;The facility has the option of issuing either separate reports or one combined report. If two reports are issued, each must contain its own overall final assessment (21 CFR 900.12(c)(1)(iv)). In either case, the facility can report the exam(s) on the same piece of paper.
If the facility decides to issue a single combined report, the facility needs to be aware of the following:
- A combined report must contain a single overall final assessment for the two exams (21 CFR 900.12(c)(1)(iv)).
- The combined report should make it clear that it is combining the results of the screening and diagnostic studies. This is especially important if questions arise about whether the exams were billed correctly.
- Issuing a single combined report with a single final assessment may skew the facility’s medical audit results.
- Though some computerized reporting systems may consider this a single exam (rather than two), FDA would still allow facilities to count both exams toward meeting the continuing experience requirement.