Fertility Centers Of Illinois

Summary Statement of Deficiencies 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 laboratory policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative; the laboratory failed to ensure attestation statements were signed by the laboratory director (LD) on four of four events and by the testing personnel (TP) on two of four events from 2023 through the date of survey, 08/26/2025, in the specialty of hematology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Quality Control", which stated, under "Quality Control to be performed semi-annually:", "Proficiency testing samples must be tested with the laboratory's regular patient workload by personnel who routinely perform testing in the laboratory using routine methods of the laboratory (the individual performing testing on the samples must attest to this policy)"; and "Each step in the handling, preparation, processing and testing of the samples must be documented and a copy maintained with the report for those results as provided by the agency. These records will be kept along with the attention statement, signed by the laboratory director ...." 2. Review of CAP PT attestation forms revealed a lack of LD signatures on four of four events and a lack of TP signatures on two of four events. CAP PT Event: LD Signature: TP Signature: 2023 SEM-B No No 2024 SEM-A No Yes 2024 SEM-B No No 2025 SEM-A No Yes 3. Interview with the laboratory representative on 08/26/2025, at 10:55 am, confirmed the laboratory failed to ensure attestation statements were signed by the LD on four of four events and by the TP on two of four events from 2023 through the date of survey, 08/26/2025, in the specialty of hematology. 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 -- 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 laboratory records, College of American Pathologists (CAP) proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative; the laboratory failed to perform bi-annual method accuracy evaluations for one of two semen analysis measurements performed, sperm motility, in the specialty of hematology from 2023 through the date of survey, 08/26/2025. Findings include: 1. Review of laboratory records revealed the laboratory performing semen analysis measurements including sperm count and sperm motility in the specialty of hematology. 2. Review of CAP PT records revealed a lack of bi-annual method accuracy evaluations for the semen analysis measurement of sperm motility. 3. Interview with the laboratory representative on 08/26/2025, at 08:59 am, confirmed the laboratory failed to perform bi-annual method accuracy evaluations for one of two semen analysis measurements performed, sperm motility, in the specialty of hematology from 2023 through the date of survey, 08/26/2025. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of documentation, and inter with the laboratory representative; the laboratory failed to have two of two semen analysis policies and procedures reviewed, approved, signed, and dated by the laboratory director (LD) in the specialty of hematology. Findings include: 1. Review of laboratory policies and procedures revealed no LD approval, including signature and date, by the LD on two of two semen analysis policies and procedures: a. "Subject: Quality Control" b. "Subject: Semen Analysis" 2. Interview with the laboratory representative on 08/26/2025, at 09:21 am, confirmed the laboratory failed to have two of two semen analysis policies and procedures reviewed, approved, signed, and dated by the LD in the specialty of hematology. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory technical supervisor (TS); the laboratory failed to report complete Viscosity Reference Ranges for semen analysis on four of four final patient reports. Findings Include: 1. Laboratory procedures manual and final reports of four patients (PT) from dates; 10/09 /2020 (PT 1), 11/22/2021 (PT 2), 10/01/2021 (PT 3), and 01/04/2022 (PT 4) were reviewed. 2. Surveyor review of four of four patient (PT) final reports revealed: PATIENT VISC. RES* RR** (PT 1) Very increased Average (PT 2) Average Average (PT 3) Average Average (PT 4) Average Average 3. Review of the reference ranges chart utilized for examining patient samples on page 32 of the laboratory procedure manual revealed: Result RR** Viscosity Average/Increased/Decreased 4. On survey date 05/26/2022, at 10:50 am, the above findings were confirmed by the TS. * VISCOSITY RESULT ** REFERENCE RANGE (WHO 5TH EDITION) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory records; Laboratory Personnel Report (Form 209); laboratory procedures manual; personnel records, and interview with the technical supervisor, the technical supervisor failed to be responsible for ensuring that each individual performing tests received training and education appropriate for the type and complexity of laboratory services performed. Findings include: 1. Review of laboratory records from the previous survey performed in August of 2017 show that there were 2 testing personnel who performed all laboratory testing in 2017. 2. There were a total of 7 testing personnel listed on Form 209. 3. Six of 7 testing personnel listed on Form 209 were new testing personnel. 4. The laboratory's procedures manual has a section titled, "New Employee Orientation Checklist." It states, "1. This log is for documenting employee training in new tasks/assays. 2. Documentation is recorded for each task as it is completed." 5. Review of personnel records show that there was no documentation of training for 5 of 7 testing personnel. 6. On survey date 09/02/20 at 10:30 AM, the technical supervisor confirmed the surveyor's findings. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the 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 -- performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records; Laboratory Personnel Report (Form 209); laboratory procedures manual; personnel records, and interview with the technical supervisor, the technical supervisor failed to be responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Findings include: 1. Review of laboratory records from the previous survey performed in August of 2017 show that there were 2 testing personnel who performed all laboratory testing in 2017. 2. There were a total of 7 testing personnel listed on Form 209. 3. Six of 7 testing personnel listed on Form 209 were new testing personnel. 4. The laboratory's procedures manual has a section titled, "EMPLOYEE COMPETENCY TESTING." It states, "During the first year of employment for an individual competency will be assessed every 6 months." 5. Review of personnel records show that there was no documentation to show the start date and 6-month competency assessment for 5 of 7 testing personnel listed on Form 209. 6. On survey date 09/02/20 at 10:30 AM, the technical supervisor confirmed the surveyor's findings. 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 Personnel Report (Form 209); laboratory procedures manual; personnel records, and interview with the technical supervisor, the technical supervisor failed to be responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year Findings include: 1. There were a total of 7 testing personnel listed on Form 209. 2. The laboratory's procedures manual has a section titled, "EMPLOYEE COMPETENCY TESTING." It states, "All employees are to be evaluated at least once during the calendar year. During a calendar year, every testing employee will be graded for competency for all tests they perform." 3. Review of personnel records show that there was no documentation to show a competency assessment for 6 of 7 testing personnel listed on Form 209. 4. On survey date 09/02/20 at 10:30 AM, the technical supervisor confirmed the surveyor's findings. -- 2 of 2 --