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 onsite survey and review of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for Hematology and White Blood Cell Differential for two consecutive events, 2019 event 3 and 2020 event 1, resulting in unsuccessful proficiency testing performance. See D2131." D2131 HEMATOLOGY CFR(s): 493.851(g) 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 scores and interview, the laboratory failed to achieve a score of 80 percent for Hematology and White Blood Cell Differential in two consecutive events in 2019 and 2020, resulting in unsuccessful performance. The findings include: 1. During a review on 9-28-20 of the CMS-153 Unsuccessful Proficiency Testing Report, included the Centura Health EUC with unsatisfactory proficiency testing scores for Hematology and White Blood Cell Differential. 2. During a review on 9-28-20 of the CMS-155 report, the College of American Pathologists (CAP) Hematology and White Blood Cell Differential score for event 3 of 2019 was 0%. 3. During a review on 9-28-20 of the CMS-155 report, the American Proficiency Institute (API) Hematology and White Blood Cell Differential score for event 1 of 2020 was 73%.4. On 10-20-20 during the on-site recertification survey, at approximately 11:00 am, the Technical Consultant stated that the site had been closed for several months and that proficiency testing had not been submited and there had also been clerical errors causing the failures. The Technical Consultant also explained that alternate proficiency testing assessments had been performed and all results would have passed. The Technical Consultant provided documentation of the results of alternate proficiency testing as well as calibration and quality control charts and documentation. -- 2 of 2 --