Spring Creek Urology Specialists Llc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 10/21/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory's analytes' list, proficiency testing (PT) records, policies /procedures, test accuracy verification records and staff interview, the laboratory failed to document twice-yearly evaluation of accuracy for two of two molecular microbiology targets for which PT agency did not offer samples, Prevotella bivia and Citrobacter braakii. Findings included: 1. Review of laboratory's molecular microbiology target/analyte list revealed Prevotella bivia and Citrobacter braakii as reportable targets. 2. Review of laboratory's PT records revealed the laboratory used American Proficiency Institute (API) as their PT provider. Further review of the API molecular microbiology target list revealed API did not offer samples for testing of Prevotella bivia and Citrobacter braakii. 3. Review of laboratory's "Split sample Analysis Protocol" (document SOP# QUAL 21.0.0, effective 03/01/2022) revealed: "Split sample analysis may be defined as the analysis of a sample by the laboratories primary method and a comparison method (a similar method used by another CLIA- certified laboratory)." And, "Split sample analysis may be used to determine the following: ... As a means of verifying the accuracy of testing non-regulated analytes for which the laboratory does not participate in proficiency testing." 4. The laboratory was asked to provide documentation of twice-yearly evaluation of accuracy for 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 -- detection of Prevotella bivia and Citrobacter braakii and no such documentation was available for review. 5. In an interview on 10/21/2025 at 1030 hours in the breakroom, the laboratory's Technical Supervisor (as indicated on submitted Form CMS 209) stated that the laboratory sent samples for the above targets for split sample analysis with another laboratory, but was unable to obtain that laboratory's final reports, and thus unable to perform split sample accuracy evaluation. This confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory's random patient reports and staff interview, the laboratory failed to document name and address of the testing laboratory for five of five random patient reports reviewed from August 2025. Findings included: 1. Review of five random patient reports from August 28, 2025, revealed no name and address of the testing facility documented on the final reports. The reports reviewed were for the following patients' samples: Sample: 4793C894879 4793C890407 4793C895901 4793C896188 4793C889302 2. In an interview on 10/21/2025 at 1130 hours in the breakroom, the laboratory's Technical Supervisor (as indicated on submitted Form CMS 209) confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 10/17/2023. The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories. STANDARD LEVEL DEFICIENCIES were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) instructions, laboratory's proficiency testing (PT) documents for 2022 and 2023, and staff interview, the laboratory failed to document attestation of PT being tested in the same manner as patients for one of four PT events reviewed. Findings included: 1. Review of API instructions for PT revealed:"SIGNATURES REQUIRED - For all PT results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years. " 2. Review of laboratory's PT documents for 2022 and 2023 revealed the following one of four reviewed PT events did not have a signed attestation document: 2022 Microbiology - 2nd Event Submitted electronically to API on: 06/24/2022 3. In an interview on 10/17/2023 at 1000 hours in the office, the laboratory's Technical Supervisor (as indicated on submitted form CMS 209), after review of the data, confirmed the findings. Key: CMS - Centers for Medicare and Medicaid 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 D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D6108- 42 C.F.R. 493.1447 Condition: Technical Supervisor high complexity D6141- 42 C.F.R. 493.1459 Condition: General Supervisor high complexity Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the