Summary:
Summary Statement of Deficiencies D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor review of documented humidity readings in the laboratory and interview with the laboratory director, the laboratory director did not ensure the laboratory could meet its established humidity range for 39 of 41 days in November and December 2025, two of two winter months reviewed. Findings include: 1. Review of the "Temperature Log" indicated the laboratory's acceptable humidity range was 30% to 65%. Review of the log records from November and December 2025, showed the laboratory documented daily humidity readings on working days. Testing personnel documented readings that were less than 30% for 39 of 41 days in November and December 2025. 2. Interview with the laboratory director on January 9, 2026, at 10:40 AM confirmed the laboratory's acceptable humidity range was 30% to 65%, that the daily humidity readings were less than 30% for 39 of 41 days of the two months reviewed, and that the laboratory director did not ensure the laboratory could meet its humidity range in November and December 2025. 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 --