Comprehensive Cancer Centers Of Nv-Wigwam

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 May 16, 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. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the 2022, 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) records, a review of the director approved policy, a review of the completed CMS-209 form and an interview conducted on May 16, 2024 at approximately 2:15 PM with Technical Consultants 1 and 2, the laboratory failed to ensure that the hematology proficiency testing specimens were rotated among all personnel performing patient testing. Findings include: 1. A review of the laboratory proficiency testing attestation records for the API PT Hematology/Coagulation 2022 test events 1, 2 and 3, a review of the API PT Hematology/Coagulation 2023 test events 1, 2 and 3, and a review of the API PT Hematology/Coagulation 2024 test event 1 revealed that the specimens for all test events were performed only by testing personnel number 1 identified on the completed CMS-209 form. 2. A review of the director approved procedure entitled "Proficiency Testing" in the section entitled "Specimen Handling" stated in step 3, "PT samples should be rotated among the testing personnel in the laboratory." 3. The Technical Consultants 1 and 2 identified on the CMS-209 form confirmed the findings during an interview conducted on May 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 -- 16, 2024 at approximately 2:15 PM. The laboratory performs approximately 63,000 hematology tests annually. -- 2 of 2 --

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 2/22/2022. 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 desk review of federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 2/22/2022, 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 -- the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the first and third testing events of 2021 with a score of 0% and 48%, respectively, resulted in unsuccessful proficiency testing performance for white blood cell differentials. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for white blood cell differentials in the first and third testing events of 2021. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 desk review of federal database CASPER Report 155D and API PT evaluation forms on 2/22/2022, the laboratory did not 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 the white blood cell differentials in the first and third testing events of 2021. 2. CASPER Report 155D and the AAB PT evaluation both reported a score of 0% for the first testing event of 2021 and a score of 48% for the third testing event of 2021. 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 desk review of federal database CASPER Report 155D and API PT evaluation forms, on 2/22/2022, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. 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 desk review of federal database CASPER Report 155D and API PT evaluation forms on 2/22/2022, the laboratory director failed to ensure that proficiency testing samples were tested as required. Findings include: 1. The laboratory failed to achieve satisfactory performance for white blood cell differentials in the first and third testing events of 2021 resulting in unsuccessful PT performance. 2. CASPER Report 155D and API PT evaluation forms reviewed reported a 0% score for the first testing event of 2021 and a 48% score for the third testing event of 2021 for white blood cell differentials. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This statement of deficiencies was generated as a result of the on-site CLIA recertification survey conducted at your facility on March 14, 2018. 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. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the director approved laboratory policy and procedure manual and an interview with the laboratory area manager, the laboratory failed to have the laboratory director approve changes that were made to the policy and procedure manual. Findings include: 1. The laboratory failed to have 17 revised policy and procedures be approved by the laboratory director. 2. The laboratory director last signed and dated the laboratory policy and procedure manual on 1/25/16. There were 17 revised policy and procedures that had been added to the manual that had the signature and date of another person that was not the director of this laboratory. This was confirmed by the laboratory area manager on March 14, 2018 at approximately 3: 00 PM. The laboratory performs approximately 56,059 patient Hematology tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the laboratory temperature recording logs from February 1, 2016 through March 14, 2018 and an interview with the laboratory area manager, the laboratory failed to follow the established temperature requirements for room temperature and freezer temperature for the storage of laboratory supplies and patient specimens. Findings include: 1. The laboratory failed to follow the freezer temperature requirement of minus 15 degrees centigrade or below for the storage of patient specimens that were to be sent to reference laboratories for test analysis. 2. The laboratory failed to follow the room temperature requirement of 15 to 25 degrees centigrade for the storage of laboratory supplies and reagents. 3. The freezer temperature recording logs for August 2016 and Septemer 2016 found 24 of 38 freezer temperature recordings that were outside of the established acceptable temperature range with no