If you work in a CAP accredited laboratory you must be able to demonstrate competency for any individuals who are involved in performing laboratory testing under the GEN.55500 guideline that states, the competency of each person performing patient testing to perform his/her assigned duties is assessed. You also need to provide documentation for evidence of compliance, which means records of a competency assessment, and an SOP for how the competency assessment is performed. Competency refers to the ability of each person to perform their job duties accurately, as opposed to a system of tracking a specimen from entry into the lab to diagnosis, which may provide evidence of overall laboratory performance, but not individual competency.
There are 6 elements of a competency assessment as outlined by CAP.
Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing
Monitoring the recording and reporting of test results
Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
Direct observations of performance of instrument maintenance and function checks
Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples
Assessment of problem-solving skills.
These elements need to be addressed for every lab area including fixation and processing, embedding, microtomy, routine staining, special staining and IHC. There are various methods for performing a competency assessment and you can combine several different methods into your comprehensive plan. The guidelines reference direct observation, which for straightforward tasks such as loading and starting the tissue processor, or changing solutions, could literally mean observing the employee perform the tasks and noting them on a checklist. Having checklist forms that list duties to be assessed and reference any relevant SOPs, so that the evaluator can indicate whether the employee has reviewed the protocols, is a common element of assessment. You can find sample competency assessment checklists for free as an NSH member in the member resources section of elearn.nsh.org.
Other areas may not be as easy as looking over the employee’s shoulder. This is where additional assessment methods such as written tests with images can come in handy. You need to be able to demonstrate problem solving skills, so a convenient way to do this is written assessments with images showing artifacts and the employee must identify the artifact, probable root causes, and provide troubleshooting measures to resolve the problem.
Remember that with everything in the lab, documentation is key. You need to keep records of the competency assessments administered, as well as an SOP of the assessment itself. Though competency assessments are required for CAP, they are also a useful way to identify areas where your employees need further training, so you shouldn’t just file them away. Conduct a SWOT (strengths, weaknesses, opportunities and threats) analysis of your laboratory and create a continued development plan. Determine what areas need continuing education, in-service training sessions, etc.
Speaking of continuing education… you can find more information about developing a comprehensive competency assessment plan that is compliant with your regulating body in two of the on-demand webinars available on NSH’s Online Learning Center, Developing a Compliance Driven Competency Assessment presented by Skip Brown, and Taming Medusa: Assessing the Six Elements of [CLIA/CAP] Proficiency in Histology, presented by Linda Parramore Culpepper.