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 American Proficiency Institute (API) performance summary review and confirmation by Technical Consultant and laboratory supervisor via email on 8/24 /2020, the laboratory failed to achieve successful participation in two consecutive events for white blood cell differential proficiency testing performance. (See D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) performance summary review and confirmation by Technical Consultant and laboratory supervisor via email on 8/24 /2020, the laboratory failed to achieve successful participation in two consecutive events for white blood cell (WBC) differential proficiency testing performance. Findings include: 1. API summary report included documentation that the laboratory failed WBC differential in two consecutive events (first and second hematology events of 2020) with scores of 32% and 24% respectively. 2. The laboratory was contacted by email on 8/21/2020 to verify the test results of 32% for the first event of 2020 and 24% for the second event of 2020. 3. Based on an interview conducted by email on 8/24/2020 the laboratory confirmed the scores for WBC differential testing were correct, and that they had failed two consecutive events for WBC differential proficiency testing. -- 2 of 2 --