Reinstatement After Failure to Successfully Participate in

6060 - Reinstatement After Failure to Successfully Participate in Proficiency Testing (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The laboratory must meet the requirements for reinstatement when: • A laboratory has been required to cease testing an analyte or subspecialty without analytes or a specialty; • The laboratory’s certificate has been suspended or limited; or • The laboratory voluntarily withdraws testing of the unsuccessful area of participation. Reinstatement requires satisfactory performance on two consecutive PT events for the specialty, subspecialty, or analyte that the laboratory previously failed. Sustained satisfactory performance (two consecutive events) demonstrates that the laboratory has identified and corrected the area of failure that caused the original unsuccessful performance. A laboratory that has had its certificate suspended, limited, or cancelled due to unsuccessful PT participation may not be reinstated or receive Medicare or Medicaid payments for a period of at least six months. The laboratory must re-apply to CMS to have the specialty, subspecialty, or analyte recertified. A revised application and certificate are necessary during the period of suspension or limitation. The laboratory may be required to pay a fee to cover the cost of issuing the revised certificate. The laboratory may voluntarily withdraw from testing prior to CMS sending the letter to impose (i.e., imposed sanction notice) a sanction or limitation to the laboratory if it notifies the SA that it has stopped testing the unsuccessful analyte(s), subspecialty, or specialty. The laboratory must still complete the two consecutive re-instatement PT events with satisfactory scores and correct the problem that caused the unsuccessful performance. If the laboratory satisfactorily completes the two re-instatement events and has not received the imposed sanction notice, it will be considered as back in compliance. This may be completed in less than 6 months. The SA will monitor this in coordination with CMS and utilize the same procedure as indicated for all unsuccessful PT performance. Re-instatement (non-routine in the PT system) PT samples are NOT included in the grading for routine PT events that are sent 3 times per year and are, therefore, not counted toward a determination of PT performance. If a laboratory voluntarily stops testing in the area of failure, it may resume testing when it has demonstrated sustained satisfactory performance for two consecutive testing events; the PT samples may be tested as soon as the laboratory has identified and corrected the cause of the original unsuccessful performance. Reinstatement samples (referred to as non-routine in the CASPER reports) should be purchased from the program in which the laboratory is enrolled for the failed analyte. If samples are not immediately available, the laboratory may purchase the samples from another approved program. CMS will make the final determination whether reinstatement requirements are met.