Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a lack of available documentation and confirmed during interview with the Technical Supervisor #2 (TS#2), the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. Findings: 1. Upon review of the laboratory procedures, the current Laboratory Director (LD) did not approve, sign, and date the laboratory procedure/policy for: 16 of 16 procedures in the laboratory at time of survey. 2. The following procedures were not signed by the current LD: a. G001-02/493.1242 IML Quality Policy b. G002-02/493.1231 Patient Confidentiality Policy c. G003-02/493.1232 Sample Identification d. G004-02/493. 1233 Complaint Investigation e. G005-02/493.1234 Customer Complaint, Communications & Error Handling f. G006-02/493.1235 Personnel Competency g. G007-01/493/1242 Specimen Handling, Test Ordering & Reporting h. G008-01/493. 1242 Reference Laboratory Services i. G009-01B/493.1236 Evaluation of Proficiency Testing j. T002-02,03/493.1251 11-Dehydro Thromboxane B2 k. T-004/493.1251 CRE2 Urinary Creatine Test Procedure l. M002-02/393.1254 Instrument Maintenance and function Checks m. G010-01/493.2328