Ohm Labs Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Ohm Labs Llc on June 3, 2025 to September 9, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain their proficiency testing record for the second event of Toxicology in the specialty of Chemistry in 2023. Findings Included: Review of Chemistry proficiency testing revealed there was no documentation for the second event of toxicology proficiency testing for 2023. On 6/3/2025 at 2:08 PM, Technologist B confirmed the second event from 2023 for toxicology could not be located. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have separate user identifications for using the Indiko Plus instrument for patient chemistry testing. Findings Included: On 6/03/2025 at 3:52 PM, the Indiko Plus Instrument had 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 -- unknown username linked to all digitally transmitted chemistry reports. There were no unique usernames and the technologists were using the same usernames for testing on the instrument. Review of LIS manual revealed there was no policy for identifying users on the Indiko Plus instrument. On 6/4/2025 at 11:56 AM, Technologist A confirmed none of the technologists had a separate usernames when using the Indiko Plus Instrument. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on December 8, 2022. OHM Labs Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, review of the Reagent Calibration Log, and interview, the laboratory failed to ensure the Synermed Negative DAU (Drugs of Abuse) Calibrator used on the Synermed IR-500 toxicology analyzer was not expired prior to performing the calibration for the analyte Buprenorphine on 11/22/2022. Findings: Observations made during a tour of the laboratory on 12/08/2022 at 9:55 AM, revealed the opened bottle of Synermed Negative DAU Calibrator lot number 122111-0 expired on 11/12 /2022 Review of the Reagent Calibration Log revealed the calibration of Buprenorphine was performed on 11/22/2022 using the expired Synermed Negative DAU Calibrator lot number 122111-0. On 12/08/2022 at 10:04 AM, the General Supervisor stated she used the expired calibrator for the Buprenorphine calibration. 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 --