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 the lack of a quality assessment (QA) plan and laboratory director interview, the laboratory failed to establish written policies and procedures for staff to follow since testing began in March 2019 for an ongoing mechanism to monitor, assess, and take