AVOXimeter 1000E Competency Documentation 6 month and annual - massgeneral 2025

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General POCT Testing Procedures A sample is obtained for analysis. The sample is applied to the POCT device. Once the test is performed, the result is obtained and can be directly transferred to the patients electronic medical records (EMR) if the POCT device is integrated or interfaced with the EMR system.
Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patient specimens. Thereafter, competency assessment must be performed at least annually.
Patient identification errors are the most frequent preanalytical POCT errors. To assure proper patient identification, recommended practice is to use barcoding systems which may link sample, operator, instrument and test result to the patient record.
You should commit to an employee training and assessment program to ensure that all testing personnel remain qualified to do the work. No CLIA requirements exist for personnel qualifications to perform waived testing; however, testing sites must meet all applicable state or local personnel regulations.
i-vi), the six elements of competency are: 1) Direct observations of routine patient test performance; 2) Monitoring the recording and reporting of test results including critical results; 3) Review of intermediate test results or worksheets, proficiency testing results, quality control records, and preventive

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In addition, CLIA 88 mandates that the competency of laboratory testing personnel conducting non-waived moderate and/or high complexity testing must be assessed semi-annually after the individual begins patient testing, and thereafter annually (CFR 493.1413. 9 and 493.1451. 9).

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