Summary:
Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on document review and interview, the laboratory director failed to: 1) evaluate the laboratory's proficiency testing (PT) performance for two of three analytes (sperm viability and sperm morphology) during 2018 and 2019 (refer to D6091); 2) establish a