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: The laboratory failed to maintain satisfactory participation in two consecutive proficiency testing (PT) events for the white blood cell, red blood cell, hemoglobin, hematocrit, platelet count and automated white blood cell differential analytes (Refer to 2130), and the hematology speciality (Refer to D2131), resulting in the first unsuccessful PT occurrence. 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 Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the white blood cell (WBC), red blood cell (RBC), hemoglobin (Hgb), hematocrit (Hct), platelet count (PLT), and automated white blood cell differential (WBC Diff) analytes in two consecutive PT events, resulting in the first unsuccessful PT occurrence for the WBC, RBC, Hgb, Hct, PLT, and automated WBC Diff. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the WBC, RBC, Hgb, Hct, PLT, and automated WBC Diff analytes: 2021 event two: 0% 2021 event three: 0% 2) Review of the laboratory's proficiency testing performance evaluation reports revealed the following: 2021 event two: Sample numbers HD-6, HD-7, HD-8, HD-9, and HD- 10 scored as 'Fail- No Results Received' for the WBC, RBC, Hgb, Hct, PLT, and automated WBC Diff analytes. 2021 event three: Sample numbers HD-11, HD-12, HD-13, HD-14, and HD-15 scored as 'Fail- No Results Received' for the WBC, RBC, Hgb, Hct, PLT, and automated WBC Diff analytes, resulting in the first unsuccessful PT occurrence for the WBC, RBC, Hgb, Hct, PLT, and automated WBC Diff. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain a satisfactory overall testing event score of 80% for the Hematology specialty in 2021 event two and 2021 event three, resulting in the first unsuccessful PT occurrence for the Hematology specialty. The finding include: 1) Review of the CMS 155 revealed the following scores for the specialty of hematology: 2021 Event two = 0% 2021 Event three = 0% 2) Review of the laboratory's 2021 event two PT evaluation report revealed a score of 0% for 'No Results Received' for the hematology speciality. 3) Review of the laboratory's 2021 event three PT evaluation report revealed a score of 0% for 'No Results Received' for the hematology speciality resulting in the first unsuccessful PT occurrence. -- 2 of 2 --