Illume Fertility

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to report patient test results accurately on the final patient test report in the specialty of hematology. 1. Record review on 7/22/2025 of the laboratory's test report for patient#1 revealed the following: a. 'Measure: Grade of Motility/Prog; Normal Values: 2.5 - 4.0'. b. 'Measure: Grade of Motility; Normal Values: none to slight'. c. Lack of documentation of semen 'Agglutination' reporting on the test report. 2. Record review on 7/22/2025 of the 'Andrology Laboratory Standard Operation Procedures, Normal Values - Semen Analysis Values' revealed the following normal reference ranges: a. 'Measure: Forward Progression; Normal Values: 2.5 - 4.0'. b. 'Measure: Agglutination; Normal Values: None to Slight'. 3. Staff interview on 7/22/2025 at 11:45 AM with the laboratory 's General Supervisor (GS) confirmed the above findings. The GS further commented that this was due to a software glitch. 4. The laboratory performs 1,600 semen analysis annually 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 1 --

Summary Statement of Deficiencies D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the correct quality control (QC) ranges for sperm motility were maintained and within acceptable limits prior to reporting patient test results in the specialty of Hematology. Findings include: 1. Record review on 4/6/2021 of the American Association of Bioanalysts (AAB) 'S2 Andrology & Embryology' Proficiency Testing (PT) 2019 Evaluation form revealed the sperm motility acceptable range for specimen #7 was '64-107'. 2. Record review on 4/6/2021 of the laboratory's QC binder and 'Daily Count, Morphology, Motility QC' monthly logs for the period January 2020 through April 2021 revealed the following: a. AAB PT Event S2 2019 specimens were used as quality control material and labeled as Specimen 'A' and Specimen 'B'. b. The motility acceptable ranges were handwritten on the top of each monthly log sheet. c. The motility acceptable range for Specimen 'B' was written as '64-107' for the months of January through May 2020. d. The motility acceptable range for Specimen 'B' was incorrectly written as '64-167' for the months June 2020 through April 2021. e. Specimen 'B' Motility was above the acceptable limit of 107 as follows: i. 9 of 9 days in December 2020. ii. 1 of 10 days in January 2021. iii. 1 of 13 days in March 2021. f. The AAB Event 2 2019 evaluation form depicting the acceptable motility ranges was not in the QC binder. g. The daily QC logs were reviewed and signed by the general supervisor #1 (GS#1) monthly. 3. Staff interview with GS#1 on 4/6/2021 at 10:52 AM confirmed the following: a. Specimen #7 from the AAB Event 2 2019 was Specimen 'B' used for 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 -- QC as indicated on the QC log. b. The handwritten numbers of 64-107 changed in June 2020 to 64-167 and may have been due to the number being copied incorrectly from the prior month. c. The AAB Event 2 2019 evaluation form was not available in the QC binder for reference. d. The motility for specimen 'B' was out of range as indicated in 2e above with no

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to provide documentation for testing personnel (TP) training records to ensure TP can independently perform and report test results accurately in the specialty of Hematology. Findings include: 1. Record review of TP training and competency records on 3/25/19 revealed: (a) TP#1 hired on 5/15/17 did not have site specific training records prior to testing patient samples. (b) TP#2 hired on 12/17/17 did not have site specific training records prior to testing patient samples. 2. Staff interview with laboratory manager on 3/25/19 at 10:30 AM confirmed the above findings. 3. The laboratory performs 550 high complexity tests annually 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 1 --