What can we expect during the Preoperational Inspection?
After the application and payment have been submitted, your facility may be inspected at any time. The inspection is considered to be a “snapshot in time,” which means the report will reflect the observations and current conditions at the time of the inspection.
As this is a general inspection, before a facility is operational, some items reviewed may not be required by the resident state. NABP does not make a final determination or draw a conclusion that your facility has “passed” the inspection or is “compliant” for a specific state regulation. It is up to each individual state to review the inspection report and determine whether the observations documented in the Preoperational Inspection meet state (and/or federal) requirements.
The Preoperational Inspection covers informational questions in the following areas:
- General Operations and Licensure
- Personnel Information/Statistics
- Facility Information/Statistics
- Business Model Description
- Anticipated Onsite Activities/Scope of Services
- Controlled Substance (CS) Security
- Drug, Biologic, and Device Storage – Temperature and Humidity
- Minimum Standards
- Policies and Procedures
- Records Review