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 review of the Laboratory's Quality Assurance Program (LQAP) procedure, Laboratory Equipment Checklist log, and interview, the laboratory failed to follow the LQAP procedures for sixteen out of sixteen months for the laboratory equipment and temperature review. Findings include: 1. Review of the LQAP procedure, section III- D states "The laboratory director will review the QC records weekly." Review of the Laboratory Equipment Checklist log of equipment and temperature readings showed the laboratory director (LD) failed to document weekly review of the Laboratory Equipment Checklist log records from January 2018 through April 2019. 2. Interview with LD on July 18, 2019 at 9:00 AM confirmed the laboratory failed to follow LQAP procedure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --