Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on June 10, 2023. Pediatrics in Brevard PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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: Based on review of the laboratory's test reports and interview, the laboratory failed to have the full name of the laboratory for three of three patients, (#1, #2, #3) and failed to have the units of measurement for hemoglobin for two (#2, #3) of three patient (#1, #2, #3) on the laboratory's test reports. Findings: Review of the test reports for patient's #1, #2, and #3, showed only the initials of the laboratory were listed on the test reports. Review of the test reports for patients #2, and #3, showed the units of measurement (grams per deciliter) for hemoglobin was not listed on the test reports. On 07/10/2023 at 12:55 PM, the Technical Consultant acknowledged the laboratory's full name and units of measurement for hemoglobin were not on the test reports. D5807 TEST REPORT CFR(s): 493.1291(d) 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 -- 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 the laboratory's test reports and interview, the laboratory failed to have the reference range for hemoglobin for two (#2, #3) of three patient (#1, #2, #3) on the laboratory's test reports. Findings: Review of the test reports for patients #2, and #3, showed the reference range for hemoglobin was not listed on the test reports. On 07/10/2023 at 12:55 PM, the Technical Consultant acknowledged the reference range for hemoglobin was not on the test reports. -- 2 of 2 --