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 consecutive events for HCT (Hematocrit) analyte, resulting in the first unsuccessful proficiency testing (PT) occurrence for the HCT analyte. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 2020 Proficiency Testing (PT) performance summary records from the College of American Pathologists (CAP) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the HCT (Hematocrit) analyte in the 1st and 2nd events of 2020, resulting in the first unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory HCT analyte scores of 60% for the 1st and 2nd events of 2020. 2. A review of the laboratory's CAP Proficiency Testing records revealed the 2020 1st event had unacceptable performance for HCT resulting in a 60% score. 3. A review of the laboratory's CAP Proficiency Testing records revealed the 2020 2nd event had unacceptable performance for HCT resulting in a 60% score, resulting in the first unsuccessful PT occurrence. =================================== -- 2 of 2 --