Development of the Statement of Deficiencies

6130.1 - Development of the Statement of Deficiencies (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Choose the most appropriate regulatory citation and corresponding D-tag when documenting a deficiency. For example, if deficient practices are a result of failure of the laboratory to properly perform quality assessment, cite the deficiency using the quality assessment requirements. Note, however, where a laboratory does not have a quality assessment program, one should cite the quality assessment requirements and the laboratory director for not ensuring that the quality assessment programs are established and maintained to ensure the quality of laboratory services provided. If deficient practices are the result of a laboratory’s failure to perform (or perform correctly) certain specific tasks or requirements, then cite the deficiency in the specific area of the regulation such as personnel, general laboratory systems, preanalytic systems, analytic systems or postanalytic systems. Supporting information for documenting deficiencies should be complete, clear, and concise. Write deficiency statements in terms that allow a reasonably knowledgeable person to understand the aspects of the requirements that are not met. Avoid writing the same deficiency in several places. Write your statement of evidence following the format described in the Principles of Documentation Guidelines https://www.cms.gov/regulations-and- guidance/legislation/clia/downloads/principles-of-documentation-oct-2018.pdf For some cited deficiencies, the CLIA Data System may require that you list the appropriate specialty or subspecialty identifier code(s) and test complexity (moderate, high or both) for each D-tag. This is applicable to standard and condition-level deficiencies.