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 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 ABO/RH testing as evidenced by: Failure to attain a testing event score of at least 100 percent in ABO /RH testing is unsatisfactory performance as cited at 2153. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) 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 attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of 2018 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 ABO/RH testing as evidenced by: A. The laboratory received a score of 80% for ABO/RH testing in the second proficiency testing event of 2018. B. The laboratory received a score of 80% for ABO/RH testing in the third proficiency testing event of 2018. 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 2018 proficiency testing results, it was determined the Laboratory Director failed to ensure that