Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Findings: 1. Review of the patient reports from the EMR revealed that the normal range for one analyte that did not match the normal range as stated in the Reference Range procedure manual with regards to Complete Blood Counts (CBCs) at time of survey. 2. Review of the procedure manual for White Blood Cell count (WBC) found the expected values or normal range was 4.5-9.8 x10mm3/mcL for female patient. 3. Review of the patient report for WBC contained a normal range of 4.5-13.0 x10mm3 /mcL for a 15 year old female. 4. Interview with the Laboratory Director, stated the Laboratory Interface System (LIS) Cerner breaks down reference ranges for CBCs with regards to age and gender. 5. Review of the Reference Range procedure with regards to CBCs only had two categories; Male and Female. There are no age ranges in the procedure for CBCs in the Reference Range procedure. 6. Interview with the Laboratory Director (LD) on 3/31/22 at 11:15 a.m. confirmed, the laboratory failed to ensure the test report included normal ranges as determined by the laboratory at time of survey. 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 --