At the annual Clinical Laboratory Quality Regional Meeting held in Newport News, Virginia, this past September, Jean Ball, MBA, MT(HHS), MLT(ASCP)—an inspection services manager in the laboratory accreditation program at the College of American Pathologists (CAP)—indicated that GEN.55500 Competency Assessment – Nonwaived Testing is the most frequently cited deficiency.1 Furthermore, according to the Code of Federal Regulations (CFR) § 493.1407,2 in addition to being responsible for the overall operation and administration of the laboratory, the laboratory director is specifically responsible for “the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, [sic] and proficiently and for assuring compliance with the applicable regulations.” Assessing testing personnel competency is mandatory, but laboratory inspection data has shown it is challenging to perform correctly and completely.
Given that competency assessment is intended to verify that laboratory personnel can accurately apply their knowledge and experience to perform patient testing,3 timely completion of competency assessments is a necessary, yet challenging element of laboratory management. Fortunately, there is a straightforward method to develop a competency program laboratory personnel will understand and embrace, and which meets the required standards.
The obvious necessity of performing competency assessments is dictated by regulatory law, accrediting standards, and the laboratory’s mandate to ensure working staff members know how to properly perform and report on testing. Although the CFR does not require competency of waived testing, CAP requires competency on both waived and non-waived testing; specifically, the CAP standard GEN.55499 Competency Assessment - Waived Testing4 mandates competency assessment of laboratory personnel performing waived tests. Of particular note here, competencies of waived tests do not have to include all of the six indicated elements of non-waived testing. Rather, the laboratory can choose the elements to be assessed, and there are advantages to this process.
Tests categorized as waived by the FDA are widely used in clinical laboratories (particularly in physicians’ practice offices). CAP requires that laboratory assess the competency of individuals performing waived tests, but allows the laboratory’s medical director to determine the elements used to evaluate competency. Though waived tests are important in diagnosing disease states, they do not tend to produce results that are critical to the patient’s health (in this case meaning the result or lack of result has the potential to cause immediate, irreparable harm to the patient). Therefore, the Review critical results element does not need to be included in assessments for waived tests. Similarly, waived tests do not require the testing individual to perform some type of quality control before usage, nor do they require proficiency testing, obviating the need to assess these elements. Furthermore, the elements most commonly selected when assessing competency for waived testing are Direct observation of routine patient test performance and Evaluation of problem-solving skills. (The remaining elements are discussed below.)
Key on Assessment Timeliness
Integral to the success of a competency assessment program is performing specific actions at appropriate times. The CFR mandates competency be assessed “…at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually… (CFR 493.1413(9) and 493.1451(9)).”2 The CAP repeats this requirement in the standard GEN.55500 Competency Assessment - Nonwaived Testing.4 Common to these is the idea that the assessments must be performed after the individual begins to perform patient testing (ie, post training), not upon date of hire.
Given the national shortage of qualified laboratory personnel (due to diminishing school choices, high cost of education, attrition, etc), many laboratory managers are looking to place testing personnel on the schedule as soon as possible after hiring. However, the competency clock does not begin unless the employee has been properly trained and approved to perform patient testing on a specific system. Thus, laboratories must be diligent in documenting the dates that new staff members begin performing actual patient testing on their own. The performance of patient testing often is an aspect of training, but training testing should not be considered when determining the initiation of patient testing, as training and competency are different experiences.
Senior technologists or department supervisors should notify the laboratory director when employees have completed training on a test system, are approved to begin patient testing, and can be placed on the working schedule. For example, urinalysis usually has a short training period, and many community laboratories begin new-personnel training in that department. Once that employee begins actual patient testing for urinalysis, the laboratory should establish the dates for the semi-annual (6 months from testing start date) and annual (12 months from testing start date) competency assessments. This concept is complicated somewhat due to the fact that most technologists are trained in multiple disciplines.
Continuing the example above, the same employee that begins patient testing in urinalysis will still require training in other laboratory departments. However, at the employee’s first 6-month assessment, the competency of all the test systems the employee has been trained on and is releasing patient test results at that point should be assessed. So, assume the example employee began urinalysis testing in March, then finished training in core chemistry in June and hematology in August, and is releasing patient results in both departments. The initial 6-month competency (due in September in this case) should comprise of all the test systems in urinalysis, chemistry, and hematology on which the employee is performing patient testing. This means each semi-annual competency will often incorporate different disciplines. Thus, it is essential for senior technologists, department managers, and the lab director to be aware that any given employee is likely to have more than one department requiring competency assessment at each six-month interval, and document that process accordingly.
A benefit of the second 6-month competency is that it occurs in the following year. As a result, the second 6-month competency is considered the annual for that year. An employee would not need to have an annual competency assessment in the same year the second 6-month competency assessment was completed.
It is rare for a complete competency assessment to be properly performed in one day, and given that staff members under evaluation are still working during the assessment, it is best to spread the process out over a few days or weeks. A lab may set its competency evaluation to begin 1 to 2 weeks prior to the employee’s 6-month testing anniversary and be completed within 1 to 2 weeks of that date.
Clearly Distinguish Assessor Personnel
In any assessment program, it is important for the individuals who will be performing the competency assessments to be clearly designated. In selecting these assessors, laboratory management must take into account and evaluate all types of patient testing being performed by testing personnel both in and outside the lab. All non-waived testing is categorized by the FDA as moderate complexity or high complexity. If the laboratory is only performing moderate-complexity tests, then assessors must qualify as a Technical Consultant (bachelor’s degree in a physical, chemical, or biological science, medical laboratory technology, or nursing.) If the laboratory is only performing high-complexity tests, the individual must qualify as a General Supervisor. The CFR and CAP allow several ways for an individual to qualify as a General Supervisor (refer to 42 CFR § 493.1461 Standard; General supervisor qualifications and CAP GEN.53600 General Supervisor Qualifications/Responsibilities for the specific qualifications).
Most hospital-based laboratories perform a mixture of moderate- and high-complexity testing (eg, automated CBC instrumentation often is considered moderate-complexity by the FDA; however, a manual differential is categorized as a high-complexity test). To avoid having unqualified personnel assessing moderate-complexity testing, laboratories with mixed–complexity test menus would do well to designate qualified, bachelor-degreed individuals to perform competency assessments, at a minimum. Of further note, the laboratory director should remember that the duties of competency assessments must be delegated to the Technical Consultant(s) and General Supervisor(s) by the medical director in writing.
The Necessary Elements of Assessment
The actual performance of non-waived testing competency assessment can be challenging given that all six elements of competency must be assessed for each test system. Responsibilities related to the six elements of competency required for assessment of non-waived tests (moderate and high complexity) can be found in the standards for the laboratory’s Technical Consultant (CFR §493.1413) and Technical Supervisor (§493.1451).2 Competency assessments may be performed and comprise data created throughout the competency assessment time period.
Summarizing the six elements:
Numbers 1 and 4 in this list require direct observation by assessors who can document their observations of a test system by noting the accession/sample number used in the assessment, and the date the employee was responsible for running the instrument and performing maintenance. Assessments of both elements 1 and 4 can be completed on a day the employee is normally scheduled to be working in the department in question. The two elements requiring a review of records, numbers 2 and 3, also be assessed the same day the individual is scheduled in the department in question.
Assessing element 5, PT and/or blind sample test results, can be assisted by rotating surveys among the employees. If the laboratory is large or the test system has had few PT opportunities, it would be prudent for the assessment to involve previously analyzed or blind samples. Furthermore, blind samples are particularly useful for assessing employees who are part-time and are difficult to schedule for assessments. Laboratories should ensure the documentation of the blind sample results includes whether the result the employee submitted is acceptable or unacceptable.
There are several ways to approach the assessment of element 6. Troubleshooting logs or well-documented solutions the employee may have implemented in the test system may be used to influence the assessment, but most laboratories have employees complete and pass a written exam covering several test systems.
The CAP provides a competency assessment template for accredited laboratories to assist in documenting testing personnel competency assessments, a version of which can be customized to fit a specific lab’s needs.5 Laboratories also may choose to only keep the completed template in the employee folder and documented evidence supporting the competency in separate location. This is acceptable as long as the supporting documentation can easily be provided if requested by an inspector.
Assessing the competency of testing personnel is a mandatory requirement of laboratory regulatory and accrediting bodies. Ensuring semi-annual competencies are completed at the appropriate time is an area of confusion and failure for many laboratories, so understanding why, when, and how competency assessments should be properly performed is key to maintaining quality, meeting requirements of the CFR, and successfully passing a CAP inspection. Dedicating time and resources to developing a comprehensive competency assessment program will help a laboratory avoid receiving the most frequently cited inspection deficiency.
Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), is a laboratory quality coordinator at Sentara Healthcare, based in Norfolk, Virginia, and has been an ASCP medical technologist for over 30 years. He also has been performing CAP inspections for more than 15 years and is a certified quality auditor. Darryl provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara system. He received his MHA from Ashford University and his doctorate of psychology from The University of the Rockies.
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