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 a review of Quality Control (QC) records for the Seimens Dimension XPAND Chemistry analyzer, patient data log, laboratory policy and an interview with the Technical Consultant (TC), the laboratory failed to ensure QC was within acceptable range before reporting patient results. The findings include: 1. A review of the QC records for the Seimens Dimension XPAND Chemistry analyzer revealed both levels of control for Alkaline Phosphatase were outside the acceptable range on 1/29 /2018. 2. Patient data log revealed a total of 10 patient chemistry profiles which included Alkaline Phosphatase were performed on 1/29/2018. 3. A review of the laboratory policy states "...patient results can't be reported if both controls for same test [are] not within 2 S.D. (standard deviations)..." 4. During an interview conducted on 2/13/2018 at 3:30 PM, the TC confirmed patient results should not be reported until QC is within the acceptable established range. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --