Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The conditions not met were: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies and procedures, accuracy assessments, pre-survey paperwork, and interview, the laboratory failed to verify the accuracy of urine cytology diagnostic interpretations at least twice annually for two of two years reviewed in 2022, 2023, and 2024. Findings follow. A. Review of the laboratory's policy and procedure titled General Laboratory Policy.006 Proficiency Testing, reviewed 05/08/2024, under Pathology stated, "The laboratory is enrolled in the CAP PIP and NGC PT programs as part of the pathologist assessment program. All PT materials are processed and reported to CAP by the pathologist. CAP documents are retained and matched with results from CAP when received. After review by the medical director, they are filed in the CAP PT binder. Urology Austin coordinates testing with [name redacted] for interpretation of slides evaluated utilizing Fluorescent In-Situ Hybridization (FISH). [Name redacted] provides Urology Austin with actual CAP material that has been completed by their laboratory. The Urology Austin pathologist reads the smears and reports results to [name redacted]. A report is then received from [name redacted] documenting our findings and how we scored in comparison to their graded results. [Name redacted] provides two to three sets of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- challenge slides per calendar year for our interpretation to satisfy the Alternative PT Assessment. Any discordance with [name redacted] results require