Summary:
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 a desk review of the Centers for Medicare and Medicaid Services CASPER Report 153 & 155 (CMS153 &155) and the proficiency testing agency, American Academy of Family Physicians (AAFP) performance summary determined the laboratory failed to maintain satisfactory performance for the specialty of Hematology for Hematocrit (HCT) analyte in event one and two in 2018, resulting in the first unsuccessful occurrence. (Refer to D2123, D2130) D2123 HEMATOLOGY CFR(s): 493.851(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the CMS 153 & 155 Casper report and the AAFP performance summary the laboratory failed to participate in the 2nd event in 2018 for the specialty Hematology for the analytes Red Blood Cells(RBC), Hematocrit (HCT), Hemaglobin (HGB), White Blood Cells (WBC), and Platelets (PLT) resulting in a score of zero in 2018 The findings include: 1 Review of the CMS Casper 153 &155 report revealed the laboratory failed to participate in the 2nd event for the specialty Hematology for analytes RBC, HCT, HGB, WBC), and PLT resulting in a score of zero in 2018 2. Review of the AAFP performance summary report the laboratory failed to participate in the 2nd event for the specialty Hematology for analytes RBC, HCT, HGB, WBC), and PLT resulting in a score of zero in 2018 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 review of the CMS 153 & 155 Casper report and the AAFP performance summary the laboratory failed to achieve successful performance for the 1st event and 2nd event in 2018 for the specialty Hematology for HCT analyte. The findings include: 1 Review of the CMS Casper 153 &155 report revealed the laboratory failed to achieve successful performance for the 1st event score of 60% and 2nd event score of zero for HCT analyte in 2018 2. Review of the AAFP performance summary report the laboratory failed to achieve successful performance for the 1st event score of 60% and 2nd event score of zero for HCT analyte in 2018 -- 2 of 2 --