Volume 39 Number 1 | February 2025

Carly Preston, MLS(ASCP)CM, ASCLS Today Volunteer Contributor

Carly PrestonDuring the 2023 November Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting, the Centers for Medicare and Medicaid (CMS) released a report compiling its 15-year investigation into the most common deficiencies cited against laboratories. The goal of the report was to identify and expand upon trends and patterns which could be brought forward (and remediated) by the laboratory regulatory community.1 Other laboratory accrediting agencies, such as College of American Pathologists (CAP), Commission on Office Laboratory Accreditation (COLA), and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) reviewed deficiency data from similar time periods and found trends similar to those in the CLIAC report.2-4 The similarities demonstrate that, no matter what type of certification a laboratory holds, the laboratories consistently have the same type of deficiencies.

The common theme found within the data from all the agencies is that the deficiencies do not directly impact patient care or patient care activities. As there is a constant demand for workforce in the laboratory, having the ability from a top-down perspective to do non-patient care activities is difficult.3 However, regulatory oversite is a necessity, and these deficiencies can often be remedied by collaboration between laboratory leadership and bench staff, and a duty to be shared between both supervisory and frontline personnel. This means new ways or alternative ways of oversight than what has been in place are needed.

“As turnover rates and lack of staff plague the laboratory, a great knowledge base is being lost, making it pertinent to look for credible resources and to share knowledge amongst all members of the laboratory community.”

Competency Assessment

The studies showed that the most common deficiencies cited across all agencies involved competency assessment. Depending on the accrediting agency, and the prior knowledge of the supervisor, it can be very confusing to determine what is included in a competency assessment, what the intervals should be, and who is authorized to perform them. This is especially true as new leadership is pushed forward in a post-COVID, post-great resignation world.

As per CLIA, competency assessment on moderate to complex testing is to be performed “at least semi-annually during the first year the individual tests patient specimens. Thereafter, competency assessment must be performed at least annually.”5 CAP and other specific state regulatory agencies also have requirements for waived testing competency. In large facilities, with multitudes of staff, keeping up with competencies is a full-time job. Unfortunately, staff shortages make it almost impossible to have one FTE dedicated to this position. The burden of competencies must be shared between supervisory personnel and testing personnel, and in certain states, the buy-in for testing personnel is much higher, since if they are found to be performing testing without current, appropriate competency, their state license can be penalized or revoked.

One approach to remedying this is to create a quarterly activity, which could be created to review employee hiring dates and perform biannual competency assessment based on the findings. In some cases, it can even be done by asking human resources to set up a notification in their software for a six-month hire date notification. CMS, CAP, COLA, and JCAHO stated that sample competency forms are available as a resource to laboratory staff that adhere to all their regulatory rules if followed. There is no need to re-invent the wheel when these accrediting agencies are trying to help laboratory leadership.

Proficiency Testing

The next most common deficiencies cited involved director responsibilities and their specific tasks not being completed, especially regarding proficiency testing (PT).1-4 PT performance and review is a supervisory duty that often gets pushed to the back burner. Reviewing proficiency testing data does not feel critical to patient care or perhaps as consequential as other supervisory activities, such as getting timecards approved or fulfilling a requirement for a team project. However, if left unattended, it has some substantial consequences, i.e., testing revocation, shut down, etc.

PT results are automatically reported to accrediting agencies and are a large red flag for the laboratory. Every PT event is supposed to be reviewed by the director, and if an unsatisfactory result is obtained, a documented investigation and/or remediation is to be performed. Investigation forms are provided by most PT platforms and can be added into the PT binder upon completion. Once again the regulating agencies are providing forms to help complete the regulatory tasks that are required.

Procedure Manuals

The final most common deficiency involves procedure manuals.1-4 In the current laboratory climate, procedure manuals are being harshly scrutinized. As new personnel and locum staff make their way into the laboratories, the procedure manual is meant to be an invaluable resource for how to perform testing in that laboratory. This means the procedure manual is supposed to be complete, accurate, and up to date with current laboratory practice at that facility. Unfortunately, inspectors often find this is not the case,3 and this task does not have to rest solely on leadership’s shoulders. An annual review of procedures is a great time to sit with key staff members and ensure that they are clear, concise, and relevant to the current procedure. This often results in better procedural outcomes, as those personnel are more directly involved in the work that the procedures cover and can provide better insight to them.

As turnover rates and lack of staff plague the laboratory, a great knowledge base is being lost, making it pertinent to look for credible resources and to share knowledge amongst all members of the laboratory community. All the accrediting agencies have resources available to not only interpret the various regulatory statues but also provide templates of forms that can be used in the laboratory. CLIAC is also working with CMS to create a laboratory leadership resource to help bridge the gap in the loss of knowledge that has been experienced in the laboratory community. All the above-mentioned citations are preventable and can be easily fixed with a small amount of time, maintenance, and consideration. Having a laboratory team that is a part of these tasks can lessen the burden on laboratory leadership while helping to develop new leaders in the laboratory and decrease the knowledge deficit that occurs when turnover takes place.

References
  1. Sutterer K, CLIA Top 10 Standard Deficiencies. CLIAC November 2023 Meeting; 2023 Nov 8-9; Atlanta, GA
  2. Nucifora K, A New Look at the Most Frequent Citations. CLIAC November 2023 Meeting; 2023 Nov 8-9; Atlanta, GA
  3. Datto M, Most Common Deficiencies-CAP Accreditation. CLIAC November 2023 Meeting; 2023 Nov 8-9; Atlanta, GA
  4. Null A, Assessing the Most Common Standards Findings. CLIAC November 2023 Meeting; 2023 Nov 8-9; Atlanta GA
  5. Centers for Medicare & Medicaid Services [Internet]. What Do I need to Do to Assess Personnel Competency?; November 2012. Available from: https://www.cms.gov/regulations-andguidance/legislation/clia/downloads/clia_compbrochure_508.pdf
  6. Brandush G, Efforts to Address the CLIA Top 10 Laboratory Deficiencies Introduction. CLIAC November 2023 Meeting; 2023 Nov 8-9; Atlanta, GA

Carly Preston is the Director of Laboratory Services at Caldwell Memorial Hospital in Columbia, Louisiana.