Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/07/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the office manager during an exit conference performed at the conclusion of the survey. 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 interview with the histology technician, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 12/07/2023 at 10:05 am, identified the following expired supplies that appeared to be available for use: (a) Tissue Marking Dyes: i. Avantik Red - lot #112131 with an expiration date of 12/31/2022 ii. Avantik Black - lot #112649 with an expiration date of 12/31/2022 iii. Avantik Green - lot #112722 with an expiration date of 12/31/2022 iv. Avantik Yellow - lot #111915 with an expiration date of 12/31/2022 v. CDI's Blue - lot #7275 with an expiration date of 10 /2019 (b) One gallon bottle of Avantik Eosin Working Solution lot #245-04 with an expiration date of 10/04/2023 (2) Interview with the histology technician on 12/07 /2023 at 11:35 am confirmed the expired supplies were available for use. 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 --