Ut Erlanger Hixson Primary Care

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: The laboratory failed to maintain satisfactory performance for the analyte Red Blood Cell (RBC) in the 1st, 2nd and 3rd events of 2020 resulting in the second unsuccessful performance occurrence. (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. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 155 (CMS 155) and American Proficiency Testing (API) performance summary, the laboratory failed to maintain satisfactory performance in Red Blood Cell (RBC) for the 1st, 2nd and 3rd event 2020, resulting in the second unsuccessful performance occurrence. The findings include: 1. Review of the CMS 155 report revealed the following scores for 2020: 1st event a score of 60% 2nd event a score o% 3rd event a score of 0% 2. Review of API performance summary revealed the following scores for 2020: 1st event a score of 60% 2nd event a score o% 3rd event a score of 0% -- 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: The laboratory failed to successfully participate in proficiency testing (PT) for the specialty Hematology to include Cell I.D. or White Blood Cell Differential (WBC Diff), Red Blood Cells (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC) and Platelets (PLT) resulting in the 1st unsuccessful PT occurrence. (Refer to 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 2 -- 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 Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and American Proficiency Institute (API) performance summary report, the laboratory failed to achieve satisfactory performance in the 1st and 2nd event 2020 for the analyte Red Blood Cells (RBC), and the 2nd and 3rd event 2020 for Cell I.D. or White Blood Cell Differential (WBC Diff), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC) and Platelets (PLT) resulting in the 1st unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 report revealed the following scores: Cell I.D. or WBC Diff event 2 and 3 -2020 score of 0% RBC analyte-event 1-2020 score of 60%, event 2 -2020 score of 0% HCT, HGB, WBC and PLT event 2 and 3 score of 0% 2. Review of the API performance summary report revealed the following scores: Cell I.D. or WBC Diff event 2 and 3 -2020 score of 0% RBC analyte-event 1-2020 score of 60%, event 2 -2020 score of 0% HCT, HGB, WBC and PLT event 2 and 3 score of 0% -- 2 of 2 --