DOI: 10.1128/CMR.17.3.681-694.2004
Article Figures & Data
Figures
- FIG. 1.
Example of how the six areas of required CLIA competency assessment can be addressed and documented. FQ, fluoroquinolones. Reprinted from reference 4 with permission.
- FIG. 2.
Example of how the assessment form can be used for documentation of competency.
Tables
- 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. - TABLE 2.
JACHO standards regarding competency assessment
Standard no. Standard Explanation HR.2.10 Orientation provides initial job training and information. As appropriate, each staff member, student, and volunteer is oriented and then assessed to the following: The organization assesses and documents each person's ability to carry out assigned responsibilities safely, competently, and in a timely manner on completion of orientation. The organization documents that each person has completed orientation and has been evaluated for competency in performing required laboratory tasks as well as other parameters defined in his or her job descriptions. Documentation of orientation participation includes written approval by the laboratory director or appropriate supervisor noting that the individual is capable of performing laboratory duties and confirmation by the employee that he or she feels qualified after orientation to perform the tasks required. HR.2.30 Ongoing education, including in-services, training, and other activities, maintains and improves competence. The following occurs for staff, students, and volunteers who work in the same capacity as staff providing care, treatment, and services: Training occurs when job responsibilities or duties change. Participation in ongoing in-services, training, or other activities occurs to increase staff, student, or volunteer knowledge of work-related issues. Ongoing in-services and other education and training are appropriate to the needs of the population(s) served and comply with law and regulation. Ongoing in-services, training, or other activities emphasize specific job-related aspects of safety and infection prevention and control. Ongoing in-services, training, or other education incorporate methods of team training, when appropriate. Ongoing in-services, training, or other education reinforce the need and ways to report unanticipated adverse events. Ongoing in-services or other education is offered in response to learning needs identified through performance improvement findings and other data analysis (that is, data from staff surveys, performance evaluations, or other needs assessments). Ongoing education is documented. At a minimum, for supervisory staff, attendance at outside workshops, institutes, and local, regional, or national society meetings occurs as feasible. Standard HR.3.10 Competence to perform job responsibilities is assessed, demonstrated, and maintained. Competency assessment is systematic and allows for a measurable assessment of the person's ability to perform required activities. Information used as part of competency assessment may include data from performance evaluations, performance improvement, and aggregate data on competency, as well as the assessment of learning needs. This standard encompasses the following: The laboratory director or appropriate laboratory supervisor regularly assesses the continued competency of staff on all laboratory work shifts through performance evaluations. Staff members are evaluated for competency in performing required laboratory tasks as applicable, as well as for all other parameters defined in their job descriptions. Supervisory staff are evaluated for performance of their job responsibilities, as defined in their job descriptions. A job description and a completed competency assessment, an evaluation, or an appraisal tool are on file for each contracted or employed individual. Each staff member's performance is evaluated and documented after orientation and annually thereafter. An individual qualified to provide technical judgments about performance evaluates technical staff. The procedures to assess and document annually the competency of technical staff include but are not limited to the following: Routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing, and testing. The recording and reporting of test results. QC, proficiency testing, and preventive maintenance performance. Instrument function checks and calibration performance. Test performance assessment as defined by laboratory policy (e.g., testing previously analyzed specimens, internal blind testing samples, and external proficiency or testing samples). Assessment of problem-solving skills as appropriate to the job. If a test method or instrumentation changes or the individual's duties change, his or her performance is reevaluated to include skills in the areas of change. Each laboratory employee performing such tests participates in the program. Acceptable performance criteria are established. Performance levels are documented. When indicated, remedial action is taken and documented. Standard LD.2.90 The laboratory director is responsible for determining the qualifications and competence of laboratory staff. The director determines the procedures and tests that staff members are qualified and authorized to perform and is responsible for determining the competence and qualifications of laboratory staff. The director ensures that the level of supervision provided and the level of testing complexity is commensurate with the education, training, and experience of staff. The director must also require that staff demonstrate the ability to perform all duties before actually testing patient specimens and that staff maintain competencies to perform required tasks. - TABLE 3.
Summary of competency assessmenta
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. ↵ a This 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.
