Upper Chesapeake Hematology/Oncology Svcs Llc

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant (TC), the laboratory failed to label the staining jars with the identity and expiration date of the contents contained within. Findings: 1. The laboratory performed a Wright stain on peripheral blood smears. 2. It was observed that the three staining jars were not labeled with the identity and expiration dates for the staining reagents contained within. 3. During the survey on 04/16/2025 at 9:45 AM, the TC confirmed that the staining reagent jars were not labeled with the identity and expiration dates for the contents contained within. 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 review of the procedure, review of maintenance logs, and interview with the technical consultant (TC), the laboratory failed to perform monthly maintenance activities for the hematology analyzer for three of 19 months reviewed. Findings: 1. 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 -- The laboratory performed hematology testing using a Beckman Coulter DxH 520 analyzer. 2. The testing procedure does not mention monthly maintenance activities, but the monthly "DxH 520 Maintenance/Quality Control Log" (maintenance log) listed two monthly activities: 1) Perform Bleach Cycle and 2) Clean WBC Bath Filter. 3. The maintenance logs for 08/2023 through 02/2025 were reviewed (19 months). 4. The monthly maintenance activities were not documented as completed in three of the 19 months reviewed (07/2024, 04/2024, and 09/2023. 5. During the survey on 04/16 /2025 at 1:00 PM, the TC confirmed that monthly maintenance activities were not documented in three of 19 months. -- 2 of 2 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the competency reviews for the high complexity testing personnel and interview with the point of care (POC) coordinator, the technical supervisor did not ensure that the high complexity testing personnel maintained their competency by performing the hematology slide review twice a year as required. Findings: 1. Review of the Summary sheet dated "01-01-2018 - 01-01-2019" for "Upper Chesapeake Health" showed that 3 of the 4 high complexity testing personnel had performed only one of the two required competency reviews for 2018. 2. During the survey on 04/17 /19 at POC coordinator confirmed that 3 of the 4 high complexity testing personnel had performed only one of the two required competency reviews for 2018. both 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 --