Inspector Insights

Inspector Insights

Frank Smith, MD

December 14, 2012


Frank Smith, MD, of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati College of Medicine, has performed FACT inspections for 12 years and is often complimented for his effectiveness as an inspection team leader. What makes him a successful inspector? He would summarize his approach into four categories: organization, communication, taking care of people, and managing expectations.


Dr. Smith takes his role as Team Leader seriously – he understands the importance of making the inspection process efficient for both inspectors and applicants. He accomplishes this with extensive preparation before the on-site inspection.

One of his claims to fame as a FACT inspector is his pre-inspection team teleconference. After the inspection date is determined and the inspection team receives the organization’s pre-inspection submission, Dr. Smith’s assistant sets up a teleconference for the inspection team approximately one month from the inspection date. The pre-inspection teleconference is typically organized as follows:

  • Confirmation that all team members received their inspection binders 
  • Review of the proposed agenda 
  • Major concerns, missing information, or needed follow-up from the applicant 
  • Assignment of a team member to contact the applicant to discuss the proposed agenda 

Dr. Smith also takes care to organize his inspection binder and notes. He offers to clinical inspectors this helpful tip: to prepare for the data audit portion of the clinical inspection, decide which data points you plan to audit and then transfer the data from the submitted TED forms to the data audit worksheets before the inspection. This results in less flipping through voluminous amounts of paper the day of the inspection, because you will only have to find those data points in the primary source data.


Communication among inspection team members and with the applicant is key to a good working relationship. In addition to the pre-inspection teleconference, Dr. Smith makes himself available and tells his team members that they may call him if any issues come up while they are preparing for the inspection. He arranges for the inspection team to meet the night before the inspection for dinner or for breakfast on the inspection day.

During the day of the inspection, he reiterates the importance of the working lunch. He spends about 30 minutes discussing with his inspection team issues, themes, and patterns discovered during the morning portion of the inspection. He also assesses what information is missing so that it can be requested immediately after the working lunch. The team rejoins briefly before the exit interview so that they can provide each other a summary of what they’ve found and have an opportunity to quietly organize.

Communication with the applicant is also critical. Introductions at the beginning of the day ensure everyone has a chance to meet and gain an understanding of each other’s roles. Dr. Smith always tells the Clinical Program Director before the inspection starts that if significant issues are found, he may request a private meeting with the Director. He also communicates with the Clinical Program Director regarding the progress that is being made and a tentative time for the exit interview.

Taking Care of People

Dr. Smith believes it is the Team Leader’s responsibility to set the tone of the inspection. Team Leaders must be organized, polite, and helpful to reduce anxiety. Through this behavior, everyone will understand that the FACT inspection and accreditation process is intended to be a professional and collegial activity meant to raise everyone’s quality of processes. Everyone improves and learns as a result of inspections, including the inspectors themselves, and both inspectors and applicants should try to enjoy the inspection day. Humor is a great way to diffuse tension.

To Dr. Smith, it’s often the little things that count. For example, he puts forth great effort to ensure transportation to and from the airport, hotel, and inspection site for the inspection team is organized and that everyone knows where they need to be and when. He prefers to use a rental car or taxi cab to get to and from the applicant’s facilities rather than an escort from the applicant to avoid a potentially awkward situation if the inspection results are poor.

Managing Expectations

While Dr. Smith bases his inspection philosophy on being collegial, he does not shy away from the obvious reality that on-site inspections are hard work. So that everything goes well and that the inspection is thorough and fair, he makes sure everyone knows what is expected of him or her.

For inspection teams, he demonstrates through example that preparation is crucial. While it is understood that FACT inspectors are busy volunteers, the last thing an inspector should do is wait to prepare until the flight to the inspection. He also asks the inspectors to complete their inspection reports before returning home if possible. If the team inspected a large and/or complex program, he will even ask the team to stay an extra night to complete the report. He notes that memories of inspection findings are not like wine – they do not get better with age.

At the time the applicant is given the proposed inspection agenda, Dr. Smith ensures applicants are given clear instructions regarding what they must contribute in order to conduct an efficient inspection. The following instructions are given during the first contact between an inspection team member (as chosen during the pre-inspection team teleconference) and the applicant’s contact person, which allows the applicants a few weeks to prepare:

  • A dedicated, knowledgeable person from the program must be assigned to each inspector for the whole inspection day. Clinical inspectors need two dedicated individuals: one who is familiar with the medical records and quality management documents to help the inspector find the information and one who can retrieve documents requested throughout the day.
  • Documentation should be assembled in the order of the inspection checklist. Primary source data for the data audit should be in the order requested.
  • If electronic records are used, the applicant should print out the required pages. Inspectors should not be expected to find electronic records themselves.
  • The applicant must be prepared to give an approximately 10 minute overview of its program at the beginning of the day. Dr. Smith especially likes to know the history of the program, how many transplants are performed, and if there is any research focus.

On the day of the inspection, Dr. Smith explains to the applicant that the role of the inspectors is to be the eyes and ears of FACT. No accreditation decision is made until the report is reviewed by the Accreditation Committee. He also uses humor to warn everyone that inspectors will appear to be from Missouri (the “Show-Me” state): applicant personnel will hear the inspectors say “show me” frequently throughout the inspection.

Dr. Smith believes that the training that inspectors receive plays a major role in the success of the inspectors. He credits much of his knowledge to his trainer, Dr. Fred LeMaistre, who he refers to as, “the master of organization, communication, and thoughtfulness.” In turn, he enthusiastically shares his wisdom to help other inspectors. We hope his insights into the inspection process are helpful to both inspectors and applicants as they prepare for upcoming FACT inspections.

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