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: Based on record review and staff interview the laboratory failed to include reference ranges in the final test reports in the sub-specialty of endocrinology. Findings include: 1. Record review of six (6) final patient test reports for endocrinology tests revealed reference ranges for the following tests were not included in the final test report. a. Progesterone b. Luteinizing hormone c. Estradiol d. Follicle stimulating hormone e. Beta HCG 2. Staff interview the technical supervisor (TS) on 4/11/19 at 12:45 PM confirmed the above finding. The TS stated the laboratory performed a software update recently for their computer system and it was overlooked. 3. The laboratory performs 10,772 tests in the sub-specialty of endocrinology annually. 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 --