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. § 493.1289

Standard: Analytic systems quality assessment

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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 analytic systems specified in §§ 493.1251 through 493.1283.

(b) The analytic 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 analytic systems quality assessment reviews with appropriate staff.

(c) The laboratory must document all analytic systems quality assessment activities.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Notes of Decisions
Cited in 1 case, 2020–2020 · leading case: Belser v. Quest Diagnostics Inc (D.S.C. 2020).
Sort: Relevance Newest Treatment
Belser v. Quest Diagnostics Inc (D.S.C. 2020). “Specifically, Plaintiff contends that Defendants violated the following regulations: 42 C.F.R. § 493.1289 Standard: Analytic systems quality assessment.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.