Editors: Olga Pozdnyakova, MD, PhD, Geoffrey Wool, MD, PhD, David Bernard, MD, PhD & Raul S. Gonzalez, MD
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Q. Now that the CMS allows direct observation for competency assessment to be performed virtually, does the CAP also allow it? If so, can you provide guidance?
A. December 2025—The CAP allows virtual direct observation for competency assessment where permitted by national, state (or provincial), or local laws and regulations. A provision for this has been included in CAP checklist requirements GEN.55505 and POC.06915, Competency Assessment Frequency–Nonwaived Testing. A memorandum from the Centers for Medicare and Medicaid Services (QSO-25-10-CLIA Revised) indicated that the updated State Operations Manual interpretive guidelines removed guidance addressing the need for direct observation for competency assessment to be performed in person, in light of the availability of technology that allows for virtual observations.
All provisions applicable to in-person direct observation for competency assessment also apply to virtual direct observation, so laboratories should consider several factors if they choose to perform the latter. Employees who perform virtual observations must be qualified to assess competency for the type and complexity of testing conducted and be delegated to do so by name or job title. These individuals must have their qualifications accessible at any CAP/CLIA facility where they are performing a CLIA function. Competency assessment records, including sign-off from the observer, must be maintained in accordance with record-retention guidelines, such as GEN.20377 Record and Material Retention–General Laboratory, and accessible to an inspector during an inspection.
There are additional considerations specific to the use of virtual platforms. The technology used for observation must allow the observer to fully assess all steps of the process at an appropriate level of definition and detail. Computer or instrument screens, log sheets, and manual test reactions must be visible and legible when relevant to the testing process. It is crucial that the observer and person being assessed communicate effectively and interact in real time with audio of sufficient quality. Recorded videos may not be used to demonstrate direct observation.
If the laboratory chooses to use technology such as video conferencing to perform virtual direct observation for competency assessment, it must develop laboratory procedures that define when this is acceptable, specify what platforms can be used, and provide instructions for using the platform.
Virtual observations can provide laboratories with greater flexibility in performing competency assessments. However, it is important to ensure that the quality of the observations are the same whether in person or remote.
Centers for Medicare and Medicaid Services. Revised: Revisions to State Operations Manual, Appendix C—Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA)); Advance Copy. June 23, 2025. QSO-25-10-CLIA Revised. www.cms.gov/files/document/qso-25-10-clia-revised.pdf
College of American Pathologists. GEN.20377 Record and material retention–general laboratory. In: Laboratory general checklist. Dec. 26, 2024.
College of American Pathologists. GEN.55505 Competency assessment frequency–nonwaived testing. In: Laboratory general checklist. Dec. 26, 2024.
College of American Pathologists. POC.06915 Competency assessment frequency–nonwaived testing. In: Point-of-care testing checklist. Dec. 26, 2024.
Lena Portillo, MS, MT(ASCP)
Checklist Technical Content Analyst
College of American Pathologists
Northfield, Ill.
Q. We have implemented quality control at 10x in accordance with the Westgard rules. I use three levels of QC. If the results of two levels of QC are moving properly above and below the mean and only one level is showing a trend of a 10x rule violation, what corrective action should I take?
A. What is commonly known as the Westgard rules dates back to 1981, when a combination of multiple statistical QC rules was first published by James O. Westgard.1 That combination included a 10x rule: If 10 values were on one side of the mean, on any level, the rule was violated, the analytical run was rejected, and troubleshooting needed to be completed. It did not matter if there were no rule violations on the other levels.
Westgard rules, like laboratories, have evolved over time. The use of 21st-century instruments and methods raises the question: What rules are necessary to catch medically important errors in test methods? To know this answer, the laboratory must have a defined quality requirement, sometimes referred to as a performance specification or quality goal. In the context of a quality goal, known more familiarly as an allowable total error, one can see whether the combination of imprecision and bias renders the test method unreliable.
The number of rules needed to monitor the method depends on the sigma metric of the method. For labs that achieve a six sigma level of analytical performance, few QC rules are needed. For labs that have a sigma metric of three or lower, all Westgard rules, and probably others, are needed to monitor the method. Westgard Sigma Rules is a free, simplified tool to help labs streamline their QC.2
Circling back to the reader’s question, if there is four sigma or higher performance, it’s not necessary to use a 10x rejection rule. For three sigma performance, the 10x rule is necessary and the run described by the reader must be rejected and troubleshooted.
- Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem. 1981;27(3):493–501.
- Westgard JO, Westgard SA. Introducing Westgard Sigma Rules. Westgard QC. September 2014. https://bit.ly/Westgard-sigma-rules
Sten Westgard, MS
Director, Client Services and Technology
Westgard QC
Madison, Wis.