Beacon Cancer Care, Pllc

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 a direct observation and an interview with the laboratory lead on 8/11/2025, the laboratory failed to discontinue the use of expired total protein reagents on June 1, 2025. The findings include: 1. A direct observation of the laboratory's chemistry testing reagents on 8/11/2025 identified that the laboratory failed to discontinue the use of 8 bottles of Alfa Wassermann total protein reagent, lot F4845, expiration 5/31 /2025 prior to the expiration. 2. An interview with the laboratory lead on 8/11/2025 at 4:28 pm confirmed the failure to discontinue the use of the expired reagents. 3. The laboratory reports performing 9,818 total protein tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the laboratory maintenance logs and an interview with the laboratory lead on 8/11/2025, the laboratory failed to perform maintenance on the Ace Axcel chemistry instrument as required by the instrument manufacturer, Alfa Wassermann, in 2024 and 2025. The findings include: 1. A review of the Ace Axcel maintenance logs identified that the laboratory failed to have documentation of 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 -- weekly maintenance as required by the manufacturer for 2024 and 2025. The laboratory failed to document inspecting the air filter/cleaning if required, cleaning of the exterior surfaces, the ISE module, the ISE sample port and touch plate assembly for the following: May 2024 4 of 4 weeks July 2024 3 of 4 weeks October 4 of 4 weeks December 2024 1 of 5 weeks January 2025 3 of 4 weeks March 2025 2 of 4 weeks April 2025 1 of 4 weeks May 2025 1 of 4 weeks June 2025 1 of 5 weeks 2. A review of the Ace Axcel maintenance logs identified that the laboratory failed to have documentation of monthly maintenance as required by the manufacturer for 2024. The laboratory failed to document rinsing probe and fluid lines with 10% bleach, cleaning bottle cap and cap connectors, performing sample delay, optical calibration and table offset, and clean reference housing for the following months: May 2024 October 2024 3. An interview with the laboratory lead on 8/11/2025 at 3:22 pm confirmed that the laboratory failed to document maintenance as required by the instrument manufacturer in 2024 and 2025. 4. The laboratory reports performing 137,516 chemistry tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the American Proficiency Institute (API), the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessments and an interview with the laboratory supervisor on 7/13 /2023, the laboratory failed to test PT samples with the regular patient workload by personnel who regularly perform the laboratory testing. The findings include: 1. A review of the CMS 209 and competency assessments identified four (4) testing personnel performing complete blood count (CBC) testing on the Sysmex XN430 analyzer. 2. A review of PT records from API for hematology for 2022 events one, two and three and 2023 event one identified that one (1) of four (4) testing personnel performed all PT events for 2022 and 2023. The laboratory failed to have three (3) of four (4) personnel who regularly perform CBC testing perform PT testing in 2022 and 2023. 3. An interview with the laboratory supervisor on 7/13/2023 at 2:10 pm confirmed that one (1) of four (4) testing personnel performed all the CBC PT testing for 2022 and 2023. 4. The laboratory reports performing 12,000 CBC tests annually. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and an interview with the laboratory manager on 2/10/2022, the Laboratory Director failed to approve, sign and date the laboratory policies and procedures. The findings include: 1. A record review of the laboratory policies and procedures binder identified that Laboratory Director failed to approve, sign and date 20 of 20 policies and procedures. 2. An interview with the laboratory manager on 2/10/2022 at 8:35 am confirmed that the Laboratory Director failed to approve the laboratory's policies and procedures. 3. The laboratory reports performing 27,500 hematology tests annually. 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 --