Nursedx Of Nevada Llc

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 7, 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. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a random patient audit of six patients tested between the dates of May 28, 2024 and November 11, 2025, and an interview with the technical consultant and the laboratory director, the laboratory failed to ensure that the Estimated Glomerular Filtration Rage (EGFR) were calculated using the race neutral equation. Findings include: 1. A random patient audit of six patients tested between the dates of May 28, 2024 and November 11, 2025 revealed that three of the six EGFR patient values reported were not calculated using the race neutral equation. The dates of the the reports were reviewed from February 14, 2025, July 7, 2025, and November 25, 2025. 2. The finding was confirmed during an interview with the technical consultant and the laboratory director conducted on January 7, 2026 at approximately 1:45 PM.. According to the provided CMS-116 form, the laboratory performs 400,000 chemistry tests annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) 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 -- (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures, and an interview with the technical consultant, the laboratory owner and laboratory director, the laboratory failed to establish a policy and procedure to periodically test the calculated results, the results sent via interfaced systems, and patient specific data for the laboratory information system (LIS) and there was no documentation of periodic checks of the LIS system.. Findings include: 1. There was no established policy and procedure to test the LIS to ensure that the calculated results, the results sent via interface between the instruments and the LIS, and the patient specific data was accurate and reliable. 2. There was no documentation of LIS testing to ensure that results that were calculated, the results sent via interface, and the patient specific data was accurate and reliable. 3. The findings were confirmed during an interview conducted on January 7, 2026 at approximately 1:15 PM. According to the provided CMS-116 form, the laboratory performs approximately 400,000 chemistry tests and 160,000 hematology tests annually. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, the lack of staff training for the Beckman Coulter AU 480 reagents introduced into the laboratory, and an interview with the technical consultant and the laboratory director, the technical consultant failed to ensure that training and competency assessments was performed and documented for the testing personnel prior to performing patient testing using the new reagents. Findings include: 1. A review of the laboratory menu revealed that the laboratory had changed the reagents used for chemistry testing on the Beckman Coulter AU 480 from the brand previously in use prior to June, 2025. The laboratory previously used Clear Chem brand reagents. The laboratory introduced the Beckman Coulter brand of reagents for chemistry testing. 2. There were no records of training and competency assessment for five of five testing personnel when the new reagents were placed in use during June, 2025. 3. The laboratory director and the technical consultant confirmed that the reagents were placed into use in June, 2025, and confirmed that no training for the new procedures had been performed and documented during an interview conducted on January 7, 2026 at approximately 11: 00 AM. According to the provided CMS-116 form, the laboratory performs 400,000 chemistry tests annually. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory training and competency records for 2024 and 2025, a review of the provided CMS-209 form, and an interview with the technical consultant, the technical consultant failed to ensure that annual competency assessments were completed for each testing personnel for the Sysmex XN-530. Findings include: 1. There was no annual competency assessment performed and documented for one of five testing personnel in 2024 for the Sysmex XN-530 hematology analyzer. The 2024 Sysmex XN-530 competency assessment for personnel number four listed on the CMS-209 form was not available at the time of the survey. 2. The technical consultant confirmed the finding during an interview conducted on January 7, 2026 at approximately 10:30 AM. According to the provided CMS-116 form, the laboratory performs 160,000 hematology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on November 5, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health 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. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on the findings herein, the Condition: Successful Participation (in a proficiency testing program) was not met. A review of the federal database CASPER Report 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 -- 0155D and the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on November 5, 2024 found that the laboratory failed to successfully participate in a proficiency testing program. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for Aspartate Aminotransferase (AST) in the first PT event of 2024 and the third PT event of 2024. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the federal database CASPER Report 0155D and the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on November 5, 2024, the laboratory failed to successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for Aspartate Aminotransferase (AST) in the first PT event of 2024 and the third PT event 2024. 2. Both the CASPER Report 0155D and the API PT evaluation reported a score of 0% for the first PT event of 2024 and the third PT event of 2024. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the findings herein, the Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director was not met. A review of the federal database CASPER Report 0155D and the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on November 5, 2024 found that the laboratory director failed to ensure successful participation in a proficiency testing program. Findings include: The laboratory director failed to ensure successful participation with the API PT program shown by the unsuccessful performance for Aspartate Aminotransferase (AST) in the first PT event of 2024 and the third PT event of 2024. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the federal database CASPER Report 0155D and the Amerian Proficiency Institute (API) proficiency testing (PT) evaluation forms on November 5, 2024, the laboratory director failed to ensure successful participation in a proficiency testing program. Findings include: 1. The laboratory director failed to ensure successful participation with the API PT program shown by the unsuccessful performance for Aspartate Aminotransferase (AST) in the first PT event of 2024 and the third PT event 2024. 2. Both the CASPER Report 0155D and the API PT evaluation reported a score of 0% for the first PT event of 2024 and the third PT event of 2024. -- 3 of 3 --