Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals, lack of documentation, and interview with the Technical Consultant (TC) #2, the laboratory failed to establish a competency assessment procedure to assess 3 of 3 Technical Supervisors (TS), and 2 of 2 Technical Consultants(TC) for their supervisory responsibilities from 1/6/2025 to the day of survey. Findings Include: 1. On the day of survey, 3/27/2025, at 10:30 am, the laboratory could not provide a competency assessment procedure to assess the competency for 3 of 3 TS (CMS 209 Personnel #2, #3, #4) and 2 of 2 TC (CMS 209 personnel #5 and #7) from 1/6/2025 to 3/27/2025. 2. The TC #2 could not provide competency assessment documentation for 3of 3 TS or 2 of 2 TC from 1/6/2025 to 3 /27/2025. 3. TheTC #2 confirmed the findings above on 3/27/2025, at 12:30 pm. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: A. Based on observation in the laboratory, review of laboratory temperature records, and interview with the Technical Consultant(TC) #2, the laboratory failed to monitor daily temperatures to ensure reagent stability and proper operating conditions from 1/6 /2025 to 3/27/2025 for 1 of 1 refrigerator/freezers and 1 of 1 room temperature thermometer on the days the laboratory was closed. Findings include: 1. On the day of survey, 3/27/2025, at 11:30 am, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory: - Sysmex XN-L Check. Storage requirements 2C to 8C. - Sysmex Cell Pack. Storage requirements 2C to 35C. - Sysmex LyserCell. Storage requirements 15C to 35C. - Sysmex Cell Clean. Storage requirements 1C to 30C. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document refrigerator/freezer/room temperatures for 24 of 81 days from 1/6/2025 to 3/27/2025. 3. The TC #2 confirmed the findings above on 3/27/2025 at 12:45 pm. B. Based on review of procedures, review of laboratory temperature records, and interview with the Technical Consultant (TC) #2, the laboratory failed to ensure frozen specimens for reference lab testing were stored at proper temperatures for 1 of 1 freezer from 1/6/2025 to 3/27/2025. Findings include: 1. On the day of survey, 3/27/2025 at 9:30 am, when reviewing the laboratory procedure titled "Abnormal Results Reporting", part #8 stated "tests to be sent to the reference lab for testing are stored in the freezer at -15C. to -30C". 2. Review of temperature logs revealed a posted acceptable freezer temperature of 68F to 77F(-15C to 3C). The laboratory failed to ensure proper freezer temperatures for send out Quest specimens for 81 of 81 days. 3. The TC#2 confirmed the findings above on 3/27/2025 at 12:45 pm. -- 2 of 2 --