Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) (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: Based upon review of patient reports and interview with laboratory staff the laboratory did not make a reference range for complete blood cell (CBC) assays available to the individual responsible for using the test results. Findings follow: A) Review of the final report for a CBC assay on a patient ( identified as number 1 on a separate patient identification list) revealed that, under the heading "Reference Range", the report was blank and no reference range was given. B) In an interview on 8/21/25 at 01:40 p.m., laboratory staff member (2 on form CMS 209) confirmed that the reference range was not included on the report identified above, and that investigation of other CBC reports showed that the reference range was not included. 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 --