Summary:
Summary Statement of Deficiencies 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: During an onsite recertification survey on 11/08/2018, based on the laboratory procedure manual, lack of documentation and testing personnel interview, the laboratory failed to ensure that testing personnel were evaluated annually after the first year of testing patient specimens for 2 of 2 testing personnel (employees 1 and 2 of CMS 209). Findings include: 1. The laboratory listed 2 testing personnel on the CMS-209 on the day of the survey. 2. Documentation of an annual training and evaluation for the year 2017 was unavailable for review on the day of the survey for 2 of 2 testing personnel (employees 1 and 2 of CMS 209). 3. Testing personnel confirmed during an onsite interview that the laboratory had failed to ensure that testing personnel were evaluated at least annually after the first year of testing patient specimens. 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 --