It is necessary to the success of the inspection to complete your checklists as directed by FACT. An incomplete inspection may require a repeat site visit or extensive responses from the applicant. For example, if an inspector assigned to review unrelated and related cord blood banking only reviews unrelated donations, the bank may have to be reinspected or address several standards in its response. As another example, a program may state it does not meet required marrow collection numbers, but a marrow collection inspection must still occur if assigned by FACT.

 

We understand that inspectors may be told something different on-site than what was originally assigned by FACT. If an applicant asks you to refrain from a certain aspect of an inspection, please take the following steps:

 

• Remind the applicant that failure to undergo inspection of certain locations or processes may require a reinspection and jeopardize accreditation.

• If the applicant continues to refuse, contact the FACT office immediately for assistance with clarifying accreditation goals.

• If a complete inspection still cannot be performed, clearly document within the inspection report those standards for which you were unable to verify compliance.

• If you observe activities being performed that were not part of the inspection assignment, such as marrow collection or immune effector cell therapy, request permission from the applicant to conduct the inspection to prevent the need for a reinspection. If the applicant objects, offer a reminder of the points above, note the activities you were unable to inspect, and proceed with the inspection as assigned.