Northwest Arkansas Pathology At Mercy Med Ctr

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 upon observation, review of temperature records, lack of documentation, and interview the laboratory failed to monitor the temperature and humidity on each day of operation. . Findings follow: A) During a tour of the laboratory on 7/23/26 at 10: 35am a Tissue-Tek Cryo3 Flex Cryostat with operating temperature and humidity requirements was observed in the laboratory. B) A review of the laboratory's temperature records revealed that no room temperatures or humidities were recorded for the laboratory for 83 of 83 days of operation in the year of 2026. C) The Tissue- Tek Cryo3 Flex Cryostat OperatingManual (Sakura, Models 6200, 6201, 6202, 6203, 6204, 6205) states "The ambient operating temperature range of the instrument is 29- 35C." and "The ambient operaing humidity range is 15% to 85% relative humidity. D) Upon request, the laboratory could not present the temperature and humidity records for 83 of 83 days of operation in 2026. E) In an interview on 7/23/26 at 10:36am, the laboratory staff member (#2 on the entrance/exit conference sign in sheet) confirmed that temperature and humidity records were not available. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (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 laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 7/23/26 at 10:34am, one (of one) containers of "Cancer Diagnostics Inc Tissue Marking Dye Orange" (REF 0727-6, Lot 24155, expiration 2026-6-30, GTIN: 00850048122178) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 7/23/26 at 10:34am, one (of one) containers of "Cancer Diagnostics Inc 3-Stain Dip Kit Solution B" (REF #FX1089, Lot 2416210, expiration 2026-6-20)was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 7/23/26 at 10:36am laboraotry personnel (#2 listed on the entrance/exit conference sign in sheet) confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies 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: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory had reagents available for use when they had exceeded their expiration date. Survey findings include: A. During a tour of the laboratory, at 9:50 a.m. on 4/21/2023, the surveyor observed one CDIS Tissue Marking Dye Green (lot # 20161) in the cabinet above the staining area. The dye had an expiration date of 06/30/2022. B. During a tour of the laboratory, at 9:50 a.m. on 4 /21/2023, the surveyor observed one CDIS Tissue Marking Dye Black (lot # 20349) in the cabinet above the staining area. The dye had an expiration date of 12/31/2022. C. In an interview at 9:50 a.m. on 04/21/2023, laboratory personnel #3 (as listed on the entrance/exit conference sheet) confirmed the expired reagents were available for use when they had exceeded their expiration date. 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 --