Geisinger Oral Pathology

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 on review of laboratory records, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Nikon Eclipse Ci-L Plus Microscope used to perform histopathology slide examinations from 12/20/2023 to the date of survey. Findings include: 1. The operating conditions listed in the instruction manual for the Nikon Eclipse Ci-L Plus microscope states: "temperature: 0 C to 40C, maximum relative humidity: 60%." 2. On the date of the survey, 08/14/2025 at 1:25 pm, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for the 1 of 1 Nikon Eclipse Ci - L Plus microscope (s/n 71173) used to perform histopathology slide examinations from 12/20/2023 to 08/14/2025. 3. The laboratory performed 17,979 histopathology slide examinations from 12/20/2023 to 08/14/2025. 4. The LD confirmed the findings above on 08/14/2025 at 1:36 pm. 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 D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a lack of documentation and interview with the senior director anatomic pathology (CDAP) and laboratory director (LD), the laboratory failed to provide documentation of adequate slide processing for immunohistochemical (IHC) staining performed offsite from 08/31/2023 to the day of survey. Findings Include: 1. The technical component for oral pathology slide examinations performed at Geisinger Medical Center (39D0189233). 2. On the day of the survey, 12/20/2023 at 12:00 pm, the laboratory could not provide documentation of positive and negative reactivity for IHC prepared at the offsite location from 08/31/2023 to the day of the survey. 3. The laboratory performed 1727 oral pathology slide examinations from 8/31/2023 to the day of survey. 4. The CADP and LD confirmed the finding above on 12/20/2023 at 11: 45 am. 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 --