Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted May 31, 2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation and confirmed in an interview the laboratory failed to ensure 22 of 29 expired blood collection tubes, Greiner bio-one K2EDTA and BD Vacutainer Serum, were not available for use in patient testing on May 31, 2023. The findings included: 1. In a tour of the laboratory on 5/31/2023 at 12:10 hours the surveyor observed the following 22 blood collection tubes available for patient collection and testing in the phlebotomy area: 9 Greiner bio-one, 4mL K2EDTA, lot B22013U5, collection tubes with an expiration date of 5/16/2023 13 BD Vacutainer, 10 mL Serum, lot 1123114, collection tubes with an expiration date of 4/30/2023 2. In an interview on 5/31/2023 at 12:15 hours, in the laboratory, testing person 4 confirmed that the above blood collection tubes were available for potential patient testing and had not been removed from the laboratory. 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 --