Southern Oncology Specialists

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of 2020 and 2021 API (American Proficiency Institute) PT( proficiency testing) records, and interview with the laboratory supervisor 3/18/22, the laboratory failed to test PT specimens the same number of times as they test patient specimens. Findings: The laboratory's "Proficiency Testing" policy states, "..6. Replicate analysis of survey samples is acceptable only if patient specimens are routinely analyzed in the same manner.." Review of the "Quality Assessment" program revealed critical value ranges for the following: WBC(white blood cell): less than 2 and greater than 30,000 K/uL(cells per microliter); HGB(hemoglobin): less than 6 and greater than 20 g/dL(grams per deciliter); HCT(hematocrit): less than 18 and greater than 50 %(percent); Platelet: less than 50 and greater than 999,999 K/uL. Interview with the laboratory supervisor at approximately 3 p.m. confirmed all critical value results are repeated and verified prior to being reported. Review of the 2020 and 2021 API PT records revealed the laboratory failed to verify all critical value results obtained for the PT samples for 2 of 3 events in 2021. Examples include: a. 2021 1st event sample #4: HCT result of 17%; b. 2021 2nd event sample #9: HGB result of 5.6 g/dL and HCT result of 17%. 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 -- D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory's procedures, review of 2020 and 2021 API(American Proficiency Institute) PT(proficiency testing) records, and absence of documentation 3 /18/22, the laboratory failed to ensure the testing personnel signed the attestation statements for 3 of 3 testing events in 2020. Findings: The laboratory's PT procedure stated, "...C. Submission of Proficiency Testing results...2. All personnel who performed the testing of survey materials must sign the attestation page..." Review of the 2020 and 2021 API PT records revealed the testing personnel failed to sign the attestation statements for the 2020 Hematology/Coagulation 1st, 2nd, and 3rd testing events. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, review of laboratory hematology maintenance records, and absence of documentation 3/18/22, the laboratory failed to perform and document maintenance as required by the manufacturer. Findings: Review of the Sysmex XN-330 Troubleshooting manual stated for maintenance, "weekly(run cell clean auto)- Execute routine cleaning- the routine cleaning must be executed once every 1,000 analyses, or once a week. Routine cleaning consists of aspirating CELL CLEAN AUTO and rinsing the fluid line... Daily maintenance- Maintenance task- Shutdown...To maintain optimum instrument performance, periodic maintenance must be executed. When using the instrument on a continuous basis, execute 'Daily Maintenance' once every 24 hours..." Review of the Sysmex XN- 330 maintenance records revealed maintenance documentation was unavailable for the following: a. There was no weekly maintenance documentation for all of 2020, January- July 2021, October- December 2021, and January 2022; b. There was no daily maintenance documentation prior to December 2020. -- 2 of 2 --

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 API(American Proficiency Institute) proficiency testing results 1/7/21, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) Differential in two out of three consecutive testing events. 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 2020 API(American Proficiency Institute) proficiency testing results 1/7/21, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) Differential in two out of three consecutive 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 0% for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils, resulting in an unsatisfactory score of 0% for WBC Differential on the 2020 Hematology 1st event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 0% for Basophils, Eosinophils, Neutrophils, and 40% for Lymphocytes, resulting in an unsatisfactory score of 24% for WBC Differential on the 2020 Hematology 3rd 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 2020 API (American Proficiency Institute) proficiency testing results 1/7/21, 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 2020 API(American Proficiency Institute) proficiency testing results 1/7/21, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 0% for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils, resulting in an unsatisfactory score of 0% for WBC -- 2 of 3 -- Differential on the 2020 Hematology 1st event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 0% for Basophils, Eosinophils, Neutrophils, and 40% for Lymphocytes, resulting in an unsatisfactory score of 24% for WBC Differential on the 2020 Hematology 3rd event. -- 3 of 3 --