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 review of laboratory policies and procedures and personnel records, and interview with the technical consultant, the laboratory failed to establish and follow written policies and procedures to assess consultant competency for 2017 and 2018. Findings include: 1. Policies and procedures lacked information on the processes used to assess Technical Consultant competency. 2. The personnel records for technical consultant lacked documentation of a competency assessment for 2017 and 2018. 3. At 10:30 AM on 03/19/2019, the Technical Consultant confirmed the surveyor's findings. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of policies and procedures, laboratory records, personnel records, and interview with the testing person 3 (TP2); the technical consultant failed to be responsible for identifying training needs and assuring that each individual performing 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 -- testing received regular in service training and education appropriate for the type and complexity of the laboratory services performed. Findings include: 1. The laboratory's written procedures gives instructions as follows: "Laboratory Director or designate (Trainer) performs the orientation training. The Trainer initials each item as the employee demonstrated competency in the performance of the individual tasks." 2. Review of laboratory records revealed that there were person listed on Laboratory Personnel Report - CLIA (Form 209) for the following positions: a. Laboratory Director who is also listed as Clinical Consultant b. Technical Consultant c. Three persons (TP1, TP2, and TP3) listed as moderate complexity testing personnel. 3. Review of personnel records revealed that the technical consultant was not responsible for training 3 of 3 testing personnel listed on Form 209. Records show that TP3 was the person who initialed documentation showing she was the trainer of TP2. 4. At 11:00 AM on 03/19/19, TP2 told the surveyor that she was trained by TP. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, personnel records and interview with the technical consultant; the technical consultant failed to be responsible for evaluating and documenting the performance of individuals responsible for testing, at least semiannually during the first year the individual tests patient's specimens. 1. The laboratory's written procedures gives instructions as follows: "The New employee is re-evaluated against the Internal Competency Evaluation form, approximately six months after completion of their Orientation Training. 2. Review of laboratory records revealed that in 2019, there were 3 new testing personnel listed on Laboratory Personnel Report - CLIA (Form 209) that w 3. Review of personnel records revealed that there was no documenting to show that the technical consultant performed semiannual competency assessments for 3 of 3 new testing personnel that are listed on Form 209. 4. At 10:30 AM on 03/19/19, the technical consultant confirmed the surveyor's findings. -- 2 of 2 --