Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was conducted on February 4, 2020. Oral Head and Neck Pathology 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's pathology report failed to list the address where the technical component was performed for 4 of 4 patient reports examined (#1, 2, 3 & 4). Findings: Review of the pathology reports, showed that the address where the technical component was performed was not listed for patient reports #1, #2, #3 and #4. During an interview on 2/4/20 at 11:00 AM, the Laboratory Director acknowledged that the final report did not have the address where the technical component was performed for these 4 patient reports. 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 --