Desert Oasis Healthcare Medical Group

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 07/07/2026, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2025-1 and 2025-3), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Hematocrit (Hct) resulting in unsuccessful performances. See D2121. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two out of three consecutive testing events (2025-1 and 2025-3) for the analyte Hematocrit (specialty Hematology): The finding include: 1. Hematocrit 60% - 2025 first testing event; Hematocrit 60% - 2025 third testing event; A review of the 2025 first and third event scores from American Proficiency Institute (API) confirmed the above findings. . 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 a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute (API) records for 2025-1 and 2025-3 events, the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful participation of the proficiency testing. 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 proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute (API) records for 2025-1 and 2025-3 events, the laboratory director failed to ensure successful proficiency testing participation as required in this subpart. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control records and interview with the laboratory technical consultant on January 26, 2024, at 11:35 am, the laboratory failed to have control procedures that monitor the precision of the complete analytic process. The findings include: 1. The laboratory performed Troponin test using the Triage Meter instrument. The laboratory used a control procedure by running quality control materials on each day of patient testing to detect immediate errors and system failure. However, the laboratory lacked a control procedure that will monitor the precision of the test over time. Test precision is usually monitored over time by a Levey-Jennings chart of the control. The laboratory did not monitor the trend and shift of the control over time and thus failed to detect any system failure. As a result, the laboratory failed in proficiency testing in 2023 and passed after re-calibration of the instrument. Therefore, the accuracy of the Troponin test results rendered by the laboratory cannot be assured and might have had harmed patients. 2. The laboratory technical consultant on January 26, 2024, at 11:35 am, affirmed that the laboratory did not use a Levey-Jennings chart to monitor test precision. 3. The laboratory's testing 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 -- declaration form, signed by the laboratory director on 1/15/2024 stated that the laboratory performs approximately 1,224 Troponin 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, patients test, quality control and quality assessment records, and interview with the laboratory technical consultant on January 26, 2024, at 11:35 am, the laboratory failed to establish the quality assessment for the analytical system. The findings include: The laboratory did not have a system in place to assess the quality of its work, see D5441. Quality assessment is an ongoing review process that encompasses all facets of the laboratory's technical and non-technical functions at all location/sites where testing is performed. When the laboratory discovers an error or identifies a potential problem, actions must be taken to correct the situation. This correction process involves identification and resolution of the problem, and development of policies that will prevent recurrence. QA of the Analytic System includes assessing: Test procedures; Accurate and reliable test systems, equipment, instruments, reagents, materials, and supplies; Specimen and reagent storage condition; Equipment/instrument/test/system maintenance and function checks; Establishment and verification of method performance specifications; Calibration and calibration verification; Control procedures; Comparison of test results;