Tennessee Reproductive Medicine, Pllc

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of accu-beads manufacturer quality control ranges, review of laboratory procedure, random review of quality control (QC) records, and interview with the general supervisor, the laboratory failed to define the correct QC range for one of two levels of quality control used for manual sperm counts, with unacceptable QC documented for vial one for 49 of 74 days reviewed in 2024 with 387 patient samples tested and reported. The findings include: 1. Observation of the laboratory on 05.05.2025 at 8:45 a.m. revealed a microscope used for patient testing for manual semen analysis and accu-beads quality control vial one (lot number: 240403351, expiration date: 03.2026) and vial two (lot number: 231310181, expiration date: 10.2025). 2. A review of accu-beads manufacturer quality control ranges revealed the following ranges for vial one: fixed coverslip: 35 +/- 5 (30- 40) M/ml, and Hemacytometer: 46 +/- 7 (39-53) M/ml. 3. A review of the laboratory's Semen Analysis procedure revealed that it performs manual microscopic analysis for sperm counts using the Makler Chamber (hemacytometer methodology). 4. A random review of the Sperm Count Quality Control logs revealed that the quality control range documented on the QC log was "30 - 40." This range was the incorrect QC 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 -- range for the laboratory's methodology. The review also revealed unacceptable QC for 17 of 26 days in May 2024 with 145 patient samples tested and reported, 17 of 24 days in June 2024 with 112 patient samples tested and reported, and 15 of 24 days in July 2024 with 130 patient samples tested and reported. 5. An interview with the general supervisor on 05.05.2025 at 11:30 a.m. confirmed the above survey findings. Word Key: M/ml = million per milliliter -- 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 laboratory's procedure manual, the document titled "Andrology Stain Quality Control", patient log for semen analysis with morphology and interview with the practice manger, the laboratory failed to follow policy for documentation of daily stain quality control for 40 of 40 days in 2022. The findings include: 1. Review of the laboratory's Semen Analysis procedure revealed the following statement under the Stain Quality Control section, "Frequency: This process should be performed each day that staining is performed". 2. Review of the document titled "Andrology Stain Quality Control", revealed the following: - No documentation of daily stain quality control from 09.16.2022-09.29.2022 - October 2022 and November 2022: no logs available for surveyor review 3. Review of patient log for semen analysis revealed semen analysis with morphology was performed on the following dates: 09.19.2022, 09.20.2022, 09.21.2022, 09.27.2022, 09.28.2022, 09.29.2022, 10.03.2022, 10.04.2022, 10.05.2022, 10.06.2022, 10.07.2022, 10.10.2022, 10.11.2022, 10.12.2022, 10.13.2022, 10.14.2022, 10.18.2022, 10.19.2022, 10.24.2022, 10.25.2022, 10.26.2022, 10.27.2022, 10.28.2022, 10.31.2022, 11.01.2022, 11.02.2022, 11.03.2022, 11.07.2022, 11.08.2022, 11.09.2022, 11.14.2022, 11.15.2022, 11.16.2022, 11.17.2022, 11.21.2022, 11.22.2022, 11.23.2022, 11.28.2022, 11.29.2022, and 11.30.2022 (40 days total). 4. Interview with the practice manager on 08.30.2023 at 2:45 p.m. confirmed the laboratory failed to follow policy for documentation of daily stain quality control for 40 of 40 days when patient testing occurred 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 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 observation of the laboratory, review of the laboratory procedure manual, review of training and competency records for testing personnel, review of the CMS Laboratory Personnel Report (CMS 209 form), and interview with the practice manager, the laboratory failed to establish written policies and procedures for personnel training and competency assessment. The findings include: 1. Observation of the laboratory on 06.21.2022 at approximately 10 a.m. revealed the following for high complexity test for patient testing: Manual Semen Analysis 2. Review of the laboratory procedure manual revealed no testing personnel policies and procedures. 3. Review of CMS 209 form and testing personnel records revealed no annual competency assessment on testing persons one and three for 2021 and no initial training in 2020, 6 month competency and annual competency in 2021 for testing person two (date of hire: 11.30.2020). 4. Interview with the practice manager on 06.21.2022 at 12:30 p.m. confirmed the laboratory failed to establish policies and procedures for personnel training and competency assessment in 2021 for testing persons one and three and in 2020 and 2021 for testing person two. =================================== 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 --