Advanced Ambulatory Surgery Center Of

Summary Statement of Deficiencies D0000 Based on an on-site revisit survey conducted on April 8, 2026 for Advanced Ambulatory Surgery Center of Carlsbad NM. The laboratory was found to be incompliance with 42 CFR Part 493, Laboratory Requirements. No additional deficincies were identified. 51996 Based on a Recertification survey performed on January 14, 2026, the laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plans (IQCP), Quality Control (QC) Logs, and Patient Test Report, the laboratory failed to follow established QC procedures for the Abbott i-STAT CHEM8+ (CHEM8) and i-STAT Kaolin Activated Clotting Time (ACT) assays in 2025. Refer to D5445 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless 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 -- otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plans (IQCP), Quality Control (QC) Logs, and Patient Test List, the laboratory failed to perform QC at the frequency specified in the laboratory's IQCPs for 41 of 77 Abbott i-STAT CHEM8+ (CHEM8) and 4 of 6 i-STAT Kaolin Activated Clotting Time (ACT) tests performed in 2025. Findings include: 1. Review of the IQCPs for CHEM8 and ACT indicated QC must be performed for each assay: a. Each new lot b. Each new shipment c. Every 30 days after the lot/shipment is in use d. After system maintenance and Software Upgrades 2. Review of the CHEM8 and ACT QC Logs revealed QC was performed the following Days: a. CHEM8: 01/28/2025 05/07/2025 08/11/2025 08 /27/2025 b. ACT: 01/28/2025 05/07/2025 08/26/2025 3. Review of the Patient Test List revealed patient results were reported the following dates: a. CHEM8: MM/DD /YYYY (number patient results reported) 01/07/2025 (1), 01/08/2025 (2), 01/09/2025 (4), 01/14/2025 (5), 01/22/2025 (3) 02/28/2025 (1) 03/05/2025 (1), 03/11/2025 (2), 03 /12/2025 (1), 03/25/2025 (3), 03/26/2025 (1) 04/15/2025 (2), 04/19/2025 (1), 04/22 /2025 (1), 04/30/2025 (1) 06/10/2025 (1), 06/17/2025 (1) 07/15/2025 (2), 07/30/2025 (1) 10/03/2025 (1), 10/21/2025 (1), 10/29/2025 (1) 11/18/2025 (1), 11/26/2025 (1) 12 /09/2025 (1), 12/16/2025 (1) b. ACT: MM/DD/YYYY (number patient results reported) 03/26/2025 (2) 10/31/2025 (1) 12/17/2025 (1) 4. The laboratory reported 77 CHEM8 and 6 ACT tests in 2025. D5781

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 --