Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Highland Pediatrics laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 interview with the laboratory manager, the laboratory failed to make available pertinent reference intervals to the authorized person who ordered the tests based on the following: The surveyor reviewed six (6) final patient test reports for calendar years 2018 and 2019 for Urine Chlamydia trachomatis (CT) and Urine Neisseria gonorrhoeae (NG) in Office Practicum, the physician office's electronic medical record (EMR). The review revealed that there was no reference interval for Urine CT and Urine NG available to the ordering providers for six (6) out of the six (6) final patient test reports reviewed. The laboratory manager confirmed through interview on 02/12/2020 at 2:00 P.M. that laboratory failed to make reference intervals available to the authorized person who ordered the test. The laboratory performs 1019 Urine CT tests and 1016 Urine NG tests 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 --