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 2016 and 2017 CMS Casper Reports 155D, 153D and the American Proficiency Institute (API) proficiency testing results, it was determined the Laboratory failed to have successful participation in proficiency testing for the test of Red Blood Cell Count as evidenced by: Failure to achieve satisfactory performance for the test Red Blood Cell Count (RBC) in three out of five proficiency testing events is a subsequent failure as cited at D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (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 2016 and 2017 CMS Casper Reports 155D, 153D and the American Proficiency Institute proficiency testing results, it was determined the Laboratory had a subsequent unsuccessful performance for the test of Red Blood Cell Count (RBC) as cited at D2016 and D2130. D2130 HEMATOLOGY 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 2016 and 2017 CMS Casper Reports 155D, 153D and the American Proficiency Institute, it was determined the Laboratory had three out of five consecutive failures which constitutes a subsequent unsuccessful performance for the test of Red Blood Cell Count (RBC) as evidenced by: A. The Laboratory received a score of 40% for the test of RBC in the second proficiency testing event of 2016. B. The Laboratory received a score of 100% for the test of RBC in the third proficiency testing event of 2016. C. The Laboratory received a score of 40% for the test of RBC in the first proficiency testing event of 2017. D. The Laboratory received a score of 100% for the test of RBC in the second proficiency testing event of 2017. E. The Laboratory received a score of 60% for the test of RBC in the third proficiency testing event of 2017. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2016 and 2017 proficiency testing results, it was determined the Laboratory Director failed to ensure that