Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Surgical Pathology Laboratories PA-MLU5 on 03/25/2026. The laboratory is not in compliance with 42 CFR Part 493 CLIA requirements. A standard deficiency was cited as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observations, record review, and interview, the laboratory failed to ensure protection from chemical hazards for two of two years 03/2024 through 03/2026. Findings included: 1. A tour of the mobile unit was performed 03/26/2026 at 10:10 a. m. An autostainer was observed with no fume hood present. 2. The safety data sheet for Sub-X Xylene Substitute with a revision date of 01/16/2018 was reviewed. Exposure controls or personal protection included Good ventilation of the work station and "wear respiratory protection". 3. The Laboratory Supervisor was interviewed on 03/26/2026 at 10:10 a.m. They confirmed the lab did not use a fume hood when utilizing this reagent. 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 --