Dothan Medical Associates

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of the 25-0H Vitamin D (Vit.D) Quality Control (QC) Certificate and an interview with the Testing Personnel 1 (TP1), the laboratory failed to provide the surveyor the worksheets for one of the three 25-OH Vitamin D kits in use in the ELISA testing for approximately nine months. The findings include: 1. A review of the Vit.D QC certificates revealed Kit Lot E250429AY, Expiration of 04-28-26, had no documentation of performance verification when it was put in use, 10-06-25. 2. TP1 confirmed the above findings during the Day 2 exit conference on 08-26-2026 at 4:00 PM. 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 review of the personnel records, and an interview with the Testing Personnel 1 (TP1), the Laboratory Director (LD) failed to assess and document the annual competency for one of the two TP listed on the CMS 209 (Laboratory Personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Report) for 2024-2026. The findings include: 1. A review of the personnel records revealed the LD had not documented the annual competency assessment of TP1 for the Vitros XT 3400 analyzer utilized in the Chemistry specialty. 2. TP1 confirmed the above findings during the Day 1 exit conference on 08-25-2026 at 4:00 PM. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) and the College of American Pathologists (CAP) Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the Laboratory Director (LD) failed to document review and evaluation of PT performance. This was noted on one of the three Chemistry events in 2025, and one of the two Special Immunology events had no documentation of review and

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to acheive satisfactory testing performance for Direct Bilirubin. This was noted for two out of five Proficiency Testing events reviewed for the specialty of Chemistry. The findings include: 1. A review of Medical Laboratory Evaluation (MLE) proficiency testing reports revealed the following scores: A. 2023 M2 - Direct Bilirubin 40% B. 2023 M3 - Direct Bilirubin 60% 2. During an interview on 4/16/2024 at 2:40 PM, Testing Personnel #1 confirmed the laboratory to have ongoing failures with Direct Bilirubin PT despite attempts to correct the issue. 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 --