Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Reproductive Resources, INC, CLIA ID 19D0705675, on October 14, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies, quality control records, test menu, and interview with personnel, the laboratory failed to document values of the semen analysis cell count quality controls (QC) that were performed in duplicate. Findings: 1. Review of the laboratory's "Quality Control and Quality Assurance" policies under the " Andrology Laboratory: Quality Control Procedures for Techniques Performed in Andrology Lab" section revealed "Control specimens are tested in the same manner and by the same personnel as patient specimens. Each workday that a semen analysis is performed one high-count and one low-count aliquot is analyzed by each technician who is performing semen analysis that day." 2. Review of the laboratory's "QC Beads" logs for August 19, 2024 through September 17, 2025 revealed "Sperm Count Controls each taken as average of 2 counts." The laboratory documented the average value of each control level, not each individual value, as well as, the average. 3. In interview on October 14, 2025 at 11:28 am, the Laboratory Director stated she tested each level of control in duplicate like the patients. The Laboratory Director further stated she did not document the individual values for each control that is tested in duplicate. The Laboratory Director stated she documented the average value of each control only. 4. Review of the laboratory's test menu revealed the laboratory performs 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 -- forty eight (48) semen analysis samples annually. II. Based on review of the laboratory's policies, quality control records, patient test records, and interview with personnel, the laboratory failed to document two (2) levels of pH quality controls (QC) each day of patient testing for semen analysis testing for three (3) of twenty one (21) days reviewed. Findings: 1. Review of the laboratory's "Quality Control and Quality Assurance" policies under the " Andrology Laboratory: Quality Control Procedures for Techniques Performed in Andrology Lab" section revealed "Control specimens are tested in the same manner and by the same personnel as patient specimens. Each work day that a semen analysis is done, a pH strip (7-8) is tested against 7.0 and 8.0 control solutions. Results are recorded on the pH Strip QC Log in the General Lab and Andrology QC Log book. The results are reviewed during the quarterly QC/QA review." 2. Review of the January 2025 through September 2025 "pH Strip QC Log" and patient test records revealed the laboratory did not perform the pH QC for the following three (3) days and patients: January 13, 2025: Patient Met27956 February 14, 2025: Patient Met27964 August 8, 2025: Patient BR3542 3. In interview on October 14, 2025 at 11:20 am, the Laboratory Director confirmed the pH QC was not performed for the identified three (3) dates and patients. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory policies, quality control records, patient test reports, test menu, and interview with personnel, the laboratory failed to perform quality control (QC) every eight (8) hours of patient testing for manual sperm counts for two (2) of twenty six (26) patients reviewed. Findings: 1. Review of the laboratory's "Quality Control and Quality Assurance Manual" under the "Andrology Laboratory" section revealed "Control specimens are tested in the same manner and by the same personnel as patient specimens. Techniques requiring QC include semen analysis and insemination preparation. Each workday that a semen analysis is performed one high- count and one low-count aliquot is analyzed by each technician who is performing semen analysis that day. The laboratory director monitors this data during her routine quarterly QC review and makes recommendations as appropriate." 2. Review of the laboratory's test menu revealed the laboratory utilizes Accubeads as their quality control for semen analysis testing. 3. Review of the laboratory's January 2025 through September 2025 quality control (QC) and patient test records revealed the laboratory did not perform at least one level of QC every eight (8) hours for the following two (2) of twenty six (26) patients: January 13, 2025: Patient Met27956 August 8, 2025: Patient BR3542 4. In interview on October 14, 2025 at 11:20 am, the Laboratory Director confirmed the sperm count QC was not performed for the identified two (2) dates and patients. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of