Huntington Reproductive Center Medical Group

Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) (a)(3)(i) Records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's testing records, policy & procedures and interview with the laboratory technical supervisor on August 29, 2025, at 12:35 p.m., the laboratory failed to retain its sperm count test validation records. The findings include: 1. The laboratory performed sperm count test using 2 methods: automated CASA system and manual count with Mekler chamber. Surveyor review of some test records showed a large variation in the manual repeat count. To verify if this variation was within the laboratory's established precision range, the surveyor asked for the test validation records. However, the laboratory failed to provide the test validation records. Therefore, the accuracy of the laboratory's reported test results cannot be assured and may have potential to harm patients. 2. The laboratory technical supervisor on August 29, 2025, at 12:35 p.m., affirmed that the laboratory did not have the validation records and may have been misplaced. 3. The laboratory's testing declaration form signed by the laboratory director on August 28, 2025, stated that the laboratory performed approximately 500 sperm count tests, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, 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 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's testing records, policy & procedures and interview with the laboratory technical supervisor on August 29, 2025, at 12:35 p.m., the laboratory director failed to ensure the test records retention requirement. The findings include: See D3033. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation of the laboratory operations, review of the laboratory's proficiency testing result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to verify the accuracy of the semen analyses testing procedures that is not listed in subpart I of 42 CFR part 493, at least twice annually. The findings were as followed: a. The laboratory performed semen analysis and reported the patient test results including but not limited to the following tests: Sperm Motility, Sperm Count and Sperm Morphology in semen analysis procedure, which is not listed in the subpart I of 42 CFR part 493. b. At least twice annually, the laboratory must perform evaluation of proficiency testing performance and verify the accuracy of the testing results. c. To meet the requirements for the evaluation of proficiency testing performance, the laboratory elected to enroll a proficiency testing program, Andrology & Embryology, offered by the American Association of Bioanalysts (AAB), d. The laboratory attained scores of 50% for Sperm Motility in S2 2020 and S1 2021 PT events, which were unsatisfactory analyte performance for the testing events. e. The laboratory reported Sperm Motility included in semen analysis for approximately 100 patient samples monthly. f. The laboratory personnel affirmed (2/25/2022 @ 11 AM) that the laboratory attained scores of 50 % for Sperm Motility in S2 2020 and S1 2021 AAB Andrology & Embryology PT events which were unsatisfactory analyte performance for the testing events. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on observation of the laboratory operations, review of the laboratory's proficiency testing result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of 42 CFR part 493. The findings were as followed: a. The laboratory failed to ensure that the proficiency testing samples were tested as required under Subpart H of 42 CFR part 493. b. The laboratory performed semen analyses and reported the test result including but not limited to the following tests: Sperm Motility, Sperm Count and Sperm Morphology in a semen analysis procedure, which is not listed in the subpart I of 42 CFR part 493. c. To meet the requirements for the evaluation of proficiency testing performance, the laboratory elected to enroll the proficiency testing program, Andrology & Embryology, offered by the American Association of Bioanalysts (AAB), see D-5217, -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control data and random patient testing records, and interview with the laboratory Director, the laboratory failed to retain patient test records including instrument printouts documenting the analytic system activities for at least 2 years. The findings include: a. The laboratory reported a semen analysis test results on 05/05/2017 for the patient accession #542366. The laboratory did not provide any document showing that the analytic activities, i.e. sperm presence or absence, sperm count and motility were performed. Due to the lack of analytic test records, it could not be assured that the test was actually performed by the laboratory. b. On January 18, 2018 at 3:10 pm laboratory Director affirmed that the laboratory did not have any analytic records for the above patient. c. The laboratory's testing declaration form, signed by the laboratory Director on January 15, 2018, stated that the laboratory performs 639 tests annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) 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 2 -- director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of patient testing records, lack of analytical data and documentation, and interview with the laboratory Director, the laboratory Director failed to assure compliance with the regulations. The findings include: a. See D3031 -- 2 of 2 --