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 review of 2020 and 2021 hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with RN, the laboratory failed to successfully participate in PT. See tag D2130 unsatisfactory performance in two out of three consecutive testing events for the same analyte. 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 review of 2020/2021 hematology proficiency test (PT) performance, which was reported to the CLIA data base by the PT provider, and phone interview with the RN revealed that the laboratory failed to achieve satisfactory performance for analyte hematocrit (HCT) in two out of three consecutive testing events. Findings: 1. The laboratory obtained an unsatisfactory 20 percent for the HCT analyte on the second testing event of 2020. 2. The laboratory obtained an unsatisfactory 20 percent for the HCT analyte on the first testing event of 2021. 3. Phone interview with the RN on April 6, 2021 at 11:00 AM confirmed the laboratory failed to achieve satisfactory performance for HCT in two out of three consecutive PT events. -- 2 of 2 --