River City Pain Management, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 02/12/2026. The laboratory was found in substantial 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. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, test establishment studies, patient test volumes and staff interview, the laboratory failed to document specimen transport stability study as per its own policy prior to start of patient testing for one of one laboratory developed Urine Toxicology Test Panel. Findings included: 1. Review of laboratory's Urine Toxicology Test Panel's establishment study policy "Temperature Stability Study" (document: MediaLab SOP No.22 number 707160.2059 22.TOX; effective: 10/01/2025) revealed: "Sample 5 will be utilized with a temperature logger to document temperature changes during transit and then tested at the lab" 2. Review of laboratory's Urine Toxicology Test Panel's establishment studies, completed and 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 -- approved on 10/1/2025, revealed there was no documentation of the laboratory's sample 5 transit temperature study prior to start of patient testing on 10/03/2025. 3. Review of laboratory's submitted test volumes revealed the laboratory performed approximately 152,280 urine toxicology tests from October 2025 through January 2026. 4. In an interview on 02/12/2026 at 1045 hours in the office, the laboratory's Technical Supervisor (as indicated on submitted Form CMS 209) confirmed the findings. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, new test establishment studies, patients test volumes and staff interview the Laboratory Director failed to ensure that establishment studies were complete for one of one test performed by the laboratory in 2025 and 2026, the Urine Toxicology Test Panel. Refer to D5423. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, new test establishment studies, patients test volumes and staff interview the laboratory's Technical Supervisor (as indicated on submitted Form CMS 209) failed to ensure that establishment studies were complete for one of one test performed by the laboratory in 2025 and 2026, the Urine Toxicology Test Panel. Refer to D5423. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacture's maintenance requirements for the Viva ProE chemistry analyzer, review of the laboratory's Viva ProE maintenance records from January 2023 to December 2024, and staff interview, the laboratory failed to have documentation of performing required quarterly maintenance for 3 of 8 quarters. The findings included: 1. A review of the manufacture's maintenance requirements for the Viva Pro-E chemistry analyzer identified the following maintenance steps to be performed quarterly: Replace water filter Replace mixer belt Replace drying block on wash arm 2. A review of the laboratory's Viva ProE maintenance records from January 2023 to December 2024 identified the laboratory failed to have documentation of the following: a) 2nd Quarter 2023 - Replace water filter - Replace mixer belt b) 3rd Quarter 2024 - Replace water filter - Replace mixer belt c) 4th Quarter 2024 - Replace water filter - Replace mixer belt - Replace drying block on wash arm 3. Testing personnel #1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 03/17/2025 at 1030 hours in the break room. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical consultant performing semiannual competency assessments on 1 of 1 testing personnel. The findings included: 1. A review of the laboratory's personnel records determined testing personnel #1 (as listed on Form CMS 209) started performing moderate complexity testing in June 2023. 2. Further review of the personnel records for testing personnel number #1 identified a single competency assessment was performed in October 2024 (16 months after starting testing.). No other competency assessment were available for review. 3. Testing personnel #1 confirmed the findings in an interview conducted on 03/17/2025 at 0940 hours in the break room. -- 2 of 2 --