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 K—Quality System for Nonwaived Testing

42 C.F.R. § 493.1205

Condition: Virology

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If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, § 493.1265, and §§ 493.1281 through 493.1299.

Notes of Decisions
Cited in 1 case, 1998–1998 · leading case: Luckey v. Baxter Healthcare Corp., 2 F. Supp. 2d 1034 (N.D. Ill. 1998).
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Luckey v. Baxter Healthcare Corp., 2 F. Supp. 2d 1034 (N.D. Ill. 1998). “CLIA Regs The following regulations are also implicated: 42 C.F.R. § 493.1205 “The laboratory must utilize test methods, equipment, instrumentation, reagents, materials, and supplies that provide accurate and reliable test results and test reports, (a) Test methodologies and…”
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