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 desk review of Hematology proficiency testing results from the American Proficiency Institute proficiency testing agency on 09/06/2019, the laboratory failed to successfully participate in the Red Blood Cell (RBC) certified analyte in two of three consecutive testing events. See D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the American Proficiency Institute on 09/06/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the Red Blood Cell certified analyte. Findings include: The laboratory scored an unsatisfactory 0 percent in the 3rd testing event of 2018 and scored an unsatisfactory 40 percent in the 2nd testing event of 2019. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 desk review of Hematology proficiency test results from the American Proficiency Institute on 09/06/2019, the laboratory failed to successfully achieve satisfactory performance for the Red Blood Cell Count in two of three consecutive testing events. Findings include: The facility scored 0 percent in the third testing event of 2018 and scored 40 percent in the second testing event of 2019 for an unsuccessful performance. -- 2 of 2 --