Summary:
Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of procedures and interview with the office manager, the laboratory director (LD) failed to ensure a procedure was established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency. Findings: 1. Review of procedures showed no procedure available to monitor individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency. 2. Interview with the office manager on June 7, 2023 at 1:30 PM confirmed the LD failed to ensure a procedure was established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain 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 -- their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of procedures, and training documentation from 2021 and to date June 7, 2023 and interview with the office manager, the technical supervisor (TS) failed to evaluate testing personnel (TP) and assuring that the staff maintain their comptetency to perform moderate complex tests for four of four laboratory testing personnel. Findings: 1. Lack of 2021 and to date June 7, 2023 training documents showed no documentation of training for testing personnel as follows: TP #2 annual competencies for 2021 and 2022 TP #3 hire date June 2022 - initial and semiannual competencies TP#4 hire date January 2023 - initial competency TP #5 hire date 2021 - initial, semiannual and annual competencies 2. Interview with the office manager on June 7, 2023 at 1:30 PM confirmed the TS failed to evaluate TP and assuring that the staff maintain their comptetency to perform moderate complex tests. -- 2 of 2 --