Dallas Fertility Center - Medical City

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