Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the surveyor review of the Procedure Manual and interview with the Technical Supervisor (TS), the Laboratory failed to establish a procedure for validating Andrology testing from 12/27/22 to 11/22/24. The TS confirmed on 11/19 /2024 at 11:00am that the laboratory failed to have the aforementioned procedure. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on the lack of Performance Specifications (SP) records and interview with the Techincal Supervisor (TS), the Laboratory Director (LD) failed to ensure that PS were adequate to perform Andrology tests from 12/27/22 to the 11/19/24. The TS confirmed on 11/19/24 at 11:15 am that SP were not adequate. 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 --