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 review of patient reports and interview with testing personnel (TP) #2, the laboratory failed to ensure the test report included normal ranges as determined by the laboratory. Findings: 1. Review of the patient reports for Total Prostatic Specific Antigen (TPSA), Testosterone and Urinalysis revealed 2 of 3 analytes reported did not include reference ranges. 2. Review of the patient reports for urinalysis did not include the normal ranges or expected values for urine dip or urine microscopic findings for laboratory's patient population. The report was a copy of the Clinitek Status print out of urine dip results with handwritten notations for color, clarity and microscopic findings. 3. Review of the patient reports for TPSA had a comment line hand written under the patient name of: "ulup to 6.5" 4. Interview with TP #2 on 3/10 /22 at 8:45 a.m. confirmed, the laboratory failed to ensure the test report included normal ranges as determined by the laboratory. 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 --