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 a quality assessment (QA) plan for the general laboratory systems and staff interview, the laboratory failed to establish written policies and procedures for staff to follow in 2016 and 2017 for an ongoing mechanism to monitor, assess, and take