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: ==================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of three events for the automated White Blood Cell (WBC) differential, resulting in the first unsuccessful Proficiency Testing (PT) occurrence for the automated WBC Differential analyte (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 desk review of the CMS CASPER Report 0155D and the laboratory's 2019 Proficiency Testing (PT) performance summary records from the API Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the automated WBC (White Blood Cell) Differential in the 1st and 3rd events of 2019, resulting in the first unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed the score for the automated WBC Differential for the 1st event of 2019 was 56% and for the 3rd event of 2019 was 40%. 2. A review of the laboratory's 2019 API Proficiency Testing records revealed the 1st event had unacceptable performance for Basophils and Eosinophils resulting in a 0% score for a total event score of 56%. 3. A review of the laboratory's 2019 API Proficiency Testing records revealed the 3rd event had unacceptable performance for Basophils, Eosinophils and Neutrophils resulting in a 0% score for a total event score of 40% for the WBC Differential, resulting in the first unsuccessful PT occurrence. ===================================== -- 2 of 2 --