Southwest Ctr For Reproductive Health,

Summary Statement of Deficiencies D0000 An onsite survey conducted 03/19/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, quality control (QC) records, and confirmed in interview, the laboratory failed to retain one of two quality control instructions for use (IFU) that documented the acceptable concentration for two levels, a high and low count vial, of "Accu Beads" used in daily quality control for manual sperm counts. The findings included: 1. Review of the laboratory policy titled "Quality Control For Semen Analysis", section "III Procedure" stated the following: "15. Check the concentration you calculated with the concentration range listed for each vial of Accu Beads (This is shown both on the box and on the vial of Accu Beads). If your count is out of range, you must re load the Hemocytometer." 2. Review of the laboratory QC records titled "Daily QC ACCU - Beads & SA Procedures" included the following lot numbers of QC in use: August 26, 2022 - November 31, 2023 QC Beads In-Use: Low Count Vial Lot # 211410181, High Count Vial Lot # 211712351, Vials Expiration: December 2023 Surveyor asked for the IFU, or a photocopy of the box, for the low- count vial lot # 211410181 and the high-count vial lot # 211712351, that included the acceptable concentration range used to assess the acceptability of documented QC and none was provided. 3. In an interview on 3/19/2024 at 15:15, in the laboratory, testing personnel (TP) 1 confirmed that the laboratory failed to retain the documentation of the QC lot acceptable concentration range. 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 -- 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, patient test records, and staff interview, it was revealed the laboratory failed to have documentation of twice annual accuracy assessment for sperm morphology. The findings included: 1. Review of the laboratory's proficiency testing records for 2019 and 2020 ( three events per year) found the laboratory did not participate in a proficiency testing program that included sperm morphology. 2. Documentation of another means to verify the accuracy of results for sperm morphology was requested but not provided. 3. Interview of Testing Person one listed on the CMS report 209 conducted on February 24, 2021 at 11:05 AM confirmed that the laboratory did not have a means of verifying results of the sperm morphology at least twice each year D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the competency evaluation form and interview, the technical consultant failed to ensure all components of the competency evaluation were included in the competency assessment and on the evaluation form. Findings follow. 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 -- Review of the competency evaluation for testing personnel #1 for the 6-month competency evaluation did not include direct observationfor a semen analysis. The competency evaluation form listed "8. Semen Analysis, 9. Semen Analysis for ART" but did not include the direct observation of the semen analysis test, including patient preparation, specimen handling, processing, testing, and intermediate worksheets showing sperm count calculations. Interview with testing personnel #1 on the CMS form 209, on February 24, 2021 at 11:10 AM in the office acknowledged they could modify the evaluation form to reflect that. -- 2 of 2 --