Inspector Insights

Jean Sanders, MD

March 27, 2014

Jean Sanders, MD is a pediatric transplant physician, Treasurer of the FACT Board of Directors, and has conducted more than 35 inspections around the globe. Dr. Sanders is often looked to as a mentor for new volunteers and shares with them her experience as a FACT inspector which she regards to be both educational and rewarding. Serving as an inspector not only allows one the opportunity to see other transplant programs or cord blood banks, but also affords the inspector the opportunity to become exceedingly familiar with the FACT Standards which in turn may lead to improvements at their own program. Dr. Sanders recommends that inspectors should take their responsibility seriously as the inspector is a representative of FACT. In order to do a top notch inspection, the inspector must be prepared, be organized, and have good communication skills.

Dr. Sanders provides the following advice to new inspectors:

Be Prepared

1. The inspector must become familiar with FACTWeb, the online accreditation portal, and review the FACTWeb inspector guide before the first inspection using FACTWeb. I have found it helpful to have printed off this guide and have it readily available when I am completing the inspection and the inspection report.
2. Before the inspection date(s), the inspection checklist must be reviewed. I personally find it helpful to print out the short version of the checklist, and as I review the on-line FACTWeb checklist, I am able to specifically mark those standards for which there are things that I must review at the on-site inspection. This makes the on-site inspection go much easier for me and assures me that I will not miss something.
3. There are items on the checklist that can be completed before the on-site inspection, such as review of physician qualifications. These should be marked compliant, when possible, before the inspection. During the site visit, the inspector can focus on reviewing required documentation for those things that are not able to be completed beforehand and review those items where there may be a question.
4. For clinical transplant center inspectors, it is helpful to complete and print out the FACT data audit forms. These must be spot-checked at the on-site visit.
5. After the on-site inspection, those items that are marked non-compliant will appear in the inspection report. As inspectors mark items non-compliant, they should include a complete explanation as to why the program does not meet FACT Standards.

Ensuring a Successful Visit

1. The Team Leader’s responsibility is to prepare an agenda for the on-site inspection and review the proposed agenda with the organization’s leadership. Once the organization has approved the schedule or provided suggestions for revision, the Team Leader will distribute the agenda to all inspection team members and trainee(s).
2. The Team Leader will arrange a pre-inspection team meeting which preferably would be the evening prior to the inspection or early the morning of the inspection. This session allows team members to clarify responsibilities and discuss any possible concerns.
3. At the beginning of the inspection, the applicant program will present details about their organization and introduce key members of the cellular therapy program or cord blood bank. This gives the applicant the opportunity to describe their program and for the inspectors to become more familiar with the program they are inspecting. Following this presentation, the applicant program will take the inspectors on a tour of the important areas of the program that are to be inspected, e.g. the clinical in-patient unit, the out-patient area, the processing area and the cell collection area.
4. The Applicant program is to provide knowledgeable members of their team to accompany each inspector during the day(s) to assist with obtaining all required documentation that the inspectors will need. This is especially important for obtaining documentation that may be kept in the electronic medical record or is otherwise on-line.
5. On the day of the inspection, the team will meet for a working lunch to review their progress and discuss any problems encountered. There will also be a pre-exit meeting at the end of the day, again for team members to ensure all areas are inspected and share information regarding any identified deficiencies.
6. It is the inspector’s responsibility to be professional and collegial throughout the inspection process. The goal is to improve the program’s quality for the benefit of the patients. At the exit meeting, the inspectors should provide their overall observations in a polite manner. The program should not be surprised when they receive the written inspection report from the FACT Accreditation Committee.
7. The Applicant program has done a lot of work to prepare for the inspection. The inspection team should recognize the contributions of the staff members and express their appreciation at the time of the exit interview.
8. Most of all, the inspection team’s responsibility is to set the tone for the inspection, be thorough and complete, and to smile and enjoy what they are doing. If the inspection team is relaxed, so will the applicant program’s staff members.
9. Finally, the inspection report should be completed within 24-48 hours of conducting the inspection. With FACTWeb, this is easily accomplished since much of the work has been completed before and during the on-site inspection.