Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on April 07, 2026 with the following standard level deficiencies cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: I. Based on direct observation, review of the laboratory's humidity records, and interview with the Testing Personnel (TP) #1 according to the Centers for Medicare and Medicaid Services (CMS) Form 209, the laboratory failed to define humidity ranges in accordance with manufacturer instructions for two of two instruments (Sysmex XN-430 and Ortho Vitros 5600). Findings Included: 1) During a tour of the laboratory at 1:20 PM on 4/07/2026, the following analyzers were observed in use within the laboratory: a) 1 Sysmex XN-430, Manufacturer Humidity Requirements 20 to 85% non-condensing b) 1 Ortho Vitros 5600, Serial Number 56005005, Manufacturer Humidity Requirements 15 to 75% non-condensing 2) Review of the laboratory's humidity records revealed an acceptable range of 10 to 80%. 3) In an interview at 1:25 PM on 4/07/2026, TP#1 confirmed the humidity range was not defined in accordance with manufacturer instructions for the two instruments. II. Based on direct observation, review of the laboratory's room temperature records, and interview with Testing Personnel (TP) #1 according to the Centers for Medicare 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 3 -- Medicaid Services (CMS) Form 209, the laboratory failed to define, monitor and document room temperature for the reagent and supply storage room for 2 of 2 years (2024 and 2025). Findings Included: 1) During a tour of the laboratory at 1:25 PM on 4/07/2026, the following temperature-dependent supplies were observed in storage available for use: a. 700 Becton Dickinson (BD) Vacutainer Gold-Top Serum Separator Tubes (SST), Lot Number 5324071, Manufacturer storage temperature requirements 4 to 25 degrees Celsius b. 1000 BD Vacutainer Tiger-Top SST Tubes, Lot Number 367988, Manufacturer storage temperature requirements 4 to 25 degrees Celsius c. 200 BD Vacutainer Purple-Top K2E Tubes, Lot Number 5317214, Manufacturer storage temperature requirements 4 to 25 degrees Celsius 2) Review of the laboratory's room temperature records revealed no monitoring and documentation of room temperature in the reagent and supply storage room for 2024 and 2025. 3) In an interview at 1:26 PM on 4/07/2026, TP#1 confirmed the laboratory did not monitor and document laboratory temperatures in the reagent and supply storage room. D5781