Dallas Fertility Center-Perot

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 11/07/2024. 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. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's observations, staff interview, review of laboratory's policies /procedures, quality control (QC) records and annual test volumes, the laboratory failed to document the lot number and open/expiration date of Accu-beeds controls (Vial 1 and Vial 2) used to assess QC for Sperm count testing for seven of seven random months reviewed in 2023 and 2024. Findings included: 1. Surveyor's observations on 11/07/2024 at 0910 hours in the laboratory revealed a box of Spectrum Technologies Accu-beeds, marked as received on 10/10/2023, containing: Vial 1 (18M [million]/ml [milliliter]); lot number 223011181, expiring December 2024 Vial 2 (35M/ml); lot number 230604351, expiring April 2025 2. In an interview on 11/07/2024 at 1130 hours in the facility's reception area the laboratory director stated that the laboratory performed QC for sperm count with two levels of Spectrum Technologies Accu-beeds. 3. Review of laboratory's policies/procedures revealed the laboratory did not have protocols in place to ensure QC material's lot numbers and 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 -- expiration dates were documented. 4. Review of random QC records revealed the following seven of seven months did not have documentation of the lot number or expiration date of the Sperm Count QC Accu-beeds control solutions: April 2023 November 2023 March 2024 April 2024 May 2024 June 2024 August 2024 5. Review of laboratory's annual test volumes revealed that the laboratory performed approximately 40 sperm analysis tests (with sperm counts) annually. 6. In an interview on 11/07/2024 at 1135 hours in the facility's reception area the laboratory director (as indicated on submitted Form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid -- 2 of 2 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiency and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representative was 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 recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the