What time will the auditors be arriving? What is the tentative agenda?
After the second pre-audit call approximately four weeks prior to the audit (where the audit logistics are discussed), a tentative agenda will be provided to the center for reference.
The auditors will typically arrive in the late morning or early afternoon on the first scheduled day of the audit. When the auditors arrive, they will conduct a brief introductory meeting to review the audit process and the layout of the week. They will then ask for a brief tour of the medical record, where data management staff may show them where to find certain source documentation in the medical record (e.g. progress notes, laboratory values, stem cell processing records, transfusion records, etc.).
For remote audits, daily check-ins will be scheduled to occur throughout the audit week between data management staff and auditors. This may occur once or twice per day for approximately 30 minutes, depending on site preference and staff availability. These are intended to provide an opportunity for the data management staff to ask questions regarding summary findings, discuss recipient-specific scenarios, and forms instruction manuals.
On the final day of the audit, the auditors will conduct a closing meeting with data management staff that will last approximately one hour.
Will a data manager (or other staff person) need to be with the auditors during the time of the audit?
No, but there should be a communication process set-up during the introductory meeting for questions/ troubleshooting; in addition, they should plan on checking in with the auditors every few hours.
Who needs to be present the week of the audit?
Data management staff should be present to answer any questions the auditors may have and to capitalize on learning opportunities provided during the audit. A transplant physician, not necessarily the Medical Director, should be available to answer any clinical question via email (they do not need to be present for the audit, unless that is their preference).
Does the physician/Medical Director need to be present during the audit time?
The Medical Director does not need to be present during the audit time. However, a transplant physician, not necessarily the Medical Director, should be available to answer any clinical question via email (they do not need to be present for the audit, unless that is their preference). While not required, the Medical Director may choose to attend the audit opening and closing meetings, where the auditors provide a summary of the audit process and initial observations.
What hours will the auditors work?
The auditors typically work from 8:00 am to 6:00 pm, however they may request to work additional hours.
Should I provide food for the auditors?
While we appreciate the gesture of providing food for the auditors, it is not a requirement.
: In order to provide a brief break from the audit, the auditors will typically utilize a cafeteria or other facility available onsite. If there is not a suitable eating facility available onsite, a list of restaurants near the center that provide quick lunch opportunities would be appreciated.
: The auditors will typically provide their own snacks and beverages as needed throughout the day. Again, they may utilize a cafeteria/gift shop or vending machines as needed.
A list of available options and a map or directions to any of these places would be helpful and can be provided during the introductory meeting.
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