Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at T J GIUFFRIDA MD LLC from January 9, 2026 to January 15, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3001 FACILITIES CFR(s): 493.1101(a)(1) (a) The laboratory must be constructed, arranged, and maintained to ensure the following: (a)(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the Laboratory failed to ensure adequate protection with ventilation from chemical hazard required at least since May 20, 2024. Findings included: 1- During a tour of the laboratory on 01/09 /2026 at around 9:35 AM, it was observed that chemicals stored in the fireproof cabinet were already in use for Mohs laboratory. The volumes for open containers were approximately a half gallon of 95% Reagent Alcohol, 1/8 of a gallon of 100% Reagent Alcohol, 3/4 of AmeriClear Histology Clearing Solvent, and 1/4 of the Eosin Y Stain Solution 1% Alcohol. 2- Review of the laboratory's Reagent log revealed that Reagent Alcohol 100% and AmeriClear Histology Clearing Solvent were opened on 01/05/2026, and Reagent Alcohol 95% and Eosin Y Stain Solution, 1% w/v in Alcohol were opened on 01/06/2026. 3- Review of the chemical's Safety Data Sheets (SDS) were performed a) SDS's for the Reagent Alcohol, 95% and 100% stated under Precautionary Statements - Prevention "Do not breathe dust/fume/gas/mist/vapors /spray ...Use explosion-proof electrical/ventilating/lighting/equipment." b) SDS for the Eosin Y Stain Solution, 1% w/v in Alcohol stated under Precautionary Statements - Prevention "Do not breathe dust/fume/gas/mist/vapors/spray ...Use explosion-proof electrical/ventilating/lighting/equipment." 4- Review of the label for the AmeriClear Histology Clearing Solvent stated "When using, the following safety precautions are Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- recommended: ... wording "VENT HOOD" with symbol displayed. 5- During an interview with the Laboratory Director on 01/09/2026 at approximately 12:35 PM, he confirmed that the laboratory did not have a ventilation and/or hood over the stain line nor during reagent preparation. 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 observation, record review, and staff interview, the Laboratory failed to ensure that chemical waste from Histology testing was being handled in accordance to manufacturer at least from May 20, 2024, to January 09, 2026. Findings Included: 1- During a tour of the laboratory on 01/09/2026 at around 9:35 AM, it was observed there was no waste container in the laboratory. 2- Review of reagent label for Reagent Alcohol 95% and 100%, AmeriClear Histology Clearing Solvent, Eosin Y Stain Solution v/w 1% Alcohol and Hematoxylin Stain Solution Gill III stated, "Dispose of content/container to an approved waste disposal plant." 3- Review of the Procedure manual signed by the Laboratory Director on 01/05/2026 revealed that the laboratory did not include a policy for how to dispose of waste from the Hematoxylin & Eosin Stain protocol. 4- Records for chemical waste disposal for years 2024, 2025 and 2026 were requested from the laboratory on 01/14/2026 but not provided. 5- During an interview with the Laboratory Director on 01/09/2026 at approximately 12:58 PM, the Laboratory Director could not provide an approved waste container and admitted to not having a procedure for handling waste from the stainer. -- 2 of 2 --