Southwest Medical Associates-Tenaya

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA desk review of proficiency testing obtained from the national database and verified with the laboratory onsite on May 27, 2026. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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. 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. 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 -- 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, a review of the College of American Pathologists (CAP) proficiency testing (PT) evaluation forms and an interview with the laboratory supervisor and the Registered Nurse (RN) Manager on May 27, 2026 found that the laboratory failed to successfully participate in two consecutive proficiency testing events, specifically the 2025 Point of Care Cardiac Markers (PCARM) third event and the 2026 PCARM first event, in the specialty of Routine Chemistry for the analyte B-Type Natriuretic (BNP). Refer to 2096. Findings include: The laboratory failed to maintain successful participation with the CAP PT program shown by the unsuccessful performance for B-Type Natriuretic (BNP) in two consecutive test events, specifically the third PT event of 2025 and for the first PT event of 2026. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, a review of the College of American Pathologists (CAP) proficiency testing (PT) evaluation forms on May 27, 2026, and an interview with the laboratory supervisor and the Registered Nurse (RN) Manager the laboratory failed to successfully participate in two consecutive proficiency testing events, specifically the 2025 Point of Care Cardiac Markers (PCARM) third event and the 2026 PCARM first event, in the specialty of Routine Chemistry for the analyte B- Type Natriuretic (BNP). Findings include: 1. The laboratory failed to ensure successful participation with the CAP PT program shown by the unsuccessful performance for BNP in the third PT event of 2025 and first PT event 2026. 2. The CASPER Report 0155D reported a score of 0% for the third PT event of 2025 and 0% for the first PT event of 2026. 3. The laboratory records for the CAP PT evaluations for the third PT event of 2025 reported a score of 0% and 0% for the first PT event of 2026. 4. During an interview conducted with the laboratory supervisor and the RN Manager on May 27, 2026 at approximately 10:15 am, it was confirmed that the laboratory failed to submit results to CAP for the third PT event of 2025 and for the first PT event of 2026. 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: Successful Participation (in a proficiency -- 2 of 3 -- testing program) was not met. A review of the federal database Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, a review of the College of American Pathologists (CAP) proficiency testing (PT) evaluation forms and an interview with the laboratory supervisor and the Registered Nurse (RN) Manager on May 27, 2026 found that the laboratory director failed to ensure successful participation in two consecutive proficiency testing events, specifically the 2025 Point of Care Cardiac Markers (PCARM) third event and the 2026 PCARM first event, in the specialty of Routine Chemistry for the analyte B-Type Natriuretic (BNP). Findings include: The laboratory director failed to ensure successful participation with the CAP PT program shown by the unsuccessful performance for B-Type Natriuretic (BNP) in the third PT event of 2025 and for the first PT event of 2026. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the federal database CASPER Report 0155D, a review of the College of American Pathologists (CAP) proficiency testing (PT) evaluation forms on May 27, 2026, and an interview with the laboratory supervisor and the Registered Nurse (RN) Manager the laboratory director failed to ensure successful participation in two consecutive proficiency testing events, specifically the 2025 Point of Care Cardiac Markers (PCARM) third event and the 2026 PCARM first event, in the specialty of Routine Chemistry for the analyte B-Type Natriuretic (BNP). Findings include: 1. The laboratory director failed to ensure successful participation in the CAP PT program shown by the unsuccessful performance for BNP in the third PT event of 2025 and first PT event 2026. 2. The CASPER Report 0155D reported a score of 0% for the third PT event of 2025 and 0% for the first PT event of 2026. 3. The laboratory records for the CAP PT evaluations for the third PT event of 2025 reported a score of 0% and 0% for the first PT event of 2026. 4. During an interview conducted with the laboratory supervisor and the RN Manager on May 27, 2026 at approximately 10:15 am, it was confirmed that the laboratory failed to submit results to CAP for the third PT event of 2025 and 0% for the first PT event of 2026. -- 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 August 26, 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 College of Amerian Pathologists (CAP) proficiency testing (PT) evaluation forms on 08/26/2024 found that the laboratory failed to successfully participate in a proficiency testing program. Findings include: The laboratory failed to maintain successful participation with the CAP PT program shown by the unsuccessful performance for platelets in the third PT event of 2023 and first PT event of 2024. Refer to D2121. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the federal database CASPER Report 0155D and the College of Amerian Pathologists (CAP) proficiency testing (PT) evaluation forms on 08/26/2024, the laboratory failed to successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the CAP PT program shown by the unsuccessful performance for platelets in the third PT event of 2023 and first PT event 2024. 2. Both the CASPER Report 0155D and the CAP PT evaluation reported a score of 60% for the third PT event of 2023 and first 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 College of Amerian Pathologists (CAP) proficiency testing (PT) evaluation forms on 08/26/2024 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 CAP PT program shown by the unsuccessful performance for platelets in the third PT event of 2023 and first 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 College of Amerian Pathologists (CAP) proficiency testing (PT) evaluation forms on 08/26/2024, 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 CAP PT program shown by the unsuccessful performance for platelets in the third PT event of 2023 and first PT event 2024. 2. Both the CASPER Report 0155D and the CAP PT evaluation reported a score of 60% for the third PT event of 2023 and first PT event of 2024. -- 3 of 3 --