Code of Federal Regulations Title 42. Public Health § 42.438.352 External quality review protocols

(a) The data to be gathered;

(b) The sources of the data;

(c) The activities and steps to be followed in collecting the data to promote its accuracy, validity, and reliability;

(d) The proposed method or methods for validly analyzing and interpreting the data once obtained;  and

(e) Instructions, guidelines, worksheets, and other documents or tools necessary for implementing the protocol.