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 and interview with the Operations Manager (OM), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) from 12/6/18 to the date of survey. The findings include: 1. The BA procedure did not include the name of the referring pathologist, CLIA number of the reviewing laboratory or referring pathologist's current licence. 2. The OM confirmed on 9/14/21 at 2:15 pm that the BA procedure was not in detail. 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 --