Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of intracellular markers quality control (QC), interview with testing personnel (TP) #1, and interview with technical supervisor (TS) #1, the laboratory failed to perform a negative and positive control for TdT each day of patient testing from January 2023 to date July 9, 2025. Findings: 1. Review of intracellular marker QC revealed no negative and positive QC for TdT each day of patient testing. 2. Interview with TP #1 on July 9, 2025 stated "I run intracellular marker QC monthly". 3. Interview with TS #1 on July 9, 2025 10:30 AM confirmed the laboratory failed to perform a negative and positive control each day of patient testing for the TdT intracellular marker. 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 --