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 Anti D QC(quality control) records, laboratory temperature records, proficiency testing records and quarterly QA (quality assurance) checklist from 6/1/16 through the day of survey 4/5/18, the laboratory records mentioned were documented as reviewed by an individual who does not meet the qualification requirements for technical consultant found in 493.1411 of this subpart. The following records were not reviewed by the technical consultant listed on the CMS 209 Personnel Form: 1. Refrigerator and room temperature records from 1/4/17 through 4 /5/18 2. Quarterly QA Checklist - 4/3/16 through 4/4/18 3. Proficiency testing event results- 2nd and 3rd events of 2016: 1st, 2nd, 3rd events of 2017 4. Quality control /patient daily testing log (includes positive and negative control results) D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records since last survey 6/1/16 and confirmation with staff, the technical consultant failed to evaluate annually 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 -- document the performance of testing personnel #1, #2 and #3 (as listed on the Centers for Medicare & Medicaid 209 form) for 2016 and 2017. The annual evaluations available the day of survey were performed by personnel other than the qualified technical consultant listed on the CMS 209 form. -- 2 of 2 --