Comprehensive Cancer Centers Of Nevada-Twain

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 8/07/2022. 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 8/07/2022, 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 consecutive testing events for the first and second testing events of 2022 with a score of 20% in the first event of 2022 and a 0% in the second event of 2022 resulted in unsuccessful proficiency testing performance for the analyte, albumin. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for albumin in the first and second testing events of 2022. 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 desk review of federal database CASPER Report 155D and API PT evaluation forms on 8/07/2022, 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 albumin in the first and second testing events of 2022. 2. CASPER Report 155D and the API PT evaluation both reported a score of 20% for the first event and 0% for the second testing event of 2022. 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 8/07/2022, 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 8/07/2022, 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 albumin in the first and second testing events of 2022 resulting in unsuccessful PT performance. 2. CASPER Report 155D and API PT evaluation forms reviewed reported 20% for the first testing event and 0% for the second testing event of 2022 for albumin. -- 3 of 3 --

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 April 25, 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. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the 2020 and 2021 American Proficiency Institute (API) Hematology/Coagulation Proficiency Testing (PT) results, a review of the 2020 and 2021 College of American Pathologists (CAP) Electrophoresis Proficiency Testing (PT), and an interview with the Technical Consultant, the laboratory failed to review the participant summary to evaluate the laboratory results submitted to the proficiency testing programs for ungraded results and educational challenges. Findings include: 1. A review of the 2020 API Hematology/Coagulation test event one revealed that there was no documentation of a review of the data summary for the ungraded result for the Educational Blood Cell Identification specimen ECI-01. 2. A review of the 2020 API Hematology/Coagulation test event two revealed that there was no documentation of a review of the data summary for the ungraded result for Blood Cell Identification specimen BCI-09, and for the Educational Blood Cell Identification ECI-06. 3. A review of the 2020 API Hematology/Coagulation test event three revealed that there 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 -- was no documentation of a review of the data summary for the ungraded result for the Blood Cell Identification specimen BCI-11, and for the Educational Cell Identification specimen ECI-13. 4. A review of the 2021 API Hematology /Coagulation test event one revealed that there was no documentation of a review of the data summary for the Educational Blood Cell Identification for specimen ECI-03. 5. A review of the 2021 API Hematology/Coagulation test event two revealed that there was no documentation of a review of the data summary for the ungraded result for Blood Cell Identification specimen BCI-07, and for the ungraded Platelet Estimate result for specimen DIF-02. 6. A review of the 2021 API Hematology/Coagulation test event three revealed that there was no documentation of a review of the data summary for the ungraded result for the Educational Blood Cell Identification specimen ECI-15, and for the ungraded Platelet Estimate result for specimen DIF-03. 7. A review of the CAP 2020 Electrophoresis test event A revealed that there was no documentation of a review of the participant summary for the educational challenge for specimens SPE-01 and SPE-02 for the following tests: albumin electrophoresis (% and g/dl), alpha 1 globulin (% and g/dl), alpha 2 globulin (% and g/dl), beta globulin (% and g/dl), and total gamma globulin (% and g/dl). 8. A review of the CAP 2020 Electrophoresis test event B revealed that there was no documentation of a review of the participant summary for the educational challenge for specimens SPE-01 and SPE- 02 for the following tests: albumin electrophoresis (% and g/dl), alpha 1 globulin (% and g/dl), alpha 2 globulin (% and g/dl), beta globulin (% and g/dl), and total gamma globulin (% and g/dl). 9. A review of the CAP 2021 Electrophoresis test event A revealed that there was no documentation of a review of the participant summary for the educational challenge for specimens SPE-01 and SPE-02 for the following tests: albumin electrophoresis (% and g/dl), alpha 1 globulin (% and g/dl), alpha 2 globulin (% and g/dl), beta globulin (% and g/dl), and total gamma globulin (% and g/dl). 10. A review of the CAP 2021 Electrophoresis test event B revealed that there was no documentation of a review of the participant summary for the educational challenge for specimens SPE-01 and SPE-02 for the following tests: albumin electrophoresis (% and g/dl), alpha 1 globulin (% and g/dl), alpha 2 globulin (% and g/dl), beta globulin (% and g/dl), and total gamma globulin (% and g/dl). 11. The findings were confirmed during an interview with the Technical Consultant on April 25, 2022 at approximately 11:30 AM. The laboratory performs approximately 1,520,000 chemistry tests and 206,982 hematology tests annually. -- 2 of 2 --

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 23, 2020. 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. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing results in Hematology for testing years 2018 and 2019 and an interview with the laboratory manager, the laboratory failed to take and document

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 February 28, 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. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing results from testing years 2016 and 2017 for the laboratory testing categories of General Immunology, Routine Chemistry, Urinalysis, Endocrinology and Hematology and an interview with the laboratory area manager, the laboratory failed to maintain a copy of all records of documentation for each step in the testing and reporting of results for all proficiency testing samples. Findings include: 1. The laboratory failed to have documentation of the attestation statement for API proficiency testing performed in 2016 for the testing categories of General Immunology, Routine Chemistry, 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 -- Urinalysis, Endocrinology and Hematology. 2. The laboratory failed to maintain a copy of the laboratory testing records for proficiency testing samples performed in the testing categories of General Immunology, Routine Chemistry, Urinalysis, Endocrinology and Hematology. This was confirmed by the laboratory area manager on February 28, 2018 at approximately 1:30 PM. The laboratory performs approximately 1,403,067 patient laboratory tests annually in the testing categories of General Immunology, Routine Chemistry, Urinalysis, Endocrinology and Hematology. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the laboratory temperature recording logs from January 1, 2016 through December 31, 2017 and an interview with the laboratory area manager, the laboratory failed to follow the established freezer temperature requirement for the storage of reagents and patient specimens for laboratory analysis. Findings include: 1. The laboratory failed to follow the freezer temperature requirement of minus 14 degrees centigrade or below for the storage of reagents and patient specimens for laboratory analysis. 2. The freezer temperature recording log for January 2016 found 20 of 20 freezer temperature recordings that were outside of the established acceptable temperature range with no