Summary:
Summary Statement of Deficiencies D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: I. Based on review of the temperature records and interview with the technical consultant, the technical consultant did not ensure that the testing personnel were documenting the correct temperature on the PM (evening) worksheets. Findings: 1. The PM temperature worksheets for 2017 and 2018 were reviewed. 2. The second column on the worksheet requires the testing person to document the "Lab Refrig PM (34-36F)." The temperatures documented for 2017 through March 2018 were documented as a single digit, e.g., 3, 4, 5 or 6 and were not within the defined reference range of 34-36. 3. The third column on the worksheet requires the testing person to document the "Lab Freezer PM (0 to -4F)." The temperatures documented for 2017 through March 2018 were documented as double digits, e.g., 17, 18, 19, 20, 21, 22 or 23 and were not within the defined reference range of 0 to 4. 4. During the survey on 04/23/17 at 11:30 AM the technical consultant confirmed that the testing personnel on the evening (PM) shift were not documenting the refrigerator and freezer temperatures using the required temperature reference ranges. II. Based on review of the temperature records and interview with the technical consultant, the technical consultant did not ensure that the testing personnel were documenting