October 11, 2024
Competency Assessments – Why Do They Matter?
- by Bridget Smudrick, BS, MLS (ASCP), Director of CLIA Compliance
At first thought, competency assessments seem like another mundane aspect of running a laboratory. In fact, these assessments may even seem like a waste of precious time that we never seem to have enough of as medical professionals. However, a proper competency assessment may be the most important tool a practitioner has when it comes time to evaluate your staff. In this blog, we will discuss the requirements for a competency assessment, when and what to evaluate and who is responsible for completing that assessment. At the conclusion of this discussion, the importance of competency assessments and why they matter will be clear.
Competency Assessment Requirements
As with everything laboratory related, we must turn to the set of federal regulations established in 1988, we affectionately refer to as CLIA, for answers. CLIA requires that all laboratories establish and follow written policies and procedures in order to establish employee as well as consultant competency. In fact, the regulations provide a definition of competency, explain what to evaluate, explain when to complete these evaluations, explain who must be evaluated and also explain who is responsible for performing the evaluation. Documentation of the competency assessment is also required by CLIA. The laboratory may draft a version of a competency assessment form or use a version provided online by an accrediting agency like CAP or COLA. However the laboratory decides to perform and document the competency assessment, the “who must be evaluated” never changes. Any staff member who performs specimen testing must have the required competencies as part of their personnel file. In fact, everyone from the Laboratory Director down to the testing staff are all required to be evaluated for competency under federal CLIA regulations if specimen testing is a part of their responsibilities.
What and When to Evaluate Your Laboratory Personnel
Let’s first discuss the “what” of a competency. Competency, by definition, is the ability to apply skill, knowledge, and experience to perform duties as assigned by a position. In our case, the competency assessment is used to ensure that laboratory personnel are fulfilling their duties as required. Federal CLIA regulations state that the following six procedures are to be used for the proper assessment of personnel:
- 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, quality control records, proficiency testing results, and preventive maintenance records.
- Direct observations 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.
- Assessment of problem-solving skills.
Now, let’s discuss the “when” of competency assessments. CLIA regulations also dictate how often these assessments must be performed. Evaluating and documenting the competency of personnel is required at least semiannually during the first year of patient testing and then annually thereafter. These assessments do not have to be disruptive. In fact, incorporating the review of competency requirements during routine laboratory work may be just the trick to minimize the impact on your workflow.
Who Is Responsible For Competency Assessments
The “who is responsible” is possibly the simplest aspect of the competency assessment. As a matter of fact, CLIA regulations assign this responsibility depending on the complexity level of the laboratory. The technical consultant or the technical supervisor is responsible for performing and documenting the competencies of testing staff. For laboratories considered moderate complexity, the technical consultant is responsible and for high complexity laboratories, the technical supervisor holds this responsibility. However, it must be pointed out that the Laboratory Director is ultimately responsible for all aspects of laboratory operations and will be held to that standard during the inspection process along with the technical consultant and technical supervisor. Failing to comply with completing and documenting competency assessments will result in citations and a required plan of correction following your inspection. Therefore, it is best to maintain compliance with the established regulations which correspond to these assessments.
Competency Assessment Case Study
In order to provide an example of how our tips may be useful, please consider the following scenario. A new client contacted our team because they were cited during an inspection for failure to complete competency assessments as required. In fact, this laboratory had never performed even one! In order to bring the laboratory back into compliance, our team was contracted. First, we completed competency assessments on all staff members performing patient testing. Secondly, we provided the laboratory with a form to document the patient lookback required to evaluate any harm that may have come to all patients tested by the staff members who had not received a competency assessment. Finally, we drafted a formal response to the inspection which was accepted by CMS. Hours of extra work were required to correct this citation taking time away from patient care. All of this extra work could have all been avoided with proper preparation and adherence to CLIA regulations.
Reach Out to DoctorsManagement For CLIA Compliance
Compliance to federal regulations regarding competency assessments is a simple matter of the correct knowledge base. In fact, having knowledge of requirements for a competency assessment, when and what to evaluate and who is responsible for completing that assessment will help your laboratory avoid the citations related to this topic during an inspection. With proper preparation and the correct staff members on hand to assist, your laboratory will be able to trust that your staff is competent and produces results you can trust. After all, reliable results allow your office to provide the best standard of care for your patients.
DoctorsManagement has been assisting laboratories in maintaining CLIA compliance for over 30 years. Our CLIA Compliance team is ready and able to assist with all areas of compliance. For instance, we offer assistance with topics such as quality control, quality assessment, proficiency testing, records retention, personnel file review, inspection preparation, inspection response and more. Our expert team has all of the forms, manuals and experience required to create an atmosphere of compliance for your laboratory.