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 July 11, 2019, at approximately 12:00 pm that the laboratory failed to have procedures for; 1) Quality control and calibration criteria; 2) Batch testing; 3) Explanation of the Indeterminate test result. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of procedures and an interview with the technical supervisor and testing person, the director failed to ensure that the laboratory's QA program was maintained as part of the laboratory's overall quality systems program. Refer to D 5401 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 --