Rejuvenating Fertility Center, Pllc

Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on May 07, 2026 with the following standard level deficiencies cited. 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 review of the laboratory's submitted Form Centers for Medicare and Medicaid Services (CMS) 209, written policies and procedures, and interview with the Clinical Consultant (CC), the laboratory failed to establish written policies and procedures to assess consultant competency for 2 of 2 consultants (TS & CC). Findings Included: 1) Review of the laboratory's Form CMS 209 revealed 1 Technical Supervisor (TS) and 1 CC listed in consultant/supervisory roles. 2) Review of the laboratory's policy titled 'Rejuvenating Fertility Clinic Personnel Competency SOP' did not contain established policy and procedural components to assess consultant competency. 3) In an interview on 5/07/2026 at 10:13 AM, the CC confirmed the laboratory policies and procedures for consultant competencies were not established. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) 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 -- Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: I. Based on direct observation, manufacturer's instructions, review of the laboratory's temperature logs, and interview with the Clinical Consultant (CC), the laboratory failed to define room temperature in accordance with manufacturer instructions for the Tosoh Bioscience AIA-Pack Multi-Analyte Controls for 2 of 2 years (2024 and 2025). Findings Included: 1) In direct observation on 5/7/2026 at 10:45 AM in the laboratory, one Tosah Bioscience Analyzer was observed in use in the testing of Estradiol, Progresterone, Follicle-stimulating hormone (FSH), Luteinizing Hormone (LH), Human chorionic gonadotropin (hCG). 2) Review of the manufacturer's instructions for the Tosah Bioscience AIA-Pack Quality Control (QC) titled 'AIA-Pack Multi- Analyte Control MAC' stated the following: "Preparation of Reagents ...Add exactly 3.0mL of reagent grade water, put the stopper back on the vial and allow the reconstituted material to stand for at least 30 minutes at 18 to 25 degrees Celsius." 3) Review of the laboratory's temperature logs for 2024 and 2025 titled 'Rejuvenating Fertility Center Quality Control Sheet' revealed a defined acceptable temperature range of 16 to 33 degrees Celsius, with the following dates where recorded temperatures exceeded the manufacturer's upper threshold (June 2025 random review): 6/4/2025, 26 degrees Celsius; 6/5/2025, 27 degrees Celsius; 6/6/2025, 27 degrees Celsius. 4) In an interview on 5/07/2026 at 10:48 AM, the CC confirmed the defined acceptable laboratory room temperature ranges for 2024 and 2025 did not adhere to manufacturer instructions. II. Based on direct observation, manufacturer's instructions, review of the laboratory's freezer temperature logs, and interview with the Clinical Consultant (CC), the laboratory failed to define freezer temperature ranges in accordance with manufacturer instructions for 2 of 2 packages of Bio-Rad Liquicheck Immunoassay Plus Controls. Findings Included: 1) In direct observation on 5/7/2026 at 12:09 PM in the laboratory two packages of Bio-Rad Liquicheck Immunoassay Plus Controls were observed (Lot Number 1003960) in the freezer (Serial Number #VSA0950766), with manufacturer storage temperature requirements of -70 to -20 degrees Celsius. 2) Review of the laboratory's freezer temperature logs within the document titled 'Rejuvenating Fertility Center Quality Control Sheet' revealed a defined acceptable temperature range of -20 to -5 degrees Celsius for the Freezer. During a random review, in June 2025, all 23 testing days the laboratory was open, the temperature range was recorded less than -20 degrees Celsius (ranging from -16.8 to -13.3 degrees Celsius). 3) In an inteview on 5/07/2026 at 12:10 PM, the CC confirmed the defined acceptable freezer temperature ranges were not in accordance with manfucturer storage requirements. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 record review and staff interview, the laboratory failed to attest that proficiency testing (PT) samples were performed in the same manner as patient specimens. Findings include: 1. Record review on 1/19/22 of the 2021 American Association of Bioanalysts PT documents for Semen analysis (SA-event 1) and Endocrinology tests (Chemistry/Non-Chemistry-event 2) attestation pages revealed the pages were not signed by the laboratory director (LD). 2. Staff interview with the LD on 1/19/22 at 2:15 PM confirmed the above finding. 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 record review and staff interview, the laboratory failed to follow its procedure manual for calibration verification for the laboratory tests in the subspecialty of endocrinology. Findings include: 1. Record review of the laboratory's procedure manual for calibration verification on 1/19/22 for the Tosoh analyzer Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- revealed the laboratory must perform calibration verification at least semiannually for the endocrinology tests (Follicle stimulating hormone, Luteinizing hormone, Beta human chorionic gonadotropin, Estradiol and Progesterone). 2. The laboratory did not have documentation for the Tosoh analyzer semiannual calibration verification. 3. Staff interview with the laboratory director (LD) and the testing personnel #1 on 1/19 /22 at 11:45 AM confirmed the above findings. 4. The laboratory performs 5,100 endocrinology tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)