Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on May 28, 2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard- level deficiencies were cited. 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 review of laboratory procedure, lack of documented quality assessment (QA) activities and interview with general supervisor (GS) #4, the laboratory failed to establish policies and procedures for an ongoing mechanism to monitor and assess general laboratory systems requirements specified at 493.1231 through 493.1236 for 2 of 2 years (May 2024 to May 2026). Findings: 1. Review of laboratory procedure, Root Cause Analysis of Nonconformances and Development of