Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 14, 2023. South Lake Gastroenterology Inc 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 record review, and interview, the laboratory failed to list the current address of the laboratory where the technical component was performed for five of five patients' pathology reports, (#1, #2, #3, #4, #5). Findings: Review of patients' pathology report showed the address of the laboratory where the professional component was performed listed the previous address of the laboratory for five of five patients' reports reviewed, (#1, #2, #3, #4, #5). According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 03/10/2023, the laboratory had an annual test volume of 12,000 tests. On 03/14/2023 at 10:05 AM, the Laboratory Director stated the address where the technical component was performed listed the laboratory's previous 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 --