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 review of policies/procedures and an interview with the laboratory technical supervisor and testing person, the laboratory failed to have a complete policy /procedure manual. Findings Include: The technical supervisor and testing person confirmed on February 28, 2018, at approximately 1:00 pm that the laboratory failed to have procedures for; 1) transportation of specimens transferred between the laboratory and the other seven (7) offices owned by the owner of the laboratory; 2) turnaround time (TAT) for specimens; 3) How often the column used to separate the solvents will need to be changed; 4) a tracking log for those specimens coming from the other offices belonging to the owner of the laboratory. 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 --