Tulane Medical Center-Andrology

Summary Statement of Deficiencies D0000 A Recertification survey was conducted January 27, 2025 at Tulane Medical Center Andrology - CLIA ID # 19D0695435. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing records as well as interview with laboratory personnel, the laboratory failed to test proficiency testing (PT) samples in the same manner as patient testing for three (3) of three (3) events reviewed. Findings: 1. Review of the laboratory's 2023 and 2024 College of American Pathologists (CAP) proficiency testing (PT) records revealed testing personnel attested to performing PT samples as follows: a) SEM-B 2023 Semen Analysis - Testing Personnel 1 and Testing Personnel 2 signed the attestation but did not identify the samples performed b) SEM-A 2024 Semen Analysis - Testing Personnel 1 and Testing Personnel 2 signed the attestation but did not identify the samples performed. c) SEM-B 2024 Semen Analysis - Testing Personnel 1 and Testing Personnel 2 signed the attestation but did not identify the samples performed. 2. Further review of the PT records revealed multiple testing personnel tested each sample as follows: a) SEM-B 2023 Semen Analysis - SEM 11: Tested by Testing Personnel 1, Testing Personnel 2, and a person not listed as Testing Personnel on 11/9/2023 - SEM 12: Tested by Testing Personnel 1, Testing Personnel 2, and a person not listed as Testing Personnel on 11/9 /2023 b) SEM-A 2024 Semen Analysis - SEM 01: Tested by Testing Personnel 1, Testing Personnel 2, and a person not listed as Testing Personnel on 4/23/2024 - SEM 02: Tested by Testing Personnel 1, Testing Personnel 2, and a person not listed as 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 -- Testing Personnel on 4/23/2024 c) SEM-B 2024 Semen Analysis - SEM 11: Tested by Testing Personnel 1 on 10/24/2024, Testing Personnel 2 on 10/24/2024 and 10/30 /2024, and a person not listed as Testing Personnel on 10/29/2024 - SEM 12: Tested by Testing Personnel 1 on 10/24/2024, Testing Personnel 2 on 10/24/2024 and 10/30 /2024, and a person not listed as Testing Personnel on 10/29/2024 3. In interview on January 27, 2025 at 10:39 a.m., the Laboratory Director stated patient samples are tested by one personnel only. He further stated the three (3) personnel identified above tested all the samples and he took the average of all the results obtained for each sample and submitted the average to the CAP PT program. 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 the laboratory's patient test records and proficiency testing (PT) records as well as interview with personnel, the laboratory failed to verify the accuracy of performance for sperm morphology and motility testing at least twice per year in 2023 and 2024. Findings: 1. Review of the following randomly selected patient final test report revealed the laboratory performed the following testing for semen analysis: a) MRN: 1002497275 - Composition and count - Sperm motion - Sperm morphology 2. Review of 2023 and 2024 PT records revealed the laboratory performed twice a year verification of sperm count testing, but did not perform morphology and/or motility. 3. In interview on January 27, 2025 at 11:26 a.m., the Laboratory Director stated the laboratory reports sperm morphology and motility in addition to sperm counts, but the clinicians utilize the count. He confirmed the laboratory did not perform twice per year verification for sperm morphology and motility testing as identified above. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure for proficiency testing. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have complete policies for Proficiency Testing (PT) to include but not limited to the following: - Testing and resulting PT samples in the same manner as patient samples - Twice a year verification for testing in which the laboratory is not enrolled in a PT program -

Summary Statement of Deficiencies D0000 A Recertification survey was performed on April 6, 2023 at Tulane Andrology, CLIA ID # 19D0695435. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 proficiency testing records and interview with personnel, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the proficiency attestation statement for one (1) of three (3) proficiency testing (PT) events. Findings: 1. Review of the College of American Pathologists (CAP) proficiency testing records revealed the attestation statement was not signed by the Laboratory Director and Testing Personnel for Semen Analysis event Sem-A 2022. 2. In interview on April 6, 2023 at 10:56 a.m., the Laboratory Director confirmed the attestation for the event identified was not signed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with 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 5 -- personnel, the laboratory failed to review the performance evaluation for three (3) of three (3) proficiency testing events reviewed. Findings: 1. Review of the College of American Pathologists (CAP) proficiency testing records revealed the laboratory did not review the evaluations for the following proficiency testing events for Semen Analysis: Sem-B 2021 Sem-A 2022 Sem-B 2022 2. In interview on April 6, 2023 at 10:56 a.m., the Laboratory Director confirmed the evaluations were not signed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of patient test records and the laboratory's policy and procedure manual, as well as interview with personnel, the laboratory failed to follow their policy for repeat sperm count testing. Findings: 1. Review of the laboratory's policy "Patient Sample Sperm Count SOP" revealed the following: -Tulane Andrology Lab performs duplicate testing on patient manual sperm counts utilizing Leja 20 micron 2 chamber slide system. -If the percentage difference between the two values is less than or equal to 15%, an average of the two readings should be calculated to obtain the mean value of the counts. -If the percentage difference between the two readings is greater than 15%, the technician should repeat the analysis with a 3rd drop of sample and record the value for the 3rd drop. -After counting the 3rd drop, the median of the three readings should be reported as a final count result. 2. Review of the "Tulane Andrology Laboratory - Quality Assessment Q/C Sperm Count" patient record from September 21, 2022 revealed the following results for one (1) of one (1) patients tested that day: Patient LG2-9/22 Drop 1 = 42.3 Drop 2 = 50.3 (Surveyor calculation of percent difference = 19%) 3. Further review of the "Tulane Andrology Laboratory - Quality Assessment Q/C Sperm Count" record for September 21, 2022 revealed the laboratory did not repeat the sample with a third drop. 4. In interview on April 4, 2023 at 11:16 AM, the Laboratory Director confirmed although the patient results identified above had a greater than fifteen percent difference between the two counts, a third drop was not performed. II. Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have complete policies for: a) Proficiency Testing (PT) to include but not limited to: * Ensuring that you are enrolled for Proficiency Testing. *What documents need to be signed and who needs to sign them. *What records to maintain. *How to evaluate your scores from the PT Provider. *Who needs to document review of the PT scores. *What steps to take if

Summary Statement of Deficiencies D0000 A Certification Survey was performed on December 12, 2018 at Tulane Andrology, CLIA ID # 19D0695435. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the laboratory failed to label solutions utilized for manual semen analysis with expiration dates and storage requirements. Findings: 1. Observation by surveyor during laboratory tour on December 12, 2018 revealed the following solutions in smaller containers without expiration dates and storage requirements included on the label: a) Quick III Solution I b) Morphology Staining Fixative 2. In interview on December 12, 2018 Personnel 2 stated he pours the solutions from the larger bottles into smaller containers for use. Personnel 2 stated the smaller containers are labeled with the solution name. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 observation, record review, and interview with personnel, the laboratory failed to ensure control material has not exceeded its expiration date. Findings: 1. Observation by surveyor during laboratory tour on December 12, 2018 revealed the following expired items: a) Quality Control (QC), Lot number: 16070, Quantity: one (1) vial b) QC, Lot number: 16080, Quantity: one (1) vial 2. Review of the laboratory's quality control records revealed the identified quality control material was prepared April 25, 2016. 3. In interview on December 12, 2018, Personnel 1 stated QC expires two years from preparation date. Personnel 1 stated the identified QC was old. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Findings: 1. The laboratory failed to label solutions utilized for manual semen analysis with expiration dates and storage requirements. Refer to D5415. 2. The laboratory failed to ensure control material has not exceeded its expiration date. Refer to D5417. -- 2 of 2 --