Strategy for Repeat Deficiencies

6134.1 - Strategy for Repeat Deficiencies (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) A repeat deficiency is defined as a deficient practice cited on a current Form CMS- 2567, Statement of Deficiencies that was also cited during a prior CLIA survey of the laboratory. If during a recertification, complaint, or validation survey of the laboratory it is determined that a repeat deficiency exists, use the following strategy to help ensure the receipt of an acceptable plan of PoC or a credible AoC that will result in effective, meaningful, and sustained corrective actions by the laboratory. Laboratories must not be given multiple opportunities to correct repeat deficiencies. If repeat deficiencies are not corrected quickly, the SA should refer the laboratory to CMS for possible enforcement action. (This strategy may not be applicable to certain repeat deficiencies, e.g., the laboratory’s failure to have appropriately qualified laboratory personnel in rural areas.) Strategy for Repeat Deficiencies: 1. Cite each repeat deficiency and, if found, all other deficient practices on Form CMS- 2567. Principles of Documentation do not preclude the surveyor from identifying a deficient practice as a repeat deficiency on Form CMS-2567. 2. Using the routine process, request the laboratory to submit an acceptable PoC or a credible AoC. 3.Review the submitted plan of correction or allegation of compliance and determine whether the laboratory’s submission meets the criteria for an acceptable plan of correction or a credible allegation of compliance. Based on established criteria, if the plan of correction is not acceptable or the allegation of compliance is not credible, give the laboratory no more than one additional opportunity to provide an acceptable or credible submission, or forward the case to CMS for possible enforcement action. Consideration should be made to the laboratory’s compliance history, seriousness of the deficient practice, and the degree to which the laboratory’s submission has met established criteria. 4. If the laboratory’s submission meets established criteria for an acceptable plan of correction or a credible allegation of compliance, compare the currently submitted plan of correction or allegation of compliance for the repeat deficiency to the plan of correction or allegation of compliance the laboratory submitted when the deficiency was previously cited. If the currently submitted plan of correction or allegation of compliance for the repeat deficiency is the same as the previously submitted plan of correction or allegation of compliance, the plan of correction is not acceptable or the allegation of compliance is not credible. Give the laboratory no more than one additional opportunity to provide an acceptable or credible submission or forward the case to CMS for possible enforcement action. Consideration should be made to the laboratory’s compliance history, seriousness of the deficient practice, and the degree to which the laboratory’s current submission is the same as the laboratory’s previous submission. 5. If the laboratory’s submission for the repeat deficiency is different from the plan of correction or allegation of compliance submitted by the laboratory for the prior survey, consider whether the laboratory’s current submission resolves the underlying cause of the problem and is adequate to prevent recurrence of the deficient practice. If it is determined that the laboratory’s current submission does resolve the underlying cause of the problem or is not adequate to prevent the deficient practice from recurring, give the laboratory no more than one additional opportunity to provide an appropriate submission, or forward the case to CMS for possible enforcement action. Consideration should be made to the laboratory’s compliance history, seriousness of the deficient practice, and the degree to which the laboratory’s current submission is likely to resolve the underlying cause of the problem(s) and prevent recurrence of the deficient practice. 6. If it is determined that the laboratory’s current submission resolves the underlying cause of the problem and is adequate to prevent the deficient practice from recurring, review evidence from the laboratory to ensure that the corrective/remedial action has been implemented before determining that the laboratory’s submission is acceptable or credible. The above strategy is summarized in the following flow chart: