Conceptions Fertility Laboratories Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CONCEPTIONS FERTILITY LABORATORIES LLC from 12/10/2025 to 12/16/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient reports for semen analysis and staff interview, the laboratory failed to ensure that the patient reports had the name of the Laboratory at least since 05/07/2024. Findings included: 1-Review of 4 final patient reports: P#1 (date 05/07/2024), P#2 (date 11/05/2024), P#3 (date 03/05/2025) and P#4 (date 12/09 /2025); revealed that the reports failed to list the name of the laboratory that did the semen analysis as it is listed in the Certificate of Compliance. 2-During an interview on 12/10/2025 at 01:45 PM, Testing Personnel #1 confirmed that the patient reports failed to show the name of the laboratory that performed the semen analysis and on 12 /15/2025 the Technical Supervisor confirmed that the reports did not have the correct name of the laboratory. 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 D0000 An announced CLIA recertification survey was conducted at Conceptions Fertility Laboratories LLC on March 12-13, 2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory supervisor failed to monitor monthly quality control (QC) logs for Daily Temperature log and Liquid Nitrogen QC log for 10 out of 12 months in 2023. Findings included: 1- Review of the Daily Temperature logs and Liquid Nitrogen QC logs revealed that 10 (January, February, March, April, May, June, July, August, September, and November) out of 12 months reviewed in year 2023 were not signed by laboratory supervisor. 2 - Based on interview 3/12/2024 at 3:54 PM the Laboratory Supervisor admitted to have missed the review of the QC logs and signature of the QC logs was not done. 3- The laboratory supervisor signed all Daily Temperature and Liquid Nitrogen QC logs for each month before survey exit. 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 D0000 A recertification survey was conducted on February 22, 2022. Conceptions Fertility Laboratories LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D 5200- General Laboratory Systems - Condition level Deficiency cited. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems. Findings: Cross Reference D5209: Based on record review and interview, the laboratory failed to document the initial and annual competency assessment for one out of one Technical Supervisor (TS) from 08/10/2020 to 02/22/2022, and the annual competency of one out of one General Supervisor (GS) for 2021. This is a repeat deficiency from the initial survey on 08/10/2020. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the initial and annual competency assessment for one out of one Technical Supervisor (TS) from 08/10/2020 to 02/22/2022, and the annual competency of one out of one General Supervisor (GS) for 2021. This is a repeat deficiency from the initial survey on 08/10 /2020. Findings: Review of the Laboratory Personnel Report dated and signed by the Laboratory Director on 08/07/2020 for the initial survey on 08/10/2020 and the Laboratory Personnel Report dated and signed by the same Laboratory Director on 02 /22/2022 for the recertification survey on 02/22/2022, showed the TS on both of the Laboratory Personnel Reports were the same person. Review of personnel folder for the TS revealed that there were no competency evaluations in the folder. Review of personnel folder for the GS revealed that there was no competency evaluations in the folder for 2021. On 02/22/2022 at 2:05 PM, Technical Supervisor stated that there was no competency evaluation performed on herself. On 0222/2022 at 2:02 PM, General Supervisor stated that the competency evaluation for 2021 was not done. 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)

Summary Statement of Deficiencies D0000 An initial certification survey conducted on 08/10/2020 found that Conceptions Fertility Laboratories LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview, the laboratory failed to document the initial competency assessment for 1 out of 1 Technical Supervisor (TS), 1 out of 1 General Supervisor (GS) and 2 out of 2 Testing Personnel (TP) after the laboratory started operations since March 2020. Findings include: 1) A review of CMS 209 form, Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 08 /07/2020; revealed that: -The Laboratory Director and Clinical Consultant was the same person, the laboratory has 1 TS, 1 GS and 2 TP (A and B). - GS was also testing personnel (TP) A. 2) Review of employee folders revealed that they were missing the initial competency for TS, GS, and TP (A and B) after laboratory started operations on March 2020. During an interview on 08/07/202 at 11:30 AM, with TS, she confirmed that the laboratory failed to document the initial competency assessment for the positions listed above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier 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 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's Semen Analysis Report failed to list the correct location, CLIA number and laboratory director, for the semen morphological evaluation performed for 2 out of 2 (# 1 and 2) patients report examined since the laboratory started operations in March 2020. Findings Include: Review of the Semen Analysis Report for patients # 1 (date 3/16/2020) and #2 (date 7 /14/2020), showed that the address, CLIA number and laboratory director listed corresponded with the information for another facility, operated by the same group. During an interview on 8/10/2019 at 11:30 am, with Technical Supervisor, she confirmed that the Semen Analysis report failed to include the correct address, CLIA number and laboratory director. -- 2 of 2 --