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 observation of the laboratory, review of the February 2018 complete blood count (CBC) quality control (QC) records, two patient CBC reports, and interview with the technical consultant, the laboratory failed to have two levels of hemoglobin QC acceptable, prior to reporting patient results. The findings include: 1) Observation of the laboratory on July 9, 2018 at 1:45 p.m. revealed the Abbott Cell-Dyn Emerald in use for patient CBC testing. 2) Review of the February 2018 CBC QC records revealed on February 8, 2018 two levels of hemoglobin were not within acceptable limits. Lot number 7324 Low level QC reported as 4.8 g/dL (4.9-5.9 acceptable limits) and normal level QC reported as 10.4 g/dL (10.5-11.9 acceptable limits). 3) Review of two patient CBC reports (patient number one and patient number two) revealed on February 8, 2018 hemoglobin was performed and reported. 4) Interview on July 9, 2018 at 2:00 p.m. with the technical consultant confirmed on February 8, 2018 two levels of hemoglogin QC were not within acceptable limits, with patient testing performed and reported. 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 --