The Secretary, in coordination with the National Governor's Association, must develop protocols for the external quality reviews required under this subpart. Each protocol issued by the Secretary must specify—
- (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.