Reproductive Medicine Associates

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor interview with the laboratory technical supervisor (TS), review of the laboratory directors (LD) credentials and an in-office review of the laboratory's requirements for LD with New Jersey State Clinical Laboratory Licensure (NJCLL) under New Jersey Administrative Code: N.J.A.C. 8:44-2.3 Laboratory Director Qualifications, the laboratory failed to maintain a qualified LD who meets NJCLL requirements since 7/27/21. The findings include: 1. The laboratory failed to maintain a LD who holds a NJ Bioanalytical Laboratory Director (NJBALD) License which is required by NJCLL. 2. The laboratory type is indicated as Independent, not Physician Office Laboratory (POL) which does have an exemption for the NJBALD License requirement, on the CMS-116 form provided at the time of the survey. 3. The TS confirmed on 12/12/23 at 11:00 am that the laboratory performs testing on patients outside of the practice and is therefore an Independent laboratory and that the LD does not hold a NJBALD License. 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 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 six of six 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 2021 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 and Sperm Count 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 -- Traditional in Andrology & Embryology events 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. 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 one out of one TP on 12/1/17 and 6/1/18. The findings include: 1. Criteria # 5 (Testing proficiency sample) and 6 (Assessmnet of problem solving skills) were not assessed. 2. The TP confirmed on 6/5/18 at 11:00 am that CA was not performed correctly. 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: a) Based on surveyor review of Procedure Manual (PM), observation of maintenance sticker and interview with the Testing Personnel (TP), the laboratory failed follow every six month Microscope Maintenance (MM) frequency in the calendar year 2017. The finding includes: 1. There were no maintenance records available to substantiate that the laboratory performed maintenance in 2017. 2. The TP confirmed on 6/5/18 at 11:00 am that MM was not performed in 2017. b) Based on surveyor review of PM, 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 -- observation of centrifuge and interview with the TP, the laboratory failed to follow procedure PNLAAND 310 from 1/24/17 to the date of survey. The finding includes: 1. The PM stated centrifuge specimens at 1,500 rpms but the centrfuge speed was programmed 1,700 rpms. 2. The TP confirmed on 6/5/18 at 10:30 am that the PM was not followed. 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 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 surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that specimen source was accuarte on the FR from 1/24/17 to the date of survey. The TP confirmed on 6/5/18 at 10:30 am that the specimen source was not correct on the FR. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure the Reference Interval (RI) was correct on the FR for pH test performed on Semen specimen from 1/24/17 to the date of the survey. The finding includes: 1. The PM had a pH range of >= 7.2 but the FR had a range of >7.2. 2. The TP confirmed on 6/5/18 at 10:45 am that the laboratory failed to have the correct pH test RI on the FR. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Files (PF) and interview with the Testing -- 2 of 3 -- Personnel (TP), the laboratory director failed to ensure that all personnel records were included in PF for one of one TP from 1/24/17 to the date of survey. The findings include: 1. There was no training record in the PF. 2. The were no transcripts of education to substaintiate the diploma certificate. 3. The TP confirmed on 6/5/18 at 11: 00 am that records in the PF were not complete. -- 3 of 3 --