Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 25, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 testing personnel (TP) document review and staff interview the laboratory director (LD) failed to ensure TP receive appropriate training for the type and complexity of services offered as required. Findings include: 1. TP document review revealed no 2019 initial training documents were available at the time of survey for Staff #3 (CMS 209). 2. An interview with the Technical Consultant in the breakroom on January 25, 2021 at approximately 2:30 P.M. confirmed the lack of aforementioned 2019 initial training for Staff #3 (CMS 209). 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 3 -- 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 testing personnel (TP) document review and staff interview, the Technical Consultant (TC) failed to evaluate and document the performance of TP for moderate complexity testing semiannually the first year of testing as required. Findings include: 1. TP competency document review revealed the TC failed to perform semiannual competencies in 2019 for Staff #3 (CMS 209). 2. An interview with the TC in the breakroom on January 25, 2021 at approximately 2:30 P.M. confirmed the lack of 2019 semiannual competency performed for Staff #3(CMS 209). 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 testing personnel (TP) document review and staff interview the technical consultant (TC) failed to evaluate and document the performance of moderate complexity TP annually as required. Findings include: 1. TP competency document review revealed the TC failed to perform a 2020 annual competency for Staff #3 (CMS 209) and Staff #4 (CMS 209). 2. An interview with the Technical Consultant in the breakroom on January 25, 2021 at approximately 2:30 P.M. confirmed the lack of an 2020 annual competency performance for the aforementioned TP. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on testing personnel (TP ) document review and staff interview, the laboratory failed to employ qualified TP to perform moderate complexity testing as required. Findings include: For details refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have -- 2 of 3 -- successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on testing personnel (TP ) document review and staff interview, the laboratory failed to employ qualified TP to perform moderate complexity testing as required. Findings include: 1. TP document review revealed Staff #3 (CMS 209) was unqualified to perform moderate complexity testing due to lack of education documentation available at the time of survey. 2. An interview with the Technical Consultant in the breakroom on January 25, 2021, at approximately 11:00 A.M. confirmed the lack of education documentation for the aforementioned TP. This is a REPEAT DEFICIENCY. -- 3 of 3 --