Summary:
Summary Statement of Deficiencies D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 technical supervisor/technical consultant (TS/TC), the laboratory director did not ensure the humidity levels in the laboratory were appropriate for the testing performed for 39 of 40 operating days in November and December 2025, two of two months reviewed. Findings include: 1. Review of the "Laboratory Master Log (East)" indicated the laboratory's acceptable humidity range was 30% to 85%. 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% on 39 of 40 operating days in December 2025 and January 2026. 2. Interview with the TS/TC on March 31, 2026, at 2:15 PM confirmed the laboratory's acceptable humidity range was 30% to 85%, and that the laboratory director did not ensure the humidity levels in the laboratory were appropriate for the testing performed for 39 of 40 operating days during the two months of records reviewed. 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 --