Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 review of Complete Blood Count (CBC) Quality Control (QC) procedure for performing 3 levels of acceptable QC daily, review of monthly instrument QC records, and interview with the laboratory supervisor confirmed the laboratory failed to run 3 levels of acceptable QC on 07.01.2020 and 07.02.2020 prior to patient testing. The findings include: 1. Review of QC procedure states 3 levels of acceptable CBC QC materials will be performed daily. 2. Review of instrument monthly QC records for July 2020 confirmed no documentation of 3 levels of acceptable CBC QC material on 7.1.2020 and 7.2.2020 prior to patient samples being tested. 3. Interview with laboratory supervisor on August 5, 2021 at approximately 1:00 PM confirmed the laboratory failed to follow CBC QC procedure for running 3 levels of acceptable CBC QC on 7.1.2020 and 7.2.2020. =================================== 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 --