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 Hematology Analytes, resulting in the first unsuccessful proficiency testing (PT) occurrence for Hematology (Refer to D2123). ==================================== D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a 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 -- score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS 0155D report and the laboratory's 2018 Proficiency Testing records for Hematology, the laboratory failed to participate in the 2nd and 3rd events of 2018 resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS 0155D report revealed 0% scores for events two and three of 2018 for the Hematology analytes. 2. Review of the Proficiency Testing records for 2018 revealed "Failure to Participate" for Hematology in events two and three, resulting in 0% scores and the 1st unsuccessful proficiency test for Hematology analytes to include: Red Blood Cell Count, Hematocrit, Hemoglobin, White Blood Cell Count, Platelet Count and the Automated White Blood Cell Differential. ===================================== -- 2 of 2 --