Sterling Urgent Care

Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with CLIA regulations (42 CFR Part 493 effective April 24, 2003.), all previous deficiencies found were corrected. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a direct observation and an interview with the laboratory compliance manager on 5/6/2025, the laboratory failed to discontinue the use of expired vacutainer blood specimen collection tubes. The findings include: 1. A direct observation of the laboratory's blood specimen collection tubes on 5/6/2025 identified that the laboratory failed to discontinue the use of one (2) BD K2 EDTA tube lot 3136182, expiration 9/30/2024; one (1) Greiner Bio One K2 EDTA tube lot B230833N, expiration 11/30/2024 and two (2) Greiner Bio One K2 EDTA tubes lot B2311378, expiration 3/2/2025, prior to the expiration dates. 2. An interview with the laboratory compliance manager on 5/6/2025 at 3:29 pm confirmed the above finding. 3. The laboratory reports performing 3,456 waived and moderate complexity tests annually 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. 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 a review of the laboratory maintenance logs, instrument manuals and an interview with the laboratory compliance manager on 5/6/2025, the laboratory failed to perform maintenance as required by the Sysmex pocH-100i manufacturer. The findings include: 1. A review of maintenance logs for the Sysmex pocH-100i instrument identified that the laboratory failed to have documentation of the performance of daily and biweekly maintenance for December 2023. 2. An interview with the laboratory compliance manager on 5/6/2025 at 3:30 pm confirmed the above finding. 3. The laboratory reports performing Sysmex pocH-100i 456 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on a review of patient test reports and an interview with the laboratory manager on 10/25/2023, the laboratory failed to specify the test method for Prostate Specific Antigen (PSA) testing on patient test reports. The findings include: 1. A review of patient test reports for PSA testing identified that the laboratory failed to list the analyzer and methodology used for performing the test to ensure proper test interpretation. 2. An interview with the laboratory manager on 10/25/2023 at 3:13 pm confirmed that the laboratory failed to list the analyzer and testing methodology on PSA test reports. 3. The laboratory reports performing 10 PSA tests annually. 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 --