Beacon Medical Group Ireland Rd

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. Preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Mohs micrographic surgery (Mohs) quality control (QC) slides for eight (PT#1 through PT #8) of ten patients reviewed from January 2024 to January 2025. Findings include: 1. Mohs QC slides were not retained for eight of ten patient records (PT#1 through PT #8) for the following: a. PT #1 had no QC slide. Mohs procedure completed on 1-11- 2024. b. PT #2 had no QC slide. Mohs procedure completed on 2-12-2024. c. PT #3 had no QC slide. Mohs procedure completed on 3-07-2024. d. PT #4 had no QC slide. Mohs procedure completed on 4-11-2024. e. PT #5 had no QC slide. Mohs procedure completed on 9-16-2024. f. PT #6 had no QC slide. Mohs procedure completed on 11- 06-2024. g. PT #7 had no QC slide. Mohs procedure completed on 12-03-2024. h. PT #8 had no QC slide. Mohs procedure completed on 1-09-2025. 2. During an interview on 4-22-2025 at 2:46 pm, SP-01(Laboratory Director) confirmed the slide quality was not documented." 3. Review of document titled, "Mohs/Dermatology Quality Control Procedure" signed but not dated by the laboratory director under procedure #6, "Storage of Materials" stated, "slides must be maintained for 10 years. Slides are kept for a minimum of 1year on site." 4. The annual test volume for histopathology is 1500. 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 -- D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document staining quality acceptability for microscopic surgery (Mohs) in the specialty of histopathology for eight of (PT #1 through PT#8) ten patients reviewed from January 2024 to January 2025. Findings include: 1. Patient record review indicated the following patients had Mohs slides read by the laboratory director without quality control documentation. Patients Slide Examination Date PT # 1 1-11-2024 PT #2 2-12- 2024 PT# 3 3-07-2024 PT#4 4-11-2024 PT#5 9-16-2024 PT#6 11-06-2024 PT#7 12- 03-2024 PT#8 1-09-2025 2. Review of document titled, "Mohs/Dermatology Quality Control Procedure" signed but not dated by the laboratory director under procedure #1, states, "On a daily basis the quality of staining will be documented on the Mohs maintenance checklist." 3. In an interview on 4-22-2025 at 2:46pm, SP-01(Laboratory Director) confirmed the slide quality was not documented. 4. The annual test volume for Histopathology is 1500. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documentation and interview, the laboratory failed to perform twice annual verification of accuracy in one of one subspeciality Histopathology for Mohs Surgery (Mohs) and for two (PT1 and PT2) of seven patients reviewed in 2022. Findings include: 1. Review of the "Enclosure I Methodology Testing List", signed by the laboratory director on 7/13/23, indicated the "Proficiency Program" for histopathology/Mohs slides as "Sample Exchange". 2. Review of proficiency testing (PT) documents indicated one verification of accuracy was successfully performed for the first half of 2022 for Histopathology (Mohs). 3.On 7/24/2023 at 1:45pm, upon request for the "sample exchange" documents for the second half of 2022, SP2 (Histology Technician) verified that the facility is unable to locate documentation of a second slide exchange in 2022. SP2 further indicated a second slide exchange was performed, but the documentation was misplaced. 5. Review of patient files indicated the following patients had slides reviewed without twice annual verification being performed in 2022: Patient Date of Testing PT1 8/1/22 PT2 10/6/22 6. The laboratory was unable to provide the second slide exchange for 2022 within seven days of the survey with additional communication with the laboratory via email 7/28/2023 and phone call 8/3/2023. 7. Total histopathology annual test volume is 1424. 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 --