Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Cardiac quality control (QC) records, the patient results log, and an interview with the Laboratory owner, the laboratory failed to ensure two levels of quality control were acceptable and documented every 30 days per the manufacturers requirements. This was noted for 152 days out of 12 months reviewed in 2024 through 2025. The findings include: 1. A review of the Cardiac QC records for the Quidel Triage analyzer revealed the following dates QC was not performed or documented every 30 days: a) QC performed on 10/4/2024 and 11/11/2024; 6 days late. b) QC performed on 11/11/2024 and 12/19/2024; 8 days late. c) QC performed on 12/19/2024 and 2/13/2025; 24 days late. d) QC performed on 2/13/2024 and 4/2 /2025; 20 days late. e) QC performed on 5/31/2025 and 10/3/2025; 94 days late. 2. A further review of the patient log revealed the following dates patients were affected: a) 6/8/2025; 1 patient affected. b) 7/11/2025; 1 patient affected. c) 9/17/2025; 1 patient affected. d) 9/22/2025; 2 patient affected. e) 9/23/2025; 1 patient affected. f) 9/28 /2025; 1 patient affected. 2. During an interview on 11/3/2025 at 2:33 PM, the Laboratory owner confirmed the above findings. 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 --