Galen East Laboratory

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 of the laboratory and staff interviews, the laboratory failed to ensure that it did not use nine of nine lots of tissue marking dyes beyond their expiration dates in histopathology patient testing in 2024 and 2025. The findings include: 1. Observation of the laboratory on 07/30/2025 at 09:20 a.m. revealed two grossing stations used for gross examination of tissue specimens. Both stations contained marking dyes used for marking tissue. The following dyes had expired: Grossing station 1: Color Lot No Exp Date Orange 22349 12.31.24 Green 23062 03.31.25 Yellow Illegible Illegible Red 22203 10.21.24 Grossing station 2: Color Lot No Exp Date Green 22322 11.30.24 Red 22306 11.30.24 Yellow 22308 11.30.24 Orange 22214 08.31.24 Violet 22276 10.31.24 The histology technician discarded the dyes on the day of the survey. 3. An interview with the histology technician on 07/30 /2025 at 9:20 a.m. confirmed that the laboratory used the observed tissue marking dyes for patient testing after expiration. . 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 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer's operating manuals, environmental records request, and interview with the lead histotech, the laboratory failed to monitor room humidity for the Leica EG 1150 H Paraffin Embedding Station, Leica EG 1150 C Cold Plate, and Sakura Tissue-Tek SCA Coverslipper in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on April 13, 2023 at 9:30 a.m. revealed the Leica EG 1150 H Paraffin Embedding Station (serial #038837689), Leica EG 1150 C Cold Plate (serial #038838038), and Sakura Tissue-Tek SCA Coverslipper (serial #90060107) in use for processing tissues removed during surgical procedures in preparation for histopathology procedures. 2. Review of the manufacturer's operating manuals revealed the following: - Leica EG 1150 H Paraffin Embedding Station environmental conditions require a maximum relative humidity of 60%. - Leica EG 1150 C Cold Plate environmental conditions require a maximum relative humidity of 80%. - Sakura Tissue-Tek SCA Coverslipper environmental conditions require an operating humidity range 30% - 70%. 3. Request of environmental records revealed no records for monitoring room humidity available for surveyor review. 4. Interview on April 13, 2023, at approximately 11:45 a.m. with the lead histotech confirmed the laboratory failed to monitor room humidity for the use of the Leica EG 1150 H Paraffin Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Embedding Station, Leica EG 1150 C Cold Plate, and Sakura Tissue-Tek SCA Coverslipper in 2021, 2022, and 2023. -- 2 of 2 --