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 CBC Quality Control (QC) records for November 9, 2018, CBC QC not tested until after patient CBC testing and upon interview with the Laboratory Manager, determined the laboratory failed to ensure CBC QC was acceptable before reporting seven patient CBC results on 11/09/2018. The findings include: 1. Review of Hematology Complete Blood Count (CBC) quality control records for November 9, 2018. 2. CBC quality control documented at 6:31 p.m. with seven patient CBC's documented between 10:11 a.m. and 3:57 p.m. on 11/09/2018. 3. Interview with the Laboratory Manager at approximately 12:30 p.m. February 12, 2019 confirmed that CBC quality control was not ran prior to seven patient CBC's tested and reported on 11/09/18. ===================================== 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 --