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 lack of Quality Assessment (QA) documentation and interview with testing personnel 1, the laboratory failed to establish written policies and procedures to ensure the quality of the laboratory services provided. The findings include: 1. QA policies and procedures for the general lab system (GLS) were not presented for review during the survey, including but not limited to, policies and procedures specific to biannual verification testing, personnel competency, instrument maintenance and