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 dermatology microscopy quality control (QC) records and interview with technical consultant #1 (TS), the laboratory failed to document a negative and positive control material each day of patient testing for mycology and parasitology microscopic examinations performed in January 2023. Findings Include: 1. On the day of the survey, 02/22/2023 at 11:44 am, a review of the dermatology microscopy QC records revealed the laboratory did not document a negative and positive control material each day of patient testing for mycology and parasitology microscopic slide examinations performed in January 2023 for the following: - 1 of 9 days of patient testing in January 2023 (01/13/2023) 2. The laboratory performed 1 mycology and 1 parasitology slide examination on 01/13 /2023. 3. TC#1 confirmed the findings above on 02/22/2023 around 01:00 pm. 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 --