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 proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to successfully participate in PT in 2022 and 2023 for Chloride (CL) under the specialty of Chemistry. Findings include: 1. The API 2022 Chemistry - Core 2nd Event Performance Summary and Comparative Evaluation and the API 2023 Chemistry - Core 1st Event Performance Summary and Comparative Evaluation were reviewed on April 18, 2023. The API reports indicated the laboratory failed to achieve satisfactory performance for CL in two out of three consecutive testing events in 2022 and 2023 resulting in unsuccessful performance. See D2096 . 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 -- 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 a review of proficiency testing (PT) reports from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Chloride (CL) in two out of three consecutive testing events in 2022 and 2023, constituting unsuccessful performance. Findings include: 1. The API 2022 Chemistry - Core 2nd Event Performance Summary and Comparative Evaluation and the 2023 API 2023 Chemistry - Core 1st Event Performance Summary and Comparative Evaluation were reviewed on April 18, 2023. PT results from API indicated that the laboratory had unsatisfactory performance for CL as follows: -Score of 40% during the 2nd event of 2022 -Score of 40% during the 1st event of 2023 . -- 2 of 2 --