Rgal Pathology Laboratory

Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of documentation, and interview with the Pathology Manager (PM), the laboratory failed to establish and maintain a policy to ensure all complaints and problems reported to the laboratory were documented and investigated when needed for 2 of 2 months from 11/1/2025 to 12/29/2025. Findings include: 1. On the day of complaint investigation, 12/29/2025 at 11:00 am, review of the laboratory Quality Management policy stated, "8.c. Occurrence reports may also be used to document patient or employee complaints and follow up regarding laboratory policies, procedures, or actions that may impact quality or safety." 2. The laboratory could not provide documentation to ensure all complaints and problems reported to the laboratory were documented and investigated as needed for 2 of 2 months from 11/1/2025 to 12/29/2025. 3. The PM confirmed the finding above on 12 /29/2025 at 12:30 pm. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically 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 -- transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Pathology Manager (PM), the laboratory failed to have an adequate system in place to ensure test results were accurately and reliably sent from the point of data entry to final report destination for 2 of 2 months from 11/1/2025 to 12/29/2025. Findings include: 1. On the day of the complaint investigation, 12/29/2025 at 12:00 pm, the laboratory failed to provide records for the periodic checks performed to verify that patien test results were accurately transmitted between the LIS (Vital Axis) and the EMR (eClinicalWorks) for 2 of 2 months from 11/1/2025 to 12/29/2025. 2. The PM confirmed the findings above on 12/29/2025 at 12:30 pm. -- 2 of 2 --

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 Pathology Lab Manager (PLM), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 3 of 3 Olympus BX46 and 1 of 1 Olympus BX45 Microscopes used to perform histopathology slide examinations from 06/29/2023 to the date of survey. Findings include: 1. The operating environment listed in the instruction manual for the Olympus biological microscope states: "microscope should be kept at temperatures between 5C-40C/41F- 104F, with a maximum humidity of 80%." 2. On the date of the survey, 04/03/2025 at 10:00 am, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for 3 of 3 Olympus BX46 and 1 of 1 Olympus BX45 microscope used to perform histopathology slide examinations from 06/29/2023 to 04/03/2025. 3. The laboratory performed 242,000 (CMS-116 estimated annual volume) histopathology slide examinations in 2024. 4. The PLM confirmed the findings above on 04/03/2025 at 10: 00 am. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES 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 -- CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report (CMS-209), competency assessment (CA) records and interview with Pathology Lab Manager (PLM), the Technical Supervisor (TS) failed to evaluate the competency of 16 of 24 testing personnel (TP) that performed histopathology testing in 2024. Findings include: 1. On the day of survey, 04/03/2025 at 9:45 am, review of the laboratory's CA records revealed the TS failed to perform competency assessment on the following TP that performed macroscopic histopathology slide examinations in 2024: - TP8 - TP9 - TP10 - TP11 - TP12 - TP13 - TP14 - TP15 - TP16 - TP17 - TP18 - TP19 - TP20 - TP 22 - TP23 - TP24 2. The PLM confirmed the findings above on 04/03/2025 at 9:45 am. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a lack of competency records and interview with the Laboratory Director (LD) and Testing Personnel (TP) #2 (CMS 209), the Laboratory failed to establish and follow written policies and procedures to assess 2 of 3 Technical Supervisors (TS) (CMS 209, TS #2, TS #3) and 2 of 3 General Supervisors (GS) (CMS 209, GS #2, GS #3) for their supervisorial responsibilities for the Histopathology examination from 07 /14/2021 to the day of the survey. Findings include: 1. On the day of survey, 06/29 /2023 at 11:30 AM, a review of the competency record revealed that the laboratory failed to establish a competency assessments procedure for 2 of 3 TS and 2 of 3 GS for their supervisorial responsibilities for Histopathology examination performed from 2021 to 2023. 2. The laboratory filed to provide competency assessment documentation for 2 of 3 TS and 2 of 3 GS for 2021 and 2022. 3. TP #2 confirmed the findings above on 06/29/2023 around 12:50 PM. D5783