Quest for Quality
The Centers for Medicare and Medicaid Services (CMS) have recently increased their emphasis on Competency Assessment because studies have shown that additional education/training of laboratory personnel produces higher quality laboratory results, and laboratory errors with potential patient impact are often caused by lack of competent personnel.1
Competency assessment is the means to confirm that training is effective, and that personnel are competent to perform laboratory testing that produces quality results. According to CLIA ’88, the competency of testing personnel must be assessed semi-annually for the first year of patient testing, and annually thereafter. Competency must also be demonstrated whenever new testing methods, kits and/or instruments are added to your laboratory’s test menu (see the Figure for the legislation text.)2
Competency assessment is not limited to testing personnel. Clinical consultants, technical consultants/technical supervisors and general supervisors must also have their competency to perform regulatory responsibilities evaluated. The competency of lab directors is not assessed directly since they are held to additional standards and criteria to confirm that they are fulfilling the responsibilities of their positions. However, their competency must be assessed if they are performing Provider Performed Microscopy (PPM) testing.
While CLIA does not specifically require assessment of the competency of personnel performing only pre-analytic and post-analytic activities, it is good practice to do so.
CLIA lists six specific “procedures for evaluation” of the competency of testing personnel that must be used:
- direct observation of test performance;
- monitoring test result recording and reporting;
- review of test worksheets, and QC, PT and maintenance records;
- direct observation of instrument maintenance;
- assessment of test performance using previously analyzed specimens, or blind sample testing such as PT; and
- assessment of problem-solving skills.
Other, additional methods may be used, when appropriate (Fig).2
Since CLIA does not define how you should utilize these methods, it is acceptable to utilize them in ways you deem appropriate and best for your laboratory. Quizzes, checklists, document reviews and other tools can be used, as long as all of the six methods are addressed. When applicable, note that a specific method does not apply to a particular individual. This will provide documentation that the method was addressed and not overlooked. Ensure that the reviewer signs/initials and dates the documentation at the time of the evaluation. Since competency assessment is the responsibility of the technical consultant/technical supervisor, reviewers should be personnel who meet the regulatory qualification requirements for the TC/TS positions.
Table 1 lists examples of actions that would be acceptable for each assessment method.
Competency assessments must be documented and this documentation must be maintained in the personnel files. The documentation must state whether competency was demonstrated and what corrective actions were taken if competency was not demonstrated. Table 2 provides an example of acceptable documentation for competency assessment.