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 patient test reports from February 3, 2026, and staff interview, the laboratory failed to include the facility's address on 10 of 10 test reports. The findings included: 1. A sampling of 10 patient reports from February 3, 2026 determined 10 of 10 test reports did not have the laboratory's address included (see patient alias list). 2. The technical consultant confirmed the findings in an interview conducted on 02/04 /2026 at 0945 hours in the break room confirmed the findings. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance plan, review of quality 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 -- assurance reports from 2024 and 2025, and staff interview, the laboratory failed to have documentation of the laboratory director initialing 24 of 24 monthly reviews. The findings included: 1. The laboratory's quality assurance plan under the section titled "Quality Assurance Records" stated: "All records are dated and initialed by the staff performing the review, by the technical consultant, and by the laboratory director." 2. A review of the laboratory's quality assurance reports from 2024 and 2025 determined the laboratory director failed to initial 24 of 24 quality assurance reports. 3. The technical consultant confirmed the findings on 02/04/2026 at 1026 hours in the break room. -- 2 of 2 --