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: A desk review on October 9, 2019 revealed the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the analyte Red Blood Cells (RBC). Findings include: 1. First event 2019 revealed a score of 0% for RBC. 2. Second event 2019 revealed a score of 60% for RBC. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events which resulted in unsatisfactory performance for the regulated analyte RBC. D2130 HEMATOLOGY 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 -- 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: A desk review on October 9, 2019 revealed the laboratory failed two of three events and failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the subspecialty, Hematology for the same analyte. Findings include: 1. Based upon review of proficiency testing in 2019 from API for 0775 Red Blood Cells (RBC) revealed the laboratory received the following scores: Event 1 2019 RBC testing 0% Event 2 2019 RBC testing 60% -- 2 of 2 --