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 ten (10) random patient histopathology slide and report sampling from 03/1/2019 to 11/04/2020, review of quality control documents, written laboratory policies and procedures and an interview with the laboratory director, it was determined that the laboratory failed to 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. The finding included: 1. On 03 /02/2020 (survey date) no documentation could be retrieved to show that the laboratory had a written policy for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified. This correction process must involve identification and resolution of the problem, and development of policies that will prevent recurrence. Policies for preventing problems that have been identified must be written as well as communicated to the laboratory personnel, other staff, and clients, When (preanalytic, analytic and postanalytic) issues were found the laboratory relied only on verbal communication and no documentation could be retrieved to show ongoing mechanism, assessment and