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 the review of proficiency testing (PT) records, the laboratory failed to successfully participate in PT from American Proficiency Institute (API) under the specialties: 1. Routine Chemistry for the regulated analyte: Albumin. See D2096. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) from the provider API for Chemistry, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte Albumin.. Findings: 1. Review of API PT scores for 2022 revealed the following performance scores for Albumin: a. Second testing event 2022 revealed a score of 60%. b. Third testing event 2022 revealed a score of 60% . 2. Phone interview with the lab manager on December 5, 2022 at 2:55 p.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte Albumin. -- 2 of 2 --