Assessing Outcome or Potential Outcome

6116.7 - Assessing Outcome or Potential Outcome (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) If the information gathered indicates that the laboratory has established, implemented, and maintained appropriate ongoing mechanisms for ensuring quality test results by monitoring, evaluating, and resolving any problems in its practices, and findings do not warrant a more in-depth review, conclude the survey. However, if an assessment of the laboratory’s performance cannot be made based on the cross-section of information collected, it may be necessary to expand the cross-section (e.g., number of sites, observations, or number of records). If the findings reveal potential problem areas with any test procedures, ensure the review is sufficient in breadth and depth to substantiate whether a negative or potentially negative outcome exists. If a problem or potential problem related to patient test results is found, determine the nature and seriousness of the problem. The OOSP allows the freedom to increase or decrease the number and types of records reviewed, the personnel interviewed, and the observations made as individual needs are identified. Analyze the findings for the degree of severity, pervasiveness, comparison with historical survey results, frequency of occurrence, and impact on delivery of services, i.e., accuracy, reliability, and timeliness of test results. A single occurrence of a deficiency directly related to a potential adverse impact on patient testing may be cited. On the other hand, some preliminary findings may have so slight an impact on outcome that they do not warrant a citation. However, there are four CLIA condition-level requirements the surveyor must cite if non-compliance is found, regardless of the presence or absence of any negative outcome or potential harm (see section 6130.5 “Mandatory Citations”). Figure 4-1, steps one through four, presents the decision process for whether or not to cite deficiencies during a survey. After a preliminary finding is established by the surveyor, the first step is to determine whether or not it is a mandatory citation. If yes, go to step #5; if no, go to step #2. Step 2 is to determine if the problem or potential problem is related to laboratory testing. If the answer is no, then no deficiency is cited. On the other hand, if the answer to this question is yes, then the third step is to determine if the identified problem does or could potentially impact patient test results. If the surveyor determines there is no impact or potential impact to patient test results, then the surveyor uses the OOSP to determine whether deficiencies should be cited. If the surveyor concludes that there is an impact or potential impact to patient test results, then the fourth step is to determine if the problem may be the result of, or otherwise related to, noncompliance with CLIA regulatory requirements. If yes, then the surveyor must cite a deficiency. If no, then consult with CMS on whether other Federal regulations are applicable. If the laboratory is subject to a State Licensure Program, consult with the SA supervisor for further instruction. NOTE: Any condition-level deficiency is an actionable deficiency. Any standard- level deficiency that has an impact or potential impact on patient test results is also an actionable deficiency.