Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Center for Reproductive Medicine of Alabama on August 8, 2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing results for Sperm Analysis and interview with Testing Person #2, the laboratory failed to score at least 80% for Sperm Count and Viability in the specialty of Hematology in 1out of 2 testing events reviewed for 2018. Findings Included: Review of AAB proficiency testing results found the 2nd testing event in 2018 had a score of 50 % for Sperm Count and 50 % for Sperm Viability. During an interview on 08/08/19 at 11:30 AM, Testing Person #2 confirmed the proficiency testing failures. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --