Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 22 and 23, 2022. Laboratory Corporation of America Clinical Laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. 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 observation and interview with the Laboratory Manager, the laboratory failed to properly label a plastic container of blue liquid in the hematology department. Findings include: 1. During the laboratory tour at 8:15 a.m. on 9/23/2022, a plastic container of blue liquid was observed in the hematology area, having only a date written on the label. 2. During interview with the Laboratory Manager on 9/23 /2022 at 11:00 a.m., it was confirmed the plastic container of blue liquid was used for Wright Stains and did not have a label to include the identity, preparation date and expiration date. D5781