Reproductive Medicine Associates Of New York Llp

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a surveyor's review of the American Association of Bioanalysts (AAB) proficiency testing ( PT) records an and interview with the laboratory director/testing person, the laboratory failed to have the AAB PT test results released to New York State Department of Health (NYSDOH), Physician Office Laboratory Evaluation Program (POLEP) and Center for Medicare and Medicaid Services (CMS) in the calendar years 2019 and 2020. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory Quality Control (QC) records, laboratory procedures for sperm viability and fructose screening and interview with the laboratory director/testing person, the laboratory failed to perform and document 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 -- positive and negative controls and reactivity for the stains used sperm viability testing and fructose screening in calendar years 2019 and 2020. FINDINGS 1. The laboratory director/testing person confirmed on April 27, 2021 at 11:00 AM that the quality control records for the sperm viability and fructose screening were not available for review at this survey. 2. The FertiPronv sperm viability procedures utilizes stain A 20 ml of 1% Eosin Y in saline and stain B 30 ml of 10% Nigrosin in saline for sperm viability procedure. a. The laboratory did not record the reactivity results as non- viable sperm stained and viable does not stain b. Approximately 50 patient's sperm specimens were tested and reported for sperm viability for the calendar years 2019 and 2020. 3. The Fructose Screening procedure utilizes Indole stain to indicate if fructose is present in seminal plasma of the sperm. a. The laboratory did not record the control results (positive-yellow-orange/negative- no color) each day of patient testing. b. Approximately 30 patient's sperm were tested and reported for fructose in the calendar years 2019 and 2020. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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's review of laboratory policies and procedures, lack of laboratory Quality Control (QC) records and an interview with the laboratory director/testing person, the laboratory director failed to ensure that all components of quality control for sperm viability and fructose screening were maintained to provide quality laboratory services. Refer to: D5449 -- 2 of 2 --

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 a review of procedures and an interview with the laboratory director, the laboratory failed to follow manufacturer's procedures, laboratory procedures and CLIA regulations for performing semen analysis quality control (QC) and patient testing. Finding Include: On February 22, 2018 at approximately 12:45 PM it was confirmed by the laboratory director, that the laboratory failed to follow the Accubeads package insert and CLIA regulations for performing and documenting in duplicate QC testing. The laboratory's QC log sheets were reviewed from August 2016 through the date of this survey and failed to show that Accubead QC were performed in duplicate. This is a repeat citation from the survey of July 18, 2016. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, patient worksheets and an 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 -- interview with the laboratory director, the laboratory failed to test and document QC material each day of patient testing in duplicate. Findings Include: It was confirmed by the laboratory director on Feburary 22, 2018 at approximately 12:45, that the laboratory performs two level of control material. Review of QC records from August 2016 through the date of this survey showed that the laboratory failed to test and document the two levels of Accubeads QC material in duplicate. Approximately 1100 patient specimens were tested and results released during this time period. This is a repeat citation from the survey of July 18, 2016. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 in a review of QC procedures, records and confirmed in an interview by the laboraory dirctor on February 22, 2018 at approximately 1:45 PM that the laboratory director failed to ensure that the QC program for hematology testing was maintained to assure quality laboratory services. Refer to: D5401 and D5443 This is a repeat citation from the survey of July 18, 2016. -- 2 of 2 --