Precision Toxicology Llc Dba Precision Diagnostics

Summary Statement of Deficiencies 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 surveyor observation of the laboratory work area and interview with the General Supervisor (GS), the laboratory failed to establish a safety procedure to protect employees from hazardous waste in the laboratory work area. Findings include: 1. On 2/26/2024 at 2:00 PM a 55 gallon drum containing liquid chemical waste from high performance liquid chromatography (HPLC) composed of water, ethanol, methanol, ammonium acetate and formic acid was observed in the laboratory accessioning and initial drug screening work area. 2. Record review on 2/29/2024 of an email received on 2/28/2024 from the GS in reference to the contents of the 55 gallon drum noted in #1, the GS stated, "It's mostly HPLC liquid waste which consists of water, some methanol and very small amounts of formic acid." 3. Record review on 3/8/2024 of an email received on 3/7/2024 from the GS in reference to the contents of the 55 gallon drum noted in #1, the GS stated, "There could be sometimes very small amounts of ethanol or ammonium acetate in addition to the ones described before in the hazardous waste barrel. The hazardous waste sticker on the side of the barrel has the waste classified as "Flammable Liquid", EPA Waste Code D001." 4. Surveyor review on 3/8/2024 of the Environmental Protection Agency website's definition of EPA Waste Code D001 revealed, "EPA assigned D001 as the waste code for ignitable hazardous wastes." 5. Record review on 3/8/2024 of the laboratory's 'EHS 102 Hazard Communication Written Program,' procedure attached to an email received on 3/9 /2024 from the GS revealed, the procedure did not address the safe storage of 55 gallons of chemical waste in laboratory work areas. 6. Record review on 3/8/2024 of 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 -- the laboratory's 'EHS 105 Safety Policy and Training Program,' procedure attached to an email received on 3/9/2024 from the GS revealed, the procedure did not address the safe storage of 55 gallons of chemical waste in laboratory work areas. 7. Staff interview on 2/26/2024 with the GS confirmed the findings in #1 above. The GS stated, "We do not have anywhere else to store this 55 gallon drum of chemical waste." -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the Precision Toxicology, LLC dba Precision Diagnostics laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to ensure that temperature conditions for reliable test system operation met the laboratory's established acceptable criteria as evidenced by the following: a) A review of temperature records for May 2018 (twenty two (22) days of laboratory operation) was performed. b) The review revealed that the temperature of the laboratory refrigerator was above the acceptable temperature range of two (2) to eight (8) degrees Celsius for twenty two (22) out of the twenty two (22) days reviewed (5/1,5/2, 5/3, 5/4, 5/7, 5/8, 5 /9, 5/10, 5/11, 5/14, 5/15, 5/16, 5/17, 5/18, 5/21, 5/22, 5/23, 5/245/25, 5/29, 5/30 and 5 /31/18). c) The review also revealed that the temperature of the laboratory freezer was above the acceptable temperature range of minus 30 degrees Celsius for twenty two (22) out of the twenty two (22) days reviewed (5/1,5/2, 5/3, 5/4, 5/7, 5/8, 5/9, 5/10, 5 /11, 5/14, 5/15, 5/16, 5/17, 5/18, 5/21, 5/22, 5/23, 5/245/25, 5/29, 5/30 and 5/31/18). d) The temperature of the refrigerator on 6/28/18 at 12:12 PM was observed to be 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 -- 10.64 degrees Celsius e) For both the refrigerator and freezer there was no corresponding documentation of any remedial or