Vol. 18 • Issue 3
• Page 18
The Molecular Edge
This is the conclusion of a two-part series that began in the January issue.
The most significant obligation for a clinical laboratory is to provide accurate laboratory test results. For nearly half a century, laboratories have documented their system of monitoring quality of specimens, reagents, assay performance and instrument functions. In recent years, regulatory agencies have required documentation of ongoing competency assessment of personnel performing the tasks that generate test results.1-3
Initial training and competency assessment of technologists are "assay/task" specific. Approximately six months after this initial assessment, competency is re-verified and is again "assay/task" specific. Thereafter, an annual assessment of technologists' overall competency is documented. It is the latter process of annual, overall competency assessment that is the focus of this article.1, 2, 4
Annual competency testing is an important component of quality assurance in the laboratory. However, the additional reagents and time needed to conduct a program of testing each technologist on every molecular assay, instrument and process annually could potentially be an overwhelming drain on an institution's resources.
Fortunately, the College of American Pathologists (CAP) explains that technologists need to successfully complete six basic elements each year to establish competency, rather than be tested on each assay/task/instrument annually.5 HLA technologists should consult regulations from the American Society for Histocompatibility and Immunogenetics for additional requirements.6
The six basic elements of competency as presented in CAP's General Laboratory checklist (GEN.55500) are enumerated below. The bullet points following each element describe the actions required of each technologist in our molecular laboratory and represent our effort to fulfill the requirements for annual competency assessment.
1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing.
• Perform an assay (different from last year's assessment) under the observation of an approved technologist. Submit an "Observation of Performance Form" that documents steps from receiving a sample for the assay through release of results in the computer system and filing of records.
2. Monitoring the recording and reporting of test results.
• See element #1 above.
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records.
• Select one:
• Submit copies of two completed test runs, including all worksheets and quality control documents. Assays submitted must be different from last year's competency assessment.
• Pass a graded exam (within established guidelines) covering an aspect of a specific laboratory process or technology such as real-time PCR.
• Submit documentation that reflects completion of routine instrument maintenance on two molecular instruments.
• Submit two variance reports documenting corrective action for assay(s) with unacceptable results.
4. Direct observation of performance of instrument maintenance and function checks.
• Perform instrument maintenance (different from last year's assessment) under the observation of an approved technologist. Submit a completed "Observation of Performance Form."
5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
• List all proficiency testing (PT) you performed in the last year.
• Submit investigation and corrective action forms, as applicable.
• Select an assay not on your PT list to perform for element #1 assessment.
• Submit documentation of entry and release of results through the CAP e-Lab system.
6. Evaluation of problem-solving skills.
• Select one:
• Design and complete an internal assessment to evaluate efficiency or effectiveness of a process within the laboratory.
• Graph a monitor for six months to evaluate trends/shifts.
• Select one:
• Submit documentation of two examples of troubleshooting skills (e.g., instruments or assays).
• Give a presentation to section staff on troubleshooting an assigned analyzer or assay.
When selecting assay(s) for element #3, submission of documentation of completed test runs, or element #5, blind-testing, the director might want to categorize assays according to the potential for performance error. Generally, highly automated molecular assays with FDA-approved kits will have lower "error potential" than manual assays performed on an infrequent basis. The highly automated assays might be the best candidates to satisfy element #3.
Manual molecular assays that are run routinely and have few QC failures might be considered to have a moderate error potential. The most challenging assays that require more technical manipulation and data interpretation than other assays would have the highest error potential. Assays with moderate to high error potential would be good candidates for blind-testing (element #5) and observed performance (element #1). If a technologist has successfully performed PT testing, this may be used to fulfill the blind-testing requirement.
Assessment of Other Areas
The six elements discussed above involve assessment of technical and critical thinking skills. Laboratory directors should consider assessment of additional skills also important for competent functioning as a technologist (e.g., intrapersonal skills7 nd safety).
A. Interpersonal skills. In my laboratory, technologists are asked to do the following:
• Participate in a quality improvement team or initiative.
• Participate in team work assessment:
• Write an exemplar recognizing a co-worker's contribution to the team.
• Invite a co-worker to submit an exemplar describing your contribution to the team.
Note: in each instance, the co-worker should be different from last year's submission.
B. Safety skills. Technologists are instructed to do the following:
• Name a hazardous chemical used in the laboratory.
• Locate the MSDS sheet.
• Verbally explain proper handling and disposal of the chemical.
• Select one: Locate and explain all measures in the laboratory used to minimize exposure to UV light or complete an online safety course.
• Lastly, miscellaneous items could be rotated on the competency document. Consider using items that caused confusion during the year (e.g., explain a new document control system or how to produce corrected reports).
The process of assessing competency of technologists should be written in a formal laboratory document (SOP) describing the frequency of monitoring pre-analytical, analytical and post-analytical tasks. The SOP should define acceptable criteria and action to be taken if acceptable performance standards are not met, (e.g., retraining, viewing computer tutorial, etc.). The SOP and associated form(s) should be designed so that it is apparent which skills are being assessed and how they are measured (Table).
Dr. Carr is technical director, Virology and Molecular Microbiology, St. Jude Children's Research Hospital, Memphis, TN.