Total Healthcare

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