42 CFR § 493.1250 - Condition: Analytic systems.

---
identifier: "/us/cfr/t42/s493.1250"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.1250 - Condition: Analytic systems."
title_number: 42
title_name: "Public Health"
section_number: "493.1250"
section_name: "Condition: Analytic systems."
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"
---


# 493.1250 Condition: Analytic systems.

Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in §§ 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in § 493.1289 for each specialty and subspecialty of testing performed.