Care Fertility

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.1487 Testing Personnel, high complexity D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of American Association of Bioanalysts (AAB) Medical Laboratory Evaluation proficiency testing (PT) records, and confirmed in interview, the laboratory failed to attest to the routine integration of proficiency samples into the patient workload for two of two Embryology, Andrology and Fetal events in 2024 (Events S1 and S2) and one of one Embryology, Andrology and Fetal event in 2025 (Event S1). Findings included: 1. Review of AAB PT records Embryology, Andrology and Fetal events in 2024 (Events S1 and S2) and 2025 (Event S1): "Attestations The undersigned analyst attests that samples were tested in the same manner as patient samples." 2. Further review of Embryology, Andrology and Fetal PT records for 2024 and 2025 revealed the following: Events S1 2024 the testing analyst and director or director's designee failed to sign the attestation statements. Event S2 2024 the testing analyst failed to sign the attestation statements. Event S1 2025 the testing analyst and director or director's designee failed to sign the attestation statements. 3. During an interview on 08/29/2025 at 10:53 a.m., the Technical Supervisor, after a review of records confirmed the laboratory failed to attest to the routine integration of proficiency samples into the patient workload. D2015 TESTING OF PROFICIENCY TESTING SAMPLES 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 -- 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 review of laboratory policy, American Association of Bioanalysts (AAB) Medical Laboratory Evaluation proficiency testing (PT) records, and confirmed in interview, the laboratory failed to retain a copy of all Embryology, Andrology and Fetal PT records for two of two events in 2024 (Events S1 and S2) and one of one event in 2025 (Event S1). Findings included: 1. Review of the laboratory's policy "Evaluation of AAB Proficiency Testing" stated: "Quality Assurance (QA) programs developed for the Embryology, Andrology and Endocrinology Laboratories to provide a framework whereby each laboratory assures a high quality of accurate, reliable and prompt service to our patients and their physicians. It is the policy of the Center for Assisted Reproduction to monitor and evaluate the ongoing and overall quality of the testing process. Quality control materials will be used to ensure reliability of testing. Proficiency testing through the American Association of Bioanalysts (AAB) is performed throughout the year and reviewed by the Laboratory Director and/or Laboratory Manager and/or Laboratory Supervisor. The first objective of this program is to identify trends and patterns of performance or potential problems. Second, to implement

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Based upon the onsite survey conducted 09/18/2019, this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493.1250 Analytic Systems 493.1441 Laboratory Director, (high complexity) 493.1487 Testing Personnel (high complexity) The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory. NOTE: The laboratory was asked to cease SpermMar IgG and SpermMar IgA testing for sperm antibodies. The laboratory voluntarily ceased sperm antibody testing on patients. See letter dated 09/19/2019 and signed by the laboratory director. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the