Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ)
“Testing personnel competency is the most common deficiency reported by laboratory inspectors across the nation,” said Jean Ball, a College of American Pathologists (CAP) Inspection Manager, at the 2019 Clinical Laboratory Quality Regional Meeeting in Newport News, Virginia.
Verifying that laboratory testing personnel are knowledgeable about how to perform patient testing is paramount to ensuring quality patient care. The Clinical Laboratory Improvement Amendments (CLIA) 1988 regulations, the Commission on Office Laboratory Accreditation (COLA), the Joint Commission, and CAP require competency assessments of all personnel performing non-waived laboratory testing. Clinical laboratories are inspected by either Centers for Medicare and Medicaid Services (CMS) or a deemed accrediting body, such as CAP, to verify that testing personnel are qualified and competent to perform patient testing. However, the CAP reports that competency is the most frequently cited deficiency in laboratories across the nation. (The two most frequently cited standards are GEN.55499 Competency Assessment - Waived Testing and GEN.55500 Competency Assessment - Nonwaived Testing.)
There are several assessment pitfalls that laboratory managers should look out for in their efforts to meet competency regulations and standards. Common failures contributing to a laboratory receiving competency-derived deficiencies include missing elements, lack of assessor signatures, unqualified assessors, use of evidence for competency not completed in the assessment year, and not meeting the timeframe for the semiannual (six-month) competencies (required for new employees).
CLIA specifically spells out the elements required for personnel to be assessed for non-waived testing: Direct observation of test performance, monitoring test results, instrument maintenance, proficiency testing or blind samples, and reporting including criticals; review of worksheets, quality control, proficiency testing, and maintenance records; and evaluation of problem-solving skills.
Frequently, laboratories miss documenting a required element such as criticals or fail to use a blind sample when proficiency samples are not available. Missing information or blank fields on competency documentation draws the attention of inspectors and prompts them to ask questions. If an element does not apply to an employee or test system, the inspector will write “N/A” and the lab manager should be prepared to explain why the element is not applicable. (For example, if an employee works a specific shift that does not perform quality control on an analyzer, he or she may receive an “N/A” in the corresponding field. The inspector may then ask to review the staffing schedule to verify the employee has never worked a shift that performs quality control.)
Another error that would lead to a lab receiving a deficiency is competency forms not having an assessor’s signature, or the assessor not being qualified to assess the test system due to its complexity. Clinical laboratories have a mixture of moderate-complexity and high-complexity tests (for example, an automated CBC is moderate-complexity, but a manual differential is a high-complexity test).
Timing is important in assessing competency. Annual competencies may be completed throughout the calendar year. However, labs may get confused about the timing of the semi-annual competency for new employees. CLIA and the CAP considers an employee new if he or she has not performed testing under the laboratory’s CLIA number. CLIA does not recognize systems; therefore, an employee who may have been working in a laboratory that is part of a larger health care system is considered a new employee when working in another laboratory that is a part of the same health care system but has a different CLIA number. To put it simply, new hires and transfers are both new employees in the eyes of CLIA and must have the training and two semi-annual competencies in the first year of performing patient testing. Labs must train transfers regardless of whether they have been working on the same equipment in the same health care system. The employee’s file must contain training for the CLIA number corresponding to where patient testing is being performed.
Laboratory managers should be aware that the hire or transfer date is not the start of the clock for the six-month competency. The clock begins when the employee has been trained on a test system (entering patient test results can be a part of the training period), the trainer signs off, and the employee begins performing patient testing unobserved. The date the employee is placed on the schedule is often used as the six-month competency clock starting date. Managers can notify the employee and supervisors of the two six-month dates on the day the employee is placed on the schedule.
Only two six-month competencies should be in the employee folder. Many laboratories erroneously interpret the standards as requiring two six-month competencies in each discipline. That is incorrect. Only two-six month competencies are required in the first year of patient testing, and they often cover multiple disciplines and test systems depending on training and the laboratory.
Awareness of these common competency pitfalls will help the laboratory avoid having to complete a Phase II write-up (with evidence of corrective actions) to respond to a competency deficiency.