Maryville Treatment Center

Summary Statement of Deficiencies 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 the 2021/2022/2023 performance evaluations and interview with testing personnel (TP) #2, the technical consultant (TC), whom is also the laboratory director, failed to evaluate and document performance evaluations at least semiannually during the first year for two of two testing personnel. Findings: 1. Review of 2021/2022/2023 performance evaluations showed semiannual performance evaluations were not performed by the TC for TP #2 and TP #6. 2. Interview with TP #2 on September 7, 2023 at 09:30 AM confirmed the TC did not evaluate and document the semiannual performance evaluations. 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 review of 2021/2022/2023 performance evaluations and interview with the testing personnel (TP) #2, the technical consultant (TC), whom is also the laboratory director, failed to evaluate and document the annual performance evaluation for 7 of 7 testing personnel (TP). Findings: 1. Review of 2021/2022/2023 performance 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 -- evaluations showed the TC failed to evaluate and document the annual performance evaluation for the following: Testing Personnel #1, #4, #7, #8, #9, and #10 for years 2021, 2022, and 2023 Testing Personnel #2 for year 2023 2. Interview with the TP #2 on September 7, 2023 at 09:30 AM confirmed the TC failed to evaluate and document the annual performance evaluations. -- 2 of 2 --

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with testing personnel #14 the laboratory director failed to ensure an approved procedure manual is available to all personnel responsible for any aspect of the testing process. Findings: 1. Review of procedure manual showed no approved procedure for Cardiac Status Troponin . 2. Review of procedure manual showed no approved procedure for competency assessment. 3. Review of procedure manual showed no approved procedure for performing proficiency testing. 4. Interview with testing personnel #14 on April 9, 2019 at 10:30 AM confirmed the laboratory director failed to ensure an approved procedure manual is available to all personnel. 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: 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 -- Based on review of competencies for 2017, 2018 and interview with testing personnel #14 the technical consultant failed to evaluate and document competency semiannually during the first year for one of eight testing personnel. Findings: 1. Review of competencies showed no evaluation or documentation of testing personnel #3 semiannually during the first year. 2. Interview with testing personnel #14 on April 9, 2019 at 10:30 AM confirmed the technical consultant failed to evaluate and document competency semiannually during the first year for testing personnel #3. 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 review of annual competencies for 2017, 2018 and interview with testing personnel #14 the technical consultant failed to evaluate and document competency for one of fifteen testing personnel in 2017. Findings: 1. Review of annual competencies in 2017 showed no evaluation and documentation of competency for testing personnel #8. 2. Interview with testing personnel #14 on April 9, 2019 at 10:30 AM confirmed the technical consultant failed to evaluate and document annual competency for testing personnel #8. -- 2 of 2 --