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: Based on review of laboratory records (including quality control, calibrations, temperatures, maintenance and proficiency testing results, preventive maintenance records and interview with staff at 1:00 pm on the day of survey, 10/17/18, the following records had not been documented as reviewed by the technical consultant: 1. Temperature logs (interview room, donor area, supply rooms) from 6/12/18 through 10/18/18 2. Refractometer controls (KOVA Refractrol low and high) from 6/12/18 through 10/18/18 3. General maintenance records from 6/12/18 through 10/18/18 4. Calibration verification (linearity) from 6/12/18 through 10/18/18 5. System monitoring report (quarterly performance) from 8/18 through 10/18/18 6. Proficiency testing results for the 3rd event of 2018 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --