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 June 24, 2026. The findings and conclusions of any investigation by the 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. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on a review of the Medical Director Monthly Site Visit Log, the Nevada Administrative Code (NAC) Chapter 652, and an interview with the office manager, the laboratory failed to ensure that the laboratory director was on the premises at least once per month for 17 of 20 months between November 2024 and June 2026, as required by NAC 652.370(2). Findings include: 1. A review of the Medical Director Monthly Site Visit Log showed that the laboratory director was onsite only three times-April 14, 2025; December 9, 2025; and June 22, 2026-resulting in 17 missed monthly visits of 20 total months during the period of November 2024 through June 2026. 2. NAC 652.370(2) states: "The director must be on the premises of the laboratory at least once each month. If the director is absent from the laboratory for 1 month or more, the director shall provide a licensed substitute to serve in his or her place, unless the laboratory is in a rural area and the Division determines that a substitute is not necessary." 3. These findings were confirmed during an interview with the office manager on June 24, 2026, at approximately 10:30 AM. According to the CMS-116 submitted at the time of the survey, the laboratory performs 3,153 histopathology 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 3 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a random audit of five patient records from January 8, 2025 through March 16, 2026, a review of maintenance logs, and interviews with the office manager and the histology technician, the laboratory failed to document temperatures for the room, cryo cold plate, paraffin oven, water bath, and slide dryer, and failed to document decontamination of the grossing cutting board for 16 of 16 working days between December 9, 2025 and December 31, 2025. Findings include: 1. A review of one patient record dated December 18, 2025 revealed that temperatures for the room, cryo cold plate, paraffin oven, water bath, and slide dryer were not documented, and that decontamination of the grossing cutting board was not performed or documented for 16 of 16 working days between December 9 and December 31, 2025. 2. A review of the December 2025 maintenance log confirmed that temperatures for the room, cryo cold plate, paraffin oven, water bath, and slide dryer were not documented, and that grossing cutting board decontamination was not performed or documented for 16 of 16 working days during the same period. 3. These findings were confirmed during interviews with the office manager and the histology technician on June 24, 2026, at approximately 11:30 AM. According to the CMS-116 submitted at the time of the survey, the laboratory performs 3,153 histopathology tests annually. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of