CTBS Exam with Questions With
100%
Correct Answers | Updated &
Verified
202
3
standard operating procedure manuals must be available to fda and aatb
inspectors -
Correct
Answer-
Responsible for quality checking residual chemical levels in processed bone
graft. in a very small piece of tissue (described as less than 100 mg ) The
residual Ethylene glycol level can be up to 5000 parts per million - Correct
Answer-
Clostridium species is difficult to eradicate . Rejection if found on any type of
tissue. Clostridium Pefringens causes gangrene . - Correct Answer-
Microorganisms leading to tissue discard - Correct Answer-
(C,v, ct)
Clostridiu
m
Fungi
(yeasts,mold)
Streptococcus pyogenes (Group a
strep)
(MS,OA
)
Clostridiu
m
Streptococcus pyogenes (Group a
strep)
S
Clostridium
Enterococcus sp
Fungi(yeasts,molds)
Gram negative bacilli
Staphylococcus aureus
Streptococcus pyogenes (group a strep)
CTBS Exam
,Physical assessments are completed on a deceased donor while physical
examinations
refers to a living donor - Correct
Answer-
Container labels must include - Correct Answer-1. tissue
identification number
2. descriptive name of tissue ( size
,anterior/posterior etc)
3. expiration
date
4. storage
conditions
5. quantity of tissue (example weight,dimensions, number of
viable cells)
6. reference to package
insert
7. disinfection or sterilization procedure
utilized
8. preservative (if utilized) and or method of
preservation
9. potential residues from processing
agents/solutions
10. Name and address of tissue bank responsible for determining
donor eligibility
Summary of records content (Needed when tissue has been deemed suitable
for transportation - Correct Answer-Includes :
-That Tissue was prepared from a donor determined eligible based on
screening and testing results
-name and address of establishment that made the donor eligibility
assessment
-communicable disease testing performed by laboratory (FDA registered CLIA
certified) -List of all results of relevant communicable disease testing
Domestic Transport package label must include - Correct Answer-1. Name
address and telephone number of the distribution facility
2. Name and address of Destiination
3. Prominent identification information of contents example donated human
tissue
4. Recommended storage conditions
5.Validated expiration date/ time of the transfer package when the storage
temperature must be controlled
6. Type and quantity of refrigerant or other hazardous materials enclosed in
the transfer package
7. Any special handling instructions when applicable example do not freeze
CTBS Exam
,Deviation - Correct Answer-May be intentional
Any enterococcus species found on skin cultures will cause
fresh skin to be
automatically discarded - Correct
Answer-
Birth tissue drai - Correct Answer-Obtained/information verified no
more than 14 days
on either side of the day
delivery
First use of amniotic membrane grafts - Correct Answer-Skin substitute
Storage of BT - Correct Answer-Standards do not list any storage conditions
these must
be established by a tissue
bank
Common preservation of BT - Correct Answer-Cryopreservation and
lyophilization
Physical examination on a birth tissue donor must be performed during
admission for
delivery or within 14 days prior to delivery -
Correct Answer-
Birth tissue blood specimens - Correct Answer-Shall be collected at the
time of donation
or within seven days prior to or after
donation
West Nile virus NAT on birth tissue donor's shall be done between June 1
through
October 31 every year; cmv testing occasionally and same standard
donation panel - Correct Answer-
BT: if delivery takes place within a hospital OR or designated delivery room
then no site
evaluation is required - Correct
Answer-
Gestational tissue includes - Correct Answer-Placenta,Wharton's jelly,
amniotic fluid, chorionic membrane, amniotic membrane, placental/chorionic
disc, umbilical vein's and Umbilical cord tissue
Accreditation is valid for three years: Accreditation process: apply, inspect,
evaluate and
review - Correct
Answer-
Accreditation application is provided 12 months prior to expiration. Due
nine months
prior to expiration. - Correct
Answer-
Accreditation inspections scheduled within 90 days of application
CTBS Exam
, receipt - Correct
Answer
-
Informed consent applies to living donors only - Correct Answer-
Informed consent applies to living donors only - Correct Answer-
What side of the tissue would you expect to find umbilical cord - Correct
Answer-Fetal
sid
e
What side of the placenta is attached to the uterine wall - Correct Answer-
Maternal side
Where could you find Wharton's jelly - Correct Answer-Commonly in the
umbilical cord it
cushions the
vessels
How many veins in an umbilical cord - Correct Answer-One; two arteries
What is the age limit for birth tissue donor's - Correct Answer-None
banks need to
establish age of
consent
How many vessels in an umbilical cord - Correct Answer-Three
The donor record shall be retained for at least 10 years past Date of
distribution, date of
transplantation, date of disposition, date of expiration. Which ever
comes latest. -
Correct
Answer-
Donor eligibility records shall be retained indefinitely for Dura mater
donors - Correct
Answer
-
Records of training must be kept for 16 years after termination - Correct
AnswerError - Correct Answer-A deviation from SOPM or applicable laws
and regulations
Accident - Correct Answer-Any occurrence not associated with a deviation
from standard operating procedures, 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, bio compatibility, Or freedom
from transmissible pathogens of the tissue or the ability to trace tissue to
the donor
CTBS Exam
100%
Correct Answers | Updated &
Verified
202
3
standard operating procedure manuals must be available to fda and aatb
inspectors -
Correct
Answer-
Responsible for quality checking residual chemical levels in processed bone
graft. in a very small piece of tissue (described as less than 100 mg ) The
residual Ethylene glycol level can be up to 5000 parts per million - Correct
Answer-
Clostridium species is difficult to eradicate . Rejection if found on any type of
tissue. Clostridium Pefringens causes gangrene . - Correct Answer-
Microorganisms leading to tissue discard - Correct Answer-
(C,v, ct)
Clostridiu
m
Fungi
(yeasts,mold)
Streptococcus pyogenes (Group a
strep)
(MS,OA
)
Clostridiu
m
Streptococcus pyogenes (Group a
strep)
S
Clostridium
Enterococcus sp
Fungi(yeasts,molds)
Gram negative bacilli
Staphylococcus aureus
Streptococcus pyogenes (group a strep)
CTBS Exam
,Physical assessments are completed on a deceased donor while physical
examinations
refers to a living donor - Correct
Answer-
Container labels must include - Correct Answer-1. tissue
identification number
2. descriptive name of tissue ( size
,anterior/posterior etc)
3. expiration
date
4. storage
conditions
5. quantity of tissue (example weight,dimensions, number of
viable cells)
6. reference to package
insert
7. disinfection or sterilization procedure
utilized
8. preservative (if utilized) and or method of
preservation
9. potential residues from processing
agents/solutions
10. Name and address of tissue bank responsible for determining
donor eligibility
Summary of records content (Needed when tissue has been deemed suitable
for transportation - Correct Answer-Includes :
-That Tissue was prepared from a donor determined eligible based on
screening and testing results
-name and address of establishment that made the donor eligibility
assessment
-communicable disease testing performed by laboratory (FDA registered CLIA
certified) -List of all results of relevant communicable disease testing
Domestic Transport package label must include - Correct Answer-1. Name
address and telephone number of the distribution facility
2. Name and address of Destiination
3. Prominent identification information of contents example donated human
tissue
4. Recommended storage conditions
5.Validated expiration date/ time of the transfer package when the storage
temperature must be controlled
6. Type and quantity of refrigerant or other hazardous materials enclosed in
the transfer package
7. Any special handling instructions when applicable example do not freeze
CTBS Exam
,Deviation - Correct Answer-May be intentional
Any enterococcus species found on skin cultures will cause
fresh skin to be
automatically discarded - Correct
Answer-
Birth tissue drai - Correct Answer-Obtained/information verified no
more than 14 days
on either side of the day
delivery
First use of amniotic membrane grafts - Correct Answer-Skin substitute
Storage of BT - Correct Answer-Standards do not list any storage conditions
these must
be established by a tissue
bank
Common preservation of BT - Correct Answer-Cryopreservation and
lyophilization
Physical examination on a birth tissue donor must be performed during
admission for
delivery or within 14 days prior to delivery -
Correct Answer-
Birth tissue blood specimens - Correct Answer-Shall be collected at the
time of donation
or within seven days prior to or after
donation
West Nile virus NAT on birth tissue donor's shall be done between June 1
through
October 31 every year; cmv testing occasionally and same standard
donation panel - Correct Answer-
BT: if delivery takes place within a hospital OR or designated delivery room
then no site
evaluation is required - Correct
Answer-
Gestational tissue includes - Correct Answer-Placenta,Wharton's jelly,
amniotic fluid, chorionic membrane, amniotic membrane, placental/chorionic
disc, umbilical vein's and Umbilical cord tissue
Accreditation is valid for three years: Accreditation process: apply, inspect,
evaluate and
review - Correct
Answer-
Accreditation application is provided 12 months prior to expiration. Due
nine months
prior to expiration. - Correct
Answer-
Accreditation inspections scheduled within 90 days of application
CTBS Exam
, receipt - Correct
Answer
-
Informed consent applies to living donors only - Correct Answer-
Informed consent applies to living donors only - Correct Answer-
What side of the tissue would you expect to find umbilical cord - Correct
Answer-Fetal
sid
e
What side of the placenta is attached to the uterine wall - Correct Answer-
Maternal side
Where could you find Wharton's jelly - Correct Answer-Commonly in the
umbilical cord it
cushions the
vessels
How many veins in an umbilical cord - Correct Answer-One; two arteries
What is the age limit for birth tissue donor's - Correct Answer-None
banks need to
establish age of
consent
How many vessels in an umbilical cord - Correct Answer-Three
The donor record shall be retained for at least 10 years past Date of
distribution, date of
transplantation, date of disposition, date of expiration. Which ever
comes latest. -
Correct
Answer-
Donor eligibility records shall be retained indefinitely for Dura mater
donors - Correct
Answer
-
Records of training must be kept for 16 years after termination - Correct
AnswerError - Correct Answer-A deviation from SOPM or applicable laws
and regulations
Accident - Correct Answer-Any occurrence not associated with a deviation
from standard operating procedures, 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, bio compatibility, Or freedom
from transmissible pathogens of the tissue or the ability to trace tissue to
the donor
CTBS Exam
