Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of competency assessment records, laboratory procedures, and interview with the laboratory director, the laboratory does not have a process to evaluate the competency of the technical consultant. Findings include: 1. Review of laboratory competency assessment records and procedures showed no documentation that the competency of the technical consultant has been evaluated in meeting the position requirements listed in Subpart M. 2. Interview with the laboratory director on October 11, 2019 at 10:45 AM confirmed that the laboratory does not have a procedure to evaluate the competency of the technical consultant in meeting the position responsibilities. 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 surveyor review of laboratory records, competency assessment records, and interview with the laboratory director, the technical consultant failed to evaluate the competency of one of three testing personnel. Findings include: 1. Review of 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 -- laboratory records show testing personnel A started working in this laboratory as a "float" technologist in June 2018. 2. Review of competency assessment records for testing personnel A, show competency assessment records from SSM Health St. Mary's Hospital-Janesville and SSM Health Dean Medical Group-Evansville laboratories. No competency assessment records were completed in 2018 for the non- waived hematology, urine microscopy, potassium hydroxide (KOH), and wet prep testing performed in this laboratory. 3. Interview with the laboratory director on October 11, 2019 at 10:15 AM confirmed the technical consultant did not assess and document the competency for one of three testing personnel on the testing performed specific for this laboratory. This is a repeat deficiency previously cited June 20, 2013 and September 27, 2017. -- 2 of 2 --