Summary:
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: Based on record review and interview, the laboratory failed to include the correct name and address of the location where the test was performed on four of seven (PT#1, PT#2, PT#5, and PT#7) patient test reports reviewed. Findings include: 1. Review of test reports indicated the laboratory failed to include the correct name and address of the laboratory location where the test was performed on the following test reports: PT#1 on 01/07/21 PT#2 on 01/12/21 PT#5 on 06/03/21 PT#7 on 11/05/21 2. On 05/16/22 at 2:45pm, SP-1 (Clinical Laboratory Manager) acknowledged the laboratory did not change the incorrect name and address (Marion County Public Health Department STD Lab, 640 Eskanazi Ave., Indianapolis, IN 46202) on the laboratory report from the previous site where testing was originally being performed. 3. Annual test volume for specialty/subspecialty for Microbiology is 4,689, Immunology is 7,594, and Chemistry is 4,206. 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 --