Duke City Recovery Toolbox

Summary Statement of Deficiencies D0000 A validation survey was conducted on 3/17/2026. Standard level deficiencies were cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions (package insert), direct observation, and review of calibration records, the laboratory failed to label 1 of 1 Thermo Scientific CEDIA Negative Calibrator bottle with the revised expiration date. Findings included: 1. Review of the package insert for Thermo Scientific CEDIA Negative Calibrator stated, "Stability after opening the bottle: 60 days or until the printed expiration date, whichever comes first." 2. During a tour of the laboratory on 3 /17/2026 at 3:06 pm, one bottle of in-use CEDIA Negative Calibrator was observed in the refrigerator labeled with an open date "o: 8/4/25" (lot # 75190044, expiration date 4/30/2026). The bottle was not labeled with the revised expiration date of 10/4/2025. 3. Review of CEDIA Negative Calibrator records from the Mindray BS-480 for 6- Acetylmorphine (6AM) included 7 days (random sampling) when the expired calibrator was used. Refer to D5417. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- 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 review of manufacturer's instructions (package insert), direct observation, review of calibration records, and in interview with the technical consultant, the laboratory failed to ensure that expired calibration was not used on the Mindray BS- 480 for 7 of 7 days (random sampling). Findings included: 1. Review of the package insert for Thermo Scientific CEDIA Negative Calibrator stated, "Stability after opening the bottle: 60 days or until the printed expiration date, whichever comes first." 2. During a tour of the laboratory on 3/17/2026 at 3:06 pm, one bottle of in-use CEDIA Negative Calibrator was observed in the refrigerator labeled with an open date "o: 8/4/25" (lot # 75190044, expiration date 4/30/2026). The bottle was not labeled with the revised expiration date of 10/4/2025 and was available for use. 3. Review of CEDIA Negative Calibrator from the Mindray BS-480 for 6-Acetylmorphine (6AM) included the following days when the expired calibrator was used (random sampling): 10/14/2025, 11/3/2025, 11/28/2025, 12/29/2025, 1/26/2026, 2/23/2026, and 3/16 /2026. 4. During an interview on 3/17/2026 at 3:06 pm, the technical consultant confirmed the expired calibrator was in-use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies were cited during a validation survey completed on 01/09 /2020 for the federal requirements of 42 CFR Part 493 for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of 2018-2019 proficiency test records, laboratory policy, and interview with the General Supervisor, the laboratory failed to ensure attestation statements were physically signed by the Laboratory Director and testing personnel. Findings are: A. Review of 2018-2019 proficiency test records revealed the laboratory director failed to physically sign attestations statements for 5 of 5 test events in 2018 and 4 of 4 in 2019. 1. CAP (College of American Pathologists) Proficiency testing program UT (Urine Toxicology) -A 2019, kit date 04/03/19 Undated electronic signature for both the Laboratory Director and Testing Person #1. UT-B 2019, kit date 08/21/19 Undated electronic signature for both the Laboratory Director and General Supervisor (as the testing person) UT-C 2019, kit date 11/14/19 Undated electronic signature for both the Laboratory Director and General Supervisor (as the testing person) DMPM (Drug Monitoring for Pain Management) - A, kit dated 03/07/18 Undated electronic signature for both the Laboratory Director and General Supervisor (as the testing person) DMPM, kit dated 09/12/18 Undated electronic signature for the Laboratory Director. The testing person did not sign. 2. API (American Proficiency Institute) Proficiency Program Chemistry - Miscellaneous (Urine Drug Screens) 2018- 1 Electronic signature for the Laboratory Director on 05/09/18. 2018-2 Electronic signature for the Laboratory Director on 10/25/18. 2019-1 Electronic signature for the Laboratory Director on 05/03/19. 2019-2 Electronic signature for the Laboratory 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 -- Director on 10/17/19. B. Review of the laboratory's Proficiency Testing Policy, reviewed by the Laboratory Director on 08/25/17, 08/07/18, and 08/16/18 indicated; "The Lab Director will review and sign all attestations, results, and