Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel (TP) records available on 1/20/22, the CMS (Centers for Medicare and Medicaid Services) 209 form and interview with the technical consultant/laboratory director (TC/LD), the laboratory director had not ensured that TP#4 and TP#5 as listed on the CMS 209 personnel form had received the appropriate documented training prior to performing moderate complexity testing in the clinic laboratory. Findings Include: 1. Based on lack of training documentation available the day of survey, TP #4 had no documented training prior to performing moderate testing on patients beginning on 1/19/21. 2. Based on lack of training documentation available the day of survey, TP #5 had no documented training prior to performing moderate testing on patients beginning on 12/20/21. 3. Interview with the TC/LD at 12:30 p.m. on 1/20/22 confirmed that no initial training for TP #4 or TP #5 had been documented for all moderate testing performed in the laboratory. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the 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 -- 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 testing personnel records from 2/5/20 through 1/20/22, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the laboratory director (LD)/ technical consultant(TC) , the technical consultant (TC) failed to evaluate and document the performance semiannually of TP #1, TP #2, TP #3, and TP #4 who were responsible for performing moderate testing during the first year of employment. Findings include: 1. Review of the personnel records for TP #1 through TP #4 revealed there was no semiannual laboratory evaluation/competency documented as performed by the technical consultant during the first year of testing patients using moderate complexity testing. a. TP #1 began employment in February 2020 as a laboratory testing personnel. b. TP #2 began employment on 11/11/20 as a laboratory testing personnel. c. TP #3 began employment on 11/30/19 as a laboratory testing personnel. d. TP #4 began employment on 1/19/21 as a laboratory testing personnel. 2. An interview with the TC /LD at 1:00 p.m. on 1/20/22 confirmed no semiannual evaluation/competency was performed on TP #1, TP#2, TP #3 or TP #4. 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 laboratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with laboratory director (LD)/technical consultant (TC) as listed on the CMS 209 form, the technical consultant failed to evaluate annually and document the performance of TP #1, TP #2, TP #3, TP #4 and TP #6 who are responsible for performing moderate laboratory testing. Findings include: 1. Based on laboratory personnel records available for review on the day of survey, no annual evaluations or competencies had been performed by the technical consultant since the last survey on 2/5/20. This included no evaluations or competencies for the following: a. TP #1 for 2021. b. TP #2 for 2021 c. TP #3 for 2020 and 2021 d. TP #4 for 2022 e. TP #6 for 2020 and 2021 2. Interview with TC/LD confirmed no annual evaluation/competencies for TP #1, TP #2, TP #3, TP #4 or TP #6 had been documented as performed by the technical consultant. -- 2 of 2 --