Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the histopathology slide staining procedure, lack of Quality Control (QC) log and interview with the District Manager (DM), the laboratory failed to perform and document QC procedures using the number and frequency established by the laboratory for Hematoxylin and Eosin (H&E) stain from 05/23/2023 to the day of the inspection. Findings include: 1. On the day of the survey, 06/14/2023 at 11:37 AM, the laboratory failed to provide QC documentation for the H&E slide staining procedure. 2. According to the laboratory's H&E QC procedure manual, QC slides should be made daily and documented on the QC log. 3. 3 patient slides were made on 05/23/2023. 4. DM confirmed the above findings on 06/14/2023 at 11:50 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 --