Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on August 7, 2026, with the following standard-level deficiencies cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on personnel competency assessment record review and interview, the laboratory failed to establish and implement policies and procedures to assess the competency of one (1) of one (1) Technical Consultant (TC) in accordance with their respective supervisory position responsibilities. Findings: 1. Review of competency assessment records on August 7, 2026, at approximately 10:00 AM, revealed that the laboratory had not established a policy or procedure to assess the competency of the TC relative to their supervisory responsibilities. No competency assessment documentation was identified for the TC. 2. Interview with the Laboratory Manager on August 7, 2026, at approximately 10:10 AM, confirmed that the laboratory lacked documented competency assessments for the TC specific to their supervisory position responsibilities. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. 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 -- This STANDARD is not met as evidenced by: Based on instrument cross-check record review, policy review, and interview, the laboratory failed to follow their established system to perform and document a twice- yearly comparison of test results using their two (2) of two (2) Quidel Triage Meter Pro instruments (used for D-Dimer, Troponin, and Urine Drug Screen testing) during calendar year 2025. Findings: 1. Review of 2025 instrument cross-check comparison records for the Quidel Triage Meter Pro instruments (Serial Numbers 00097669 and 00095399) on August 7, 2026, at approximately 11:30 AM, revealed the laboratory performed only one (1) cross-check on March 24, 2025. No second cross-check was performed during calendar year 2025. 2. Review of the Destin Hospital General Laboratory Policy on August 7, 2026, at approximately 11:45 AM, indicated: "The comparison of laboratory analytes when using more than one methodology inside the hospital is necessary to assure that a patient sample yields clinically comparable results on all laboratory instruments. This comparison should be performed every six months." 3. Interview with the Laboratory Manager on August 7, 2026, at approximately 12:00 PM, confirmed that the laboratory did not perform the required second instrument comparison during calendar year 2025. -- 2 of 2 --