TABLE 1.

CAP guidelines addressing competency assessment

CAP no.	Phase deficiency	Question	Note	Commentary
GEN.54750	II	For laboratories subject to U.S. federal regulations, do all testing personnel meet CLIA '88 requirements?	There must be evidence in personnel records that all testing personnel have been evaluated against CLIA '88 requirements, and that all individuals qualify.	All testing personnel in the laboratory must meet the requirements specified in CLIA '88. There must be an indication in personnel records that testing personnel's qualifications have been evaluated and met.
GEN.55200	II	Are there annual reviews of the performance of existing employees and an initial review of new employees within the first 6 months?		The laboratory must conduct an annual performance review of all employees. New employees must be reviewed within 6 months of employment, and annually thereafter.
GEN.55500	II	Has the competency of each person to perform his/her assigned duties been assessed?	The manual that describes training activities and evaluations must be specific for each job description. Activities requiring judgment or interpretive skills must be included. The records must make it possible for the inspector to determine what skills were assessed and how those skills were measured. The competency of each person to perform duties assigned must be assessed following training, and periodically thereafter. Some elements of competency assessment include, but are not limited to, 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, QC records, proficiency testing results, and preventive maintenance records; direct observation 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; and evaluation of problem-solving skills.	The competency of each person to perform the duties assigned must be assessed following training and periodically thereafter. Retraining and reassessment of employee competency must be done when problems are identified with employee performance. The training and assessment program must be documented and should be specific for each job description. Activities requiring judgment or interpretive skills must be included. The records must make it possible for the inspector to be able to determine which skills were assessed and how those skills were measured. Some elements of competency assessment include, but are not limited to, 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, QC records, proficiency testing results, and preventive maintenance records; direct observation 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; and evaluation of problem-solving skills.
GEN.57000	I	If an employee fails to demonstrate satisfactory performance on the competency assessment, does the laboratory have a plan of corrective action to retrain and reassess the employee's competency?	If it is determined that there are gaps in the individual's knowledge, the employee should be reeducated and allowed to retake the portions of the assessment that fell below the laboratory's guidelines. If, after reeducation and training, the employee is unable to satisfactorily pass the assessment, then further action should be taken, which may include supervisory review of work, reassignment of duties, or other actions deemed appropriate by the Laboratory Director.	The laboratory should have a documented corrective-action plan to retrain and reassess employee competency when problems are identified with employee performance. If, after reeducation and training, the employee is unable to satisfactorily pass the assessment, then further action should be taken, which, may include supervisory review of work, reassignment of duties, or other actions deemed appropriate by the Laboratory Director.
GEN.58500	I	Is there documentation of retraining and reassessment for employees who initially fail to demonstrate satisfactory performance on competency assessment?		Documentation of retraining and reassessment of employees who initially fail competency assessment should be available.