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FACT Inspector Standards Review Questions 5th Edition Cord Blood Standards

Inspector Name: ____________________________

Note: A score of 90% or higher is required to achieve active inspector status.

Inspector Techniques

1. As a FACT inspector, it is inappropriate to divulge or share information about the inspected Cord Blood Bank (CBB) with anyone outside the FACT office or the inspection team.

True

False

2. The best time to look over the pre-inspection materials is before you travel to the CBB so you have a

chance to obtain missing documents or answers to any questions you may have.

True

False 3. All pre-inspection documentation submitted by the CBB is located in the bank’s online Compliance

Application.

True

False 4. The FACT Accreditation Coordinator may leave notes pertaining to specific standards to the inspection

team in the Compliance Application, which can be found by clicking, “Review Notes.”

True

False 5. Members of the inspection team should have a team meeting the night before the inspection and every

evening during the inspection to review the application, identify concerns, and plan the inspection

schedule.

True

False 6. The role of the CBB inspection team leader is to: (Select all that apply.)

Develop the inspection agenda with suggestions from the CBB.

Conduct pre-inspection and mid-inspection meetings.

Schedule the initial and exit interviews with the CBB Director.

Submit the final inspection report to the FACT office. 7. If you disagree with some of the Standards, it is acceptable to express this with the FACT Office staff, the

FACT and/or NetCord Board of Directors, or the FACT-NetCord Standards Committee, but not with the

CBB you are inspecting.

True

False 8. A CBB is in compliance with a standard but it is not using a method or approach that your bank uses. It is

acceptable to cite this as a deficiency.

True

False

9. Trainee inspectors must: (Select all that apply.)

Observe the inspection process.

Complete the Inspection Checklist.

Ask CBB personnel to demonstrate compliance.

Privately raise concerns with the inspector(s).

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10. Which is true regarding the exit interview? (Select all that apply.)

The inspector should summarize the findings so there are no surprises in the accreditation report.

The inspector may speculate on a CBB’s accreditation result.

The inspector should emphasize that the final accreditation report may differ from the inspector’s

observations during the exit interview.

Exit interviews are an important step in the inspection day and are taken seriously by CBBs.

11. The inspector and other FACT representatives may accept dinner, gifts, and other tokens of

appreciation from the applicant CBB before, during, or after the inspection and accreditation process.

True

False 12. CBBs’ answers on the Compliance Application are for informational purposes only and do not need to be

verified during the on-site inspection.

True

False 13. Inspectors may choose to turn in their printed checklist and handwritten notes rather than enter the

information in the Compliance Application.

True

False 14. The inspection team should stress that the CBB should not make changes in its practices based on

comments during the exit interview, but should wait until they receive the inspection report.

True

False 15. Inspectors should turn off their cell phones and pagers during the inspection.

True

False

Cord Blood Bank Operational Standards

16. [B1.3] Claims made in advertising must be supported by scientific evidence.

True

False

17. [B1.6.1] Which is true regarding CBB Director requirements? (Select all that apply.)

CBB Directors must have a minimum of two years of experience in immunogenetics of

transplantation, basic or clinical immunology, immunohematology, basic or clinical hematology,

transfusion medicine, blood or tissue banking, or cryobiology.

CBB Directors must have a doctoral degree.

The CBB Director must have HLA expertise.

The CBB Director must participate in continuing education, but no specific topics are required.

18. [B1.6.5] CBBs must have a Quality Unit Supervisor to establish and maintain Quality Management

(QM) systems and to monitor compliance with the Standards. Which of the following is true regarding

this individual? (Select all that apply.)

The Quality Unit Supervisor must establish and maintain systems to review, modify, approve, and

implement all QM SOPs.

The CBB Director can serve as the QM Supervisor.

The QM Supervisor must participate regularly in educational activities related to QM, CB banking, and/or cellular therapy product collection, processing, and administration.

The QM Supervisor can report to the Processing Facility Supervisor.

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19. [B2.2 and B2.3] Which of the following is true regarding QM requirements related to organizational

structure? (Select all that apply.)

The QM Plan must document the relationship and interaction among all participating

facilities and services, including information technology services, testing laboratories, storage

facilities, registries, and outcomes databases.

The QM Plan must include, or summarize and reference, an organizational chart of key

personnel, functions, and interactions within the CBB, the CB Collection Sites, and the CB

Processing Facility.

The QM Plan must include, or summarize and reference, policies and SOPs for development

and implementation of written agreements with external parties only if such relationships exist.

Written agreements must require external parties to comply with the Standards and Applicable Law.

20. [B2.4] The QM Plan must include, or summarize and reference, personnel requirements for each

position in the CBB, including a system to document for each staff member qualifications, training,

competency, and continued education. Each staff member’s records must be included in the QM Plan.

True

False

21. [B2.6.1] SOPs, policies, worksheets, forms, labels, and educational materials must all comply with the

CBB’s document control system.

True

False

22. [B2.5] Which of the following must be a part of the CBB’s change control system? (Select all that apply.)

A description of the proposed change and who is affected.

Identification of risks of the change to the donor, CB unit, or recipient.

Determination of impact on existing processes, policies, and Standard Operating Procedures.

Methods for communication of the change and training, if applicable.

23. [B2.10] CBBs are required to conduct audits of key CBB functions to ensure compliance to the QM

Program and SOPs. Which of the following is true? (Select all that apply.)

There must be a written schedule of planned audits, either within the QM Plan itself or

referenced in the QM Plan but included in a separate SOP or addendum.

It is acceptable to conduct an audit of a portion of a key function, such as the maternal

screening process for donor management.

The results of audits must be used to recognize problems, detect trends, and identify

improvement opportunities.

If the CBB believes issues found by an audit are limited to a particular function within the CBB,

the results can be shared solely with the supervisor of that area.

24. [B2.15] Which of the following is required for outcome analysis? (Select all that apply.)

Outcome data must be trended and evaluated.

Outcome data only need to be analyzed for individual CB units.

Issues discovered during the analysis must be investigated.

A written stability program must evaluate a minimum of three CB units per manufacturing method.

25. [B2.14] Linkage of the CB unit to the infant donor and mother must be retained only until administration of

the CB unit.

True

False 26. [B3.6] All personnel at the CBB, CB Collection Sites, and CB Processing Facilities must follow the

applicable SOPs and policies established by the CBB, even if they are not direct employees of the

CBB.

True

False

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27. [B3.7] Which of the following is true regarding personnel training of new or revised SOPs? (Select all

that apply.)

All personnel must be trained on every new or revised SOP before implementation.

All personnel must be trained after implementation of a new or revised SOP.

Individual staff members must be trained before performing a new or revised SOP.

CBBs can implement an SOP even if not all personnel have been trained. 28. [B4.1] All CBB facilities must be safe, sanitary, and secure. The space must be of adequate size,

including enough room to separate areas used for processing and storage of CB units to prevent mix- ups,

product contamination, and cross-contamination.

True

False

29. [B5.1] Which of the following is true regarding CBBs that include multiple CB Collection Sites and/or CB

Processing Facilities? (Select all that apply.)

The CBB must employ coordinated policies and SOPs.

The CBB must include activities of each site and/or facility in its quality assessment systems.

The CBB must regularly interact with each site and/or facility.

The CBB must delegate staff training and competency evaluation to the site and/or facility. 30. [B5.2] Records must be created for each stage of donor management and cord blood collection,

processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, distribution,

and/or disposal. Which of the following is true regarding these records? (Select all that apply.)

The records can be made concurrently with each stage or after the CB unit is placed in long-

term storage.

The records must identify the person immediately responsible for each step.

The records must include appropriate dates and times to provide a complete history of the work

performed.

Records must be detailed enough to allow for a clear understanding by a person experienced in

CBB procedures.

31. [B5.5] Even if testing or follow-up excludes the risks, CBBs must defer donors from unrelated

donation if there is a family history of a genetic or malignant disease.

True

False

32. [B5.5.6] When a mother does not meet the established screening criteria, the CB unit may not be placed in

long-term storage.

True

False 33. [B5.7] Which of the following is true for testing performed by external laboratories? (Select all that apply.)

Testing must be performed by laboratories accredited, certified, or licensed to perform such

testing in accordance with Applicable Law.

The CBB must verify that testing laboratories are accredited, certified, or licensed as required by

these Standards.

The CBB must maintain a record of all samples sent to external laboratories.

Records must include sample identifiers, results, date sent, and date results are received. 34. [B5.9.2] Cord tissue collection, processing, and storing must be integrated in the CBB’s QM Plan.

True

False 35. [B5.8.2] The CBB must have policies and SOPs that outline circumstances where the infant donor’s

mother (or legal guardian) and/or her physician can be contacted.

True

False

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36. [B6.1] Which of the following is true regarding ISBT 128 coding and labeling? (Select all that apply.)

CB units must be identified with the proper name, modifiers, and attributes as defined at the publication of the NetCord-FACT Standards, even if ISBT 128 is updated in the future.

Proper names, modifiers, and attributes are defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions, which is available online.

The CBB must have ISBT 128 fully implemented, including the technology for printing labels.

At a minimum, an implementation plan for ISBT 128 must be in place. 37. [B6.2] Labels must be controlled in a manner to prevent use of an incorrect or obsolete version.

Which of the following is a control required by the Standards? (Select all that apply.)

Stocks of unused labels representing different products must be stored and maintained in a

controlled manner.

Unused pre-printed labels must be stored in completely separate drawers.

Unused labels that are obsolete must be destroyed.

Obsolete label templates must be destroyed without archival.

38. [B6.3] Which of the following is required for labeling operations? (Select all that apply.)

Information manually entered on a label must be verified by at least two people before the CB

unit can progress to the next stage of processing, storage, or distribution.

A system of checks must be used to prevent errors in transferring information to labels.

All data fields on labels must be completed.

CB units subsequently repackaged into new containers must be labeled with the new labels

before they are detached from the original container.

39. [B6.4] Which of the following is a requirement for product identification? (Select all that apply.)

CBBs must use both a human and machine-readable system for reviewing information on

labels of CB units and samples.

Each CB unit must be assigned a unique numeric or alphanumeric identifier that is not used for

any other CB unit, although it can be used for other purposes in the CBB.

If a supplementary identifier(s) is assigned to a CB unit, there should only be one supplementary

identifier visible on the CB unit bag, and it cannot obscure the original identifier.

If a single CB collection is stored in multiple fractions, there must be a system to identify each

fraction.

40. [B6.6] Label content must be correctly and appropriately applied to labels. Which of the following

elements must be affixed to a CB unit at completion of collection? (Select all that apply.)

Unique numeric or alphanumeric identifier.

Proper name.

Collection site identifier.

Name and volume or concentration of anticoagulants. 41. [B7.5] Which of the following is required for equipment calibration?

Calibration is only required annually.

All equipment with a critical measuring function must be calibrated against a traceable standard.

If no traceable standard is available, calibration is not required.

There must be a defined process for action to take for CB units manufactured on equipment found to be out of calibration.

42. [B7.9] Records of recent equipment maintenance, cleaning, sanitizing, calibration, and other activities

must be displayed on or near each piece of equipment.

True

False 43. [B8.6] Whenever possible, supplies and reagents used for CB collection, processing, or

cryopreservation must be approved for human use. If not possible, the supplies and reagents must be of

the appropriate grade for the intended use, as qualified by the CBB.

True

False

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44. [B9.2] What is required to be in the inventory records to allow easy retrieval of the correct CB unit? (Select

all that apply.)

CB unit unique identifier.

Maternal donor identifier.

Storage device identifier.

Location within the storage device. 45. [B10.2.5] After a CB unit has been transferred, but before the transferred inventory is made available for

search, the integrity and viability of thawed CB units must be verified to ensure the transport or shipping

method did not compromise CB unit viability.

True

False 46. [B11.4] All records pertaining to the CB unit must be maintained for only 10 years after release for

administration.

True

False

47. [B11.7] If two or more facilities participate in the manufacture of a CB unit, the records: (Select all that

apply.)

Must plainly show the extent of responsibility of each facility.

Must be maintained at the central CBB.

Must be separated by which facility is responsible for them, with protection from access by

another participating facility.

Related to the safety of the CB unit must be furnished to the facility of final disposition. 48. [B11.8.1] An electronic record system that performs calculations for processing personnel is a critical

system that must meet the Standards.

True

False 49. [B12.3] If a CBB discontinues the processing of new CB units: (Select all that apply.)

There must be competent staff to oversee, maintain, and distribute the inventory.

A process to distribute CB unit contiguous segments and samples for testing must be

maintained.

The Clinical Program must rely on registry information for CB unit identification and test results.

The records of the entire inventory in storage must be maintained.

Cord Blood Donor Management and Collection Standards

50. [C1.2] Which of the following is required for written agreements? (Select all that apply.)

There must be a written agreement between the CBB and the collecting health care professional.

There must be documentation that a health care professional has agreed to perform the collection.

Written agreements must outline responsibilities for complying with CBB policies and Standard Operating Procedures.

Written agreements are only required for fixed CB Collection Sites. 51. [C1.3] Which of the following is required for nonfixed CB Collection Sites? (Select all that apply.)

There must be secure storage of the CB unit, associated samples, maternal samples, and

documents until they are distributed to the CB Processing Facility.

There must be a designated area for appropriate and secure storage and preparation of the

reagents, supplies, and equipment needed for the collection procedure.

There must be adequate space for the collection procedure.

There must be limited access controlled by a key card.

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52. [C1.4] Which of the following is required for CB collection kits prepared by and sent from the CBB? (Select

all that apply.)

The kit must include adequate instructions and materials to store and transport or ship the

collection kit prior to collection.

The kit must include adequate instructions and materials to collect, label, store, pack, and

transport or ship the collection to the CBB.

The collection kit must be transported or shipped under validated conditions only when sending the CB unit to the CBB.

The temperature of the collection kit must be continuously monitored when shipped from the CBB

to the donor family or CB collection site.

53. [C1.5] Which of the following records must be provided to the CBB? (Select all that apply.)

Identity of supplies and reagents, including manufacturer, lot number, and expiration date.

Documentation of appropriate storage of supplies and reagents.

Documentation of appropriate storage of CB units, associated samples, and maternal samples.

Documentation of the external temperature at the location of CB collection.

54. [C2.3] Since CB collection personnel are usually not at the CBB, the bank does not need to maintain

documentation of training.

True

False

55. [C2] Which of the following are acceptable ways to facilitate communication between the CB Collection

Sites and the CBB? (Select all that apply.)

At fixed CB Collection Sites, employ CBB personnel whose reporting structure is outlined

in the organizational chart.

Have the CBB Medical Director visit each of the CB Collection Sites.

Provide the collecting licensed healthcare professional at non-fixed CB Collection Sites a way

to contact the CBB Medical Director with questions or concerns before, during, and after CB

collection.

Include in the training materials for the collecting licensed healthcare professional at non-fixed

CB Collection Sites that the CBB will solely be responsible for following up after the CB

collection to verify the success of the procedure.

56. [C4] The quality of the informed consent process depends on the mother’s ability to understand the

information. Therefore, the process must: (Select all that apply.)

Begin before the mother reaches the third trimester of pregnancy.

Be obtained and documented while the mother is able to concentrate on the information and is

not distracted by aspects of labor.

Be in a language and with terms the mother understands.

Allow the mother the opportunity to ask questions. 57. [C4.3] A full informed consent for collection, processing, testing, and storage of the CB unit must be

obtained from the maternal donor prior to collection of the CB unit.

True

False

58. [C4.5 and C5.1] If a CB unit originally intended for related use is to be made available for unrelated

allogeneic use, the infant donor and maternal evaluation and consent processes must have

included all requirements for unrelated allogeneic CB units.

True

False

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59. [C5.4] If the history for communicable disease risk behavior was obtained in advance of the maternal

donor’s presentation for delivery, the history must be updated to include information up to the time of

delivery.

True

False 60. [C5.6] What maternal samples are required? (Select all that apply.)

Blood from the birth mother that is obtained within seven days before or after collection for the

communicable disease testing required in D11.1.

A sufficient volume of blood from the birth mother to maintain a minimum volume of 3.6 mL of

serum and/or plasma from non-heparinized samples divided into at least two vials in order to meet

D5.3.1.

A sufficient volume of blood from the genetic mother for the preparation of at least 50µg genomic DNA.

Maternal blood sample for microbial culture. 61. [C5.5] What information is required for the evaluation of the infant donor? (Select all that apply.)

History of the current pregnancy and delivery.

The infant donor’s gender and gestational age.

Results of the infant’s physical examination and if the infant is free of any finding suggestive of

disease potentially transmissible through administration of a CB unit.

Time of delivery. 62. [C6.1.1] The safety of the mother and infant donor is paramount; however, it is acceptable to modify

delivery practices in an attempt to increase CB unit volume.

True

False

63. [C6.2] Additional safeguards are required for in utero CB collection to ensure the safety of the mother and

infant donor, including: (Select all that apply.)

In utero collections should only be performed on documented singleton deliveries. If performed in a multiple gestation pregnancy, all infants must be delivered before any CB collection begins.

In utero CB collections should only occur in uncomplicated deliveries as determined by the CBB

Medical Director.

Unrelated CB units collected in utero must only be obtained from infant donors after a

minimum of 34 weeks’ gestation.

Related CB units collected in utero at less than 34 weeks’ gestation must be based on an

evaluation of infant donor safety by the licensed health care professional responsible for the

delivery.

64. [C6.3] The CB collection procedure must be validated. What are the minimum parameters that must be

validated? (Select all that apply.)

Acceptable progenitor cell viability.

Cell recovery.

Rate of microbial contamination.

Duration of time required to perform the collection. 65. [C7] Which of the following is required for maintaining the temperature of CB units during transport or shipping to

the CB Processing Facility? (Select all that apply.)

CB units must be placed in an outer container that is qualified and validated to maintain a

designated temperature range.

The temperature inside the outer container must be continuously monitored when the CB unit is

shipped.

The temperature inside the outer container must be continuously monitored when the CB unit is transported.

CBBs can choose to either validate the container or continuously monitor the temperature during

transport or shipping.

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66. [C7.5 and C7.6] For transport or shipping of a CB unit from the CB Collection Site to the CB Processing

Facility, the outer container must: (Select all that apply.)

Be made of material adequate to withstand conditions incident to handling during

transportation or shipping.

Be labeled with the information required in Appendix I, Cord Blood Unit Labeling Table.

Include the name of the infant donor and intended recipient, if applicable.

Be secured. Cord Blood Processing Facility Standards

67. [D1] The CB Processing Facility must be maintained in a manner that prevents the spread of

transmissible diseases and CB unit mix-ups, contamination, and cross-contamination. Which of the

following is required by the Standards? (Select all that apply.)

The facility must provide adequate lighting, ventilation, access to hand decontamination, and air

quality.

There must be documentation of facility cleaning and sanitation.

Temperature and humidity must always be controlled and monitored.

Environmental conditions for temperature, humidity, ventilation, and air filtration and

classification must be defined. If appropriate, these conditions must be monitored.

68. [D1 and D2] The inspector should tour all areas of the CB Processing Facility where work is being

performed to see if: (Select all that apply.)

Personnel comply with the Standards.

The facility is secure.

The area is clean and orderly.

Research activities are adequately separated. 69. [D4.1] The CB Processing Facility must evaluate the CB unit upon receipt before accepting it for

processing. Which of the following evaluations is required? (Select all that apply.)

The appropriateness of the appearance, labeling, and identification of the CB unit.

Only the identification of the reference samples and maternal samples.

The integrity of the collection bag and outer container.

The receipt of the package within an acceptable amount of time as defined by the CBB. 70. [D4.1.2] The CB Processing Facility must ensure that a signed consent accompanies each unrelated CB

unit before processing is completed.

True

False 71. [D4.2] Control of the processing procedure is critical to CB unit safety. Which of the following controls is

required? (Select all that apply.)

The CB unit’s unique identifier must be affixed to the CB unit at all times.

Information regarding processing steps that have been completed on a CB unit must

accompany the CB unit or be available electronically during all stages of processing.

Processing must be performed according to validated SOPs.

Failure of the processing procedure to achieve acceptable end-points must be evaluated and

documented both to correct and/or mitigate the immediate problem and to prevent it from

recurring.

72. [D4.2.6] Unrelated CB units may be cryopreserved and placed in long-term storage up to 72 hours after

collection.

True

False

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73. [D5.1.1] Each CB unit must have a minimum volume of 200 µL of cord blood integrally attached to the

unit’s bag, but there are no requirements for how many segments must be present.

True

False

74. [D5.1] Storage of reference and maternal samples must be at a temperature that adequately preserves

the samples for the intended use, including which of the following specific requirements? (Select all that

apply.)

Reference samples intended for viability or potency analysis must be stored at -150⁰C or colder.

Reference samples used for purposes other than viability analysis must be stored at -150⁰C or

colder.

Serum or plasma used for purposes other than viability testing must be stored at -70⁰C or colder.

Serum or plasma must be stored at -150⁰C or colder. 75. [D6.2] Cryopreservation procedures must include at least which of the following elements? (Select all that

apply.)

Total nucleated cell concentration within a defined range.

The cryoprotectant, its final concentration, and the duration of cell exposure prior to

freezing.

Method of freezing and end-point temperature of cooling.

Thawing instructions. 76. [D7.1] Each CB unit storage device must be located in a secure area, and either the device or the secure

area must have locking capability.

True

False

77. [D7.4] A CB unit must be quarantined until: (Select all that apply.)

The CBB Director or designee has approved the release of the CB unit from quarantine status.

The quality unit has approved the release of the CB unit from quarantine status.

Review of maternal communicable disease risk history, other medical history, maternal test

results, and CB unit microbial culture results as required by Applicable Law.

It is appropriately labeled with warning statements when tested positive for infectious disease. 78. [D8.3] The level of liquid nitrogen in CB unit freezers must be continuously monitored.

True

False

79. [D8.4] Alarm systems required on storage devices for CB units and associated reference and maternal

samples must meet at least which of the following criteria? (Select all that apply.)

The alarm system must be active only during normal business hours.

The alarm system must have audible and visible signals.

The alarm system must be capable of notifying designated personnel 24 hours a day.

Alarm parameters must be set to allow staff sufficient time to salvage CB units and samples.

80. [D9.3] The disposal of CB units must be documented, including at least which of the following items?

(Select all that apply.)

Unique numeric or alphanumeric identifier of the CB unit.

Reason, date, and method of disposal.

Individual who disposed of the CB unit.

Notification of the infant donor’s family for related CB units.

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81. [D10.2] Which of the following testing control procedures is required? (Select all that apply.)

The use of established and validated assays and test procedures for the evaluation of the CB

unit.

Verification of new reagent lots to provide comparable results to current lots or give results in

agreement with suitable reference ranges before or with placement into service.

Use of reference or quality control material at all times; tests without such material may not be

performed.

Functional checks performed for testing instruments, as appropriate, prior to testing.

82. [D10.3 and Appendix III] Which of the following required tests must be performed on a reference sample

obtained after processing but before cryopreservation? (Select all that apply.)

Microbial culture.

HLA typing.

ABO/Rh.

Viable CD34. 83. [D10.3 and Appendix III] Which specific HLA typing is required?

HLA-A, B, and DRB1 at low resolution for unrelated CB units.

HLA-A, B, and DRB1 at high resolution for all CB units.

HLA-C at high resolution.

HLA-DQB1.

84. [D10.3 and Appendix III] Optional testing before release for administration includes hemoglobinopathy

testing.

True

False

85. [D10.3 and Appendix III] Many tests have not been licensed by the applicable governmental authority for

the testing of CB units. Which of the following tests on reference samples from the CB unit are required

even if there are no licensed tests available? (Select all that apply.)

HIV, type 1.

Hepatitis C virus.

Treponema pallidum (syphilis).

None of the above.

86. [D10.3.1] CBC with differential testing must include enumeration of neutrophils, lymphocytes, monocytes,

and platelets.

True

False

Cord Blood Selection and Release Standards

87. [E1.2] If both unrelated and related CB units are included in a CBB, the bank must have a defined

process to prevent listing of related units for unrelated use.

True

False 88. [E1.6] Reserving and allocating CB units has a direct impact on the appropriate and timely selection of a

CB unit for a specific recipient. Which of the following is required? (Select all that apply.)

The CBB must have policies and SOPs for reserving and allocating CB units.

Reservation of a CB unit cannot be in place simultaneously for more than one potential

recipient or for more than one Clinical Program.

Reservation of a CB unit can be in place simultaneously for multiple potential recipients as long

as the CB unit is ultimately released on a first-come, first-serve basis.

The CBB must notify all listing organizations in a timely manner when a CB unit is

removed from inventory.

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89. [E2.1] In addition to maternal screening and testing results, which of the following records is required to be

reviewed prior to listing an unrelated CB unit for search? (Select all that apply.)

Time of collection.

Infant donor’s ethnicity/race, gender, and physical examination.

Consents.

Processing and cryopreservation parameters. 90. [E2.2] Unrelated CB units can only be made available for search after testing and medical review has been

completed in accordance with Applicable Law and the quality unit has reviewed the unit records.

True

False 91. [E3.1] The CBB must retain documentation of requests indefinitely for which of the following? (Select all

that apply.)

Requests for samples.

Requests for and results of testing.

Requests for information on the banking process.

Requests for CB units.

92. [E3.2] Before a CB unit is released from the CBB, a sample from a contiguous segment of that unit must

be tested to verify the HLA type and, if possible, cell viability. Any histocompatibility discrepancy must be

resolved and communicated to the registry and the Clinical Program.

True

False 93. [E3.3] At the time of selection for administration, the CBB and/or registry must provide the Clinical

Program information regarding the CB unit, including at least: (Select all that apply.)

All HLA Class I and Class II typing results, including prior results.

Viable CD34.

The method of collection.

Instructions for thawing and administering the CB unit, including expected range of results based upon CBB internal validation results or published documentation.

94. [E4.3] If a CB unit is requested for which maternal screening indicates potentially transmissible disease,

who must approve release? (Select all that apply.)

The recipient’s physician.

The CBB Medical Director.

Either the CBB Director or Medical Director for specific authorization to release the unit.

The quality unit for specific authorization to release the unit.

95. [E4.7] If a Clinical Program lacks experience in handling CB units, the CBB should offer a practice CB unit. This practice CB unit must be clearly labeled as a CB unit for nonclinical use only.

True

False

96. [E5.3] What is required of a liquid nitrogen-cooled dry shipper used to transport or ship cryopreserved CB units? (Select all that apply.)

The dry shipper must contain an electronic data logger that continuously monitors the temperature.

A secured lid only if the outer container lid is not secured.

Validation that the dry shipper maintains a temperature of -150⁰C or colder for at least 48 hours

beyond the expected time of arrival at the receiving facility.

Labeling with the information required in Appendix I, Cord Blood Unit Labeling Table.

97. [E5.5] An unrelated CB unit may be returned to the CBB inventory after it has left the premises if it is still

frozen.

True

False

13

98. [E6.3] The transportation and shipping records must document at least the following information:

(Select all that apply.)

The CBB responsible for distributing the CB unit.

The date and time of packaging of the CB unit at the CBB.

The person who packed the CB unit.

The identity of the courier and tracking information.

99. [E7.1] The purpose for collection of clinical outcome data is to ensure that procedures in use by the

CBB result in a safe and effective CB unit.

True

False

100. [E7.2] The CBB must have a policy or SOP to obtain certain information from the Clinical Program,

registry, or outcomes database including at least: (Select all that apply.)

Cell yield results on the thawed CB unit.

Adverse events associated with administration of the CB unit

Time to neutrophil and platelet engraftment.

Survival rates.