Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of laboratory policies procedures, laboratory records, lack of documentation, and interview with the technical supervisor (TS); the laboratory failed to ensure external negative and positive control materials were tested each day of testing for six of six testing dates reviewed in the sub-specialties of bacteriology and mycology prior to reporting patient results, affecting 12 patients. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Processing/ Testing Patients", which stated, under "Testing", "External QC must be performed with each batch of testing." 2. Review of laboratory records revealed the laboratory failed to run/document external QC on six of six patient testing dates reviewed. Patient: Date of Test: 20631 02/12/2026 20632 02/10/2026 20633 02/09 /2026 20640 03/04/2026 20642 03/05/2026 20643 03/12/2026 3. Interview with the TS on 07/22/2026 at 3:39 pm, confirmed the laboratory failed to ensure external negative and positive control materials were tested each day of patient testing in the sub-specialties of bacteriology and mycology prior to reporting patient results, affecting 12 patients. 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 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 -- 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 policies procedures, patient test reports, lack of documentation, and interview with the technical supervisor (TS); the laboratory failed to ensure patient test reports included all required information, including the address of the laboratory where Polymerase Chain Reaction (PCR) Wound Analysis Panel testing was performed, for six of six patient test reports reviewed in the specialty of microbiology from the beginning of testing, February 2026, through March 2026, affecting 12 patients. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Processing/ Testing Patients", which stated, under "Result Reporting", "official report must contain all essential information including: Laboratory Name [and] Laboratory Contact..." 2. Review of patient test reports for PCR Wound Analysis Panel testing failed to indicate the address of the laboratory location where the test was performed for six of six test reports reviewed. Patient: Date of Test: 20631 02/12/2026 20632 02/10/2026 20633 02/09/2026 20640 03/04/2026 20642 03/05/2026 20643 03/12/2026 3. Interview with the TS on 07/22 /2026, at 3:39 pm, confirmed the laboratory failed to ensure patient test reports included all required information, including the address of the laboratory where PCR Wound Analysis Panel testing was performed, for six of six patient test reports reviewed in the specialty of microbiology from the beginning of testing, February 2026, through March 2026, affecting 12 patients. -- 2 of 2 --