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 CMS (Centers for Medicare and Medicaid Services) CASPER reports, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to successfully participate in Proficiency Testing (PT) for the WBC Diff (White Blood Cell Differential) for two consecutive testing events, Event #3, 2021 and Event #1, 2022. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 satisfactory performance for the same analyte in two consecutive 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 CMS (Centers for Medicare and Medicaid Services) CASPER reports, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to perform satisfactorily in Proficiency Testing (PT) for the WBC Diff (White Blood Cell Differential) for two consecutive testing events, Event #3, 2021 and Event #1, 2022. These consecutive failures constitute unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following for the WBC Diff: a) Event #3, 2021; 60 % b) Event #1, 2022; 0 % These consecutive failures constitute unsuccessful PT participation. 2. During a telephone interview on May 10, 2022 at 1:55 PM, the testing personnel confirmed she was aware of both failures, explaining the failure for Event #3, 2021 as a failure to enter the correct results (staff entered the percentages); and the second failure was due to the laboratory not submitting the results to PT provider timely for grading. -- 2 of 2 --