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 policy manual and interview with staff, the laboratory failed to establish written policy and procedure for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general lab system. Findings include: 1. The surveyor reviewed a policy titled "Quality Assessment Plan" signed by the laboratory director on 1/17/18. 2. Within the General Laboratory Section of the policy, there was no section listing ongoing "General Laboratory Assessment". 3. This finding was confirmed during interview with testing personnel at 12:30pm. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of