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), Temperature Records and interview with the Office Manager (OM), the laboratory failed to follow the PM to check the temperature in the room where Histopathology slides were read and stored from 5/23/17 to the date of the survey. The findings include: 1. The PM stated Temperature was checked weekly but the laboratory did not document the temperature or define an acceptable temperature range. 2. The Control Company Traceable Thermometer found in the room was not working at the time of the survey and was due for calibration on 2/27/15. 3. The OM confirmed on 5/1/19 at 10:10 am that the PM wasn't followed. 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 --