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 review of 2021 and 2022 CMS CASPER Reports 155D, 153D and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to participate in proficiency testing for the specialty of Hematology and each Hematology analyte. Survey Finding follow: Based on review of 2021 and 2022 CMS CASPER Reports 155D, 153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for White Blood Cell Differential (WBC DIFF), Red Blood Cell Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell Count (WBC), and Platelet (PLTS). Survey Findings Follow: Failure to 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 -- achieve satisfactory performance for the test of WBC DIFF, RBC, HCT, HGB, and PLTS in two of three proficiency testing events is unsuccessful performance as cited at D2123. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 2021 and 2022 CMS CASPER Reports 155D, 153D and the American Proficiency testing results, it was determined the laboratory failed to participate in the third proficiency testing event of 2021 and the second proficiency testing event of 2022, resulting in a score of 0% for the specialty of Hematology and each Hematology analyte. Based on review of the 2021 and 2022 CMS CASPER Reports 155D and 153D and API proficiency testing results, it was determined the laboratory failed to participate in the third proficiency testing event of 2021 and the second proficiency testing event of 2022, resulting in a score of 0% for the test WBC DIFF, RBC, HGB, HCT, and PLTS as evidenced by: A. The laboratory received a score of 0% for the test of WBC DIFF, RBC, HGB, HCT, and PLTS in the third proficiency testing event of 2021. B. The laboratory received a score of 0% for the test of WBC DIFF, RBC, HGB, HCT, and PLTS in the first proficiency testing event of 2022. -- 2 of 2 --