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 review of the laboratory's quality control (QC) and quality assessment records, and interview with the technical consultant, the laboratory failed to correct identified problems with QC lot management for six of nine QC lots reviewed in 2019 and 2020. The findings include: 1. Review of the laboratory's QC and quality assessment records revealed the following: Review done 8.7.19 for July 2019 QC records-noted problems with overlap in QC lots. No