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 and interview with laborabory supervisor, determined the laboratory failed to run 3 levels of acceptable QC on 6/21/2019 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. On 6/21/2019, 2 of 3 levels of CBC QC material were unacceptable prior to 67 patient samples being tested. 3. Interview with laboratory supervisor on September 25, 2019 at approximately 12:30 p.m. confirmed the laboratory failed to follow CBC QC procedure for running 3 levels of acceptable CBC QC on 6/21/2019. =================================== 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 --