Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on January 28, 2026. The findings and conclusions of any investigation by the Nevada Health Authority-Division of Healthcare Purchasing and Compliance shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 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 a review of the laboratory Individualized Quality Control Plan (IQCP) for the Activated Clotting Time (ACT) test, a random patient audit of five patients tested between the dates of May 29, 2024 and October 27, 2025, and an interview with the laboratory supervisor, the laboratory failed to follow the IQCP for one of five months reviewed. Findings include: 1. The established director approved IQCP stated that two levels of quality control must be performed with each new lot number of cartridges, each new shipment of cartridges, every 30 days after the lot/shipment is in use and after system maintenance and software upgrades. 2. A random patient audit of five patients tested between the dates of May 29, 2024, September 11, 2024, January 7, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 2025, June 30, 2025 and October 27, 2025 revealed that the laboratory performed two levels of quality control for the ACT cartridge lot number D4JLR100 on July 31, 2024. 3. The laboratory failed to perform two levels of quality control within 30 days of July 31, 2024. 4. The patient reviewed was tested on September 11, 2024, which was greater than 30 days after the previous quality control performance. 5. The findings were confirmed during an interview with the laboratory supervisor on January 28, 2026 at approximately 2:45 PM. According to the provided CMS-116 form, the laboratory performs 1500 hematology tests annually. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of the director approved Individualized Quality Control Plan (IQCP) for the Activated Clotting Time (ACT) test, a review of the laboratory quality control records between the dates of May 29, 2024 and October 27, 2025, a random patient audit of five patients tested between the dates of May 29, 2024 and October 27, 2025, a review of the laboratory quality assessment monthly checklist for September, 2024, and an interview with the laboratory supervisor and technical consultant, the technical consultant failed to detect and failed to ensure that