Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ)
The simple reality these days is that laboratories are having to do more with less personnel. Often, the individuals in charge of a department are spending a lot of time working on the bench as well as fulfilling supervisory responsibilities. Completing the annual competency assessment of laboratory testing personnel performing non-waived testing (mandated by the CLIA ’88 regulations) within the required timeframe is easy to overlook. Getting this task completed in a timely manner requires planning on the part of laboratory managers and department heads.
Laboratories often relegate competency assessments solely to department supervisors despite other personnel being qualified to perform the assessments, thus unnecessarily reducing the number of assessors available.
An employee who has earned a bachelor’s degree in a chemical, physical, biological science, medical technology, or nursing can be an assessor of moderate and high complexity testing (assuming the individual has been trained and is competent to perform patient testing on a designated test system). For laboratories accredited by the College of American Pathologists (CAP), assessors will also need to be listed in the CLIA Role section of the laboratory’s CAP website as technical consultants and general supervisors.
Annual competency assessments of employees performing patient testing in laboratories only conducting high-complexity testing such as cytogenetics can be completed by individuals who qualify as general supervisors. The Code of Federal Regulations (CFR) lists several ways in which an individual may qualify as a general supervisor (§493.1461 and §493.1462). Managers of anatomic pathology labs with grossing histology technicians should be aware that these employees are considered high-complexity testing personnel and must also have competency assessed annually.
Clinical laboratory managers of large labs with specialty departments must ensure that all assessors are qualified for the test systems that the departments are using to perform patient testing. Some specialty labs, such as molecular, may predominantly perform high-complexity tests but may also use some moderate-complexity test kits. Laboratory managers at community hospitals should ensure all employees qualified to perform assessments assist in completing the portions requiring direct observation.
Competency documentation may be collected throughout the same calendar year of the competency assessment. Managers will find it is helpful to require that employees collect evidence of competencies such as copies of quality control logs, worksheets, successful troubleshooting, accession numbers of critical results called, and preventive maintenance. The documentation can be kept in a separate, easily accessible folder. The completed, signed competency template should be saved in the employee’s primary personnel folder.
Many labs cross-train testing personnel as generalists, and this presents challenges as competency assessments must be completed in every department where an employee works. To avoid overwhelming the employee and assessors, the laboratory manager should schedule a specific month or months of the year for competency to be completed for each discipline. Having a defined schedule reduces the likelihood of an employee having to complete competencies in multiple departments at the same time.
As listed in the CFR (§493.1413.8.i-vi and §493.1451.8.i-vi), the six elements of competency are: 1) Direct observations of routine patient test performance; 2) Monitoring the recording and reporting of test results including critical results; 3) Review of intermediate test results or worksheets, proficiency testing results, quality control records, and preventive maintenance records; 4) Direct observation of performance of instrument maintenance and function checks; 5) Proficiency or blind sample test results; and 6) Evaluation of problem-solving skills including written tests, instrument troubleshooting, or sample handling issues.
It should be noted that elements one and four require direct observations by a qualified assessor. Small hospital laboratories with limited qualified assessors often struggle to get the competency of second or third shift employees assessed due to the direct observation requirement.
Scheduling specific months for competency allows assessors to coordinate direct observations with the staffing schedule. If the majority of qualified assessors work on the day shift, they will need to plan to come in early, or the night shift will need to stay later to get the direct observation elements of competency completed.
If a qualified assessor works the night shift, then he or she may perform the competency assessment during the shift (if possible). However, the night shift assessors will need to schedule times to have their assessments completed if they are the only qualified assessor on the shift.
Proficiency testing and blind samples
The competency element five requires the laboratory to assess testing personnel performance through proficiency testing (PT) or blind sample testing. At the beginning of the year, lab managers and department heads should discuss and develop a plan to ensure every employee receives either a proficiency or blind sample.
There are a limited number of samples from proficiency tests available (most analytes have a maximum of five challenges per survey). The laboratory should determine how many samples will be required for all employees for each test system and be prepared to save PT samples to use after the survey submission time has expired.
Blind samples created from previously analyzed tests will have known results. The laboratory must determine the range of acceptable results for a given analyte. It is suggested to use the same criteria (i.e., s.d) used to evaluate proficiency tests provided by the survey vendor. On a resulting form, the assessor should indicate whether the result received was acceptable or not.
Annually assessing the competency of laboratory testing personnel is a challenging but necessary component of laboratory operation. Lab managers should have a well-defined competency program complete with qualified assessors and a schedule with competency time- periods, and ensure all non-waived test systems for all disciplines are covered. Coordination with department supervisors at the beginning of the year goes a long way toward ensuring each employee has been assessed, and all necessary documentation has been verified and is available if needed for an inspector.