Summary:
Summary Statement of Deficiencies D0000 Based on the survey conducted 06-15-2018, the laboratory was found to be out of compliance with the following conditions of 42 CFR: 493.803 Successful Participation 493.807 Reinstatement of Nonwaived Laboratories 493.1403 Moderate Complexity Laboratory Director 493.1409 Technical Consultant-Moderate Complexity . 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 American Proficiency Institute (API) proficiency testing (PT) documentation for 2016, 2017 and 2018, the laboratory failed to participate successfully in the specialty of hematology. Refer to D 2121 I-IV. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: . Based on review of API PT documentation for testing in hematology for 2016, 2017 and 2018, the laboratory failed to participate successfully in testing for the following analytes: Analyte Event Score 0765 WBC diff 3rd 2016 0% 1st 2017 0% 1st 2018 0% 0775 RBC count 1st 2017 0% 2nd 2017 20% 1st 2018 0% . D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2016, 2017 and 2018 and staff interview, the laboratory failed to attain scores of at least 80% for each analyte in hematology testing using the Abbott Cell-Dyn Emerald analyzer in the 3rd event 2016, 1st event 2017, 2nd event 2017 and 1st event 2018. Findings: I. API 3rd Event 2016 A. Review of API PT documentation for the 3rd event of 2016 showed scores of 0 for percent granulocytes, percent lymphocytes and percent monocytes/mids on all samples (HEM-11, HEM-12, HEM- 13, HEM-14 and HEM-15), resulting in a score of 0 for analyte 0765, Cell identification or WBC differential. B. In an interview at the site on 06-15-2018, the laboratory technical consultant (CMS form 209) stated the scores were the result of a clerical error. Examination of testing results from the instrument, dated 11-18-2016, showed that the operator had entered the results for the total number of cells in a given category as opposed to the percentage of the whole. A self-check is noted in performance review and