Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at East Lake Pediatrics on 06/12 /2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 record review and interview with the Medical Assistant, the laboratory failed to have the correct address of the laboratory location where the complete blood count (CBC) and SARS-CoV-2 testing was performed for 4 (Patient #1, #2, #3, #4, ) out of 4 patient reports reviewed from 10/24/22 to 06/12/23. Findings included: Review of patient reports for Patient #1 (CBC testing 11/3/22), Patient #2 (SARS- CoV-2 testing 11/16/22), Patient #3 (CBC testing 12/5//22), and Patient #4 (SARS- CoV-2 testing 5/8/23), revealed all of the reports were missing the address for the location of patient testing. On 06/12/23 at 11:45 am, the Medical Assistant confirmed the reports were missing the testing address. 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 --