Advanced Reproductive Specialists Llc

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on February 10, 2020. Advanced Reproductive Specialists was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document competency assessments on 1 out of 1 testing personnel in 2018 and 2019 (A). Findings: Review of the competency records showed that there was no documentation of competencies on Testing Personnel A for 2018 and 2019. During an interview on 2 /10/20 at 2:02 PM, the Medical Technologist stated they didn't do a competency evaluation on Testing Personnel A in 2018 and 2019. 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) 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's Semen Analysis Report failed to list the location where the semen morphological evaluation was performed for 3 out of 3 (#1, 2, 3) patient reports examined. Findings: Review of the Semen Analysis Report for patients #1, #2 and #3 showed that the address of the location where the semen morphological evaluation wase performed was not listed. During an interview on 2/10/20 at 2:32 PM, the Medical Technologist stated that the Semen Analysis Report did not have the address where the semen morphological evaluation was performed. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have a written policy to access employee training and competency (D5209), failed to achieve satisfactory performance for Sperm Motility Forward Progress for 2017 (D5217), failed to establish and follow a written quality assessment policy (D5291), failed to establish and follow a written policy for proficiency testing (D5291), and failed to maintain complete proficiency testing records (D5291). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a written policy to access employee training and competency. Findings: Review of the laboratory procedure manual did not show a policy on training and evaluating 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 3 -- competency of employees. During an interview on 2/08/18 at 11:45 AM, the Medical Technologist stated the lab did not have a policy on training and competency. 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 record review and staff interview, the laboratory failed to achieve satisfactory performance for Sperm Motility Forward Progress for 2017. Findings: The laboratory is enrolled in proficiency testing for semen analysis with the American Association of Bioanalysts (AAB) in Embryology, Andrology and Fetal. Review of the AAB proficiency testing records showed that the laboratory received a score of 50% for sperm motility forward progression for the 1st event of 2017, and failed to perform the proficiency testing for the 2nd event in 2017. Review of the laboratory's