Related reading

Quality Control, Method Evaluation, and Quality Management

Adopted bench policy

The fictional laboratory uses two control levels and Levey-Jennings review for quantitative statistical quality control.¹ One 1_2s observation is a warning. The 1_3s, 2_2s, R_4s, 4_1s, and 10x conditions reject the run under this policy.² After rejected QC, the bench holds patient testing until the cause is corrected and rerun QC is acceptable. It requires review of the unacceptable run and patient results since the last acceptable run to determine whether any were adversely affected.³

Case data

All analyzer, control, and patient-workload data are fictional.

References

1. Clinical and Laboratory Standards Institute. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 4th ed. CLSI guideline C24. Clinical and Laboratory Standards Institute; 2016.
2. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem. 1981;27(3):493-501.
3. Centers for Medicare & Medicaid Services. REVISED: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA)) – Advance Copy. QSO-25-10-CLIA REVISED. Published June 23, 2025. Accessed September 1, 2026.