Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of post vasectomy sperm count test accuracy and interview with testing personnel #1 the laboratory failed to perform test accuracy for one of two testing events in 2016. Findings: 1. Review of "post vas sperm count lab competency log" showed the laboratory did not perform test accuracy two times in 2016. 2. Interview with testing personnel #1 on March 12, 2017 at 10:00 AM confirmed the laboratory failed to perform test accuracy two times in 2016 for "post vas sperm count." 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 --