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 personnel records review (year 2024-2025) and laboratory general supervisor interview on September 5, 2025 at 9:30 A.M., it was determined that the laboratory failed to established competence evaluation of the following personnel: the technical supervisor, technical consultant and general supervisor. The findings include: 1. The personnel records review showed that the laboratory did not performed competence evaluation of the following personnel: the technical supervisor, technical consultant and general supervisor. 2. . The laboratory general supervisor confirmed on September 5, 2025 at 9:30 A.M. that the laboratory failed to established competence evaluations for technical supervisor, technical consultant and general supervisor. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; 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: Based on personnel records, personnel competence written policies review and laboratory general supervisor interview on September 5, 2025, at 10:00 AM, it was determined that the laboratory director failed to established the competency evaluation of the technical supervisor, technical consultant and laboratory general supervisor. Refer to D5209. -- 2 of 2 --