Unsuccessful Performance in Proficiency Testing

6054 - Unsuccessful Performance in Proficiency Testing (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) If it is determined that a laboratory has performed PT unsuccessfully, the SA follows the procedures listed below. All sanctions are imposed in accordance with 42 CFR Part 493 Subpart R and taken by CMS. If an initial unsuccessful PT performance by a laboratory (that is, the laboratory has never performed unsuccessfully for the particular test, specialty, subspecialty, or analyte) is confirmed, the SA may recommend to CMS that the laboratory undertake additional training, obtain technical assistance, or both, rather than recommending the imposition of alternative or principal sanctions. No onsite survey is necessary to initiate this action. NOTE: The SA may recommend training and/or technical assistance for an initial unsuccessful PT performance EXCEPT when one or more of the following exists: • There is immediate jeopardy to patient health or safety; • The laboratory fails to adequately correct the problem causing the unsuccessful performance; • The laboratory has a history of poor compliance with CLIA requirements. See 42 CFR 493.803(c) for regulatory specifications. If CMS agrees with the recommendation of technical assistance and/or training, a credible allegation of compliance to show that the laboratory corrected the problem that caused the unsuccessful performance should be obtained from the laboratory. Documentation of the SA determinations and follow-up should be maintained. For an initial unsuccessful PT performance, CMS may allow the SA to request that a laboratory undertake training and technical assistance (T&TA) provided: 1) the laboratory has a good history of compliance; 2) there is no immediate jeopardy, no PT referral, no current significant quality problems; and 3) the laboratory has agreed to correct the problem causing the unsuccessful PT. • The SA must first verify that the PT scores are accurate by contacting either the PT program or the laboratory to review the results of the testing that caused the unsuccessful performance. After verification of the scores, the SA (with CMS consent – NOTE: This may be a blanket consent for SAs for all initial unsuccessful PT performance) sends the laboratory a letter proposing T&TA with a Form CMS-2567 citing the condition-level deficiency. The letter should also include the consequences of another PT failure. • The laboratory may continue testing during this period. • The laboratory must document completion of the T&TA and correction of the problem(s) that caused the unsuccessful PT performance. The documentation must be submitted promptly to the SA. • When the laboratory completes the T&TA and notifies the SA, it is documented as back into compliance by the SA. • These actions for the initial unsuccessful PT performance must be entered into the CLIA enforcement database in a timely manner by CMS. For a non-initial unsuccessful PT performance, the SA must verify that the scores are accurate by contacting either the PT program or the laboratory to review the results of the testing that caused the unsuccessful performance. • If the subsequent unsuccessful PT performance is confirmed in a different analyte, subspecialty, or specialty, CMS has the option, based on the laboratory’s compliance history, SA recommendation, and the specific circumstances that caused the failure, to impose another T&TA rather than impose a sanction as specified in subpart R. If CMS determines that another T&TA is warranted, follow the procedure noted above for an initial unsuccessful PT performance. • If the failure is for the same test, analyte, specialty, or subspecialty, then a more stringent sanction, as noted below, is imposed. • If the imposition of a more stringent sanction is decided, the SA refers the Form CMS- 2567 with condition-level noncompliance to CMS. • CMS then sends a letter along with the Form CMS-2567 citing the condition-level deficiency(ies) to the laboratory that proposes sanctions, including, but not limited to, a limitation of the laboratory’s certificate in the area of failure, and cancellation of their Medicare and/or Medicaid payment immediately for no less than six months in the area of failure. If the effective date of the sanctions is not delayed (such as in the case of immediate jeopardy) or laboratory does not appeal the sanctions, they are imposed. • In order to come back into compliance and remove the sanctions, the laboratory must obtain satisfactory scores in 2 consecutive re- instatement PT events. • The laboratory may choose to use 2 routine PT events as their reinstatement PT, or they may obtain off-cycle re-instatement PT samples from their PT program or any other CMS-approved PT program. • The scores of the re-instatement PT are entered into the CLIA PT database as ‘non-routine’ by the PT program and may be found at the bottom of CASPER Report 155. The laboratory will receive copies of their re-instatement scores from the PT program from which it purchased the two re-instatement events. To initiate the appropriate enforcement actions, use the guidance at Sections 6276- 6280. Please see the Notice of Proposed Limitation of the CLIA Certification and Suspensions of Medicare Payments When a Laboratory Has Failed to Participate Successfully in a Proficiency Testing Program.