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Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration records and an interview with the Technical Consultant (TC), the Laboratory failed to perform calibration for the Sysmex XP-300 Hematology analyzer according to the manufacturer's specification. This was noted for one of the two possible calibrations in 2024. The findings include: 1. A review of the Hematology calibration records revealed the Sysmex XP-300 was calibrated on 02-20-2024 but no other calibration was performed and documented for 2024. The next calibration was performed with preventive maintenance on 01-23- 2025. 2. An interview with TC on 03-19-2026 at 1:05 PM revealed an email from BIOMEDICAL ENGINEERING dated 12-05-2024 was sent to inform her that the Sysmex user manual procedure intervals did not include a 6- month or 12-month intervals. Surveyor also noted on the same email that effective 2025, a service vendor will be onsite at 12-month interval to address the necessary parts replacement of the Sysmex XP-300. 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 Hematology maintenance records, a review of the Sysmex XP-300 quick guide, and an interview with the Technical Consultant, the Laboratory failed to document weekly maintenance on the Sysmex XP-300 Hematology analyzer as per the manufacturer's requirements for 22 months reviewed from 2022 to 2024. The findings include: 1. A review of the Sysmex XP-300 Hematology analyzer records revealed no documentation of weekly maintenance for the following months: a. June through December 2022. b. January through December 2023. c. January through March 2024. 2. A further review of the Sysmex XP-300 quick guide revealed on page 9, "Weekly Maintenance: Clean the SRV tray." 3. During an interview on 4/16 /2024, at 12:01 PM, the Technical Consultant confirmed the above findings. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on reviews of proficiency testing (PT) records and an interview with the Technical Consultant, the surveyor determined the laboratory failed implement procedures to ensure proficiency testing failures were effectively investigated, with

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2017 - 2019 CAP (College of American Pathologists) Proficiency Testing records and an interview with Technical Consultant #2, the laboratory failed to document