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 observation of reagents in the laboratory and interview with testing personnel, the labels on two of two stain pour-off bottles did not include the expiration dates of the stains. Findings include: 1. Observation of reagents in the laboratory on June 27, 2022 at 10:30 AM revealed two pour-off bottles of stains labeled eosin and hematoxylin that did not include the expiration dates of the stains. 2. Interview with testing personnel (staff A) at 10:30 AM on June 27, 2022 revealed testing personnel transferred stain from large containers to intermediate storage bottles to allow easy filling of containers on the linear stain line. Further interview confirmed testing personnel had not labeled the storage bottles with the expiration date of the eosin or hematoxylin stains. 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 --