Expectations of FACT Inspectors
All FACT Inspectors are active professionals in cellular therapy or cord blood banking and satisfy specific educational and practical experience prerequisites to ensure they are proficient in the areas they inspect.
Once determined eligible to serve as an inspector, the individual must:
- Complete the inspector training program, which includes an in-person workshop and online sessions, completion of the respective Standards Inspector Test, and a training inspection.
- Perform 2 FACT inspections annually, but no less than one inspection every 24 months.
- Commit the necessary time for each inspection, including time to prepare, visit the site, and write the inspection report.
- Maintain qualifications, including completion of the Standards Inspector Test for each new edition of relevant Standards and participating in or viewing 2 hours of FACT education annually.
- Complete FACT Conflict of Interest & Acknowledgements.
- Inform FACT of changes that may affect inspector status.
- Comply with relevant FACT Standard Operating Procedures, including compliance with timeframes for report submission.
- Be objective, consistent, and collegial when fulfilling the FACT Inspector role.
- Respect confidentiality of organization practices, documents, and the deliberations of the inspection team.
- Read FACT newsletters and emails.
Performing a FACT inspection
Important Information for FACT Inspections
Inspectors are asked to review the following information prior to each inspection to encourage efficient and accurate information to facilitate a smooth and efficient process:
Making Travel Arrangements
Inspectors are responsible for making their own travel arrangements so that flights fit the inspectors’ schedules.
Booking Travel: Contact Corporate Travel Management (844-378-2955) and identify yourself as a FACT Inspector to have your airfare billed directly to FACT. Please be conscientious of cost when requesting airline tickets. Preferred airlines or non-stop flights should only be selected if they are among the least expensive flights available.
Making a Hotel Reservation: Make a hotel reservation using the information provided by FACT in the email with the details of the inspection sent to you.
Planning Your Arrival: Plan to arrive the day before the inspection and do not book your flight until at least 7PM on the last day of the inspection.
Extending Your Stay: If a return flight is unavailable the evening of the inspection, FACT will cover the expense of an additional night. FACT will also reimburse for an additional night if it is used to complete the inspection report.
Preparing for the Inspection
Inspectors must be well prepared for the inspection so adequate time can be devoted to the elements that can only be examined onsite.
Set an Agenda: Team Leaders contact the Program Director to set an agenda for the inspection. Send the confirmed agenda to the rest of the team.
Access a copy of the Compliance Application: You may print the Compliance Application if desired for use onsite, or you may also complete the Compliance Checklist online throughout the inspection day.
Review the program documents: Use the FACTWeb Compliance Application to organize and become familiar with the program.
Initiate a request for information (RFI): If additional documents are required, allow the program to upload requested documents.
Schedule an inspection team meeting: The night before inspection, Team Leaders schedule a virtual or live meeting for ALL inspection team members to finalize plans for the onsite inspection. Assign all facilities to be inspected to an inspector.
Conducting the On-Site Inspection
Keep in mind the planned agenda and take clear notes during the inspection to facilitate efficiency and thoroughness.
Introductory Meeting: Briefly describe the inspection team’s plans for the day.
Before Inspection: Request missing documents at the start of the inspection so they can be compiled for your review during the inspection.
During Inspection: Inspect and evaluate your assigned facility against the FACT Standards using the printed checklist.
Before Exit Interview: Discuss with team members their general sense of the inspection and major issues observed.
During Exit Interview: Team Leader lists the major deficiencies noted and explains that the final decision on accreditation status will be determined by the Board of Directors following the Accreditation Committee’s review of the inspection report.
Completing the Inspection Report
Submit a timely and complete report within 3 days of the inspection so that the accreditation process can continue according to established timelines.
Determine Compliance: Mark each standard in the Compliance Application as “compliant” or “not compliant” if not already completed.
Detail Non-Compliant Items: Review each standard marked “not compliant” and clearly describe the deficiency.
Check Report: View the applicable section(s) of the inspection report, review it for accuracy, and submit it online.
Submit for Review: Within 2 weeks of the inspection, the team leader reviews the complete inspection report, clarifies any unclear deficiencies and identifies missing details, and submits the final inspection report online.
Presenting Inspection Findings to the Accreditation Committee
Inspector involvement in preparing the accreditation report provides the Accreditation Committee a clear understanding of the results of the inspection.
Review and comment on the accreditation report: Complete your review within the timeframe specified.
Attend the Accreditation Committee meeting: Ensure you are available to answer questions.
Keep all documents concerning the inspection: You should keep documents until you have been notified that the program has been accredited.
Closing the Inspection
Submit a completed Expense Reimbursement Form: Keep original receipts documenting expenses to FACT. Inspectors are reimbursed after completion of the inspection report and upon receipt of the expenses.
Document your impressions: Review the inspection process and provide comments or suggestions in the Inspection Evaluation.
Destroy all documents after accreditation: All documents should be destroyed after notification that the organization received FACT accreditation, including but not limited to, notes that are associated with this inspection, completed checklists, inspection summaries, documents received during the inspection, and correspondence generated during the process.
Finalize the inspection process by addressing any outstanding items with FACT.
Participating in training inspections
The on-site training inspection is an important piece of a trainee inspector’s education, and its success depends largely on how the mentor and the trainee take advantage of the opportunity. Prior to an on-site inspection, FACT will verify that the trainee meets prerequisite inspector requirements. An experienced inspector will be asked to be a mentor before being assigned a trainee.
The FACT Inspector Services reviews the mentor and trainee evaluations and inspection reports. A trainee must have a satisfactory evaluation from the mentor before becoming an active inspector. If additional feedback is required, the FACT Inspector Services will provide it to the trainee and inform the mentor. If the mentor or trainee feels that an additional training inspection is warranted, the FACT Inspector Services will contact the trainee to schedule an additional training inspection. Upon receipt of a satisfactory evaluation, the trainee will become an active inspector.
Mentor Responsibilities
The main objective of the training inspection is to train the new inspector through observation and discussion during an actual inspection.
The mentor must agree to:
Contact the trainee before the inspection: Discuss how he or she plans on training the individual
Prepare for how he or she will train the individual: Determine how you will provide the training while still conducting a thorough on-site inspection
Provide preparation tips and answer questions: Address all during the preinspection conversation
Explain his or her approach: Clearly outline approach and findings throughout the day. Do not have these conversations in front of applicant personnel
Demonstrate exemplary behavior: Ensure appropriate time management as well as adherence to FACT policies, procedures, and timelines
Complete the entire inspection: The mentor must not delegate any portion of the inspection or Compliance Application to the trainee. Program personnel have worked hard to prepare for the inspection and deserve to be assessed by an active inspector
Review the trainee’s inspection checklist: Provide feedback to the trainee via email or telephone
Complete the inspection evaluation: Submit the evaluation, including a summary of feedback to the trainee, to the FACT Inspector Services
Trainee responsibilities
Trainees should take advantage of the opportunity to observe the on-site inspection in a respectful, nonintrusive manner.
The trainee should:
Verify the assigned inspection area: Ensure the inspection assignment aligns with his or her area of expertise
Review inspection resources: Read the FACT Inspector Roles and Responsibilities on this webpage and follow the instructions provided in the Performing a FACT Inspection section.
Participate in the preinspection team meeting: Engage with the inspection team to understand roles, expectations, and logistics
Attend all portions of the inspection: Be present for the introductory meeting, the full on-site inspection, and the exit interview
Observe the mentor’s process: Take note of how the mentor conducts the facility tour, interviews personnel, and reviews records
Refrain from direct questioning: Do not ask questions of applicant personnel during the inspection. All questions should be directed privately to the mentor or raised during team meetings
Complete an inspection checklist: Document findings while accompanying the mentor throughout the inspection
Submit required materials: Send the completed inspection checklist and report to both the FACT Inspector Services and the mentor for review
Provide evaluation feedback: Record impressions of the inspection process on the inspection evaluation form
