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 2018 Hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2130, unsatisfactory performance in two consecutive Monocyte/Mids PT challenges. 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 2018 hematology proficiency test (PT) performance, which was reported to the CLIA data base by the PT provider, revealed that the laboratory failed to achieve satisfactory performance for the hematology analyte Monocytes/Mid in two consecutive testing events. Findings: 1. The laboratory obtained an unsatisfactory 60 per cent for the analyte Monocytes/Mid on the first testing event of 2018. 2. The laboratory obtained an unsatisfactory 0 per cent for the analyte Monocytes/Mid on the second testing event of 2018. 3. Email correspondence with the technical consultant on August 16, 2018 confirmed the laboratory failed to achieve satisfactory performance for the hematology analyte Monocytes/Mid in two consecutive testing events in 2018. -- 2 of 2 --