Per the CLIA 88 regulations, laboratories must employ a quality system that incorporates an 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 the 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."
Event management features that inspectors will expect laboratories to have in place include a well-defined system of event management with the following specific features:
- Identified events are investigated and analyzed
- Specific information on investigated events is captured accurately and in a timely manner
- Assessment and review of identified issues that are determined to require improvement measures
