42 C.F.R. § 438.352 External quality review protocols.
Title 42 - Public Health
Each protocol 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.
Title 42: Public Health
PART 438—MANAGED CARE
Subpart E—External Quality Review
§ 438.352 External quality review protocols.