The competency of each person performing patient testing to perform his/her assigned duties is assessed.
NOTE: Prior to starting patient testing and prior to reporting patient results for new methods or instruments, each individual must have training and be evaluated for proper test performance as required in GEN.55450. Retraining and reassessment of employee competency must occur when problems are identified with employee performance.
For waived testing:
● Competency assessment must be performed at least annually (semiannual assessment not required)
● The laboratory may select which elements to assess for each test system For nonwaived testing:
?During the first year of an individual's duties, competency must be assessed at least semiannually
?After an individual has performed his/her duties for one year, competency must be assessed at least annually
?Competency assessment must include all six elements described below for each individual on each test system during each assessment period, unless an element is not applicable to the test system
Elements of competency assessment include but are not limited to:
1Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing
2Monitoring the recording and reporting of test results, including, as applicable, reporting critical results
3Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
4Direct observation of performance of instrument maintenance and function checks
5Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
Evaluation of problem-solving skills