Volume 2024 | No. 2
SURVEYOR
CLINICAL LABORATORY
06.08.05 Calibration/Control Failures Overview of the requirement:
06.08.01 Comparison of test results
When control or calibration materials fail to meet established criteria for acceptability, the laboratory must document corrective actions. Patient test results from the unacceptable test run must be evaluated for accuracy. Compliance is assessed through interview and document review. Surveyors noted a lack of policy or process for reevaluation of patient test results after QC identifies a failure. In a few cases, policies exist but were not followed.
Overview of the requirement:
If the same test is performed using different methods, different instruments, and/or at multiple locations, the laboratory must compare results at least twice annually and review against written criteria for acceptable variation in test values. Compliance is assessed through interview and document review. Deficiencies were cited for missing policies and for failure to perform comparison studies for specific testing methods.
Comment on deficiencies:
Comment on deficiencies:
Frequency of citation:
18%
Examples of surveyor findings:
n The laboratory failed to evaluate patient test results back to the last acceptable quality control run when a quality control failure was corrected by changes made to the test system. Examples include EXL-LM Vitamin B12 recalibrated. EXL-LM Lipase was recalibrated, new reagent lot. EXL-200 Ammonia, EXL-200 ALT, EXL-LM Valproic acid, EXL-LM T Uptake - new flex reagents opened. n No process or policy exists to evaluate patient test results back to the last acceptable QC run when a test run fails and is corrected by recalibration, reagent replacement, or troubleshooting. Examples of test run failures without patient lookbacks include: 1-3SD failure for triglyceride - resolved by recalibration, 1-3SD failure for TSH - resolved by replacing the reagent and recalibration, 2-2SD failure for AST - resolved by recalibration, 2-2SD failure for AST - resolved by recalibration. n Laboratory policy states that the Laboratory Director or Technical Consultant will evaluate all patients tested since the last acceptable control run. There was no documentation of this review for failures on the Monthly QA Checklist as specified in the policy. Examples of failures that required a change to the system such as calibration or a change in reagents include: ethanol, albumin, and total bilirubin tests within the past 12 months. n Audit for a policy and procedure that addresses the standard requirement. n Train staff on the requirement. n Perform regular review of QC logs to ensure that the process included patient result look backs.
Frequency of citation:
18%
Examples of surveyor findings:
n Comparison studies between automated differential and manual differential are not being performed. There is no policy in place to perform differential comparison studies. n No correlations were being performed between the Sysmex XN analyzers and manual differentials. n The laboratory was not performing correlations for the three methods (i.e., vision, manual gel, and manual tube) used for ABO/Rh blood types, antibody screens, and antihuman globulin (AHG) crossmatches. n Laboratory policy QA-16 did not list all tests and methods to correlate and did not specify the criteria for the selection of samples or the criteria to use for the evaluation of acceptability between methods. n No comparison of test results have occurred in the last two years for drug screens between the Dimension and the Alere iCup drug screen methodologies.
Tips for compliance:
Develop a list of tests/equipment that require comparison testing.
Tips for compliance:
n Develop written policy and procedures for performing comparison studies that includes criteria for evaluation and acceptable performance. n Develop a calendar/schedule to ensure that the comparison studies are completed twice each year. n If correlations fail to meet the acceptable performance as outlined in the organization’s policy, take and document corrective actions.
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