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: During a PT desk review performed on 5/29/2018, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the regulated analyte white blood cell differential (WBC Diff) for two consecutive proficiency testing events reviewed (2017, Event 1 and 2018, Event 3). See 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: During a PT desk review performed on 5/29/2018, based on review of CASPER report 155D and graded reports from API, the laboratory failed to achieve satisfactory performance for WBC Diff in two consecutive testing events in 2017 and 2018 (2017, Event 3 and 2018, Event 1). Findings include: 1. Review of the CASPER report 155D revealed of the following proficiency testing scores for WBC Diff: a. 2017, Event 3: 67% b. 2018, Event 1: 67% 2. The scores were confirmed upon review of the graded reprot from API. -- 2 of 2 --