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 the CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: urea nitrogen (BUN). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for two of two proficiency testing events for the chemistry analyte: BUN. Refer to D2087 and D2096. D2087 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 2 -- CFR(s): 493.841(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 the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the analyte: urea nitrogen (BUN), which is unsatisfactory performance for the testing events. Findings include: BUN PT Event Score 1st event 2018 60% 3rd event 2017 40% D2096 ROUTINE CHEMISTRY 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte urea nitrogen (BUN) in two of two consecutive testing events. Findings include: Unsatisfactory performance for two of two consecutive proficiency testing events constitutes unsuccessful performance for BUN: BUN PT event Score 1st event 2018 60% 3rd event 2017 40% -- 2 of 2 --