---
kind: "section"
citation: "42 C.F.R. § 493.1240"
title: "42"
number: "493.1240"
heading: "Condition: Preanalytic systems."
url: "https://uscodex.org/cfr/42/493.1240"
---

# §493.1240. Condition: Preanalytic systems.


Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in §§ [493.1241](/cfr/42/493.1241.md) and [493.1242](/cfr/42/493.1242.md), 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 preanalytic systems and correct identified problems as specified in [§ 493.1249](/cfr/42/493.1249.md) for each specialty and subspecialty of testing performed.


## Notes

### Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.