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—

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(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.