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Comprehensive and Detailed Explanation:

Under the Clinical Laboratory Improvement Amendments (CLIA), waived tests are those deemed “simple” with low risk of error when performed correctly. Examples include glucometers, urine pregnancy tests, and certain rapid infectious disease kits. However, CLIA-waived does not mean exempt from quality control or regulatory oversight. Facilities must still follow the manufacturer’s instructions, perform QC at the recommended frequency, document competency assessments, and maintain records. Incorrect handling, storage, or failure to follow procedures can still yield inaccurate results, which directly affects patient care. Phlebotomists and POCT operators must ensure that waived testing is carried out with the same diligence as moderate or high-complexity testing. Training, adherence to instructions, and documentation are critical elements. ASCP-aligned objectives stress that patient safety depends on accurate results, regardless of complexity level. Therefore, waived status indicates lower technical requirements but does not eliminate the need for proper training, monitoring, and compliance.