Reproductive Medicine Associates

Summary Statement of Deficiencies 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 the Quality Control (QC) material and interview with the Testing Personnel (TP), the laboratory failed to follow all procedures written for "Laboratory Quality Control and Quality Assurance" from September 2021 to the date of the survey. The findings include: 1. The procedure "Laboratory Quality Control and Quality Assurance" stated "Accubeads: New reagent lot # is to be/will be counted/quantified at least 30 times and results collated and be evaluated to the package insert data/results for comparison. 2. There as no documented evidence the above mentioned procedure was performed on the lot #202411181 and 20171135 being used at the time of survey. 3. The TP confirmed on 12/8//22 at 1:30 pm that the laboratory did not follow the PM. 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 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 -- 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 the lack of Quality Control Verification (QCV) records and interview with the Testing Personnel (TP), the laboratory failed to verify QC material before use for Semen Analyses from September 2021 to the date of survey. The TP confirmed 12/8 /22 at 1:15 pm that QC material was not verified before putting in use. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR), Work Records (WR) and interview with the Testing Personal (TP), the laboratory failed to have WR on one out of five FR reviewed from 6/22/22 to the date of the survey. The TP confirmed on 12/8 /22 at 1:00 pm that the laboratory did not maintain all work records.. -- 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 five of five 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 General Supervisor (GS), 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 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 -- events S1, S2 2020 and S1 2021. 2. The GS #3 listed on CMS form 209 confirmed on 7/27/21 at 10:00 am that the laboratory failed to evaluate the above mentioned coded results. 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 D5785