Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a lack of review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Laboratory Director (LD) also qualified as the Technical Consultant (TC), the laboratory failed to ensure proficiency (PT) testing records were complete and retained for at least two years. This was noted for five of seven PT events reviewed in 2023 through 2024. The findings include: 1. A lack of review of the AAB-MLE PT records revealed no evidence of PT documentation, during the survey, of review and attestation pages from the Laboratory Director,or designee, and TP for the following surveys: a) 2023 Chemistry M3, b) 2024 Chemistry M1-M3, c) 2025 Chemistry M1. 2. During the laboratory tour on 11/12/2025, at 9:15 AM, the Laboratory Director told the surveyor the PT documentation could not be located prior to the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- reports. This STANDARD is not met as evidenced by: Based on a review of the environmental records, policy and procedures, and an interview with the Laboratory Director, the Laboratory failed to ensure the room temperature for RPR (Rapid Plasma Reagin) patient testing stayed within the limits specified by the laboratories policy and procedures. The surveyor noted the room temperature was below acceptable ranges for 15 days of 31 days in October 2025. The findings include: 1. A review of environmental records revealed the room temperature was below the specified performance parameters for RPR patient testing for 15 days in October 2025. 2. A further review of the Reagents/Media/Equipment Policy 5.3.1 Performance parameters revealed, "Before testing ensure that the RPR suspension is at room temperature 22-30 degrees Celsius." 3. During an interview on 11/12/2025, at 2:26 PM, the Laboratory Director confirmed the above findings. D5781