C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 493—LABORATORY REQUIREMENTS › Subpart A—General Provisions

42 C.F.R. § 493.1

Basis and scope

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This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It implements sections 1861(e) and (j), the sentence following section 1861(s)(13), and 1902(a)(9) of the Social Security Act, and section 353 of the Public Health Service Act, as amended by section 2 of the Taking Essential Steps for Testing Act of 2012. This part applies to all laboratories as defined under “laboratory” in § 493.2 of this part. This part also applies to laboratories seeking payment under the Medicare and Medicaid programs. The requirements are the same for Medicare approval as for CLIA certification.

[57 FR 7139, Feb. 28, 1992, as amended at 79 FR 25480, May 2, 2014]
Notes of Decisions
Cited in 6 cases (2 in the last 5 years), 1998–2022 · leading case: Cent. Kansas Med. Ctr. v. Hatesohl, 425 P.3d 1253 (Kan. 2018).
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Cent. Kansas Med. Ctr. v. Hatesohl, 425 P.3d 1253 (Kan. 2018). · cites it 2× “"); 42 C.F.R. § 493.1 et seq. (Clinical Laboratory Improvement Amendments of 1988 [CLIA]); K.”
Michele Yates v. Pinellas Hematology & Oncology, P.A., 21 F.4th 1288 (11th Cir. 2021). “§ 263a(b); 42 C.F.R. §§ 493.1 , .3(a), .15, .43–49; Center for Medicare and Medicaid Services, Medicare Claims Processing Manual, § 70.”
Abigail Ginsberg v. Quest Diagnostics, Inc., 117 A.3d 200 (N.J. Super. Ct. App. Div. 2015). “§§ 263a to 263a-7 (certification of laboratories, including embryo laboratories); 42 C.F.R. §§ 493.1 to 493.2001 (regulation of clinical laboratories); N.”
Cornelio v. Stamford Hosp., 717 A.2d 140 (Conn. 1998). “” 42 C.F.R. § 493.1257 (g); see 42 C.F.R. § 493.”
Smalley v. Becerra (E.D. Mo. 2022). “Appendix C to the SOM, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (“Appendix C”), contains instructions to state agencies on how to implement and enforce the CLIA regulations ( 42 C.F.R. § 493.1 et seq.). The highest-level violations…”
Belser v. Quest Diagnostics Inc (D.S.C. 2020). “42 C.F.R. § 493.1 . Enforcement procedures are reserved to the Centers for Medicare and Medicaid Services and the Secretary of Health and Human Services.”
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