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 records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 9/10/2021, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty, bacteriology, for three out of four consecutive proficiency testing events: 2020 testing event 2 and 2021 testing events 1 and 2 (refer to D2028). D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- Failure to achieve an overall testing event score of satisfactory performance for 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 proficiency testing reports and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 9/2/2021, the laboratory failed to achieve an overall testing event score of satisfactory performance for three out of four consecutive testing events for the subspecialty, bacteriology. The laboratory received unsatisfactory performance scores of zero for 2020 testing event 2 and 2021 testing events 1 and 2 for the subspecialty, bacteriology. -- 2 of 2 --