Summary:
Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the laboratory director failed to specify in writing the responsibilities and duties of each consultant and supervisor and failed to identify which examination and procedures each testing personnel is authorized to perform for 6 of 6 technical supervisors (TS), 1 of 1 technical consultants (TC), and greater than 20 testing personnel (TP) working in 4 laboratory departments. Findings include: 1. The laboratory had employees performing patient testing in 4 different locations in the hospital (main laboratory, respiratory therapy {RT}, emergency room {ER}, and histology). 2. The laboratory manager identified, during the survey, 6 technical supervisors over different specialties in the main laboratory, and 1 technical consultant over moderately complex testing performed in RT on the ABL 800. The laboratory personnel form listed 2 employees performing histology grossing, as well as greater than 10 employees performing moderately complex testing in the ER on the Istat. 3. The laboratory lacked documentation of which duties were delegated to each TS in the main laboratory as well as which duties were delegated to the RT TC. 4. The laboratory lacked documentation of which tests each testing person was authorized to perform. 5. The laboratory manager stated on 01/30/2019 at approximately 4:00 p.m. that employees in each testing location were authorized to perform specific tests based 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 -- on their job description, but the laboratory lacked documentation of what testing personnel in different areas were authorized to perform. -- 2 of 2 --