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 and 2019 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analytes of Creatinine (CREAT), Glucose (GLU), Sodium (NA), Chloride (CL), and Blood Urea Nitrogen (BUN). As evidenced by: Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 2018 and 2019 CMS Casper Reports 0155 D and 0153 D and the API proficiency testing results it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analytes of Creatinine (CREAT), Glucose (GLU), Sodium (NA), Chloride (CL), and Blood Urea Nitrogen (BUN). As evidenced by: A. The laboratory received a score of 0% in the third proficiency testing event of 2018 and the second proficiency testing event of 2019 for the analyte CREAT. B. The laboratory received a score of 60% in the first proficiency testing event of 2019 and 0% in the second proficiency testing event of 2019 for the analyte GLU. C. The laboratory received a score of 0% in the first and second proficiency testing event of 2019 for the analyte NA. D. The laboratory received a score of 60% in the first proficiency testing event of 2019 and 0% in the second proficiency testing event of 2019 for the analyte CL. E. The laboratory received a score of 20% in the third proficiency testing event of 2018 and 0% in the second proficiency testing event of 2019 for the analyte BUN. 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 and 2019 proficiency testing results, it was determined the Laboratory Director failed to ensure that