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 review of the CMS (Centers for Medicare and Medicaid) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Total Bilirubin for two consecutive testing events, Event #1 and #2, 2021. These failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the Casper reports revealed the laboratory scored sixty percent (60 %) for Total Bilirubin for Event #1, 2021 and 20 % for Event #2, 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 -- 2021. 2. A review of the API proficiency testing evaluations confirmed the above noted scores, which resulted in an initial unsuccessful proficiency testing participation. 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 the CMS (Centers for Medicare and Medicaid) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Total Bilirubin for two consecutive testing events, Event #1 and #2, 2021. These failures resulted in an initial unsuccessful participation for the laboratory. Refer to D2016. -- 2 of 2 --