Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Office Manager (OM) the laboratory failed to follow and review their monthly quality assurance procedures from 11/1/22 to 6/30/23. The findings include: 1. The monthly quality assurance checklists were unmarked for the following dates: a) November 2022 b) January 2023 c) February 2023 d) March 2023 e) May 2023 f) June 2023 2. The Laboratory Director and Histotech both signed all of the unmarked quality assurance checklists. 3. The OM confirmed on 8/27/24 at 1:30pm the laboraotry failed to review and follow the quality assurance checklist procedures for the above mentioned 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 --