Summary:
Summary Statement of Deficiencies 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: Based on review of laboratory records, lack of documentation, and interview with the Laboratory Administrative Director (LAD), the laboratory failed to monitor relative humidity to ensure proper operating conditions were met for 2 of 2 instruments used to perform chemistry blood gas analyses from 2024 until day of survey. Findings include: 1. On the day of survey, 04/14/2026, at 10:35am, the laboratory could not provide documentation for monitoring room humidity to ensure operating conditions were met for the following 2 of 2 instruments used to perform chemistry blood gas analyses from 2024 until day of survey: - 1 of 1 Siemens Epoc: manufacturer's system requirements for relative humidity 0-85%. - 1 of 1 Werfen GEM Premier 5000: manufacturer's system requirements for relative humidity 0-95%. 2. The laboratory performed 1,450 chemistry blood gas analyses in 2025 (CMS 116, estimated annual volume, dated 04/14/2026). 3. The LAD confirmed the findings above on 4/14/2026 at 11:30 am. 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 --