Alpine Medical Clinic

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 a lack of documentation and an interview with Testing Person 1 (TP1), the laboratory failed to monitor and document the room temperature and humidity in the room where hematology testing using the Sysmex Poch-100i CBC analyzer was performed. Findings include: 1. A request was made to review the room temperature and humidity in the laboratory, and documentation could not be provided. 2. An on- site interview with the TP1 on 12/17/2025 at 14:00 PM confirmed that room temperature and humidity levels were not documented. 3.The laboratory reports performing approximately 1,400 hematology 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 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 a review of refrigerator temperature logs and an interview with the laboratory director, the laboratory failed to document the temperature of the refrigerator where the Complete Blood Count (CBC) controls were stored for 43 of 61 days in June and July 2023. Findings include: 1. Temperature logs for June and July revealed temperature documentation for the refrigerator where the Streck EightCheck 3WP X-TRA controls are stored were missing for 26 of 30 days in June and 17 of 31 days in July 2023. 2. In an interview on September 13, 2023 at approximately 3:30 PM, the laboratory director confirmed the refrigerator temperature was not documented as required. 3. The laboratory reports performing approximately seventy- seven CBCs 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 --