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Quality Control and Lab Safety


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Quality Control and Lab Safety
For non-waived tests, laboratory regulations require, at the minimum, analysis of at least two levels of control materials once every 24 hours. If necessary, laboratories can assay QC samples more frequently to ensure accurate results. Quality control samples should be assayed after calibration or maintenance of an analyzer to verify the correct method performance.[83] To minimize QC when performing tests for which manufacturers’ recommendations are less than those required by the regulatory agency (such as once per month), the labs can develop an individualized quality control plan (IQCP) that involves performing a risk assessment of potential sources of error in all phases of testing and putting in place a QC plan to reduce the likelihood of errors.[84] 
Westgard multi-rules are used to evaluate the quality control runs. In case of a rule violation, proper corrective and preventive action should be taken before patient testing is performed. The criteria for acceptable performance for amylase assay by the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) proficiency program is within ± 30% of the mean value of laboratory peer groups.[85]
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Enhancing Healthcare Team Outcomes
Interprofessional healthcare team members must communicate effectively when laboratory results point towards a non-pancreatic cause. Knowing the different conditions that may affect amylase levels is also important.[86] Lipase is typically preferred instead of amylase due to its higher specificity. Lipase typically stays elevated for up to two weeks, while amylase concentrations remain elevated for up to five days. Therefore, amylase is not as clinically useful as lipase if there is a delay between symptom onset and the time the patient seeks medical attention.[18] 
The 2013 American College of Gastroenterology mentions that co-ordering lipase and amylase is neither cost-effective nor treatment advantageous. It also states that ordering amylase alone is unreliable and does not increase diagnostic efficiency compared to lipase.[12] If there is access to lipase testing, adding amylase increases the cost to the patient and has little value in supporting the diagnosis of pancreatitis.[87]
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