Summary:
Summary Statement of Deficiencies D0000 A Validation survey was conducted at Northern Louisiana Medical Center Respiratory-CLIA ID # 19D0701211 on May 13, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard 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 record review and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory did not have detailed instructions for: a) Downtime Policies and Procedures for when test systems are inoperable. 2. In interview on May 13, 2019 at 13:24 pm, Personnel 4 confirmed the policy and procedure manual was incomplete. D5781