Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 laboratory polices and procedures, laboratory records, lack of documentation, and interviews with the technical supervisor (TS) and testing personnel (TP) #1; the laboratory failed to include the address of the laboratory that performed the Polymerase Chain Reaction (PCR) testing for two of four Urinary Tract Infection (UTI) Identification panels and three of three Antibiotic Resistance (ABR) panels in the specialty of microbiology. Findings include: 1. Review of laboratory policies procedures revealed the procedure titled, "Quality Assurance and Procedures", which stated, under "4.4. Post Analytic Phase: ... 4.4.1. Test Reports: ... We verify that reports have all essential information, including: positive patients identification, name and address of the testing lab, report date, units of measurement or interpretation of results, and reference intervals." 2. Review of two of four UTI Identification panel patient reports found the laboratory failed to indicate the address of the performing laboratory on the final reports. Patient: Date of Testing: 1485412 06 /12/2025 1410854 07/08/2025 3. Review of three of three ABR panel patient reports found the laboratory failed to indicate the address of the performing laboratory on the final reports. Patient: Date of Testing: 1451197 02/25/2025 1354903 02/26/2025 1485412 06/12/2025 4. Interviews with the TS and TP #1 on 07/09/2025, at 11:37 am, 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 -- confirmed the laboratory failed to include the address of the laboratory that performed the PCR testing for two of four UTI Identification panels and three of three ABR panels in the specialty of microbiology. -- 2 of 2 --