Who Must Report “Adverse Events”?
Any physician, physician assistant or specialist assistant directly or indirectly involved with the OBS procedure must report an OBS adverse event. In such a case, the expectation is that the form will be completed in its entirety, since the reporter will be part of the OBS practice. The mandated licensees involved in the OBS procedure may file a single form, but each licensee must sign the form. It is the personal responsibility of each mandated licensee to ensure that an adverse event form has been filed. Any physician, physician assistant or specialist assistant in a hospital setting who believes that a patient complaint, complication, condition, emergency room visit, hospital admission or death is related to an OBS procedure must report an OBS adverse event as soon as they suspect that there is some relationship to an OBS surgical procedure . In such a case, the reporter may not be able to complete the form in its entirety, but should submit as much information as possible.
