[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR438.352] [Page 219] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 438_MANAGED CARE--Table of Contents Subpart E_External Quality Review Sec. 438.352 External quality review protocols. 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.