Reproductive Medicine Associates

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory reagents, and interview with theOffice Manager (OM), the laboratory failed to ensure protection from chemical and physical hazards from 7/27/21 to the date of survey. The findings include: 1. All flammable and inhalation risk reagents were not kept in a flammable cabinet. 2. Flammable reagents where observed under the laboratory sink. 3. The OM confirmed on 10/17/23 at 11:00 pm that the laboratory did not ensure protection from chemical and physical hazards. 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: Based on surveyor review of the Procedure Manual (PM),observation of Leucoscreen reagents and interview with the Office Manager (OM), the laboratory failed to have a procedure on making Leucoscreen staining reagent from 7/27/21 to the date of survey. The findings include: 1. The Leucoscreen staining regent was kept in a specimen 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 -- collection container wrapped in tinfoil with Leucoscreen and expiration date 10/20/23 written in black marker on it. 2. The GS stated that "The laboratory makes the stain at an offsite location". 3. There was no procedure in the PM on how to prepare the Leucoscreen staining reagent. 4. The OM confirmed on 10/17/23 at 10:45 pm that the laboratory failed to have the above mentioned procedure. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with theOffice Manager (OM), the laboratory failed to verify commercial QC material with each new lot and/or shipment of QC used for Semen Anaylisis tests 7/27/21 to the date of survey. The finding includes: 1. There was no documented evidence that Accubead Lot numbers 211712351 and 21210181 were verified before being put into use. 2. The OM confirmed on 10/17/23 at 10:20 am that the QC material was not verified before putting in use. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on the lack of Performance Specifications (PS) and interview with the Office Manager (OM), the Laboratory Director (LD) failed to ensure the PS procedures for Semen Analysis (SA) and Anti Sperm Antibodies (ASA) tests were adequate on the date of survey. The findings include: 1. The laboratory moved to a new address August 2023 2. There was no evidence that PS was performed for SA and ASA after the laboratory changed locations. 3. The OM confirmed on 10/17/23 at 11:30 pm the LD failed to ensure the PS were adequate. -- 2 of 2 --

Summary Statement of Deficiencies 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 the lack of Competency Assessment (CA) records and interview with the Laboratory Manager (LM), the laboratory failed to follow written procedures to perform a CA on four of four Testing Personnel for the calendar years 2019 and 2020. The LM confirmed on 7/27/21 at 11:30 am that the CA procedure was not followed . 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 surveyor review of Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to evaluate coded results obtained from the American Association of Bioanalysts (AAB) for Andrology & Embryology events from May 2020 to the date of survey. The findings include: 1. The laboratory did not evaluate Code ? (This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus) response from AAB for the following: a) Antisperm Antibody IgG+IgA in Andrology & Embryology events S1, S2 2020 and S1 2021. 2. The LM confirmed on 7/27/21 at 10: 00 am that the laboratory failed to evaluate the above mentioned coded results. 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 -- D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to verify the accuracy of Andrology test results obtained from the American Association of Bioanalysts (AAB) from May 2020 to the date of survey. The findings include: 1. The laboratory received a 100 but results were not graded. 2. There was no documented evidence the laboratory verified: a) Antisperm Antibody IgG+IgA in Andrology & Embryology events S1, S2 2020 and S1 2021. 2. The LM confirmed on 7/27/21 at 12:10 pm accuracy of the PT results were not verified D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform a CA correctly on eight out of eight TP in the calendar year 2017 and 2018. The finding includes: 1. Criteria # 5 (Testing proficiency sample) and 6 (Assessment of problem solving skills) were not assessed. 2. The TP #1 listed on CMS form 209 confirmed on 2/5/19 at 1:00 pm that CA was not performed correctly. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Andrology test results obtained from the American Association of Bioanalysts (AAB) for the S1 2018 event. The findings include: 1. The laboratory received a 100 but results were 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 -- not graded. 2. There was no documented evidence the laboratory verified: a. Sperm Count, video b. Sperm Progression - Forward Progression 3. The TP #1 listed on CMS form 209 confirmed on 2/5/19 at 12:20 pm accuracy of the PT results were not verified D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) results and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when the laboratory received a grade of 50% for Andrology / Semen Motility performed with the American Association of Bioanalysts (AAB) in 1- 2018. The findings include: 1. The laboratory received a grade of 50% in the AAB 1 - 2018 for Sperm Motility - Forward Progression, semiquantitative. 2. No evaluation was documented for the unacceptable analyte score. 3. The TP #1 listed on CMS form 209 confirmed on 2/5/19 at 12:50 pm that the laboratory did not perform and document