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 a lack of procedures and an interview with the laboratory director, the laboratory failed to have a procedure for equipment maintenance. Findings Include: The laboratory director confirmed on March 7, 2019, at approximately 10:45 am that the laboratory failed to have a procedure available indicating how often maintenance will be performed on the microscope. 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 --