Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted from December 06, 2024 to December 11, 2024. J BRAHMATEWARI MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 store 100% Reagent alcohol, Eosin-Y Alcoholic 0.25% and X-S Xylene Substitute according to the "STATLAB" manufacturer's instructions at least since 02/06/2023. The findings included: 1-During a tour of the laboratory on 12/06/2024 at 02:45 PM., observed 1 full gallon and 1/3 gallon of 100% Reagent alcohol, 2/3 gallon of Eosin-Y Alcoholic 0.25%, and one full gallon of X-S Xylene Substitute under a bench cabinet with a sign "CHEMICAL STORAGE". 2-Review of STATLAB product label placed in front of the reagent Eosin-Y Alcoholic 0.25% and X-S Xylene Substitute, stated in the storage section "Keep container tightly closed in a fireproof locked place." 3- Review of the safety data sheet for 100% Reagent alcohol revealed that the storage conditions were to "Store locked up." 4-Interview on 12/06/2024 at 03:11 PM the laboratory's risk assessment consultant confirmed that the reagents were not stored locked or in a flammable cabinet. 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 --