Uchealth - Longmont Clinic Lab

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on September 3, 2026, deficiencies were cited for UCHealth Longmont Clinic in Longmont, Colorado. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, a review of the laboratory documents, and an interview with the general supervisor (GS), the laboratory failed to evaluate and define the relationship between test results using the different methodologies, specifically automated cell identification and manual cell identification. Findings include: 1. A review of the laboratory test menu revealed that this laboratory performs both automated differential and manual differential. 2. A review of the laboratory documents revealed that there is no documentation of comparison between the two methodologies of automated and manual differentials. 3. An interview with the general supervisor (GS) on 9/3/2026 at 2:23 PM confirmed that there was no comparison performed between automated and manual cell identification. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) scores and staff confirmation, the laboratory failed to achieve successful PT performance in 2 of 3 consecutive testing events in the specialty of Immunology for the 3rd event of 2017 and 1st event of 2018. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) scores and laboratory manager confirmation, the laboratory failed to achieve satisfactory performance for the the analyte of rubella in the specialty of Immunology in 2 of 3 consecutive PT events. Findings include: Rubella: 3rd Event of 2017: 0% 1st Event of 2018: 60% -- 2 of 2 --