TABLE 3.

Summary of competency assessment^a

Items that must be included in a competency assessment program	Description of each item	Examples of each item
Direct observation of routine patient test performance	This is the actual observation of work as it is being performed by the laboratory staff. These observations are not limited to test performance but include all processes in which the employee is involved, including specimen collection and preparation, as well as the actual testing of the specimen.	Direct observation is used for areas involving a higher degree of decision making or which have a significant impact on patient care (e.g., new positive blood cultures, positive cerebrospinal fluid specimens, susceptibility testing, accurate interpretation of test reactions, following appropriate work instructions).
Monitoring the recording and reporting of test results	Review of patient results for the proper and correct recording and reporting.	This can be accomplished by the documentation of observation of an employee writing or entering patient test results on report forms or into the computer or by review of worksheets with report forms or computer entries.
Review of intermediate test results, QC records, proficiency testing results, and preventive maintenance records	This is as it is implied: one must review intermediate patient results, QC records, proficiency testing results and preventive maintenance records.	This can be accomplished by review of worksheets or computer entries for accurate recording of patient results, review of QC worksheets or printouts for acceptable results (within QC parameters) and for review of preventive maintenance records for the appropriate and timely checks and documentation.
Direct observation of performance of instrument maintenance and function checks	Direct observation must be used when employees are performing maintenance procedures and check of instruments.	One must directly observe an employee when performing maintenance procedures and function checks on instruments in the laboratory, such as the automated identification/susceptibility testing instrument, molecular diagnostic instrumentation, and blood culture instrumentation.
Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples	One must assess employee competence by giving them unknown samples to evaluate as they would evaluate patient samples in the laboratory.	This can be accomplished by split-sample analysis, previously analyzed specimens, blind internal proficiency testing, or external proficiency testing such as CAP surveys, etc.
Assessment of problem-solving skills	One must assess the ability of employees to solve problems that arise during their practice.	This can be accomplished by (i) asking the employees to write up a situation where they had to solve a problem that related to an investigation they performed or (ii) giving a fictitious (or real) example of a problem encountered in the laboratory and asking the employee how he or she would handle the situation.

^aThis table summarizes the information included in the “Elements of a competency assessment program” section of this paper, to include the six areas of CLIA required assessment, a description of each requirement, and examples of how each could be accomplished.