Dallas Fertility Center - Medical City

Summary Statement of Deficiencies D0000 An announced routine recertification survey of the laboratory was completed on 06/23 /2026. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 policy, laboratory maintenance logs, and confirmed in interview, the laboratory failed to follow their own procedure for performing and documenting morphology stain replacement for ten of ten events in 2025 and three of three events in 2026. Findings include: 1. Review of the laboratory's policy titled "ANDRO-SOP-04 Morphology Staining" stated: "9. Procedure Notes d. To avoid stain contamination or inadequate staining resulting in false positive diagnosis of bacteriospermia or other inaccuracies, all three staining solutions should be examined for cloudiness, presence of foreign bodies, or other signs of improper staining daily and must be replaced every two weeks ..." 2. Review of the laboratory's maintenance log titled "Medical City ANDROLOGY Start-Up / Shutdown" determined morphology stain was replaced on the following days: 2025: Stain Changed: 01/30/2025 Stain Changed: 02/20/2025 (21 days elapsed) Stain Changed: 03 /27/2025 (35 days elapsed) Stain Changed: 04/24/2025 (28 days elapsed) Stain Changed: 05/27/2025 (33 days elapsed) Stain Changed: 06/03/2025 (7 days elapsed) Stain Changed: 07/29/2025 (56 days elapsed) Stain Changed: 07/31/2025 (2 days elapsed) Stain Changed: 08/07/2025 (7 days elapsed) Stain Changed: 09/02/2025 (26 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 -- days elapsed) 2026: Stain Changed: 01/22/2026 (142 days elapsed) Stain Changed: 02 /26/2026 (35 days elapsed) Stain Changed: 04/28/2026 (61 days elapsed) 3. The Clinical Consultant (as listed on the CMS-209 form) confirmed the findings during an interview on 06/23/2026 at 1310 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, manufacturer's instructions, quality control (QC) logs, patient final reports, and confirmed in interview, the laboratory failed to ensure two levels of sperm count quality control were within established acceptability, prior to reporting patient test results for 12 of 12 patient test results in 2026. Findings include: 1. Review of the laboratory's policy titled "ANDRO-SOP-14 Semen Analysis Quality Control (Accu-beads)" stated: "Quality Control: ...When counting each side of the counting chamber, for each control, the counts must be within 10% of each other. If this does not occur, then the affected control must be repeated." 2. Review of the manufacturer's instructions "accu-beads+ A Quality Control Check for Automated and Manual Sperm Counting Methods" stated: "Manual Counting Procedures ...The results should be within 10% of each other to be considered valid." 3. Review of the laboratory's QC logs determined quality control values were out of range for the following days: a. 01/22/2026: QC Level: Low Value 1: 17 Value 2: 20 Difference: 16.2% b. 02/03/2026 QC Level: Low Value 1: 16 Value 2: 20 Difference: 22.2% c. 02 /26/2026: QC Level: Low Value 1: 16 Value 2: 18 Difference: 11.8% d. 03/17/2026: QC Level: Low Value 1: 18 Value 2: 15 Difference: 18.2% e. 03/19/2026 QC Level: Low Value 1: 17 Value 2: 15 Difference: 12.5% f. 03/24/2026 QC Level: Low Value 1: 16 Value 2: 18 Difference: 11.8% g. 04/16/2026 QC Level: Low Value 1: 15 Value 2: 19 Difference: 23.5% h. 04/28/2026 QC Level: Low Value 1: 15 Value 2: 18 Difference: 18.2% i. 05/05/2026 QC Level: Low Value 1: 18 Value 2: 16 Difference: 11.8% j. 05/07/2026 QC Level: Low Value 1: 16 Value 2: 20 Difference: 22.2% 4. Further review of patient reports determined testing was performed on days in which QC was outside acceptable limits. The patients were: 01/22/2026: a) Accession #: 731654 b) Accession #: 731470 02/03/2026: a) Accession #: 734197 02/26/2026: a) Accession #: 738839 03/17/2026: a) Accession #: 744085 03/19/2026: a) Accession #: 745968 03/24/2026: a) Accession #: 734333 b) Accession #: 746891 04/16/2026: a) Accession #: 751161 04/28/2026: a) Accession #: 755620 05/05/2026: b) Accession #: 757536 05/07/2026: c) Accession #: 742995 5. The Clinical Consultant (as listed on the CMS-209 form) confirmed the findings during an interview on 06/23/2026 at 1148 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced onsite routine recertification survey was performed on 05/17/2024 and the laboratory was found to not be in compliance with the following CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1487 Laboratories performing high complexity testing; testing personnel D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, review of proficiency testing (PT) records and confirmed in interview, the laboratory failed to verify the accuracy of sperm count for one of two testing events in 2023 (Event 2), sperm motility for one of two testing events in 2022 (Event 2), and one of two events in 2023 (Event 1). Findings include: 1. Review of the laboratory's policy titled "Policy for Proficiency Testing" determined: "If a proficiency test sample(s) receives and unacceptable score, the laboratory director will evaluate and document any

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and certification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the