Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), observation of two Auto Stainer (AS) and interview with the Office Manager (OM), the laboratory failed to label staining solutions used in the AS from 2/24/2017 to the date of the survey. The finding includes: 1. None of the 24 reagent wells were labled. 2 The OM comfirmed on 1/31/19 at 1:00 pm that all the reagnet wells were not labeled. 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 --