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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services Casper report 153 & 155 (CMS 153 & 155) and the Collage of American Pathologist (CAP) evaluation report, the laboratory failed to maintain satisfactory performance for the specialty of Hematology for the analyte Hematocrit (HCT) in the 3rd event of 2018 and 2nd event of 2019 resulting in the first unsuccessful occurrence. (Refer to D2130). D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) 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 review of the CMS 153 & 155 and the Collage of American Pathologist (CAP) evaluation report, the laboratory failed to achieve successful performance for the specialty of Hematology for the analyte Hematocrit (HCT) in the 3rd event of 2018 and 2nd event of 2019 resulting in the first unsuccessful performance in 2019. The findings include: 1. Review of the CMS Casper report 153 & 155 revealed a score of 40% for the analyte Hematocrit in the 3rd event 2018 and a score of 20% in the 2nd event 2019. 2. Review of CAP evaluation report revealed a score of 40% for the analyte Hematocrit in the 3rd event 2018 and a score of 20% in the 2nd event 2019. -- 2 of 2 --