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 record review and interview with the laboratory director (LD), the laboratory failed to establish written policies and procedures for an ongoing quality assessment mechanism to monitor, assess, and, when indicated, correct problems identified in the laboratory's general laboratory systems for 4 (June 2026 - September 2026) of 4 months reviewed. Findings include: 1. A review of the laboratory's Policies and Procedures Manual, page 6, Section 13, "Quality Control and