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 personnel records, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, lack of documentation of initial training, and interview with the current technical consultant (TC) at 2:25 p.m. on 5/23 /2023, the laboratory director failed to ensure that one of one initial trainings due during the survey period was performed. Testing Personnel (TP) #3 had no documented initial training prior to performing moderate complexity testing. Findings include: 1. Review of training records for the laboratory from 10/7/2021 through 5/23 /2023 revealed that no initial training was documented for TP #3 by the former technical consultant (one of one initial trainings due during this time period). 2. TP #3 began performing moderate complexity testing on 12/1/2021. Training for moderate complexity testing was performed and documented by the new/current technical consultant on 12/30/2022. TP #3 performed moderate complexity testing without documented training for 13 months. 3. The technical consultant confirmed in an interview at 2:25 p.m. on 5/23/2023 that the laboratory director failed to ensure that TP #3 received appropriate training to perform moderate complexity testing prior to testing patient specimens. 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 -- 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 testing personnel (TP) records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the current technical consultant (TC) at 2:15 p.m. on 5/23/2023, the former TC failed to evaluate and document the competencies of TP #1, TP #3 and TP #4 responsible for performing moderate complexity testing for 3 of 3 semiannual competencies due during the time period reviewed. Findings include: 1. The surveyor reviewed personnel records for the laboratory from 10/7/2021 through 5/23/2023. 2. Three of three semiannual competencies due during this time period were not documented as performed (TP #1, TP #3, TP #4). 3. The current technical consultant confirmed in an interview at 2:15 p.m. on 5/23/2023 that no semiannual competencies for TP #1, TP #3, and TP #4 had been documented as performed for the time period reviewed. 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 for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the current technical consultant (TC) at 2:00 p.m. on 5/23/2023, the former TC failed to evaluate annually and document the competency of TP #2 who is responsible for performing moderate complexity testing for 1 of 4 annual competencies due during the time period reviewed. Findings include: 1. The surveyor reviewed personnel records for the laboratory from 10/7/2021 through 5/23/2023. 2. One of four annual competencies due during this time period were not documented as performed (TP #2). 3. The new/current technical consultant confirmed in an interview at 2:00 p.m. on 5/23 /2023 that no annual competency for TP #2 had been documented as performed for 2021. -- 2 of 2 --