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 the review of proficiency testing (PT) records from American Proficiency Institute (API) and interview with the laboratory operations manager, the laboratory failed to successfully participate in PT for the analyte: 0765 Cell I.D. or WBC Diff for two consecutive proficiency testing events: 2022 Event 2 and 2022 Event 3 (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 a desk review of proficiency testing (PT) from the provider API for Hematology, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two consecutive testing events for the regulated analyte, 0765 Cell I.D. or WBC Diff. Findings: 1. Review of API PT scores for 2022 revealed the following performance scores for 0765 Cell I.D. or WBC Diff: a. Second testing event 2022 revealed a score of 60%. b. Third testing event 2022 revealed a score of 60% . 2. Phone interview with the laboratory operations manager on January 6, 2022 at 11:05 a. m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two consecutive testing events for the regulated analyte 0765 Cell I.D. or WBC Diff. -- 2 of 2 --