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 surveyor review of the Procedure Manual (PM), Quality Control (QC) records and interview with the Office Manger (OM), the laboratory failed to follow the QC new lot verification procedure to ensure QC was within the acceptable ranges before it was put into use for analytes performed on the Qiagen Fast Pack analyzer from 2/11/16 to the date of the survey. The findings include: 1. The laboratory did not verify QC lots as follows: a. Lot 16050001 and 1605002 - expiration date 6/21/17 b. Lot 1606030 - expiration date 9/9/17 c. Lot 1704036 - expiration date 10/15/18 2. The OM confirmed on 4/26/18 at 1:20 pm that the laboratory did not follow the PM. D5781