CLIA States: "Competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation."

Our program addresses this critical inspection focus with the 6 key CLIA components for competency assessment:

  1. "Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing" - Detailed observation forms are provided for each type of test to make documenting the observation process easy & complete.
  2. "Monitoring the recording and reporting of test results" - Results are submitted to an online, secure database with a record of submission history.
  3. "Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records" - Test worksheets are included to allow easy documentation of all steps of the analyses and calculations. Supervisors document their review before submitting results to us.
  4. "Direct observations of performance of instrument maintenance and function checks" - Our easy competency checklist will guide you through the aspects that need assessed to ensure no aspect of competency evaluation is missed for inspections.
  5. "Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples" - High quality virtual and physical test materials for evaluation. Result reporting includes the as- saved reference ranges for each specimen to allow comparison to established values. Peer ranges are not used for competency. Results are compared to an assayed value.
  6. "Assessment of problem solving skills" - Multiple competency questions covering general semen analysis knowledge, calculations, problem solving and result evaluation are included with this subscription. No more internal question development and grading required.

It is easy to confuse proficiency testing and competency testing. Simply put, competency tests the 6 parts of analyst ability, while proficiency tests the lab accuracy.

In other words, proficiency testing alone is not sufficient to meet the regulatory requirement. Labs that use proficiency testing samples for their competency may appear to have technologists collaborating on proficiency test answers, depending on the timing of each analysis and result submission.

Competency doesn't have to be time consuming and confusing. We make it easy. Our Competency Challenge Program is offered twice a year usually in late spring and fall. Events include all components of competency evaluation, making it easy for your lab to complete this important annual CLIA requirement (required twice the first year of performance, and annually afterward). Participants have a month to perform the analyses, complete observations and submit results online. Once results and observation forms are received and graded, a certificate of participation and an individual result report is issued for each technologist.

Order one unit per technologist for each type of testing performed. Each technologist receives their own physical samples to remove the risk of a sample compromise by another technologist before analysis. Events are ordered individually, because most technologists only need annual competency.

Products include the materials for analysis described for each item number below, plus problem solving and general knowledge questions, observation forms and online result entry. Individual performance reports and certificates sent upon completion.

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