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 a routine desk review of the CMS-155 report for proficiency testing performance and an interview with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for compatibility testing for two consecutive events (Event 3 in 2021 and Event 1 in 2022). See D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- 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 proficiency testing scores from the American Proficiency Institute (API) and an interview with the laboratory manager, the laboratory failed to achieve a score of 100% for compatibility testing for Event 3 in 2021 and Event 1 in 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/11/2022, at 1:00 PM, revealed the compatibility testing scores for Event 3 in 2021 and Event 1 in 2022 were both 80%. 2. An interview with laboratory manager on 10/12/2022, at 3: 15 PM, confirmed two consecutive unsuccessful proficiency scores for compatibility testing due to clerical and laboratory errors. -- 2 of 2 --