Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 13, 2020. 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 quality control (QC) document review and staff interview, the laboratory failed to perform required daily QC for each day of testing. Findings include: 1. QC document review revealed the laboratory lacked documentation at the time of survey for Parasitology (Wet Preparation) positive and negative controls for November, 2019 (8 out of 8 days). 2. QC document review revealed the laboratory lacked documentation at the time of survey for KOH (Potassium Hydroxide) positive and negative controls for the following dates: 2018 -- August (14 out of 15 days); 2019 -- August, (6 out of 11 days) and October (4 out of 9 days); 2020 -- January(7 out of 12 days) and September (7 out of 9 days). 3. An interview with the office manager in her office on 10/13/2020 at approximately 12:20 p.m. confirmed the lack of Parasitology and KOH QC documentation for the aforementioned dates. 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 --