42 CFR § 493.1249 - Standard: Preanalytic systems quality assessment.
---
identifier: "/us/cfr/t42/s493.1249"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.1249 - Standard: Preanalytic systems quality assessment."
title_number: 42
title_name: "Public Health"
section_number: "493.1249"
section_name: "Standard: Preanalytic systems quality assessment."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "493"
part_name: "LABORATORY REQUIREMENTS"
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. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17)."
regulatory_source: "55 FR 9576, Mar. 14, 1990, unless otherwise noted."
cfr_part: "493"
---
# 493.1249 Standard: Preanalytic systems quality assessment.
(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at §§ 493.1241 through 493.1242.
(b) The preanalytic systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of preanalytic systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all preanalytic systems quality assessment activities.
[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, 2003]