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 results) from the last survey on 5/4/17 through the day of current survey 4/11/18, and confirmation with staff at 11:30 am, the technical consultant listed on the CMS (Centers For Medicare & Medicaid) 209 Personnel form failed to document review of the laboratory records. On the day of survey, the laboratory records 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, freezer and room temperature records from 6/1/17 through 2/28/18 2. Medonic M Series QC (quality control), calibration - 5/1/17 through 2/28/18 3. Proficiency testing event results- 1st, 2nd and 3rd events of 2017 4. RA- Sure Vue RF Quality control/patient daily testing log (includes positive and negative control results) from 5/18/17 through 2/28/18 5. Clinitek Advantus QC and maintenance - 6/1/17 through 1/31/18 6. Beckman Counter Access 2 QC, calibrations and maintenance - 11/29/16 through 4/9/18 7. Biosite Triage Meter Plus QC, calibration verification - 6/15/17 through 2/5/18 8. Dimension Xpand QC, maintenance, calibration - 6/1/17 through 1/31/18 D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 -- performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records since the last survey and the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, the technical consultant failed to evaluate and document the performance of Testing Personnel #1, responsible for moderate complexity testing, at least semiannually during the first year this individual tested patient specimens. 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 and confirmation with staff, the technical consultant failed to evaluate and document the performance of testing personnel #1 (as listed on the Centers for Medicare & Medicaid 209 form) for 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 --