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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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CLIA '88 Requirements

Per the CLIA 88 regulations, laboratories must employ a quality system that incorporates assessment of corrective actions. Standard 493.1239*, titled, General laboratory systems quality assessment, describes a systematic approach to corrective action:
"(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 general laboratory systems requirements specified at §§493.1231 through 493.1236.
(b) The general laboratory 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 general laboratory systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all general laboratory systems quality assessment activities."
Inspectors will have an expectation that laboratories have a well-defined system of event management, which features:
  • Information about events that are captured accurately and timely
  • Events that are investigated and analyzed
  • Assessment and review of issues that require improvement measures
*Title 42, part 493 of the CLIA standards can be accessed on the Centers for Disease Control and Prevention's (CDC's) website: CLIA Laws and Regulations; Standards and Certification: Laboratory Requirements (42 CFR 493). Available at: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5. Accessed April 13, 2017.