Summary:
Summary Statement of Deficiencies D0000 The Darius J Karimipour, MD PC laboratory was found to be in substantial compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). No deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to report positive SARS-CoV-2 test results for 1 (tested on 1/12/22) of 1 individual that had tested positive since the laboratory had started testing. Findings include: 1. A review of the laboratory's testing log revealed one individual that had tested positive on 1/12/22 using the laboratory's Quidel QuickView SARS Antigen Test. 2. An interview on 2/27/23 at with the Laboratory Director revealed the laboratory had not reported the positive result for the individual listed above to the health department. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --