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 reviews of personnel and proficiency testing (PT) records, and an interview with Testing Personnel #1, the laboratory failed to implement policies and procedures to ensure competency in Urine Sediment Examination after two PT failures in 2022. The findings include: 1. A review of MLE (Medical Laboratory Evaluation) PT records revealed the laboratory failed two out of three surveys in 2022 in the sub- specialty of Urine Sediment Examination. There was no documentation of remedial actions for the failures. (Refer to D5221.) The surveys were performed by two different testing personnel. 2. A review of personnel records revealed no indication of how the competency assessments was performed for microscopic examinations. 3. During an interview on 7/25/2023 at 1:40 PM, Testing Personnel #1 confirming the above findings. . 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 MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) records, and an interview with Testing Personnel #1, the laboratory failed to perform and document remedial actions for failing scores on two out of three 2022 surveys in 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 -- the sub-specialty of Urine Sediment Examination. The findings include: 1. A review of the MLE PT records revealed the following failing scores in the sub-specialty of Urine Sediment Examination: a) 2022-Event M1: 0% b) 2022-Event M3: 50% 2. The Review sheets for these surveys revealed the laboratory had documented no