donor's lifetime.
◍ ACQUISITION (BT).
Answer: The point after delivery at which tissue is under the control of the
tissue bank.
◍ What does AAMI stand for?.
Answer: Association for the Advancement of Medical Instrumentation
◍ 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% Dextrose in water, or total parenteral nutrition (TPN)..
Answer: Crystalloid
◍ ANNUAL.
Answer: 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.
◍ The combination of the packaging system and the container utilized to
transport tissue..
Answer: Transport System
◍ Enough information for a person to make a voluntary decision. Must include
the core elements..
Answer: Adequate information
◍ INFORMED CONSENT.
Answer: 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.
◍ ESTABLISH.
Answer: Define, document and implement.
◍ DOCUMENT OF AUTHORIZATION.
Answer: 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.
◍ TRANSPORT SYSTEM.
Answer: The combination of the packaging system and the container utilized
to transport tissue.
◍ AUTOLOGOUS.
Answer: 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.
◍ The time interval from subjecting cardiac tissue to cold rinse (or transport)
solution at recovery to the beginning of disinfection.
Answer: Cold Ischemic Time (C)
◍ The status of an HCT/P upon verifying and documenting that the HCT/P
meets the release criteria on the basis of a review of manufacturing and
tracking records pertaining to the HCT/P, documented by a responsible
person with the date when the determination that the HCT/P is available for
distribution has been made..
Answer: available for distribution
◍ DONOR.
Answer: A living or deceased individual who is the source of tissue.
◍ Allograft heart valve grafts shall be evaluated and sized by.
Answer: Internal valve annulus diameter, and recorded in millimeters (mm)
