Summary:
Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory quality assurance plan, laboratory records, and interview with the lead testing personnel, the laboratory failed to follow the quality assurance plan in 2019. The findings include: 1) Observation of the laboratory on January 14, 2020 at 12:30 p.m. revealed temperature dependent equipment/instruments in use for storage and preparation of reagents and tissue for histopathology testing. 2) Review of the laboratory's quality assurance plan revealed the following: The laboratory will identify problems and apply