Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed on December 1, 2020 at St. Tammany Parish Hospital Toxicology, CLIA ID # 19D2176483. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to have complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include a written policy for the following: a) Twice a year instrument comparison of test results for the Waters analyzers for Toxicology testing; to include but not limited to acceptability criteria 2. In interview on December 1, 2020 at 3:02 pm, the Quality Assurance Coordinator confirmed the laboratory did not have a written policy for instrument comparison of test results for Toxicology testing. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D5401. -- 2 of 2 --