Monitoring of PT Scores

6050 – Monitoring of PT Scores (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The SA routinely monitors their state’s laboratory performance by reviewing CASPER Report 153, PT Unsatisfactory/Unsuccessful Report, from the PT Monitoring System. All SAs are required to conduct PT desk reviews for their Certificate of Compliance laboratories at least every 30-45 days using the PT Monitoring System Reports 153 and 155. The SA must verify the scores using information from the PT provider and/or the laboratory prior to recommending an action and take any necessary follow-up actions based on their findings in collaboration with CMS. PT must also be reviewed during the onsite survey. Prior to the onsite survey, the SA will review CASPER Report 155, PT Individual Laboratory Profile, which will display the individual laboratory’s PT performance. The SA may print the reports on prior individual laboratory performance to take with them on survey and compare any specific PT results that the PT system scores indicate as unsatisfactory or unsuccessful. The SA must ensure that the laboratory has effectively corrected all problems that lead to an unsatisfactory or unsuccessful PT performance and has taken steps to prevent a recurrence of the problem(s) that caused the unsatisfactory or unsuccessful performance. The SA should also review quality control results with patient results during the period of time when the poor performance occurred. Unsuccessful participation in PT, unsatisfactory PT performance and unsuccessful PT performance are defined at 42 CFR 493.2, Definitions. Unsuccessful participation in PT is defined as any of the following: Unsatisfactory performance for the same analyte in two consecutive or two out of three testing events; repeated unsatisfactory overall testing event scores for two consecutive or two out of three testing events for the same specialty or subspecialty; or an unsatisfactory testing event score for those subspecialties not graded by analyte (i.e., bacteriology, mycobacteriology, virology, parasitology, mycology, blood compatibility, immunohematology, or syphilis serology) for the same subspecialty for two consecutive or two out of three testing events. Unsatisfactory PT performance means failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event. Unacceptable PT performance means unsatisfactory performance for a single analyte. Unacceptable performance is not used to describe an unsatisfactory score for a subspecialty (such as bacteriology or virology) that does not contain analytes. Unsuccessful performance may be used interchangeably with unsuccessful participation for non-cytology PT. A rolling time frame is used to determine unsuccessful PT performance wherein the laboratory incurs either two unsatisfactory scores for two of three consecutive testing events or two consecutive testing events, for an analyte, subspecialty, or specialty. The time frame does not stop, nor does it re-set annually. It will be based on information available in the CASPER reports. The SA will recommend sanctions or enforcement actions to CMS for failure to meet PT requirements for successful participation. This may only be done after the SA has verified the PT results from the PT program or from the laboratory. Specifically, SA follow-up action for unsuccessful PT performance should consist of: • Obtaining the results for each unsatisfactory analyte, subspecialty, or specialty that contributed to the laboratory’s unsuccessful performance from the laboratory or from the PT program; and • Reviewing the PT performance reports and determining if the unsatisfactory results truly represent the laboratory’s failure to perform and report the test(s) satisfactorily. For example, clerical errors and delays in reporting still constitute failure; however, an instrument failure, a PT program data input error, or a backorder of necessary reagents may not be within the laboratory’s control. Careful reviews will provide a fair evaluation of the laboratory’s performance and insight into the reason(s) for the PT failure. Problems regarding PT samples such as matrix effects and scoring are to be handled between the laboratory and the PT program.