42 CFR § 438.352 - External quality review protocols.

---
identifier: "/us/cfr/t42/s438.352"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 438.352 - External quality review protocols."
title_number: 42
title_name: "Public Health"
section_number: "438.352"
section_name: "External quality review protocols."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "MEDICAL ASSISTANCE PROGRAMS"
part_number: "438"
part_name: "MANAGED CARE"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1302."
regulatory_source: "67 FR 41095, June 14, 2002, unless otherwise noted."
cfr_part: "438"
---


# 438.352 External quality review protocols.

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.