Reproductive Medicine Associates

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Records and interview with the General Supervisor (GS), the laboratory failed to perform correlation studies for Endocrinology tests performed on the Roche e801 analyzers twice per year from 7/21 /21 to the date of the survey. The GS confirmed on 1/8/25 at 11:00 am that the laboratory did not perform a correlation study twice a year. D5781

Summary Statement of Deficiencies 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 events S1, S2 2020 and S1 2021. b) Sperm Cell ID and Sperm Viability in Andrology & Embryology event S2 2020. c) Sperm Count Traditional in Andrology & Embryology event 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). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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. b) Sperm Cell ID and Sperm Viability in Andrology & Embryology event S2 2020. c) Sperm Count Traditional in Andrology & Embryology event S1 2021. 2. The LM confirmed on 7/27/21 at 12:20 pm accuracy of the PT results were not verified D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 maintain attestation statements provided by the American Associations of Bioanalysts (AAB) for Andrology and Endocrinology PT in the calendar year 2017 and 2018. The findings include: 1. Attestation statements were not maintained for: a. 2nd Q 2017 Endocrinology PT b. 2nd Q 2018 Andrology PT c. 1st, 2nd & 3rd Q 2018 Endocrinology PT 2. The TP #9 listed on CMS 209 confirmed on 11/27/16 at 10:30 am that the attestation statements were not maintained. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system 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 4 -- determined under 493.1253. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Bio Rad Manufacture Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory failed to follow the MPI for BioRad Lyphochek Immunoassay control material used on the Centaur in the calendar year 2018. The findings include: 1. The TP stated that the laboratory used the MPI control ranges. 2. A review of Quality Control (QC) documentation revealed QC ranges were outside the MPI range as follows: a. Centaur XPT: FSH High - Levels 1, 3 b. Centaur XPT: LH Low - Levels 1, 3 c. Centaur CP: FSH Low - Levels 1, 2 - High Level 1 d. Centaur CP: LH High - Levels 1, 2, 3 e. Centaur CP: PRL Low - Level 2 f. Centaur CP:HcG Low - Levels 2, 3 g. Centaur CP: E2 High- Levels 1, 2, 3 3. The TP #9 listed on CMS form 209 confirmed on 11/27/18 at 11:30 am that MPI was not followed. b) Based on surveyor review of the MPI and interview with the TP, the laboratory failed to follow the MPI for FructoScreen tests from 11/02/16 to the date of the survey. The findings include: 1. The MPI stated: a. Pipette samples and reagents into a well of the Plate but the laboratory did not use a plate. b. Read optical density of wells at 470 nm using a microplate reader but the laboratory read results visually. 2. The TP #9 listed on CMS form 209 confirmed on 11/27/18 at 11:40 am that MPI was not followed. c) Based on surveyor review of the MPI and interview with the TP, the laboratory failed to follow the MPI for Accubeads from 11/02/16 to the date of the survey. The finding includes: 1. The MPI stated to count Vial 1 and 2 two times and average if counts were within 10% of each other but the laboratory counted each vial once. 2. The TP #9 listed on CMS form 209 confirmed on 11/27/18 at 11:50 am that the MPI was not followed. 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. This STANDARD is not met as evidenced by: Based on surveyor observation of the reagents and interview with the Testing Personnel (TP), the laboratory had expired material for Semen Morphology tests from 6/29/18 to the date of survey. The findings include: 1. Reagents were expired as follows: a. Andrology Stain Solution II - Lot 6236 expired 6/29/18 b. Andrology Stain Solution III - Lot 7107 expired 11/9/18 2. Approximately 10 patients samples were stained per day. 3. The TP #9 listed on CMS 209 confirmed on 11/27/18 at 10:50 am that the laboratory had expired reagents. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as -- 2 of 4 -- applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on lack of Performance Specifications (PS) records and interview with the Testing Personnel (TP), the laboratory failed to have PS for FructoScreen tests from 11 /02/16 to the date of the survey. The TP #9 listed on CMS form 209 confirmed on 11 /27/18 at 12:30 pm PS were not established before reporting patients. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Records and interview with the Testing Personnel (TP), the laboratory failed to perform correlation studies for Endocrinology tests performed on the Advia Centaur analyzers twice per year from September 2017 to the date of the survey. The TP #9 listed on CMS form 209 confirmed on 11/28/18 at 11:00 am that the laboratory did not perform a correlation study twice a year. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to establish a procedure to verify new QC material used in Endocrinology tests before use from 11/02/16 to the date of the survey. The TP #9 listed on CMS form 209 confirmed on 11/28/18 at 12:10 pm the laboratory did not have a procedure to verify new Endocrinology QC. 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) -- 3 of 4 -- 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 the FR for Endocrinology testing included all required information from 11/02/16 to the date of the survey. The findings include: 1. The FR did not have the "Test Report Date". 2. The FR did not have units of measurement for all analytes on the FR. 3. The FR did not have the name of test performed and reported one test as "P". 4. The TP #9 listed on CMS form 209 confirmed on 11/27/18 at 12:20 pm that the laboratory did not have required information on the FR. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's Quality Assurance (QA) Plan and interview with the Testing Personnel (TP), the laboratory failed to maintain Andrology Data Entry Verification in the QA plan from December 2016 to the date of the survey. The TP #9 listed on CMS form 209 confirmed on 11/27/18 at 12:00 pm the QA plan was not maintained. -- 4 of 4 --