Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/30/2021 found that the PATHOLOGY ON THE GO clinical laboratory was not 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 observation and staff interview, the laboratory failed to remove 1 bottle of Gram Stain from the laboratory after the expiration date on 4/30/2020. Findings include: 1-Observation taken while on tour on 03/30/2021 at 9:30 AM revealed that the laboratory had the following expired reagent: - 1 bottle of Gram Stain with lot number 8262944 expired since 04/30/2020. During an interview on 03/30/2021 at 9: 30 am with testing personnel A, she confirmed the existence of the expired reagents. 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 --