All inspectors have specific educational and practical experience prerequisites to ensure they are proficient in the areas they inspect. Inspectors are active in the field of cellular therapy administration, cord blood banking, or cellular therapy product collection and processing. All FACT inspectors are volunteers who are experts with the most current knowledge of the field. Many inspectors are the researchers and innovators who are responsible for advancing cellular therapy.
Inspector Qualifications
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Initial Qualifications
FACT’s aim is to send out the most qualified inspectors whose range of experience matches that of the applicant they will inspect. To become an inspector, you are required to complete an application form detailing your professional qualifications.
Remember that some qualifications require maintenance over time. For example, an inspector must be a member of a professional society (i.e. ASTCT, ISCT, ASFA) and be employed at an organization that is either FACT accredited or is an active applicant for FACT accreditation. An inspector may continue as a FACT inspector for two years after he/she leaves a FACT-accredited or applicant program, if eligible.
Please keep the FACT Accreditation Office updated on new areas of expertise, additional qualifications you have achieved, and any changes in your contact information (e.g., work telephone, fax numbers, email address, mailing address, assistant’s contact information) as they occur.
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Insurance
FACT provides insurance for its inspectors to cover any damage or accidents that occur at an applicant’s facility during an inspection. Details of this insurance may be obtained from the FACT Accreditation Office. In general, work-related insurance policies provided by your employer will still apply when you are performing an inspection. If in doubt, check with your employer.
Inspector Training
and Development
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FACT’s inspector training and development program is designed to ensure knowledge and understanding of current Standards, create awareness of commonly deficient and/or misinterpreted standards, and provide tools and suggestions for conducting high-quality inspections. New inspectors are required to participate in an in-person Inspector Training Course, complete a Cord Blood or Cellular Therapy Inspector Test, and view a Professional Inspections recording prior to attending an in-person training inspection with an assigned mentor.
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By serving as a FACT inspector, your learning will continue over time. In addition to the educational value of on-site inspections, you are encouraged to take advantage of the many free educational events provided by FACT.
Although the inspection may be a training opportunity for you, it is a very real inspection for the applicant.
To prevent confusion and to ensure the applicant’s compliance is assessed by experienced inspectors, do not interact directly with program personnel (e.g., ask questions, share observations during the exit interview). If there are differences of opinion between an applicant staff member and the inspector, you should not become directly involved.
It is absolutely appropriate for you to raise concerns or questions with your mentor in private and to draw attention to something that may violate a standard.
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There are steps in the trainee inspection when you will actually perform the work. Before the inspection, you will review the program’s compliance application and documents. If you have questions about any of the documents, or about the inspection in general, contact your mentor or FACT accreditation coordinator (not the program personnel). Print out the inspection checklist (emailed to you by your FACT accreditation coordinator and available in the Accreditation Portal) and take it with you to the inspection or download it to a laptop or tablet device for easy electronic viewing.
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Upon arriving at the location of the inspection, attend the pre-inspection team meeting and observe the entire inspection: the introductory meeting, the facility tour, the documentation review, and the exit interview. While your mentor is conducting the inspection, complete the trainee inspection checklist. Ask any questions of your mentor when you are alone with the inspection team or your mentor. After the inspection compare your findings with your mentor's. Within three days of the inspection, submit your completed checklist (including descriptions of deficiencies in the comments column) to your mentor in the Portal and complete the post-inspection evaluation. Review your mentor's inspection report with him/her for an example of how to format and present findings in reports. Once completed, review your mentor's comments at the end of your inspection report, and discuss with your mentor as needed.
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Training Inspections
After completing the application process and initial training requirements, you will be scheduled for a FACT on-site inspection with an experienced inspection team. You are there to observe experienced inspectors, improve your understanding of the Standards and accepted interpretations, become familiar with the inspection process, practice report preparation, and gain confidence. An inspector with the same area of expertise (clinical, collection, processing, or banking) will be your mentor, whom you will accompany during the on-site inspection. As we are getting to know you, it is helpful to verify that your assigned training inspection matches your area of expertise.
The trainee inspector’s role during the on-site inspection is strictly observational. You are there to observe the mentor’s process of touring the facility, interviewing personnel, and reviewing records.
