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 the 2016, 2017, and 2018 provider performance testing reported to the CLIA database by the American Proficiency Institute (API) and review of the final reports from API, the laboratory failed to achieve satisfactory performance for the white blood cell differential in five of eight testing events. Refer to 2130. 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 review of the 2016, 2017, and 2018 provider performance testing reported to the CLIA database by the American Proficiency Institute (API) and review of the final reports from API, the laboratory failed to achieve satisfactory performance for the hematology analyte white blood cell differential. Findings include: Unsatisfactory performance for five of eight testing events constitutes subsequent unsuccessful performance for the hematology analyte white blood cell differential. White Blood Cell Differential PT Event Score 2nd event 2016 73% 1st event 2017 60% 2nd event 2017 0% 2nd event 2018 0% 3rd event 2018 0% -- 2 of 2 --