Hello. Thank you for formulating the draft Guidance Document 30-12. A few comments:

Bullet 3 under #4: What defines "appropriate documentation", is it only informed consent or otherwise.

Bullet 5 under #4:  There is no way for an SLP or A to ensure equipment is in "good working order and properly maintained" on the patient's site.

Bullet 2 under #5:  Is there an expectation as to specific training. And how will competence be assessed. Is documentation of training and competence required, and what form would that take.

~LPV