Pre-Inspection Review
Reviewing documentation before an inspection is vital to ensuring the best use of time on-site and improves the quality of the inspection. There is a lot that must be covered on-site and inspectors are encouraged to take advantage of the opportunity for a head start. Please do not wait until you get on the plane to read the information.
Reviewing documents before an inspection reduces stress and anxiety for inspectors and applicants. By reviewing documents in advance you can anticipate future events during the inspection, including incomplete documentation, misunderstanding of the Standards, and unclear structure and services of an organization.
Applicants are required to complete the compliance application and submit documentation to the FACT Accreditation Office prior to the on-site inspection. Sometimes it may be useful to request additional documentation in advance. Requests for documentation should be coordinated with the FACT Accreditation Office to ensure that the applicant does not receive multiple requests for the same information.
Every applicant is different, so make certain you understand how the documentation is organized. Items that you may categorize as procedures may appear in their policies and vice versa. The basic structure of documentation under different quality systems (such as ISO) may be different than that of FACT. Be careful to check that seemingly missing information is not available or presented in a different format. The FACT Accreditation Office requests copies of the Table of Contents from the SOP Manual, which is helpful to determine where to look for information.
The inspector can access the checklist and documents online. Indicate compliance with standards by verifying pre-inspection submissions within the organization’s compliance application. Note questionable items to ensure you address these when you visit. Examples include selection of “not applicable” on the inspection checklist when they are actually relevant to the inspection or the selection of “yes” indicating compliance, despite the lack of supporting documentation. Review the previous inspection report and plan time to verify on-site that past deficiencies have been corrected on-site. The more you complete ahead of time, the more efficient the on-site inspection is likely to be.
A critical issue is the geographical layout and size of the applicant’s facilities. If the facility is large and consists of multiple sites, you may feel that you require assistance from the other team members or additional time. This should be communicated to the inspection team leader and to the FACT Accreditation Office promptly. In the case of cord blood banks, it is especially important to be aware of all the collection sites working with the bank and if there are multiple storage facilities. If you feel you will not be able to complete your inspection in one day (cellular therapy inspections) or two days (cord blood bank inspections), you should notify the team leader and contact the FACT Accreditation Office to make arrangements for an extended stay, additional help, or a return visit as dictated by the situation.