The Centers for Medicare and Medicaid Services (CMS), state regulations, and various accreditation agencies all require competency testing at defined intervals. Written policies and procedures to evaluate competency must be included in standard operating procedures (SOPs) for the laboratory (sample policy attached below). All policies and procedures must be approved by the Laboratory Director and the competency assessment plan must include the evaluation of all testing phases (pre-analytic, analytic, and post-analytic). Each employee must be assessed for the phase(s) of testing performed in their assigned job. Focus should include an evaluation of each individual's acceptable performance of:
- All necessary tasks required of the job
- The necessary/required processes and procedures followed to complete all tasks
- Achieving accurate laboratory results
- Reporting and interpreting test results
- Other appropriately related duties and responsibilities of the specific position
- Retrospective evaluation of documents, proficiency testing, and other testing performance may be included in the assessment process.
Below are some suggested items that provide a job-specific focus for competency assessment. Does the individual:
- collect sufficient patient sample and correctly process the specimen used for the testing?
- add the testing solutions and processed patient sample in the proper amount and order?
- use test solutions and reagents from the same test kit and lot number?
- perform the test correctly by adding the proper order and amount of patient specimen and reagent(s)?
- complete the test report correctly, using the appropriate test units of measurement?
- adhere to the laboratory’s quality control (QC) policies and document QC activities?
- adhere to the laboratory’s policies for instrument calibrations and maintenance activities?
- maintain records of the patient testing results?
- treat proficiency testing samples in the same manner as patient specimens and maintain records indicating such?
- follow the laboratory’s corrective action policies and procedures when a test system fails to meet the laboratory’s acceptable level of performance?
- identify problems that may affect test performance or reporting test results and either correct the problem or notify the Technical Consultant or Director?
- document all corrective action taken when there is a test system failure?