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 record review of the CMS database and the American Association of Bioanalysis and Medical Laboratory Evaluation proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the chemistry specialty analyte uric acid. Findings include: The laboratory failed to attain a score of at least 80% of acceptable responses for the chemistry analyte uric acid, which is unsatisfactory performance. Refer to 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 2 -- 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 Bioanalysis and Medical Laboratory Evaluation proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the chemistry analyte uric acid, which is unsatisfactory performance for 2 (2022 3rd event and 2023 2nd event) of 3 consecutive testing events. Findings include: A review of the CMS database and the American Association of Bioanalysis and Medical Laboratory Evaluation proficiency testing reports revealed the following proficiency testing results for uric acid: PT Event Uric Acid Score 3rd event 2022 40% 2nd event 2023 20% -- 2 of 2 --