Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on July 30, 2024, at Advanced Ambulatory Surgery Center of Carlsbad NM found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. 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 direct observation, review of the systems manual, lack of documentation, and interview with the Technical Consultant, the laboratory failed to monitor and document the room temperature and humidity was within manufacturer's specifications for the iStat analyzer since beginning patient testing in May 2024. Findings included: 1. During a tour of the laboratory on 07/30/2024 at 11:00 am, an iStat analyzer, serial number: 433155 was observed. 2. A review of the systems manual for the iStat analyzer listed, "Operating Temperature: 16 - 30 C(Celsius) or 61 - 86F (Fahrenheit), Relative Humidity: 10 - 90% " 3. The laboratory was unable to provide evidence of room temperature and humidity being monitored and documented as specified by the manufacturer's instructions. 4. An interview on 07/30/2024 at 11: 20 am, with the Technical Consultant confirmed the above findings. 5. The laboratory reported performing 2508 iStat 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 --