Advanced Reproductive Health Centers Chicago Ivf

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records, review of laboratory policy and procedures, review of American Association of Bioanalysts-Medical Laboratory Evaluation (AAB- MLE) proficiency testing (PT) records and interview with testing personnel (TP) #1; the laboratory failed to have PT samples tested using personnel who routinely perform testing, 1 of 2 TP failed to perform PT events from 2023 until the date of survey. Findings include: 1. Review of the Laboratory Personnel Report and laboratory competency documents revealed two TP authorized to perform semen analysis. 2. Review of laboratory policy and procedure manuals identified the procedure, "Chicago IVF Proficiency Testing" which stated, under the section titled "Testing", "Run specimens exactly as patient specimens, using "PT" as the patient name and the specimen number as the patient identification number." 3. Review of laboratory testing records for five of five AAB-MLE PT events, revealed TP #1 performed and submitted all five testing events. Year: Event: TP: 2023 2 1 2024 1 1 2024 2 1 2025 1 1 2025 2 1 4. Interview with TP #1 on 10-14-2025, at 12:01 pm, confirmed that the laboratory has TP #1 always perform and submit the results for AAB-MLE PT. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with the General Supervisor (GS); the laboratory failed to attest to the routine integration of PT samples for four of five AAB-MLE PT events reviewed from Event 2 of 2023 through Event 1 of 2025. Findings include: 1. Review of laboratory policy and procedure manuals identified the procedure, "Chicago IVF Proficiency Testing" which stated, under the section titled "Post-testing", "The Director and testing personnel must sign the attestation statement. Electronic submission of results generates a form for this purpose." 2. Review of five AAB-MLE PT attestation records, from Event 2 of 2023 through Event 2 of 2025, revealed no laboratory director (or designee) signature or testing personnel (TP) signature on four of five attestation records. a. Embryology, Andrology & Fetal S2 2023 submitted on 11-09- 2023 b. Embryology, Andrology & Fetal S1 2024 submitted on 04-12-2024 c. Embryology, Andrology & Fetal S2 2024 submitted on 11-01-2024 d. Embryology, Andrology & Fetal S1 2025 submitted on 04-17-2025 3. An interview with the GS at 12:01 PM, on 10-14-2025, confirmed the LD (or Designee) and TP #1 and TP #2 failed to attest to the routine integration of PT samples for the events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299. Findings Include: 1. The laboratory's control procedures failed to detect errors due to operator performance and monitor the accuracy and precision of test performance over time due to variance in operators for semen analysis testing. See D5441. 2. The laboratory failed to ensure two levels of quality control (QC) materials were ran each day of testing for 2 of 6 patient testing dates reviewed for semen analysis testing. See D5447. 3. The laboratory failed to test the staining material Spermac stain for intended reactivity each day of use for semen analysis testing for 5 of 5 patient testing dates reviewed. See D5473. 4. The laboratory failed evaluate patient testing when Accu-bead controls failed to meet the laboratory's established criteria for 5 of 5 dates identified on quality assurance incident reports. See D5783. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory's control procedures failed to detect errors due to operator performance and monitor the accuracy and precision of test performance over time due to variance in operators for semen analysis testing. Findings include: 1. Review of patient testing found for 1 of 5 patient testing dates reviewed found the daily accu-bead controls were performed by an individual not authorized to perform semen analysis testing based on review of the CMS-209 laboratory personnel report. Patient Identification Test Date QC Log P1 01-24-2020 Performed by a nurse not identified on the CMS- 209 2. Review of the January 2020 "Q.C. Log-Accubead Daily Count Log (v. 12.19.02)" identified 5 additional patient testing dates (01-20-20, 01-22-20, 01-23-20, 01-24-20, and 01-27-20) where accu-bead quality controls were performed by individuals not authorized to perform semen analysis testing. 3. Review of the "Semen Specimen Accession Log" for the above mentioned testing dates identified 19 additional patients (P6 through P24) that had semen analysis testing performed when accu-bead quality controls were performed by individuals not authorized to perform semen analysis testing. 4. On survey date 01-29-2020, at 2:10 pm, TP#1 confirmed additional nursing staff performed accu-bead controls on the above mentioned dates but were not authorized to perform semen analysis testing. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to ensure two levels of quality control (QC) materials were ran each day of testing for 2 of 6 patient testing dates reviewed for semen analysis testing. Findings include: 1. Review of patient testing found for 2 of 6 patient testing dates the laboratory failed to perform and document 2 levels of accu-bead controls on the laboratory's quality control log. Patient Identification Test Date QC Log P5 12-13- 2019 No QC documented P27 06-21-2019 No QC documented 2. Review of the "Semen Specimens Accession Log" revealed 5 patients' had semen analysis testing performed when the accu-bead controls were not performed and documented (12-13- 2019 and 06-21-2019). 3. On survey date 01-29-2020, at 2:10 pm, TP#1 confirmed the laboratory failed to perform and document two levels of accu-bead quality control materials for the dates identified. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) -- 2 of 3 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to test the staining material Spermac stain for intended reactivity each day of use for semen analysis testing for 5 of 5 patient testing dates reviewed. Findings Include: 1. Review of patient test results for semen analysis found for 5 of 5 testing dates reviewed Spermac stain reactivity was not performed or documented. Patient Identification Test Date P1 01-24-2020 P2 02-16-2018 P3 09-21-2018 P4 03- 27-2019 P5 12-13-2019 2. Review of the manufacturer's product insert for Spermac stain found under the section "staining procedure" that the testing personnel should observe the following characteristics: acrosome = dark green nucleus = stained red equatorial region = pale green midpiece and tail = green 3. Review of the patient test volume worksheet found 467 patients were tested for semen analysis in 2019 when no reactivity of Spermac stain was performed and documented. 4. On survey date 01-29- 2020, at 2:10 pm, TP#1 confirmed the laboratory failed to test and document staining reactivity for Spermac stain each day of patient testing for semen analysis. D5783

Summary Statement of Deficiencies 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 records and interview with the laboratory technical supervisor (TS) #2; the laboratory failed to establish policies and procedures to assess employee competency. Findings Include: 1. Review of the laboratory's policy and procedure manual found no policy had been established to assess the competency of personnel listed on the CMS-209 which include the technical supervisors, general supervisors, clinical consultants and testing personnel. 2. On survey date 01-10-2018 at 11:20am TS#2 confirmed the laboratory had failed to establish a competency assessment policy. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with technical supervisor (TS) #2; the laboratory's technical supervisors failed to ensure annual competency 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 -- assessments were completed for 2 of 2 testing personnel. Findings Include: 1. Review of competency assessment records for testing personnel (TP) #1 and TP#2 from 2016 through 2017 found that semen analysis competency assessments were not completed in 2016 and 2017 for TP#2 and in 2017 for TP#1. 2. During survey date 01-10-2018, at 11:20 am, the surveyor's findings were confirmed by TS#2. -- 2 of 2 --