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: . Through a review of the Proficiency testing records for 2020, Survey Exception Reports, lack of documentation, and interviews with staff, it was determined the laboratory failed to prevent the recurrence of problems in the General Laboratory Systems. Survey findings follow: A. A review of the Proficiency testing records for 2020 Urine Colony Count proficiency testing results revealed for the first and second event of 2020 (two of two testing events) the laboratory received a score of 50% for the test Urine Colony Counts. B. A review of the Survey Exception Report for the first Urine Colony Count proficiency testing event of 2020 revealed the