Summary:
Summary Statement of Deficiencies 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 review of the laboratory's quality control (QC) records and interview with the histotechnologist (HT), the laboratory failed to document a negative and positive control material each day of patient testing for mycology microscopic examinations performed from 02/24/2022 to 12/05/2023. Findings Include: 1. On the day of the survey, 12/05/2023 at 11:02 am, a review of the laboratory's KOH (Potassium Hydroxide) QC records revealed the laboratory did not document a negative and positive control material each day of patient testing for the following 6 of 16 KOH microscopic slide examinations performed in 2022: - 08/15/2022: Mycology (KOH wet mount) - 08/16/2022: Mycology (KOH wet mount) - 08/19/2022: Mycology (KOH wet mount) - 08/22/2022: Mycology (KOH wet mount) - 08/23/2022: Mycology (KOH wet mount) - 08/24/2022: Mycology (KOH wet mount) 2. The HT confirmed the findings above on 12/05/2023 at 11:46 am. 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 --