Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 12, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient document review and staff interview, the laboratory failed to perform qualitative quality control (QC) at least once a day patient specimens were tested as required. Findings inclue: 1. Patient document review revealed QC was not performed for Potassium Hydroxide (KOH) and Wet Preparation (Parasitology) for the following time periods: 2018 (July - December), 2019, 2020, and 2021 thus far. 2. An interview with the clinic administrator in the upstairs breakroom on 1/12/2021 at approximately 2:30 p.m. confirmed the lack of QC performed for KOH and Wet Preparation for the aforementioned time periods. 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 --