Children's Clinic, The

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 reference range for total bilirubin (TBil) assays available to the individual responsible for using the test results. Findings follow: A) Review of the final report for a TBil assay on 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 7/16/25 at 02:40 p.m., laboratory staff members (2 and 3 on form CMS 209) confirmed that the reference range was not included on the report identified above, and that investigation of other TBil 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 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Through interview and review of patient result reports it was determined that routine chemistry, immunology, and microbiology testing is referred to an outside reference laboratory (laboratory identified as laboratory #2 on a separate laboratory identification list) and those results lack the name and address of the performing laboratory. Findings follow: A. In an interview on 3/20/19 at approximately 08:45 AM, the laboratory staff member, identified as number three on the CMS 209 form, stated that routine chemisry testing, immunology testing, and micobiology testing is referred to an outside laboratory, identified as laboratory #2 on a separate laboratory identification list, which is the laboratory's main reference laboratory and results are electronically reported via computer interface. B. Review of patient results of routine chemistry, immunology, and microbiology testing revealed that the name and address of laboratory #2 as performing laboratory was not present on the patient report on two of two results reviewed. C. In an interview on 3/20/19 at approximately 12:00 PM, the laboratory staff member, identified as number three on the CMS 209 form, confirmed that the chemistry, immunology, and microbiology results reviewed were performed by laboratory #2 and that the name and address of the performing laboratory was not included on the final report. D. In an interview on 3/20/2019, at approximately 12:00 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- PM. the laboratory staff member, identified as number three on the CMS 209 form, and the technical consultant, identified as number two on the CMS 209 form, confirmed that all routine chemistry, immunology, and microbiology testing referred to laboratory #2 would not list the name and address of laboratory #2 as the performing laboratory. -- 2 of 2 --