East Tennessee Reproductive Endocrine Lab

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a random review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) attestation statements and staff interview, the laboratory director (or designee) and testing personnel failed to sign four of four proficiency testing attestation statements from 2023 and 2024. The findings include: 1. A random review of the laboratory's CAP PT records revealed the laboratory director (or designee) and testing personnel failed to sign the following attestation statements: 2023 FH9-B (Hematology-event two), 2023 C-A (General Chemistry- event one), 2024 FH9-A (Hematology-event one), and 2024 C-A (General Chemistry- event one). 2. An interview with the laboratory manager on 10.01.2024 at 1:45 p.m. confirmed the above survey findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 observation of the laboratory, review of the manufacturer's instruction manuals, environmental records, and staff interview, the laboratory failed to monitor ambient humidity in the areas where patient testing occurred in 2023 and 2024. The findings include: 1. Observation of the laboratory on 10.01.2024 at 9:45 a.m. revealed two testing areas with the following analyzers in use for patient testing: -area one: Siemens Atellica chemistry analyzer, serial number: FL400690569 -area two: Sysmex XN-10 hematology analyzer, serial number 82423, Fisher Scientific Excyte Erythrocyte sedimentation rate analysis analyzer, serial number 01637, and a Siemens Clinitek Advantus urinalysis analyzer, serial number KPS62222245. 2. A review of the manufacturer's instruction manuals revealed the following humidity requirements: Siemens Atellica: 20-80 percent (%) Sysmex XN-10: 20-85% Fisher Scientific Excyte: 10-98% Siemens Clinitek Advantus: 20-80% 3. A review of the laboratory maintenance logs revealed no humidity records were available for the two areas where the laboratory performed patient testing using the Siemens Atellica, Sysmex XN-10, Fisher Scientific Excyte, and Siemens Clinitek Advantus in 2023 or 2024. 4. An interview with the laboratory manager on 10.01.2024 at 1:45 p.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the procedure manuals and interview with the laboratory's general supervisor #2, determined that the laboratory failed to follow their own written policy for reviewing procedures in 2022. The findings include: 1. Review of the laboratory's procedure manuals revealed, "The medical or laboratory director or the director's designee should review all copies of this procedure at least once a year. The director should keep a log of the copies being maintained." 2. Review of the procedure manuals' logs revealed no documented signatures for 2022. 3. Interview with the laboratory's general supervisor #2 at approximately 1:00 pm on June 1, 2023, confirmed there was no documented review of the laboratory's procedure manuals in 2022. 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 --

Summary Statement of Deficiencies D5785