TITLE 42 - PUBLIC HEALTH

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

493.1289 - Standard: Analytic systems quality assessment.

  (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]