Summary:
Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) records for Microbiology and interview with the clinic administrator the laboratory failed to check each batch of Trypticase Soy Agar (TSA) and MacConkey (MAC) agar for select or inhibit specific organisms for growth between July 26, 2017 and June 4, 2019. Findings include: 1. Review of the Microbiology QC records did not show each batch of TSA and MAC agar for select or inhibit specific organisms for growth between July 26, 2017 and May 29, 2019. 2. Interview with the clinic administrator on June 4, 2019 at 11:00 am confirmed the laboratory failed to check each batch of Trypticase Soy Agar (TSA) and MacConkey (MAC) agar for select or inhibit specific organisms for growth between July 26, 2017 and June 4, 2019. 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 --