Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies cited. 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: I. Based on surveyor observation, review of manufacturer's instructions, maintenance logs, and confirmed in interview, the laboratory failed to document monthly maintenance performed for two of six months reviewed in 2024 and one of two months reviewed in 2025. Findings Included: 1. During a tour of the facility on 04/15 /2025 at 09:53 AM, the surveyor observed one Siemens V-Twin analyzer (Serial Number: 23-1333) performing patient testing. 2. Review of manufacturer's instructions for the Siemens V-Twin chemistry analyzer (Version: 23516) revealed the following: "Weekly Maintenance Rinsing the Probes 1. Fill the probe rinse bottle on the reagent rotor with sodium solution and the tube in the W position on the sample rotor, with fresh 10% cleaning solution or probe rinse solution." 3. Review of laboratory monthly maintenance logs in 2024 and 2025, revealed the following months monthly maintenance was not documented on the Siemens V-Twin system: a. November 2024 b. December 2024 c. January 2025 The surveyor requested documentation of monthly maintenance performed on the Siemens chemistry analyzer for the above months in 2024 and 2025, and no documentation was provided. 4. In an interview on 04/15/2025 at 11:22 AM in the facility office, Testing Person 1 (TP-1) confirmed the above findings. II. Based on surveyor observation, review of manufacturer's instructions, maintenance logs, and confirmed in interview, the laboratory failed to document quarterly maintenance performed on the Siemens V- Twin for four of four quarters in 2024. Findings Included: 1. During a tour of the 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 -- facility on 04/15/2025 at 09:53 AM, the surveyor observed one Siemens V-Twin analyzer (Serial Number: 23-1333) performing patient testing. 2. Review of manufacturer's instructions for the Siemens V-Twin chemistry analyzer (Version: 23516) revealed the following: "Quarterly Maintenance Replace the drying block" 3. Review of laboratory maintenance logs in 2024, revealed the following: No quarterly maintenance was documented in 2024 on the Siemens V-Twin analyzer. The surveyor requested documentation of quarterly maintenance performed on the Siemens analyzer in 2024, and no documentation was provided. 4. In an interview on 04/15 /2025 at 11:22 AM in the facility office, Testing Person 1 (TP-1) confirmed the above findings. -- 2 of 2 --