Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Reproductive Medicine Group LLC on 6/5/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 observation and interview it was determined the laboratory safety procedures failed to be established and observed to ensure protection from physical hazards for three of three chemicals. Findings included: 1. Wright's Dip Stat #1, #2, and #3 chemicals used for hematology sperm testing were observed on 6/5/25 at 9:50 a.m., stored in a cabinet under the laboratory sink. All three chemicals had the fire image on the labeling as well as a danger notice "highly flammable liquid". Signage on the outside of the cabinet door indicated Hazardous Chemicals were stored there. There was no safety cabinet to store the chemicals in observed. 2. The Technical Consultant confirmed on 6/5/25 at 9:50 a.m., the Wright's Dip Stat #1, #2, and #3 chemicals were not safely stored and should be stored in a safety cabinet. The Technical Consultant confirmed there was not a safety cabinet available at the time of the survey. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty 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 -- 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 record review and interview, the laboratory failed to verify the accuracy of Hematology Sperm Morphology for 3rd event of 2023 and 1st event of 2025 assigned a proficiency testing scores that did not reflect laboratory test performance. Findings included: 1. The American Proficiency Institute (API) proficiency performance evaluations for Hematology Sperm Morphology for 3rd event of 2023 documented for SCL-14, SCL-19, SCL-20, and SM-04 and for 1st event of 2025 for SCL-04. SCL-06, SCL-07, and SCL-08 "Not Graded" and "See Data Summary". The Performance Review and