Richard C. Meagher, PhD, is the Section Chief of Cell Therapy Laboratory Services at Memorial Sloan Kettering Cancer Center in New York, NY. Although Dr. Meagher is a research scientist by day, he is also a FACT inspector, and has been since the inception of the FACT accreditation process. He performed his first inspection in the year 2000, and has since completed 48 inspections (or an average of 3 inspections a year). In addition to volunteering as an inspector, he is a co-chair of the FACT Cellular Therapy Processing Facility Standards Committee and a member of the FACT Cellular Therapy Standards Steering Committee.
Becoming an Inspector
Dr. Meagher was motivated to become a FACT Inspector for the educational experience. He has visited a variety of programs both small and large with an amazing degree of heterogeneity in complying with the Standards. Given the experience he has gained as an inspector, programs in turn frequently ask for his help to achieve compliance with the Standards. The following are additional benefits and advantages Dr. Meagher believes FACT inspectors enjoy:
1. Involvement with FACT helps inspectors remain current with the regulations and provides ideas for complying with them.
2. Inspectors’ own programs benefit from their gained experience.
3. Inspectors have many opportunities to meet their peers and form new relationships.
4. FACT provides an incredible amount of support to inspectors free of charge, such as webinars, advice and recommendations about laudable practices, and the online FACTWeb accreditation portal.
If considering whether to become a FACT inspector, Dr. Meagher says, “Just do it.” He believes the benefits and rewards of becoming an inspector far outweigh the time commitment spent preparing for and conducting an inspection. “You will become much more knowledgeable about the Standards, how to implement them, and how to successfully conduct and/or pass an inspection. Remember that your responsibility as an inspector is to help improve the program and correct or modify identified deficiencies. The inspector experience teaches you very quickly that your peers are looking for help to improve; as an inspector you provide that help. “
Advice to Current Inspectors
Dr. Meagher is one of the most experienced FACT inspectors. Given the number of inspections he has performed, he has a lot of advice to offer current inspectors:
1. Use the tools that FACT provides to you and certainly take advantage of the collective knowledge of the FACT office staff, which is exceptional.
2. When requested to perform an inspection, it is important to do your homework BEFORE you show up for the inspection. In the new electronic age it is easier than ever to conduct a full review of the documentation that is initially required by the FACT office prior to the inspection.
3. Use your inspection preparation time to identify issues that will need further clarification, and, if necessary, request additional information before conducting the inspection.
4. Use the previous accreditation reports to help guide your current inspection, with an eye on new or revised standards that may have been released.
5. Establishing a cordial atmosphere is critical to conducting a successful inspection. The inspected program or facility personnel will likely be nervous. Assure them that your responsibility is to help.
6. During the inspection it is the inspectors’ responsibility to ask questions to clarify any perceived issues. A useful tactic is to ask the question from different perspectives to make sure the program personnel understand what information you are seeking.
7. Examination of the quality management plan and how it is implemented lays a foundation for assessing compliance with the Standards.
Advice to Accreditation Applicants
1. Starting the preparation process for an onsite inspection early is the ultimate key to success.
2. Check for applicable new or revised standards and conduct a gap analysis to determine which standards apply, and whether you have documentation to substantiate compliance.
3. Assemble a binder with the applicable standards indicated and the corresponding documentation.
4. The inspection process is normally only a one day event. Making sure that the inspector has all of the information needed to make an informed recommendation for accreditation rests with the program or facility.
5. Commonly observed deficiencies are related to communication among personnel across departments and quality management activities.
FACT is incredibly grateful to Dr. Meagher’s commitment to FACT and the organizations he has served as an inspector. We encourage all inspectors to greet FACT inspections with the same enthusiasm he displays.
Would you like to share your advice and experiences from serving as a FACT inspector? Submit your story on the FACT website.