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 observation of the laboratory, review of laboratory test menu, laboratory policy, laboratory personnel records, and staff interviews, the laboratory failed to follow the established procedure for testing personnel competency assessment when the laboratory did not perform all six required elements for the ABO type, Rhesus type (Rh), Antibody screen, Antibody Identification, Compatibility, white blood cell (WBC) and platelet (PLT) analytes, and did not assess competency for hemoglobin S solubility (Sickle Cell Screening) analyte, or tube method testing for the ABO type, Rh type, Compatibility, Antibody Screen, or Antibody Identification for one of three testing personnel that performed patient testing in 2024. The findings include: 1. Observation of the laboratory on 02/27/2025 at 10:00 a.m. revealed Ortho Clinical Diagnostics system and reagents used for performing ABO type, Rh type, Antibody Screen, Antibody Identification, and Compatibility testing (primary method: gel /backup method: tube) patient testing and the Sysmex XE2100D (serial A1621) for the WBC and PLT analytes used to determine donor eligibility. 2. A review of the laboratory's test menu revealed that the laboratory performed Sickle Cell Screening with the Streck SICKLEDEX kit. 3. A review of the laboratory policy titled "QRS-B5 Competency Assessment" in the section "Technical Services Staff Assessment Requirements" revealed six elements that were required to assess competency: (1) Direct observation of routine patient test performance, (2) Monitoring the recording and reporting of test results, (3) Review of intermediate test results or worksheets, quality control records, proficiency testing records, and preventative maintenance records, (4) Direct observation of performance of instrument maintenance and 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 -- function checks, (5) Assessment of test performance through blind samples, proficiency testing, and (6) Assessment of problem-solving skills. 4. A review of the laboratory's personnel records revealed the following: Testing person Two annual competency assessment completed on 12/30/2024: "N/A" for the following: Direct Observation of routine task performance- Blood Grouping and Antibody Screen, Crossmatches, Quality Control and Maintenance, Antibody identification. Review of records- Sysmex and Pathogen Reduced (PR) Platelet Process The annual competency assessment did not include the tube (backup) method for the ABO type, Rh type, Antibody Screen, Antibody Identification, Compatibility testing analytes or the Sickle Cell Screening analyte performed with the Sickledex kit. 5. An interview with laboratory general supervisor three on 02/27/25 at 11:45 a.m. confirmed the survey findings. Word Key: N/A- Not Applicable D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedures, lack of documentation, and staff interviews, the laboratory failed to compare the ABO, Rhesus (Rh) type, Antibody Screen, Antibody Identification, and Compatibility testing analytes performed using the Ortho Gel method (primary) to the Ortho tube method (backup) twice annually in 2024. The findings include: 1. Observation of the laboratory on 02/27/2025 at 10:00 a.m. revealed Ortho Clinical Diagnostics system and reagents and equipment used for performing transfusion medicine testing (ABO type, Rh type, Antibody Screen, Antibody Identification, and Compatibility testing. During the observation, the laboratory liaison stated that the primary method for the laboratory was the Ortho Gel method, and the laboratory used the Ortho tube method as a backup method. 2. A review of the laboratory procedure manual revealed procedures for the Ortho Gel and tube methods. 3. Documentation for twice a year comparison for the ABO type, Rh type, Antibody Screen, Antibody Identification, and Compatibility testing between the Gel (primary) methods and the tube (backup) method for 2024 was not available on the date of the survey (02/27/2025.) 4. An interview with the laboratory general supervisor, three, and laboratory liaison on 02/27 /2025 at 1:00 p.m. confirmed the survey findings. -- 2 of 2 --