Southern Oncology Specialists

Summary Statement of Deficiencies 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 CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018, 2019, and 2020 API(American Proficiency Institute) proficiency testing results 1/20/21, the laboratory failed to successfully participate for WBC(White blood cell) differential on five of eight consecutive test events, failed to successfully participate for Platelets on two of three consecutive test events, and failed to successfully participate for the specialty of Hematology on two consecutive test events. See the deficiencies cited at D2130 and D2131. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018, 2019, and 2020 API(American Proficiency Institute) proficiency testing results 1/20/21, the laboratory failed to achieve satisfactory performance for WBC(white blood cell) differential on five of eight consecutive test events and failed to achieve satisfactory performance for Platelets on two of three consecutive test events, resulting in unsuccessful performance. Findings: 1. WBC Differential: a. Desk review of CMS Casper report 155D and 2018 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 granulocytes % samples, 5 of 5 lymphocytes % samples, and 5 of 5 monocytes % samples and received a score of 0% for WBC differential on the API 2018 2nd Hematology test event. b. Desk review of CMS Casper report 155D and 2018 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 granulocytes % samples, 5 of 5 lymphocytes % samples, and 5 of 5 monocytes % samples and received a score of 0% for WBC differential on the API 2018 3rd Hematology test event. c. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 1 of 5 granulocytes % samples, 2 of 5 lymphocytes % samples, and 3 of 5 monocytes % samples, and received a score of 60% for WBC differential on the API 2019 2nd Hematology test event. d. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 lymphocytes % samples and 5 of 5 monocytes % samples, and received a score of 33% for WBC differential on the API 2020 2nd Hematology test event. e. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 lymphocytes % samples, 5 of 5 basophils % samples, 5 of 5 eosinophils % samples, 5 of 5 monocytes % samples, and 5 of 5 neutrophils % samples, and received a score of 12% for WBC differential on the API 2020 3rd Hematology test event. 2. Platelets: a. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 platelet samples, and received a score of 60% for platelets on the API 2020 1st Hematology test event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 platelet samples, and received a score of 0% for platelets on the API 2020 3rd Hematology test event. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 CMS (Centers for Medicare and Medicaid Services) Casper -- 2 of 4 -- reports 153D and 155D and desk review of 2020 API (American Proficiency Institute) proficiency testing results 1/20/21, the laboratory failed to achieve satisfactory performance for the specialty of Hematology on two consecutive test events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 33% for White Blood Cell Differential, and a score of 0% for Leukocyte Count, resulting in an overall score of 72% for the specialty of Hematology on the API 2020 2nd Hematology test event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 12% for White Blood Cell Differential, a score of 60% for Erythrocyte Count, a score of 20% for Hematocrit, and a score of 0% for Platelets, resulting in an overall score of 48% for the specialty of Hematology on the API 2020 3rd Hematology test event. 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 CMS(Centers for Meicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018, 2019, and 2020 API(American Proficiency Institute) proficiency testing results 1/20/21, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018, 2019, and 2020 API (American Proficiency Institute) proficiency testing results 1/20/21, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. WBC Differential: a. Desk review of CMS Casper report 155D and 2018 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 granulocytes % samples, 5 of 5 lymphocytes % samples, and 5 of 5 monocytes % samples and received a score of 0% for WBC differential on the API 2018 2nd Hematology test event. b. Desk review of CMS Casper report 155D and 2018 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 granulocytes % samples, 5 of 5 lymphocytes % samples, and 5 of 5 monocytes % samples and received a score of 0% for WBC differential on the API 2018 3rd Hematology test event. c. Desk review of CMS Casper report 155D and -- 3 of 4 -- 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 1 of 5 granulocytes % samples, 2 of 5 lymphocytes % samples, and 3 of 5 monocytes % samples, and received a score of 60% for WBC differential on the API 2019 2nd Hematology test event. d. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 lymphocytes % samples and 5 of 5 monocytes % samples, and received a score of 33% for WBC differential on the API 2020 2nd Hematology test event. e. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 lymphocytes % samples, 5 of 5 basophils % samples, 5 of 5 eosinophils % samples, 5 of 5 monocytes % samples, and 5 of 5 neutrophils % samples, and received a score of 12% for WBC differential on the API 2020 3rd Hematology test event. f. Desk review of CMS Casper reports 153D and 155D revealed the laboratory failed to achieve satisfactory performance for WBC differential on five of eight consecutive proficiency testing events, resulting in non-initial unsuccessful performance. 2. Platelets: a. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 platelet samples, and received a score of 60% for platelets on the API 2020 1st Hematology test event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 platelet samples, and received a score of 0% for platelets on the API 2020 3rd Hematology test event. 3. Hematology: a. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 33% for White Blood Cell Differential, and a score of 0% for Leukocyte Count, resulting in an overall score of 72% for the specialty of Hematology on the API 2020 2nd Hematology test event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 12% for White Blood Cell Differential, a score of 60% for Erythrocyte Count, a score of 20% for Hematocrit, and a score of 0% for Platelets, resulting in an overall score of 48% for the specialty of Hematology on the API 2020 3rd Hematology test event. -- 4 of 4 --

Summary Statement of Deficiencies 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 CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results on 11/20/19, the laboratory failed to successfully participate in proficiency testing for White Blood Cell Differential. See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results on 11/20/19, the laboratory failed to achieve satisfactory performance for White Blood Cell Differential in three of four consecutive test events, resulting in unsuccessful performance. Findings: 1. Review of CMS Casper 155D revealed the laboratory received a score of 0% for White Blood Cell Differential on the 2018 2nd and the 2018 3rd Hematology events and received a score of 60% for White Blood Cell Differential on the 2019 2nd Hematology event. 2. Review of 2018 and 2019 API proficiency testing results revealed: a. The laboratory received a score of 0% for White Blood Cell Differential on the 2018 2nd and the 2018 3rd Hematology events. b. The laboratory received a score of 80% for granulocytes %, a score of 60% for lymphocytes %, and a score of 40% for monocytes %, resulting in a score of 60% for White Blood Cell Differential on the 2019 2nd Hematology event. 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 CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results on 11/20/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. See the deficiency cited at 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; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results on 11/20/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Review of CMS Casper 155D revealed the laboratory received a score of 0% for White Blood Cell Differential on the 2018 2nd and the 2018 3rd -- 2 of 3 -- Hematology events and received a score of 60% for White Blood Cell Differential on the 2019 2nd Hematology event. 2. Review of 2018 and 2019 API proficiency testing results revealed: a. The laboratory received a score of 0% for White Blood Cell Differential on the 2018 2nd and the 2018 3rd Hematology events. b. The laboratory received a score of 80% for granulocytes %, a score of 60% for lymphocytes %, and a score of 40% for monocytes %, resulting in a score of 60% for White Blood Cell Differential on the 2019 2nd Hematology event. -- 3 of 3 --