PT Referral

6061 – PT Referral (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) If the SA identifies or suspects PT referral is occurring or has occurred, whether during an onsite survey, complainant’s allegations, PT desk review, or other means, contact CMS immediately. If CMS directs the SA to investigate the potential PT referral, collect all information related to the PT referral including all records, interviews, and observations. Send all PT referral documents for review to CMS immediately. CMS will provide a recommendation for sanctions in accordance with Subpart R for all PT referral cases. See section 6276.2 for enforcement and sanction information related to PT referral. Documentation forwarded to CMS should include, at a minimum: • Form CMS-2567 • SOP for PT and the specific analyte, test, specialty, or subspecialty approved at the time of the survey • Survey notes and evidence • PT submission forms • Any written communication between lab personnel • Instrument printouts • Narrative from the surveyor If it is determined that PT samples or PT results have been referred to another laboratory, ‘PT Referral’ is cited. The SA prepares a Form CMS-2567 including the deficiencies related to the PT referral at D2000 and D2013. (Per Mandatory Citations). Do not solicit an Allegation of Compliance from a laboratory when it has been determined that the laboratory intentionally referred its PT samples to another laboratory for analysis and submitted the other laboratory’s results as its own. The regulations divide the PT referral sanctions into three categories based on the severity and the extent of the referrals. 1. The first category is for the most egregious violations, encompassing cases of repeat PT referral or cases where the laboratory reports another laboratory’s test results as its own. For example, a laboratory may have two distinct sites, Laboratory A and Laboratory B, that operate under different CLIA numbers. Laboratory A has received PT samples to be tested as part of its enrollment in PT as required by the CLIA regulations. If Laboratory A were to refer PT samples to Laboratory B, receive test results back at Laboratory A from Laboratory B prior to the event cut-off date, and report to the PT program those results obtained from Laboratory B, the scores for the PT event would not reflect the performance of Laboratory A but the performance of Laboratory B. The PT scores would actually be reflective of the accuracy and reliability at Laboratory B rather than A, the purpose of the PT would be undermined. 2. The second category PT referral includes when a laboratory reports its own PT sample results but obtains test results for PT samples from another laboratory on or before the cut-off date. For example, a laboratory refers PT samples to another laboratory that operates under a different CLIA number before the PT event close date and, while the laboratory reports its own results to the PT program, it receives results from the second laboratory prior to the event close date. Such a referral situation allows the referring laboratory an opportunity to confirm, check, or change its results prior to reporting its results to the PT program. 3. The third category of PT referral can include when a laboratory reports its own PT sample results but obtains test results for PT samples from another laboratory after the cut-off date, or when a referring laboratory sends PT samples for confirmatory, distributive, or reflex testing, even if they do not receive test results from another laboratory prior to the event cut-off date and reports their own results. For example, a laboratory may place PT samples in an area where other patient specimens are picked up by a courier to take to a reference laboratory. The reference laboratory courier may take the PT samples along with the patients’ specimens. The laboratory personnel notice that the PT samples are missing and contact the reference laboratory to inquire if they have received the PT samples along with the patients’ specimens. The reference laboratory is instructed to discard the PT samples and not test them since they were picked up in error. In this case, the “referring” laboratory realized the error, contacted the receiving laboratory, and did not receive results back for any of the PT samples. Inter-laboratory communication is also prohibited when laboratories perform tests on proficiency testing samples by CLIA regulations at 42 CFR 493.801(b)(4) (D2012). When a laboratory with multiple testing sites or separate locations participates in any communications across sites/locations concerning PT sample results before the date by which the laboratory must report PT results to the PT program, the laboratory is in violation of the inter-laboratory communication prohibition and the SA should report this to CMS. Additionally, if a laboratory is on the receiving end of a PT referral, they should report it to CMS. Laboratories experiencing poor performance for analytes using a PT program other than the one that is designated for CLIA compliance purposes or for analytes, tests, specialties, and subspecialties not listed in Subpart I should address the failures via their own internal quality assurance protocol. To avoid implications of PT referral, laboratories using previously tested PT samples for competency assessment, training or other in-house purposes should wait until after the PT event cut-off date for reporting results to the PT program. If a laboratory chooses to use PT samples from a CMS-approved PT program for the purpose of meeting the quality assessment requirements at 42 CFR 493.1236(c) and intentionally refers those samples to another laboratory, as stated at 42 CFR 493.801(b)(4), it may have its certificate revoked as stated in 42 CFR 493.1840. This refers to ALL samples purchased from a PT program; samples for tests listed in subpart I AND samples for tests not listed in subpart I that must be checked for accuracy twice per year for quality assessment (QA) purposes. Laboratories with Certificates of Waiver are not exempt from the ban against referral of PT sample and other penalties required when PT referral has been substantiated.