Summary:
Summary Statement of Deficiencies D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interview with the technical supervisor (TS) the laboratory failed to provide a fume hood for testing personnel handling toxic chemicals. The laboratory performs approximately 309,508 toxicology tests annually. Findings: 1. Record review of the laboratory procedure manual showed that acetonitrile and methanol were used in the preparation of patient samples and instrument reagents. 2. An observation on February 14, 2024 at approximately 1:15 PM, revealed the lab failed to have a fume hood for testing and reagent preparation. 3. In an interview on February 14, 2024 at approximately 1:20 PM, the TS confirmed that the laboratory does not have a fume hood. Sample preparation and instrument reagents are prepared with acetonitrile and methanol on the open bench. 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 --