Novant Health New Garden Medical Associates

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment plan, review of 2019 and 2020 quality assessment records, and interview with the TC (technical consultant) 6/9/21, the laboratory director failed to ensure that the quality assessment plan was followed to assure the quality of laboratory services provided. The laboratory's "Quality Assessment Plan" states "... V. PROCESSES / PROGRAM COMPONENTS Quality Assessment Activities 1. Quality Assessment Activities, also known as monitors, will be completed by the testing personnel throughout each year in moderately and highly complex laboratories. 2. Each activity (monitor) will include instructions for completion and reporting. 3. All laboratory personnel must be familiar with and follow the written quality assessment plan and safety policies. ..." The plan includes monitors for each quarter (1st, 2nd, 3rd, 4th) and an "Annual General Laboratory Assessment". The monitors for each quarter include different items to monitor the preanalytic, analytic, and postanalytic portions of the testing process. Review of 2019 and 2020 quality assessment records revealed: 1. For 2019, the 1st Quarter "General Laboratory Assessment" and a "Year End Summary" monitor were the only records available. Both were signed by the TC 5/10/19, but neither was signed by the laboratory director. It was unclear whether the Year End Summary monitor was for 2018 or 2019. 2. For 2020, the "Annual General Laboratory Assessment" signed by the TC 12/30/20 was the only record available. The comments section of the "Annual 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 -- General Laboratory Assessment" included the following notation by the TC "QA monitors will be reeducated and reinstated for 2021". During interview at approximately 11:20 a.m., the TC confirmed that quality assessment monitors were not completed by testing personnel as required in the quality assessment plan. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the TC (technical consultant) 8/9/18, the laboratory failed to follow established policies for evaluating the competency of testing personnel. Review of personnel records for TP (testing personnel) #2 revealed TP #2 was trained in December 2017. Review of the semiannual competency documentation for TP #2 revealed the documentation was incomplete and did not include evaluation for the performance of instrument maintenance and for problem-solving skills. In addition, the documentation was not signed and dated by the technical consultant. During interview at approximately 11:15 a.m., the TC confirmed that the competency evaluation was incomplete. She stated that TP #2 had not completed all the requirements needed to complete the evaluation. 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: 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 personnel records 8/9/18 and the deficiency cited at D6065, the laboratory failed to verify that 1 of 2 testing personnel (TP #2) met the minimum education requirements to perform moderate complexity testing. 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 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 review of personnel records and interview with the TC (technical consultant) 8/9/18, the laboratory failed to verify that 1 of 2 testing personnel (TP #2) met the minimum education requirements for performing moderate complexity testing. Review of personnel records for TP #2 revealed there were no education credentials available at the time of the survey. During interview at approximately 11: 10 a.m., the TC stated that TP #2 had been asked to bring in her education records, and the TC confirmed the records were not available for review. -- 2 of 2 --